University of Zambia
School of Medicine
Department of Pharmacy
PRACTICAL PHARMACEUTICS
DOSAGE FORM DESIGN
For
Clinical Pharmacy Sessions
2007
Index
General Laboratory Instructions ………………………………..………………..... 3
Liquid Dosage forms …………….…….……………..………….…………..……... 5
(1) Monophasic Liquid Dosage Forms (L.D.F.):
(I) Aqueous solutions:
(a) Aromatic waters ......................................................................................................... 6
Chloroform water ……………….…………………….……….…………… ... … 6
(b) Syrups
Codeine phosphate syrup ……………….……………………..…………….. ...8
(c) Solutions:
(1) Internal use:
Strong sodium salicylate mixture ……………….…………………… ...... 10
(2) External use:
Compound Sodium Chloride Mouthwash ……………….…….. .. …..12
Phenol Gargle ……………….…………………….………………..… . 14
Ephedrine nasal drops ……………….…………………….…………... 16
(II) Non-aqueous solutions:
Phenobarbitone elixir ……………….…………………….………………… .. 19
Paracetamol Paediatric elixir ……………….…………………….……….. .. 22
(2) Polyphasic Systems : .
(I) Suspensions.
Suspension Containing Diffusible Solids… ……………..………………….…..24
Calcium Carbonate Mixture .............................................................................................. 25
Paediatric Kaolin Mixture BP 1980 ……………………… ……………….... .28
Suspension Containing Indiffusible Solids ……………………………….….….32
Suspending Agents …………………………….…..………..........…………....32
Sulphadimidine Mixture Paediatric ……………….….………………….…….......... 34
Calamine lotion BP 1988 …………………………….……………………….…….36
Sulpha drug mixture …………………………….……………………................39
(II) Emulsions …………………………………………………………………………….... 42
1



Types ……………………………………………………..…………………....... 42


Emulsion preparation …………………………………………………….…….. 43
Liquid paraffin emulsion ……………….…………………….…………………. 47
Concentrated peppermint emulsion ............................................................................. 50
Castor oil emulsions ……………….…………………….…..……………….… 52
Granulation
Non-Effervescent Granules..................................................................................................... 58
Methyl cellulose Granules................................................................................................... 58
Effervescent Granules ............................................................................................................... 61
Sodium Phosphate effervescent Granules ................................................................... 61
Powders.......................................................................................................................................... 64
Calcium Carbonate Compound Powder ............................................................................. 65
Oral Rehydration Solutions ...................................................................................................... 67
Tablet Triturates ………………………………………………………………………70
Pharmaceutical Calculations questions ………………………………………… ... 74
2
GENERAL LABORATORY INSTRUCTIONS
a) Cleaning Regulations and Appearance :
(1) Each student is responsible for the appearance of the bench
and balance at all times.
(2) Insoluble materials must not be thrown into the sink. Oleagenous
materials should be wrapped before discarding in the container.
(3) Each student should wear a clean, ironed white laboratory coat.
(4) Students are required to have clean towels so that spilled liquids
or chemicals can be cleaned up immediately.
b) Regulations Concerning Chemicals and Reagents :
(1) Students are supposed to use the nearest reagent shelf.
(2) Do not waste chemicals. Use just the calculated amounts of chemicals.
(3) Do not contaminate chemicals by using improper techniques or
dirty equipment.
(4) When pouring from a reagent bottle, the label must be facing up and
be sure to re-stopper each reagent bottle with its own stopper.
c) Regualtions Concerning the Balance :
(1) The balance must be closed when it is not in use.
(2) Weighing papers must be used to protect the pans.
(3) Clean the balance immediately, if you have spilled any substance on it.
d) Regulations Concerning Weighing Technique :
(1) Check and adjust the balance including "zero-in."
(2) Use folded weighing papers to hold the weighed substance.
(3) Open the balance, place weighing paper on each pan, zero-in the balance.
(5) Hold the container in the left hand and transfer the substance from the container
to the weighing paper on the balance with the aid of a clean spatula.
e) Regulations Concerning the Preparation :
Grading of the preparation will include the following points :
(1) Appearance (visual observation for defects e.g. color, quantity, consistency, etc...)
(2) Proper necessary label is used.
3
(3) Wrong calculations will mean a failure in that preparation.
(4) The student must have complete knowledge of the preparation,
its ingredients and its compounding procedure.
(5) The bottle must be clean, no finger prints, and should be properly closed.
(6) If the preparation is not accepted, it must be reprepared and
resubmitted. Repeated preparations will NOT receive full credit.
f) Regulations Concerning Labelling :
(1) Use white labels for internal and red labels for external use preparations.
(2) Labels will be written in the following manner :
Mansoura Universirty
College of pharmacy
Title of the Preparation(Pharmacopia, if any)
If not pharmacopieal, % of main active ingredient(s)
Sig. : ...……………………………………………………
Additional label (if any): ...……….………………………
Name: …………................................. Date: ……….....
(3) The label should be centered in the distance from the base to the neck
of the container.
(4) If the preparation is not official, the concentration(s) of the
active ingredient(s) should be substituted for B. P. or U. S. P.
(5) No licking of the label will be permitted.
g). Regulations Concerning Laboratory Time :
(1) Students are not to leave the laboratory during the section without
obtaining permission to minimize their absence.
(1) Leave the laboratory on time at the end of each period and preferably 5
minutes before.
(2) Students are not permitted to work in the laboratory at other than the
regular hours.
4
PHARMACEUTICAL DOSAGE FORMS
Pharmaceutical dosage forms are divided into :
(A) Liquids.
(B) Solids.
(C) Semisolids.
(A) LIQUID DOSAGE FORMS
Definition :
 These are liquid pharmaceutical preparations intended to be used


