M.Pharm.Semester-I to IV Prospectus No.

20161429
Published by
(Pharmaceutics) Registrar,
Sant Gadge Baba
Amravati University
ºÉÆiÉ MÉÉb÷MÉä ¤ÉɤÉÉ +¨É®úÉ´ÉiÉÒ Ê´ÉtÉ{ÉÒ`ö Amravati - 444 602

SANT GADGE BABA AMRAVATI UNIVERSITY

+ɪÉÖÌ´ÉYÉÉxÉ Ê´ÉtɶÉÉJÉÉ
(FACULTY OF MEDICINE)

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ºÉjÉ-1 ´É 3, ʽþ´ÉɳýÒ-2015 ´É ºÉjÉ-2 ´É 4, =x½þɳýÒ-2016

PROSPECTUS
OF
MASTER OF PHARMACY (PHARMACEUTICS ) EXAMINATIONS
SEMESTER-I & III, WINTER-2015
SEMESTER-II & IV, SUMMER-2016

_____________________________________________________________________________________

Ó “ªÉÉ +¦ªÉɺÉGòʨÉEäòiÉÒ±É (Prospectus) EòÉähÉiÉɽþÒ ¦ÉÉMÉ ºÉÆiÉ MÉÉb÷MÉä ¤ÉɤÉÉ +¨É®úÉ´ÉiÉÒ

2015 Ê´ÉtÉ{ÉÒ`öÉSªÉÉ {ÉÚ´ÉÉÇxÉÖ¨ÉiÉÒ Ê¶É´ÉÉªÉ EòÉähÉɺɽþÒ {ÉÖxɨÉÖÇÊpùiÉ ËEò´ÉÉ |ÉEòÉʶÉiÉ Eò®úiÉÉ ªÉähÉÉ®ú
xÉɽþÒ.”
Visit us at www.sgbau.ac.in Ó “No part of this prospectus can be reprinted or published without
Price Rs........../- specific permission of Sant Gadge Baba Amravati University.”
 INDEX
M.Pharm. (Pharmaceutics)
Semester-I & IV
(Prospectus No.20161429)

Sr. Subject Page

No. No.
1. Special Note for Information 1-2
of the students
2. Direction No. 12 of 2013 3 - 20
3. Direction No. 5 of 2014 21-23
Semester-I
4. Research Methodology & Biostatistics 24 - 26
5. Biotechnology and Bioinformatics 27 - 28
6. Quality Control of Pharmaceutical Products 28 - 29
7. Drug Regulatory Affairs 30 - 31
8. Product Development and Formulation 31 - 32
9. Laboratory Course -1 33
Semester-II
10. Novel Drug Delivery System 34 - 35
11. Biopharmaceutics And Pharmacokinetics 36 - 37
12. Industrial Pharmacy 37 - 39
13. Advanced Pharmaceutics And Cosmetology 39 - 40
14. Selected Topics In Pharmaceutics 40 - 42
15. Laboratory Course –II 42 - 43
Semester-III
16. Seminar on research envisaged for dissertation NIL
17. Seminar on recent trends in Pharm. Sciences NIL
Semester-IV
18. Dissertation & Viva-Voce NIL
19. Seminar (on Dissertation) NIL
 1 2

SANT GADGE BABA AMRAVATI UNIVERSITY Ordinance No.109 : Recording of a change of name of a
SPECIAL NOTE FOR INFORMATION OF THE STUDENTS University Student in the records of the
University
(1) Notwithstanding anything to the contrary, it is notified for general
Ordinance No. 6/2008 : For improvement of Division/Grade.
information and guidance of all concerned that a person, who has passed the
qualifying examination and is eligible for admission only to the corresponding Ordinance No.19/2001 : An Ordinance for Central Assessment
next higher examination as an ex-student or an external candidate, shall be Programme, Scheme of Evaluation and
examined in accordance with the syllabus of such next higher examination Moderation of answerbooks and
in force at the time of such examination in such subjects, papers or preparation of results of the examinations,
combination of papers in which students from University Departments or conducted by the University, Ordinance
Colleges are to be examined by the University. 2001.
(2) Be it known to all the students desirous to take examination/s for
which this prospectus has been prescribed should, if found necessary for
any other information regarding examinations etc. refer the University
Registrar
Ordinance Booklet the various conditions/provisions pertaining to
Sant Gadge Baba Amravati University
examinations as prescribed in the following Ordinances-

Ordinance No. 1 : Enrolment of Students.

Ordinance No.2 : Admission of Students
Ordinance No. 4 : National Cadet Corps
Ordinance No. 6 : E xam i n a ti on in Gen er a l (r el eva n t
extracts)
Ordinance No. 18/2001: An Ordinance to provide grace marks for
passing in a Head of passi ng and
Inprovement of Division (Higher Class)
and getting Distinction in the subject and
condonation of defficiency of marks in a
subject in all the faculties prescribed by
the Statute NO.18, Ordinance 2001.
Ordinance No.9 : Conduct of Examinations
(Relevant extracts)
Ordinance No.10 : Pr ovi din g for E xem pt ion s and
Compartments
Ordinance No. 19 : Admission of Candidates to
Degrees
 3 4

SANT GADGE BABA AMRAVATI UNIVERSITY 14 & onwards for all semesters of M.Pharm. and resolved to refer
DIRECTION
the Draft Schemes of teaching and examinations alongwith other related
provisins, and Draft Ordinance to the Ordinance Committee for framing
NO. 12 / 2013 Dated : 14/06/2013 Ordinance/Regulation for placing it directly before Management Council.
AND
Subject : Examinations Leading to the Degree of ¦Éä¹ÉVÉÒ {ÉÉ®ÆúMÉiÉ
Whereas, the Summer-2013 examinations are already in process
(Master of Pharmacy) (Two year - Four Semester Degree and the Academic Session 2013-14 is commencing from June, 2013.
Course) (Credit Grade Based System), Direction, 2013.
AND
Whereas, Direction No.22 of 2010 in respect of Examinations Whereas, the above revised schemes and provisions are to be
Leading to the ¦Éä¹ÉVÉÒ {ÉÉ®ÆúMÉiÉ (Master of Pharmacy) (Two year - Four Semester implemented instead of the provisions of Direction Nos. 22 of 2010, 9/
Degree Course), Direction 2010 is in existence in the University. 2011, 5/2012 & 26/2012.
AND AND
Whereas, the above Direction was corrected vide Direction Nos.9/ Whereas, the above revised schemes and provisions are to be
2011, 5/2012, 26/2012. regulated by framing the Ordinance.
AND AND
Whereas, the aforesaid Directions are related to semester pattern Whereas, making of Ordinance is a time consuming process.
and credit grade system. The credit grade system is provided in above Now, therefore, I, Dr.Mohan K.Khedkar, Vice-Chancellor, Sant
directions on the base of the marking system. Gadge Baba Amravati University, Amravati in exercise of powers conferred
AND upon me under sub-section (8) of Section 14 of the Maharashtra Universities
Whereas, all above Directions are still to be converted into Act, 1994, do hereby direct as under-
respective Ordinance. 1. This Direction may be called “Examinations Leading to the Degree
of ¦Éä¹ÉVÉÒ {ÉÉ®ÆúMÉiÉ (Master of Pharmacy) (Two year - four Semester
AND
Degree Course) (Credit Grade Based System), Direction, 2013”.
Whereas, the B.O.S. in Pharmaceutical Sciences in its meeting 2. This Direction shall come into force from-
held on 27.8.2012, reviewed the above Directions and recommended the
i) Summer-2013 Examination for M.Pharm. Semester-II & IV.
fresh revised draft schemes of teaching and examinations along with other
ii) Academic Session 2013-14 & onwards for M.Pharm. Semester-I
details, and credit system on teaching hours basis with some necessary
to IV.
additions/deletions in the provisions of above direction.
3. In this Direction unless the context otherwise requires the expression
AND “Department” shall mean the Department of Pharmaceutical Sciences
Whereas, while considering the revised schemes and provisions, and “College” shall mean affiliated college approved for conducting
the B.O.S. recommended that the paper titles and syllabus be kept as it is. M.Pharm. course.
AND 4. The several courses leading to the Degree of ¦Éä¹ÉVÉÒ {ÉÉ®ÆúMÉiÉ (Master of
Whereas, the faculty of Medicine in its meeting held on 2.3.2013 Pharmacy) shall be as follows :
has accepted the above recommendations of the B.O.S. and recommended I) Pharmaceutics
to the Academic Council with some corrections. II) Pharmaceutical Chemistry
III) Pharmacology
AND
IV) Pharmacognosy & Phytochemistry
Whereas, the Academic Council in its meeting held on 18.4.2013 V) Biotechnology
vide item No.24 3) A) R-3 accepted the recommendations of the faculty of VI) Quality Assurance
Medicine to be implemented for Summer-2013 examinations of regular VII) Industrial Pharmacy
students of M.Pharm. Semester-II & IV, and from Academic Session 2013- VIII) Bio pharmaceutics
 5 6

