B.Pharm - UofM - CBCS - Scheme and Syllabus - PCI - 2019-20 - 27062019
B.Pharm - UofM - CBCS - Scheme and Syllabus - PCI - 2019-20 - 27062019
B.Pharm - UofM - CBCS - Scheme and Syllabus - PCI - 2019-20 - 27062019
for
CHOICE BASED CREDIT SYSTEM
for
Undergraduate Programme
(Bachelor of Pharmacy, B. Pharm.)
in
PHARMACY
Revised Course (Revised 2019)
from the academic year 2019-2020
1
COURSE OFSTUDY
The course of study for B. Pharm shall include Semester Wise Theory & Practical as given in
Table – I to VIII. The number of hours to be devoted to each theory, tutorial and practical
course in any semester shall not be less than that shown in Table – I toVIII.
2
Table-II: Course of study for semester II
3
Table-IV: Course of study for semester IV
4
Table-VI: Course of study for semester VI
5
Table-VIII: Course of study for semester VIII
6
#
Applicable ONLY for the students studied Mathematics / Physics / Chemistry at HSC and appearing for
Remedial Biology course.
7
Schemes for internal assessments and end semester examinations semester wise
Semester I
Internal Assessment End Semester Exams
Course Total
Name of the course Continuous Sessional Exams
code Total Marks Duration Marks
Mode Marks Duration
Human Anatomy and
BP101T 10 15 1 Hr 25 75 3 Hrs 100
Physiology I– Theory
Pharmaceutical Analysis I –
BP102T 10 15 1 Hr 25 75 3 Hrs 100
Theory
BP103T Pharmaceutics I – Theory 10 15 1 Hr 25 75 3 Hrs 100
Pharmaceutical Inorganic
BP104T 10 15 1 Hr 25 75 3 Hrs 100
Chemistry – Theory
Communication skills –
BP105T 5 10 1 Hr 15 35 1.5 Hrs 50
Theory *
BP106RBT Remedial Biology/ 5 10 1 Hr 15 35 1.5 Hrs 50
BP106RMT Mathematics – Theory*
Human Anatomy and
BP107P 5 10 4 Hrs 15 35 4 Hrs 50
Physiology – Practical
Pharmaceutical Analysis I –
BP108P Practical 5 10 4 Hrs 15 35 4 Hrs 50
BP109P Pharmaceutics I – Practical 5 10 4 Hrs 15 35 4 Hrs 50
Pharmaceutical Inorganic
BP110P 5 10 4 Hrs 15 35 4 Hrs 50
Chemistry – Practical
Communication skills –
BP111P 5 5 2 Hrs 10 15 2 Hrs 25
Practical*
Remedial Biology –
BP112RBP 5 5 2 Hrs 10 15 2 Hrs 25
Practical*
Total 70/75$/80# 115/125$/130# 23/24$/ 185/200$/210# 490/525$/ 31.5/33$/ 675/725$/
26#Hrs 540# 35# Hrs 750#
#
Applicable ONLY for the students studied Mathematics / Physics / Chemistry at HSC and appearing for Remedial Biology (RB)course.
$
Applicable ONLY for the students studied Physics / Chemistry / Botany / Zoology at HSC and appearing for Remedial Mathematics
(RM)course.
* Non-University Examination(NUE)
8
Semester II
9
Semester III
10
Semester IV
11
Semester V
12
Semester VI
13
Semester VII
End Semester
Internal Assessment
Course Exams Total
Name of the course
code Continuous Sessional Exams Marks
Marks Duration Total Marks Duration
Mode
Instrumental Methods of Analysis
BP701T 10 15 1 Hr 25 75 3 Hrs 100
– Theory
BP702T Industrial Pharmacy – Theory 10 15 1 Hr 25 75 3 Hrs 100
BP703T Pharmacy Practice – Theory 10 15 1 Hr 25 75 3 Hrs 100
Novel Drug Delivery System –
BP704T 10 15 1 Hr 25 75 3 Hrs 100
Theory
Instrumental Methods of Analysis
BP705 P 5 10 4 Hrs 15 35 4 Hrs 50
– Practical
BP706 PS Practice School* 25 - - 25 125 5 Hrs 150
Total 70 70 8Hrs 140 460 21 Hrs 600
* The subject experts at college level shall conductexaminations
14
Semester VIII
15
Total 40 60 4 Hrs 100 450 16 Hrs 550
16
SEMESTER I
17
BP101T HUMAN ANATOMY AND PHYSIOLOGY-I (Theory)3 L + 1T / Week
Scope: This subject is designed to impart fundamental knowledge on the structure
andfunctions of the various systems of the human body. It also helps in understanding
both homeostatic mechanisms. The subject provides the basic knowledge required to
understand the various disciplines of pharmacy.
Objectives: Upon completion of this course the student should be able to
1. Explain the gross morphology, structure and functions of various organs of the human
body.
2. Describe the various homeostatic mechanisms and their imbalances.
3. Identify the various tissues and organs of different systems of human body.
4. Perform the various experiments related to special senses and nervous system.
5. Appreciate coordinated working pattern of different organs of each system
Sr. Content Hours
No.
1 UNIT I 10
1.1 Introduction to human body 2
Definition and scope of anatomy and physiology, levels of structural
organization and body systems, basic life processes, homeostasis, basic
anatomical terminology
1.2 Cellular level of organization 4
Structure and functions of cell, transport across cell membrane, cell
division, cell junctions. General principles of cell communication,
intracellular signaling pathway activation by extracellular signal molecule,
Forms of intracellular signaling: a) Contact-dependent b) Paracrine c)
Synaptic d) Endocrine
1.3 Tissue level of organization 4
Classification of tissues, structure, location and functions of epithelial,
muscular and nervous and connective tissues
2 UNIT II 10
2.1 Integumentary system Structure and functions of skin 1
2.2 Skeletal system 6
Divisions of skeletal system, types of bone, salient features and functions
of bones of axial and appendicular skeletal system.
Organization of skeletal muscle, physiology of muscle contraction,
neuromuscular junction
2.3 Joints 3
Structural and functional classification, types of joints movements and its
18
articulation
3 UNIT III 10
3.1 Body fluids and blood 6
Body fluids, composition and functions of blood, hemopoeisis, formation
of hemoglobin, anemia, mechanisms of coagulation, blood grouping, Rh
factors, transfusion, its significance and disorders of blood, Reticulo
endothelial system.
3.2 Lymphatic system 4
Lymphatic organs and tissues, lymphatic vessels, lymph circulation and
functions of lymphatic system
4 UNIT IV 08
4.1 Peripheral nervous system: 3
Classification of peripheral nervous system: Structure and functions of
sympathetic and parasympathetic nervous system. Origin and functions of
spinal and cranial nerves.
4.2 Special senses 5
Structure and functions of eye, ear, nose and tongue and their disorders.
5 UNIT V 07
Cardiovascular system 4
Heart – anatomy of heart, blood circulation, blood vessels, structure and
functions of artery, vein and capillaries, elements of conduction system of
heart and hear beat, its regulation by autonomic nervous system, cardiac
output, cardiac cycle.
Regulation of blood pressure, pulse, electrocardiogram and disorders of 3
heart.
Total 45
19
6. Textbook of Human Histology by Inderbir Singh, Jaypee brother’s medical publishers,
New Delhi.
7. Textbook of Practical Physiology by C.L. Ghai, Jaypee brother’s medical publishers, New
Delhi.
8. Practical workbook of Human Physiology by K. Srinageswari and Rajeev Sharma, Jaypee
brother’s medical publishers, New Delhi.
Reference Books (Latest Editions)
1. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins Co,
Riverview, MI USA
2. Text book of Medical Physiology- Arthur C, Guyton and John. E. Hall. Miamisburg, OH,
U.S.A.
3. Human Physiology (vol 1 and 2) by Dr. C.C. Chatterrje ,Academic Publishers Kolkata
20
BP102T PHARMACEUTICAL ANALYSIS (Theory)3 L + 1T / Week
Scope: This course deals with the fundamentals of analytical chemistry and principles
ofelectrochemical analysis of drugs
Objectives: Upon completion of the course student shall be able to
1. understand the principles of volumetric and electro chemical analysis
2. carryout various volumetric and electrochemical titrations
3. develop analytical skills
21
4 UNIT IV 08
4.1 Redox titrations
Concepts of oxidation and reduction
4.2 Types of redox titrations (Principles and applications)
Cerimetry, Iodimetry, Iodometry, Bromatometry, Dichrometry,
Titration with potassium iodate
5 UNIT V - Electrochemical methods of analysis 07
5.1 Conductometry- Introduction, Conductivity cell, 2
Conductometrictitrations, applications.
5.2 Potentiometry - Electrochemical cell, construction and workingof 3
reference (Standard hydrogen, silver chloride electrode and calomel
electrode) and indicator electrodes (metal electrodes and glass
electrode), methods to determine end point of potentiometric titration
and applications.
5.3 Polarography - Principle, Ilkovic equation, construction and working of 2
dropping mercury electrode and rotating platinum electrode,
applications
Total 45
Recommended Books: (Latest Editions)
1. A.H. Beckett & J.B. Stenlake's, Practical Pharmaceutical Chemistry Vol I & II,
Stahlone Press of University of London
2. A.I. Vogel, Text Book of Quantitative Inorganic analysis
3. P. Gundu Rao, Inorganic Pharmaceutical Chemistry
4. Bentley and Driver's Textbook of Pharmaceutical Chemistry
5. John H. Kennedy, Analytical chemistry principles
6. Indian Pharmacopoeia.
22
BP103T PHARMACEUTICS- I (Theory)3 L + 1T / Week
Scope: This course is designed to impart a fundamental knowledge on the
preparatorypharmacy with arts and science of preparing the different conventional dosage
forms.
Objectives: Upon completion of this course the student should be able to:
1. Know the history of profession of pharmacy
2. Understand the basics of different dosage forms, pharmaceutical incompatibilities and
pharmaceutical calculations
3. Understand the professional way of handling the prescription
4. Preparation of various conventional dosage forms
23
Liniments and Lotions.
3.2 Biphasic liquids: 7
o Suspensions: Definition, advantages and disadvantages,
classifications,Preparation of suspensions; Flocculated and
Deflocculated suspension & stability problems and methods to
overcome.
o Emulsions: Definition, classification, emulsifying agent, test for the
identificationof type ofEmulsion, Methods of preparation & stability
problems and methods to overcome.
4 UNIT IV 08
4.1 Suppositories: Definition, types, advantages and disadvantages, types of 5
bases,methods of preparations. Displacement value & its calculations,
evaluation of suppositories.
4.2 Pharmaceutical incompatibilities: Definition, classification, physical, 3
chemicaland therapeutic incompatibilities with examples.
5 UNIT V 07
Semisolid dosage forms: Definitions, classification, mechanisms and
factorsinfluencing dermal penetration of drugs. Preparation of ointments,
pastes, creams and gels. Excipients used in semi solid dosage forms.
Evaluation of semi solid dosages forms
Total 45
Recommended Books (Latest edition)
1. H. C. Ansel et al., Pharmaceutical Dosage Form and Drug Delivery System, Lippincott
Williams and Walkins, New Delhi.
2. Carter S.J., Cooper and Gunn’s-Dispensing for Pharmaceutical Students, CBS publishers,
New Delhi.
3. M.E. Aulton, Pharmaceutics, The Science& Dosage Form Design, Churchill Livingstone,
Edinburgh.
4. Indian pharmacopoeia.
5. British pharmacopoeia.
6. Lachmann. Theory and Practice of Industrial Pharmacy,Lea& Febiger Publisher, The
University of Michigan.
7. Alfonso R. Gennaro Remington. The Science and Practice of Pharmacy, Lippincott
Williams, New Delhi.
8. Carter S.J., Cooper and Gunn’s. Tutorial Pharmacy, CBS Publications, New Delhi.
9. E.A. Rawlins, Bentley’s Text Book of Pharmaceutics, English Language Book Society,
Elsevier Health Sciences, USA.
10. Isaac Ghebre Sellassie: Pharmaceutical Pelletization Technology, Marcel Dekker, INC,
New York.
24
11. Dilip M. Parikh: Handbook of Pharmaceutical Granulation Technology, Marcel Dekker,
INC, New York.
12. Francoise Nieloud and Gilberte Marti-Mestres: Pharmaceutical Emulsions and
Suspensions, Marcel Dekker, INC, New York.
25
BP104T PHARMACEUTICAL INORGANIC CHEMISTRY (Theory)3 L + 1T / Week
Scope: This subject deals with the monographs of inorganic drugs and pharmaceuticals.
Objectives: Upon completion of course student shall be able to
1. know the sources of impurities and methods to determine the impurities in inorganic drugs
and pharmaceuticals
2. understand the medicinal and pharmaceutical importance of inorganic compounds
1 UNIT I 10
2.1 Acids, Bases and Buffers: Buffer equations and buffer capacity in 4
general,buffers in pharmaceutical systems, preparation, stability,
buffered isotonic solutions, measurements of tonicity, calculations and
methods of adjusting isotonicity.
2.2 Major extra and intracellular electrolytes: Functions of 4
majorphysiological ions, Electrolytes used in the replacement
therapy: Sodium chloride*, Potassium chloride, Calcium gluconate*
and Oral Rehydration Salt (ORS), Physiological acid base balance.
2.3 Dental products: Dentifrices, role of fluoride in the treatment of 2
dentalcaries, Desensitizing agents, Calcium carbonate, Sodium
fluoride, and Zinc eugenol cement.
3 UNIT III - Gastrointestinal agents 10
3.1 Acidifiers: Ammonium chloride* and Dil. HCl 1
3.2 Antacid: Ideal properties of antacids, combinations of antacids, 3
Sodium Bicarbonate*, Aluminum hydroxide gel, Magnesium
hydroxide mixture2
3.3 Cathartics: Magnesium sulphate, Sodium orthophosphate, Kaolin 2
andBentonite
26
3.4 Antimicrobials: Mechanism, classification, Potassium permanganate, 4
Boricacid, Hydrogen peroxide*, Chlorinated lime*, Iodine and its
preparations
4 UNIT IV - Miscellaneous compounds 08
4.1 Expectorants: Potassium iodide, Ammonium chloride*. 1
4.2 Emetics: Copper sulphate*, Sodium potassium tartarate 2
4.3 Haematinics: Ferrous sulphate*, Ferrous gluconate 2
4.4 Poison and Antidote: Sodium thiosulphate*, Activated charcoal, 2
Sodiumnitrite
4.5 Astringents: Zinc Sulphate, Potash Alum 1
5 UNIT V 07
Radiopharmaceuticals: Radio activity, Measurement of
radioactivity,Properties of α, β, γ radiations, Half life, radio isotopes
and study of radio isotopes - Sodium iodide I131, Storage conditions,
precautions & pharmaceutical application of radioactive substances.
Total 45
27
BP105T COMMUNICATION SKILLS (Theory) 2hours/week
Scope: This course will prepare the young pharmacy student to interact effectively
withdoctors, nurses, dentists, physiotherapists and other health workers. At the end of
this course the student will get the soft skills set to work cohesively with the team as a
team player and will add value to the pharmaceutical business.
Objectives: Upon completion of the course the student shall be able to
1. Understand the behavioural needs for a Pharmacist to function effectively in the areas of
pharmaceutical operation
2. Communicate effectively (Verbal and Non-Verbal)
3. Effectively manage the team as a team player
4. Develop interview skills
5. Develop Leadership qualities and essentials
28
to Use WrittenCommunication - Complexity of the Topic, Amount of
Discussion’ Required, Shades of Meaning, Formal Communication
3.3 Writing Effectively: Subject Lines, Put the Main Point First, Know 2
Your Audience,Organization of the Message
4 UNIT IV 5
4.1 Interview Skills: Purpose of an interview, Do’s and Dont’s of an 2
interview
4.2 Giving Presentations: Dealing with Fears, Planning your Presentation, 3
Structuring YourPresentation, Delivering Your Presentation,
Techniques of Delivery
5 UNIT V 4
Group Discussion: Introduction, Communication skills in group
discussion, Do’s andDont’s of group discussion
Total 30
29
BP106RBT REMEDIAL BIOLOGY (Theory) 2hours/week
Scope: To learn and understand the components of living world, structure and
functionalsystem of plant and animal kingdom.
