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PHARMACEUTICAL
POWDERS
Prepared By. SUMANA
Dept. of. Pharmaceutics
SDCP, Mangalore
POWDERS
ā€¢ A pharmaceutical powder is a mixture of finely divided drug and chemicals in dry form.
ā€¢ These are solid dosage form of medicament which is meant for internal and external use.
ā€¢ They are available in crystalline or amorphous form.
ļƒ˜ ADVANTAGES
ā€¢ More stable than liquid dosage forms
ā€¢ More convenient to swallow than tablet or capsules
ā€¢ Can be prepared into granules for use in preparing tablets and or reconstituted to liquid form
ā€¢ Rapid therapeutic effect due to high surface area
ā€¢ Useful for bulky drugs with large dose
ā€¢ Chances of incompatibility are less compared to liquid dosage forms.
ā€¢ Powders are more easy to transport than the liquid dosage form.
ā€¢ The onset of action of powdered drug is rapid as compared to other solid dosage form. E.g. tablets, capsules
ā€¢ Children & elderly patients can easily take powdered drug as such or by dispersing it in water or other liquid.
ā€¢ Economical dosage forms (minimal use of machinery / special techniques}
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
DISADVANTAGES
ā€¢ Drugs having bitter, nauseous and unpleasant taste canā€™t be dispensed in powdered form.
ā€¢ Deliquescent and hygroscopic drugs canā€™t be dispensed in powder form
ā€¢ Drugs which get affected by atmospheric conditions are not suitable for dispensing in powder forms.
ā€¢ The dispensing of powder is time consuming.
MIXING OF POWDERS
1. SPATULATION
2. TRITURATION
3. GEOMETRIC DILUTION
4. SIFTING
5. TUMBLING
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
1. SPATULATION
ā€¢ Mixing of powders done by movement of spatula throughout the powders on a sheet of paper or on
a porcelain tile.
ā€¢ This method is useful in mixing
ļ±Small amount of powder
ļ±Solid substances that liquefy or form eutectic mixtures, when in close & prolonged contact with
one another (since very little compaction occurs]
ā€¢ This method is not suitable for large quantities of powder or powders containing one or more
potent substances (because homogenous blending may not occur}
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
2. TRITURATION
ā€¢ It is used to reduce particle size as well as to mix powders.
ā€¢ Apparatus
ā€¢ Porcelain mortar & pestle (for size reduction as well as mixing}
ā€¢ Glass mortar & pestle (for chemicals that stains the porcelain surface}
ā€¢ Glass mortar cleans more readily after use.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
3. GEOMETRIC DILUTION
ā€¢ This method is used when potent substances are to be mixed with a large amount of diluent.
ā€¢ The potent drug & equal quantity of diluent is placed on a mortar & then slightly triturated.
ā€¢ 2nd portion of diluent in equal quantity to the above powder mixture is added to mortar & triturated.
ā€¢ The process is continued, adding diluent in equal quantities to the powder mixture in the mortar at each step; until all the
diluent is incorporated.
ā€¢ For example; Potent drug - 100mg
Lactose (diluent) - 900mg
ļƒ˜ 100mg of potent drug + 100mg Lactose - 200mg of mixture
ļƒ˜ 200mg of mixture + 200mg of lactose-400mg of mixture
ļƒ˜ 400mg of mixture + 400mg of Lactose - 800mg of mixture.
ļƒ˜ 800mg of mixture + remaining portion of Lactose (200mg) = 1000mg of mixture
6
4. SIFTING
ā€¢ Powders are mixed by passing through sifters.
ā€¢ This results in a light fluffy product & generally not acceptable for incorporation of potent drugs into diluent base.
5. TUMBLING
ā€¢ It is the process of mixing powders in a large containers rotated by an electric motor.
ā€¢ These blenders are used in Industries as large volume powder mixers.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
CLASSIFICATION OF POWDERS
ā€¢ {Based on method of dispensing}
1. BULK POWDERS FOR INTERNAL USE
2. BULK POWDERS FOR EXTERNAL USE
3. SIMPLE & COMPOUND POWDERS FOR INTERNAL USE
4. POWDERS ENCLOSED IN CACHETS & CAPSULES
5. COMPRESSED POWDERS (TABLET TRITURATES)
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
BULK POWDERS
ā€¢ Powders are dispensed in bulk, when accuracy of dosage is not important.
ā€¢ Bulk powder contains several doses of powder.
ā€¢ They are supplied in wide-mouthed containers that permits easy removal of a spoonful powder.
ā€¢ The non potent substances which are supplied in bulk are antacids and laxatives etc.
1. BULK POWDER FOR INTERNAL USE
ā€¢ They are mixture of finely divided drugs and or chemicals in a dry form that may be intended for internal use (oral
powders)
ļƒ˜ Types:
a) Oral powder
b) Powder spray
e) Dry powder inhalers
d) Effervescent powders
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
Example :
A) Send 25.0 g of Rhubarb powder B.P.C. (Gregoryā€™s Powder)
Rx
Rhubarb, in powder-250.0g
Light magnesium carbonate -325.0 g
Heavy magnesium carbonate-325.0 g
Ginger, in powder-100.0 g
Make a powder
Direct: 0.5 to 5.0 g to be taken twice a day.
Method: Powder all ingredients. Weigh & mix them in ascending order of their weight. Transfer the
powder in a wide mouth bottle & dispense.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
B) Send 50.0 g of compound bismuth powder
Rx
Calcium carbonate - 75. 0 g
Heavy magnesium carbonate - 75.0 g
Sodium bicarbonate ā€“ 25.0 g
Bismuth carbonate ā€“ 25.0 g
Make a powder
Direct: 5 g to be taken twice a day.
Method: Powdered all ingredients. Weigh & mix them in ascending order of their weight. Transfer
the powder in a wide mouth bottle & dispense.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
2. BULK POWDERS FOR EXTERNAL USE
ā€¢ Bulk powders for external use contain non-potent medicaments.
ā€¢ These powders are supplied in cardboard, glass or plastic containers, which
often designed for the specific method of application.
ā€¢ The bulk powders for external use are:
A) Dusting powders
B) Insufflations
C) Snuffs
D) Dentifrices
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
A. DUSTING POWDERS
ā€¢ These are used externally for local application not intended for systemic action. The desired characteristics of powders include
a) Homogeneity
b) Non-irritability
c) Free flow
d) Good spreadability and covering capability.
e) Adsorption and absorption capacity.
f) Very fine state of subdivision, and
g) Capacity to protect the skin against irritation caused by friction, moisture or chemical irritants.
ā€¢ Dusting powders usually contain substances such as zinc oxide, starch and boric acid or natural mineral substances such as
kaolin or talc.
ā€¢ Dusting powders are meant for external use & are generally applied in a very fine state of sub division to avoid local irritation.
ā€¢ Hence, dusting powders should be passed through sieve no. 80 to enhance their effectiveness.
ā€¢ Dusting powders are of 2 types:
a) Medical dusting powders
b) Surgical dusting powders
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
MEDICAL DESTING POWDERS
ā€¢ Used mainly for superficial skin conditions.
ā€¢ Must be free from pathogenic microorganisms.
