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Practical For Students

This document appears to be a laboratory manual for second year pharmacy students at Hail University College of Pharmacy. It outlines the topics and experiments to be covered in the Pharmaceutics I Practical course (PHTG 222). The manual provides instructions on performing experiments to prepare various pharmaceutical solutions, syrups, suspensions, and emulsions. It also outlines general safety guidelines and procedures to follow when conducting experiments in the laboratory.

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0% found this document useful (0 votes)
110 views50 pages

Practical For Students

This document appears to be a laboratory manual for second year pharmacy students at Hail University College of Pharmacy. It outlines the topics and experiments to be covered in the Pharmaceutics I Practical course (PHTG 222). The manual provides instructions on performing experiments to prepare various pharmaceutical solutions, syrups, suspensions, and emulsions. It also outlines general safety guidelines and procedures to follow when conducting experiments in the laboratory.

Uploaded by

A H
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Hail University

College of Pharmacy
Pharmaceutics Department

Laboratory manual on

For Second year students


Pharmaceutics I Practical PHTG 222
Pharmaceutics I Practical PHTG 222

Group: ………
Student Name: ……………………………. Student ID: ……………

Topics Signature Date Grade

Lugol's Iodine Solution, B.P. …………………. ……………….. …………..

Hydrogen Peroxide 3% …………………. ……………….. …………..

Chloroform Water, B.P. …………………. ……………….. …………..

Peppermint Water, B.P. …………………. ……………….. …………..

Sodium Bicarb. Ear Dp, B.P. …………………. ……………….. …………..

Simple Syrup …………………. ……………….. …………..

Ferrous Sulphate Syp U.S.P. .…………………. ……………….. …………..

Diffusible Suspension …………………. ……………….. …………..

Antacid Oral Susp. B.P. .…………………. ……………….. …………..

External Calamine Lotion .…………………. ……………….. …………..

Mineral Oil Emulsion .…………………. ……………….. …………..

Fixed Oil Emulsion .…………………. ……………….. …………..

Total Grade …………..


Pharmaceutics I Practical PHTG 222

Table of Contents

Title and Safety Measurements........................................................3


 Lab Safety Page
 Introduction................................................................................................8
Solution
 Lugol's Iodine Solution, B.P....................................................................19
 Hydrogen Peroxide 3%............................................................................22

 Chloroform Water, B.P............................................................................25

 Aromatic Water (Peppermint Water, B.P.).............................................28


 Otic Solution (Sodium Bicarbonate Ear Drop, B.P.)..............................30
Pharmaceutical Syrup
 Simple Syrup............................................................................................32
 Medicated Syrup (Ferrous Sulphate Syrup U.S.P.)…............................35
Pharmaceutical Suspension
 Diffusible Suspension..............................................................................37
 Indiffusible Suspension...........................................................................41
o Antacid Oral Suspension B.P.
o External Calamine Lotion
Emulsion
 Mineral Oil Emulsion...............................................................................45
 Fixed Oil Emulsion..................................................................................49
Pharmaceutics I Practical PHTG 222

GENERAL GUIDELINES

1. Conduct yourself in a responsible manner at all times in the


laboratory.

2. Follow all written and verbal instructions carefully. If you do not


understand a direction or part of a procedure, ASK YOUR
INSTRUCTOR BEFORE PROCEEDING WITH THE ACTIVITY.

3. Never work alone in the laboratory. No student may work in the


pharmaceutics laboratory without instructor permission and in the
presence of the instructor and/or lab technician.

4. When first entering a pharmaceutics laboratory, do not touch any


equipment, glass wears, chemicals, or other materials in the laboratory
area until you are instructed to do so.

5. Perform only those experiments authorized by your instructor.


Carefully follow all instructions, both written and oral. Unauthorized
experiments are not allowed.

6. Do not eat food, drink beverages, or chew gum in the laboratory.


Do not use laboratory glassware as containers for food or beverages.

7. Be prepared for your work in the laboratory. Read all procedures


thoroughly before entering the laboratory. Never fool around in the
laboratory. Horseplay, practical jokes, and pranks are dangerous and
prohibited.

8. Always work in a well-ventilated area.

9. Observe good housekeeping practices. Work areas should be kept


clean and tidy at all times.

10. Be alert and proceed with caution at all times in the laboratory.
Notify the instructor and/or lab technician immediately of any unsafe
conditions you observe.
Pharmaceutics I Practical PHTG 222

11. Dispose of all chemical waste properly. Never mix chemicals in


sink drains. Sinks are to be used only for water. Check with your
instructor and/or lab technician for disposal of chemicals and
solutions.

12. All Labels and instructions must be read carefully. If you don’t
know what does the label mean ask the instructor and/ or lab
technician.

13. Keep hands away from face, eyes, mouth, and body while using
chemicals or lab equipment. Wash your hands with soap and water
after performing all experiments.

14. Experiments must be personally monitored at all times. Do not


wander around the room, distract other students, startle other students
or interfere with the laboratory experiments of others.

15. Know the locations and operating procedures of all safety


equipment including: first aid kit(s), and fire extinguisher. Know
where the fire alarm and the exits are located.

16. Know what to do if there is a fire drill during a laboratory period;


containers must be closed, and any electrical equipment turned off.

17. Contact lenses may be not be worn in the laboratory.

18. Dress properly during a laboratory activity. Long hair, dangling


jewelry, and loose or baggy clothing are a hazard in the laboratory.
Long hair must be tied back, and dangling jewelry and baggy clothing
must be secured. Shoes must completely cover the foot. No sandals
allowed on lab days.

19. Keep your staff within their specified location or keep them outside
the lab. Never over crowed the bench work area with your staff or with
labware/ glassware.
Pharmaceutics I Practical PHTG 222

CLOTHING 20. A lab coat or smock should be worn during laboratory experiments
as well as gloves, filtering face mask and or goggles when needed. NO
EXCEPTIONS TO THIS RULE!