Objectives: Upon completion of the course, the student shall be able to
1. know the classification and salient features of five kingdoms of life
2. understand the basic components of anatomy & physiology of plant
3. know understand the basic components of anatomy & physiology animal with special
reference to human
Sr. No. Content Hours
1 UNIT I 7
30
Exchange of gases, transport of gases and regulation of respiration
Respiratory volumes
3 UNIT III 7
3.1 Excretory products and their elimination 2
Modes of excretion
Human excretory system- structure and function
Urine formation
Rennin angiotensin system
3.2 Neural control and coordination 2
Definition and classification of nervous system
Structure of a neuron
Generation and conduction of nerve impulse
Structure of brain and spinal cord
Functions of cerebrum, cerebellum, hypothalamus and medulla
oblongata
3.3 Chemical coordination and regulation 2
Endocrine glands and their secretions
Functions of hormones secreted by endocrine glands
3.4 Human reproduction 1
Parts of female reproductive system
Parts of male reproductive system
Spermatogenesis and Oogenesis
Menstrual cycle
4 UNIT IV 5
4.1 Plants and mineral nutrition: 3
Essential mineral, macro and micronutrients
Nitrogen metabolism, Nitrogen cycle, biological nitrogen fixation
4.2 Photosynthesis 2
Autotrophic nutrition, photosynthesis, Photosynthetic pigments,
Factors affecting photosynthesis.
5 UNIT V 4
5.1 Plant respiration: Respiration, glycolysis, fermentation (anaerobic). 1
5.2 Plant growth and development 1
Phases and rate of plant growth, Condition of growth,Introduction to
plant growth regulators
5.3 Cell - The unit of life 1
Structure and functions of cell and cell organelles.Cell division
31
5.4 Tissues 1
Definition, types of tissues, location and functions.
Total 30
Text Books
1. Text book of Biology by S. B. Gokhale
2. A Text book of Biology by Dr. Thulajappa and Dr. Seetaram.
Reference Books
1. A Text book of Biology by B.V. Sreenivasa Naidu
2. A Text book of Biology by Naidu and Murthy
3. Botany for Degree students By A.C.Dutta.
4. Outlines of Zoology by M. Ekambaranatha ayyer and T. N. Ananthakrishnan.
5. A manual for pharmaceutical biology practical by S.B. Gokhale and C. K. Kokate
32
BP106RMT REMEDIAL MATHEMATICS (Theory) 2hours/week
Scope: This is an introductory course in mathematics. This subject deals with
theintroduction to Partial fraction, Logarithm, matrices and Determinant, Analytical
geometry, Calculus, differential equation and Laplace transform.
Objectives:Upon completion of the course the student shall be able to:
1. Know the theory and their application in Pharmacy
2. Solve the different types of problems by applying theory
3. Appreciate the important application of mathematics in Pharmacy
Sr. Content Hours
No.
1 UNIT I 6
1.1 Partial fraction
Introduction, Polynomial, Rational fractions, Proper and Improper
fractions, Partial fraction , Resolving into Partial fraction, Application of
Partial Fraction in Chemical Kinetics and Pharmacokinetics
1.2 Logarithms
Introduction, Definition, Theorems/Properties of logarithms, Common
logarithms, Characteristic and Mantissa, worked examples, application of
logarithm to solve pharmaceutical problems.
1.3 Function:
Real Valued function, Classification of real valued functions
2 UNIT II 6
Matrices and Determinant:
Introduction matrices, Types of matrices, Operation on matrices,
Transpose of a matrix, Matrix Multiplication, Determinants, Properties of
determinants , Product of determinants, Minors and co-Factors, Adjoint or
adjugate of a square matrix , Singular and non-singular matrices,
Inverse of a matrix, Solution of system of linear of equations using matrix
method, Cramer’s rule, Characteristic equation and roots of a square
matrix, Cayley–Hamilton theorem, Applicationof Matrices in solving
33
Pharmacokinetic equations
3 UNIT III 6
Calculus
Differentiation : Introductions, Derivative of a function, Derivative of a
constant, Derivative of a product of a constant and a function , Derivative
of the sum or difference of two functions, Derivative of the product of two
functions (product formula), Derivative of the quotient of two functions
(Quotient formula) – Without Proof, Derivative of xn w.r.tx,where n is any
rational number, Derivative of ex,, Derivative of loge x , Derivative
of ax,Derivative of trigonometric functions from first principles (without
Proof), Successive Differentiation, Conditions for a function to be a
maximum or a minimum at a point. Application
4 UNIT IV - Analytical Geometry 6
4.1 Introduction: Signs of the Coordinates, Distance formula,
4.2 Straight Line : Slope or gradient of a straight line, Conditions
forparallelism and perpendicularity of two lines, Slope of a line joining two
points, Slope – intercept form of a straight line
4.3 Integration: Introduction, Definition, Standard formulae, Rules of
integration , Method of substitution, Method of Partial fractions,
Integration by parts, definite integrals, application
5 UNIT V 6
5.1 Differential Equations : Some basic definitions, Order and
degree,Equations in separable form , Homogeneous equations, Linear
Differential equations, Exact equations, Application in
solvingPharmacokinetic equations
5.2 Laplace Transform : Introduction, Definition, Properties of
Laplacetransform, Laplace Transforms of elementary functions, Inverse
Laplace transforms, Laplace transform of derivatives, Application to solve
Linear differential equations, Application in solving Chemicalkinetics
and Pharmacokinetics equations
Total 30
Recommended Books (Latest Edition)
1. Differential Calculus by Shanthinarayan
2. Pharmaceutical Mathematics with application to Pharmacy by Panchaksharappa Gowda
D.H.
3. Integral Calculus by Shanthinarayan
4. Higher Engineering Mathematics by Dr.B.S.Grewal
34
BP107P HUMAN ANATOMY AND PHYSIOLOGY (Practical) 4 Hours/week
1. Study of compound microscope.
2. Microscopic study of epithelial and connective tissue
3. Microscopic study of muscular and nervous tissue
4. Identification of axial bones
5. Identification of appendicular bones
6. Introduction to hemocytometry.
7. Enumeration of white blood cell (WBC) count
8. Enumeration of total red blood corpuscles (RBC) count
9. Determination of bleeding time
10. Determination of clotting time
11. Estimation of hemoglobin content
12. Determination of blood group.
13. Determination of erythrocyte sedimentation rate (ESR).
14. Determination of heart rate and pulse rate.
15. Recording of blood pressure.
36
BP109P PHARMACEUTICSI (Practical) 4 Hours / week
1 .Syrups
a) Syrup IP’66
b) Compound syrup of Ferrous Phosphate BPC’68
2. Elixirs
a) Piperazine citrate elixir
b) Paracetamol pediatric elixir
3.Linctus
a) Terpin Hydrate Linctus IP’66
b) Iodine Throat Paint (Mandles Paint)
4. Solutions
a) Strong solution of ammonium acetate
b) Cresol with soap solution
c) Lugol’s solution
5. Suspensions
a) Calamine lotion
b) Magnesium Hydroxide mixture
c) Aluminimum Hydroxide gel
6. Emulsions
a) Turpentine Liniment
b) Liquid paraffin emulsion
7. Powders and Granules
a) ORS powder (WHO)
b) Effervescent granules
c) Dusting powder
d) Divded powders
8. Suppositories
a) Glycero gelatin suppository
b) Coca butter suppository
c) Zinc Oxide suppository
8. Semisolids
a) Sulphur ointment
b) Non staining-iodine ointment with methyl salicylate
c) Carbopal gel
9. Gargles and Mouthwashes
a) Iodine gargle
b) Chlorhexidine mouthwash
37
Recommended Books: (Latest Editions)
1. H. C. Ansel et al., Pharmaceutical Dosage Form and Drug Delivery System,
Lippincott Williams and Walkins, New Delhi.
2. Carter S.J., Cooper and Gunn’s-Dispensing for Pharmaceutical Students, CBS
publishers, New Delhi
3. M.E. Aulton, Pharmaceutics, The Science& Dosage Form Design, Churchill
Livingstone, Edinburgh.
4. Indian pharmacopoeia.
5. British pharmacopoeia.
6. Lachmann. Theory and Practice of Industrial Pharmacy,Lea& Febiger Publisher, The
University of Michigan.
7. Alfonso R. Gennaro Remington. The Science and Practice of Pharmacy, Lippincott
Williams, New Delhi.
8. Carter S.J., Cooper and Gunn’s. Tutorial Pharmacy, CBS Publications, New Delhi.
9. E.A. Rawlins, Bentley’s Text Book of Pharmaceutics, English Language Book
Society, Elsevier Health Sciences, USA.
10. Isaac Ghebre Sellassie: Pharmaceutical Pelletization Technology, Marcel Dekker,
INC, New York.
11. Dilip M. Parikh: Handbook of Pharmaceutical Granulation Technology, Marcel
Dekker, INC, New York.
12. Francoise Nieloud and Gilberte Marti-Mestres: Pharmaceutical Emulsions and
Suspensions, Marcel Dekker, INC, New York.
38
BP110P PHARMACEUTICAL INORGANIC CHEMISTRY (Practical)
4 Hours / Week
I Limit tests for following ions
a) Limit test for Chlorides and Sulphates
b) Modified limit test for Chlorides and Sulphates Limit test for Iron
c) Limit test for Heavy metals Limit test for Lead
d) Limit test for Arsenic
II Identification test
a) Magnesium hydroxide Ferrous sulphate Sodium Bicarbonate Calcium
gluconate Copper sulphate
III Test for purity
a) Swelling power of Bentonite
b) Neutralizing capacity of aluminum hydroxide gel
c) Determination of potassium iodate and iodine in potassium Iodide
VI Preparation of inorganic pharmaceuticals
a) Boric acid
b) Potash alum
c) Ferrous sulphate
Recommended Books (Latest Editions)
1. A.H. Beckett & J.B. Stenlake's, Practical Pharmaceutical Chemistry Vol I & II,
Stahlone Press of University of London, 4th edition.
2. A.I. Vogel, Text Book of Quantitative Inorganic analysis
3. P. Gundu Rao, Inorganic Pharmaceutical Chemistry, 3rd Edition
4. M.L Schroff, Inorganic Pharmaceutical Chemistry
5. Bentley and Driver's Textbook of Pharmaceutical Chemistry
6. Anand & Chatwal, Inorganic Pharmaceutical Chemistry
7. IndianPharmacopoeia
39
BP111P COMMUNICATION SKILLS (Practical) 2 Hours / week
Thefollowing learning modules are to be conducted using wordsworth® English
language lab software
1. Basic communication covering the following topics
a. Meeting People
b. Asking Questions
c. Making Friends
d. What did you do?
e. Do’s and Dont’s
2. Pronunciations covering the following topics
a. Pronunciation (Consonant Sounds)
b. Pronunciation and Nouns
c. Pronunciation (Vowel Sounds)
3. Advanced Learning
a. Listening Comprehension / Direct and Indirect Speech
b. Figures of Speech
c. Effective Communication
d. Writing Skills
e. Effective Writing
f. Interview Handling Skills
g. E-Mail etiquette
h. Presentation Skills
Recommended Books: (Latest Edition)
1. Basic communication skills for Technology, Andreja. J. Ruther Ford, 2 nd Edition,
Pearson Education, 2011
2. Communication skills, Sanjay Kumar, Pushpalata, 1stEdition, Oxford Press,
2011
3. Organizational Behaviour, Stephen .P. Robbins, 1stEdition, Pearson, 2013
4. Brilliant- Communication skills, Gill Hasson, 1stEdition, Pearson Life, 2011
5. The Ace of Soft Skills: Attitude, Communication and Etiquette for success,
Gopala Swamy Ramesh, 5thEdition, Pearson, 2013
6. Developing your influencing skills, Deborah Dalley, Lois Burton, Margaret,
Green hall, 1st Edition Universe of Learning LTD, 2010
7. Communication skills for professionals, Konar nira, 2ndEdition, New arrivals –
PHI, 2011
8. Personality development and soft skills, Barun K Mitra, 1stEdition, Oxford
Press, 2011
9. Soft skill for everyone, Butter Field, 1st Edition, Cengage Learning India
pvt.ltd, 2011
40
10. Soft skills and professional communication, Francis Peters SJ, 1 stEdition, Mc
Graw Hill Education, 2011
11. Effective communication, John Adair, 4thEdition, Pan Mac Millan,2009
12. Bringing out the best in people, Aubrey Daniels, 2ndEdition, Mc Graw Hill,
1999
41
BP112RBP REMEDIAL BIOLOGY (Practical) 2 Hours / week
1. Introduction to experiments in biology
a) Study of Microscope
b) Section cutting techniques
c) Mounting and staining
d) Permanent slide preparation
2. Study of cell and its inclusions
3. Study of Stem, Root, Leaf, seed, fruit, flower and their modifications
4. Detailed study of frog by using computer models
5. Microscopic study and identification of tissues pertinent to Stem, Root Leaf, seed,
fruit and flower
6. Identification of bones
7. Determination of blood group
8. Determination of blood pressure
9. Determination of tidal volume
Reference Books
1. Practical human anatomy and physiology. by S.R.Kale and R.R.Kale.
2. A Manual of pharmaceutical biology practical by S.B.Gokhale, C.K.Kokate
and S.P.Shriwastava.
3. Biology practical manual according to National core curriculum .Biology
forum of Karnataka. Prof .M.J.H.Shafi
42
SEMESTER II
43
BP201T HUMAN ANATOMY AND PHYSIOLOGY-II (Theory)3 L + 1T / Week
Scope: This subject is designed to impart fundamental knowledge on the structure
andfunctions of the various systems of the human body. It also helps in understanding both
homeostatic mechanisms. The subject provides the basic knowledge required to understand
the various disciplines of pharmacy.
Objectives: Upon completion of this course the student should be able to:
1. Explain the gross morphology, structure and functions of various organs of the human
body.
2. Describe the various homeostatic mechanisms and their imbalances.
3. Identify the various tissues and organs of different systems of human body.
4. Perform the hematological tests like blood cell counts, haemoglobin estimation,
bleeding/clotting time etc and also record blood pressure, heart rate, pulse and
respiratory volume.
5. Appreciate coordinated working pattern of different organs of each system
6. Appreciate the interlinked mechanisms in the maintenance of normal functioning
(homeostasis) of human body.
44
2.2 Energetics 2
Formation and role of ATP, Creatinine Phosphate and BMR.
3 UNIT III 10
3.1 Respiratory system 5
Anatomy of respiratory system with special reference to anatomy of lungs,
mechanism of respiration, regulation of respiration
Lung Volumes and capacities transport of respiratory gases, artificial
respiration, and resuscitation methods.
3.2 Urinary system 5
Anatomy of urinary tract with special reference to anatomy of kidney and
nephrons, functions of kidney and urinary tract, physiology of urine
formation, micturition reflex and role of kidneys in acid base balance, role
of RAS in kidney and disorders of kidney.