SURGICAL DUSTING POWDERS
ā€¢ Used in body cavities, on wounds & on umbilical cords of infants.
ā€¢ These must be sterilized before use.
Method of preparation
ā€¢ Dusting powders are generally prepared by mixing 2 or more ingredients one of which must be
either starch, talc or kaolin.
ā€¢ Talc & kaolin are more commonly used because they are chemically inert.
ā€¢ However, these ingredients readily gets contaminated with pathogenic bacteria, these must be
sterilized by DRY HEAT METHOD (160Ā°C for 2 hours) before use.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
ā€¢ Dusting powders are dispensed in SIFTER TOP containers or aerosol containers.
ā€¢ Pressure aerosol containers are costlier than sifter top containers but they help in easy application
of the preparation.
ā€¢ Dusting powder can also be applied with the help of powder puff or sterilized gauze pad.
ā€¢ Dusting powders are generally considered to be non-toxic but the inhalation of its fine powdered
ingredients by infants may lead to pulmonary inflammation.
Dusting powder
ā€¢ Rx
Purified talc (sterilised) 50gm
Starch 25gm
ZnO 20gm
Salicylic acid 5gm
ā€¢ Method: Powder all the ingredients. Mix them in ascending order of their weight. Pass the mixed
powder mixture through sieve no.80.
ā€¢ After sifting, mix the powders lightly. Transfer the mixture in sifter top container.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
B. SNUFFS
ā€¢ These are finely divided powders which are inhaled into nostrils.
ā€¢ They posses antiseptic, bronchodilators and decongestant action.
ā€¢ They are mainly used by the patients suffering from bronchial asthma.
ā€¢ These are dispensed in flat metal boxes with hinged lid.
C. DENTIFRICES/TOOTH POWDERS
ā€¢ They consist of very finely divided solid particles, which are applied with the help of a tooth brush for
cleansing the surface of the teeth.
ā€¢ The cleaning action mainly depends on the abrasive substance.
ā€¢ Abrasive substances such as calcium sulphate, sodium chloride, sodium carbonate & magnesium carbonate
are commonly used.
ā€¢ Use of a strong abrasive substance is avoided since it may damage the enamel of the teeth.
ā€¢ A suitable flavouring agent, detergent or soap may be included in the formulation of a dental powder.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
ā€¢ Eg: Dispense 50 g of dentifrices
Rx
Hard soap, in fine powder 50 g
Precipitated calcium carbonate 935 g
Saccharin sodium 2 g
Peppermint oil 4 ml
Cinnamon oil 2 ml
Methyl salicylate 8 ml
Make a tooth powder.
Method: Triturate the saccharin sodium, the oil and Methyl salicylate with about one half of the
precipitated calcium carbonate and mix the soap with the remaining portion of precipitated calcium
carbonate. Mix two powders thoroughly and then pass it through a fine sieve.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
D. INSUFFLATIONS
ā€¢ These are medicated powders meant for introduction into body cavities such as nose, throat, ears &vagina with the help of
apparatus known as ā€œinsufflatorā€
ā€¢ It sprays / blows the powder as a thin stream of finely divided particles all over the site of application
ā€¢ Insufflations are used to produce a local effect or to produce a systemic effect from a drug that is destroyed in gut.
ā€¢ Nowadays, insufflations are available as pressure aerosols.
ā€¢ DISADVANTAGES OF INSUFFLATIONS:
ā€¢ Dose accuracy is a problem.
ā€¢ Insufflators get blocked when wet powders are used
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
ā€¢ 3. SIMPLE & COMPOUND POWDERS FOR INTERNAL USE
SIMPLE POWDERS
ā€¢ These are the powders which consist of a single ingredient either in crystalline or amorphous form.
ā€¢ When the powders are in crystalline form, they should be reduced to fine form.
ā€¢ The minimum quantity of each powder should not be less than 100mg so that it can be handled conveniently by patients &
weighed accurately.
ā€¢ The weight required for each dose is calculated & total number of dose are wrapped in separate papers. (300mg of Aspirin
6 doses}
ā€¢ Example:
ļƒ˜ Dispense 6 powders of Aspirin, each powder containing 300mg of Aspirin
Rx
Aspirin 300mg
ā€¢ Direction: 1 powder to be taken after every 8 hours
ā€¢ Method: Powder the aspirin & weigh required quantity.
ā€¢ Weigh 300mg for each powder. Wrap each dose in individual powder paper. Prepare 6 powders. Pack it flap to flap &
restrained with elastic band.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
COMPOUND POWDERS
ā€¢ These are the powders which consist of 2 or more ingredients either in crystalline or amorphous form; which
are mixed together & then dispensed into number of doses.
ā€¢ When the powders are in crystalline form, they should be reduced to fine form.
ā€¢ The minimum quantity of each powder should not be less than 100mg so that it can be handled conveniently
by patients & weighed accurately.
ā€¢ The weight required for each dose is calculated & total number of dose are wrapped in separate papers.
ā€¢ Example: Dispense 5 doses of Aspirin, Paracetamol &Caffeine powder.
Rx
Aspirin 300mg
Paracetamol 150mg
Caffeine 50mg
Method: Powdered all ingredients. Weigh the calculated quantity of each ingredient. Mix them in ascending
order of their weight.
Weigh 500mg of mixed powder for each dose. Wrap each dose in individual paper & then packed.
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4. POWDERS ENCLOSED IN CACHETS
ā€¢ Cachets are the solid unit dosage forms of medicament in which drug is enclosed in tasteless sheet made by
pouring mixture of rice flour and water between two hot, polished, revolving cylinders. Water is evaporated
and sheet of wafer formed, drug is enclosed in it.
TYPES:
1. DRY SEAL CACHETS
2. WET SEAL CACHETS
ā€¢ Cachets are known as ā€œWAFER CAPSULEā€
ā€¢ They are very hard to swallow as such; hence they are softened by dipping in water for few seconds & then
placed in tongue & swallowed with a large quantity of water.
ā€¢ After swallowing, cachets get disintegrated & drug is released.
ADVANTAGES OF CACHETS:
ā€¢ Easy preparation (minimal machinery use)
ā€¢ Disintegrate quickly in stomach
ā€¢ Large doses can be incorporated in cachets (even upto 1.5gm) 22
DISADVANTAGES OF CACHETS:
ā€¢ Must be softened before swallowing
ā€¢ Easily damaged
ā€¢ Canā€™t protect the drug from moisture & light
ā€¢ Shell of cachets are fragile
ā€¢ Occupy more space
5. TABLET TRITURATES (moulded tablets)
ā€¢ These are powders moulded into tablets.
ā€¢ Moulded tablets are flat, circular disc & usually contain potent substance which is mixed with lactose,
dextrose or other suitable diluent.
ā€¢ The apparatus used for preparation of tablet triturates is made up of stainless steel or plastic.
ā€¢ The moulds are available in several sizes having capacity ranging from 30mg to 250mg.
ā€¢ Generally 50-250 tablet triturates can be prepared at a time from a tablet triturate mould.
ā€¢ The solid medicament & diluent are finely powdered & converted into stiff paste with the help of alcohol
60%.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
Tablet mould:
ā€¢ it consists of an upper perforated plate which is having exactly the same number of holes as that of number of pegs in a
lower plate.