ACCIDENTS AND INJURIES


21. Report any accident (spill, breakage, etc.) or injury (cut, burn,
etc.) to the instructor immediately, no matter how trivial it seems. Do
not panic.

22. If you or your lab partner is hurt, immediately (and loudly) yell out
the instructor’s name and/ or lab technician to get their attention. Do
not panic.

23. If a chemical should splash in your eye(s) or on your skin,


immediately flush with running water for at least 20
minutes. Immediately (and loudly) yell out the instructor’s name and/
or lab technician to get their attention.
HANDLING CHEMICALS
24. All chemicals in the laboratory are to be considered
dangerous. Avoid handling chemicals with fingers. Always use a
tweezer. When making an observation, keep at least 1 foot away from
the specimen. Do not taste, or smell any chemicals.

25. Check the label on all chemical bottles twice before removing any
of the contents. Take only as much chemical as you need.

26. Never return unused chemicals to their original container.

27. Never remove chemicals or other materials from the laboratory


area.
Pharmaceutics I Practical PHTG 222

HANDLING GLASSWARE AND


EQUIPMENT 27. Never handle broken glass with your bare hands. Use a brush and
dustpan to clean up broken glass. Place broken glass in the designated
glass disposal container.

28. Examine glassware before each use. Never use chipped, cracked,
or dirty glassware.

29. If you do not understand how to use a piece of equipment, ASK


THE INSTRUCTOR FOR HELP!

30. Do not immerse hot glassware in cold water. The glassware may
shatter.

31. Labels and equipment instructions (standard operation procedures


(SOPs)) must be read carefully before use. Set up and use the
equipment as directed by your instructor.

32. Never move or change the place of any lab equipment as you may

affect its calibration.


HEATING SUBSTANCES
33. While using hot plate, take care that “hair, clothing, and hands are
a safe distance from the hot plate at all times”.

34. Heated glassware remains very hot for a long time. They should be
set aside in a designated place to cool, and picked up with caution.
Use tongs or heat protective gloves if necessary.

35. Never look into a container that is being heated.

36. Do not place hot apparatus directly on the laboratory desk. Always
use an insulated pad. Allow plenty of time for hot apparatus to cool
before touching it.
Pharmaceutics I Practical PHTG 222

Date: ... /…/….. Week/ Lab: .…/….

Prepare the following prescription


R/
X 75 g
Y 75 g
Z 850 g
T Q.S. to 1L
Q.S. b.i.d. PRN
Insert 1 Supp. Rectally q HS for 10 d
2.5 ml with 30 ml water t.d.s. p.c. , p.o.

Uses

Calculation:

Needed volume
- Calculation (Correction) Factor
= Prescribed volume

- Concentration % = _Active ingredient amount _x 100 = …(W/W, W/V, V/V or V/W)


Preparation Total amount

- Procedure error % = (Theoretical amount – Prepared amount) x 100 = ±…..%


Theoretical amount

- Specific gravity= _Weight_ = ……. (gm/ ml)


Volume
- Total drug Dose = prescribed dose X prescribed times X prescribed days =....................(ml or gm)

- 1 drop 0.05 ml
….. drops …… ml

…..drops =..........ml X 1
0.05 ml
- Equivalent amount = _Needed amount _x 100
Available Conc.
Pharmaceutics I Practical PHTG 222

Procedure

1. Perform your calculation, and prepare your clean glassware (Porcelain evaporating
dish, Water bath, Electronic balance, Ointment Spatula, Thermometer, and Beaker).
2. Weigh/measure accurately ……………………….
3. …………………………………………………....
4. ………………………………………………..…..
5. …………………………………………………….
6. Transfer to the final package and attach the label.
7. Store properly.

General Considerations
- White label is used with systemic preparations while red label is used with topical
preparations.
- Red label or preparations for external use only, the following precautions are
always mentioned “For external use only, Keep out of reach of children. Avoid
contact with eyes. In case of contact, rinse with water. Discontinue use if rash or
irritation develops. Don’t use if injured, for intact skin only” these cautions may
be differed according to the preparation and its intention of use.
- White label or preparations for systemic use, the following precautions are always
mentioned “Keep out of reach of children. Doesn’t use if you are sensitive to any
of the preparation’s ingredients and discontinue if sensitivity happened.
- Temperature, humidity, and sunlight effects should be mentioned considered in
the storage conditions
- Understanding of Latin number, house hold measurements, and units conversions
is very important.
- Measuring and weighing tools are very important to know: identify them, the
difference between them, how and when to use properly.
- Glass mortar and pestle are designed primarily for preparing solutions,
suspensions, and/or ointments (reduction of sot aggregates). Glass is
comparatively a non porous material, and not stained easily, thus it is particularly
useful with flavoring oils and colored preparations. Wedgwood mortars are suited
well for comminution of crystalline solids or hard lumps. Porcelain mortar and
Pharmaceutics I Practical PHTG 222

pestle is used with uncolored preparations and blending homogeneous small size
powder. Both wedgwood and porcelain are the same but Porcelain is glazed and
less porous.
- 1drop in the metric system is standardized to equal exactly 0.05 ml.
Labeling (White or Red label)

Name:
Concentration:
Signature:
Uses:
Precautions:
Storage Conditions:
Prepared By:
Mfg. Date: ../../…. Exp. Date: ../../….
Activity
- Perform calculations to prepare 10 ml and rewrite your prescription.
- Mention the followed method in the preparation and write the procedure.
- Attach labels to the final product.
- Mention the role of each prescribed ingredient.

Ingredient Role

- Evaluate your final preparation.