5. There shall be four examinations leading to the Degree of ¦Éä¹ÉVÉÒ {ÉÉ®ÆúMÉiÉ M.Pharm. Examination. But his/her result of Semester-IV shall not be
(Master of Pharmacy) namely the first semester examination at the end declared till he/she clears all lower semester examinations.
of first semester, second semester examination at the end of second 9. The fee for each examination shall be as prescribed by the University
semester, third semester examination at the end of third semester and from time to time.
Final semester examination at the end of fourth semester in each of the 10. The scheme of teaching and credits to be given with maximum marks
courses specified in paragraph 4 above. The duration of the course allotted to each subject and the sessionals, papers, practicals,
shall be of two Academic years (consisting of two semesters in each dissertation, and viva-voce, and seminars if any, in which a candidate
year). The supplementary examination shall be held for all semesters is to be examined, and the minimum marks which an examinee must
of M.Pharm. examinations for FF grade examinees. obtain in order to pass the examination and computation of S.G.P.A.
6. The duration of each semester shall be of six months. and C.G.P.A., shall be as indicated in the Annexures-I to IX appended
7. The Master of Pharmacy First, Third Semester Examination shall be with this Direction.
held in winter, and the Second and Fourth semester examination in 11. (i) The scope of the subject shall be as indicated in the syllabus.
summer at such places and on such dates as may be fixed by the Borad (ii) The medium of instructions and examinations shall be in English.
of Examinations. Subject to the compliance with the provisions of this 12. An examinee passing in a subject or a part thereof, shall be exempted
Direction and of other ordinances in force from time to time, an from appearing in that subject at all subsequent examinations.
applicant for admission to - 13. An applicant for admission to an examination shall satisfy the Head of
A) Semester-I of First M.Pharm. shall have passed not less than one the Department /Principal in the Terminal and other Tests conducted
academic year previously the B.Pharm. examination of this during the academic year regarding his suitability to take the
University or of any other university recognised as equivalent examination.
thereto and shall have prosecuted a regular course of study in the
14. The Head/ Principal shall maintain in his office a complete record of
department/college as prescribed in this Direction.
marks obtained by the candidate in the sessionals. He shall send it to
Provided that, the first Semester examinee shall have passed the the Controller of Examinations in a sealed cover the final marks in
final B.Pharm. examination by securing not less than 45% marks sessional examination obtained by every applicant.
or its equivalent grade point in C.G.P.A. for SC/ST category and
50% marks or its equivalent grade point in C.G.P.A. for others.” 15. In order to pass an examination, an examinee shall obtain not less than
B) The Final M.Pharm. (Semester-III & IV) Examinee shall have 50% of the total marks allotted to each written paper/practical and its
satisfactorily completed Ist and IInd Semester i.e. the First respective sessional examination taken together as shown concerned
M.Pharm. Examination of this university, and shall have prosecuted annexures.
a regular course of study in the Department/College as prescribed 16. If a student fails in an examination his/her marks of Internal/ Sessional
in this Direction. An applicant for the examination to the Final Assessment of Theory of the examination shall be carried over for the
M.Pharm. (Semester-III & IV) shall not be allowed to take the next examination. However, he can give a declaration to the effect that
examination if he/she fails to submit his/her dissertation on or before his Internal/Sessional Assessment marks of the Theory should not be
the 20th December or 31st May of the calendar year in which he/ counted and his/her marks in the Theory shall be only on the basis of
she has to take the examination. external examination.
8. A) Without prejudice to the other provisions of Ordinance No.6 17. Improvement of Internal Assessment :-
relating to the examination in general, the provisions of paragraphs If a Ex-student desires for improvement of internal assessment
5,8,10,26 and 31 of the said ordinance shall apply to every of theory/practical, he may reappear for an examination and fresh
collegiate candidate.
marks for internal assessment will be considered. There is only
B) An unsuccessful examinee at the First M.Pharm. Examination one chance to appear for improvement of internal assessment
(Semester-I & II), may be allowed to carry out his research work examination for internal theory/practical subject after fail in the
for dissertation for Final M.Pharm. (Semester-III & IV)
regular examination only.
Examination and be permitted to appear for the Semester-IV of
 7 8

Examination of the subject head “Project and the Seminars” will iv) An examinee who fails to submit his/her dissertation within the
be conducted by the institute. The criteria for marks distribution is prescribed date or whose dissertation has not been accepted or
specified in the scheme of examination. The institute must submit fails to present himself for Viva-voce, may subject to other
the marks awarded in the Project report and in Seminar to the provisions of this Direction be readmitted to the examination at
Controller of Examination along with the periodic test marks (i.e. any subsequent examination provided that,
internal assessment marks). Once the candidate has passed in the a) he/she pay the fees as prescribed by the University
subject head “Project report and seminar,” the candidate will not b) his/her application is received by the Registrar not later than
one month before the date of commencement of the
be allowed to reappear for examination in this subject head.
examination.
18. i) An examinee for the Third and fourth semester of final year c) he/she submits his dissertation on the same subject two weeks
M.Pharm. examination shall carry out research for not less than prior to the examination date. Examinee whose dissertation
six months under regular faculty guide who shall be the internal has not been accepted shall resubmit his/her work, with such
examiner. A person from industry or Research Institute possessing additional work as may be directed at the next examination.
Post-Graduate qualification in Pharmaceutical Science in However, an examinee wishing to submit dissertation on a
appropriate subject and not less than 5 yrs. experience in an fresh subject shall be required to join the department/college
industry or Research Institute in a responsible capacity may also as a regular student.
be considered for appointment as Guide/Co-guide/Internal/ 19. As soon as possible after examinations the Board of Examinations
Extermal examiner. shall publish result of the examinees and the branchwise merit list
ii) The examinee shall submit three copies of his dissertation to the shall be notified as provided in Ordinance No.6.
Head of the Department/Principal of the college not later than 20. Examinees who have passed in all the subjects prescribed for the first
30th December or 31st May of the calender year in which he/she Year (semester I and semester II) and final M. Pharm. (Semester III
has to take the examination, duly certified by the guide that the and Semester IV) examinations shall be eligible for the award of degree
work has been done satisfactorily under his guidance. The of Master of Pharmacy.
Principal of concerned college shall submit the copies of 21. Provision of Ordinance no. 18 of 2001 relating to “An ordinance to
dissertation within 15 days to the University. provide grace marks for passing in a Head of passing and improvement
iii) a) The examination based on the dissertation shall be carried of division (Higher Class) and getting distinction in the subject and
out by condonation of deficiency of marks in a subject in all the faculties
i) The Guide as Internal Examiner and prescribed by the Statute No.18” shall apply to the examinations under
ii) One External Examiner out of University area this Direction.
b) The examiners may after conducting the seminar, dissertation 22. An examinee who does not pass or who fails to present himself/herself
work and viva-voce examination shall award the marks, out for the examination shall be eligible for admission to the same
of the marks prescribed for dissertation. In case of any dispute, examination on payment of a fresh fee and such other fees as may be
the decision of the External examiner shall be final. The marks prescribed.
shall be sealed under the signature of the External examiner i) A candidate who has passed the M. Pharm. Examination in any
& shall be handed over to the Principal for sending it to the course specified in paragraph 4 may offer himself/herself in any
University other course as a candidate for the M. Pharm. Examination. Such
a candidate may be exempted from appearing in papers in which
c) If the dissertation is not found upto the mark & if the candidate he/she has already passed under this Direction at the first semester
fails in the dissertation, the External examiner shall give his examination, if there is equivalence in the syllabus. However he/
suggestions / recommendations for re-submission / she is required to appear for the Semester-II, III & IV of respective
modification in the dissertation to the Principal along with a specialization.
copy to the Controller of Examination of University for ii) An examinee passing the examination under subparagraph (i)
information. shall not be eligible for inclusion of his name in Merit List.
 9