either internally or externally.
 Liquid dosage forms (L. D. F.) are either non-sterile or sterile.
 The non-sterile L. D. F. are of two types. :
(1) Monophasic Systems :
(I) Aqueous solutions: - e.g. :
(a) Aromatic waters.
(b) Syrups.
(c) Solutions: which are either for:
(1) Internal use (e.g. Simple Mixtures and Oral Drops).
(2) External use (e.g. Mouth Washes, Gargles, Nasal Drops, Enemas, …etc)
(II) Non-aqueous solutions e.g.: Elixirs, Spirits, Tinctures, Collodions and Liniments.
(2) Polyphasic Systems : - e.g.
(I) Suspensions.
(II) Emulsions.
(III) Colloids.
(IV) Aerosols.
5
NON-STERILE LIQUID DOSAGE FORMS
(1) MONOPHASIC SYSTEMS
(I) Aqueous Solutions
(a) AROMATIC WATERS
Definition : These are aqueous solutions of AROMATIC principles. They are
used mainly as vehicles for the administration of other drugs.
CHLOROFORM WATER (B. P. 1993)
Definition : This is an example of aromatic water in which the active constituent
is a volatile principle and not a volatile oil.
Rx
Chloroform
Purified water to
2.5 ml
1000 ml
Make chloroform water, send
50 ml
Sig.: to be used as a vehicle.
Calculation:
Procedure :
(1) Transfer the calculated amounts of chloroform and purified water to a bottle.
(2) Shake the chloroform and water vigorously. (i.e. it is prepared by simple
mixing and shaking of the two liquid ingredients).
(3) Close the bottle and stick on the written label.
Uses of the prescription ingredients :
(1) Chloroform :
(a) Externally
: It has rubefacient action and is used as a counterirritant. It is used as a solvent for fats, fixed and
volatile oils.
(b) Internally: It has agreable taste and causes a sensation of warmth.
6
Itis used as a carminative and as a flavoring agent in
pharmaceutical mixtures and other preparations.
(c) Chloroform in a concentration of 0.25 % is a useful preservative for
pharmaceutical mixtures.
Label:
Name :
Date:
Notes:
(1) Chloroform is miscible 1 in 200 parts of water.
(2) The prolonged use of preparations containing chloroform may give rise
to liver damage, especially in children.
(3) Chloroform water double strength (B. P. 93) is composed of :
Rx
Chloroform 5 ml Purified water, frequently boiled and cooled
to 1000 ml
(4) Chloroform and its preparations should be stored in airtight containers, with
glass stoppers or other suitable closures, and protected from light.
(5) Chloroform is a colorless, heavy, volatile liquid with a characteristic odor
and sweet burning taste. It is non-inflammable.
7
(b) SYRUPS
CODEINE PHOSPHATE SYRUP (B. P. 1993)
Rx
Codeine phosphate
ʓ IV
Purified water, freshly boiled and cooled
flʓ IV
Chloroform spirit
flʓ VII
Syrup
to
flᶚ XXXIV
Send20 ml
Sig. : 5 ml t.d.s.
Calculations :
Procedure :
(1) Read the prescription carefully, check the calculations for the amounts to be
used and check the balance and be sure that it is ready for weighing.
(2) Dissolve the calculated amount of codeine phosphate in the water.
(3) Add ¾ of syrup and mix well.
(4) Add the chloroform spirit and mix.
(5) Transfer to a measuring cylinder and complete to the final volume with syrup.
(6) Transfer to the bottle, close and stick on the label.
Uses of the prescription ingredients :
(1) Codeine phosphate: anti-tussive and analgesic.
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(2) Chloroform spirit: flavoring agent and preservative.
(3) Syrup: sweetening agent, vehicle and preservative.
Label:
Name :
Date:
Notes:
(1) Codeine phosphate is soluble 1 in 4 parts of water while codeine sulphate
is soluble 1 in 30 parts of water.
(2) Codeine preparations are subject to abuse. Prolonged use of high
doses has produced dependance and constipation.
(3) Codeine phosphate requires protection against light, therefore a
light resistant container is necessary.
9
(c) SOLUTIONS
(1) Oral Solutions
STRONG SODIUM SALICYLATE MIXTURE (B. P. 1993)
Rx
Sodium salicylate
100 g
Sodium metabisulphite
1g
Peppermint emulsion, concentrated
Chloroform water, double strength
Water
Send
to
25 ml
500 ml
1000 ml
20 ml.
Sig. : 2.5 ml. t.d.s.
Calculations :
Procedure :
(1) Read the prescription carefully, check the calculations for the amounts to be
used and check the balance and be sure that it is ready for weighing.
(2) Weigh and dissolve sodium metabisulphite in ¾ of water, If sodium
metabisulphite present as stock solution, measure and mix with ¾ water.
(3) Then add sodium salicylate and mix to dissolve.
(3) Add the concentrated peppermint emulsion and the chloroform water.
(4) Transfer to a measure and adjust to the final volume with water.
(5) Transfer to a suitable bottle, stopper and stick on the label.
10
Uses of the prescription ingredients :
(1) Sodium salicylate : analgesic, antipyretic, anti-inflammatory and antirheumatic.
(2) Sodium metabisulphite : antioxidant (reducing agent).
(3) Chloroform water : preservative and flavoring agent.
Label:
Name :
Date:
Notes:
(1) Sodium salicylate is soluble 1 in 1 part of water.
(2) Sodium metabisulphite is soluble 1 in 2 parts of water.
(3) Sodium salicylate is a phenolic compound which is liable to oxidation.
(4) Because of the instability of sodium salicylate, sodium metabisulphite is
included in the preparation and a direction " Store in a cool place " is
advisable.
(5) The container should be a dark bottle to protect the preparation from light.
(6) Peppermint emulsion tends to separate on storage and should be
shaken thoroughly before measurement.
11
(2) External Solutions
(i) MOUTH-WASHES
Definition :
These are usually aqueous solutions in concentrated form of a
substance with deodorant, antiseptic, local anaesthetic, or
astringent properties.
COMPOUND SODIUM CHLORIDE MOUTH WASH (B. P. 1993)
Rx
Sodium chloride
1.5 g
Sodium bicarbonate
1.0 g
Concentrated Peppermint emulsion
2.5 ml
Chloroform water, double strength
50
ml
100
ml
Water
to
Send 50 ml
Sig. : To be diluted with an equal volume of warm water before use.
Calculation:
Procedure :
(1) Read the prescription carefully, check the calculations for the amounts to be
used and check the balance and be sure that it is ready for weighing.
(2) Dissolve the given amount of sodium chloride and sodium bicarbonate in
3/4 the given volume of water in a beaker.
(3) Add the concentrated peppermint emulsion, chloroform water and mix well.
12
(4) Transfer to the measuring cylinder and adjust the volume with the
remaining amount of water.
(5) Transfer to a bottle, close and stick on the label.
Uses of the prescription ingredients :
Concentrated Peppermint emulsion : Flavoring agent.
Label:
Name :
Date:
Notes :
(1) Mouth washes are used to clean and deodorise the buccal cavity.
(2) Mouth washes may be a simple preparation (e.g. Compound Sodium Chloride
Mouthwash), or may contain antibacterial agents, (e.g. Alkaline phenol
mouthwash), astringents (e.g. zinc sulphate and zinc chloride Mouth wash).
13
(ii) G A R G L E S
Definition :
Gargles are aqueous solutions, usually in concentrated form,
intended for use, after dilution, as a prophylactic or in the
treatment of an infection of the throat.
 A quantity of the liquid is taken and suspended in the throat by slowly
exhaling through it. The liquid is then rejected unless the patient has

been directed to swallow the liquid after gargling.
PHENOL GARGLE (Extrapharmacopoeia 1989)
Rx
Phenol glycerin
50 ml
Amaranth solution
10 ml
Purified water
to
1000 ml
Send 20 ml.
It should be diluted with an equal volume of warm water before use.
Sig. : The diluted solution should be used t.d.s.
Calculations :
Procedure :
(1) Read the prescription carefully, check the calculations for the amounts to be
used and check the balance and be sure that it is ready for weighing.
(2) Mix the calculated volume of phenol glycerin and amaranth solution in a
beaker.
(3) Add 3/4 water and mix.
14
(4) Transfer to the measuring cylinder. Wash and adjust to the final volume with
water.
(5) Transfer to a clean bottle, , close the bottle and stick on the written label.
Uses of the prescription ingredients :
(1) Phenol is an antiseptic and disinfectant which is effective against gram
positive and gram negative bacteria and some fungi.
(2) Amaranth solution is a red coloring material used in medicines, food stuffs
and cosmetics.
How to use gargles:
Label:
Name :
Date:
Compare between mouthwashes and gargles:
15
(iii) NASAL DROPS
Definition : They are liquid preparations for installation into the nasal cavity by
means of a dropper. They usually contain substances with
antiseptic, local analgesic or vasoconstriction properties.
EPHEDRINE NASAL DROPS (B. P. 1993)
Definition : Ephedrine nasal drops are a solution of ephedrine hydrochloride in a
suitable aqueous vehicle.
Prepare the following prescription :
Rx
Ephedrine hydrochloride
0.5 %
Sodium chloride
0.9 %
Chlorbutanol
0.01 %
Purified water
Send
to
100 ml
10 ml.
Sig. : Two drops to be placed in each nostril as directed.
Calculations :
Procedure :
(1) Read the prescription carefully, check the calculations for the amounts to be
used and check the balance and be sure that it is ready for weighing.
(2) Add the weighed amounts of ephedrine hydrochloride and sodium
chloride to water in a beaker and mix well, add chlorbutanol.
(3) Transfer to clean bottle, close and stick on the label.
16
Uses of the prescription ingredients :
(1) Ephedrine hydrochloride is used to relieve nasal congestion associated with
common cold, rhinitis or sinusitis.
(2) Sodium chloride solution 0.9 % is used as nasal drops to relieve nasal
congestion.
(3) Chlorbutanol is a preservative.
Label:
Name :
Date:
Notes:
(1) Ephedrine HCL is soluble 1 in 4 parts of water and 1 in 17 parts of alcohol.
(2) Sodium chloride is soluble 1 in 3 parts of water and 1 in 10 parts of
glycerol. A 0.9 % sodium chloride solution in water is iso-osmotic with
serum and lachrymal secretions.
(3) Appropriate labels are " Not to be taken " or " For use only in the nose."
(4) The continued use of nasal decongestants may lead to rebound
congestion (Drug induced rhinitis).
17
(II) NON-AQUEOUS SOLUTIONS
 These are solutions in which the solvent is other than water e.g.
alcohol, glycerol, ether, acetone or oil. They are classified according to