Evaluated Item Result
State Liquid Semisolid Solid
Appearance Clarity For Clear Turbid
Transparency Liquids Transparent Translucent Opaque
Homogeneity
Colour
Odour/ Taste Characteristic/ palatable or unpalatable odour and taste
pH
Volume/ Weight (ml or mg) Theoretical (prepared): Actual (filling): Error%: (±10%)
Specific Gravity (mg/ ml)
Pharmaceutics I Practical PHTG 222

Abbreviation Latin Meaning


aa ana of each
AAA apply to affected area
a.c. ante cibum before meals
a.d. auris dextra right ear
ad lib. ad libitum use as much as one desires; freely
admov. admove apply
agit agita stir/shake
alt. h. alternis horis every other hour
a.m.m. ad manu medicae at doctors hand
a.m. ante meridiem morning, before noon
amp ampule
amt amount
aq aqua water
a.l., a.s. auris laeva, auris sinistra left ear
A.T.C. around the clock
a.u. auris utraque both ears
bis bis twice
b.d./b.i.d. bis in die twice daily
B.M. bowel movement
BNF British National Formulary
bol. bolus as a large single dose (usually intravenously)
B.S. blood sugar
B.S.A body surface areas
b.t. bedtime
BUCC bucca inside cheek
cap., caps. capsula capsule
c, c. cum with (usually written with a bar on top of the "c")
cib. cibus food
cc cum cibo with food, (but also cubic centimetre)
cf with food
comp. compound
Pharmaceutics I Practical PHTG 222

cr., crm cream


CST Continue same treatment
D or d days or doses
D5W dextrose 5% solution (sometimes written as D5W)
D5NS dextrose 5% in normal saline (0.9%)
D.A.W. dispense as written (i.e., no generic substitution)
dc, D/C, disc discontinue or discharge
dieb. alt. diebus alternis every other day
dil. dilute
disp. dispersible or dispense
div. divide
dL deciliter
d.t.d. dentur tales doses give of such doses
DTO deodorized tincture of opium
D.W. distilled water
elix. elixir
e.m.p. ex modo prescripto as directed
emuls. emulsum emulsion
et et and
eod every other day
ex aq ex aqua in water
fl., fld. fluid
ft. fiat make; let it be made
g gram
gr grain
gtt(s) gutta(e) drop(s)
H hypodermic
h, hr hora hour
h.s. hora somni at bedtime
h.s hour sleep or half-strength
ID intradermal
IJ, inj injectio injection
IM intramuscular (with respect to injections)
Pharmaceutics I Practical PHTG 222

IN intranasal
IP intraperitoneal
IU international unit
IV intravenous
IVP intravenous push
IVPB intravenous piggyback
kg kilogram
L.A.S. label as such
LCD coal tar solution
lin linimentum liniment
liq liquor solution
lot. lotion
MAE Moves All Extremities
mane mane in the morning
M. misce mix
m, min minimum a minimum
mcg microgram
m.d.u. more dicto utendus to be used as directed
mEq milliequivalent
mg milligram
mg/dL milligrams per deciliter
mist. mistura mix
mitte mitte send
mL millilitre
nebul nebula a spray
N.M.T. not more than
noct. nocte at night
non rep. non repetatur no repeats
NPO nil per os nothing by mouth
NS normal saline (0.9%)
1/2NS half normal saline (0.45%)
N.T.E. not to exceed
o_2 both eyes, sometimes written as o2
Pharmaceutics I Practical PHTG 222

od omne in die every day/once daily (preferred to qd in the UK[4])


od oculus dexter right eye
om omne mane every morning
on omne nocte every night
o.p.d. once per day
o.s. oculus sinister left eye
o.u. oculus uterque both eyes
oz ounce
per per by or through
p.c. post cibum after meals
pig./pigm. pigmentum paint
p.m. post meridiem evening or afternoon
p.o. per os by mouth or orally
p.r. per rectum by rectum
PRN, prn pro re nata as needed
pulv. pulvis powder
PV per vaginam via the vagina
q quaque every, per
q.a.d. quaque alternis die every other day
q.a.m. quaque die ante meridiem every day before noon
q.d.s. quater die sumendus four times a day
q.p.m. quaque die post meridiem every day after noon or every evening
q.h. quaque hora every hour
q.h.s. quaque hora somni every night at bedtime
every 1 hour; (can replace "1" with other
q.1 h, q.1° quaque 1 hora
numbers)
q.d., q1d quaque die every day
q.i.d. quater in die four times a day
q4PM at 4pm
q.o.d. every other day
qqh quater quaque hora every four hours
q.s. quantum sufficiat a sufficient quantity
QWK every week
Pharmaceutics I Practical PHTG 222

R rectal
rep., rept. repetatur repeats
RL, R/L Ringer's lactate
without (usually written with a bar on top of the
s sine
"s")
according to the art (accepted practice); use your
s.a. secundum artem
judgement
SC, subc, subcut,
subcutaneous
subq, SQ
s.i.d/SID semel in die once a day
sig signa write on label
SL sublingually, under the tongue
sol solutio solution
s.o.s., si op. sit si opus sit if there is a need
ss semis one half or sliding scale
sliding scale insulin or sliding scale
SSI, SSRI
regular insulin
SNRI
Serotonin–norepinephrine reuptake inhibitor
(antidepressant)
SSRI selective serotonin reuptake inhibitor
(antidepressant) (a specific class of antidepressant)
stat statim immediately
SubQ subcutaneously
supp suppositorium suppository
susp suspension
syr syrupus syrup
tab tabella tablet
tal., t talus such
tbsp tablespoon
troche trochiscus lozenge
t.d.s. ter die sumendum three times a day
t.i.d. ter in die three times a day
t.i.w. three times a week
top. topical
T.P.N. total parenteral nutrition
Pharmaceutics I Practical PHTG 222

tr, tinc., tinct. tincture


tsp teaspoon
U unit
u.d., ut. dict. ut dictum as directed
ung. unguentum ointment
U.S.P. United States Pharmacopoeia
vag vaginally
w with
w/a while awake
wf with food (with meals)
w/o, s without
X times
Y.O. years old
μg microgram
Pharmaceutics I Practical PHTG 222
Pharmaceutics I Practical PHTG 222
Pharmaceutics I Practical PHTG 222

Date: ... /…/….. Week/ Lab: .…/….

