classical dosage form

pharm.d, 3rd prof 1

CLASSICAL DOSAGE FORM.

By.sadia iftikhar

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pharm.d, 3rd prof 2

DOSAGE FORMDEFINITION

“the means by which drug molecules are delivered to sites of action within the body is called DOSAGE FORM”

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pharm.d, 3rd prof 3

NEED OF DOSAGE FORM.1- Accurate dose.2- Protection e.g. coated tablets,

sealed ampules.3- Protection from gastric juice.4- Masking taste and odour.5- Placement of drugs within body tissues.6- Sustained release medication.7- Controlled release medication.8- Optimal drug action.9- Insertion of drugs into body

cavities (rectal, vaginal)10- Use of desired vehicle for insoluble drugs.

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pharm.d, 3rd prof 4

CLASSICAL DOSAGE FORM:DEFINITION

• They are the conventional dosage forms in which no advanced or computerized technique is used for their preparation.

• These were used in old days and now their use is almost obsolete.

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pharm.d, 3rd prof 5

• OTHER NAME: classical dosage form is also referred to as “obsolete dosage form”.It is from the Latin word “obsoletus” which

means “ancient”..these are named so because these are replaced

by modern techniques & newer dosage forms which are more easier to deliver like aerosols.

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pharm.d, 3rd prof 6

DOSAGE FORM USED BY ANCIENT CIVILIZATIONS

• GREEK & ROMANS: ointments, powders,pills,

pessaries, gargles,enemas (early known as clysters or glisters)

ARABS: introduce a number of

sweet preparations like syrups, conserves, confections, electuaries and juleps.

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pharm.d, 3rd prof 7

• BRITINS:• leeches, ointments, poultices, plasters, fomentations,

internal medicines sweetened with honey, herbs mixed with water, ale or wine, inhalations of vapours, and fumigation using hot herbal decoctions

• 15th CENTUARY:• the introduction of printing meant that books such as

pharmacopoeias became more widely available. These contained formulas for frequently-prescribed medicines and also methods for making them. As well as herb simples, containing a single remedy, they included many medicines with a large number of ingredients

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pharm.d, 3rd prof 8

Secundum artem

• The activities of apothecary or pharmacist in compounding a medicine using traditional method was often referred to as “secundum artem” , litterally means “to make favourably with skills”

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pharm.d, 3rd prof 9

EQUIPMENTS USED FOR MANIPULATION OF PRODUCTS.bogue molds,,catcher sealing equipment,,decoction app.,,infusion pots & mugs,,lozenge container ,board,roller,cutter,,,plaster iron,,mortar & pestles

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pharm.d, 3rd prof 10

CLASSIFICATION OF DOSAGE FORM:

• SEMISOLID DOSAGE FORM

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• LIQUID DOSAGE FORM:

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LIQUID DOSAGE FORM

• DEFINITION: “ Concentrated aquous preparation of

sugar or sugar substitutes with or without added medicinal agents & flavourants”

1.SYRUPS:

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• IMPORTANCE OF SYRUP: CONCENTRATION Syrups are veryimportant in old dosage form

because of the virtue of high sucrose concentration, it can prevent decomposition of matter extracted from vegetable drugs.

OSMOTIC PRESSURESyrup exert an osmotic pressure which inhibit

growth of bacteria, fungi & moulds2/26/2015


HYDROLYSISSucrose also contribute in microbial growth

retardation , as during making of syrup when heat is applied then sucrose is partly hydrolysed into reducing sugars glucose & fructose.

TYPES OF SYRUPS:.medicated syrups.non medicated syrups

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• PREPARATION:DEPENDENCE: Preparation of syrup depends on physical

& chemical properties of ingredients.METHODS: .by aid of heat .by agitation

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• BY AID OF HEAT: .this method is applied when: .quick preparation is needed .components not damage or volatile by heat. .in this method add sugar in water and heat until the

sugar dissolve. .then in this mixture add heat stable components(if

necessary).then cool it and adjust volume with water.