23. The Ordinance No.6 of 2008 regarding Improvement of Division /

Grade shall be applicable to the examinees under this Direction.
24. Notwithstanding anything to the contrary in this Direction, no person
shall be admitted to an examination under this Direction if he has already
passed the same examination in the course or an equivalent examination
of any other statutory University.
25. The Degree in the prescribed form shall be signed by the Vice-
Chancellor.
26. The provisions and schemes provided under the Direction Nos. 22/
2010, 9/2011, 5/2012 & 26/2012 shall stand cancelled after
enforcement of this Direction.

Dated : 13/6/2013
Sd/-
(Dr.M.K.Khedkar)
Vice-Chancellor,
Sant Gadge Baba Amravati University,
Amravati

*****
10
11
12
13
14
15
 16
Annexure-VII

Annexure-VIII
SCHEME FOR MARK DISTRIBUTION OF SEMESTER III & IV
SEMISTER-III
The topic for the research envisage for dissertation and seminar
on recent trends in Pharmaceutical science shall be assigned to him/
her by the Guide within one month from the date of the commencement of
the third semester.
 17 18

Annexure-IX 13) Academic calendar showing dates of commencement and end of

Sant Gadge Baba Amravati University, Amravati teaching, internal assessment tests and term end examination shall
M. Pharm Syllabus be duly notified before commencement of each semester every year
Credit-grade based performance and assessment system (CGPA)) by the affiliated colleges.
FEATURES OF THE CREDIT SYSTEM 14) The term end examination, however, shall be conducted by the Sant
Gadge Baba Amravati University in the allotted centers.
1) Master’s degree would be of 76 credits each. 15) The research project shall be compulsory.
2) One credit course of theory will be of one clock hour per week running 16) A student who passes the internal tests but fails in Term End
for 12 weeks. Examination of a course shall be given FF grade.
3) Two credit course of theory will be of two clock hours per week running 17) Student with FF grade in a course would be granted credit for that
for 12 weeks. course but not the grade for that course and shall have to clear the
4) Four-credit course of theory will be of four clock hours per week concerned course.
running for 12 weeks. 18) Grades-Marks for each course would be converted to grades as shown
5) One credit course of practicals will consist of 4 hours of laboratory in following Table 1.
exercise for 6 weeks. Table 1: Grade point for Theory/ Practical/Laboratory course /Seminar
6) Two credit courses of practicals will consist of 4 hours of laboratory
exercise for 12 weeks. Grade Range of Marks obtained Grade point
7) Four credit course of practical will consist of 8 hours of laboratory out of 100 or equivalent
exercise for 12 weeks. fraction
8) Every student shall have to complete minimum 57 credits (75%) in AA 90-100 10
first two semester. AB 80-89 9
9) First year may divide into two semesters (Semester-I & II) and shall BB 70-79 8
have 10 theory courses, 2 practical course and 2 seminar BC 60-69 7
5 Theory courses x 4 credits = 40 credits CC 55-59 6
1 Laboratory courses x 4 credits = 08 credits CD 50-54 5
20 Seminar = 08 credit FF Below 50 0
Total = 56 credits ZZ Absent in Examination

10) Second year may divide into two semesters (Semester-III & IV) i.e.- 19) Equivalence of the conventional division/class with the CGPA in final
Third Semester – 1) Seminar on Research Envisaged semester is in accordance with the following Table-2, Grade Points
for SGPA and CGPA of M.Pharm. shall be as per Table-3.
for Dissertation
2) Seminar on Recent Trends in
Pharmaceutical Sciences
}
08 Credits
Table-2: Equivalence of class/Division to CGPA
Sr. No. CGPA Class/Division
Fourth Semester - 1) Dissertation
2) Seminar on Dissertation } 12 Credits 1.
2.
7.5 or more than 7.5
6.00 or more but less than or
First Class with Distinction
First Class
11) Scheme Of Syllabus And Credit System : The syllabus for the first equal to 7.49
semester is common to all M. Pharm. Specialization Courses which 3. 5.50 or more but less than or Higher Second Class
consist of total five theory paper and one laboratory course and seminar equal to 5.99
(2 per each subject).
12) Four credits shall be given for conducting the seminars for 04 hrs. in 4. 5.00 or more but less than or Second Class
week. equal to 5.49
 19 20

Table-3 : Grade Points for SGPA and CGPA of M.Pharm. Where SGPA (n) is the nth semester SGPA of the student and
Cn is the nth semester total credit. The SGPA and CGPA are
Grade Point Final Grade
rounded off to the second place of decimal.
9 - 10 AA
8 - 8.99 AB ACADEMIC CALENDAR AND TERMS
7 - 7.99 BB
6 - 6.99 BC The terms and academic activities of the college affiliated to Sant
5.5 - 5.99 CC Gadge Baba Amravati University under CGPA shall be as per the dates
5 - 5.49 CD given below, only the years shall be changed i.e. the dates shall remain
same as given below irrespective of the year.
0 - 4.99 FF
Absent in Examination ZZ Beginning of First Term : As per University academic calendar
(Semester I, and III)
20) Based on the grade points obtained in each subject, Semester Grade
Vacation : As per University academic calendar
Point Average (SGPA) and then Cumulative Grade Point Average
Beginning of Second Term : As per University academic calendar
(CGPA) are computed as follows.
(Semester II, and IV)
Computation of SGPA and CGPA
Every student is awarded point out of maximum out of 10 point in ****
each subject. (Based on 10 point scale). Based on the Grade point
obtained in subject the Semester Grade Point Average (SGPA) and
Cumulative Grade Point Average (CGPA) are computed. The
computation of SGPA and CGPA is as under.
Semester Grade Point Average (SGPA) is the weightage average of
point obtained by a student in a semester and computed as follows.
U1xM1 + U2xM2 + …UnMn
SGPA = —————————————
U1+U2+……Un
Where U1, U2,………… are subject credit of the respective course
and M1, M2,…….. are the grade point obtained in the respective
subject (out of 10).
The Semester Grade Point Average (SGPA) for all the four semester is
also mentioned at the end of every semester.
The Cumulative Grade Point Average (CGPA) is used to describe the
overall performance of a student in the course and is computed as
under. CGPA shall be calculated on final semester of the course (i.e
from Semester I-IV).