Solution
Lugol's iodine solution B.P.
Objective
- Learning how to mix solid particles to prepare a solution.
Prepare the following prescription

R/
Potassium iodide (KI) 10 g (167 gr)
Iodine (I2) 5 g (83 gr)
Distilled water qs to 100 ml
Fait: Mist. Mitte 10 ml

Signature according to the intended use


- Oral 0.3 ml t.i.d. for thyroid gland (hyperthyroidism).
- Sufficient amount undiluted for antimicrobial effect.

Calculation

Needed volume
Calculation (Correction) Factor
= Prescribed volume

Procedure
1. Perform your calculation, and prepare your clean glassware (glass mortar and pestle,
electronic balance, filter paper, spatula, and measuring cylinder).
2. Wear the gloves and grind the pre weighed amount of potassium iodide in a glass
mortar and dissolve it portion wise with the half amount of distilled water.
3. Slowly add the pre weighed amount of iodine crystals, with trituration.
4. Filter and complete the volume with water.
5. Transfer the prepared solution to the final package and attach the label.
Pharmaceutics I Practical PHTG 222

6. Attach the label and store properly in a tightly stoppered/ closed brown bottle.

Note:
- Activity of Lugol's iodine solution is attributed to its content of iodide ion while
presence of elemental iodine is the major cause of its toxicity and side effects.
- I2 is partial soluble in water, therefore KI is added to its solution to form triiodide
ion ( I3−) which is highly water soluble:
KI(aq) + I2(s) → KI3(aq)
- Iodine is highly reactive, therefore plastic or metal containers are not
recommended for its storage (glass containers are preferred as considered an inert
containers).
- Lugol's solution is affected by light and humidity so it should be stored in a
tightly stoppered amber glass bottle at dark place below or at ambient temperature
25 °C.
Pharmaceutics I Practical PHTG 222

Labeling (White or Red label)

Name:
Concentration:
Signature:
Uses:
Precautions:
Storage Conditions:
Prepared By:
Mfg. Date: ../../…. Exp. Date: ../../….

Activity
- Perform calculations to prepare 10 ml and rewrite your prescription.
- Attach label to the final product.
- Mention the role of each prescribed ingredient.

Ingredient Role

- Evaluate your final preparation.

Evaluated Item Result


Appearance
Homogeneity
Colour
Odour/ Taste
pH
Volume/ Weight Theoretical (prepared): Actual (filling): Error%:
Specific Gravity
Pharmaceutics I Practical PHTG 222

Date: ... /…/….. Week/ Lab: .…/….


Hydrogen Peroxide 3%

Objective
- Learning how to mix 2 miscible liquid to prepare one phase solution.
Prepare the following prescription

R/
Hydrogen Peroxide (H2O2) 2.5-3 gm
Distilled Water (H2O) qs, to 100 ml

Signature according to the intended use


- Use undiluted to treat small wounds or for removing bandage adhesive left on skin.
- 3-4 drops in one ear to remove wax then flush with warm water
- Dilute with one time of water rinse your mouth with it for 1 min.

Calculation

- Correction Factor = Needed amount


Prescribed (given) amount

- Equivalent amount = _Needed amount _x 100


Available Conc.

Procedure
1- Perform your calculation, and prepare your clean glassware (dropper, electronic
balance, volumetric flask, beaker and measuring cylinder).
2- Add water to the equivalent volume of Hydrogen Peroxide.
3- Mix your solution through stirring with a glass rod or by
shaking. 4-Transfer to the final package and attach the label.
5- Store at proper place.
Pharmaceutics I Practical PHTG 222

Note
There is no 100% H2O2 as it is a very unstable compound which decomposes
exothermically into water and oxygen spontaneously. Above 70%, H2O2 is likely to
explode. Therefore, it should be kept away from light at 15-30°C
Check your H2O2 solution concentration and weigh the equivalent amount to your
prescription
Use Distilled/dechlorinated water as if organic, inorganic substances or chlorine is
present it will react with hydrogen peroxide.
The disinfection mechanism of hydrogen peroxide
Based on the release of free oxygen radicals:
2 H2O2 → 2 H2O + (O-O)2-

Pollutions are decomposed by free oxygen radicals, and only water remains. Free radicals
have both oxidising and disinfecting abilities. Hydrogen peroxide eliminates proteins of
micro-organisms through oxidation.

Labeling (White or Red label)

Name:
Concentration:
Signature:
Uses:
Precautions:
Storage Conditions:
Prepared By:
Mfg. Date: ../../…. Exp. Date: ../../….
Pharmaceutics I Practical PHTG 222

Activity
- Perform calculations to prepare 10 ml and rewrite your prescription.
- Attach label to the final product.
- Mention the role of each prescribed ingredient.

Ingredient Role

- Evaluate your final preparation.

Evaluated Item Result


Appearance
Homogeneity
Colour
Odour/ Taste
pH
Volume/ Weight Theoretical (prepared): Actual (filling): Error%:
Specific Gravity
Pharmaceutics I Practical PHTG 222

Date: ... /…/….. Week/ Lab: .…/….

Chloroform Water, B.P.

Objective
- Learning how to mix 2 sparingly soluble miscible liquids to prepare one
phase solution.

Prepare the following prescription

R/
Chloroform (CHCL3) 5 ml
Distilled Water (H2O), qs to 1000 ml

Uses
- Antiseptic, Preservative, vehicle and for general anesthetic.