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NEED OF HEAT: heat is applied in this method because: .rapid sugar solution is formed . .inversion of sugar is certain because sucrose ,being a

disaccharide, hydrolyse into d-glucose & l-fructose.COLOUR OF SIMPLE SYRUP: simple syrup is darken In colour because of l-fructose.TASTE:Invert sugar is more sweeter.

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• BY AGITATION: .in this method no heat is applied .in it there is simple mixing of sugar in water. .then make up final volume with water. ADVANTAGE: this method is applied to avoid heat induced

inversion of sugar.DISADVANTAGE: time consuming process.2/26/2015


• USES & EXAMPLES: .MEDICATED SYRUPS: medicated syrups are made of ingredients used in

extemporaneous dispensing.and thus form a stock solution for certain drugs

e.g: Tolu syrup bp .FLAVOURED SYRUPS: They are used as flavourant & vehicles for extemporenous

preparatione.g: blackcurrant syrup bp, lemon syrup bp, orange syrup bp.

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• CLASSICAL SYRUP BOTTLES: FLARED NECK BOTTLE:This type of bottles were designed to contain stock syrups.these bottles are flared neck.stoppers were designed to fit loosely in the neck of

bottle..this fitting of stopper in neck was sufficient to prevent

evaporation of volatile components..the stopper was not tight enough to allow drying sugar

crusts to cause the stopper to become crust.

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• 2.DECOCTION: This word is derived from LATIN “DECOCTA”Which means “boiling”.DEFINITION: “extraction of water soluble drug substances by boiling”APPARATUS: .flask .beaker .sieve( for filteration)

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• GENERAL METHOD: .add drug in cold water and heat to boil. .continue boil for stated time usually 10 min. .cool & filter the mixture. .marc is transferred to sieve & water pass through it to

produce required volume. .this process left an aquous preparation similar to “clear

soup”. .if decoction was followed by evaporation then a solid or

semi-solid extract was produced.2/26/2015


• ODER OF ADDING INGREDIENTS DURING PROCESS:

.hard ligneous drugs should be added first i.e in the beginning of process.

.aromatic & volatile oils should be added near the end of process in order to minimize loss of active principle by heating.

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• EXAMPLES: 1.DECOCTION OF CHONDRUS BP (decoctum

chondri)..formula: chondrus 25g, water 1l..method : .wash chondrus with cold water to

remove impurities & boil with 1200ml of water for 15min.strain while hot & pass more water through it to produce the required volume when cooled.it should be freshly prepared.

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..Dose: 30-120 ml, or as per required.…use: it was used as a DEMULSENT in IRRITATING

COUGH.

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3.ACACIA BARK:.weigh acacia bark..add 120ml water, boil for 10min..cool and strain it through sieve or muslin cloth and

pass sufficient water to produce required volume.PRECAUTION: if enamelled pan is used then it should

be checked that enamel is not chipped off, as some drugs like acacia contain tannin which will act as uncovered iron to form tannate,which will blacken the decoction

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LIMITATION OF DECOCTION:.only few drugs suited to prepare by this

method..because by decoction only aqueous preparation

of those drugs is possible which are thermostable i.e not degraded by heat

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• Dispensing bottle of decoction

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• 3.ELIXIRS:DEFINITION: “clear ,sweetened ,hydroalcoholic solutions

intended for oral use and are usually flavoured to enhance their palatibility”

TYPES:.Medicated elixir.non medicated elixir

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• GENERAL PREPARATION:.simple mixing is required..alcohol soluble substances dissolve in alcohol..dissolve water soluble substances in water..then add latter in former..when two solutions are completely mixed,then

make up the volume with solvent.