4 UNIT IV 10
Endocrine system
Classification of hormones, mechanism of hormone action, structure and
functions of pituitary gland, thyroid gland, parathyroid gland, adrenal
gland, pancreas, pineal gland, thymus and their disorders
5 UNIT V 9
5.1 Reproductive system 6
Anatomy of male and female reproductive system, Functions of male and
female reproductive system, sex hormones, physiology of menstruation,
fertilization, spermatogenesis, oogenesis, pregnancy and parturition
5.2 Introduction to genetics 4
Chromosomes, genes and DNA, protein synthesis, genetic pattern of
inheritance
Total 45
45
5. Principles of Anatomy and Physiology by Tortora Grabowski. Palmetto, GA, U.S.A.
6. Textbook of Human Histology by Inderbir Singh, Jaypee brothers medical publishers,
New Delhi.
7. Textbook of Practical Physiology by C.L. Ghai, Jaypee brothers medical publishers,
New Delhi.
8. Practical workbook of Human Physiology by K. Srinageswari and Rajeev Sharma,
Jaypee brother’s medical publishers, New Delhi.
Reference Books:
1. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins Co,
Riverview, MI USA
2. Text book of Medical Physiology- Arthur C, Guyton and John. E. Hall. Miamisburg,
OH, U.S.A.
3. Human Physiology (vol 1 and 2) by Dr. C.C. Chatterrje ,Academic Publishers Kolkata
46
BP202T PHARMACEUTICAL ORGANIC CHEMISTRY –I(Theory)
3 L + 1T / Week
Scope: This subject deals with classification and nomenclature of simple
organiccompounds, structural isomerism, intermediates forming in reactions, important
physical properties, reactions and methods of preparation of these compounds. The
syllabus also emphasizes on mechanisms and orientation of reactions.
Objectives: Upon completion of the course the student shall be able to:
1. write the structure, name and the type of isomerism of the organic compound
2. write the reaction, name the reaction and orientation of reactions
3. account for reactivity/stability of compounds,
4. identify/confirm the identification of organic compound
Sr. No. Content Hours
General methods of preparation and reactions of compounds superscripted
with asterisk (*) to be explained
To emphasize on definition, types, classification,
principles/mechanisms,applications, examples and differences
1 UNIT I 7
Classification, nomenclature and isomerism Classification of Organic
Compounds, Common and IUPAC systems of nomenclature of organic
compounds (up to 10 Carbons open chain and carbocyclic compounds)
Structural isomerisms in organic compounds.
2 UNIT II - Alkanes*, Alkenes* and Conjugated dienes* 10
2.1 SP3 hybridization in alkanes, Halogenation of alkanes, uses of paraffins. 3
Stabilities of alkenes, SP2 hybridization in alkenes
2.2 E1 and E2 reactions – kinetics, order of reactivity of alkyl halides, 7
rearrangement of carbocations, Saytzeffs orientation and evidences. E1
verses E2 reactions, Factors affecting E1 and E2 reactions. Ozonolysis,
electrophilic addition reactions of alkenes, Markownikoff’s orientation,
free radical addition reactions of alkenes, Anti Markownikoff’s
orientation.
Stability of conjugated dienes, Diel-Alder, electrophilic addition, free
radical addition reactions of conjugated dienes, allylic rearrangement
3 UNIT III 10
3.1 Alkylhalides* 5
SN1 and SN2 reactions - kinetics, order of reactivity of alkyl halides,
stereochemistry and rearrangement of carbocations.
SN1 versus SN2 reactions, Factors affecting SN1 and SN2 reactions
47
Structure and uses of ethylchloride, Chloroform, trichloroethylene,
tetrachloroethylene, dichloromethane, tetrachloromethane and iodoform.
3.2 Alcohols*- Qualitative tests, Structure and uses of Ethyl alcohol, Methyl 5
alcohol,chlorobutanol, Cetosteryl alcohol, Benzyl alcohol, Glycerol,
Propylene glycol
4 UNIT IV 10
Carbonyl compounds* (Aldehydes and ketones)
Nucleophilic addition, Electromeric effect, aldol condensation, Crossed
Aldol condensation, Cannizzaro reaction, Crossed Cannizzaro reaction,
Benzoin condensation, Perkin condensation, qualitative tests, Structure
and uses of Formaldehyde, Paraldehyde, Acetone, Chloral hydrate,
Hexamine, Benzaldehyde, Vanilin, Cinnamaldehyde
5 UNIT V 8
5.1 Carboxylic acids* 5
Acidity of carboxylic acids, effect of substituents on acidity, inductive
effect and qualitative tests for carboxylic acids ,amide and ester
Structure and Uses of Acetic acid, Lactic acid, Tartaric acid, Citric acid,
Succinic acid. Oxalic acid, Salicylic acid, Benzoic acid, Benzyl benzoate,
Dimethyl phthalate, Methyl salicylate and Acetyl salicylic acid
5.2 Aliphatic amines* - Basicity, effect of substituent on Basicity. Qualitative 3
test, Structure anduses of Ethanolamine, Ethylenediamine, Amphetamine
Total 45
48
BP203T BIOCHEMISTRY (Theory)3 L + 1T / Week
Scope: Biochemistry deals with complete understanding of the molecular levels of
thechemical process associated with living cells. The scope of the subject is providing
biochemical facts and the principles to understand metabolism of nutrient molecules in
physiological and pathological conditions. It is also emphasizing on genetic organization of
mammalian genome and hetero & autocatalytic functions of DNA.
Objectives: Upon completion of course student shell able to:
1. Understand the catalytic role of enzymes, importance of enzyme inhibitors in design of
new drugs, therapeutic and diagnostic applications of enzymes.
2. Understand the metabolism of nutrient molecules in physiological and pathological
conditions.
3. Understand the genetic organization of mammalian genome and functions of DNA in
the synthesis of RNAs and proteins.
51
BP204T PATHOPHYSIOLOGY (Theory) 4 hours/week
Scope: Pathophysiology is the study of causes of diseases and reactions of the body tosuch
disease producing causes.This course is designed to impart a thorough knowledge of the
relevant aspects of pathology of various conditions with reference to its pharmacological
applications, and understanding of basic pathophysiological mechanisms. Hence it will not
only help to study the syllabus of pathology, but also to get baseline knowledge required to
practice medicine safely, confidently, rationally and effectively.
Objectives: Upon completion of the subject student shall be able to:
1. Describe the etiology and pathogenesis of the selected disease states;
2. Name the signs and symptoms of the diseases; and
3. Mention the complications of the diseases.
52
3.1 Haematological Diseases: 3
Iron deficiency, megaloblastic anemia (Vit B12 and folic acid),
sickle cell anemia, thalasemia, hereditary acquired anemia,
hemophilia
Total 45
54
BP205T COMPUTER APPLICATIONS IN PHARMACY (Theory)3hours/week
Scope: This subject deals with the introduction Database, Database Management system,and
computer application in clinical studies and use of databases.
Objectives: Upon completion of the course the student shall be able to:
1. know the various types of application of computers in pharmacy
2. know the various types of databases
3. know the various applications of databases in pharmacy
55
5 UNIT V
Computers as data analysis in Preclinical 6
development:Chromatographic dada analysis(CDS), Laboratory Hours
Information management System (LIMS) and Text Information
Management System(TIMS)
Total 30
56
BP206T ENVIRONMENTAL SCIENCES (Theory) 3 hours/week
Scope: Environmental Sciences is the scientific study of the environmental system and the
status of its inherent or induced changes on organisms. It includes not only the study of
physical and biological characters of the environment but also the social and cultural factors
and the impact of man on environment.
Objectives: Upon completion of the course the student shall be able to:
1. Create the awareness about environmental problems among learners.
2. Impart basic knowledge about the environment and its allied problems.
3. Develop an attitude of concern for the environment.
4. Motivate learner to participate in environment protection and environment improvement.
5. Acquire skills to help the concerned individuals in identifying and solving environmental
problems.
6. Strive to attain harmony with Nature
7. Acquire skills to help the concerned individuals in identifying and solving environmental
problems.
Total 30
57
Recommended Books (Latest edition):
1. Y.K. Sing, Environmental Science, New Age International Pvt, Publishers, Bangalore
2. Agarwal, K.C. 2001 Environmental Biology, Nidi Publ. Ltd. Bikaner.
3. Bharucha Erach, The Biodiversity of India, Mapin Pu blishing Pvt. Ltd., Ahmedabad –
380 013, India,
4. Brunner R.C., 1989, Hazardous Waste Incineration, McGraw Hill Inc. 480p
5. Clark R.S., Marine Pollution, Clanderson Press Oxford
6. Cunningham, W.P. Cooper, T.H. Gorhani, E & Hepworth, M.T. 2001, Environmental
Encyclopedia, Jaico Publ. House, Mumbai, 1196p
7. De A.K., Environmental Chemistry, Wiley Eastern Ltd.
8. Down of Earth, Centre for Science and Environment
58
BP207P HUMAN ANATOMY AND PHYSIOLOGY (Practical) 4 Hours/week
Practical physiology is complimentary to the theoretical discussions in physiology.
Practicals allow the verification of physiological processes discussed in theory classes
through experiments on living tissue, intact animals or normal human beings. This is
helpful for developing an insight on the subject.
1. To study the integumentary and special senses using specimen, models, etc.,
2. To study the nervous system using specimen, models, etc.,
3. To study the endocrine system using specimen, models, etc
4. To demonstrate the general neurological examination
5. To demonstrate the function of olfactory nerve
6. To examine the different types of taste.
7. To demonstrate the visual acuity
8. To demonstrate the reflex activity
9. Recording of body temperature
10. To demonstrate positive and negative feedback mechanism.
11. Determination of tidal volume and vital capacity.
12. Study of digestive, respiratory, cardiovascular systems, urinary and reproductive
systems with the help of models, charts and specimens.
13. Recording of basal mass index .
14. Study of family planning devices and pregnancy diagnosis test.
15. Demonstration of total blood count by cell analyser
16. Permanent slides of vital organs and gonads.
Recommended Books (Latest Editions)
1. Essentials of Medical Physiology by K. Sembulingam and P. Sembulingam. Jaypee
brothers medical publishers, New Delhi.
2. Anatomy and Physiology in Health and Illness by Kathleen J.W. Wilson, Churchill
Livingstone, New York
3. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins
Co,Riverview,MI USA
4. Text book of Medical Physiology- Arthur C,Guyton andJohn.E. Hall. Miamisburg,
OH, U.S.A.
5. Principles of Anatomy and Physiology by Tortora Grabowski. Palmetto, GA, U.S.A.
6. Textbook of Human Histology by Inderbir Singh, Jaypee brothers medical publishers,
New Delhi.
7. Textbook of Practical Physiology by C.L. Ghai, Jaypee brothers medical publishers,
New Delhi.
8. Practical workbook of Human Physiology by K. Srinageswari and Rajeev Sharma,
Jaypee brother’s medical publishers, New Delhi.
59
Reference Books:
1. Physiological basis of Medical Practice-Best and Tailor. Williams & Wilkins Co,
Riverview, MI USA
2. Text book of Medical Physiology- Arthur C, Guyton and John. E. Hall. Miamisburg,
OH, U.S.A.
3. Human Physiology (vol 1 and 2) by Dr. C.C. Chatterrje ,Academic Publishers Kolkata
60
BP208P PHARMACEUTICAL ORGANIC CHEMISTRY -I (Practical)
4 Hours / week
61
BP209P BIOCHEMISTRY (Practical) 4 Hours / Week
1. Qualitative analysis of carbohydrates (Glucose, Fructose, Lactose, Maltose, Sucrose and
starch)
2. Identification tests for Proteins (albumin and Casein)
3. Quantitative analysis of reducing sugars (DNSA method) and Proteins (Biuret method)
4. Qualitative analysis of urine for abnormal constituents
5. Determination of blood creatinine
6. Determination of blood sugar
7. Determination of serum total cholesterol
8. Preparation of buffer solution and measurement of pH
9. Study of enzymatic hydrolysis of starch
10. Determination of Salivary amylase activity
11. Study the effect of Temperature on Salivary amylase activity.
12. Study the effect of substrate concentration on salivary amylase activity.
62
BP210P COMPUTER APPLICATIONS IN PHARMACY (Practical) 2 hours/ week
1. Design a questionnaire using a word processing package to gather information
about a particular disease.
2. Create a HTML web page to show personal information.
3 Retrieve the information of a drug and its adverse effects using online tools
4 Creating mailing labels Using Label Wizard , generating label in MS WORD
5 Create a database in MS Access to store the patient information with the required
fields Using access
6. Design a form in MS Access to view, add, delete and modify the patient record in the
database
7. Generating report and printing the report from patient database
8. Creating invoice table using – MS Access
9. Drug information storage and retrieval using MS Access
10. Creating and working with queries in MS Access
11. Exporting Tables, Queries, Forms and Reports to web pages
12. Exporting Tables, Queries, Forms and Reports to XML pages
63
SEMESTR III
64
BP301TPHARMACEUTICAL ORGANIC CHEMISTRY–II (Theory)
3 L + 1T / Week
Scope: This subject deals with general methods of preparation and reactions of
someorganic compounds. Reactivity of organic compounds are also studied here. The
syllabus emphasizes on mechanisms and orientation of reactions. Chemistry of fats and
oils are also included in the syllabus.
66
BP302T PHYSICAL PHARMACEUTICS-I (Theory) 3 L + 1T / Week
Scope:
The course deals with the various physical and physicochemical properties, andprinciples
involved in dosage forms/formulations. Theory and practical components of the subject help
the student to get a better insight into various areas of formulation research and development,
and stability studies of pharmaceutical dosage forms.
Objectives: Upon the completion of the course student shall be able to:
1. Understand various physicochemical properties of drug molecules in the designing the
dosage forms
2. Know the principles of chemical kinetics & to use them for stability testing and
determination of expiry date of formulations
3. Demonstrate use of physicochemical properties in the formulationdevelopment and
evaluation of dosage forms.
68
BP303T PHARMACEUTICAL MICROBIOLOGY (Theory) 3 L + 1T / Week
Scope:
Study of all categories of microorganisims especially for the production of alchol
antibiotics, vaccines, vitamins enzymes etc..
69
of Fungi and Virus.
3.2 Classification and mode of action of disinfectants. Factors influencing 4
disinfection, antiseptics and their evaluation, for bacteriostatic and
bactericidal actions
3.3 Sterility testing of products (solids, liquids, ophthalmic and other sterile 3
products) according to IP, BP and USP
4 UNIT IV 08
4.1 Designing of aseptic area, laminar flow equipments; study of different 3
sources of contamination in an aseptic area and methods of prevention, clean
area classification.
4.2 Principles and methods of different microbiological assay. Methods for 3
standardization of antibiotics, vitamins and amino acids.
4.3 Assessment of a new antibiotic and testing of antimicrobial activity of a new 2
substance.
5 UNIT V 07
5.1 Types of spoilage, factors affecting the microbial spoilage of pharmaceutical 2
products, sources and types of microbial contaminants, assessment of
microbial contamination and spoilage.
5.2 Preservation of pharmaceutical products using antimicrobial agents, 2
evaluation of microbial stability of formulations.
5.3 Growth of animal cells in culture, general procedure for cell culture, 2
Primary, established and transformed cell cultures.
5.4 Application of cell cultures in pharmaceutical industry and research. 1
Total 45
Reference Books (Latest Editions to be adopted)
1. W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific
publications, Oxford London.
2. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers & Distributors,
Delhi.
3. Pelczar, Chan Kreig, Microbiology, Tata McGraw Hill edn.
4. Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology.
5. Rose: Industrial Microbiology.
6. Probisher, Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan
7. Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution.
8. Peppler: Microbial Technology.
9. I.P., B.P., U.S.P.- latest editions.
10. Ananthnarayan : Text Book of Microbiology, Orient-Longman, Chennai
11. Edward: Fundamentals of Microbiology.
12. N.K.Jain: Pharmaceutical Microbiology, Vallabh Prakashan, Delhi
70
BP304T PHARMACEUTICAL ENGINEERING (Theory) 3 L + 1T / Week
Scope: This course is designed to impart a fundamental knowledge on the art and scienceof
various unit operations used in pharmaceutical industry.