Calculation
- Correction Factor = Needed amount
Prescribed (given) amount

Procedure
1. Perform your calculation, and prepare your clean glassware (dropper, pipette,
volumetric stoppered flask, or measure cylinder and stoppered conical flask).
2. Add water to the equivalent needed volume of Chloroform (Measure Chloroform
in caution and avoid its inhalation)
3. Mix your solution through vigorous shaking.
4. Transfer to the final package and attach the label.
5. Store at proper place.
Pharmaceutics I Practical PHTG 222

Note
- There is always a slight excess of Chloroform in your solution remain at the
bottom of the container as it is heavier than water and its solubility in water is
about 1: 800 parts.
- High volatility of Chloroform creates equilibrium of loss and restoration of
strength by evaporation of the remained amount.
- Chloroform water, is used in expectorants preparations, but it has been banned in
the US by the FDA in manufactured products intended for internal use.
- When dispensing the solution assure on “it should not be shaken and only the
supernatant liquid is used”.
- Avoid direct sunlight, and store in a cool, dry, well ventilated place, avoid
rubber, plastics containers, and closures.

Labeling (White or Red label)

Name:
Concentration:
Signature:
Uses:
Precautions:
Storage Conditions:
Prepared By:
Mfg. Date: ../../…. Exp. Date: ../../….
Pharmaceutics I Practical PHTG 222

Activity
- Perform calculations to prepare 100 ml and rewrite your prescription.
- Attach label to the final product.
- Mention the role of each prescribed ingredient.
- Imagine you are a pharmacist and will dispense a prescription containing
chloroform preparation (Cough syrup)with a signature 5ml T.D.S. what are the
precautions and instructions shall you say to the patient. (Fill the previous label)

Ingredient Role

- Evaluate your final preparation.

Evaluated Item Result


Appearance
Homogeneity
Colour
Odour/ Taste
pH
Volume/ Weight Theoretical (prepared): Actual (filling): Error%:
Specific Gravity
Pharmaceutics I Practical PHTG 222

Date: ... /…/….. Week/ Lab: .…/….

Aromatic Water
Peppermint Water, B.P.
Objective
- Learning how to prepare aromatic water by alternative solution method.

Prepare the following prescription

R/
Peppermint oil 2ml
Talc 15 g
Purified water q.s. to 1000 ml

15 ml b.i.d. a.c.
Uses
- Antiflatulent and carminative, mildly sedative to the colic, or as a flavored
vehicle.
Calculation:

Procedure:
Pharmaceutics I Practical PHTG 222

Note
- Excessive exposure to light and temperature changes may cause losing of
desirable characteristics of aromatic water. (high temp. increases volatility and
aroma loss while low temp. produces cloudiness through phase separation)
- Aromatic water should be freshly prepared with small or needed quantities to
avoid its deterioration by time.
- Talc powder is used as a dispersing or suspending agent as it increases the surface
of volatile substance insuring more rapid saturation of the water.
- Aromatic water should be clear or slightly clear with a pleasant odor, if not stop
using and get rid of it.
- Aromatic waters are saturated solutions of volatile oils in water and are used to
provide a pleasant flavor or aroma.
- It’s recommended to not use peppermint oil with infants or children below 2
years.

Activity
- Perform calculations to prepare 100 ml and rewrite your prescription.
- Write the followed procedure.
- Attach label to the final product.
- Mention the role of each prescribed ingredient.
- Evaluate the quality of your preparation.
Pharmaceutics I Practical PHTG 222

Date: ... /…/….. Week/ Lab: .…/….

Otic Solution

Prepare the following prescription


Sodium bicarbonate ear drop B.P.

R/
Sod. Bicarbonate 50 gm
Glycerol 300 ml
Distilled water q.s. to 1000 ml

3-4 gtts T.D.S. a.d./3d then a.s. 3d


Uses
- Soften and remove ear wax.
Calculation:

Procedure:

Note
- Sod. Bicarbonate is a softening agent for ear wax.
- Glycerol is a thickening agent and self preservative vehicle as has antimicrobial
activity.
Pharmaceutics I Practical PHTG 222

- Thickening agents or viscosity enhancers: increase viscosity, and enhance


suitability for applications, spreadability, and residence time resulting in better
penetration and therapeutic action.
- When using wax softener, hearing may be negatively affected till complete wax
removing (so it’s not used at the same time with both ears but alternately with
each other).
- Isotonic nasal solution pH is 5.5-6.5while isotonic eye solution pH is around 7-
7.4
- Using buffers (pH modifiers) are very important to adjust pH for: better stability
during preparation and storage, best therapeutic activity, avoid irritation (patient
comfort and compliance) or/ and less side effects.
- Don’t use wax softener or ear drops cleansing solutions in case of perforated
/ruptured ear drum.
Activity (exam simulation)
Prepare the following prescription and write the followed procedure (specify the
role of each ingredient)

R/
Sodium Chloride 50 gm
Sodium Bicarbonate 50 gm
Sodium Borate (Borax) 50 gm

2-5 gm in 120 ml warm water


U.D. Uses
- Nasal wash in allergic rhinitis and nasal congestion.

Activity
- Perform calculations to prepare 10 ml and rewrite your prescription.
- Write the followed procedure.
- Attach label to the final product.
- Mention the role of each prescribed ingredient.
- Evaluate the quality of your preparation.
Pharmaceutics I Practical PHTG 222

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Simple Syrup
Objective
- Learning how to prepare B.P. & E.P. simple syrup by solution with Heat method
and agitation without heat.

Prepare the following prescription


Simple Syrup E.P.

R/
Sucrose 667 gm
Purified water q.s. to 1000 gm

Uses
- Sweet vehicle.
Calculation:

Procedure (Solution with Heat):

1. Perform your calculation, and prepare your clean glassware (beaker, measure
cylinder, glass rod, funnel and filter paper).
2. Dissolve the required amount of Sucrose in a beaker with the required amount
of boiling water.
3. Use boiling water bath (avoid over heat) with glass rod stirring to hasten the
solution formation.
4. Filter the hot solution if not clear.
5. Complete your volume with boiling water.
6. Transfer to the final package, shake continuously till it cools well.
7. Attach the label.
8. Store at proper place.
Note
- U.S.P. and B.P. syrup concentration is 85% w/v while E.P. syrup concentration is
66.7% w/w.
Pharmaceutics I Practical PHTG 222

- Syrups should be carefully prepared in clean equipment to prevent contamination.