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• PRECAUTION DURING PREPARATION:Alcoholic solution can never be added in

aqueous solution because alcoholic strength can be disturbed & alcoholic subtances may be separated out

So, aqueous sloutions are added in alcoholic solution

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• EXAMPLE: CHLORAL HYDRATE ELIXER BP1998..formula: chloral hydrate 40g black currant syrup 200ml dist. Water 20ml simple syrup qs 1000ml..method:Add chloral hydrate in water, then add black currant

syrup .then add simple syrup to make up final volume...use: sedative, hypnotic 2/26/2015


• Dispensing bottle of elixir

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4.OINTMENTS

• DEFINITION:- • ‘Ointments are semisolid greasy preparations for application to

the skin, rectum and mucosa. The base is usually anhydrous and contains the medicament in solution or suspension.’’

• TYPES;• 1) Medicated

• 2) Non-medicated

•

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OINTMENT BASES

• Ointment bases may be used for their physical effects or as vehicle for medicated ointments

• CLASSIFICATION OF OINTMENT BASES;• Ointment bases are generally classified by USP into 4 groups:• 1- Oleaginous bases (Petrolatum USP, white petrolatum, yellow

ointment USP, white ointment USP)• 2- Absorption bases (Hydrophilic petrolatum USP, Lanoline USP)

• 3- Water Removable bases (Hydrophilic ointment USP)

• 4- Water Soluble bases (Polyethylene Glycol ointment NF)

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PREPARATION OF OITMENTS

• Ointments are prepared by 2 general methods;• ( depends generally on the nature of ingredients)• A) Incorporation• B) Fusion.

• INCORPORATION• Components are mixed until a uniform preparation is attained.• On small scale as in extemporaneous compounding the pharmacist may

mix the components by using,• Pestle and mortar OR• Spatula may be used to rub the ingredients together • (on an ointment slab, non absorbent parchment paper)

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• FUSION• By fusion method, all or some of components of ointment are combined

by being melted together and cooled with constant stirring until congealed.

• Components which are not melted are added to congealing mixture.• Heat labile substances and volatile components are added last when

temperature is cool enough not to cause decomposition and volatilization.• Fusion may be conducted in porcelain dish or glass beaker.

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PACKAGING AND STORAGE• Ointments and other semisolid preparations are packaged either in • Large mouth ointment jar or• In metal or plastic tubes.• Semisolid preparations must be stored in well closed containers to protect

against contamination &• In a cool place to protect against product separation in heat.

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EXAMPLE

• PREPARATION OF 40g OF SIMPLE OINTMENT:• Cetostearyl alcohol BP 2g 49-56*C• Hard paraffin BP 2g 50-61*C• Wool fat BP 2g 38-44*C• White or yellow soft paraffin BP 34g 38-56*C• Firstly weigh all the ingredients and note their melting points.• Then place Hard paraffin into an evapourating dish and melt over a water bath.• Remove from heat and add other ingredients in descending order of melting point

until all are melted.• Stirr until cold and pack in amber glass jar. Label and dispense.

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Direction for label• Name and address of pharmacy: …………………………• Name of patient: …………………………………………• Date of dispensing: ………………………………………• Expiry date: Do not use after 3 months.• Auxiliary label: For external use only. Stored at a dry place in a well closed

container.• Precaution: Keep out of the reach and site of children. Protect from moist

and heat.

• DOSE: As per required.

• USE: Used as emollient.

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OTHER USES

• ZINC OINTMENT BP: Used to treat nappy rash and eczematous.

• CALAMINE AND COAL TAR OINTMENT: Used in the treatment of psoriasis and other skin conditions as anti-inflammatory, antipruritic and anti-scaling properties.

• METHYL SALICYLATE OINTMENT BP: Used as rubifacient to relieve pain and other rheumatic conditions.

• SALICYLIC ACID AND SULPHUR OINTMENT BPC:• Used to treat acne.

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5.LOTIONS• DEFINITION:• LOTIONS ARE FLUID PREPARATIONS FOR EXTERNAL APPLICATION WITHOUT FRICTION.

