Академический Документы
Профессиональный Документы
Культура Документы
Faculty of Pharmacy
Department of Pharmaceutics
PRACTICAL PHARMACEUTICS
DOSAGE FORM-I
For
2015 2016
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
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
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
(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
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 counter-
irritant. 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
It is 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 IV
Purified water, freshly boiled and cooled fl IV
Chloroform spirit fl VII
Syrup to fl XXXIV
Send 20 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 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.
8
(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
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 of water, If sodium
metabisulphite present as stock solution, measure and mix with 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.
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.
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.
Label:
Name : Date:
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.
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.
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.
Name : Date:
Notes:
(1) Phenobarbitone is soluble 1 in 1000 parts of water, and 1 in 10 parts of
alcohol.
20
(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).
21
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 1000 ml
Send 20 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.
22
(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.
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.)
(i) suspensions
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 Syrup
25
For Chloroform Water to 30 ml
= 30 ml (sum of the volume of liquids) = .. ml (A)
Then calculate 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 ad. 30 ml
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 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 to 1000 ml
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 Water to 20 ml
= 20 ml (sum of the volume of liquids) = A ml
Then calculate 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 to 20 ml
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 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."
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 to 1000 ml
Send 20 ml.
Sig. : 5 ml q.i.d.
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 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 1000 ml
Send 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 Bentonite
For glycerol
36
Then calculate 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 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".
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 .
39
For Propylhydroxybenzoate (if stock solution)
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 m 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 m 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)
Fixed oils
4 2 1
(except linseed oil)
Mineral oils 3 2 1
Linseed oils 2 2 1
Volatile oils 2 2 1
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
Send 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
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 :
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:
55
LIQUID PARAFFIN EMULSION
Rx
Liquid paraffin 15 ml
Water to 45 ml
Ft. emulsion, send 30 ml
Sig. 5 ml b.i.d.
Calculation:
Method of Preparation:
56
Comments and Precautions:
Uses:
Label:
Name : Date:
57
GRANULATIONS
PREPARATION OF NON-EFFERVESCENT GRANULES
Lactose 31.68 g
Vanillin 0.2 g
Calculations :
58
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.
(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
(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
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
Color Q. S.
Make effervescent granules. Send 20 g.
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.
(4) Moisten the powder mixture with alcohol 96 %, which will act as a binder to
(4) Add extra binder if needed and mix continuously until the mass will retain its
(5) Force the mass through a sieve of suitable size (2.8 mm).
(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
(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
63
POWDERS
METHOD OF PREPARATION :
64
PREPARATION OF A BULK POWDER FOR INTERNAL USE
CALCIUM CARBONATE COMPOUND POWDER (BPC 79)
ANTACID POWDER
Rx
Calcium carbonate 375 g
Sodium bicarbonate 375 g
Heavy Magnesium carbonate 125 g
Light kaolin 125 g
Send 20 g.
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.
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 3.5 g
Potassium chloride 1.5 g
Sodium bicarbonate 2.5 g
Anhydrous glucose 20 g
Make a packet
Sig. : One packet for solution 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.
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
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.
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.
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 0.015 g
Lactose 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 :
74
5) What is the cost of 1000 ml. of glycerin (sp. gr. 1.249) bought at 500
cents/453.6 g?
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 :
76
77
ATTENDANCE SHEET
Student Name : .
Student Number : .
78