ā€¢ The upper plate is placed on a clean tile & the paste is filled into holes completely with the help of spatula.
ā€¢ Upper plate is then placed over the lower plate.
ā€¢ A little pressure is applied over the top plate which will eject the moulded tablets.
ā€¢ Ejected tablets are spread over on a clean surface & dried by using hot air oven or by keeping them in a warm place.
DISPENSING OF POWDERS INVOLVING SPECIAL PROBLEMS
ā€¢ VOLATILE SUBSTANCES
ā€¢ HYGROSCOPIC SUBSTANCES
ā€¢ DELIQUESCENT SUBSTANCES
ā€¢ EUTECTIC MIXTURES
ā€¢ INCORPORATION OF LIQUIDS
ā€¢ EXPLOSIVE SUBSTANCES
ā€¢ POTENT DRUGS
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
VOLATILE SUBSTANCES
ā€¢ Certain vegetable powders contain volatile oils.
ā€¢ Volatilization of substances like menthol, camphor may takes place on incorporation in powders.
ā€¢ To prevent loss of volatile oils, these drugs first triturated lightly in mortar.
ā€¢ Volatilization can be minimized by the use of double wrapping.
ā€¢ The inner wrapper should be of wax paper & outer wrapper may be of any thick paper.
HYGROSCOPIC SUBSTANCES
ā€¢ The substances which absorb moisture from the atmosphere are called as hygroscopic substances.
ā€¢ Such substances are usually supplied in granular form in order to expose less surface area to the atmosphere.
ā€¢ These powders should not be finely powdered.
ā€¢ These powders should be double wrapped.
DELIQUESCENT SUBSTANCES
ā€¢ Certain substances absorb moisture to such a large extent that they go into solution state & are called as deliquescent
substances.
ā€¢ Examples: NH4Cl, NaBr, NaI, ZnCl2
ā€¢ Such substances are usually supplied in granular form in order to expose less surface area to atmosphere.
ā€¢ These powders should not be finely powdered.
ā€¢ These powders should be double wrapped & further can be wrapped in aluminum foil or plastic cover.
25
EUTECTIC MIXTURES
ā€¢ When 2 or more substances of low melting point are mixed together they liquefy due to the formation of a
new compound which has a melting point lower than the room temperature.
ā€¢ Such substances are known as eutectic substances.
ā€¢ Examples: Menthol, thymol, camphor, phenol, chloral hydrate etc.
ā€¢ These substances can be dispensed by 2 methods:
ļƒ¼ Dispense as separate set of powders with directions that one set of each kind shall be taken as a dose.
ļƒ¼ Mixing with an equal amount of inert absorbent (talc, kaolin, lactose)
INCORPORATION OF LIQUIDS
ā€¢ If the quantity of liquid to be added is small, it may be triturated with an equal quantity of powder & then rest
of the liquid incorporated in small amounts with continuous trituration.
ā€¢ If quantities of liquid are large then absorbent material must be added.
EXPLOSIVE SUBSTANCES
ā€¢ When an oxidizing agent (potassium chlorate) is mixed with reducing substances (tannic acid); there are
chances of violent explosion which may lead to serious consequences.
ā€¢ As far as possible, such prescriptions should not be dispensed.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
ā€¢ If unavoidable; then powder each ingredient separately & dispense them in separate paper & with suitable
direction to the patient regarding its use.
ā€¢ Dispense the following explosive powder.
Rx
Potassium chlorate 0.6gm
Tannic acid 0.3gm
Sucrose 0.3gm
POTENT DRUGS
ā€¢ The substances having a maximum dose of less than 60mg & poisonous substances are regarded as potent
drugs.
ā€¢ Small quantities of potent drugs should not be weighed on dispensing balance.
ā€¢ Usually potent drug is mixed with a suitable diluent (lactose) by following geometrical dilution method &
then dispensed.
ā€¢ The whole of the diluent should never be added to the drug at one time otherwise the potent drug will not be
mixed uniformly.
Rx
Codeine phosphate 10mg
Make a powder & send such 5 powders.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
Direction: Take I powder before going to bed.
Method: The quantity of codeine phosphate prescribed is very small & not possible to weigh on dispensing
balance.
ā€¢ Hence weigh 100mg (minimum weighable quantity) & 900 mg of lactose. Mix them in geometric dilution
method.
ā€¢ After complete mixing, weigh 100mg (which contains 10mg of codeine phosphate) & pack in paper.
ā€¢ Prepare 5 such powders, label & dispense.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
GRANULES
ā€¢ These are the aggregates of the particles of drug. They are prepared by using any granulating agent like starch paste.
ā€¢ Granules facilitate the incorporation of colours & flavours to render the product attractive & tasteful.
ā€¢ Drugs which are unstable in liquid form can be dispensed as granules; which are to mixed with water just before its
administration.
ADVANTAGES OF GRANULES
ā€¢ Improves stability against humidity
ā€¢ Improves palatability
ā€¢ Effervescent granules do not show violent effervescent reaction upon addition to water compared to effervescent powders.
ā€¢ Ensures uniform distribution of drugs.
ā€¢ Increases bulk density that in turn reduces the volume & size of container required for packing.
ā€¢ Suitable for large dose of drugs
DISADVANTAGES OF GRANULES
ā€¢ Not suitable for water sensitive drugs.
ā€¢ Slower drug action compared to powders.
ā€¢ Involves multi-step process like moistening & drying.
ā€¢ Requires more skill while preparing granules than in making powders.
29
EFFERVESCENT GRANULES
ā€¢ These are specially prepared solid dosage form of medicament, meant for internal use.
ā€¢ They usually contain a medicament mixed with citric acid, tartaric acid, sodium bicarbonate.
ā€¢ Saccharin / sucrose can be added as sweetening agent.
ā€¢ Before administration, the desired quantity is dissolved in water; the acid & bicarbonate reacts
together producing effervescence.
ā€¢ The release of COā‚‚ masks the bitter & saline taste of drug.
ā€¢ COā‚‚ helps in absorption of drugs in stomach.
METHOD OF PREPARATION OF EFFERVESCENT GRANULES
1. HEAT METHOD ( Heat fusion method)
2. WET METHOD
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
1. HEAT METHOD
ā€¢ A large stainless steel or porcelain evaporating dish is placed over boiling water bath.
ā€¢ The dish must be sufficiently hot before transferring the powder into it.
ā€¢ Citric acid liberates water of crystallization, which is utilized to make a coherent mass.
ā€¢ If the powders are added first & then heated the dish will results in slow liberation of water of
crystallization & the water evaporates quickly.
ā€¢ Hence powders are added to the hot dish to produce a coherent mass.
ā€¢ The water needed for granulation is provided from two sources:
a) From water of crystallization of citric acid - The citric acid contains one molecule of water of crystallization which is
liberated during heating.
b) The water produced from the reactions of citric acid and tartaric acid with sodium bicarbonate.
3NaHCO3 + C6H8O7.H2O C6H5Na3O7 + 3CO2 ā†‘ + 3H2O
Sodium Citric acid Sodium citrate
bicarbonate
2NaHCO3 + C4H6O6 C4H4Na2O6 + 2CO2 ā†‘ + 2H2O
Sodium Tartaric acid Sodium tartarate
Bicarbonate
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
ā€¢ Generally, heating stage takes 1 to 5 minutes.