n=4

å SGPA(n )C (n )
CGPA = n =1
n =4

å C (n )
n =1
 21 22

SANT GADGE BABA AMRAVATI UNIVERSITY 3) Following corrections shall be made in Direction No.12/2013
in respect of Examinations Leading to the Degree of ¦Éä¹ÉVÉÒ {ÉÉ®ÆúMÉiÉ
DIRECTION (Master of Pharmacy) (Two year - Four Semester Degree Course)
(Credit Grade Based System), Direction 2013 :
NO. 5 / 2014 Dated : 03/03/2014
i) In para 2. i), the words, “Semester-II & IV” be substituted
Subject : Corrigendum to Direction No.12/2013 in respect of by the words “Semester-I & II”.
Examinations Leading to the Degree of ¦Éä¹ÉVÉÒ {ÉÉ®ÆúMÉiÉ ii) In Semester-I & II of M.Pharm. Examination (All
(Master of Pharmacy) (Two year - four Semester Specializations) under Annexures-I to VI, against the Title
Degree Course) (Credit Grade Based System). of Paper ‘Seminar’,
(a) the hours, credits ‘04(04)’ shown under Scheme of
Whereas, Direction No.12 of 2013 in respect of Examinations Teaching ‘Lecture (Credits)’ be deleted and the hours,
Leading to the Degree of ¦Éä¹ÉVÉÒ {ÉÉ®ÆúMÉiÉ (Master of Pharmacy) (Two credits ‘08(04)’ be inserted in the column of ‘Practical
year - Four Semester Degree Course) (Credit Grade Based System), (Credits)’.
Direction, 2013 is in existence in the University. (b) the marks ‘50’ be added in the column of Scheme of
AND Internal Examination-Practical.
Whereas, the Academic Council in its meeting held on (c) the marks ‘25’ be read in the column of Scheme of
17.2.2014 vide item No.22 4) A) R-3 II) accepted the External Examination-Minimum Marks for Passing-
Practical.
recommendations of the Faculty of Medicine to be implemented from
Academic Session 2013-14 & onwards and resolved to refer the iii) In Semester-III of M.Pharm. Examination (All
matter to Ordinance Committee. Specializations) under Annexures-I to VI, against the Title
of Papers ‘Seminar on Research Envisaged for
AND Dissertation’ and ‘Seminar on Recent Trends in
Whereas, the above corrections are to be regulated by framing Pharmaceutical Sciences’ -
the Ordinance. (a) the figure & word ‘04 Credits’ shown in the column of
AND Scheme of Teaching-Lecture (Credits) be shifted in the
Whereas, making of Ordinance is a time consuming process. column of Practical (Credits).
Now, therefore, I, Dr.J.A.Tidke, Vice-Chancellor, Sant Gadge (b) the marks ‘40 & 60’ shown in the column of Scheme
Baba Amravati University, Amravati in exercise of powers conferred of Internal Examination-Theory be shifted in the
upon me under sub-section (8) of Section 14 of the Maharashtra column of Scheme of Internal Examination-Practical
Universities Act, 1994, do hereby direct as under- respectively.
(c) the marks ‘60 & 90’ shown in the column of Scheme
1) This Direction may be called “Corrigendum to Direction No.12/ of External Examination-Theory-Marks be shifted in
2013 in respect of Examinations Leading to the Degree of ¦Éä¹ÉVÉÒ the column of Scheme of External Examination-
{ÉÉ®ÆúMÉiÉ (Master of Pharmacy) (Two year - Four Semester Degree Practical-Marks respectively.
Course) (Credit Grade Based System), Direction, 2014.”. (d) the marks ‘50 & 75’ shown in the column of Scheme of
2) This Direction shall come into force from the Academic Session External Examination-Minimum Marks for Passing-
2013-14 & onwards for M.Pharm. Theory be shifted in the column of Scheme of External
Examination-Minimum Marks for Passing-Practical
respectively.
 23 24

iv) The Scheme of Teaching, Credits & Examination SYLLABUS PRESCRIBED FOR MASTER OF PHARMACY IN
prescribed for Semester-IV of M.Pharm. Examination (All Pharmaceutics
Specializations) under Annexures-I to VI be substituted (Implemented from the Session 2010-11)
by the following scheme.
The several courses leading to the Master Degree of Pharmacy covers
following subjects namely
1. Pharmaceutics
2. Pharmacology
3. Pharmaceutical chemistry
4. Pharmacognosy
5. Quality assurance
6. Industrial Pharmacy

* - of respective specialization 1. There are four semesters leading to Degree of Master in Pharmacy.
The theory syllabus for first semester shall be compulsory to all
Dated : 01/03/2014 above M. Pharm courses. Second semester syllabus covers in the
Sd/- field of above mention specialization.
(Dr.J.A.Tidke) 2. In third semester examination the research envisage for dissertation
Vice-Chancellor, and one seminar on recent trends in Pharmaceutical science shall be
Sant Gadge Baba Amravati University, assigned to him/her by the Guide within one month from the date of
Amravati the commencement of the third semester.
3. In forth semester examination the dissertation work shall be perform
by him/her and at the end student shall deliver the seminar on
***** dissertation work and viva voce examination.
Seminar
Each candidate shall deliver 2 seminars per subject covering the current
research interest as in journal in the field of pharmaceutical sciences.
Evaluation of seminar shall be based on the communication, representation
and skill in oral presentation

M.Pharm. Semester-I
COMMON TO ALL M. PHARM COURSES
Subject code: MC-101
Subject : RESEARCH METHODOLOGY & BIOSTATISTICS
THEORY 60 Hours (4 hrs. /week)
SECTION- A
I. Research
1. Meaning of research, purpose of research and types of research
(clinical experimental, basic, applied and patent and oriented research)
objects of research
 25 26

2. Literature survey: SECTION- B

Using library, book and journals, MEDLINE- internet getting patents IV. Cost Analysis of Projects and Clinical Trials
and reprints of articles as sources for literature survey. V. Biostatistics
3. Selecting a problem and preparing a research proposal for different Statistical analysis of data including variance, standard deviation,
types of research sources of procurements of grants. Parametric and Non-Parametric statistic test, corelation of data
4. Documentation: and its interpretation, computer data analysis, bio statistics for
Importance of documentation in case of research record and GMP/ clinical trials.
GLC Scientific method in medicine
Techniques of documentation in case of research record and GMP Scientific equations of therapy
and GLC Reference Books
Uses of computer packages in clinical trials (1) Research in education – John W. Best Jems V. Kahn
Documentation in clinical trails (2) Research methodology – C. R. Kothari
5. Research report/paper writing/thesis writing / poster presentation: (3) Methodology and techniques of social research – Willkinson and
Different parts of research report or paper Bhandarkar
Title-title of project with authors name (4) Presentation skills – Michel Halton – Indian society for institute
Abstract-statement of the problem, background list in brief, purpose education
and scope (5) Practical introduction to copyrights – Gavin Mofariane
Key words (6) Thesis projects in sciences and engineering – Richard M. Devis
Methodology-subject, apparatus/instrumentation and procedure (7) Scientist in legal system – Ann Labor Science
Results-tables, graphs, figures and statistical presentation (8) Thesis and assessment writing – Janolthon Anderson
Discussion-support or non-support to hypothesis. Practical and (9) Writing a technical paper – Donald Manzel
theoretical implications (10) Effective business report writing – Lel and Brown
Acknowledgements (11) Protection of industrial property rights – Purshottam Das and Gokul
References Das
Errata (12) Spelling for millions – Edna Furmess
Importance of spell check (13) Preparation for publications – King Edwards hospital foundation
Use of foot notes for London
II. Methods and tools used in research: (14) Information technology – The hindu speeks
Research design (futures of good design, types of research (15) Documentation – genesis and development – 3792.
designs, basic principles of experimental design). (16) Ayurveda and modern medicine – R. D. Lele
Qualitative studies, quantitative studies. (17) How to write and publish a scientific paper – Robert A. Day
Simple data organization, descriptive data organization. Cambridge University Press 4th edition 1994
Limitations and sources of errors. (18) Lecture notes on patent TIFAC: DOC: 022, TIFAC July 2002.
Enquiries in forms of questionnaire, opinionnaire and interviews (19) Introduction to Statistical Methods- C. B. Gupta
III. Presentation: (20) A first course in Mathematical Statistics- C. E. Weatherborn
Importance, types, different skills (21) Introduction to Biostatistics-Mahajan
Content of presentation format of model, introduction
and endings.
Posture, gesture, eye contact, facial expression, stage fright.
Volume, pitch, speed, pauses and languages
Visual aids and seating arrangements
Question and answer session
 27 28