THEY ARE EITHER DABBED ON THE SKIN OR APPLIED ON A SUITABLE DRESSING AND COVERED WITH WATER PROFF MATERIAL TO REDUCE EVAPOURATION.

• INGRETIENTS: • Almost any lotion contains a few standard kind of ingredients.• Plain water or water based liquid.• Fats oil and butter.• Emulsifier.• Thickner.• Anti-oxidants.• Preservative.• Cent and colourants.• Other additives include Glycerine, silk amino acid (silk protein), pH balancer, and

many more.

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EXAMPLE OF LOTION

• COPPER AND ZINC SULPHATE LOTION BPC :• INGRETIENTS:• Each 100ml of lotion cotains• Zinc sulphate BP …… 1.5g• Copper sulphate BP ….... 1.0g• Conc. Camphor water BP … 2.5g• Purified water …… to make 100ml.

• METHOD OF PREPARATION:• Dissolve the copper sulphate and zinc sulphate in 90ml of purified water.• Add concentrated camphor water in small quantities.• Shake vigorously after each step and add sufficient water to produce the required volume• Pour into amber coloured glass bottle and dispense.

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DIRECTION FOR LABEL

• Name and address of pharmacy: ……………....• Name of patient: ……….………………………..• Date of dispensing: ………………………………• Expiry date: do not use after one month.• Auxiliary label: FOR EXTERNAL USE ONLY. Stored at dry place in a well closed

container, below room temperature.• Precaution; keep out of the reach of children and protect from moisture

and heat.

• DOSE: Apply as directed once a day.

• USES: It was used as a wet dressing to treat eczema, impetigo.

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OTHER USES

• Many of hand and body lotions used to treat dry skin.• Their major advantage is their development of an in-vitro release method

over oral drugs.• Used as acne face moisturizer.• Used as aging skin moisturizer. • A number of topical lotions are used therapeutically to deliver a drug

systemically. An example is Estrasorb ( Novavax, King Pharmaceuticals),• Which contains Estradiols for use in the treatment of hot flashes and night

sweats accompanying menopause.• They absorb very quickly and feel light on the skin.

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6.CREAMS

• DEFINITION:• THESE ARE SEMI-SOLID EMULSIONS FOR EXTERNAL USE. THERE ARE

TWO KINDS AQUEOUS AND OILY CREAMS IN WHICH THE EMULSIONS ARE (OIL IN WATER AND WATER IN OIL) RESPECTIVELY. THE OIL IN THE WATER TYPE IS RELATIVELY NON-GREASY. THE CREAMS ARE VERY POPULAR FORM OF EXTERNAL MEDICATION.

• OIL IN WATER EMULSION TYPE CREAM:• The vanishing creams are oil in water emulsions containing large percentage of

water and stearic acid or other oleaginous components.• After application of cream the water evapourates leaving behind a thin residue film

of stearic acid or other oleaginous components.

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EXAMPLE OF CREAM

• CETRIMIDE CREAM BP ( 30G )• INGREDIENTS:• Each 30g of cetrimide cream contains:• Cetrimide BP 150mg• Cetostearyl Alcohol BP 1.5g• Liquid paraffin BP 15g• Fresh purified water 13.35g• METHOD OF PREPARATION:• Firstly weigh all the ingredients and also note their melting points and

solubilities.• .

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• Melt cetostearyl alcohol BP over a water bath to a temperature higher then 60 degree.

• Add liquid paraffin to molten cetostearyl alcohol and remove from heat.

• Stir to form oily phase.• Transfer the freshly boiled and cooled purified water to a

beaker and to 60 degree.• Add cetrimide to purified water and remove from heat.• Stirt to form Aqueous phase.• Now add the aqueous phase to oily phase at 60 with constant

stirring, not too vigorously stirring.• Stir until cool enough to pack.• Weigh 30g of product and pack into an amber glass jar, label

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DIRECTIONS FOR LABEL• Name and address of pharmacy : ……………………..• Name of patient: ……………………………………...• Date of dispensing : …………………………………..• Expiry date: do not after 1 month.• Auxiliary label : FOR EXTERNAL USE ONLY. • stored at a dry place in a well closed container.• Precaution: keep out of the reach of children. Protect from moisture and

heat

• DOSE: Apply with rubbing to abrasion after 6-8 hourz.