the solvent as follow :
(1) Using alcohol : e.g. Elixirs and Spirits.
(2) Using glycerol : e.g. Glycerites and Ear drops.
(3) Using ether and acetone : e.g. Collodion.
(a) ELIXIRS
 Elixirs are clear, sweetened, hydroalcoholic solutions of potent
medicaments intended for oral use, and are usually flavoured to

enhance their palatability.
 Compared to syrups, elixirs are usually less sweet and less viscous.
However, because of their hydroalcoholic character, elixirs are able to
maintain water soluble and alcohol soluble components in solution. Also
because of their stability characteristics and ease with which they are
prepared, elixirs are preferred over syrups.
18
PHENOBARBITONE ELIXIR (B. P. 1993)
Definition :
Phenobarbitone elixir is a solution containing 0.3 % w/v of
phenobarbitone in a suitable flavoured vehicle containing a
sufficient volume of ethanol (96 %) or of an appropriate dilute
ethanol to give a final concentration of 38 % v/v of ethanol.
Prepare the following prescription :
Rx
Phenobarbitone
0.18 g
Orange oil
0.045 ml
Amaranth solution
0.6
Alcohol (96 %)
23.75 ml
Glycerin
15
ml
Syrup
9
ml
60
ml
Purified water
to
ml
Send 20 ml
Sig. : As sedative : One teaspoonful to be taken 3 times daily (adults).
As hypnotic : One tablespoonful to be taken before sleeping
(for adults).
One teaspoonful to be taken before
sleeping (for children).
Calculations :
19
Procedure :
(1) Read the prescription carefully, check the calculations for the amounts to be
used and check the balance and be sure that it is ready for weighing.
(2) Dissolve the weighed amount of Phenobarbitone in alcohol in a beaker.
(3) Add orange oil, glycerol, syrup and amaranth solution to the alcoholic
solution and mix well.
(4) Transfer to a measure and add sufficient water to adjust the volume to 60 ml.
(5) Transfer to a bottle, close and stick on the label.
Uses of prescription ingredients :
(1) Phenobarbitone may be used as antiepileptic agent. It is also used as
sedative and hypnotic.
(2) Orange oil is flavouring agent.
(3) Amaranth solution is red colouring solution.
(4) Alcohol is co-solvent and preservative (from 10 – 12% is self preservative).
(5) Glycerol is co-solvent and sweetening agent.
(6) Syrup is sweetening agent.
Label:
Name :
Date:
Notes:
(1) Phenobarbitone is soluble 1 in 1000 parts of water, and 1 in 10 parts of
alcohol.
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(2) Phenobarbitone is a potent drug and must be weighed accurately, because
overdose is dangerous.
(3) Dose of the drug is 100 - 200 mg daily and can be taken in divided
doses (e.g. 30 mg. three or four times per day).
(4) Elixirs should be stored in air tight containers to avoid the evaporation
of alcohol. Also, light resistant containers are used to guard against
deterioration of volatile oils.
(5) The presence of glycerin, syrup, and alcohol will assist in the dissolution of
the solute (co-solvents).
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PARACETAMOL
PAEDIATRIC
ELIXIR (B. P. 1993)
Definition : Paediatric paracetamol oral solution is a solution containing
2.4 % w/v of paracetamol in a suitable flavoured vehicle.
Prepare the following prescription :
Rx
Paracetamol
24 g
Amaranth solution
2 ml
Chloroform spirit
20 ml
Concentrated Raspberry Juice
25 ml
Alcohol (95 %)
100 ml
Propylene glycol
100 ml
Invert syrup
275 ml
Glycerol
to
Send
20 ml
1000 ml
Sig. : 5 ml t.d.s. p.c.
Calculation :
Procedure :
(1) Read the prescription carefully, check the calculations for the amounts to be
used and check the balance and be sure that it is ready for weighing
(2) Dissolve the weighed amount of paracetamol in a mixture of the alcohol and
the chloroform spirit.
(3) Dilute the Raspberry juice with the invert syrup, the amaranth solution,
propylene glycol and about half of the glycerol.
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(4) Add the solution prepared in step (3) to the paracetamol solution and mix
well.
(5) Transfer to a measure and complete to the final volume with glycerol.
(6) Transfer to a bottle, close and stick on the label.
Uses of the prescription ingredients :
(1) Paracetamol is analgesic and antipyretic.
(2) Chloroform spirit is flavouring agent and preservative.
(3) Concentrated Raspberry juice is colouring and flavouring agent.
(4) Alcohol and propylene glycol are co-solvents.
(5) Invert syrup and glycerol are sweetening agents and vehicles.
Label:
Name :
Date:
Notes:
(1) Paracetamol is soluble 1 in 79 parts of water, 1 in 20 parts of boiling water.
(2) Invert syrup is prepared by hydrolysing a 66.7 % solution of sucrose with
suitable mineral acid, and neutralising the solution with sodium carbonate.
(3) When alcohol is used, the concentration is kept low because of
its physiological activity.
(4) Where possible, paediatric elixirs are formulated as flavoured syrups
containing little or no alcohol because it is undesirable to give this solvent
to children.
Enumerate the differences between each of the following :
Elixirs and syrups
Elixirs and spirits
23
NON-STERILE LIQUID DOSAGE FORMS (CONT.)
(2) POLYPHASIC SYSTEMS
(i) suspensions
They are heterogenous systems containing coarsely dispersed materials.
a) MIXTURES CONTAINING DIFFUSIBLE SOLIDS
 They are substances that are insoluble in aqueous vehicle but they are
diffused into it by simple shaking for a time sufficient to ensure uniform