COMMON TO ALL M. PHARM COURSES Reference Books

Subject code: MC-102 1. Biotechnology-Applications and research-Paul N. Chermisinol
Subject : BIOTECHNOLOGY AND BIOINFORMATICS (Technomic publishing co. Inc)
THEORY 60 Hours (4 hrs. /week) 2. Molecular Biochemistry-Therapeutic applications and strategies (Salil
D. Patel, John Wiley and sons).
SECTION- A 3. Nelson, D.L, and Coy M.M. Lehninger’s Principles of Biochemistry’
1. Genetics: Structure and function of DNA replication & repair, Worth publishers, NewYork
expression of genetic information, structure and function of RNA, 4. Gene therapy: principle and Application by Thomas Blankenste in
transcription, genetic code, translation, post translational modification. Bi”’hausef Verlag Basel - Boston . Berlin
2. Recombinant DNA technology: Constructing recombinant DNA 5. Immunogenicity of Biopharmaceuticals by Marco van de Weert, Eva
molecules, restriction enzymes, vectors, gene cloning, genomic Horn Møller (Springer )
libraries, polymerase chain reaction based DNA cloning, restriction 6. Recombinant DNA technology by Watson and Trooze
mapping, blotting technique, DNA sequencing, pharmaceutical 7. Molecular biology of cell by Watson
applications of recombinant DNA. 8. Molecular biology of cell by Albert B, Johnson A, Lewin J.
3. Gene therapy: General introduction, potential target diseases for gene 9. Fundamental of Immunology by Paul W.E
therapy, gene transfer methods, clinical studies, pharmaceutical 10. Molecular biotechnology By Glick B.R and Pasternak J.J (ASM press)
production and regulation. 11. Molecular biology and biotechnology by Walker J.M
4. Immunology: Basics of immunology, Monoclonal antibodies & 12. Essential of genetics by Klug W.S. Cummings M.R
Hybridoma technology and its applications 13. Bioinformatics by Baxevanis A.D, Frana, Duelette B.F.
5. Vaccines-conventional vaccines, modern vaccines technologies,
genetically improved vaccines, genetically improved subunit vaccines, COMMON TO ALL M. PHARM COURSES
pharmaceutical considerations Subject code: MC-103
Subject : QUALITY CONTROL OF PHARMACEUTICAL
SECTION- B PRODUCTS
6. Quality control testing methods of Biotech products: Determining THEORY 60 Hours (4 hrs. /week)
impurities/contamination (viral, bacterial endotoxins (in-vitro) rabbit SECTION- A
Pyrogen, sterility, protein identification, finger prints by
electrophoresis, isoelectric focusing immunogenicity, and partial 1. Good manufacturing practices: GMP in manufacturing processing
sequential analysis. and quality control of drugs, control of facility, personal, production
7. Immobilization of enzyme: different techniques, effect on production and process controls, packaging and labeling controls, documents,
of enzymes, applications. WHO GMP guidelines. GMP for ayurvedic products, Good clinical
8. Plant Biotech products: Substances produced by plant cell culture, practice (GCP), Good laboratory practice (GLP), Good Pharmacy
Transgenic plants their application, Biotransformation with plant cell practice (GPP)
culture 2. Validation: Pharmaceutical process validation, equipment validation
9. Molecular biology of cancer: Causes of cancer and genetics of and sterile products validation.
cancer, New strategy for combating cancer 3. Quality control of pharmaceutical dosage forms: Solid and semi-
10. Introduction to Bioinformatics: Biological databases, sequence solid dosage forms, disperse systems and parenteral dosage forms.
analysis, protein structure, genetic and physical mapping, application SECTION- B
of bioinformatics in pharmaceutical industries and in drug discovery.
4. ICH Stability Guidelines, Schedule M and Schedule Y
5. Spectroscopic methods: Theory and applications of UV, IR, FTIR,
NMR, Mass Spectrometry, ESR and Emission spectroscopy, XRD
 29 30

6. Separation techniques: Introduction and applications of Gas-liquid COMMON TO ALL M. PHARM COURSES
chromatography, HPLC, Gel chromatography, gel electrophoresis, GC- Subject code: MC -104
MS, HPTLC, Ion Pair Chromatography. Subject: DRUG REGULATORY AFFAIRS
7. Safety into the laboratory
Designing safety into the laboratory: Laboratory accident and First aid THEORY 60 Hours (4 hrs. /week)
for chemical burns and accident, egress, hazard zoning, emergency SECTION- A
facilities, Hazards: slippery spill of Hazardous substances and their
1. Aims, objects and salient features of following legislations affecting
handling.
pharmaceutical industry.
Laboratory design-safety aspect: storage of laboratory chemicals,
· Industrial Development and Regulation Act 1951.
laboratory design;
· Consumer Protection Act.
Principle of chemical storage; inventory control; segregation.
2. Australian TGA guidelines
Reference Books 3. US-FDA, CDER guidelines
1) Automation and Validation of information in Pharmaceutical 4. New Drug Application
Processing – J. F. Despautz, Marcel and Dekker 5. Pollution and Environmental Control Act
2) Validation of aseptic pharmaceutical processing – F. J. Carleton and
J. P. Agalloco, Marcel and Dekker SECTION- B
3) Pharmaceutical process validation – J. R. Berry and R. A. Nash,
Marcel and Dekker 6. Drug Master File
4) Good Manufacturing Practices for pharmaceuticals – S. H. Will and 7. Intellectual Property Rights:
J. R. Stoker, Marcel and Dekker l Protection of patients and trademarks and design and copy rights
5) Design of Experiments for process improvement and quality and patent system in India.
Assurance – R. F. Brewer l Present status of IPR future changes expected in Indian patents.
6) Encyclopedia of pharmaceutical technology, Marcel and Dekker l What may be patented
7) Achieving sterility in medical and pharmaceutical products –
l Who may apply for patent
N.A.Halls, Marcel and Dekker
8) Impurities Evaluation of Pharmaceuticals- Satinder Ahuja l Preparation of patent proposal
9) Official and standardized methods of analysis by Colins Watson l Registration of patent in India and foreign countries and vice versa
10) Handbook of Quality Assuarance for the analytical chemistry l ICH guidelines for clinical trials, therapeutic drugs monitoring
Laboratory by Jam Dux drugs and bioequivalence.
11) Modern Instrumental Analysis, Vol 47(Comprehensive Analytical l Exclusive marketing rights
Chemistry) - Satinder Ahuja , Neil Jespessen l Black box
12) Instrumental Methods of Analysis– Willard, Merritt, Dean, CBS-
l IPR and IDMA views on patents
Publishers and Distributors, Delhi
l Human health and patent laws latent lethality
13) Pharmaceutical Analysis Modern Methods-Part A and Part B – J. W.
Munson, Marcel and Dekker l Indian patent act and copyright (Indian act)
14) Indian Pharmacopoeia-2007 8. Drug and Cosmetics Act 1940
15) Martindale: The complete Drug Reference – 2007 9. Prevention of Food Adulteration Act 1954 (5 hrs)
10. Preparation of DMF, Site Master File, Master Formula Record.
Procedure for filing of Patent.
 31 32