• USES: used to treat cuts, grazes, minor burns, minor scals, minor wounds and minor abrasions to prevent infections.

• For preoperative cleansing of skin.• For the removal of scab and crust in the skin disease.

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OTHER USES• DIFFERENT TYPE OF CREAMS USED FOR DIFFERENT PURPOSES• As lubricant and emollient. • As antipruritis• As keratolytics• Topical corticosteroids• Pemphigus vulgaris• Pemphigus foliaceous• Toxic epidermal necrosis• Many patients and physicians prefer creams to ointments because they

are easy to spread and remove.

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7.LINIMENTS

• DEFINITION :• LINIMENTS ARE FLUID, SEMI-FLUID OR OCCASIONALLY

SEMI-SOLID PREPARATIONS INTENDED FOR APPLICATION TO THE SKIN. THEY MAY BE OILY OR ALCOHOLIC OR OILY SOLUTIONS OR EMULSIONS. MOST ARE MASSAGED INTO THE SKIN ( counting irritant or stimulating type) BUT SOME ARE APPLIED ON A WARM DRESSING OR WITH A BRUSH (analgesic or soothing type). LINIMENTS MUST NOT BE APPLIED TO BROKEN SKIN.

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• Liniments with an alcoholic or hydroalcoholic vehicle are useful when rubefacient, counterirritant or penetrating action is desired;

• Oleaginous liniments are employed primarily when massage is desired.• By their nature, oleaginous liniments are less irritating to the skin than

alcoholic liniments.

• OLEAGINOUS LINIMENTS:• For oleaginous liniments the solvent may be a FIXED OILS such as:• Almond oil, Peanut oil, sesame oil or cottonseed oil.• Or VOLATLE SUBSTANCES such as:• Wintergreen oil, Turpentine oil.• Or combination of fixed or volatile oils.

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WHITE LINIMENT BP (100ML)

• INGREDIENTS:• Each 100ml of white liniment contains:• Oleic acid BP 8.5ml• Turpentine oil BP 25ml• Dilute Ammonia solution BP 4.5ml• Ammonium chloride BP 1.25g• Fresh purified water 62.5ml

• METHOD OF PREPARATION:• Accurately measure all the ingredients.• Then mix turpentine oil BP and oleic acid BP in a mortar.• Add an equal volume of purified water to the dilute ammonia solution BP.

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• Add to the oily phase and mix vigorously.• Add ammonium chloride to the remaining purified water in a beaker and

stir to dissolve.• And add this solution to above prepared mixture make up final volume.• Then transfer to an amber fluted medicine bottle.

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DIRECTIONS FOR LABEL• Name and address of pharmacy: …………………………• Name of patient: …………………………………………• Date of dispensing : ………………………………………• Expiry date : Do not use after 1 month.• Auxiliary label: FOR EXTERNAL USE ONLY. Shake well before use.• Stored at a dry place in a well closed container.• Precaution: keep out of reach of children. Protect from moisture and heat.• Do not applied to the skin areas that are broken because excessive

irritation.

• DOSE: Apply on effected area with rubbing. As per required.

• USES: Used as counter irritant and rubifacient for the treatment of sore muscles and arthritis.

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8.INFUSIONS (INFUSA)

• DEFINITION:• INFUSIONS ARE DILUTE SOLUTIONS CONTAINING THE

WATER-SOLUBLE EXTRACTS OF VEGETABLE DRUGS.