distribution in each dose.
 e.g. rhubarb; light magnesium carbonate, light kaolin and magnesium
trisilicate.
Method of preparation of mixtures containing diffusible solids:
(1) Dissolve any soluble ingredient in about 3/4 of the volume of the vehicle to
form a clear solution.
(2) Weigh other powder ingredients, which are insoluble and put them in a clean
mortar, mix with viscous liquid (if any).
(3) Add the solution previously prepared to the powder in the mortar portion
by portion to form a paste then a milky suspension.
(4) Transfer the milky mixture to the measuring cylinder.
(5) A portion of the vehicle is used to wash the mixing equipment.
(6) Add any liquid ingredients, then adjust the volume with the rest of the vehicle.
(7) Close the bottle and stick on the written label.
(8) An additional label should be fixed: " Shake the bottle before use."
Notes:
(1) In some instances the dispersed phase has an affinity for the vehicle to
be employed and readily " wetted " by it upon its addition.
(2) Other drugs are not penetrated easily by the vehicle and have a tendency
to clump together or to float on top of the vehicle. In this case the powder
must first be wetted by a so-called " Wetting agent " to make the powder
more penetrated by the dispersion medium.
24
CALCIUM CARBONATE MIXTURE
Rx
Calcium Carbonate
1.555 g
Light Magnesium Carbonate
1.555 g
Sodium bicarbonate
1.555 g
Aromatic Cardamom Tincture
1.54 ml
Syrup
15 ml
Chloroform water
ad.
150 ml
Ft. mist. Mitte 30 ml
Sig. 10 ml p.r.n.
Calculations:
The specified total volume = 150 ml
The required total volume = 30 ml.
The process is reduction in the prepared volume i.e. Factor less than
one So ………………………………………………………………………
Factor = the required total volume/ the specified total volume
= …………………………………………………………………
For Calcium Carbonate:
For Light Magnesium Carbonate
For Sodium Bicarbonate
For Aromatic Cardamom Tincture
For Syrup
25
For Chloroform Water to 30 ml
= 30 ml – (sum of the volume of liquids) = ….. ml (A)
Then calculate ¾ of A ml = ……………………………….. ml
The final calculated amounts to prepare 30 ml are:
Rx
Calcium Carbonate
………… g
Light Magnesium Carbonate
………… g
Sodium bicarbonate
………… g
Aromatic Cardamom Tincture
………… ml
Syrup
………… ml
Chloroform water
30 ml
ad.
Sig. one dessertspoonful to be taken when needed.
Method of preparation:
1. In a beaker (250 ml capacity), dissolve the weighed calculated amount of
sodium bicarbonate (……. g) in about ¾ of the vehicle (…….…. ml).
2. In a porcelain mortar, mix amounts of calcium carbonate (……. g) and
light magnesium carbonate (……. g), then levigate with syrup.
3. Then, gradually add small portions of the solution in step one to the
premixed mixture in step two with continuous trituration until a smooth thin
paste is formed
4. Add the remaining amount of the solution (prepared in step one) to the
contents of the mortar with continuous stirring. Add aromatic cardamom
tincture and mix.
5. Transfer the contents of the mortar to the measuring cylinder.
6. Rinse the mortar with small volume of the vehicle and add the rinsing to the
measuring cylinder.
7. Complete to the final volume with the vehicle.
Comments and Precautions:
An additional label “Shake the bottle before use” should be used.
Uses:
Antacid
26
Label:
Name :
Date:
27
KAOLIN MIXTURE, PAEDIATRIC (B. P. 1993)
Rx
Light kaolin
200 g
Light magnesium carbonate
50 g
Sodium bicarbonate
50 g
Concentrated peppermint emulsion
25 ml
Chloroform water double strength
500 ml
Water
1000 ml
to
Send
20 ml
Sig. : 5 ml every 4 hours.
Calculations:
The specified total volume = 1000 ml
The required total volume = 20 ml.
The process is reduction in the prepared volume i.e. Factor less than
one So ………………………………………………………………………
Factor = the required total volume/ the specified total volume
= …………………………………………………………………
For Light Kaolin
For light magnesium carbonate
For sodium bicarbonate
For concentrated peppermint emulsion
For double strength chloroform water
Why double strength chloroform water?
……………………………………………………………………………
For Water to 20 ml
= 20 ml – (sum of the volume of liquids) = A ml
Then calculate ¾ of A ml = ……………………………….. ml
28
The final calculated amounts to prepare 20 ml are:
Rx
Light Kaolin
……… g
Light magnesium carbonate
……… g
Sodium bicarbonate
……… g
concentrated peppermint emulsion
……… ml
Double strength chloroform water
……… ml
Water
20 ml
to
Sig. One teaspoonful to be taken every four hours.
Method of Preparation :
(1) Read the prescription carefully, check the calculations for the amounts to be
used and check the balance and be sure that it is ready for weighing
(2) Dissolve sodium bicarbonate in ¾ the amount of water.
(3) Put the weighed amount of light kaolin and light magnesium carbonate in a
clean mortar.
(4) Prepare the paste with the sodium bicarbonate solution and add the extra
vehicle if necessary.
(5) Incorporate the chloroform water double strength.
(6) Transfer the contents of the mortar to the measuring cylinder.
(7) Rinse the mortar with small volume of the vehicle and add the rinsing to the
measuring cylinder.
(8) Add the concentrated peppermint emulsion.
(9) Adjust to the final volume with vehicle,
(10) Close the bottle and stick on the written label and the additional label "
Shake the bottle before use."
Comments and Precautions:



Kaolin is a diffusible
solid and therefore no additional suspending agent

is required.

Container: Amber medicine bottle.
29



It should be recently prepared,
Shake the bottle before use.


1) Kaolin chemically is a purified native hydrated aluminium silicate.
2) Kaolin is insoluble in water and mineral acids.
3) This mixture contains several liquid ingredients and it may be difficult to
decide if they should be added to the mortar or the bottle. The following
rules may help :
a) If the liquid contains a volatile medicaments or solvent, add
to suspension in the bottle.
b) If the liquid is viscous e.g. syrup or glycerol, dilute with a little vehicle
and add to the dry mixed powders in the mortar where it will help in
preparing a smooth paste.
c) If the liquid is a dye solution, add to the mortar while the paste is still
thick, and mix well. If added to the suspension in the bottle it may not
penetrate quickly into small lumps of powder which will then be visible as
ugly white specks in the mixture.
4) If mixtures are made with unsterilized kaolin they must be recently prepared.
5) Labeling : A direction to shake the bottle should be given on the label.
6) Children up to 1 year, 5 milliliter and 1 to 5 years, 10 ml.
Uses of the prescription ingredinets :
1) Light Kaolin is an adsorbent. It is administered by mouth in the
symptomatic treatment of enteritis and dysentry associated with food
poisoning. It increases the bulk of the faeces. Light kaolin is applied
externally as a dusting powder.
2) Light magnesium carbonate is an adsorbent and antacid.
3) Sodium bicarbonate is an antacid.
4) Concentrated peppermint emulsion is a flavoring agent.
5) Chloroform water is used as preservative and flavoring agent.
Uses:
Anti-diarrhoeal mixture for children.
30
Label:
Name :
Date:
31
(b) MIXTURE CONTAINING INDIFFUSIBLE SOLIDS

These solids are insoluble in aqueous vehicle which do not remain evenly
distributed in the vehicle long enough to ensure a uniform distribution in


each dose.

When these solids are present in a prescription, a suspending
agent (thickening agent) must be added.

The suspending agent increases the viscosity of the liquid as such as to hold
in suspension the indiffusible solids for a sufficient time to ensure uniform


distribution of the solid in each dose.

e.g. of suspending agent are : Compound powder of Tragacanth, Bentonite
,... etc.)