Three methods may be used to prepare syrups:
1- Solution with heat. 2- Agitation without heat. 3-Percolation.
- Hot method is quickest, but it is not applicable to syrups of thermolabile or
volatile ingredients to avoid decomposing and darkening the syrup
(caramelization).
- Sucrose concentration should approach but not quite reaches the saturated point (1
gm sucrose dissolves in 0.5 ml) as the diluted solution provides an excellent
nutrient for many microorganisms but concentrated one retards their growth,
saturated solution may lead to crystallization with temperature changes.
- High osmotic pressure exerted by sucrose solution (syrup) inhibits microbial
growth so syrups considered as a self preserved but if sucrose concentration is
less than 85% w/v or 55% w/w a preservative should be added, otherwise
fermentation takes place (preservative is calculated according to the amount of
free water).
- If glycerin is present, its volume preserves an equal volume of free water. If
propylene glycol or ethanol their volumes preserve 82% of water.
- Dextrose (Glucose) may be used as an alternative to sucrose in syrups contain
acids as sucrose undergoes hydrolysis.
- Dextrose syrup needs large amount of glycerin to improve its keeping qualities
(for preservation).
- Syrup should be stored in a dark place with a temperature below 25°C.
- More than 10% alcohol leads to sucrose crystallization.
- Syrup is a vehicle of choice for
 Saline drugs (as mask their taste)
 Herbal extract drugs (as prevent their microbial decomposition)
 Oxidation liable ingredients e.g. Ferrous carbonate (dextrose and levulose
(fructose), reducing sugars of sucrose retarding oxidation process)
- Syrup specific gravity should be around 1.313 g/ml.
- Pale amber color may be reached due to caramelization.
Pharmaceutics I Practical PHTG 222

- In hot method of syrup preparation, water condenses on the inside surface or the
upper surface may fall to dilute the upper layer of the syrup leading to
fermentation or microbial contamination.

Activity
- Perform calculations to prepare 100 ml of E.P. and B.P. simple syrup using
hot solution method and agitation without heat method then rewrite your
prescription.
- Attach label to the final product.
- Evaluate your final preparation, and mention the role of each prescribed
ingredient.
Pharmaceutics I Practical PHTG 222

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Medicated Syrup

Prepare the following prescription


Ferrous Sulphate Syrup U.S.P.

R/
Ferrous Sulphate 40 gm
Ascrbic Acid/or citric acid 2.1 gm
Flavored Spirit 2 ml
Syrup U.S.P. q.s. to 1000 ml

5-15 ml to be dil with 120 ml aq, a.c., p.o.


Uses
- Iron supplement for iron deficiency anemia.
Calculation:

Procedure:

1. Perform your calculation, and prepare your clean glassware (beaker, measure
cylinder, glass rod, funnel, filter paper, mortar and pestle).
2. Prepare U.S.P. syrup, as you learned.
3. Weight the prescribed amount of ferrous sulphate and ascorpic acid mix them
well using a dry clean mortar and pestle.
4. Add the prescribed Spirit amount with levigation.
5. Add the prescribed syrup amount gradually with mixing.
6. Transfer the content to a measuring cylinder and adjust your volume.
7. Transfer to the final package.
8. Attach the label.
9. Store at proper place.
Pharmaceutics I Practical PHTG 222

Note
- Should not be used after two weeks of opening.
Table 1. Factors That Influence Iron Absorption
Physical State (bioavailability) heme > Fe2+ > Fe3+
Inhibitors phytates, tannins, soil clay, laundry starch, iron overload, antacids
Competitors lead, cobalt, strontium, manganese, zinc
Facilitators ascorbate, citrate, amino acids, iron deficiency

Figure 1: Iron absorption. Iron enters the stomach from the esophagus. Iron is oxidized to
the Fe3+ state no matter its original form when taken in orally. Gastric acidity as well as
solubilizing agents such as ascorbate prevent precipitation of the normally insoluble Fe3+ .
Intestinal mucosal cells in the duodenum and upper jejunum absorb the iron. The iron is
coupled to transferrin (Tf) in the circulation which delivers it to the cells of the body.
Phytates, tannins and antacids block iron absorption.

Activity

- Perform calculations to prepare 100 ml then rewrite your prescription.


- Attach label to the final product.
- Evaluate your final preparation, and mention the role of each prescribed
ingredient.
Pharmaceutics I Practical PHTG 222

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Pharmaceutical Suspensions
Prepare the following prescription

Diffusible Suspension
Magnesium sulfate (white Mixture) or (mist Alba) Oral Suspension B.P.

R/
Magnesium Sulfate 2.5 gm

Light Magnesium Carbonate 0.5 gm

Peppermint Water to 7.5 ml

Fiat Mist Mitte X d

15 ml o.m. for 3 d

Uses
- Saline Laxative
Calculation:

Procedure:

1. Perform your calculation, and prepare your clean glassware (mortar, pestle,
measuring cylinder, beaker, pipette & bottle).
2. Weight the prescribed amount of magnesium carbonate and triturate then add
magnesium sulfate and mix them well according to doubling up technique of
mixing.
3. Add the equivalent amount of peppermint oil prescribed in peppermint water
and triturate. *
4. Add ¾ of the prescribed vehicle portion wise with gentle stirring to make
pourable paste.
Pharmaceutics I Practical PHTG 222

5. Transfer to a measuring cylinder.


6. Complete your volume with the vehicle.
7. Transfer to the final package and attach the label.
8. Store at proper place.
* You can skip step number 3 if you have pre prepared peppermint water.