• EXPLANTION:• They were prepared by maceration drugs in water for a short period of time,

varying from 15 minutes to 2 hours.• The volume of product depends on:• The quantity of menstrum retained by marc,( which should not be pressed )• The degree of communication of drug,

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• The temperature used for preparation of infusion &• The length of maceration chosen depends upon the nature of drug and

the constituents to be extracted.• Infusion were usually prepared in earthenware vessels ( latterly glass was

used )

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STEPS INVOVLED IN PREPARATION

• The drug was added to the vessel usually suspended in some way or enclosed in muslin ( like a modern tea bag) so as to be just below the surface of water.

• If the drug sank to the bottom of vessel the mixture would need occasional stirring.

• If hot water was added to prepare the infusion it would be weighed into previously warmed vessel to prevent cracking for the measure.

• Often a layer of cloth was wrapped around the infusion container in order to reduce the heat loss and aid extraction process.

• When the specified infusion time has reached, the product was strained and the marc remove as quickly as possible so as to allow the preparation to cool before use.

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• Fresh infusion should be dispensed within 12 hours.• Infusions containing a drug that was freely soluble or those containing

high proportion of starch were prepared with cold water.

• CONCENTRATED INFUSIONS:• Some times high concentrated forms of infusion were prepared.• The BP and BPC recommended the use of concentrated infusions from

which infusion can be prepared by diluting one volume of concentrated infusion to ten volumes with water since 1968.

• Any formula that predates 1968 will be required to be diluted to eight volumes with water.

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INFUSION APPARATUS• A number of type of infusion apparatus were developed;• EXAMPLE:• ALSOP’S INFUSION JAR• SQUIRE’S INFUSION MUG• These had in built support for crude drug substance positioned at an

appropriate level in the container and also featured specially designed pouring spouts.

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EXAMPLE OF INFUSION

• INFUSION OF CATECHU BP• (INFUSUM CATECH) BP 1885• FORMULA:• Catechu in coarse powder 160gm• Cinnamon bark 30gm • Distilled water 30ml• METHOD:• Infuse in a covered vessel for half an hour and strain.• DOSE: 1-2 ft oz• USE: As astringent used in internal mixture to treat diarrhoea.

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GLYCERINE 9.(GLYCERITA OR GLYCERITES)

• DEFINITION:• ‘‘THESE ARE SOLUTIONS OF MEDICAMENTS IN GLYCEROL WITH OR

WITHOUT THE ADDITION OF WATER’’

• EXPLANATION:• Glycerine is a colorless, odourless, syrupy, sweet liquid, usually

obtained by the saponification of natural fats and oil.

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PROPERTIES OF GLYCERIN• Glycerin is a neutral, colourless thick liquid which freezes to gummy paste.• It is sweet in taste.• It has a high boiling point.• It can be dissolved in water and alcohol but not in oils.• Many things will dissolve into glycerin easier then they do into water or

alcohol. So, it is a good solvent.• It is also highly ‘‘hygroscopic’’ which means that it absorbs water from air.

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WHERE DOES GLYCERIN COME FROM????

• Up until 1889, people didn’t know how to recover glycerin from soap making process so commercially produced glycerin mostly came from candle making industry because candles were making from animal fats.

• In 1889 a viable way to separate glycerin out of soap was finally implemented

• As the soaps can make from fats and lye and the fats already contains glycerin as the part of their chemical makeup ( animal and vegetable fats contains 7-13 percent glycerin )

• When the fats and lye interact soap is formed and glycerin is left out as ‘‘by-product’’. ( glycerin is separated chemically but still blend into the soap mixture.)

• While a cool process soapmaker would simply pour into molds at this stage.

• Then salt is added which causes the soap to curdle float to the top.

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• After skimmed off the soap, they are left with the glycerin ( and a lot of impurities like partially dissolved soap, extra salt etc)

• They then separate the glycerin out by distilling it.• Finally they decolourize the glycerin by filtering it through charcoal, or by

using some other bleaching method.

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USES OF GLYCERIN• It is used for sweetening and preserving food.• Also used in the manufacture of cosmetics, perfumes and certain glues.• Used as solvent and auto mobile antifreeze.• It is used as base for lotion.• It is used to lubricate moulds.• It is used as an emollient.• It is also used to make clear soaps containing 15-20 percent pure glycerin.