ā€¢ The damp mass is then passed through a sieve to prepare the granules of suitable size, dried in an oven at a
temperature not exceeding 60Ā°C and then packed in an air tight container.
ā€¢ Loss of weight occurs during granulation as a result of:
i. Evaporation from the damp mixture.
ii. Loss of carbon dioxide.
ā€¢ These losses constitute approximately one-seventh of the weight of powder used and must be taken into
consideration while calculating the quantity of granules to be prepared.
2. WET METHOD
ā€¢ In this method, the mixed ingredients are moistened with a non-aqueous liquid (e.g. alcohol) to prepare a
coherent mass which is then passed through a number 8 sieve and dried in an oven at a temperature not
exceeding 60Ā°C.
ā€¢ The dried granules are again passed through the sieve to break the lumps which may be formed during drying.
ā€¢ The dried granules are packed in air tight containers.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
Eutectic Powder
ā€¢ When 2 or more substances of low melting point are mixed together they liquefy due to the formation of a new
compound which has a melting point lower than the room temperature.
ā€¢ Such substances are known as eutectic substances.
ā€¢ Examples: Menthol, Thymol, Camphor, Phenol, Chloral hydrate etc.
ā€¢ These substances can be dispensed by 2 methods:
ā€¢ Dispense as separate set of powders with directions that one set of each kind shall be taken as a dose.
ā€¢ Mixing with an equal amount of inert absorbent (tale, kaolin, lactose)
ā€¢ Formula: Ingredients Official formula
(1 dose)
Camphor 2 gm
Menthol 1 gm
Light kaolin 3 gm
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
Principle:
ā€¢ When solids of low melting point are mixed together, the resultant mixture has a melting point lower than
room temperature, producing a liquefied mass. Such a combination is known as a Eutectic mixture Camphor
and menthol together form a Eutectic mixture.
ā€¢ To supply these substances together in the form of powder, absorbents such as magnesium carbonate or light
magnesium oxide or kaolin can be used in either one of the following ways
a) Dispense as separate set of powders with directions that one set of each kind shall be taken as a dose.
b) Mix each ingredient separately with an equal quantity of the absorbent and then lightly mix the two portions.
c) Mix the ingredients of the eutectic mixture to obtain the liquid then triturate this liquid with enough absorbent
powder to give a free flowing powder.
ā€¢ Light kaolin or magnesium carbonate act as diluent or absorbent and prevent contact between the
medicaments and absorbs any liquid that may be produced.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
Procedure:
1. Camphor and menthol were finely powdered.
2. Required quantities of camphor, menthol and kaolin were weighed.
3. 2gm of kaolin was mixed with 2gm of camphor by light trituration.
4.1gm of kaolin was mixed with 1 gm of menthol by light trituration.
5. Two powders were mixed by spatulation in geometrical ratio.
6. Required quantity of powder was weighed and transferred to a clean, dry wide mouthed container with a screw cap.
Category: Carminative.
Direction: Dispense one packet of powder in a glass of water and drink
Storage: Store in a cool and dry place.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
Effervescent Powder
ā€¢ Effervescent powders are presented as single-dose or multidose preparations and generally contain acid substances and
carbonates or bicarbonates which react rapidly in the presence of water to release carbon dioxide. They are intended to be
dissolved or dispersed in water before administration.
Formula:
Ingredients Official formula
(1 dose)
Sodium Potassium Tartarate 7.5 gm
Sodium Bicarbonate 2.5 gm
Tartaric acid 2.5 gm
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
Principle:
ā€¢ Sodium bicarbonate and tartaric acid are hygroscopic substances. In presence of moisture sodium bicarbonate reacts
with tartaric acid and evolves carbon dioxide. Therefore they have to be enclosed in separate enclosures lined with
butter paper (double wrapper).
ā€¢ When effervescent powder is added to the water just before administration, sodium bicarbonate reacts with tartaric
acid in water and produces effervescence (by evolving carbon dioxide). It increases the taste of the mixture.
ā€¢ Sodium potassium tartarate is used as saline purgative.
Procedure:
1. Slightly excess than the required quantities of sodium potassium tartarate and sodium bicarbonate were weighed and
triturated each into a fine powder, separately.
2. Required quantities of fine powder of sodium potassium tartarate and sodium bicarbonate were weighed and mixed
by trituration in geometrical ratio.
3. It was then enclosed in a blue wrapper lined from inside with butter paper.
4. Required quantity of finely powdered tartaric acid was weighed and enclosed in a white wrapper lined with butter
paper.
5. Two powders were tied with paper ribbon and were dispensed in a neatly labeled envelop. 37
Category: Saline purgative.
Direction: Dissolve one blue colour packed paper content in a half tumbler of water, and add one white colour
packed paper content and take as directed by the physician, while effervescing.
Storage: Store in a dry place.
38
Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP,
Mangalore
IMPORTANT QUESTIONS
SHORT ESSAYS (5 MARKS)
1. Define powders. Classify powders.
2. Explain Geometric dilution with an example.
3. Discuss the different methods of mixing powders.
4. Explain simple and compound powders with an example.
5. How do you prepare effervescent granules by the fusion method ?
6. How do you dispense eutectic powders ?
7. Explain insufflations with examples.
8. Write the advantages and disadvantages of powders as the dosage form.
9. Define and classify powders based on official grades of powders.
10. Explain dusting powders with examples.
11. Explain the preparation of eutectic powders.
12. How do you prepare effervescent granules by heat method?
13. How do you dispense eutectic powders, explosive powders and potent drugs as a powder dosage form?
14. Explain insufflations, snuffs and dentifrices with suitable examples.
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Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
15. Explain dusting powders and dentifrices with examples
16. Discuss briefly about bulk powders for external use.
17. Define & classify dusting powders. Write a note on preparation of dusting powder.
18. Write the principle & procedure involved in the preparation of effervescent powders.
19. How do you dispense hygroscopic substances, deliquescent substances and volatile substances as a powder dosage
form?