Objectives: Upon completion of the course student shall be able:
1. To know various unit operations used in Pharmaceutical industries.
2. To understand the material handling techniques.
3. To perform various processes involved in pharmaceutical manufacturing process.
4. To carry out various test to prevent environmental pollution.
5. To appreciate and comprehend significance of plant lay out design for optimum use of
resources.
6. To appreciate the various preventive methods used for corrosion control in Pharmaceutical
industries
Sr. No. Content Hours
1 UNIT I 10
1.1 Flow of fluids: Types of manometers, Reynolds number and its significance, 3
Bernoulli’s theorem and its applications, Energy losses, Orifice meter,
Venturimeter, Pitot tube and Rotometer.
1.2 Size Reduction: Objectives, Mechanisms & Laws governing size reduction, 4
factors affecting size reduction, principles, construction, working, uses,
merits and demerits of Hammer mill, ball mill, fluid energy mill, Edge
runner mill & end runner mill.
1.3 Size Separation: Objectives, applications & mechanism of size separation, 3
official standards of powders, sieves, size separation Principles, construction,
working, uses, merits and demerits of Sieve shaker, cyclone separator, Air
separator, Bag filter & elutriation tank
2 UNIT II 10
2.1 Evaporation: Objectives, applications and factors influencing evaporation, 4
differences between evaporation and other heat process. principles,
construction, working, uses, merits and demerits of Steam jacketed kettle,
horizontal tube evaporator, climbing film evaporator, forced circulation
evaporator, multiple effect evaporator& Economy of multiple effect
evaporator.
2.2 Heat Transfer: Objectives, applications & Heat transfer mechanisms. 3
Fourier’s law, Heat transfer by conduction, convection & radiation. Heat
interchangers & heat exchangers.
2.3 Distillation: Basic Principles and methodology of simple distillation,flash 3
distillation, fractional distillation, distillation under reduced pressure, steam
distillation & molecular distillation
71
3 UNIT III 10
3.1 Drying: Objectives, applications & mechanism of drying process, 5
measurements & applications of Equilibrium Moisture content, rate of
drying curve. principles, construction, working, uses, merits and demerits of
Tray dryer, drum dryer spray dryer, fluidized bed dryer, vacuum dryer,
freeze dryer
3.2 Mixing: Objectives, applications & factors affecting mixing, Difference 5
between solid and liquid mixing, mechanism of solid mixing, liquids mixing
and semisolids mixing. Principles, Construction, Working, uses, Merits and
Demerits of Double cone blender, twin shell blender, ribbon blender, Sigma
blade mixer, planetary mixers, Propellers, Turbines, Paddles & Silverson
Emulsifier
4 UNIT IV 08
4.1 Filtration: Objectives, applications, Theories & Factors influencing 4
filtration, filter aids, filter medias. Principle, Construction, Working, Uses,
Merits and demerits of plate & frame filter, filter leaf, rotary drum filter,
Meta filter & Cartridge filter, membrane filters and Seidtz filter.
4.2 Centrifugation: Objectives, principle & applications of Centrifugation, 4
principles, construction, working, uses, merits and demerits of Perforated
basket centrifuge, Non-perforated basket centrifuge, semi continuous
centrifuge & super centrifuge.
5 UNIT V 07
Materials of pharmaceutical plant construction, Corrosion and its
prevention: Factors affecting during materials selected for Pharmaceutical
plant construction, Theories of corrosion, types of corrosion and there
prevention. Ferrous and nonferrous metals, inorganic and organic non
metals, basic of material handling system
Total 45
Reference Books (Latest Editions to be adopted)
1. Introduction to chemical engineering – Walter L Badger & Julius Banchero, Latest
edition.
2. Solid phase extraction, Principles, techniques and applications by Nigel J.K. Simpson-
Latest edition.
3. Unit operation of chemical engineering – Mcabe Smith, Latest edition.
4. Pharmaceutical engineering principles and practices – C.V.S Subrahmanyam et al., Latest
edition.
5. Remington practice of pharmacy- Martin, Latest edition.
6. Theory and practice of industrial pharmacy by Lachmann., Latest edition.
72
7. Physical pharmaceutics- C.V.S Subrahmanyam et al., Latest edition.
8. Cooper and Gunn’s Tutorial pharmacy, S.J. Carter, Latest edition.
73
BP305P PHARMACEUTICAL ORGANIC CHEMISTRY -II (Practical)
4 Hours / Week
I Experiments involving laboratory techniques
Recrystallization
Steam distillation
75
BP307P PHARMACEUTICAL MICROBIOLOGY (Practical)4 Hours/week
1. Introduction and study of different equipments and processing, e.g., B.O.D. incubator,
laminar flow, aseptic hood, autoclave, hot air sterilizer, deep freezer, refrigerator,
microscopes used in experimental microbiology.
2. Sterilization of glassware, preparation and sterilization of media.
3. Sub culturing of bacteria and fungus. Nutrient stabs and slants preparations.
4. Staining methods- Simple, Grams staining and acid fast staining (Demonstration with
practical).
5. Isolation of pure culture of micro-organisms by multiple streak plate technique and other
techniques.
6. Microbiological assay of antibiotics by cup plate method and other methods
7. Motility determination by Hanging drop method.
8. Sterility testing of pharmaceuticals.
9. Bacteriological analysis of water
10. Biochemical test (IMViC reactions)
11. Revision Practical Class
76
BP308P PHARMACEUTICAL ENGINEERING (Practical) 4 Hours/week
77
SEMESTER IV
78
BP401T PHARMACEUTICAL ORGANIC CHEMISTRY –III (Theory)
3 L + 1T / Week
Scope: This subject imparts knowledge on stereo-chemical aspects of organic
compoundsand organic reactions, important named reactions, chemistry of important hetero
cyclic compounds. It also emphasizes on medicinal and other uses of organic compounds.
Objectives: At the end of the course, the student shall be able to:
1. understand the methods of preparation and properties of organic compounds
2. explain the stereo chemical aspects of organic compounds and stereo chemical reactions
3. know the medicinal uses and other applications of organic compounds
Sr. Content Hours
No. Note: To emphasize on definition, types, mechanisms, examples,
uses/applications
1 UNIT I 10
Stereo isomerism
Optical isomerism –
i. Optical activity, enantiomerism, diastereoisomerism, meso compounds
ii. Elements of symmetry, chiral and achiral molecules
iii. DL system of nomenclature of optical isomers, sequence rules, RS
system of nomenclature of optical isomers
iv. Reactions of chiral molecules
v. Racemic modification and resolution of racemic mixture.
vi. Asymmetric synthesis: partial and absolute
2 UNIT II 10
Geometrical isomerism
i. Nomenclature of geometrical isomers (Cis Trans, EZ, Syn Anti systems)
ii. Methods of determination of configuration of geometrical isomers.
iii. Conformational isomerism in Ethane, n-Butane and Cyclohexane.
iv. Stereo isomerism in biphenyl compounds (Atropisomerism) and
conditions for optical activity.
v. Stereospecific and stereoselective reactions
3 UNIT III - Heterocyclic compounds: 10
Heterocyclic compounds:
Nomenclature and classification
Synthesis, reactions and medicinal uses of following compounds/derivatives
Pyrrole, Furan, and Thiophene
Relative aromaticity and reactivity of Pyrrole, Furan and Thiophene
4 UNIT IV 08
79
Synthesis, reactions and medicinal uses of following compounds/derivatives
Pyrazole, Imidazole, Oxazole and Thiazole.
Pyridine, Quinoline, Isoquinoline, Acridine and Indole. Basicity of pyridine
Synthesis and medicinal uses of Pyrimidine, Purine, azepines and their
derivatives
5 UNIT V - Reactions of synthetic importance 07
5.1 Metal hydride reduction (NaBH4 and LiAlH4), Clemmensen reduction, 2
Birch reduction, Wolff Kishner reduction
Total 45
80
BP402T MEDICINAL CHEMISTRY – I (Theory) 3 L + 1T / Week
Scope: This subject is designed to impart fundamental knowledge on the
structure,chemistry and therapeutic value of drugs. The subject emphasizes on structure
activity relationships of drugs, importance of physicochemical properties and
metabolism of drugs. The syllabus also emphasizes on chemical synthesis of important
drugs under each class.
Objectives: Upon completion of the course the student shall be able to:
1. understand the chemistry of drugs with respect to their pharmacological activity
2. understand the drug metabolic pathways, adverse effect and therapeutic value of
drugs
3. know the Structural Activity Relationship (SAR) of different class of drugs
4. write the chemical synthesis of some drugs
82
Miscelleneous:
Amides and imides:Glutethmide.
Alcohol & their carbamate derivatives: Meprobomate, Ethchlorvynol.
Aldehyde & their derivatives: Triclofos sodium, Paraldehyde.
4.2 Antipsychotics 3
Phenothiazeines: SAR of Phenothiazeines - Promazine hydrochloride,
Chlorpromazine hydrochloride*, Triflupromazine, Thioridazine
hydrochloride, Piperacetazine hydrochloride, Prochlorperazine maleate,
Trifluoperazine hydrochloride.
Ring Analogues of Phenothiazeines: Chlorprothixene, Thiothixene,
Loxapine succinate, Clozapine.
Fluro buterophenones: Haloperidol, Droperidol, Risperidone.
Beta amino ketones: Molindone hydrochloride.
Benzamides: Sulpieride.
4.3 Anticonvulsants: SAR of Anticonvulsants, mechanism of anticonvulsant 2
action
Barbiturates: Phenobarbitone, Methabarbital.
Hydantoins: Phenytoin*, Mephenytoin, Ethotoin
Oxazolidine diones: Trimethadione, Paramethadione
Succinimides: Phensuximide, Methsuximide, Ethosuximide*
Urea and monoacylureas: Phenacemide, Carbamazepine*
Benzodiazepines: Clonazepam
Miscellaneous: Primidone, Valproic acid , Gabapentin, Felbamate
5 UNIT V- Drugs acting on Central Nervous System 07
5.1 General anesthetics: 3
Inhalation anesthetics: Halothane*, Methoxyflurane, Enflurane,
Sevoflurane, Isoflurane, Desflurane.
Ultra short acting barbitutrates: Methohexital sodium*, Thiamylal
sodium, Thiopental sodium.
Dissociative anesthetics: Ketamine hydrochloride.*
5.2 Narcotic and non-narcotic analgesics 2
Morphine and related drugs: SAR of Morphine analogues, Morphine
sulphate, Codeine, Meperidine hydrochloride, Anilerdine hydrochloride,
Diphenoxylate hydrochloride, Loperamide hydrochloride, Fentanyl
citrate*, Methadone hydrochloride*, Propoxyphene hydrochloride,
Pentazocine, Levorphanol tartarate.
Narcotic antagonists: Nalorphine hydrochloride, Levallorphan
83
tartarate, Naloxone hydrochloride
5.3 Anti-inflammatory agents: Sodium salicylate, Aspirin, Mefenamic acid*, 2
Meclofenamate, Indomethacin, Sulindac, Tolmetin, Zomepriac, Diclofenac,
Ketorolac, Ibuprofen*, Naproxen, Piroxicam, Phenacetin, Acetaminophen,
Antipyrine, Phenylbutazone
Total 45
84
BP403T PHYSICAL PHARMACEUTICS-II (Theory) 3 L + 1T / Week
Scope: The course deals with the various physical and physicochemical properties,
andprinciples involved in dosage forms/formulations. Theory and practical components of the
subject help the student to get a better insight into various areas of formulation research and
development, and stability studies of pharmaceutical dosage forms.
Objectives: Upon the completion of the course student shall be able to:
1. Understand various physicochemical properties of drug molecules in the designing the
dosage forms
2. Know the principles of chemical kinetics & to use them for stability testing and
determination of expiry date of formulations
3. Demonstrate use of physicochemical properties in the formulation development and
evaluation of dosage forms
Sr. Content Hours
No.
1 UNIT I 7
Colloidal dispersions: Classification of dispersed systems & their general
characteristics, size & shapes of colloidal particles, classification of colloids
& comparative account of their general properties. Optical, kinetic &
electrical properties. Effect of electrolytes, coacervation, peptization&
protective action.
2 UNIT II 10
2.1 Rheology: Newtonian systems, law of flow, kinematic viscosity, effect of 7
temperature, non-Newtonian systems, pseudoplastic, dilatants, plastic,
thixotropy, thixotropy in formulation, determination of viscosity, capillary,
falling Sphere, rotational viscometers
2.2 Deformation of solids: Plastic and elastic deformation, Heckel equation, 3
Stress, Strain, Elastic Modulus
3 UNIT III - Coarse dispersion 10
3.1 Suspension, interfacial properties of suspended particles, settling in 7
suspensions, formulation of suspensions. Emulsions and theories of
emulsification, microemulsion and multiple emulsions;
3.2 Physical stability of emulsions, preservation of emulsions, rheological 3
properties of emulsions, phase equilibria and emulsion formulation.
4 UNIT IV 8
Micromeretics: Particle size and distribution, mean particle size, number
and weight distribution, particle number, methods for determining particle
size by different methods, counting and separation method, particle shape,
85
specific surface, methods for determining surface area, permeability,
adsorption, derived properties of powders, porosity, packing arrangement,
densities, bulkiness & flow properties.
5 UNIT V 10
5.1 Drug stability: Reaction kinetics: zero, pseudo-zero, first & second order,
units of basic rate constants, determination of reaction order. Physical and
chemical factors influencing the chemical degradation of pharmaceutical
product: temperature, solvent, ionic strength, dielectric constant, specific &
general acid base catalysis, Simple numerical problems. Stabilization of
medicinal agents against common reactions like hydrolysis & oxidation.
Accelerated stability testing in expiration dating of pharmaceutical dosage
forms. Photolytic degradation and its prevention
Total 45
86
BP404T PHARMACOLOGY-I (Theory) 3 L + 1T / Week
Scope: The main purpose of the subject is to understand what drugs do to the livingorganisms
and how their effects can be applied to therapeutics. The subject covers the information about
the drugs like, mechanism of action, physiological and biochemical effects
(pharmacodynamics) as well as absorption, distribution, metabolism and excretion
(pharmacokinetics) along with the adverse effects, clinical uses, interactions, doses,
contraindications and routes of administration of different classes of drugs.
Objectives: Upon completion of this course the student should be able to
1. Understand the pharmacological actions of different categories of drugs
2. Explain the mechanism of drug action at organ system/sub cellular/ macromolecular
levels.
3. Apply the basic pharmacological knowledge in the prevention and treatment of various
diseases.
4. Observe the effect of drugs on animals by simulated experiments
5. Appreciate correlation of pharmacology with other bio medical sciences
Sr. No. Content Hours
1 UNIT I - General Pharmacology 8
1.1 Introduction to Pharmacology- Definition, historical landmarks and scope 4
of pharmacology, nature and source of drugs, essential drugs concept and
routes of drug administration, Agonists, antagonists( competitive and non-
competitive), spare receptors, addiction, tolerance, dependence,
tachyphylaxis, idiosyncrasy, allergy
1.2 Pharmacokinetics- Membrane transport, absorption, distribution, 4
metabolism and excretion of drugs .Enzyme induction, enzyme inhibition,
kinetics of elimination
2 UNIT II - General Pharmacology 12
2.1 Pharmacodynamics- Principles and mechanisms of drug action. Receptor 6
theories and classification of receptors, regulation of receptors. drug
receptors interactions signal transduction mechanisms, G-protein–coupled
receptors, ion channel receptor, transmembrane enzyme linked receptors,
transmembrane JAK-STAT binding receptor and receptors that regulate
transcription factors, dose response relationship, therapeutic index,
combined effects of drugs and factors modifying drug action.