Known as ‘‘Melt and pour soap’’• Sometimes to preserve scientific specimens in jars in biology lab.• Glycerol can be used as laxative in suppositories in small volumes 2-10ml.

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10.TABLETS

• DEFINITION“compressed solid dosage form containing

medicament with or without excepients or diluents”.

• CLASSICAL TYPE: MOLDED TABLETADVANTAGE: one of its advantage is that it can easily

disintegrate in the presence of moisture.2/26/2015


• DOSE ADJUSTMENT: tablets are actually compressed powder

mixtures, the pharmacist can easily adjust the composition of any number of dosage.

• SOLUBILITY:Such tablets must be completely & rapidly

soluble.

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• DISADVANTAGE:They are of small size which will limit their use

to substances effective in small doses..the problem arises in the compression of

tablets is the failure to find a lubricant i,.e completely water soluble.

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• PREPARATION: MOLDING.they are prepared by molding..molded tablets are not manufactured by compression..tablet titurates are usually made from material ,using a

titurate ,mold that gives them the shape of cut sections of a cylinder.

.molded tablets are generally prepared by mixing the active drug with lactose,dextrose,sucrose,manitol,or small appropriate diluent that can serve as the base.

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.their base must be readily water soluble& should not degrade during tablet preparation.

.lactose is preferred base but manitol adds a pleasant ,coding sensation and additional sweetness in the mouth.

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• EXAMPLE TABLET TITURATESThese are administered sublingually or by placing them on

tongue followed by swallowing with a small volume of water.

e.g: nitroglycerine tablet titurates..contain 0.1 – 1mg nitroglycerine..water soluble solvent is polyethylene glycol having an

average molecular weight 300-1000..water soluble carrier is mixture of lactose & sucrose.

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• EQUIPMENTS USED FOR STORAGE AND PAKAGING FOR CLASSICAL DOSAGE FORM(TT)

1. Basket of reed2. Bota bags3. Wooden boxes4. Pottery vases5. Wooden barrels6. Woven bags

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• APPARATUS FOR MANUFACTURING:The mold is made of hard rubber,hard plastic or

metal. PARTSIt has two parts..upper part (die portion).lower part

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• UPPER PARTThe die portion is a flat plate with the thickness of

tablet to be produced with 50-200 unifrmly drilled & evenly spaced circular holes.

LOWER PARTLower part of mold has corresponding particles that fit

the holes precisely..when die is filled with material & placed a top the

punches ,the punches gently lift the fill material from holes to rest upon the punches of drying.

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• In preparing the fill ,the drug is mixed uniformly with the base by geometric dilution when potent drugs are used.

• The powdered mixture is wetted with a 50 percent mixture of water & alcohol sufficient only to dampen the powder so that it may be compact.

• The solvent action of water on portion of lactose or lactose sucrose base binds the powder mixture upon drying.

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11.EXTRACTS:

• INTRODUCTION:.these are produced by the action of various solvents

(aqueous ,alcohol, ether), by using variety of processes ( expression, maceration, perculation).

SUCCI SPISSATI.the juices of fresh plants were obtained by

expression & evaporation, the resultant extract were frequently termed as succi spissati i.e INSPISSATED JUICES.

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ACTIVE INGREDIENTExtracts were intended to contain active principles of

crude drugs while minimizing the amount of inert matter present.

In general extracts a high proportion of active principle than infusion , decoction etc.

TYPES:.solid extract.liquid extract .dry extract2/26/2015


• SOLID EXTRACT.Also known as “soft extract”..having consistency b/w pill mass ,paste or dry

extract..it was difficult to standardize the degree of

“softness”..they often hardened on storage producing

tough mass that was difficult to handle.