Examples of indiffusible solids are:
Used internally
Used externally
Aspirin
Calamine
Prepared chalk
Hydrocortisone
Phenobarbitone
Sulphur, precipitated
Succinyl sulphathiazole
Zinc oxide
Sulphadimidine, sulphaguanidine
Suspending Agents
1- Compound Powder of Tragacanth B.P. consistes of:
Tragacanth
15%
Acacia
20 %
Starch
20 %
Sucrose
45 %
It should be stored in airtight containers.
2% W/V of the total volume of the mixture i.e. Two grams of
compound powder of tragacanth are used for each 100 ml mixture.
32
2- Mucilage of Tragacanth :
Tragacanth
12.5 g
Alcohol
25 ml
Chloroform water to
1000 ml
25% V/V of the total volume of the mixture i.e. Twenty five ml of the
mucilage of tragacanth are used for each 100 ml mixture.
3- Powdered Acacia:
6 - 10% W/V of the total volume of the mixture i.e. 6-10 grams are used for
each 100 ml of the mixture.
4- Acacia Mucilage:
Acacia
400 g
Chloroform water
600 ml
25% V/V of the total volume of the mixture i.e. Twenty five ml of the
mucilage of acacia are used for each 100 ml of the mixture.
Method of preparation :
1) Powdered the indiffusible solid in the mortar.
2) Add the suspending agent and mix them thoroughly in the mortar.
3) Dissolve any soluble ingredients in about 3/4 of the vehicle.
4) Add this solution to the powder in the mortar portion by portion.
5) Transfer the preparation to a tared bottle.
6) Wash the mortar with a little of the vehicle and add them to the contents of the
bottle.
7) Complete to the final volume with the vehicle.
8) Close the bottle and stick on the written label and the additional label " Shake
the bottle before use."
33
SULPHADIMIDINE MIXTURE, Paediatric (B. P. 1993)
Definition : It is a suspension containing 10 % w/v of sulphadimidine in a
suitable flavoured vehicle.
Prepare the following prescription :
Rx
Sulphadimidine, in fine powder
100
g
Compound tragacanth powder
40
g
Raspberry syrup
200
ml
Benzoic acid solution
20
ml
Amaranth solution
10
ml
Chloroform water
Send
to
1000 ml
20 ml.
Sig. : 5 ml q.i.d.
Calculations : You are provided with sulphadimidine tablets 500 mg.
Procedure :
1) Read the prescription carefully, check the calculations for the amounts to be
used and check the balance and be sure that it is ready for weighing
2) Triturate the weighed amount of compound tragacanth powder and the
sulphadimidine in a mortar with the raspberry syrup diluted with ¾ the
34
chloroform water, to form a smooth paste.
3) Add gradually with constant stirring the amaranth solution.
4) Transfer to a tared bottle.
5) A portion of the vehicle is used to wash the equipment used for mixing.
6) Add benzoic acid solution.
7) Add sufficient vehicle to produce the required volume.
8) Close the bottle and stick on the label.
9) Do not forget to write on the label, " Shake the bottle before use."
Uses of the prescription ingredients :
1) Sulphadimidine is a bacteriostatic rather than bactericidal.
2) Compound tragacanth powder is a suspending agent.
3) Raspberry solution
: ……………………………………………………..
4) Benzoic acid solution
: ……………………………………………………..
5) Amaranth solution
: ……………………………………………………..
6) Chloroform water
: ……………………………………………………..
Label:
Name :
Date:
Notes:
1) Sulphadimidine is very slightly soluble in water, and is soluble 1 in 120 parts
of alcohol.
2) Tragacanth is partly soluble in water, in which it swells to a
homogenous gelatinous mass. It is insoluble in alcohol.
35
CALAMINE LOTION (B. P. 1993)
Rx
Calamine
150
g
Zinc oxide
50
g
Bentonite
30
g
Sodium citrate
5
g
Liquefied Phenol
5
ml
Glycerol
50
ml
Water
to
Send
1000 ml
20 ml.
Sig.: To be used as directed.
Calculations :
The specified total volume = 1000 ml
The required total volume = 20 ml
The process is reduction in the prepared volume i.e. Factor less than
one So ………………………………………………………………………
Factor = the required total volume/ the specified total volume
= …………………………………………………………………..
For calamine
For zinc oxide
For Bentonite
For sodium citrate
For liquefied phenol
For glycerol
For Purified water, freshly boiled and cooled
to
20 ml.
= 20 ml – (sum of the volume of liquids) = A ml
36
Then calculate ¾ of A ml = ……………………………….. ml
The final calculated amounts to prepare ……………… ml are:
Rx
Calamine
……….. g
Zinc oxide
……….. g
Bentonite
……….. g
Sodium citrate
……….. g
Liquified phenol
……….. ml
Glycerol
……….. ml
Purified water, freshly boiled and cooled to
……….. ml
Sig.: …………………………………………………………………..
Method of preparation:
1) Read the prescription carefully, check the calculations for the amounts to be
used and check the balance and be sure that it is ready for weighing
2) Dissolve the Sodium citrate in about ¾ of water.
3) Intimately mix the bentonite with the zinc oxide and calamine in glass
mortar add the glycerol and levigate.
4) Use the Citrate solution to make a smooth paste and for diluting it.
5) Transfer to the tarred bottle and add the liquefied phenol.
6) Complete to final volume, close the bottle and stick on the label.
7) Do not forget the label "Shake the bottle before use".
Comments and Precautions:










Calamine and zinc oxide are indiffusible solids.

So bentonite is included as a thickening agent and absorbs water.

Calamine
 and zinc oxide : mild astringent and soothing & protective to the
skin.
Sodium citrate : to make the preparation more pourable .
Liquefied phenol : preservative, antiseptic


Glycerol : emollient
and a satisfactory dispersion of bentonite is achieved
if bentonite is first
37









Container : Amber bottle.
Shake the bottle before use.
For external use only.


The lotion should be applied to the skin as required and allowed to dry.

Uses:

soothing, astringent and treating mild sunburn

Label:
Name :
Date:
Notes:
1) Phenol is soluble 1 in 12 parts of water at room temperature.
2) Glycerol is miscible with water and alcohol.
3) Calamine is insoluble in water and is almost completely soluble in
hydrochloric acid with effervescence.
4) Bentonite is insoluble in water but swells into a homogenous mass. It is
the native colloidal aluminium silicate.
5) Gum acacia can't be used as a suspending agent for lotions because it
makes the preparation sticky which is not suitable for external application.
6) This lotion is used as a protective coat for inflammatory skin diseases
and as a soothing preparation.
7) Calamine is a basic zinc carbonate colored with ferric oxide.
38
SULPHA DRUG MIXTURE
Rx
Sulphadiazine
1.9980 g
Sulphamerazine
1.9980 g
Sulphamethazine .
1.9980 g
Methylhydroxybenzoate
0.0486 g
Propylhydroxybenzoate
0.0162 g
Cinnamon syrup
24 ml
Water to
60 ml
Ft. mist. Mitte 20 ml
Sig. 5 ml q. 6h.
Calculations:
The specified total volume = 60 ml
The required total volume = 20 ml.
The process is enlargement in the prepared volume i.e. Factor more than
one So ………………………………………………………………………
Factor = the required total volume/ the specified total volume
= …………………………………………………………………..



Substances are indiffusible so we need suspending agent

Compound powder of Tragacanth:
2% W/V of the total volume of the mixture i.e. Two grams of
compound powder of tragacanth are used for each 100 ml mixture.
So the needed suspending agent =
For Sulphadiazine
For Sulphamerazine
For Sulphamethazine .
For Methylhydroxybenzoate
(If stock solution)
39
For Propylhydroxybenzoate (if stock solution)
For Cinnamon Syrup
For water
to
20 ml.
= 20 ml – (sum of the volume of liquids) = A ml
Then calculate ¾ of A ml = ……………………………….. ml The
final calculated amounts to prepare ……………… ml are:
Rx
Sulphadiazine
……….. g
Sulphamerazine
……….. g
Sulphamethazine .
……….. g
Compound powder of tragacanth
……….. g
Methylhydroxybenzoate
……….. ml
Propylhydroxybenzoate
……….. ml
Cinnamon syrup
……….. ml
Water to
……….. ml
Sig.: …………………………………………………………………..
Method of preparation:
1 - Dissolve propylhydroxybenzoate and methylhydroxybenzote in about 3/4
of the vehicle (water) in a beaker with appropriate capacity.
If you have stock solution, then ………..
2- In a porcelain mortar, grind the trisulphonamides, then mix with
the calculated amount of compound powder of tragacanth.
3- Gradually add the solution prepared in step 1 to the contents of the mortar
with continuous trituration after each addition until smooth thin paste is
formed.
4- Then add the remainder of the solution with stirring.
40
5- Transfer the contents of the mortar to the measuring cylinder.
6- Rinse the mortar with few ml of the vehicle and add the rinsing to
the measuring cylinder.
7- Complete to the final volume with the vehicle.
Comments and Precautions:
An additional label “Shake the bottle before use” should be used.
Uses :
The Label :
Name :
Date:
41
EMULSIONS








An emulsion is a polyphasic system of two immiscible liquids (usually oils and
water) in which one phase is finally divided
and uniformly distributed in the

other by the aid of emulsifying agent
The dispersed phase (internal phase) is composed of small globules of
diameters down to 0.1 µm of a liquid distributed
throughout the dispersion

medium (external or continuous phase).
Oil-in-water emulsions “o/w” emulsions.
Water-in-oil emulsions “w/o” emulsions.



Multiple emulsions
Based on the constituents and the intended application, liquid emulsions may
be employed orally, topically, or parentally.
TYPES
1. Oil in water (O/W) emulsions:




The oil is dispersed as droplets through the aqueous phase.
This type of emulsion is generally formed if:





the aqueous phase constituents > 45% of the total weight, and
A hydrophilic emulsifier is used.



