PRACTICAL PHARMACEUTICS DOSAGE FORM-I - Manspharfac.mans.edu.eg/media/clinic_main_menu/news_1092343883.pdf · PRACTICAL PHARMACEUTICS DOSAGE FORM-I For ... Pharmaceutical dosage forms

University of Mansoura

Faculty of Pharmacy

Department of Pharmaceutics

PRACTICAL PHARMACEUTICS

DOSAGE FORM-I

For

Second Level Clinical Pharmacy

Students

2015 – 2016

1

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

2

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

3

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.

4

(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.

5

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.

6

(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 2.5 ml

Purified water to 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 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.

NON-STERILE LIQUID DOSAGE FORMS

(1) MONOPHASIC SYSTEMS

7

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.

8

(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

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 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.


(1) Codeine phosphate: anti-tussive and analgesic.

9

(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.

10

(c) SOLUTIONS

(1) Oral Solutions

STRONG SODIUM SALICYLATE MIXTURE (B. P. 1993)

Rx

Sodium salicylate 100 g

Sodium metabisulphite 1 g

Peppermint emulsion, concentrated 25 ml

Chloroform water, double strength 500 ml

Water to 1000 ml

Send 20 ml.

Sig. : 2.5 ml. t.d.s.

Calculations :

Procedure :



(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.

11


(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.

12

(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

Water to 100 ml

Send 50 ml

Sig. : To be diluted with an equal volume of warm water before use.

Calculation:

Procedure :



(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.

13

(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.


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).

14

(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


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 :



(2) Mix the calculated volume of phenol glycerin and amaranth solution in a

beaker.

(3) Add 3/4 water and mix.

15

(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.


(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:

16

(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 %


Send 10 ml.

Sig. : Two drops to be placed in each nostril as directed.

Calculations :

Procedure :



(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.

17


(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).

18

(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.

19

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.


Rx

Phenobarbitone 0.18 g

Orange oil 0.045 ml

Amaranth solution 0.6 ml

Alcohol (96 %) 23.75 ml

Glycerin 15 ml

Syrup 9 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 :

20

Procedure :



(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.


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.

21

(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).

22

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.


Rx

Paracetamol 24 g


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 :


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.

23

(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.



(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

24

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.

(i) suspensions

NON-STERILE LIQUID DOSAGE FORMS (CONT.)

(2) POLYPHASIC SYSTEMS

25

CALCIUM CARBONATE MIXTURE

Rx

Calcium Carbonate 1.555 g

Light Magnesium Carbonate 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

26

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 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 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

27

Label:

Name : Date:

28

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:




So ………………………………………………………………………


= …………………………………………………………………

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


29

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 :



(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."


Kaolin is a diffusible solid and therefore no additional suspending agent is

required.

Container: Amber medicine bottle.

30

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.

31

Label:

Name : Date:

32

(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.

33

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."

34

SULPHADIMIDINE MIXTURE, Paediatric (B. P. 1993)

Definition : It is a suspension containing 10 % w/v of sulphadimidine in a

suitable flavoured vehicle.


Rx Sulphadimidine, in fine powder 100 g

Compound tragacanth powder 40 g

Raspberry syrup 200 ml

Benzoic acid solution 20 ml


Chloroform water to 1000 ml

Send 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


2) Triturate the weighed amount of compound tragacanth powder and the

sulphadimidine in a mortar with the raspberry syrup diluted with ¾ the

35

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."


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.

36

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 required total volume = 20 ml


So ………………………………………………………………………


= …………………………………………………………………..

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.


37


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.: …………………………………………………………………..




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".


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

38

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.

39

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 process is enlargement in the prepared volume i.e. Factor more than one

So ………………………………………………………………………


= …………………………………………………………………..

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)

40

For Propylhydroxybenzoate (if stock solution)

For Cinnamon Syrup

For water to 20 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.: …………………………………………………………………..


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.

41

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.


An additional label “Shake the bottle before use” should be used.

Uses :

The Label :

Name : Date:

42

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.

43

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”.

44

Ratios of components for preparation of primary emulsions are given in the

following table.

Type Oil

(by volume)

Water

(by volume)

Acacia

(by weight)

Fixed oils

(except linseed oil) 4 2 1

Mineral oils 3 2 1

Linseed oils 2 2 1

Volatile oils 2 2 1

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".

45

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.

46

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.

47

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 ad 1000 ml

Send 50 ml.

Sig. : S. O. S.

Calculations :

Vanillin : available as 1% w/v solution

Saccharin sodium : available as 2.5% w/v solution

48

Method of Preparation:

1) Prepare the emulsion by the " Continental " method


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


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 : Water : Gum

3 2 1

49

3) Additional label:“Shake the bottle before use” and “Keep in a cool place” must

be added.

Label:

Name : Date:

50

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 :


1) Peppermint emulsion: ………………………………………………………………

2) Polysorbate 20 : ………………………………………………………………

51

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.

52

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:


53


Uses:

Label:

Name : Date:

54

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:


55


Uses:

Label:

Name : Date:

Carry out calculations for:

Rx

Castor oil 40%

Cinnamon water qs. 100%

Calculation:

56

LIQUID PARAFFIN EMULSION

Rx

Liquid paraffin 15 ml

Water to 45 ml

Ft. emulsion, send 30 ml

Sig. 5 ml b.i.d.

Calculation:


57


Uses:

Label:

Name : Date:

Carry out calculations for:

Rx

Liquid paraffin 30 ml

Water to 60 ml

Ft. emulsion, mitte X doses

Sig. Coch. parv. t.i.d.

Calculation:

58

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 = ml.

59

Procedure :



(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

and dry at not more than 55 oC 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

methylcellulose refer to the approximate viscosity of 2% solution at 20 ºC .

(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.

60


(1) Methylcellulose 2500 or 4500

(2) Lactose :

(3) Acacia :

(4) Vanillin :

(5) Saccharin sodium :

(6) Amaranth solution:

Label:

Name : Date:

61

PREPARATION OF EFFERVESCENT GRANULES

SODIUM PHOSPHATE EFFERVESCENT GRANULES

Rx

Sodium phosphate (anhydrous) 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.

62

Procedure :



(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).

(6) Dry the moist granules in a temperature not exceeding 55 oC 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.

63


(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.

64

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.

65

PREPARATION OF A BULK POWDER FOR INTERNAL USE

CALCIUM CARBONATE COMPOUND POWDER (BPC 79)

ANTACID POWDER

Rx

Calcium carbonate 375 g


Heavy Magnesium carbonate 125 g

Light kaolin 125 g

Send 20 g.

Sig. : 5 ml to be taken with water t.i.d., p.c.

Calculations :

Procedure :



(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.


(1) Calcium carbonate :

(2) Sodium bicarbonate :

(3) Heavy Magnesium carbonate :

66

(4) Light kaolin :

Label:

Name : Date:

67

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


Anhydrous glucose 20 g

Make a packet

Sig. : One packet for solution in 1000 ml of water.

Procedure :



(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.

68

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


(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

69

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.

70

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).

71

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. Mixing (in case of medicated tablets)

3. Moistening

4. Forcing into holes

5. 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.

72

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.

73

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.

74

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 :

75

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 :

76

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 :

77

78

ATTENDANCE SHEET

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Student Number : ………………………….………………………………………

Date Subject Mark Dr. Name

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