2.2 Adverse drug reactions. 2
2.3 Drug interactions (pharmacokinetic and pharmacodynamic) 2
2.4 Drug discovery and clinical evaluation of new drugs -Drug discovery phase, 2
preclinical evaluation phase, clinical trial phase, phases of clinical trials and
87
pharmacovigilance
3 UNIT III –Pharmacology of peripheral nervous system 10
3.1 Organization and function of ANS, Neurohumoral transmission,co- 1
transmission and classification of neurotransmitters
3.2 Parasympathomimetics, Parasympatholytics, Sympathomimetics, 3
sympatholytics
3.3 Neuromuscular blocking agents and skeletal muscle relaxants (peripheral). 2
3.4 Local anesthetic agents 3
3.5 Drugs used in myasthenia gravis and glaucoma 1
4 UNIT IV - Pharmacology of central nervous system 08
4.1 Neurohumoral transmission in the C.N.S.special emphasis on importance of 1
various neurotransmitters like with GABA, Glutamate, Glycine, serotonin,
dopamine.
4.2 General anesthetics and pre-anesthetics. 2
4.3 Sedatives, hypnotics and centrally acting muscle relaxants 2
4.4 Anti-epileptics 2
4.5 Alcohols and disulfiram 1
5 UNIT V - Pharmacology of central nervous system 07
5.1 Psychopharmacological agents: Antipsychotics, antidepressants, anti- 2
anxiety agents, anti-manics and hallucinogens
5.2 Drugs used in Parkinsons disease and Alzheimer’s disease. 1
5.3 CNS stimulants and nootropics 1
5.4 Opioid analgesics and antagonists 2
5.5 Drug addiction, drug abuse, tolerance and dependence. 1
Total 45
Reference Books (Latest Editions to be adopted)
1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale’s
Pharmacology,.Churchil Livingstone Elsevier
2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc
Graw-Hill
3. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics
4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K.,
Bradley R.W., Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott
Williams & Wilkins
5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott’s Illustrated Reviews- Pharmacology
6. K.D.Tripathi. Essentials of Medical Pharmacology, JAYPEE Brothers Medical Publishers
(P) Ltd, New Delhi.
7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher
88
8. Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert,
9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata.
10. Kulkarni SK. Handbook of experimental pharmacology. VallabhPrakashan
89
BP405T PHARMACOGNOSY AND PHYTOCHEMISTRY I (Theory)
3 L + 1T / Week
Scope: The subject involves the fundamentals of Pharmacognosy like scope, classification of
crude drugs, their identification and evaluation, phytochemicals present in them and their
medicinal properties.
Total 45
91
3. Text Book of Pharmacognosy by T.E. Wallis
4. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers & Distribution,
New Delhi.
5. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (2007), 37th Edition,
Nirali Prakashan, New Delhi.
6. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New Delhi.
7. Essentials of Pharmacognosy, Dr.SH.Ansari, IInd edition, Birla publications, New Delhi,
2007
8. Practical Pharmacognosy: C.K. Kokate, Purohit, Gokhlae
9. Anatomy of Crude Drugs by M.A. Iyengar
92
BP406P MEDICINAL CHEMISTRY – I (Practical) 3 L + 1T / Week
I Preparation of drugs/ intermediates
1 1,3-pyrazole
2 1,3-oxazole
3 Benzimidazole
4 Benztriazole
5 2,3- diphenyl quinoxaline
6 Benzocaine
7 Phenytoin
8 Phenothiazine
9 Barbiturate
II Assay of drugs
1 Chlorpromazine
2 Phenobarbitone
3 Atropine
4 Ibuprofen
5 Aspirin
6 Furosemide
III Determination of Partition coefficient for any two drugs
93
BP407P PHYSICAL PHARMACEUTICS- II (Practical) 3 L + 1T / Week
94
7. Study of effect of hepatic microsomal enzyme inducers on the phenobarbitone sleeping
time in mice.
8. Effect of drugs on ciliary motility of frog oesophagus
9. Effect of drugs on rabbit eye.
10. Effects of skeletal muscle relaxants using rota-rod apparatus.
11. Effect of drugs on locomotor activity using actophotometer.
12. Anticonvulsant effect of drugs by MES and PTZ method.
13. Study of stereotype and anti-catatonic activity of drugs on rats/mice.
14. Study of anxiolytic activity of drugs using rats/mice.
15. Study of local anesthetics by different methods
Note: All laboratory techniques and animal experiments are demonstrated by simulated
experiments by softwares and videos
Recommended Books (Latest Editions)
1. Rang H. P., Dale M. M., Ritter J. M., Flower R. J., Rang and Dale’s
Pharmacology,.Churchil Livingstone Elsevier
2. Katzung B. G., Masters S. B., Trevor A. J., Basic and clinical pharmacology, Tata Mc
Graw-Hill
3. Goodman and Gilman’s, The Pharmacological Basis of Therapeutics
4. Marry Anne K. K., Lloyd Yee Y., Brian K. A., Robbin L.C., Joseph G. B., Wayne A. K.,
Bradley R.W., Applied Therapeutics, The Clinical use of Drugs, The Point Lippincott
Williams & Wilkins
5. Mycek M.J, Gelnet S.B and Perper M.M. Lippincott’s Illustrated Reviews- Pharmacology
6. K.D.Tripathi. Essentials of Medical Pharmacology, JAYPEE Brothers Medical Publishers
(P) Ltd, New Delhi.
7. Sharma H. L., Sharma K. K., Principles of Pharmacology, Paras medical publisher
8. Modern Pharmacology with clinical Applications, by Charles R.Craig& Robert,
9. Ghosh MN. Fundamentals of Experimental Pharmacology. Hilton & Company, Kolkata.
10. Kulkarni SK. Handbook of experimental pharmacology. VallabhPrakashan,
95
BP409P PHARMACOGNOSY AND PHYTOCHEMISTRY I (Practical)
4 Hours/Week
1. Analysis of crude drugs by chemical tests: (i)Tragaccanth (ii) Acacia (iii)Agar (iv) Gelatin
(v) starch (vi) Honey (vii) Castor oil
2. Determination of stomatal number and index
3. Determination of vein islet number, vein islet termination and paliside ratio.
4. Determination of size of starch grains, calcium oxalate crystals by eye piece micrometer
5. Determination of Fiber length and width
6. Determination of number of starch grains by Lycopodium spore method
7. Determination of Ash value
8. Determination of Extractive values of crude drugs
9. Determination of moisture content of crude drugs
10. Determination of swelling index and foaming
96
SEMESTER V
97
BP501T MEDICINAL CHEMISTRY – II (Theory) 3 L + 1T / Week
Scope: This subject is designed to impart fundamental knowledge on the structure,chemistry
and therapeutic value of drugs. The subject emphasizes on structure activity relationships of
drugs, importance of physicochemical properties and metabolism of drugs. The syllabus also
emphasizes on chemical synthesis of important drugs under each class.
Objectives: Upon completion of the course the student shall be able to
1. Understand the chemistry of drugs with respect to their pharmacological activity
2. Understand the drug metabolic pathways, adverse effect and therapeutic value of drugs
3. Know the Structural Activity Relationship of different class of drugs
4. Study the chemical synthesis of selected drugs
100
BP502T INDUSTRIAL PHARMACY I (Theory) 3 L + 1T / Week
Scope: Course enables the student to understand and appreciate the influence
ofpharmaceutical additives and various pharmaceutical dosage forms on the performance of
the drug product.
Objectives: Upon completion of the course the student shall be able to
1. Know the various pharmaceutical dosage forms and their manufacturing techniques.
2. Know various considerations in development of pharmaceutical dosage forms
3. Formulate solid, liquid and semisolid dosage forms and evaluate them for their quality
1.2 Physical properties: Physical form (crystal & amorphous), particle size, 2
shape, flowproperties, solubility profile (pKa, pH, partition coefficient),
polymorphism
1.3 Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, 2
polymerizationBCS classification of drugs
1.4 Application of preformulation considerations in the development of solid, 2
liquid oral and parenteral dosage forms and its impact on stability of dosage
forms.
2 UNIT II 10
2.1 Tablets 8
a.Introduction, ideal characteristics of tablets, classification of tablets.
Excipients, Formulation of tablets, granulation methods, compression and
processing problems. Equipments and tablet tooling.
b.Tablet coating: Types of coating, coating materials, formulation of coating
composition, methods of coating, equipment employed and defects in
coating.
c.Quality control tests: In process and finished product tests
2.2 Liquid orals: Formulation and manufacturing consideration of solutions, 2
suspensions and emulsions; Filling and packaging; evaluation of liquid orals
official in pharmacopoeia
3 UNIT III 8
3.1 Hard gelatin capsules: Introduction, Extraction of gelatin and production of 3
101
hardgelatin capsule shells. size of capsules, Filling, finishing and special
techniques of formulation of hard gelatin capsules. In process and final
product quality control tests for capsules.
3.2 Soft gelatin capsules: Nature of shell and capsule content,size 3
ofcapsules,importance of base adsorption and minimum/gram factors,
production, in process and final product quality control tests. Packing,
storage and stability testing of soft gelatin capsules
3.3 Pellets: Introduction, formulation requirements, pelletization process, 2
equipments formanufacture of pellets
4 UNIT IV 10
4.1 Definition, types, advantages and limitations. Preformulation factors and 2
essential requirements, vehicles, additives, importance of isotonicity
4.2 Production procedure, production facilities and controls. 1
4.3 Formulation of injections, sterile powders, emulsions, suspensions, large 3
volume parenterals and lyophilized products, Sterilization.
4.4 Containers and closures selection, filling and sealing of ampoules, vials and 1
infusion fluids. Quality control tests
4.5 Ophthalmic Preparations: Introduction, formulation considerations; 3
formulation of eyedrops, eye ointments and eye lotions; methods of
preparation; labeling, containers; evaluation of ophthalmic preparations
5 UNIT V 10
5.1 Cosmetics: Formulation and preparation of the following cosmetic 3
preparations:lipsticks, shampoos, cold cream and vanishing cream, tooth
pastes, hair dyes and sunscreens.
5.2 Pharmaceutical Aerosols: Definition, propellants, containers, valves, types 3
of aerosolsystems; formulation and manufacture of aerosols; Evaluation of
aerosols; Quality control and stability studies.
5.3 Packaging Materials Science: Materials used for packaging of 4
pharmaceutical products,factors influencing choice of containers, legal and
official requirements for containers, stability aspects of packaging materials,
quality control tests
Total 45
103
BP503T PHARMACOLOGY-II (Theory) 3 L + 1T / Week
Scope: This subject is intended to impart the fundamental knowledge on various
aspects(classification, mechanism of action, therapeutic effects, clinical uses, side effects and
contraindications) of drugs acting on different systems of body and in addition, emphasis on
the basic concepts of bioassay.
Objectives: Upon completion of this course the student should be able to:
1. Understand the mechanism of drug action and its relevance in the treatment of
different diseases
2. Demonstrate isolation of different organs/tissues from the laboratory animals by
simulated experiments
3. Demonstrate the various receptor actions using isolated tissue preparation
4. Appreciate correlation of pharmacology with related medical sciences
Sr. Content Hours
No.
1 UNIT I 10
Pharmacology of drugs acting on cardio vascular system
a. Introduction to hemodynamic and electrophysiology of heart.
b. Drugs used in congestive heart failure
c. Anti-hypertensive drugs.
d. Anti-anginal drugs.
e. Anti-arrhythmic drugs.
f. Anti-hyperlipidemic drugs.
2 UNIT II 10
2.1 Pharmacology of drugs acting on cardio vascular system 6
a Drug used in the therapy of shock.
b Hematinics, coagulants and anticoagulants.
c Fibrinolytics and anti-platelet drugs
d Plasma volume expanders
2.2 Pharmacology of drugs acting on urinary system 4
a Diuretics
b Anti-diuretics
3 UNIT III 10
Autocoids and related drugs
a Introduction to autacoids and classification
b Histamine, 5-HT and their antagonists.
c Prostaglandins, Thromboxanes and Leukotrienes.
d Angiotensin, Bradykinin and Substance P.
104
e Non-steroidal anti-inflammatory agents
f Anti-gout drugs
g Antirheumatic drugs
h Histamine, 5-HT and their antagonists.
i Prostaglandins, Thromboxanes and Leukotrienes.
j Angiotensin, Bradykinin and Substance P.
k Non-steroidal anti-inflammatory agents
l Anti-gout drugs
m Antirheumatic drugs
4 UNIT IV 08
Pharmacology of drugs acting on endocrine system
a Basic concepts in endocrine pharmacology.
b Anterior Pituitary hormones- analogues and their inhibitors.
c Thyroid hormones- analogues and their inhibitors.
d Hormones regulating plasma calcium level-Parathormone, calcitonin
and Vitamin-D.
e Insulin, Oral Hypoglycemic agents and glucagon.
f ACTH and corticosteroids.
5 UNIT V 07
5.1 Pharmacology of drugs acting on endocrine system 4
a. Androgens and Anabolic steroids.
b. Estrogens, progesterone and oral contraceptives.
c. Drugs acting on the uterus.
5.2 Bioassays 3
a. Principles and applications of bioassay.
b. Types of bioassay
c. Bioassay of insulin, oxytocin, vasopressin, ACTH, d-
tubocurarine,digitalis, histamine and 5-HT
Total 45
106
BP504T PHARMACOGNOSY AND PHYTOCHEMISTRY II (Theory)
3 L + 1T / Week
Scope: The main purpose of subject is to impart the students the knowledge of how
thesecondary metabolites are produced in the crude drugs, how to isolate and identify and
produce them industrially. Also this subject involves the study of producing the plants and
phytochemicals through plant tissue culture, drug interactions and basic principles of
traditional system of medicine
108
BP505T PHARMACEUTICAL JURISPRUDENCE (Theory) 3 L + 1T / Week
Scope: This course is designed to impart basic knowledge on importantlegislations related to
the profession of pharmacy in India.
Objectives: Upon completion of the course, the student shall be able to understand:
1. The Pharmaceutical legislations and their implications in the development and marketing
of pharmaceuticals.
2. Various Indian pharmaceutical Acts and Laws
3. The regulatory authorities and agencies governing the manufacture and sale of
pharmaceuticals
4. The code of ethics during the pharmaceutical practice
Sr. No. Content Hours
1 UNIT I - Drugs and Cosmetics Act, 1940 and its rules 1945 10
1.1 Objectives, Definitions, Legal definitions of schedules to the act and rules 3
1.2 Import of drugs – Classes of drugs and cosmetics prohibited from import, 2
Import under license or permit. Offences and penalties.
1.3 Manufacture of drugs – Prohibition of manufacture and sale of certain drugs 2
1.4 Conditions for grant of license and conditions of license for manufacture of 3
drugs, Manufacture of drugs for test, examination and analysis, manufacture
of new drug, loan license and repacking license
2 UNIT II - Drugs and Cosmetics Act, 1940 and its rules 1945. 10
2.1 Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F & 4
DMR (OA)
2.2 Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and 1
penalties
2.3 Labeling & Packing of drugs- General labeling requirements and specimen 2
labels for drugs and cosmetics, List of permitted colors. Offences and
penalties.