2. Water in oil (W/O) emulsions:




The water is dispersed phase and oil is the dispersion medium.
This type of emulsion is generally formed if:





the aqueous phase constituents < 45% of the total weight,


A lipophilic emulsifier is used.
3. Multiple emulsion





In these types of emulsions three phases are present, e.g.:







w/o/w

o/w/o.
Any drug present in the innermost layer phase
must now cross two-phase
boundaries to reach the external phase, thus,
Used to delay the release of an active ingredient.
42



Micro-emulsion: If the dispersed globules
are of 1 nm to 1 µm diameter,
the preparation is quite often transparent.



This type of emulsion has similar properties to a micellar system
 and
will therefore exhibit the properties of hydrophobic colloids.

Emulsion preparation
On a small scale:
– by a dry porcelain mortar and pestle, a mechanical blender or mixer such
as a Waring blender or a milk-shake mixer, a hand homogenizer, or in
certain instances a simple prescription bottle.




On a large scale:
– large volume mixing tanks may be used to form the coarse emulsion


through the action of a high speed impeller.
– the coarse product may be rendered fine by passage through:



a colloid mill, in which the particles are sheared
between the small
gap separating high speed rotar and the stator,
a large homogenizer, in which the liquid 
is forced under great
pressure through a small valve opening.
Methods





Acacia gum should be considered the most convenient emulsifying agent for
emulsions intended for internal use.

To prepare acacia-containing emulsions, using a mortar and pestle, a
thick primary emulsion should be made first.

When an emulsion contains more than one oily component, the quantity of
acacia required for each is calculated and the sum of these quantities is used.

Emulsions should be labeled “Shake the bottle before use”.

Emulsions should be “Store in a cool place”.
43

Ratios of components for preparation of primary emulsions are given in the
following table.
Type
Oil
Water
Acacia
(by volume)
(by volume)
(by weight)
4
2
1
Mineral oils
3
2
1
Linseed oils
2
2
1
Volatile oils
2
2
1
Fixed oils
(except linseed oil)




Methods of preparation of emulsion include:



The continental or dry gum method


The English or wet gum method

The bottle or the Forbes bottle method

1. Continental, French or dry gum
method Preparation of primary emulsion:
1. Calculate the proportions of oil, water, and gum to prepare primary emulsion.
2. Weigh the required proportion of gum and put it in a clean dry
porcelain mortar.
3. Add the required proportion of oil and suspend the gum in the oil (light
mixing).
4. Add the required proportion of water (all at once) while mixing thoroughly,
rapid and continuously in one direction until the primary emulsion is
formed (creamy white color and clicking sound).
5. Add the rest of the formula ingredients gradually to the primary emulsion
with mixing.
6. Transfer the prepared emulsion to a graduate and made to volume with water
previously swirled about in the mortar to remove the last portion of emulsion.
7. Transfer to a bottle, cork it and stick on the written label, and the additional
label "Shake the bottle before use".
44
2. English or wet gum method
1. The same proportions of oil, water, and gum are used as in the continental or
dry gum method, but the order of mixing is different.
2. Weigh the required proportion of gum and put it in a clean porcelain mortar ,
3. Add the required proportion of water and mix well until mucilage is formed.
4. Add the oil drop by drop with mixing in one direction till the primary
emulsion is formed (creamy white color and clicking sound).
5. Add the rest of the formula ingredients gradually to the primary emulsion
with mixing.
6. Transfer the prepared emulsion to a graduate and made to volume with water
previously swirled about in the mortar to remove the last portion of emulsion.
7. Transfer to a bottle, cork it and stick on the written label, and the
additional label "Shake the bottle before use".
3. Bottle or Forbes bottle method
1. In instances in which the intended dispersed phase is a volatile oil, the dry
gum method is generally employed for emulsification (Bottle method).
2. Powdered acacia is placed in a dry bottle, the oil are then added, and
the mixture is shaken in the capped bottle.
3. A volume of water approximately equal to the oil is then added
and thoroughly shaken until the primary emulsion is formed.
4. Then add the rest of the formula ingredients gradually to the primary emulsion
with mixing.
5. Made to volume with water.
6. This method is not suited for viscous oils, since they cannot be thoroughly
agitated in the bottle.
Containers for emulsions :
Emulsions should be supplied in wide-mouthed containers, fitted with plastic
screw closures. Metal caps should be avoided.
Labelling :
A direction to shake the bottle before use should be given on the label.
45
Preservation of emulsions :
Examples of preservatives used for emulsions :
a) Benzoic acid : e.g. liquid paraffin emulsion (B. P. C.)
b) Chloroform : e.g. liquid paraffin and magnesium hydroxide emulsion (B. P. C.)
c) Chlorocresol : e.g. proflavin emulsion (B. P. C.)
d) Cetrimide : e.g. for emulsions prepared for external use.
46
LIQUID PARAFFIN EMULSION
Rx
Liquid paraffin
400 ml
Vanillin
0.5 g
Benzoic acid solution (5%)
20 ml
Saccharin sodium
0.05 g
Acacia powder
Q.S.
Purified water
Send
ad
1000 ml
50 ml.
Sig. : S. O. S.
Calculations :
Vanillin :
available as 1% w/v solution
Saccharin sodium : available as 2.5% w/v solution
47
Method of Preparation:
1) Prepare the emulsion by the " Continental " method
Uses of the prescription ingredients :
1) Liquid paraffin emulsion is used as lubricant and faecal softener
2) Liquid Paraffin when taken by mouth it keeps the stool soft and therefore it
is useful in the treatment of chronic constipation and in painful conditions of
the anus and rectum associated with haemorroids and anal fissure.
2) Acacia powder is effective suspending and emulsifying agent for volatile,
fixed and mineral oil.
3) Vanillin: flavoring agent
4) Saccharin sodium: sweetening agent
5) Benzoic acid solution: preservative
Comments and Precautions:
1) Liquid paraffin is a mixture of liquid hydrocarbons which are obtained from
petroleum by distillation. It is insoluble in water and alcohol but soluble in
chloroform.
2) For preparing the primary emulsion the ratio is :
Liquid paraffin
3
:
Water
:
2
Gum
1
48
3) Additional label:“Shake the bottle before use” and “Keep in a cool place”
must be added.
Label:
Name :
Date:
49
CONCENTRATED PEPPERMINT EMULSION (B. P 1993)
Rx
Peppermint oil
20 ml
Polysorbate 20
1 ml
Double strength chloroform water
500 ml
Purified water, freshly boiled and cooled ad
1000 ml
Send
50 ml.
Calculations :
Procedure :
Uses of the prescription ingredients :
1) Peppermint emulsion: ………………………………………………………………
2) Polysorbate 20: ………………………………………………………………
50
3) Chloroform water : ………………………………………………………………
4) Purified water
: ………………………………………………………………
Label:
Name :
Date:
Notes:
1) Concentrated peppermint emulsion is a 2% v/v dispersion of peppermint oil
in a suitable vehicle containing a non-ionic surface active agent.
2) Additional label:“Shake the bottle before use” and “Keep in a cool place”
must be added.
51
CASTOR OIL EMULSION
Prepare the following prescription (using wet gum method).
Rx
Castor oil
16 ml
Cinnamon Water to
90 ml
Ft. emulsion, mitte 30 ml
Sig. Coch. parv. q.m.n.
Calculation:
Method of Preparation:
52
Comments and Precautions:
Uses:
Label:
Name :
Date:
53
CASTOR OIL EMULSION
Prepare the following prescription (using dry gum method).
Rx
Castor oil
16 ml
Cinnamon Water to
90 ml
Ft. emulsion, mitte 30 ml
Sig. Coch. parv. q.m.n.
Calculation:
Method of Preparation:
54
Comments and Precautions:
Uses:
Label:
Name :
Date:
Carry out calculations for:
Rx
Castor oil
40%
Cinnamon water qs.
100%
Calculation:
55
LIQUID PARAFFIN EMULSION
Rx
Liquid paraffin
15 ml
Water
45 ml
to
Ft. emulsion, send 30 ml
Sig. 5 ml b.i.d.
Calculation:
Method of Preparation:
56
Comments and Precautions:
Uses:
Label:
Name :
Date:
Carry out calculations for:
Rx
Liquid paraffin
Water
30 ml
to
60 ml
Ft. emulsion, mitte X doses
Sig. Coch. parv. t.i.d.
Calculation:
57
GRANULATIONS
PREPARATION OF NON-EFFERVESCENT GRANULES
METHYLCELLULOSE GRANULES (B. P. C.)
Rx
Methylcellulose 2500 or 4500 in powder
64.0
g
Lactose
31.68 g
Acacia powdered
4.0
g
Vanillin
0.2
g
Saccharin sodium
0.1
g
Amaranth, food grade of commerce
0.02
g
Make granules. Send 20 g.
Sig. : One teaspoonful to be taken when needed.
Calculations :
 Calculate for 30 g to compensate for the loss in the sieve.
 Using the respective stock solutions as indicated below :
(a) Amaranth
1 % W/V solution
=
ml
(b) Vanillin
10 % W/V solution
=
ml
(c) Saccharin sodium
10 % W/V solution =
58
ml.
Procedure :
(1) Read the prescription carefully, check the calculations for the amounts to be
used and check the balance and be sure that it is ready for weighing.
(2) Mix the weighed powders in a mortar in an ascending order of
weights starting with the smallest weight.
(3) Add amaranth solution, taking great care to distribute it evenly.
(4) Add vanillin and saccharin sodium and mix well.
(5) Moisten the powder mixture with purified water to form a damp mass and mix
continuously until the mass will retain its shape when molded into a ball.
(6) Force the mass through a sieve of suitable size (2.8 mm).
(7) Spread the product thinly on a large tray of white demy or grease-proof paper
o
and dry at not more than 55 C or in an open-air if the humidity is low.
(8) Transfer the dried granules into a wide-mouth glass bottle, close and stick on
the label.
NOTES :
(1) Methyl cellulose is a methyl ether of cellulose. The number indicated after
º
methylcellulose refer to the approximate viscosity of 2% solution at 20 C .
(2) The sieve size used is 2.8 mm (size of the opening)
(3) Sieve number is the number of opening per linear inch.
(4) Use airtight, screw capped, wide mouth jar
(5) The label should stress the importance of storage in a dry place.
59
Uses of the prescription ingredients :
(1) Methylcellulose 2500 or 4500
(2) Lactose :
(3) Acacia :
(4) Vanillin :
(5) Saccharin sodium :
(6) Amaranth solution:
Label:
Name :
Date:
60
PREPARATION OF EFFERVESCENT GRANULES
SODIUM PHOSPHATE EFFERVESCENT GRANULES
Rx
Sodium phosphate (anhydrous)
500 g
Sodium bicarbonate
500 g
Tartaric acid
240 g
Citric acid
210 g
Color
Q. S.
Make effervescent granules. Send 20 g.
Sig.: One teaspoonful in a half glass of water to be taken while
effervescence when needed.
Calculations :
Calculate for 30 g to compensate for the loss in the sieve.
61
Procedure :
(1) Read the prescription carefully, check the calculations for the amounts to be
used and check the balance and be sure that it is ready for weighing.
(2) Mix the weighed powders in an ascending order of weights starting with
the smallest weight.
(3) Add coloring solution, taking great care to distribute it evenly.
(4) Moisten the powder mixture with alcohol 96 %, which will act as a binder
to form a damp mass.
(4) Add extra binder if needed and mix continuously until the mass will retain
its shape when molded into a ball.
(5) Force the mass through a sieve of suitable size (2.8 mm).
o
(6) Dry the moist granules in a temperature not exceeding 55 C or in an
open-air if the humidity is low.
(7) Transfer the dried granules into a wide-mouthed glass bottle, close and
stick on the label.
NOTES :
(1) Effervescent granules prepared with tartaric acid only produce granules
which are powdery and the final product will have a salty taste. On the
other hand, if only citric acid is used, the mass will be sticky and difficult to
manipulate. Therefore a combination of the two acids is used to make a
better granulation mixture.
(2) The label should stress the importance of storage in a dry place.
62
Uses of the prescription ingredients :
(1) Sodium bicarbonate reacts with the acids when the preparation is added to
water. The evolved carbon dioxide produces the effervescence.
(2) Citric and tartaric acids : The quantity of these acids is slightly more than
is necessary to neutralize the sodium bicarbonate because effervescenct
preparations are more palatable if slightly acidic.
(3) Sodium phosphate is used as saline purgative.
63
POWDERS
Powders are pharmaceutical preparations which consist of one or more drugs in
a dry fine state of subdivision.
METHOD OF PREPARATION :