Note
- Powder for suspension should own uniform homogeneous, and small particle size
as well as homogeneous suspension without coagulation or cake formation after
reconstitution which not settles rapidly. (to insure dose uniformity suspension
must be shaken before use, and should not be used if there is a cake formation)
- Suspension should not be too viscous to be poured freely.
- Suspension is a solid dispersion of insoluble or sparingly-soluble drugs, in
aqueous or oily vehicles. They may be prepared for internal (oral suspension),
external (lotion) use, or parenteral administration of drugs e.g. Injections, Eye
drops, Ear drops, Enemas, Inhalations.
- Suspension is one of the best choices for oral insoluble ingredients especially in
case of swallowing difficulties.
Components of suspension:
I- Insoluble Active ingredients which are divided to:
a) Diffusible solids: (Dispersible solids) these are insoluble solids that are light and
easily wetted by water. They are (diffused) mixed readily with water long enough for an
adequate dose to be easily measured and so need no suspending agent in their
suspensions. Examples: Hydrophilic powders e.g. Magnesium oxide, Magnesium
carbonate, Magnesium trisilicate, Bismuth carbonate, Light kaolin. (Gum resins also
don’t need suspending agents)

b) Indiffusible solids: Most insoluble solids are not easily wetted, and may form large
porous clumps in the liquid. These solids not remain evenly distributed in the vehicle
long enough for an adequate dose to be measured and so they need a suspending agent
which is measured according to their mixture/suspensions volume. Examples for internal
use: Aspirin, Chalk, Phenobarbitone, Sulphadimidine Examples for external use:
Calamine, Hydrocortisone, Sulphur, Zinc oxide

- Suspending agent increase suspension viscosity to hold indiffusible solids for a


stated period.
- Hydrocortisone acetate may be prescribed for children as a suspension but it’s
preferable to use a crushed tablet and mixed with honey or syrup before
administration.
Pharmaceutics I Practical PHTG 222

c) Poor wettable solids: Insoluble solids in water and poorly wetted with it. and may
form large porous clumps in the liquid. It’s difficult to disperse clumps of its aqueous
dispersion. Foams produced on shaking are slow to subside due to the formed film of
unwettable solid on the surface (liquid/air interface) which stabilized it.
Examples: Hydrophobic powders e.g. Sulfur, Charcoal, and Magnesium stearate.

- Wetting agent should be used to increase the affinity of solid particles to the
surrounding medium (wetting agents facilitate particles wetting through its
adsorption at solid/liquid interface). e.g. Surfactants, glycerin, propylene glycol
and alcohol.
II- Excipients (inactive ingredients):
1. Components of the suspending system or internal phase
 Wetting agents lower the interfacial tension and contact angle between solid
particles and the liquid vehicle.
 Dispersants or deflocculating agents have little tendency to create foam or wet
particles.
 Flocculating agents are simple neutral electrolytes
 Thickeners are adsorbed on insoluble particles, increase the strength of the
hydration layer formed around suspended particles through hydrogen bonding and
molecular interaction.
2. Components of the suspending vehicle or external phase
 pH control agents and buffers are added to maintain, chemical stability, control
tonicity or physiological compatibility.
 Coloring agents, flavors, and fragrances
 Preservatives to control microbial growth

The ‘doubling-up’ technique

1. Weigh the powder present in the smallest volume (powder A) and place in the mortar.
2. Weigh the powder present in the next largest volume (powder B) and place on labeled
weighing paper.
3. Add approximately the same amount of powder B as powder A in the mortar.
4. Mix well with pestle.
5. Continue adding an amount of powder B that is approximately the same as that in the
mortar and mix with the pestle, i.e. doubling the amount of powder in the mortar at
each addition.
6. If further powders are to be added, add these in increasing order of volume as in parts
3, 4 and 5 above.
Pharmaceutics I Practical PHTG 222

Activity
- Perform calculations to prepare sufficient amount that cover the mentioned
signature then rewrite your prescription.
- Attach label to the final product.
- Evaluate your final preparation, and mention the role of each prescribed
ingredient.
Pharmaceutics I Practical PHTG 222

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Indiffusible Suspension

Prepare the following prescription


A) Antacid Oral Suspension B.P.

R/
Magnesium Carbonate 0.3 gm

Calsium Carbonate 0.6 gm

Sodium Bicarbonate 1.0 gm

Chloroform Water to 30 ml

Ft Mist Mitte 90 ml

15 ml t.d.s. p.c.

Uses
- Antacid
Calculation:

Procedure:
Pharmaceutics I Practical PHTG 222

Note
- Add Acacia gum as a suspending agent with 2% of the total volume.
- Sodium bicarbonate is has rapid onset of action and so it’s the drug of choice for
temporary relief of heart burn indigestion, and upset stomach.
- Sodium bicarbonate and calcium carbonate undergoes much more systemic
absorption than magnesium and aluminum and so not used for long-term
treatment of stomach acid problems as it may cause metabolic alkalosis.
- Sodium bicarbonate should not be used or used in caution with patient in low or
restricted sodium diet e.g. hypertensive, chronic heart failure or kidney failure
patients.
- Sodium bicarbonate and calcium carbonate should not be used with Peptic Ulcer
Disease PUD patients.

Activity
- Calculate the specific gravity of two successive different doses of your
preparation, mention specific gravity importance and give an
interpretation with a clear justification to your result.
- Rewrite your prescription after calculation and addition of the
suspending agent.
- Mention the type of your suspension and the role of each ingredient.
- Don’t forget to evaluate your final preparation.
Pharmaceutics I Practical PHTG 222

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Prepare the following prescription


B) External Calamine Lotion

R/
Calamine 8 gm

Zinc Oxide 8 gm

Glycerin 6 ml

Lime Water to 100 ml

Q.S. PRN

Uses
- Provide soothing effect when applied topically and used to protect skin from
minor irritation (itching- sun burn and allergies) reducing pain and discomfort.
Calculation:

Procedure:

1. Perform your calculation, and prepare your clean glassware (mortar & pestle,
measuring cylinder & bottle).
2. Weight the prescribed amount of solid ingredients triturate and mix them well
according to doubling up technique of mixing.
3. Add the prescribed glycerin amount with mixing to make paste.
4. Add ¾ of the prescribed water portion wise with gentle stirring to make
pourable paste.
5. Transfer to a measuring cylinder and complete your volume with water.
6. Transfer to the final package and attach the label.
7. Store at proper place.
Pharmaceutics I Practical PHTG 222

Labeling (White or Red label)

Name:
Concentration:
Use:
Signature:
Storage Conditions:
Preparation date: Expiration Date:
Precautions:

Activity
- Calculate the specific gravity of two successive different doses of your
preparation, mention specific gravity importance and give an interpretation
with a clear justification to your result.
- Rewrite your prescription after calculation.
- Mention the type of your suspension and the role of each ingredient.