2.4 Administration of the act and rules – Drugs Technical Advisory Board, 3
Central drugs Laboratory, Drugs Consultative Committee, Government drug
analysts, Licensing authorities, controlling authorities, Drugs Inspectors
3 UNIT III 10
3.1 Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; 3
its constitution and functions, Education Regulations, State and Joint state
pharmacy councils; constitution and functions, Registration of Pharmacists,
Offences and Penalties
3.2 Medicinal and Toilet Preparation Act –1955: Objectives, Definitions, 3
Licensing,Manufacture In bond and Outside bond, Export of alcoholic
109
preparations, Manufacture of Ayurvedic, Homeopathic, Patent & Proprietary
Preparations. Offences and Penalties
3.3 Narcotic Drugs and Psychotropic substances Act-1985 and Rules: 4
Objectives,Definitions, Authorities and Officers, Constitution and Functions
of narcotic & Psychotropic Consultative Committee, National Fund for
Controlling the Drug Abuse, Prohibition, Control and Regulation, opium
poppy cultivation and production of poppy straw, manufacture, sale and
export of opium, Offences and Penalties
4 UNIT IV 08
4.1 Study of Salient Features of Drugs and magic remedies Act and its 2
rules: Objectives, Definitions, Prohibition of certain advertisements, Classes
of Exempted advertisements, Offences and Penalties
4.2 Prevention of Cruelty to animals Act-1960: Objectives, Definitions, 3
InstitutionalAnimal Ethics Committee, Breeding and Stocking of Animals,
Performance of Experiments, Transfer and acquisition of animals for
experiment, Records, Power to suspend or revoke registration, Offences and
Penalties
4.3 National Pharmaceutical Pricing Authority: Drugs Price Control Order 3
(DPCO)-2013. Objectives, Definitions, Sale prices of bulk drugs, Retail
price of formulations, Retail price and ceiling price of scheduled
formulations, National List of Essential Medicines (NLEM)
5 UNIT V 07
5.1 Pharmaceutical Legislations – A brief review, Introduction, Study of drugs 1
enquirycommittee, Health survey and development committee, Hathi
committee and Mudaliar committee
5.2 Code of Pharmaceutical ethics D efinition, Pharmacist in relation to his 1
job, trade,medical profession and his profession, Pharmacist’s oath
5.3 Medical Termination of pregnancy act 1
5.4 Right to information Act 1
5.5 Introduction to Intellectual Property Rights (IPR) 3
Total 45
Reference Books (Latest Editions to be adopted)
1. Forensic Pharmacy by B. Suresh
2. Text book of Forensic Pharmacy by B.M. Mithal
3. Hand book of drug law-by M.L. Mehra
4. A text book of Forensic Pharmacy by N.K. Jain
5. Drugs and Cosmetics Act/Rules by Govt. of India publications.
6. Medicinal and Toilet preparations act 1955 by Govt. of India publications.
7. Narcotic drugs and psychotropic substances act by Govt. of India publications
110
8. Drugs and Magic Remedies act by Govt. of India publication
9. Bare Acts of the said laws published by Government. Reference books (Theory)
111
BP506P INDUSTRIAL PHARMACY(Practical)4 Hours/week
112
BP507P PHARMACOLOGY-II (Practical) 4Hours/Week
1. Morphology, histology and powder characteristics & extraction & detection of: Cinchona,
Cinnamon, Senna, Clove, Ephedra, Fennel and Coriander
2. Exercise involving isolation & detection of active principles
a. Caffeine - from tea dust.
b. Diosgenin from Dioscorea
c. Atropine from Belladonna
d. Sennosides from Senna
3. Separation of sugars by Paper chromatography
4. TLC of herbal extract
5. Distillation of volatile oils and detection of phytoconstitutents by TLC
6. Analysis of crude drugs by chemical tests: (i) Asafoetida (ii) Benzoin (iii) Colophony (iv)
Aloes (v) Myrrh
1. W.C.Evans, Trease and Evans Pharmacognosy, 16th edition, W.B. Sounders & Co.,
London, 2009.
2. Mohammad Ali. Pharmacognosy and Phytochemistry, CBS Publishers & Distribution,
New Delhi.
3. Text book of Pharmacognosy by C.K. Kokate, Purohit, Gokhlae (2007), 37th Edition,
Nirali Prakashan, New Delhi.
4. Herbal drug industry by R.D. Choudhary (1996), Ist Edn, Eastern Publisher, New Delhi.
5. Essentials of Pharmacognosy, Dr.SH.Ansari, IInd edition, Birla publications, New Delhi,
2007
6. Herbal Cosmetics by H.Pande, Asia Pacific Business press, Inc, New Delhi.
7. A.N. Kalia, Textbook of Industrial Pharmacognosy, CBS Publishers, New Delhi, 2005.
8. R Endress, Plant cell Biotechnology, Springer-Verlag, Berlin, 1994.
9. Pharmacognosy & Pharmacobiotechnology. James Bobbers, Marilyn KS, VE Tylor.
10. The formulation and preparation of cosmetic, fragrances and flavours.
11. Remington’s Pharmaceutical sciences.
12. Text Book of Biotechnology by Vyas and Dixit.
13. Text Book of Biotechnology by R.C. Dubey.
114
SEMESTER VI
115
BP601T MEDICINAL CHEMISTRY – III (Theory) 3 L + 1T / Week
Scope: This subject is designed to impart fundamental knowledge on the
structure,chemistry and therapeutic value of drugs. The subject emphasis on modern
techniques of rational drug design like quantitative structure activity relationship
(QSAR), Prodrug concept, combinatorial chemistry and Computer aided drug design
(CADD). The subject also emphasizes on the chemistry, mechanism of action,
metabolism, adverse effects, Structure Activity Relationships (SAR), therapeutic uses
and synthesis of important drugs.
Objectives: Upon completion of the course student shall be able to
1. Understand the importance of drug design and different techniques of drug
design.
2. Understand the chemistry of drugs with respect to their biological activity.
3. Know the metabolism, adverse effects and therapeutic value of drugs.
4. Know the importance of SAR of drugs.
118
BP602T PHARMACOLOGY-III (Theory) 3 L + 1T / Week
Scope: This subject is intended to impart the fundamental knowledge on various
aspects(classification, mechanism of action, therapeutic effects, clinical uses, side effects and
contraindications) of drugs acting on respiratory and gastrointestinal system,
infectiousdiseases, immuno-pharmacology and in addition, emphasis on the principles of
toxicology and chronopharmacology.
Objectives: Upon completion of this course the student should be able to:
1. understand the mechanism of drug action and its relevance in the treatment of
different infectious diseases
2. comprehend the principles of toxicology and treatment of various poisonings and
3. appreciate correlation of pharmacology with related medical sciences
a. Immunostimulants
b. Immunosuppressant
c. Protein drugs, monoclonal antibodies, target drugs to
d. antigen, biosimilars
5 UNIT V 07
5.1 Principles of toxicology 6
a. Definition and basic knowledge of acute, subacute and chronic toxicity.
b. Definition and basic knowledge of genotoxicity, carcinogenicity,
teratogenicity and mutagenicity
c. General principles of treatment of poisoning
d. Clinical symptoms and management of barbiturates, morphine,
organophosphosphorus compound and lead, mercury and arsenic
poisoning
5.2 Chronopharmacology 1
a. Definition of rhythm and cycles.
b. Biological clock and their significance leading to chronotherapy
Total 45
121
BP603T HERBAL DRUG TECHNOLOGY (Theory) 3 L + 1T / Week
Scope: This subject gives the student the knowledge of basic understanding of herbal
drugindustry, the quality of raw material, guidelines for quality of herbal drugs, herbal
cosmetics, natural sweeteners, nutraceutical etc. The subject also emphasizes on Good
Manufacturing Practices (GMP), patenting and regulatory issues of herbal drugs
Objectives: Upon completion of this course the student should be able to:
1. understand raw material as source of herbal drugs from cultivation to herbal drug product
2. know the WHO and ICH guidelines for evaluation of herbal drugs
3. know the herbal cosmetics, natural sweeteners, nutraceuticals
4. appreciate patenting of herbal drugs, GMP .
122
3 UNIT III 10
3.1 Herbal Cosmetics 4
Sources and description of raw materials of herbal origin used via, fixed oils,
waxes, gums colours, perfumes, protective agents, bleaching agents,
antioxidants in products such as skin care, hair care and oral hygiene
products.
3.2 Herbal excipients: 3
Herbal Excipients – Significance of substances of natural origin as excipients
– colorants, sweeteners, binders, diluents, viscosity builders, disintegrants,
flavors & perfumes.
3.3 Herbal formulations : 3
Conventional herbal formulations like syrups, mixtures and tablets and
Novel dosage forms like phytosomes
4 UNIT IV 10
4.1 Evaluation of Drugs WHO & ICH guidelines for the assessment of herbal 2
drugsStability testing of herbal drugs.
4.2 Patenting and Regulatory requirements of natural products: 5
a. Definition of the terms: Patent, IPR, Farmers right, Breeder’s right,
Bioprospecting and Biopiracy
b. Patenting aspects of Traditional Knowledge and Natural Products.
Case study of Curcuma & Neem.
4.3 Regulatory Issues - Regulations in India (ASU DTAB, ASU DCC), 3
Regulation ofmanufacture of ASU drugs - Schedule Z of Drugs & Cosmetics
Act for ASU drugs
5 UNIT V 07
5.1 General Introduction to Herbal Industry 3
Herbal drugs industry: Present scope and future prospects.
A brief account of plant based industries and institutions involved in work on
medicinal and aromatic plants in India.
5.2 Schedule T–Good Manufacturing Practice of Indian systems of medicine 4
Components of GMP (Schedule – T) and its objectives
Infrastructural requirements, working space, storage area, machinery and
equipments, standard operating procedures, health and hygiene,
documentation and records.
Total 45
124
BP604T BIOPHARMACEUTICS AND PHARMACOKINETICS (Theory)
3 L + 1T / Week
Scope:This subject is designed to impart knowledge and skills of Biopharmaceuticsand
pharmacokinetics and their applications in pharmaceutical development, design of dose and
dosage regimen and in solving the problems arised therein.
Objectives: Upon completion of the course student shall be ableto:
1. Understand the basic concepts in biopharmaceutics and pharmacokinetics and their
significance.
2. Use of plasma drug concentration-time data to calculate the pharmacokinetic parameters
to describe the kinetics of drug absorption, distribution, metabolism, excretion,
elimination.
3. To understand the concepts of bioavailability and bioequivalence of drug products and
their significance.
4. Understand various pharmacokinetic parameters, their significance & applications
126
BP605T PHARMACEUTICAL BIOTECHNOLOGY (Theory) 3 L + 1T / Week
Scope:
127
3 UNIT III 10
Types of immunity- humoral immunity, cellular immunity
a. Structure of Immunoglobulins
b. Structure and Function of MHC
c. Hypersensitivity reactions, Immune stimulation and Immune suppressions
d. General method of the preparation of bacterial vaccines, toxoids, viral
vaccine, antitoxins, serum-immune blood derivatives and other products
relative to immunity
e. Storage conditions and stability of official vaccines
f. Hybridoma technology- Production, Purification and Applications
g. Blood products and Plasma Substitutes
4 UNIT IV 08
4.1 Immuno blotting techniques- ELISA, Western blotting, Southern blotting. 2
4.2 Genetic organization of Eukaryotes and Prokaryotes 1
4.3 Microbial genetics including transformation, transduction, conjugation, 2
plasmids and transposons
4.4 Introduction to Microbial biotransformation and applications 2
4.5 Mutation.: Types of mutation/ mutants 1
5 UNIT V 07
5.1 Fermentation methods and general requirements, study of media, equipments, 2
sterilization methods, aeration process, stirring.
5.2 Large scale production fermenter design and its various controls. 1
5.3 Study of the production of - penicillins, citric acid, Vitamin B12, Glutamic 2
acid, Griseofulvin
5.4 Blood product collection, Processing and storage of whole volume blood, 2
dries=d human plasma, plasma substituents
Total 45
Reference Books (Latest Editions to be adopted)
1. B.R. Glick and J.J. Pasternak: Molecular Biotechnology: Principles and Applicationsof
RecombinantDNA: ASM Press Washington D.C.
2. RA Goldshy et. al., : Kuby Immunology.
3. J.W. Goding: Monoclonal Antibodies.
4. J.M. Walker and E.B. Gingold: Molecular Biology and Biotechnology by Royal Society
of Chemistry.
5. Zaborsky: Immobilized Enzymes, CRC Press, Degraland, Ohio.
6. S.B. Primrose: Molecular Biotechnology (Second Edition) Blackwell Scientific
Publication.
7. Stanbury F., P., Whitakar A., and Hall J., S., Principles of fermentation technology, 2nd
edition, Aditya books Ltd., New Delhi
128
BP606T PHARMACEUTICAL QUALITY ASSURANCE (Theory)
3 L + 1T / Week
Scope: This course deals with the various aspects of quality control and qualityassurance
aspects of pharmaceutical industries. It deals with the important aspects like cGMP, QC tests,
documentation, quality certifications and regulatory affairs.
Objectives: Upon completion of the course student shall be able to:
1. understand the cGMP aspects in a pharmaceutical industry
2. appreciate the importance of documentation
3. understand the scope of quality certifications applicable to pharmaceutical industries
4. understand the responsibilities of QA & QC departments
Sr. Content Hours
No.
1 UNIT I 10
1.1 Quality Assurance and Quality Management concepts: Definition and 4
concept of Quality control, Quality assurance and GMP
1.2 Total Quality Management (TQM): Definition, elements, philosophies 2
1.3 ICH Guidelines: purpose, participants, process of harmonization, Brief 2
overview of QSEM,with special emphasis on Q-series guidelines, ICH
stability testing guidelines
1.4 QbD: Definition, overview, elements of QbD program, tools 1
ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for
registration
1.5 NABL accreditation : Principles and procedure 1
2 UNIT II 10
2.1 Organization and personnel: Personnel responsibilities, training, hygiene 5
and personal records. Premises: Design, construction and plant layout,
maintenance, sanitation, environmentalcontrol, utilities and maintenance of
sterile areas, control of contamination.
2.2 Equipments and raw materials: Equipments selection, purchase 5
specifications, maintenance,purchase specifications and maintenance of
stores for raw materials
3 UNIT III 10
3.1 Quality Control: Quality control test for containers, rubber closures and 5
secondary packing materials
3.2 Good Laboratory Practices: General Provisions, Organization and 5
Personnel, Facilities,Equipment, Testing Facilities Operation, Test and
129
Control Articles, Protocol for Conduct of a Nonclinical Laboratory Study,
Records and Reports, Disqualification of Testing Facilities
4 UNIT IV 08
4.1 Complaints: Complaints and evaluation of complaints, Handling of return 2
good, recalling andwaste disposal.
4.2 Document maintenance in pharmaceutical industry: Batch Formula 6
Record, Master Formula
Record, SOP, Quality audit, Quality Review and Quality documentation,
Reports and documents, distribution records.
5 UNIT V 07
5.1 Calibration and Validation: Introduction, definition and general principles 6
of calibration,qualification and validation, importance and scope of
validation, types of validation, validation master plan. Calibration of pH
meter, Qualification of UV-Visible spectrophotometer, General principles
of Analytical method Validation.
5.2 Warehousing: Good warehousing practice, materials management 1
Total 45
130
BP607P MEDICINAL CHEMISTRY- III (Practical) 4 Hours / week
131
BP608P PHARMACOLOGY-III (Practical) 4Hrs/Week
133
SEMESTER VII
134
BP701T INSTRUMENTAL METHODS OF ANALYSIS (Theory) 3L + 1T / week
Scope: This subject deals with the application of instrumental methods in qualitative
andquantitative analysis of drugs. This subject is designed to impart a fundamental
knowledge on the principles and instrumentation of spectroscopic and chromatographic
technique. This also emphasizes on theoretical and practical knowledge on modern
analytical instruments that are used for drug testing.