20. Define granules. Classify them. Give advantages & disadvantages of granules.
SHORT ANSWERS (2 Marks)
1. Define hygroscopic and deliquescent powders.
2. How do you dispense potent powders?
3. Why is a double wrapping of powder required?
4. Classify powders.
5. Define cachets for example.
6. Define powder with an example.
7. Define and classify dusting powders.
8. Define eutectic powders. 40
Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
9. Define insufflations with examples.
10. Define simple and compound powders.
11. What are the ingredients of dusting powders?
12. Define geometric dilution.
13. Enlist the methods of mixing powders.
14. Define pharmaceutical powders. Give examples.
15. Give at least two advantages & disadvantages of
16. Define hygroscopic and deliquescent powders.
17. How do you dispense potent powders?
18. Why is double wrapping of powder required?
19. What are snuffs?
20. How do you dispense a powder containing volatile substances?
21. How do you dispense a powder containing hygroscopic substance?
22. How do you dispense a powder containing deliquescent substance?
23. How do you dispense a powder containing explosive substances?
24. How do you dispense a powder containing eutectic substances?
25. How do you overcome a problem during incorporation of a liquid into a powder?
26. Define effervescent granules.
27. Name any four types of powder dosage forms. 41

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Pharmaceutical . powders . pdf . Pharmacy

  • 1. PHARMACEUTICAL POWDERS Prepared By. SUMANA Dept. of. Pharmaceutics SDCP, Mangalore
  • 2. POWDERS ā€¢ A pharmaceutical powder is a mixture of finely divided drug and chemicals in dry form. ā€¢ These are solid dosage form of medicament which is meant for internal and external use. ā€¢ They are available in crystalline or amorphous form. ļƒ˜ ADVANTAGES ā€¢ More stable than liquid dosage forms ā€¢ More convenient to swallow than tablet or capsules ā€¢ Can be prepared into granules for use in preparing tablets and or reconstituted to liquid form ā€¢ Rapid therapeutic effect due to high surface area ā€¢ Useful for bulky drugs with large dose ā€¢ Chances of incompatibility are less compared to liquid dosage forms. ā€¢ Powders are more easy to transport than the liquid dosage form. ā€¢ The onset of action of powdered drug is rapid as compared to other solid dosage form. E.g. tablets, capsules ā€¢ Children & elderly patients can easily take powdered drug as such or by dispersing it in water or other liquid. ā€¢ Economical dosage forms (minimal use of machinery / special techniques} 2 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 3. DISADVANTAGES ā€¢ Drugs having bitter, nauseous and unpleasant taste canā€™t be dispensed in powdered form. ā€¢ Deliquescent and hygroscopic drugs canā€™t be dispensed in powder form ā€¢ Drugs which get affected by atmospheric conditions are not suitable for dispensing in powder forms. ā€¢ The dispensing of powder is time consuming. MIXING OF POWDERS 1. SPATULATION 2. TRITURATION 3. GEOMETRIC DILUTION 4. SIFTING 5. TUMBLING 3 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 4. 1. SPATULATION ā€¢ Mixing of powders done by movement of spatula throughout the powders on a sheet of paper or on a porcelain tile. ā€¢ This method is useful in mixing ļ±Small amount of powder ļ±Solid substances that liquefy or form eutectic mixtures, when in close & prolonged contact with one another (since very little compaction occurs] ā€¢ This method is not suitable for large quantities of powder or powders containing one or more potent substances (because homogenous blending may not occur} 4 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 5. 2. TRITURATION ā€¢ It is used to reduce particle size as well as to mix powders. ā€¢ Apparatus ā€¢ Porcelain mortar & pestle (for size reduction as well as mixing} ā€¢ Glass mortar & pestle (for chemicals that stains the porcelain surface} ā€¢ Glass mortar cleans more readily after use. 5 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 6. 3. GEOMETRIC DILUTION ā€¢ This method is used when potent substances are to be mixed with a large amount of diluent. ā€¢ The potent drug & equal quantity of diluent is placed on a mortar & then slightly triturated. ā€¢ 2nd portion of diluent in equal quantity to the above powder mixture is added to mortar & triturated. ā€¢ The process is continued, adding diluent in equal quantities to the powder mixture in the mortar at each step; until all the diluent is incorporated. ā€¢ For example; Potent drug - 100mg Lactose (diluent) - 900mg ļƒ˜ 100mg of potent drug + 100mg Lactose - 200mg of mixture ļƒ˜ 200mg of mixture + 200mg of lactose-400mg of mixture ļƒ˜ 400mg of mixture + 400mg of Lactose - 800mg of mixture. ļƒ˜ 800mg of mixture + remaining portion of Lactose (200mg) = 1000mg of mixture 6
  • 7. 4. SIFTING ā€¢ Powders are mixed by passing through sifters. ā€¢ This results in a light fluffy product & generally not acceptable for incorporation of potent drugs into diluent base. 5. TUMBLING ā€¢ It is the process of mixing powders in a large containers rotated by an electric motor. ā€¢ These blenders are used in Industries as large volume powder mixers. 7 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 8. CLASSIFICATION OF POWDERS ā€¢ {Based on method of dispensing} 1. BULK POWDERS FOR INTERNAL USE 2. BULK POWDERS FOR EXTERNAL USE 3. SIMPLE & COMPOUND POWDERS FOR INTERNAL USE 4. POWDERS ENCLOSED IN CACHETS & CAPSULES 5. COMPRESSED POWDERS (TABLET TRITURATES) 8 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 9. 9 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 10. BULK POWDERS ā€¢ Powders are dispensed in bulk, when accuracy of dosage is not important. ā€¢ Bulk powder contains several doses of powder. ā€¢ They are supplied in wide-mouthed containers that permits easy removal of a spoonful powder. ā€¢ The non potent substances which are supplied in bulk are antacids and laxatives etc. 1. BULK POWDER FOR INTERNAL USE ā€¢ They are mixture of finely divided drugs and or chemicals in a dry form that may be intended for internal use (oral powders) ļƒ˜ Types: a) Oral powder b) Powder spray e) Dry powder inhalers d) Effervescent powders 10 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 11. Example : A) Send 25.0 g of Rhubarb powder B.P.C. (Gregoryā€™s Powder) Rx Rhubarb, in powder-250.0g Light magnesium carbonate -325.0 g Heavy magnesium carbonate-325.0 g Ginger, in powder-100.0 g Make a powder Direct: 0.5 to 5.0 g to be taken twice a day. Method: Powder all ingredients. Weigh & mix them in ascending order of their weight. Transfer the powder in a wide mouth bottle & dispense. 11 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 12. B) Send 50.0 g of compound bismuth powder Rx Calcium carbonate - 75. 0 g Heavy magnesium carbonate - 75.0 g Sodium bicarbonate ā€“ 25.0 g Bismuth carbonate ā€“ 25.0 g Make a powder Direct: 5 g to be taken twice a day. Method: Powdered all ingredients. Weigh & mix them in ascending order of their weight. Transfer the powder in a wide mouth bottle & dispense. 12 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 13. 