Role Ingredient
Pharmaceutics I Practical PHTG 222

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Emulsion

Prepare the following prescription


A) Mineral Oil Emulsion

R/
Liquid Paraffin 7.5 ml

Gum Acacia Q.S.

Water to 50 ml

Uses
- Base for topical oil soluble or water soluble drugs.
Calculation:

Procedure: *

Dry Method:

1. Perform your calculation, and prepare your clean glassware (mortar &
pestle, 2 measuring cylinders, funnel & bottle).
2. Weigh the needed amount of gum acacia, and measure the prescribed oil
volume and water.
3. Transfer oil content to the mortar, add gum acacia to it, triturate and mix
them well dispersion will be formed (till 2 minutes after cracking sound).
4. Add all water volume at once, triturate and mix vigorously at one direction
till the primary emulsion is formed.
5. Complete your volume portion wise with the rest of water with continuous
trituration.
6. Transfer to the final package and attach the label.
7. Complete your volume with distilled water an shake well.
8. Store at proper place.
Pharmaceutics I Practical PHTG 222

Wet Method:

1. Perform your calculation, and prepare your clean glassware (mortar &
pestle, 2 measuring cylinders, funnel & bottle).
2. Weigh the needed amount of gum acacia, and measure the prescribed oil
volume and water.
3. Transfer gum acacia to the mortar grind it, add water content, triturate and
mix them well mucilage will be formed (till 2 minutes after cracking
sound).
4. Add oil phase in constant and small amount gradually, triturate and mix
vigorously at one direction till the primary emulsion is formed.
5. Complete your volume portion wise with the rest of water with continuous
triturate.
6. Transfer to the final package and attach the label.
7. Complete your volume with distilled water an shake well.
8. Store at proper place.

Bottle Method:

1. Perform your calculation, and prepare your clean glassware (2 measuring


cylinders, funnel, dropper & bottle).
2. Weigh the needed amount of gum acacia, and measure the prescribed oil
volume and water.
3. Transfer water content to the bottle, add gum acacia gradually, vigorous
shake and mix them well and leave it for minutes till the mucilage is
formed.
4. Add oil phase in constant and small amount gradually, shake and mix
vigorously till the primary emulsion is formed.
5. Complete your volume portion wise with the rest of water with continuous
shaking.
6. Transfer to the final package and attach the label.
7. Complete your volume with distilled water an shake well.
8. Store at proper place.

* Warnings:
- Don’t use very small mortar or a much curved base.
- Avoid inaccurate measures and don’t use the same measuring tool for liquid and oil
phase.
- Insure your dry tools in case of dry method and don’t mix oil and gum too much (oil
may cover gum particles and prevent the penetration of aqueous phase to them).
- Insure the formation of primary emulsion before dilution and dilute it wisely.
Pharmaceutics I Practical PHTG 222

Note

- The opaque milky appearance of the emulsion is due to the difference in the
refractive indices of the oil and aqueous phases (if two immiscible transparent
liquids have same refractive index, the resulting emulsion will be transparent).

- Water phase should contain water soluble ingredients e.g. drug, preservative,
coloring and flavoring agents while oil phase contain lipophilic ingredients e.g.
vitamins (A,D,E and K), drugs or antiseptics.

- Emulsifying agent must be added to concentrated emulsions due to the effect of


Brownian movement and motion resulting from density differences, and coalesces
under the force of interfacial tension to settle out as a layer of liquid.

- When an emulsion contains two or more oil liquids the quantity of acacia
(emulsifying agent) for each is calculated separately and the sum of these
quantities is used.

- Electrolytes in high concentration tend to crack emulsion, and alcoholic solutions


tend to dehydrate and precipitate hydrocolloids so they should be added in diluted
concentration as possible.

- According to the needed emulsion (o/w or w/o), emulsifying agent is selected


with a suitable H.L.B. (hydrophilic lipophilic balance) value. .

- Dispersed phase concentration should be 30-60% as if higher incorporation may


lead to phase inversion.
- The quantity for primary emulsion have been obtained by experience as:

Ratio of Contents
Type of Oil (ml) Water (ml) Gum Acacia (gm)
Fixed Oil e.g. Castor oil 4 2 1
Mineral Oil (liquid Paraffin) 3 2 1
Volatile Oil e.g. Peppermint oil 2 2 1
Oleo-resin e.g. Male fern Extract 1 2 1
Pharmaceutics I Practical PHTG 222

Activity
- Rewrite your prescription after calculation and addition of the emulsifying
agent.
- Mention the followed procedure in the preparation, the role and ratio of each
prescribed ingredient to form primary emulsion.
- Don’t forget to evaluate your final preparation.
Pharmaceutics I Practical PHTG 222

Date: ... /…/….. Week/ Lab: .…/….

Prepare the following prescription


B) Fixed Oil Emulsion

R/
Castor Oil 7.5 ml

Gum Acacia Q.S.

Water to 50 ml

Uses
- Base for topical oil soluble or water soluble drugs.
Calculation:

Procedure:

Activity
- Rewrite your prescription after calculation and addition of the emulsifying
agent.

- Mention the followed procedure in the preparation, the role and ratio of each
prescribed ingredient to form primary emulsion.
- Don’t forget to evaluate your final preparation.
- How you can differentiate between O/W and W/O emulsions?
- Specify the type of the prepared emulsion.

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