Reference: SECTION- B
(1) Guidelines of various countries like MCA, TGA, ICH.
5. PROCESS VALIDATION :
(2) Drug and cosmetic act 1940 and rules their under
Development of validation data on different formulations, Quality
(3) IPR Lecture notes
assurance and GMP : A Detailed study of current good manufacturing
(4) GLP regulation by Alen Hirsch Vol 38 Marcel Decker series
practices in manufacturing, processing, packaging and holding of drug.
(5) GMP for pharmaceuticals forth edition by S. Willing, J. Stocker
Product development approach on following formulations :
Marcel Decker series 1997.
6. LIQUID ORALS :
(6) I.P., B.P., U.S.P. International Pharmacopoeia Cough and multivitamin syrup, antiflatulant and laxative emulsions,
(7) Pharmacokinetics, Regulatory, Industrial, academic prospective by antacid and antidiaroheal suspensions.
P. G. Willing and F.T.S. Tse. 7. TOPICALS :
Antibiotic ointment, analgesic gels.
COMMON TO ALL M. PHARM COURSES
8. TABLETS :
Subject code: MC -105
Common cold, multivitamin, chewable antacid, soluble aspirin and
Subject : PRODUCT DEVELOPMENT AND FORMULATION dispersible/kid tablets.
THEORY 60 Hours (4 hrs. /week) 9. STERILE DOSAGE FORMS :
B-comlex injection, antibiotic eye and ear drops, antihistaminic nasal
SECTION- A
drops.
1. INTRODUCTION OF NEW DRUGS
Reference Books:
Steps involved in the development of a new drug, obstacles to its
1. Gennaro, Remingtons Pharmaceutical Sciences, Mack Publishing Co.
evaluation, limitations of screening procedures, animal toxicity tests.
2. Lachman, Theory and practice of Industrial pharmacy, Lea and Febiger.
Extrapolation of laboratory data to man, placebo, New drug application
3. Ansel.,Pharmaceutical Dosage Forms & Drug Delivery Systems, Lea
as per WHO norms and proforma. Requirement and guidelines on
& Febiger.
clinical trials for import and manufacture of new drugs in India.
4. Banker, Modern Pharmaceutics, Marcel Dekker Inc.
2. PREFORMULATION STUDIES 5. Racz, Drug Formulation, John Wiley and Sons.
Investigation of physical and chemical problems inherent in the 6. Aulton, Pharmaceutics : The Science of Dosage Forms Design, ELBS,
development of new formulations. London
3. PHYSICAL PROPERTIES 7. Wells, Pharmaceutical preformulation: The physico-chemical
Organoleptic properties, microscopy, intrinsic solubility and properties of Drug Substance, Ellis Horwood Ltd.
dissolution rate; powder flow and compression, properties and physical 8. Florence, Atwood, physico-chemical Principles of pharmacy, Chapman
stability. and Hall NY.
4. CHEMICAL PROPERTIES 9. Welling and Tuckerman, Good Manufacturing practices : A plan for
Chemical properties : Purity, physico-chemical parameters affecting Total Quality Control, Bhalani Publishing House, Bombay.
absorption, solid state and solution-phase stability and compatibility 10. Connors, Chemical stability of pharmaceuticals : A Handbook for
with excipients. Formulation additives : Studies on all excipients to pharmacists, Wiley Inter-Science.
be incorporated in the development of liquid orals, solid dosage forms. 11. Carstensen, Drug Stability : Principles and practices, Marcel Dekker
Stability data : Advanced studies on stability and development of
Inc.
stability data on different formulations.
 33 34

COMMON TO ALL M. PHARM COURSES M. Pharm. (Pharmaceutics)

Subject code : MC-106 Semester – II
Subject : Laboratory course -1 Subject Code : MPH-201
Practical 8 hrs. /week (Minimum 20 practicals should be conducted) Subject : NOVEL DRUG DELIVERY SYSTEM
1. Combination Drug Analysis (any two) THEORY : 60 Hours (4 hrs. /week)
Vitamins, Sulphas, Analysis of Antipyretics and Analgesics, Steroidal SECTION- A
anti-inflammatory drugs, Antihistamins. 1. SUSTAINEDAND CONTROLLED RELEASE DRUG DELIVERY
2. Illustrations of theoretical principles using assay of drugs form SYSTEMS
in various pharmacopoeias (any five). Introduction; Rationale of SRDDS; Advantages and Disadvantages
This should cover titrimetric, gravimetric, spectro-photometric of SRDDS; Factors influencing the design and performances of
(including flame photometric) methods. HPLC etc. The titrimetric SRDDS: A) Physicochemical properties of a drug influencing design
methods should include agrentometric, conductometric, and and performance; B) Biological factors influencing design and
performance of SRDDS. Different Micro- encapsulation processes.
potentiometric end point determination. The students should be
Introduction, Design and Development of oral controlled release
exposed to handling of as many instruments as possible by themselves
drug administration: Dissolution controlled, Diffusion controlled
or under the guidance of a teacher.
(Reservoir devices, Matrix devices), Membrane permeation
Validation of equipments: Autoclave, hot air oven, membrane filter controlled, Osmotic pressure controlled, Gel diffusion controlled,
(Minimum two practical). pH controlled, Ion - exchange controlled delivery systems.
Validation of an analytical method: Calibration of instruments as per 2. POLYMER SCIENCE
official procedure (UV, FTIR, Conductivity meter, flourimeter, Introduction, Polymer-classification, Applications of Polymers in
Digital pH meter, Digital balance, Potentiometer, HPLC, Gas formulation of controlled drug delivery systems, Biodegradable
chromatography) (Minimum two practical). and Nonbiodegradable polymers, Properties of following commonly
3. Interpretation of UV, IR, NMR, C 13 NMR spectra and Mass used polymers- Starch, Gelatin, Chitosan, Albumin, Cellulose
Spectroscopy of some chemicals and drugs. (Minimum three combined derivatives and Poloxamers.
spectra). 3. TRANSDERMAL DRUG DELIVERY SYSTEMS
Reference Books Permeation through skin, Factors affecting permeation, Basic
components of TDDS, Formulation approaches used in
(1) Pharmaceutical Analysis – Modern methods – Part A and Part B – J.
development of TDDS and their evaluation, Permeation enhancers.
W. Munson, Marcel – Dekker
4. MUCOADHESIVE DRUG DELIVERY SYSTEMS
(2) Quantitative Analysis of Drugs in Pharmaceutical formulations – P.
Introduction, 1) Buccal drug delivery system: Concepts, Advantages
D. Sethi, VBS Publishers, Delhi
and Disadvantages, Structure of oral mucosa, Trans-mucosal
(3) Pharmacopoeia of India. permeability, Permeability enhancers, in vitro and in vivo methods
(4) Practical Pharmaceutical Chemistry, Part I and Part II – A. H. Beckett, for Buccal absorption; 2) Nasal Drug Delivery Systems:
J. B. Stenlake, CBS Publishers, Delhi Introduction, Physiology of nose, Fundamentals of nasal absorption,
(5) Colorimetric Methods of Analysis – F. D. Snell and C. T. Snell, Van Distribution of drug in the nasal cavity, Enhancement in absorption,
Nostrand Reinhold Company, N. Y. in vitro and in vivo methods for determination of nasal absorption.
(6) Chemical Applications of Infrared spectroscopy – C. N. R. Rao, SECTION- B
Academic Press N. Y. 5. OCCULAR DRUG DELIVERY SYSTEMS
(7) Applications of Absorption Spectroscopy of Organic Compound – J. Formulation and evaluation of occular controlled drug delivery
R. Dyer, Prentice Hall Englewood. systems, ophthalmic inserts and in situ gels.
 35 36