2. BULK POWDERS FOR EXTERNAL USE ā€¢ Bulk powders for external use contain non-potent medicaments. ā€¢ These powders are supplied in cardboard, glass or plastic containers, which often designed for the specific method of application. ā€¢ The bulk powders for external use are: A) Dusting powders B) Insufflations C) Snuffs D) Dentifrices 13 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 14. A. DUSTING POWDERS ā€¢ These are used externally for local application not intended for systemic action. The desired characteristics of powders include a) Homogeneity b) Non-irritability c) Free flow d) Good spreadability and covering capability. e) Adsorption and absorption capacity. f) Very fine state of subdivision, and g) Capacity to protect the skin against irritation caused by friction, moisture or chemical irritants. ā€¢ Dusting powders usually contain substances such as zinc oxide, starch and boric acid or natural mineral substances such as kaolin or talc. ā€¢ Dusting powders are meant for external use & are generally applied in a very fine state of sub division to avoid local irritation. ā€¢ Hence, dusting powders should be passed through sieve no. 80 to enhance their effectiveness. ā€¢ Dusting powders are of 2 types: a) Medical dusting powders b) Surgical dusting powders 14 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 15. MEDICAL DESTING POWDERS ā€¢ Used mainly for superficial skin conditions. ā€¢ Must be free from pathogenic microorganisms. SURGICAL DUSTING POWDERS ā€¢ Used in body cavities, on wounds & on umbilical cords of infants. ā€¢ These must be sterilized before use. Method of preparation ā€¢ Dusting powders are generally prepared by mixing 2 or more ingredients one of which must be either starch, talc or kaolin. ā€¢ Talc & kaolin are more commonly used because they are chemically inert. ā€¢ However, these ingredients readily gets contaminated with pathogenic bacteria, these must be sterilized by DRY HEAT METHOD (160Ā°C for 2 hours) before use. 15 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 16. ā€¢ Dusting powders are dispensed in SIFTER TOP containers or aerosol containers. ā€¢ Pressure aerosol containers are costlier than sifter top containers but they help in easy application of the preparation. ā€¢ Dusting powder can also be applied with the help of powder puff or sterilized gauze pad. ā€¢ Dusting powders are generally considered to be non-toxic but the inhalation of its fine powdered ingredients by infants may lead to pulmonary inflammation. Dusting powder ā€¢ Rx Purified talc (sterilised) 50gm Starch 25gm ZnO 20gm Salicylic acid 5gm ā€¢ Method: Powder all the ingredients. Mix them in ascending order of their weight. Pass the mixed powder mixture through sieve no.80. ā€¢ After sifting, mix the powders lightly. Transfer the mixture in sifter top container. 16 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 17. B. SNUFFS ā€¢ These are finely divided powders which are inhaled into nostrils. ā€¢ They posses antiseptic, bronchodilators and decongestant action. ā€¢ They are mainly used by the patients suffering from bronchial asthma. ā€¢ These are dispensed in flat metal boxes with hinged lid. C. DENTIFRICES/TOOTH POWDERS ā€¢ They consist of very finely divided solid particles, which are applied with the help of a tooth brush for cleansing the surface of the teeth. ā€¢ The cleaning action mainly depends on the abrasive substance. ā€¢ Abrasive substances such as calcium sulphate, sodium chloride, sodium carbonate & magnesium carbonate are commonly used. ā€¢ Use of a strong abrasive substance is avoided since it may damage the enamel of the teeth. ā€¢ A suitable flavouring agent, detergent or soap may be included in the formulation of a dental powder. 17 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 18. ā€¢ Eg: Dispense 50 g of dentifrices Rx Hard soap, in fine powder 50 g Precipitated calcium carbonate 935 g Saccharin sodium 2 g Peppermint oil 4 ml Cinnamon oil 2 ml Methyl salicylate 8 ml Make a tooth powder. Method: Triturate the saccharin sodium, the oil and Methyl salicylate with about one half of the precipitated calcium carbonate and mix the soap with the remaining portion of precipitated calcium carbonate. Mix two powders thoroughly and then pass it through a fine sieve. 18 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 19. D. INSUFFLATIONS ā€¢ These are medicated powders meant for introduction into body cavities such as nose, throat, ears &vagina with the help of apparatus known as ā€œinsufflatorā€ ā€¢ It sprays / blows the powder as a thin stream of finely divided particles all over the site of application ā€¢ Insufflations are used to produce a local effect or to produce a systemic effect from a drug that is destroyed in gut. ā€¢ Nowadays, insufflations are available as pressure aerosols. ā€¢ DISADVANTAGES OF INSUFFLATIONS: ā€¢ Dose accuracy is a problem. ā€¢ Insufflators get blocked when wet powders are used 19 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 20. ā€¢ 3. SIMPLE & COMPOUND POWDERS FOR INTERNAL USE SIMPLE POWDERS ā€¢ These are the powders which consist of a single ingredient either in crystalline or amorphous form. ā€¢ When the powders are in crystalline form, they should be reduced to fine form. ā€¢ The minimum quantity of each powder should not be less than 100mg so that it can be handled conveniently by patients & weighed accurately. ā€¢ The weight required for each dose is calculated & total number of dose are wrapped in separate papers. (300mg of Aspirin 6 doses} ā€¢ Example: ļƒ˜ Dispense 6 powders of Aspirin, each powder containing 300mg of Aspirin Rx Aspirin 300mg ā€¢ Direction: 1 powder to be taken after every 8 hours ā€¢ Method: Powder the aspirin & weigh required quantity. ā€¢ Weigh 300mg for each powder. Wrap each dose in individual powder paper. Prepare 6 powders. Pack it flap to flap & restrained with elastic band. 20 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 21. COMPOUND POWDERS ā€¢ These are the powders which consist of 2 or more ingredients either in crystalline or amorphous form; which are mixed together & then dispensed into number of doses. ā€¢ When the powders are in crystalline form, they should be reduced to fine form. ā€¢ The minimum quantity of each powder should not be less than 100mg so that it can be handled conveniently by patients & weighed accurately. ā€¢ The weight required for each dose is calculated & total number of dose are wrapped in separate papers. ā€¢ Example: Dispense 5 doses of Aspirin, Paracetamol &Caffeine powder. Rx Aspirin 300mg Paracetamol 150mg Caffeine 50mg Method: Powdered all ingredients. Weigh the calculated quantity of each ingredient. Mix them in ascending order of their weight. Weigh 500mg of mixed powder for each dose. Wrap each dose in individual paper & then packed. 21
  • 22. 4. POWDERS ENCLOSED IN CACHETS ā€¢ Cachets are the solid unit dosage forms of medicament in which drug is enclosed in tasteless sheet made by pouring mixture of rice flour and water between two hot, polished, revolving cylinders. Water is evaporated and sheet of wafer formed, drug is enclosed in it. TYPES: 1. DRY SEAL CACHETS 2. WET SEAL CACHETS ā€¢ Cachets are known as ā€œWAFER CAPSULEā€ ā€¢ They are very hard to swallow as such; hence they are softened by dipping in water for few seconds & then placed in tongue & swallowed with a large quantity of water. ā€¢ After swallowing, cachets get disintegrated & drug is released. ADVANTAGES OF CACHETS: ā€¢ Easy preparation (minimal machinery use) ā€¢ Disintegrate quickly in stomach ā€¢ Large doses can be incorporated in cachets (even upto 1.5gm) 22