Objectives: Upon completion of the course the student shall be able to:
1. Understand the interaction of matter with electromagnetic radiations and its
applications in drug analysis
2. Understand the chromatographic separation and analysis of drugs.
3. Perform quantitative & qualitative analysis of drugs using various analytical
instruments.
Reference Books:
1. Instrumental Methods of Chemical Analysis by B.K Sharma
2. Organic spectroscopy by Y.R Sharma
3. Text book of Pharmaceutical Analysis by Kenneth A. Connors
4. Vogel’s Text book of Quantitative Chemical Analysis by A.I. Vogel
5. Practical Pharmaceutical Chemistry by A.H. Beckett and J.B. Stenlake
6. Organic Chemistry by I. L. Finar
7. Organic spectroscopy by William Kemp
8. Quantitative Analysis of Drugs by D. C. Garrett
9. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P. D. Sethi
10. Spectrophotometric identification of Organic Compounds by Silverstein
136
BP702T INDUSTRIAL PHARMACY II (Theory) 3L + 1T / week
Scope: This course is designed to impart fundamental knowledge on
pharmaceuticalproduct development and translation from laboratory to market
Objectives: Upon completion of the course, the student shall be able to:
1. Know the process of pilot plant and scale up of pharmaceutical dosage forms
2. Understand the process of technology transfer from lab scale to commercial batch
3. Know different Laws and Acts that regulate pharmaceutical industry
4. Understand the approval process and regulatory requirements for drug products
137
Drug Application (NDA), Clinical research / BE studies, Clinical
Research Protocols, Biostatistics in Pharmaceutical Product
Development, Data Presentation for FDA Submissions, Management
of Clinical Studies.
4 UNIT –IV 8
Quality management systems: Quality management & Certifications:
Concept ofQuality, Total Quality Management, Quality by design, Six
Sigma concept, Out of Specifications (OOS), Change control,
Introduction to ISO 9000 series of quality systems standards, ISO
14000, NABL, GLP
5 UNIT –V 7
Indian Regulatory Requirements: Central Drug Standard Control
Organization(CDSCO) and State Licensing Authority: Organization,
Responsibilities, Common Technical Document (CTD), Certificate of
Pharmaceutical Product (COPP), Regulatory requirements and
approval procedures for New Drugs.
45
Recommended Books: (Latest Editions)
1. Regulatory Affairs from Wikipedia, the free encyclopedia modified on 7th April available
at http,//en.wikipedia.org/wiki/Regulatory_ Affairs.
2. International Regulatory Affairs Updates, 2005. available at
http://www.iraup.com/about.php
3. Douglas J Pisano and David S. Mantus. Text book of FDA Regulatory Affairs A Guide
for Prescription Drugs, Medical Devices, and Biologics’ Second Edition.
4. Regulatory Affairs brought by learning plus, inc. available at
http.//www.cgmp.com/ra.htm.
138
BP703T PHARMACY PRACTICE (Theory) 3L + 1T / week
Scope: In the changing scenario of pharmacy practice in India, for successful practice
ofHospital Pharmacy, the students are required to learn various skills like drug distribution,
drug information, and therapeutic drug monitoring for improved patient care. In community
pharmacy, students will be learning various skills such as dispensing of drugs, responding to
minor ailments by providing suitable safe medication, patient counselling for improved
patient care in the community set up.
Objectives: Upon completion of the course, the student shall be able to
1. know various drug distribution methods in a hospital
2. appreciate the pharmacy stores management and inventory control
3. monitor drug therapy of patient through medication chart review and clinical review
4. obtain medication history interview and counsel the patients
5. identify drug related problems
6. detect and assess adverse drug reactions
7. interpret selected laboratory results (as monitoring parameters in therapeutics) of specific
disease states
8. know pharmaceutical care services
9. do patient counseling in community pharmacy;
10. appreciate the concept of Rational drug therapy.
Sr. Content Hours
No.
1. UNIT –I 10
1.1 Hospital and it’s organization 2
Definition, Classification of hospital- Primary, Secondary and Tertiary
hospitals, Classification based on clinical and non- clinical basis,
Organization Structure of a Hospital, and Medical staffs involved in the
hospital and their functions.
1.2 Hospital pharmacy and its organization 2
Definition, functions of hospital pharmacy, Organization structure,
Location, Layout and staff requirements, and Responsibilities and
functions of hospital pharmacists.
1.3 Adverse drug reaction 3
Classifications - Excessive pharmacological effects, secondary
pharmacological effects, idiosyncrasy, allergic drug reactions, genetically
determined toxicity, toxicity following sudden withdrawal of drugs, Drug
interaction- beneficial interactions, adverse interactions, and
pharmacokinetic drug interactions, Methods for detecting drug interactions,
spontaneous case reports and record linkage studies, and Adverse drug
139
reaction reporting and management.
1.4 Community Pharmacy 3
Organization and structure of retail and wholesale drug store, types and
design, Legal requirements for establishment and maintenance of a drug
store, Dispensing of proprietary products, maintenance of records of retail
and wholesale drug store
2 UNIT –II 10
2.1 Drug distribution system in a hospital 2
Dispensing of drugs to inpatients, types of drug distribution systems,
charging policy and labelling, Dispensing of drugs to ambulatory patients,
and Dispensing of controlled drugs.
2.2 Hospital formulary 2
Definition, contents of hospital formulary, Differentiation of hospital
formulary and Drug list, preparation and revision, and addition and
deletion of drug from hospital formulary.
2.3 Therapeutic drug monitoring 2
Need for Therapeutic Drug Monitoring, Factors to be considered during the
Therapeutic Drug Monitoring, and Indian scenario for Therapeutic Drug
Monitoring.
2.4 Medication adherence 1
Causes of medication non-adherence, pharmacist role in the medication
adherence, and monitoring of patient medication adherence.
2.5 Patient medication history interview 1
Need for the patient medication history interview, medication interview
forms.
2.6 Community pharmacy management 2
Financial, materials, staff, and infrastructure requirements.
3 UNIT –III 10
3.1 Pharmacy and therapeutic committee 2
Organization, functions, Policies of the pharmacy and therapeutic
committee in including drugs into formulary, inpatient and outpatient
prescription, automatic stop order, and emergency drug list preparation.
3.2 Drug information services 1
Drug and Poison information centre, Sources of drug information,
Computerised services, and storage and retrieval of information
3.3 Patient counseling 2
Definition of patient counseling; steps involved in patient
counseling, and Special cases that require the pharmacist
3.4 Education and training program in the hospital 3
140
Role of pharmacist in the education and training program, Internal and
external training program, Services to the nursing homes/clinics, Code
of ethics for community pharmacy, and Role of pharmacist in the
interdepartmental communication and community health education
3.5 Prescribed medication order and communication skills 2
Prescribed medication order- interpretation and legal requirements, and
Communication skills- communication with prescribers and patients.
4 UNIT –IV 8
4.1 Budget preparation and implementation 2
Budget preparation and implementation
4.2 Clinical Pharmacy 5
Introduction to Clinical Pharmacy, Concept of clinical pharmacy, functions
and responsibilities of clinical pharmacist, Drug therapy monitoring -
medication chart review, clinical review, pharmacist intervention, Ward
round participation, Medication history and Pharmaceutical care
4.3 Over the counter (OTC) sales 1
Introduction and sale of over the counter, and Rational use of common
over the counter medications.
5 UNIT –V 7
5.1 Drug store management and inventory control 3
Organisation of drug store, types of materials stocked and storage
conditions, Purchase and inventory control: principles, purchase procedure,
purchase order, procurement and stocking, Economic order quantity,
Reorder quantity level, and Methods used for the analysis of the drug
expenditure
5.2 Investigational use of drugs 2
Description, principles involved, classification, control, identification, role
of hospital pharmacist, advisory committee
5.3 Interpretation of Clinical Laboratory Tests 2
Blood chemistry, hematology, and urinalysis
45
Recommended Books (Latest Edition):
1. Merchant S.H. and Dr. J.S.Quadry. A textbook of hospital pharmacy, 4th ed. Ahmadabad:
B.S. Shah Prakakshan; 2001.
2. Parthasarathi G, Karin Nyfort-Hansen, Milap C Nahata. A textbook of ClinicalPharmacy
Practice- essential concepts and skills, 1sted. Chennai: OrientLongman Private Limited;
2004.
3. William E. Hassan. Hospital pharmacy, 5th ed. Philadelphia: Lea & Febiger; 1986.
4. Tipnis Bajaj. Hospital Pharmacy, 1st ed. Maharashtra: Career Publications; 2008.
141
5. Scott LT. Basic skills in interpreting laboratory data, 4thed. American Society of Health
System Pharmacists Inc; 2009.
6. Parmar N.S. Health Education and Community Pharmacy, 18th ed. India: CBS Publishers
& Distributers; 2008.
Journals:
1. Therapeutic drug monitoring. ISSN: 0163-4356
2. Journal of pharmacy practice. ISSN : 0974-8326
3. American journal of health system pharmacy. ISSN: 1535-2900 (online)
4. Pharmacy times (Monthly magazine)
142
BP704T NOVEL DRUG DELIVERY SYSTEMS (Theory) 3L + 1T / week
Scope: This subject is designed to impart basic knowledge on the area of novel drugdelivery
systems.
Objectives: Upon completion of the course student shall be able
1. To understand various approaches for development of novel drug delivery systems.
2. To understand the criteria for selection of drugs and polymers for the development of Novel
drug delivery systems, their formulation and evaluation
143
Pulmonary routes ofdrug delivery, Formulation of Inhalers (dry powder and
metered dose), nasal sprays, nebulizers
4 UNIT –IV 8
Nanotechnology and its Concepts: Concepts and approaches for targeted
drug deliverysystems, advantages and disadvantages, introduction to
liposomes, niosomes, nanoparticles, monoclonal antibodies and their
applications
5 UNIT –V 7
5.1 Ocular Drug Delivery Systems: Introduction, intra ocular barriers and 5
methods toovercome –Preliminary study, ocular formulations and ocuserts
5.2 Intrauterine Drug Delivery Systems: Introduction, advantages and 2
disadvantages,development of intra uterine devices (IUDs) and
45
144
BP705P INSTRUMENTAL METHODS OF ANALYSIS (Practical) 4 Hours/Week
1 Determination of absorption maxima and effect of solvents on absorption
maxima of organic compounds
2 Estimation of dextrose by colorimetry
3 Estimation of sulfanilamide by colorimetry
4 Simultaneous estimation of ibuprofen and paracetamol by UV spectroscopy
5 Assay of paracetamol by UV- Spectrophotometry
6 Estimation of quinine sulfate by fluorimetry
7 Study of quenching of fluorescence
8 Determination of sodium by flame photometry
9 Determination of potassium by flame photometry
10 Determination of chlorides and sulphates by nephelo turbidometry
11 Separation of amino acids by paper chromatography
12 Separation of sugars by thin layer chromatography
13 Separation of plant pigments by column chromatography
14 Demonstration experiment on HPLC
15 Demonstration experiment on Gas Chromatography
145
SEMESTER VIII
146
BP801T BIOSTATISITCS AND RESEARCH METHODOLOGY (Theory)
3L + 1T / week
147
3.1 Non Parametric tests: Wilcoxon Rank Sum Test, Mann-Whitney U test, 2
Kruskal-Wallistest, Friedman Test
3.2 Introduction to Research: Need for research, Need for design of 3
Experiments,Experiential Design Technique, plagiarism
3.3 Graphs: Histogram, Pie Chart, Cubic Graph, response surface plot, Counter 2
Plot graph
3.4 Designing the methodology: Sample size determination and Power of a 3
study, Reportwriting and presentation of data, Protocol, Cohorts studies,
Observational studies, Experimental studies, Designing clinical trial, various
phases.
4 UNIT –IV 8
4.1 Blocking and confounding system for Two-level factorials 2
4.2 Regression modeling: Hypothesis testing in Simple and Multiple 2
regressionmodels
4.3 Introduction to Practical components of Industrial and Clinical Trials 4
problems:Statistical Analysis Using Excel, SPSS, MINITAB®, DESIGN
OF EXPERIMENTS, R - Online Statistical Software’s to Industrial and
Clinical trial approach
5 UNIT –V 7
5.1 Design and Analysis of experiment- Factorial Design: Definition, 22, 3
23design. Advantage of factorial design
5.2 Response Surface methodology: Central composite design, Historical 4
design,Optimization Techniques
45
148
BP802T SOCIAL AND PREVENTIVE PHARMACY 3L + 1T / week
Scope: The purpose of this course is to introduce to students a number of health issues and
their challenges. This course also introduced a number of national health programmes. The
roles of the pharmacist in these contexts are also discussed.
Objectives:After the successful completion of this course, the student shall be able to:
1. Acquire high consciousness/realization of current issuesrelated to health and
pharmaceutical problems within the country and worldwide.
2. Have a critical way of thinking based on current healthcare development.
3. Evaluate alternative ways of solving problems related tohealth and pharmaceutical issues
149
family welfare programme, National tobacco control programme, National
Malaria Prevention Program, National programme for the health care for the
elderly, Social health programme; role of WHO in Indian national program
5 UNIT –V 7
Community services in rural, urban and school health: Functions of PHC,
Improvement in rural sanitation, national urban health mission, Health
promotion and education in school.
45
Recommended Journals:
1. Research in Social and Administrative Pharmacy, Elsevier, Ireland
150
BP803ET PHARMACEUTICAL MARKETING MANAGEMENT(Theory) -
ELECTIVE 3L + 1T Hours / week
Scope: The pharmaceutical industry not only needs highly qualified researchers, chemists
and, technical people, but also requires skilled managers who can take the industry forward by
managing and taking the complex decisions which are imperative for the growth of the
industry. The Knowledge and Know-how of marketing management groom the people for
taking a challenging role in Sales and Product management.
Objective: The course aims to provide an understanding of marketing conceptsand techniques
and their applications in the pharmaceutical industry.
152
BP804ETPHARMACEUTICAL REGULATORY SCIENCE (Theory) - ELECTIVE
3L + 1T Hours / week
Scope: This course is designed to impart the fundamental knowledge on the
regulatoryrequirements for approval of new drugs, and drug products in regulated markets of
India & other countries like US, EU, Japan, Australia, UK etc. It prepares the students to learn
in detail on the regulatory requirements, documentation requirements, and registration
procedures for marketing the drug products.
Objectives: Upon completion of the subject student shall be able to;
1. Know about the process of drug discovery and development
2. Know the regulatory authorities and agencies governing the manufacture and sale of
pharmaceuticals
3. Know the regulatory approval process and their registration in Indian and international
markets
Sr. Content Hours
No.
1 UNIT I 10
New Drug Discovery and development
Stages of drug discovery, Drug development process, pre-clinical
studies, non-clinical activities, clinical studies, Innovator and generics,
Concept of generics, Generic drug product development.
2 UNIT –II 10
2.1 Regulatory Approval Process 6
Approval processes and timelines involved in Investigational New
Drug (IND), New Drug Application (NDA), Abbreviated New Drug
Application (ANDA) in US. Changes to an approved NDA / ANDA.
2.2 Regulatory authorities and agencies 4
Overview of regulatory authorities of United States, European Union,
Australia, Japan, Canada (Organization structure and types of
applications)
3 UNIT –III 10
Registration of Indian drug product in overseas market
Procedure for export of pharmaceutical products, Technical
documentation, Drug Master Files (DMF), Common Technical
Document (CTD), electronic Common Technical Document (eCTD),
ASEAN Common Technical Document (ACTD)research
4 UNIT –IV 8
Clinical trials
153
Developing clinical trial protocols, Institutional Review Board /
Independent Ethics committee - formation and working procedures,
Informed consent process and procedures, GCP obligations of
Investigators, sponsors & Monitors, Managing and Monitoring clinical
trials, Pharmacovigilance - safety monitoring in clinical trials
5 UNIT –V 7
Regulatory Concepts
Basic terminologies, guidance, guidelines, regulations, laws and acts,
Orange book, Federal Register, Code of Federal Regulatory, Purple
book
45
154
BP805ET PHARMACOVIGILANCE (Theory) - ELECTIVE 3L + 1T Hours /
week
Scope: This paper will provide an opportunity for the student to learn about development
ofpharmacovigilance as a science, basic terminologies used in pharmacovigilance, global
scenario of Pharmacovigilance, train students on establishing pharmacovigilance programme
in an organization, various methods that can be used to generate safety data and signal
detection. This paper also develops the skills of classifying drugs, diseases and adverse drug
reactions.