6. TARGETED DRUG DELIVERY SYSTEMS Subject code: MPH-202

Concepts, Advantages and Disadvantages, Targeting of drugs Subject : BIOPHARMACEUTICS AND PHARMACOKINETICS
through nanoparticles, liposomes, resealed erythrocytes, THEORY 60 Hours (4 hrs. /week)
microspheres, magnetic microspheres, monoclonal antibodies,
pulsatile drug delivery. Study on colon targeting. Biosome. SECTION- A
7. Protein & Peptide Drug Delivery System 1. ABSORPTION OF DRUGS
Physical aspects, biochemistry of protein drug (structure, properties Definition, Structure of cell membrane and composition,
& stability), barrier to transport & pharmacokinetics, different routes Gastrointestinal absorption – Mechanism, Factors affecting drug
absorption: Biological, Physiological, Physico-Chemical and
of delivery. Pharmaceutical dosage form factors; Methods of determining
8. Intrauterine Drug Delivery Systems absorption: In Vitro and In Vivo methods.
Development of intrauterine devices (IUDs), copper IUDs, 2. DISTRIBUTION OF DRUGS
hormone-releasing IUDs. Definition, Distribution in blood and other fluids: cellular
distribution, drug penetration to CNS, placental transfer of drugs
REFERENCE BOOKS: and blood flow, Factors affecting drug distribution, Volume of
1. Encyclopedia of controlled delivery; By Edith Mathiowitz, Published distribution,
by Wiley Interscience Publication, John Wiley and sons, Inc, New York 3. PROTEIN BINDING
/ Chichester /Weinheim. Plasma protein binding: factors affecting, significance and kinetics
of protein binding.
2. Controlled and Novel Drug Delivery; By N.K.Jain, CBS Publishers 4. METABOLISM OF DRUGS
and Distributors, New Delhi, First edition, 1997 (reprint in 2001).
Definition, brief overview of Phase I (Oxidative, reductive and
3. Controlled Drug Delivery - Concepts and Advances; By S.P.Vyas and hydrolytic reactions) and Phase II reactions (Conjugation) of
R.K.Khar, Vallabh Prakashan, New Delhi, First edition, 2002. Biotransformation. Factors affecting biotransformation.
4. Remington’s Pharmaceutical Sciences. SECTION- B
5. Novel drug delivery system; By Y.M.Chien, Marcel Dekker, Inc. 5. EXCRETION OF DRUGS
6. Controlled Drug Delivery - Fundamentals and Applications, 2nd edition; Definition, Renal and non-renal excretion, Concept of clearance -
By Joseph R.Robinson and Vincent H.L.Lee. Renal clearance, Organ clearance & Hepatic clearance.
6. BASIC CONCEPTS OF PHARMACOKINETICS
7. Pharmaceutical Dosage forms, disperse system: Volume 1, By Herbert
Basic considerations, Pharmacokinetic models, Compartment
A.Libermann et.al, Marcel Dekker, Inc.
modeling: one compartment model - IV bolus, IV infusion, Extra-
8. Pharmaceutical Dosage forms: Tablets Volume II, Herbert A.Libermann vascular; Multi Compartment models; Two compartment model -
et.al, Marcer Dekker, Inc. IV bolus, IV infusion, Extra-vascular, Three Compartment model in
9. Bentley’s Textbook of Pharmaceutics; By E.A.Rawline, ELBS brief.
Publications. 7. NON-LINEAR PHARMACOKINETICS
10. Microencapsulation and Related Drug Process; By Patric B.Deasy. Cause of non-linearity, Michaelis-Menten equation, Estimation of
Km and Vmax.
8. DOSAGE REGIMEN
Concept of loading dose & maintenance dose, Multiple dosing with
respect to I.V. and oral route, Adjustment of dosage in renal and
hepatic impairment, Individualization of therapy, Therapeutic Drug
Monitoring.
9. Application of Pharmacokinetics in Novel drug delivery systems.
BCS Classification of drugs.
 37 38

REFERENCE BOOKS: and quality control) of some important dosage forms such as tablets,
1. Biopharmaceutics and clinical Pharmacokinetics By Milo Gibaldi. capsules, injections, liquid orals, semisolids, ophthalmic products,
2. Remington’s Pharmaceutical Sciences; By Mack publishing company, emulsions including multiple emulsions.
Pennsylvania. 4. SOLID DOSAGE FORMS:
3. Pharmacokinetics; By Milo Gibaldi, Donald Perrier; Marcel Dekker, Inc. Recent advances in tablet and capsule technology like double
compression, direct compression, lubrication and binding agents,
4. Handbook of clinical Pharmacokinetics; By Milo Gibaldi and Laurie extrusion and spheronization,; oral drug delivery systems, e.g., matrix
Prescott by ADIS Health Science Press. controlled, osmotic pressure controlled, membrane permeation
5. Biopharmaceutics and Pharmacokinetics; By Robert E. Notari. controlled, pH controlled, ion-exchange controlled, gel diffusion
controlled, hydro-dynamically balanced systems, modulation of GI
6. Biopharmaceutics; By Swarbrick. transit time, gastro-retentive systems
7. Biopharmaceuties and Pharmacokinetics- A Treatise; By
D.M.Brahmankar and Sunil B.Jaiswal., Vallabh Prakashan Pitampura, SECTION- B
Delhi. 5. COATING OF SOLID DOSAGE FORMS:
8. Clinical Pharmacokinetics, Concepts and Applications; By Malcolm Aqueous and non-aqueous film coating, polymers, process controls,
Rowland and Thomas N.Tozer. Lea and Febiger, Philadelphia, 1995. coating equipment, coating pans, Accela-cota, Hi-coater, Dria-Coater
9. Dissolution, Bioavailability and Bioequivalence; By Abdou.H.M., Mack and metering devices and spray systems, particle coating methods;
Publishing Company, Pennsylvania, 1989. advances in microencapsulation techniques.
10. Biopharmaceutics and Clinical Pharmacokinetics- An introduction; 4th 6. OPTIMIZATION TECHNIQUES IN PHARMACEUTICAL
edition, Revised and expanded By Robert. E. Notari, Marcel Dekker FORMULATION AND PROCESSING
Inc, New York and Basel, 1987. Concept of optimization, Optimization parameters, Classical
11. Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, optimization, Statistical design, and Optimization methods.
James. C.Boylan. Marcel Dekker Inc, New York, 1996. 7. METHODS OF ENHANCING BIOAVAILABILITY
Solubilization, Prodrugs, and enhancement of dissolution
Subject code : MPH-203
characteristics, cyclodextrin, permeation enhancer, solid dispersion,
Subject : INDUSTRIAL PHARMACY surfactant, bioavailability enhancers.
THEORY : 60 Hours (4 hrs. /week) 8. Optimization & Pilot plant scale up techniques for Tablets &
SECTION- A Capsules- an overview.
1. PREFORMULATION Automation & Effluent testing and Treatment in Pharmaceutical
industries.
Introduction, organoleptic properties, purity, particle size, shape, and
surface area. Solubilisation, surfactants and its importance, REFERENCE BOOKS:
temperature, pH, co-solvency; Techniques for the study of crystal 1. Theory and Practice of Industrial Pharmacy By Lachmann and
properties and polymorphism. Physicochemical characteristics of new Libermann.
drug molecules with respect to different dosage forms. 2. Pharmaceutical dosage forms: Tablets Vol. 1-3 by Leon Lachmann.
2. COMPACTION AND COMPRESSION 3. Pharmaceutical Dosage forms: Disperse systems, Vol, 1-2; By Leon
Compaction of powders with particular reference to distribution and Lachmann.
measurement of forces within the powder mass undergoing 4. Pharmaceutical Dosage forms: Parenteral medications Vol. 1-2; Leon
compression including- physics of tablet compression; Effect of Lachmann.
particle size, moisture content, lubrication etc on strength of tablets. 5. Modern Pharmaceutics; By Gillbert and S. Banker.
3. PILOT PLANT SCALE UP TECHNIQUES 6. Remington’s Pharmaceutical Sciences.
Significance of pilot plant scale up study and large scale 7. Advances in Pharmaceutical Sciences Vol. 1-5; By H.S. Bean & A.H.
manufacturing techniques (formula, equipment, process, stability Beckett.
 39 40