  • 23. DISADVANTAGES OF CACHETS: ā€¢ Must be softened before swallowing ā€¢ Easily damaged ā€¢ Canā€™t protect the drug from moisture & light ā€¢ Shell of cachets are fragile ā€¢ Occupy more space 5. TABLET TRITURATES (moulded tablets) ā€¢ These are powders moulded into tablets. ā€¢ Moulded tablets are flat, circular disc & usually contain potent substance which is mixed with lactose, dextrose or other suitable diluent. ā€¢ The apparatus used for preparation of tablet triturates is made up of stainless steel or plastic. ā€¢ The moulds are available in several sizes having capacity ranging from 30mg to 250mg. ā€¢ Generally 50-250 tablet triturates can be prepared at a time from a tablet triturate mould. ā€¢ The solid medicament & diluent are finely powdered & converted into stiff paste with the help of alcohol 60%. 23 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 24. Tablet mould: ā€¢ it consists of an upper perforated plate which is having exactly the same number of holes as that of number of pegs in a lower plate. ā€¢ The upper plate is placed on a clean tile & the paste is filled into holes completely with the help of spatula. ā€¢ Upper plate is then placed over the lower plate. ā€¢ A little pressure is applied over the top plate which will eject the moulded tablets. ā€¢ Ejected tablets are spread over on a clean surface & dried by using hot air oven or by keeping them in a warm place. DISPENSING OF POWDERS INVOLVING SPECIAL PROBLEMS ā€¢ VOLATILE SUBSTANCES ā€¢ HYGROSCOPIC SUBSTANCES ā€¢ DELIQUESCENT SUBSTANCES ā€¢ EUTECTIC MIXTURES ā€¢ INCORPORATION OF LIQUIDS ā€¢ EXPLOSIVE SUBSTANCES ā€¢ POTENT DRUGS 24 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 25. VOLATILE SUBSTANCES ā€¢ Certain vegetable powders contain volatile oils. ā€¢ Volatilization of substances like menthol, camphor may takes place on incorporation in powders. ā€¢ To prevent loss of volatile oils, these drugs first triturated lightly in mortar. ā€¢ Volatilization can be minimized by the use of double wrapping. ā€¢ The inner wrapper should be of wax paper & outer wrapper may be of any thick paper. HYGROSCOPIC SUBSTANCES ā€¢ The substances which absorb moisture from the atmosphere are called as hygroscopic substances. ā€¢ Such substances are usually supplied in granular form in order to expose less surface area to the atmosphere. ā€¢ These powders should not be finely powdered. ā€¢ These powders should be double wrapped. DELIQUESCENT SUBSTANCES ā€¢ Certain substances absorb moisture to such a large extent that they go into solution state & are called as deliquescent substances. ā€¢ Examples: NH4Cl, NaBr, NaI, ZnCl2 ā€¢ Such substances are usually supplied in granular form in order to expose less surface area to atmosphere. ā€¢ These powders should not be finely powdered. ā€¢ These powders should be double wrapped & further can be wrapped in aluminum foil or plastic cover. 25
  • 26. EUTECTIC MIXTURES ā€¢ When 2 or more substances of low melting point are mixed together they liquefy due to the formation of a new compound which has a melting point lower than the room temperature. ā€¢ Such substances are known as eutectic substances. ā€¢ Examples: Menthol, thymol, camphor, phenol, chloral hydrate etc. ā€¢ These substances can be dispensed by 2 methods: ļƒ¼ Dispense as separate set of powders with directions that one set of each kind shall be taken as a dose. ļƒ¼ Mixing with an equal amount of inert absorbent (talc, kaolin, lactose) INCORPORATION OF LIQUIDS ā€¢ If the quantity of liquid to be added is small, it may be triturated with an equal quantity of powder & then rest of the liquid incorporated in small amounts with continuous trituration. ā€¢ If quantities of liquid are large then absorbent material must be added. EXPLOSIVE SUBSTANCES ā€¢ When an oxidizing agent (potassium chlorate) is mixed with reducing substances (tannic acid); there are chances of violent explosion which may lead to serious consequences. ā€¢ As far as possible, such prescriptions should not be dispensed. 26 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 27. ā€¢ If unavoidable; then powder each ingredient separately & dispense them in separate paper & with suitable direction to the patient regarding its use. ā€¢ Dispense the following explosive powder. Rx Potassium chlorate 0.6gm Tannic acid 0.3gm Sucrose 0.3gm POTENT DRUGS ā€¢ The substances having a maximum dose of less than 60mg & poisonous substances are regarded as potent drugs. ā€¢ Small quantities of potent drugs should not be weighed on dispensing balance. ā€¢ Usually potent drug is mixed with a suitable diluent (lactose) by following geometrical dilution method & then dispensed. ā€¢ The whole of the diluent should never be added to the drug at one time otherwise the potent drug will not be mixed uniformly. Rx Codeine phosphate 10mg Make a powder & send such 5 powders. 27 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 28. Direction: Take I powder before going to bed. Method: The quantity of codeine phosphate prescribed is very small & not possible to weigh on dispensing balance. ā€¢ Hence weigh 100mg (minimum weighable quantity) & 900 mg of lactose. Mix them in geometric dilution method. ā€¢ After complete mixing, weigh 100mg (which contains 10mg of codeine phosphate) & pack in paper. ā€¢ Prepare 5 such powders, label & dispense. 28 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 29. GRANULES ā€¢ These are the aggregates of the particles of drug. They are prepared by using any granulating agent like starch paste. ā€¢ Granules facilitate the incorporation of colours & flavours to render the product attractive & tasteful. ā€¢ Drugs which are unstable in liquid form can be dispensed as granules; which are to mixed with water just before its administration. ADVANTAGES OF GRANULES ā€¢ Improves stability against humidity ā€¢ Improves palatability ā€¢ Effervescent granules do not show violent effervescent reaction upon addition to water compared to effervescent powders. ā€¢ Ensures uniform distribution of drugs. ā€¢ Increases bulk density that in turn reduces the volume & size of container required for packing. ā€¢ Suitable for large dose of drugs DISADVANTAGES OF GRANULES ā€¢ Not suitable for water sensitive drugs. ā€¢ Slower drug action compared to powders. ā€¢ Involves multi-step process like moistening & drying. ā€¢ Requires more skill while preparing granules than in making powders. 29
  • 30. EFFERVESCENT GRANULES ā€¢ These are specially prepared solid dosage form of medicament, meant for internal use. ā€¢ They usually contain a medicament mixed with citric acid, tartaric acid, sodium bicarbonate. ā€¢ Saccharin / sucrose can be added as sweetening agent. ā€¢ Before administration, the desired quantity is dissolved in water; the acid & bicarbonate reacts together producing effervescence. ā€¢ The release of COā‚‚ masks the bitter & saline taste of drug. ā€¢ COā‚‚ helps in absorption of drugs in stomach. METHOD OF PREPARATION OF EFFERVESCENT GRANULES 1. HEAT METHOD ( Heat fusion method) 2. WET METHOD 30 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 31. 1. HEAT METHOD ā€¢ A large stainless steel or porcelain evaporating dish is placed over boiling water bath. ā€¢ The dish must be sufficiently hot before transferring the powder into it. ā€¢ Citric acid liberates water of crystallization, which is utilized to make a coherent mass. ā€¢ If the powders are added first & then heated the dish will results in slow liberation of water of crystallization & the water evaporates quickly. ā€¢ Hence powders are added to the hot dish to produce a coherent mass. ā€¢ The water needed for granulation is provided from two sources: a) From water of crystallization of citric acid - The citric acid contains one molecule of water of crystallization which is liberated during heating. b) The water produced from the reactions of citric acid and tartaric acid with sodium bicarbonate. 3NaHCO3 + C6H8O7.H2O C6H5Na3O7 + 3CO2 ā†‘ + 3H2O Sodium Citric acid Sodium citrate bicarbonate 2NaHCO3 + C4H6O6 C4H4Na2O6 + 2CO2 ā†‘ + 2H2O Sodium Tartaric acid Sodium tartarate Bicarbonate 31 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 32. ā€¢ Generally, heating stage takes 1 to 5 minutes. ā€¢ The damp mass is then passed through a sieve to prepare the granules of suitable size, dried in an oven at a temperature not exceeding 60Ā°C and then packed in an air tight container. ā€¢ Loss of weight occurs during granulation as a result of: i. Evaporation from the damp mixture. ii. Loss of carbon dioxide. ā€¢ These losses constitute approximately one-seventh of the weight of powder used and must be taken into consideration while calculating the quantity of granules to be prepared. 