Objectives:
At completion of this paper it is expected that students will be able to (know, do, and
appreciate):
1. Why drug safety monitoring is important?
2. History and development of pharmacovigilance
3. National and international scenario of pharmacovigilance
4. Dictionaries, coding and terminologies used in pharmacovigilance
5. Detection of new adverse drug reactions and their assessment
6. International standards for classification of diseases and drugs
7. Adverse drug reaction reporting systems and communication in pharmacovigilance
8. Methods to generate safety data during preclinical, clinical and post approval phases of
drugs’ life cycle
9. Drug safety evaluation in paediatrics, geriatrics, pregnancy and lactation
10. Pharmacovigilance Program of India (PvPI) requirement for ADR reporting in India
11. ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning
12. CIOMS requirements for ADR reporting
13. Writing case narratives of adverse events and their quality.
155
Severity and seriousness assessment
Predictability and preventability assessment
Management of adverse drug reactions
1.3 Basic terminologies used in pharmacovigilance 2
Terminologies of adverse medication related events
Regulatory terminologies
2 UNIT –II 10
2.1 Drug and disease classification 3
Anatomical, therapeutic and chemical classification of drugs
International classification of diseases
Daily defined doses
International Non proprietary Names for drugs
2.2 Drug dictionaries and coding in pharmacovigilance 3
WHO adverse reaction terminologies
MedDRA and Standardised MedDRA queries
WHO drug dictionary
Eudravigilance medicinal product dictionary
2.3 Information resources in pharmacovigilance 2
Basic drug information resources
Specialised resources for ADRs
2.4 Establishing pharmacovigilance programme 2
Establishing in a hospital
Establishment & operation of drug safety department in industry
Contract Research Organisations (CROs)
Establishing a national programme
3 UNIT –III 10
3.1 Vaccine safety surveillance 3
Vaccine Pharmacovigilance
Vaccination failure
Adverse events following immunization
3.2 Pharmacovigilance methods 5
Passive surveillance – Spontaneous reports and case series
Stimulated reporting
Active surveillance – Sentinel sites, drug event monitoring and
registries
Comparative observational studies – Cross sectional study, case
156
control study and cohort study
Targeted clinical investigations
3.3 Communication in pharmacovigilance 2
Effective communication in Pharmacovigilance
Communication in Drug Safety Crisis management
Communicating with Regulatory Agencies, Business Partners,
Healthcare facilities & Media
4 UNIT –IV 8
4.1 Statistical methods for evaluating medication safety data Safety 3
data generation
Preclinical phase
Clinical phase
Post approval phase
4.2 ICH Guidelines for Pharmacovigilance 5
Organization and objectives of ICH
Expedited reporting
Individual case safety reports
Periodic safety update reports
Post approval expedited reporting
Pharmacovigilance planning
Good clinical practice in pharmacovigilance studies
5 Unit V 7
5.1 Pharmacogenomics of adverse drug reactions 3
Genetics related ADR with example focusing PK parameters
5.2 Drug safety evaluation in special population 2
Paediatrics
Pregnancy and lactation
Geriatrics
5.3 CIOMS 1
CIOMS Working Groups
CIOMS Form
5.4 CDSCO (India) and Pharmacovigilance 1
D&C Act and Schedule Y
Differences in Indian and global pharmacovigilance requirements
45
Recommended Books (Latest edition):
1. Textbook of Pharmacovigilance: S K Gupta, Jaypee Brothers, Medical Publishers.
157
2. Practical Drug Safety from A to Z By Barton Cobert, Pierre Biron, Jones and Bartlett
Publishers.
3. Mann's Pharmacovigilance:Elizabeth B. Andrews, Nicholas, Wiley Publishers.
4. Stephens' Detection of New Adverse Drug Reactions: John Talbot, Patrick Walle, Wiley
Publishers.
5. An Introduction to Pharmacovigilance: Patrick Waller,Wiley Publishers.
6. Cobert's Manual of Drug Safety and Pharmacovigilance: Barton Cobert,Jones& Bartlett
Publishers.
7. Textbook of Pharmacoepidemiolog edited by Brian L. Strom, Stephen E Kimmel, Sean
Hennessy,Wiley Publishers.
8. A Textbook of Clinical Pharmacy Practice -Essential Concepts and Skills:G.
Parthasarathi, Karin NyfortHansen,Milap C. Nahata
9. National Formulary of India
10. Text Book of Medicine by Yashpal Munjal
11. Text book of Pharmacovigilance: concept and practice by GP Mohanta and PK Manna
12. http://www.whoumc.org/DynPage.aspx?id=105825&mn1=7347&mn2=7259&mn3=7297
13. http://www.ich.org/
14. http://www.cioms.ch/
15. http://cdsco.nic.in/
16. http://www.who.int/vaccine_safety/en/
17. http://www.ipc.gov.in/PvPI/pv_home.html
158
BP806ETQUALITY CONTROL AND STANDARDIZATION OF HERBALS
(Theory)– ELECTIVE 3L + 1T Hours / week
Scope: In this subject the student learns about the various methods and guidelines
forevaluation and standardization of herbs and herbal drugs. The subject also provides
anopportunity for the student to learn cGMP, GAP and GLP in traditional system
ofmedicines.
Objectives: Upon completion of the subject student shall be able to;
1. know WHO guidelines for quality control of herbal drugs
2. know Quality assurance in herbal drug industry
3. know the regulatory approval process and their registration in Indian and
international markets
4. appreciate EU and ICH guidelines for quality control of herbal drugs
159
Regulatory requirements for herbal medicines.
WHO guidelines on safety monitoring of herbal medicines in
pharmacovigilance systems
Comparison of various Herbal Pharmacopoeias.
Role of chemical and biological markers in standardization of herbal
products
45
160
BP807ET COMPUTER AIDED DRUG DESIGN (Theory)- ELECTIVE
3L + 1T / week
Scope: This subject is designed to provide detailed knowledge of rational drug designprocess
and various techniques used in rational drug design process.
Objectives: Upon completion of the course, the student shall be able to understand
1. Design and discovery of lead molecules
2. The role of drug design in drug discovery process
3. The concept of QSAR and docking
4. Various strategies to develop new drug like molecules.
5. The design of new drug molecules using molecular modelling software
Sr. Content Hours
No.
1 UNIT I 10
1.1 Introduction to Drug Discovery and Development 2
Stages of drug discovery and development
1.2 Lead discovery and Analog Based Drug Design 4
Rational approaches to lead discovery based on traditional medicine,
Random screening, Non-random screening, serendipitous drug
discovery, lead discovery based on drug metabolism, lead discovery
based on clinical observation.
1.3 Analog Based Drug Design:Bioisosterism, Classification, 4
Bioisostericreplacement. Any three case studies
2 UNIT –II 10
Quantitative Structure Activity Relationship (QSAR)
SAR versus QSAR, History and development of QSAR, Types of
physicochemical parameters, experimental and theoretical approaches
for the determination of physicochemical parameters such as Partition
coefficient, Hammet’s substituent constant and Tafts steric constant.
Hansch analysis, Free Wilson analysis, 3D-QSAR approaches like
COMFA and COMSIA.
3 UNIT –III - Molecular Modeling and virtual screening techniques 10
3.1 Virtual Screening techniques: Drug likeness screening, Concept 6
ofpharmacophore mapping and pharmacophore based Screening,
3.2 Molecular docking: Rigid docking, flexible docking, manual 4
docking,Docking based screening. De novo drug design.
4 UNIT –IV 8
Informatics & Methods in drug design
161
Introduction to Bioinformatics, chemoinformatics. ADME databases,
chemical, biochemical and pharmaceutical databases.
5 UNIT –V 7
Molecular Modeling: Introduction to molecular mechanics and
quantummechanics. Energy Minimization methods and
Conformational Analysis, global conformational minima
determination.
45
162
BP808ET CELL AND MOLECULAR BIOLOGY (Theory)- ELECTIVE
3L + 1T / week
Scope:
Cell biology is a branch of biology that studies cells – their physiological properties,
their structure, the organelles they contain, interactions with their environment, their life
cycle, division, death and cell function.
This is done both on a microscopic and molecular level.
Cell biology research encompasses both the great diversity of single-celled organisms
like bacteria and protozoa, as well as the many specialized cells in multi-cellular
organismssuch as humans, plants, and sponges.
Objectives: Upon completion of the subject student shall be able to;
1. Summarize cell and molecular biology history.
2. Summarize cellular functioning and composition.
3. Describe the chemical foundations of cell biology.
4. Summarize the DNA properties of cell biology.
5. Describe protein structure and function.
6. Describe cellular membrane structure and function.
7. Describe basic molecular genetic mechanisms.
8. Summarize the Cell Cycle
References
1. Harry’s Cosmeticology, Wilkinson, Moore, Seventh Edition, George Godwin.
2. Cosmetics – Formulations, Manufacturing and Quality Control, P.P. Sharma, 4th Edition,
Vandana Publications Pvt. Ltd., Delhi.
3. Text book of cosmelicology by Sanju Nanda & Roop K. Khar, Tata Publishers.
166
BP810ET EXPERIMENTAL PHARMACOLOGY- ELECTIVE 3L + 1T/ week
Scope:This subject is designed to impart the basic knowledge of preclinical studies
inexperimental animals including design, conduct and interpretations of results.
Objectives: Upon completion of the course the student shall be able to,
1. Appreciate the applications of various commonly used laboratory animals.
2. Appreciate and demonstrate the various screening methods used in preclinical research
3. Appreciate and demonstrate the importance of biostatistics and research methodology
4. Design and execute a research hypothesis independently
168
BP8011ETADVANCED INSTRUMENTATION TECHNIQUES (Theory) –
ELECTIVE3L + 1T / week
Scope: This subject deals with the application of instrumental methods in qualitative
andquantitative analysis of drugs. This subject is designed to impart advanced knowledge
on the principles and instrumentation of spectroscopic and chromatographic hyphenated
techniques. This also emphasizes on theoretical and practical knowledge on modern
analytical instruments that are used for drug testing.
Objectives: Upon completion of the course the student shall be able to
1. understand the advanced instruments used and its applications in drug analysis
2. understand the chromatographic separation and analysis of drugs.
3. understand the calibration of various analytical instruments
4. know analysis of drugs using various analytical instruments
170
BP8012ET DIETARY SUPPLEMENTS AND NUTRACEUTICALS (Theory)
- ELECTIVE
3L + 1T/ Week
Scope: This subject covers foundational topic that are important for understanding the
need and requirements of dietary supplements among different groups in the population.
Objective: This module aims to provide an understanding of the concepts behind the
theoretical applications of dietary supplements. By the end of the course, students should
be able to:
1. Understand the need of supplements by the different group of people to
maintain healthy life.
2. Understand the outcome of deficiencies in dietary supplements.
3. Appreciate the components in dietary supplements and the application.
4. Appreciate the regulatory and commercial aspects of dietary supplements
including health claims.
171
Phytochemicals as nutraceuticals: Occurrence and characteristic
features(chemical nature medicinal benefits) of following:
a) Carotenoids- α and β-Carotene, Lycopene, Xanthophylls, leutin
b) Sulfides: Diallyl sulfides, Allyl trisulfide.
c) Polyphenolics: Reservetrol
d) Flavonoids- Rutin , Naringin, Quercitin, Anthocyanidins, catechins,
Flavones
e) Prebiotics / Probiotics.: Fructo oligosaccharides, Lacto bacillum
f) Phyto estrogens : Isoflavones, daidzein, Geebustin, lignans
g) Tocopherols
h) Proteins, vitamins, minerals, cereal, vegetables and beverages as
functional foods: oats, wheat bran, rice bran, sea foods, coffee, tea and
the like.
3 UNIT –III 10
a) Introduction to free radicals: Free radicals, reactive oxygen species,
production of free radicals in cells, damaging reactions of free radicals on
lipids, proteins, Carbohydrates, nucleic acids.
b) Dietary fibres and complex carbohydrates as functional food
ingredients..
4 UNIT –IV 8
a) Free radicals in Diabetes mellitus, Inflammation, Ischemic reperfusion
injury, Cancer, Atherosclerosis, Free radicals in brain metabolism and
pathology, kidney
damage, muscle damage. Free radicals involvement in other disorders. Free
radicals theory of ageing.
b) Antioxidants: Endogenous antioxidants – enzymatic and nonenzymatic
antioxidant defence, Superoxide dismutase, catalase, Glutathione
peroxidase, Glutathione Vitamin C, Vitamin E, α- Lipoic acid, melatonin
Synthetic antioxidants: Butylated hydroxy Toluene, Butylated hydroxy
Anisole.
c) Functional foods for chronic disease prevention
5 UNIT-V 7
a) Effect of processing, storage and interactions of various environmental
factors on the potential of nutraceuticals.
b) Regulatory Aspects; FSSAI, FDA, FPO, MPO, AGMARK. HACCP and
GMPs on Food Safety. Adulteration of foods.
c) Pharmacopoeial Specifications for dietary supplements and
nutraceuticals.
References:
1. Dietetics by Sri Lakshmi
172
2. Role of dietary fibres and neutraceuticals in preventing diseases by K.T Agusti and
3. P.Faizal: BSPunblication.
4. Advanced Nutritional Therapies by Cooper. K.A., (1996).
5. The Food Pharmacy by Jean Carper, Simon & Schuster, UK Ltd., (1988).
6. Prescription for Nutritional Healing by James F.Balch and Phyllis A.Balch 2 nd Edn.,
7. Avery Publishing Group, NY (1997).
8. G. Gibson and C.williams Editors 2000 Functional foods Woodhead Publ.Co.London.
9. Goldberg, I. Functional Foods. 1994. Chapman and Hall, New York.
10. Labuza, T.P. 2000 Functional Foods and Dietary Supplements: Safety, Good
11. Manufacturing Practice (GMPs) and Shelf Life Testing in Essentials of Functional
12. Foods M.K. Sachmidl and T.P. Labuza eds. Aspen Press.
13. Handbook of Nutraceuticals and Functional Foods, Third Edition (Modern Nutrition)
14. Shils, ME, Olson, JA, Shike, M. 1994 Modern Nutrition in Health and Disease.
15. Eighth edition. Lea and Febiger
173
BP803ETPHARMACEUTICAL PRODUCT DEVELOPMENT(Theory)ELECTIVE
3L + 1T/ WEEK
Project is a requirement for the B. Pharm. degree, wherein under the guidance of a faculty
member, a group of not more than five learners in the eighth semester, is required to do
some innovative work with the application of knowledge gained while learning various
courses in the earlier years. The area of the project shall directly relate any one of the
elective subject opted by the student in semester VIII. The learner/s is/are expected to do a
survey of literature in the subject, work out a Project plan and carry it out through survey,
experimentation and/or modeling / computation. Through the Project work the learner has
to exhibit skills for both analysis and critical thinking. The complete details of the project
have to submitted as a report of not less than 25 pages (A4, 1 inch margins, single line
space, font Times Roman, font size 12, excluding count of reference pages) to the College
before the prescribed date. The credits assigned for Project is 6 credits.
175