8. Physical Pharmacy; By Alfred martin Design and Assessment of preservative systems for cosmetics,
9. Bentley’s Textbook of Pharmaceutics – Rawbins. valuation of preservatives in cosmetic products and factors affecting
10. Good manufacturing practices for Pharmaceuticals: A plan for total activity of preservatives.
quality control, Second edition; By Sidney H. Willig. 6. PACKAGING OF PHARMACEUTICALS
11. Drug formulation manual; By D.P.S. Kohli and D.H.Shah. Eastern
Desirable features and a detailed study of different types of
publishers, New Delhi.
Pharmaceutical containers and closures (Glass, Plastics and Rubber),
12. Pharmaceutical Preformulations; By J.J. Wells. including their merits and demerits; selection and evaluation of
Subject code : MPH-204 Pharmaceutical packaging materials.
Subject : ADVANCED PHARMACEUTICS AND COSMETOLOGY REFERENCE BOOKS:
THEORY : 60 Hours (4 hrs./week) 1. Theory and Practice of Industrial Pharmacy By Lachmann and
SECTION- A Libermann.
2. Modern Pharmaceutics; By Gillbert and S. Banker.
1. STERILIZATION PROCESS
3. Remington’s Pharmaceutical Sciences.
Principle, Advantages, Disadvantages, Applications of different 4. Advances in Pharmaceutical Sciences Vol. 1-5; By H.S. Bean & A.H.
sterilization methods, equipments. Sterility testing: Principle, general Beckett.
procedure, control tests, sterility testing of some preparations like 5. Physical Pharmacy; By Alfred martin
parenterals and ophthalmic preparation, ampoules, vials, syringes
6. Bentley’s Textbook of Pharmaceutics – Rawbins.
and needles.
7. Pharmaceutical Preformulations; By J.J. Wells.
2. STABILITY TESTING 8. Harry’s Cosmeticology.
Physicochemical and biological factors affecting stability of drugs, 9. Textbook of Cosmeticology by B.M.Mittial.
Methods to find out degradation pathways, Determination of shelf 10. Textbook of Cosmeticology by P.P.Sharma.
life by accelerated stability testing, Overages.
Subject code : MPH-205
3. BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES
Definition, Objective of bioavailability, Parameters of bioavailability, Subject : SELECTED TOPICS IN PHARMACEUTICS
Determination of AUC. Estimating absorption rate of drugs; THEORY : 60 Hours (4 hrs. /week)
Measurement of bioavailability- Pharmacokinetic methods and SECTION- A
Pharmacodynamic methods. Drug dissolution rate & bioavailability. 1. EXCIPIENTS IN PHARMACEUTICAL FORMULATIONS:
In vitro drug dissolution testing models. In-vitro in-vivo correlation.
Intorudction to excipients and their importance in phyarmaceutical
Definitions: Bio equivalence, Chemical equivalence, Therapeutic
and cosmetic industry; specialized type of exdcipients used in tablets
equivalence, Pharmaceutical equivalence; Testing of bioequivalence such as directly compressible excipients and super disintergrants;
of dosage forms. durfactants in disperse systems, taste masking excipients, colors,
SECTION- B flavours, sweetening agents, gel and film forming agents, solubilizers,
4. MICROMERITICS AND RHEOLOGY their evaluation methods, quality control and material safety data sheet.
2. PARENTERAL DOSAGE FORMS:
A detailed account of micromeritics and rheology including apparatus
Formulation, stabilization and manufacture of small and large
involved in this area and their application in pharmacy.
volume, parenterals, evaluation and quality control; injectable
5. MANUFACTURING TECHNIQUES AND EVALUATION OF controlled release formulations, long acting contraceptive
COSMETICS formulations, implantable drug delivery systems.
Manufacturing of Cosmetics like creams, powders, compacts, 3. COLLOIDAL AND DISPERSE SYSTEMS:
shampoo, lipstick liquids, foam, aerosol cosmetics and their Specialized pharmaceutical emulsions like multiple emulsion,
Performance, physicochemical and microbiological evaluation. microemulsions, nanoemulsions, injectable emulsions; suspensions,
 41 42

reconstituted suspensions nanosuspensions, and gels; quality systems Vol. I, II, Marcel-Dekker
assurance of dispersed systems. 4. Ray and Weller, Handbook of Pharmaceutical Excipients,
4. SURFACTANT SYSTEM Pharmaceutical Press.
Introduction, micellization, thermodynamics and kinetics of micelle 5. Pharmaceutical dosage forms: Parenteral, Lachman, Libermann, and
formation, classification.,. Pharmaceutical aspects of Solubilization, Avis, Vol. I & II Marcel Dekker.
Solubilization in non-aqueous system, interactions with polymers 6. Park, Controlled Drug Delivery – Challenges and Strategies, CRC.
and oppositely charged species. Surfactants in emulsions and 7. Handbook of Package Engineering by Joseph. F. Handlon.
suspensions. drug absorption, antibacterial activity. 8. Packaging Materials & Containers by F.A. Paine
SECTION- B 9. Industrial Packaging by Fried man & Kipness.
5. Techniques of solubilization: 10. Packaging of Pharmaceuticals, C.F. Ross
11. Packaging laws & Regulation, Chowdhary & Subramanian
Mechanisms for enhancing solubility such as chemical modification,
micellar solubilization, cosolvency, complexation, hydrotrophy, and Subject code : MPH - 206
dielectric constant modification.
Subject : LABORATORY COURSE-2
6. PACKAGING DEVELOPMENT:
Practical 8 hrs. /week (Minimum 20 practical should be conducted)
i) Glass containers for Pharmaceuticals:
1. Preparation and evaluation of microcapsules/micro spheres by different
Glass types, their manufacture chemical performances testing techniques.
and quality control.
2. Study on diffusion of drugs through various polymer membranes.
ii) Plastics containers for pharmaceuticals: 3. Study on In-vitro dissolution of various sustained release formulations
Classification of plastics, plastic polymers and their physio- of marketed products.
chemical, mechanical and biological properties: Additives and 4. Preparation of matrix tablets using various polymers, like polyvinyl
fabrication processes, plastic container for parenteral and alcohol, polyvinyl pyrrolidone etc., and studying their release patterns.
transfusion sterile drip kits. Quality control testing and biological
5. Preparation of various polymer films, loading of drugs and studying
toxicity.
the release Pattern.
iii) Paper and paperboard : Types of paper, folding cartons, quality 6. Film coating of drug pellets for granules with sodium CMC and the
control testing to paper and paperboard.
study on In Vitro dissolution.
iv) Metal containers:Aluminum and tinplate drums collapasible 7. Preparation and evaluation of following drug delivery systems:
tubes and Aerosol containers, Lacquering, coating and lining. a. Fast dissolving tablets
v) Caps and Closures: b. Gels
Types caps closure liners, child resistant caps, and Elastomeric 8. Preparation of various drug formulations by solid dispersion technique
closures for parenterals, classification of elastomers, physical and their evaluation. (Minimum Two Practical)
chemical and biological properties and their quality control. 9. Formulations based on the cosmetics like vanishing cream, talcum
vi) Labels and labeling: powder, tooth paste, coconut oil shampoo, paste depilatory, nail polish,
Types of labels, adhesives, inject and barcoding. lipstick etc. (Minimum two Practical)
7. Corrugated and solid fibre boards and boxes: Types of corrugation 10. Other formulations based on the theory topics.
methods and types of box design and Quality control. Transit 11. Pre-formulation study of tablets.
worthiness of package: Hazards, mechanical climatic during transit, 12. Studying the stability of suspensions using the data on sedimentation
Laboratory testing methods.
volume and degree of flocculation.
REFERENCE BOOKS 13. Determinations of flow properties of powders by Angle of repose and
1. Carstensen, Pharmaceutical principles of solid dosage forms, CRC. flow through an orifice with, and without glidants.(Minimum Two
2. Pharmaceutical dosage forms: Parenteral, Lachman, Libermann, and Practical)
Avis, Vol. I & II Marcel Dekker. 14. Comparison of dissolution studies of two different marketed products.
3. Lachman, Lieberman, Pharmaceutical dosage forms: Dispersed
 43

15. Calculation ka, ke, t1/2, Cmax, Tmax.

16. Calculation of AUC and bioequivalence from the given data for two
drugs.
17. In vitro absorption studies.
18. In vitro absorption studies.
19. To study the pharmacokinetics of suitable drug after oral
administration. (Minimum Two Practical)
20. Extent of plasma-protein binding studies on the same drug (i.e. highly
and poorly protein bound drug ) at different concentrations.
21. Accelerated stability study
22. Experiment based on the theory topics.
RECOMMENDED BOOKS:
All books mentioned as reference books for theory should be used.

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