2. WET METHOD ā€¢ In this method, the mixed ingredients are moistened with a non-aqueous liquid (e.g. alcohol) to prepare a coherent mass which is then passed through a number 8 sieve and dried in an oven at a temperature not exceeding 60Ā°C. ā€¢ The dried granules are again passed through the sieve to break the lumps which may be formed during drying. ā€¢ The dried granules are packed in air tight containers. 32 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 33. Eutectic Powder ā€¢ When 2 or more substances of low melting point are mixed together they liquefy due to the formation of a new compound which has a melting point lower than the room temperature. ā€¢ Such substances are known as eutectic substances. ā€¢ Examples: Menthol, Thymol, Camphor, Phenol, Chloral hydrate etc. ā€¢ These substances can be dispensed by 2 methods: ā€¢ Dispense as separate set of powders with directions that one set of each kind shall be taken as a dose. ā€¢ Mixing with an equal amount of inert absorbent (tale, kaolin, lactose) ā€¢ Formula: Ingredients Official formula (1 dose) Camphor 2 gm Menthol 1 gm Light kaolin 3 gm 33 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 34. Principle: ā€¢ When solids of low melting point are mixed together, the resultant mixture has a melting point lower than room temperature, producing a liquefied mass. Such a combination is known as a Eutectic mixture Camphor and menthol together form a Eutectic mixture. ā€¢ To supply these substances together in the form of powder, absorbents such as magnesium carbonate or light magnesium oxide or kaolin can be used in either one of the following ways a) Dispense as separate set of powders with directions that one set of each kind shall be taken as a dose. b) Mix each ingredient separately with an equal quantity of the absorbent and then lightly mix the two portions. c) Mix the ingredients of the eutectic mixture to obtain the liquid then triturate this liquid with enough absorbent powder to give a free flowing powder. ā€¢ Light kaolin or magnesium carbonate act as diluent or absorbent and prevent contact between the medicaments and absorbs any liquid that may be produced. 34 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 35. Procedure: 1. Camphor and menthol were finely powdered. 2. Required quantities of camphor, menthol and kaolin were weighed. 3. 2gm of kaolin was mixed with 2gm of camphor by light trituration. 4.1gm of kaolin was mixed with 1 gm of menthol by light trituration. 5. Two powders were mixed by spatulation in geometrical ratio. 6. Required quantity of powder was weighed and transferred to a clean, dry wide mouthed container with a screw cap. Category: Carminative. Direction: Dispense one packet of powder in a glass of water and drink Storage: Store in a cool and dry place. 35 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 36. Effervescent Powder ā€¢ Effervescent powders are presented as single-dose or multidose preparations and generally contain acid substances and carbonates or bicarbonates which react rapidly in the presence of water to release carbon dioxide. They are intended to be dissolved or dispersed in water before administration. Formula: Ingredients Official formula (1 dose) Sodium Potassium Tartarate 7.5 gm Sodium Bicarbonate 2.5 gm Tartaric acid 2.5 gm 36 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 37. Principle: ā€¢ Sodium bicarbonate and tartaric acid are hygroscopic substances. In presence of moisture sodium bicarbonate reacts with tartaric acid and evolves carbon dioxide. Therefore they have to be enclosed in separate enclosures lined with butter paper (double wrapper). ā€¢ When effervescent powder is added to the water just before administration, sodium bicarbonate reacts with tartaric acid in water and produces effervescence (by evolving carbon dioxide). It increases the taste of the mixture. ā€¢ Sodium potassium tartarate is used as saline purgative. Procedure: 1. Slightly excess than the required quantities of sodium potassium tartarate and sodium bicarbonate were weighed and triturated each into a fine powder, separately. 2. Required quantities of fine powder of sodium potassium tartarate and sodium bicarbonate were weighed and mixed by trituration in geometrical ratio. 3. It was then enclosed in a blue wrapper lined from inside with butter paper. 4. Required quantity of finely powdered tartaric acid was weighed and enclosed in a white wrapper lined with butter paper. 5. Two powders were tied with paper ribbon and were dispensed in a neatly labeled envelop. 37
  • 38. Category: Saline purgative. Direction: Dissolve one blue colour packed paper content in a half tumbler of water, and add one white colour packed paper content and take as directed by the physician, while effervescing. Storage: Store in a dry place. 38 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 39. IMPORTANT QUESTIONS SHORT ESSAYS (5 MARKS) 1. Define powders. Classify powders. 2. Explain Geometric dilution with an example. 3. Discuss the different methods of mixing powders. 4. Explain simple and compound powders with an example. 5. How do you prepare effervescent granules by the fusion method ? 6. How do you dispense eutectic powders ? 7. Explain insufflations with examples. 8. Write the advantages and disadvantages of powders as the dosage form. 9. Define and classify powders based on official grades of powders. 10. Explain dusting powders with examples. 11. Explain the preparation of eutectic powders. 12. How do you prepare effervescent granules by heat method? 13. How do you dispense eutectic powders, explosive powders and potent drugs as a powder dosage form? 14. Explain insufflations, snuffs and dentifrices with suitable examples. 39 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 40. 15. Explain dusting powders and dentifrices with examples 16. Discuss briefly about bulk powders for external use. 17. Define & classify dusting powders. Write a note on preparation of dusting powder. 18. Write the principle & procedure involved in the preparation of effervescent powders. 19. How do you dispense hygroscopic substances, deliquescent substances and volatile substances as a powder dosage form? 20. Define granules. Classify them. Give advantages & disadvantages of granules. SHORT ANSWERS (2 Marks) 1. Define hygroscopic and deliquescent powders. 2. How do you dispense potent powders? 3. Why is a double wrapping of powder required? 4. Classify powders. 5. Define cachets for example. 6. Define powder with an example. 7. Define and classify dusting powders. 8. Define eutectic powders. 40 Prepared By: Sumana , Dept. of. Pharmaceutics, SDCP, Mangalore
  • 41. 9. Define insufflations with examples. 10. Define simple and compound powders. 11. What are the ingredients of dusting powders? 12. Define geometric dilution. 13. Enlist the methods of mixing powders. 14. Define pharmaceutical powders. Give examples. 15. Give at least two advantages & disadvantages of 16. Define hygroscopic and deliquescent powders. 17. How do you dispense potent powders? 18. Why is double wrapping of powder required? 19. What are snuffs? 20. How do you dispense a powder containing volatile substances? 21. How do you dispense a powder containing hygroscopic substance? 22. How do you dispense a powder containing deliquescent substance? 23. How do you dispense a powder containing explosive substances? 24. How do you dispense a powder containing eutectic substances? 25. How do you overcome a problem during incorporation of a liquid into a powder? 26. Define effervescent granules. 27. Name any four types of powder dosage forms. 41