 They are prepared by mixing the medicament or medicaments specified in
smallest quantity with gradually increasing quantities of the remaining
materials.
 When a small quantity of a potent medicament is present in the
prescription, it should be diluted by trituration with an amount of an inert
diluent such as lactose.
CONTAINERS AND STORAGE :
If any of the constituents are deliquescent or volatile:

 the powder should be stored and supplied in airtight containers
 when it is supplied as single doses, the powder should be doubly wrapped,
the inner wrapper consisting of waxy paper; in exceptional cases, the
wrapped powder should finally be enclosed in tin foil.
64
PREPARATION OF A BULK POWDER FOR INTERNAL USE
CALCIUM CARBONATE COMPOUND POWDER (BPC 79)
ANTACID POWDER
Rx
Calcium carbonate
Sodium bicarbonate
Heavy Magnesium carbonate
375 g
375 g
125 g
Light kaolin
Send 20 g.
125 g
Sig. : 5 ml to be taken with water t.i.d., p.c.
Calculations :
Procedure :
1) Read the prescription carefully, check the calculations for the amounts to be
used and check the balance and be sure that it is ready for weighing
(2) Incorporate the powders in order of bulk starting with the smallest one
(3) Transfer the powder into a jar.
(4) Close the jar and stick on the label.
Uses of the prescription ingredients :
(1) Calcium carbonate
:
(2) Sodium bicarbonate
:
(3) Heavy Magnesium carbonate :
65
(4) Light kaolin
:
Label:
Name :
Date:
66
PREPARATION OF A DIVIDED POWDER FOR INTERNAL USE
ORAL REHYDRATION SOLUTIONS (W. H. O. : UNICEF)
Rx
Sodium chloride
Potassium chloride
Sodium bicarbonate
3.5 g
1.5 g
2.5 g
Anhydrous glucose
Make a packet
Sig. : One packet for solution
20 g
in 1000 ml of water.
Procedure :
1) Read the prescription carefully, check the calculations for the amounts to
be used and check the balance and be sure that it is ready for weighing
(2) Incorporate the powders in order of bulk starting with potassium
chloride, followed by sodium bicarbonate, then sodium chloride and
finally add anhydrous glucose in portions adding at each addition a
quantity that approximately doubles the bulk already in the mortar.
(3) Transfer the powder into a packet.
(4) Stick on the label.
METHOD OF WRAPPING PACKETS :
(1) Select a suitable box to hold the required number of doses.
(2) Turn over one end of the required numbers of wrapping papers.
(3) After weighing each dose of the powder placing it centrally in each paper,
begin wrapping by inserting the edge of the paper under the turned up
edge and fold both loosely over itself to an extent which appears to make
the packet slightly narrower than the interior depth of the box.
(4) Bend each end in, turn over a powder knife, holding the knife 3 mm
inward from the crease made by the box.
(5) Arrange the packets either flap to flap or with all flaps in one direction with the
exception of the last one which should be turned in the opposite direction.
(6) Before placing the packets in the box, encircle them with an elastic band.
(7) In a well wrapped powder there should be no medicament within the flaps
or folds.
67
DOUBLE WRAPPING :




 White paper gives inadequate protection to volatile, hygroscopic or
deliquescent substances unless it is lined with grease proof or waxy
paper.
 The waxy paper is cut slightly smaller than the ordinary paper and is put
on top of it.
 The two papers are then folded together. The substance must not be
wrapped first in the waxy paper and then in the white one.
 Exceptionally, it may be necessary to wrap the finished packet externally
in aluminium foil.
Label:
Name :
Date:
NOTES :
(1) Administration of fluid and electrolytes by mouth to prevent or treat
dehydration due to acute diarrheal diseases is known as oral rehydration
therapy. Acute diarrhea leads to loss of essential water and salts and unless
these are adequately replaced, dehydration will develop.
(2) Oral rehydration therapy does not stop diarrhea but the diarrhea
continues for only a limited time.
(3) The universal oral rehydration salts are recommended by the WHO
and UNICEF as prescribed in this experiment.
(4) O.R.S. is marketed in a Sachets
Uses of the prescription ingredients :
(1) Sodium chloride is the most important salt for maintaining the osmotic
pressure of the blood and tissues. It is an ingredient in oral rehydration
therapy. Solutions of sodium chloride usually with the addition of dextrose
68
are given intravenously and sometimes by rectum to patients who
are unable to take fluids by mouth.
(2) Potassium chloride : Deficiency of potassium ions causes acute
muscular weakness and cardiac arrhythmias.
(3) Glucose : The chief use of dextrose is as a food and it is the substance to
which carbohydrates, when given by mouth, are mainly converted. It
provides a rapidly available source of energy. Glucose accelerates the
absorption of sodium and water from the small intestine and this process
is not impaired during acute diarrhea.
69
Tablet Triturates
(Moulded Tablets)
Preparation of plain and Medicated Tablet Triturates
Definition:
Disk like masses of molded powders composed of medicament diluted
with lactose or dextrose and sometimes binder
Components:
1) Medicament or active ingredient
2) Diluent: lactose is the mostly used diluent because its inertness,
stability and solubility
3) Moistening agent: Ethyl alcohol (25%, 75% or 90%) or butyl alcohol the
amount of the moistening agent must be adjusted because:
•
If the amount of alcohol was insufficient, the powder mass will not
have the proper cohesion to produce firm tablets.
•
If the amount of alcohol was excess, too wet mass will be produced
which result in shrinkage of tablets on drying and creeping. Also, a soggy
mass will produce hard and slowly soluble tablets. Moreover, excess
wetting require longer time for drying.
Moulds of Tablet Triturates
The moulds used for preparation of tablet triturates are:



made of stainless steel.

composed of two parts upper perforated plate and lower plate
 contains
projections correspond in position to holes in upper plate.
Preparation of Plain and medicated Tablets
•
•
•
Prepare plain tablet triturates using 5 g lactose.
Prepare medicated tablet triturates 20% drug A (1 g drug and 4 g lactose)
Calculate D.V of the drug
Method of preparation
1. Calculate for slight larger number of tablets than the number to be sent
(Calculated number = Required number + 10).
2. Finally powder all solid ingredients separately.
3. Mix the active ingredient with lactose geometrically (lactose is added
in portions).
70
4. Moistening the mixed powders by moistening agent (Ethyl alcohol)
until soft mass formed.
5. Force the moist mass through the perforation of the upper plate which is
cleaned and placed on clean slab, remove excess powder by the spatula.
6. Stand the upper plate on its edge over the lower one for 5 min to allow
evaporation of moistening agent from both surfaces of the molded tablets.
7. Press the upper plate over each lower one so that the number is
superimposed and leave to dry for 10 min (total drying time 15 min)
8. Transfer the tablets to clean paper carefully.
General Steps for Preparation
1. Powdering or grinding
2.
3.
4.
5.
Mixing (in case of medicated tablets)
Moistening
Forcing into holes
Drying
Displacement value calculation (D.V.)
Displacement Value (D.V): is defined as the weight of the medicament
which displace one part of lactose
Calculation of D.V
•
•
•
•
•
Weight of 10 plain tablets = A
Weight of 10 medicated tablets = B
Weight of lactose in 10 medicated tablets = C = B X 80/100
Weight of drug in 10 medicated tablets = D = B X 20/100
Weight of lactose displased by the drug = A - C = F
•
•
•
D.V = D / F
If D.V < 1, drug density is higher than that of lactose (B < A).
If D.V < 1, drug density is lower than that of lactose (B < A)
Important Precautions
•
•
Use the same mould for preparation of plain and medicated
tablet triturates.
Don't wash the mortar or mould with water.
71
Rx
Drug A
Lactose
0.015 g
Q.S
Send 30 tablets
N.B. The drug amount in the prescription is the amount in one tablet
To prepare prescribed tablets, you must have D.V of the drug and
average weight of one plain tablet.
If you are not provided with D.V of the drug, you must calculate it first.
Calculation of D.V of Drug (A);
1) Prepare plain tablets (5 gm lactose).
2) Prepare medicated tablets (4 gm lactose + 1 gm drug (20%)).
3) Calculate D.V as taken before (D.V = D/A-C).
If you are provided with D.V of the drug, you must prepare plain tablets
first.
D.V of drug A = 0.8
Calculation of drug amount;
Prescribed tablets No.= 30
Excess tablets No.= 10
Total tablets Number = Prescribed number + excess number
= 30 + 10 = 40
Amount of drug in 40 tablets = 40 X 0.015 = 0.6 gm.
Calculation of lactose amount;
Weight of 10 plain tablets = A
Weight of one plain tablet = A/10
Lactose amount =
Total tablet No.(Weight of one plain tab – (Weight of drug in one
tab/D.V of drug))
= 40 (A/10 – (0.015/0.8)) = gm of lactose
Now you have both drug and lactose amount to prepare prescribed
tablets as taken before
N.B. The unit of plain tablet weight must be the same as drug weight in the
law.
72
Steps for Preparation
1. Powdering or grinding
2. Mixing (in case of medicated tablets)
3. Moistening
4. Forcing into holes
5. Drying
Important Precautions





Use the same mould for preparation
of plain, medicated and

prescribed tablet triturates.
Don't compare your results with others.

Ensure that the unit of A/10 is the
same like drug amount and also will
be the same like lactose amount.
73
PHARMACEUTICAL
CALCULATION Solve the following problems:
1) If 1.5 g of a drug represents 18 doses, how many doses are represented in
0.25 g?
Answer :
2)
How many teaspoonfuls would be prescribed in each dose of a medicine
if 32 ml contained 16 doses?
Answer :
3)
How many drops would be prescribed in each dose of a medicine if 15
ml contained 60 doses? The dispensing dropper calibrates 32 drops/ml.
Answer :
4)
How many tablets of paracetamol can be used to provide a patient with
paracetamol elixir (125 mg/5 ml.) prescribed as one dessertspoonful
twice daily for five days?
N.B. : You are provided with paracetamol tablets (500
mg/tablet). Answer :
74
5)
What is the cost of 1000 ml. of glycerin (sp. gr. 1.249) bought at
500 cents/453.6 g?
Answer :
6)
Chloroform liniment contains 30 % (V/V) of chloroform. How many ml of
chloroform liniment can be prepared from 453.6 g chloroform (sp.gr.
1.475)? Answer:
7)
How many (g) of a chemical should be dissolved in 240 ml of water to
make a 4 % (W/W) solution?
Answer :
8)
If 500 ml of 15 % (V/V) solution are diluted to 1500 ml, what will be the %
(V/V)?
Answer :
75
9)
How much water should be mixed with 5000 ml of 85 % (V/V) alcohol
to make 50 % (V/V) alcohol?
Answer :
10) In what proportions may a manufacturing pharmacist mix 3 %, 5 %, 15
% and 20 % zinc oxide ointment to produce a 10 % ointment ?
Answer :
76