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• DRY EXTRACT:.replace soft extracts as he solid extract of

choice as these could be standardize..they vary less in length & were generally easier

to handle..storage was less likely to cause significant

problem.

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• LIQUID EXTRACT:.liquid extract are still commonly used in

extemporanous compounding..the main example being “liquid liquorice extract

bp”.

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12.COLLODIONS

• DEFINITION: “liquid preparations intended for external

use,containing highly volatile solvents (usually a base solution of pyroxylin {soluble gun cotton} in a mixture of ether & alcohol) that evaporate to leave a film of pyroxylin on the surface”.

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• DEVICE FOR APPLICATION: Collodion hd to be applied to skin using “soft

brush”• EXAMPLE: Their use is almost obsolete, but some modern

collodion is as follows which are listed in bp:a) Flexible collodion bpb) Salicylic acid collodion bp

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• COLLODION USP: DEFINITION: “collodion contains not less than 5% of pyroxylin

by weight”.FORMULA:.pyroxylin 40g.ether 750ml.alcohol 250mlTo make about 1000ml2/26/2015


METHOD:Dissolve pyroxylin in ether & alcohol in a closed

container.POSSIBLE USE:.as a protective to seal small wound..in the preparation of medicated collodion.

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• FLEXIBLE COLLODION USP,BP:FORMULA:.camphor 20g.castor oil 30g.collodion q.s ad 1000gMETHOD:Mix the ingrediants together in a closed container & shake the

mixture until the camphor is dissolved.USE:.as a protective for cuts & small burns .when applied to skin ,it

causes pain but it is an effective antiseptic & also exclude air from open wounds.

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• SALICYLIC ACID COLLODION:FORMULA:.salicyic acid 100g.flexible collodion qs ad 1000mlMETHOD:It is a simple solution.USE:keratolytic2/26/2015


13.GalanecalsHistory of galenicals

Galenicals a term applied: to any preparation

(elixirs,solutions ,water etc) irrespective whether it is an extract of a

crude drug. or a solution of chemicals 2/26/2015


Historically

The term is named after CLAUDIUS GALENS

A second century greek physician who codified the preparation of drugs

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Definition of galenicals

A medicinal preparation concoted mostly out of herbs or vegetable matter.

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Preparation of galenicals

True galenicals are pharmaceutical preparations obtained by

1. macerating or percolating crude drug with alcohol or some other solvent (menstrum)

2. to remove the desired active components

3. leaving undesirable components of plant in the solid phase(marc).

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Example

Vinegar Oxymels Tincture e.g Belladona tincture BPInfusion

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Uses

Galenicals were once true mainstay of therapy in dermatology.

Can be used for crusted scabies

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Label Belladona tincture BPFormula: Belladona herb ----------- 100g Ethanol [70%] -----------quantity sufficient Method: pepare about 900ml of a tincture by percolation.Dose: 0.5-2mlUse: Antispasmodic

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14.Tinctures…Historically

• Alcoholic preparations containing active ingredients of vegetable drugs

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Definition of tincture

• Alcoholic or hydroalcoholic preparations of vegetable material and chemical substances.

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Properties of tincture

Can be kept for long period without deterioration

And loss of potency Because of preservative nature of alcohol

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Preparation of tincture

Alcoholic solution of drug prepared by: by adding alcohol to a substance Then maceration or percolation

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Example

Quillaia tincture BPAromatic cardamom tincture BPGentian tincture BP

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Uses of tincture

As carminative As flavouring agentTo stimulate apetite antispasmodic

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Label

Quillaia tincture BPFormula: Quillaia liquid extract ---------50g Ethanol [45%] ----------------up to 1000mlMethod: mix the ingredients,allow to stand for 12 hours and filter.Dose: 2.5-5mlUse: as emulsifying agent

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• STORAGE of tincture: stored in well closed container to avoid

evaporation.

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15.Plasters.Historically

Plaster was an adhesive substance that required the aid of heat to spread it and was intended for external application to the skin

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Definition

Solid or semisolid mass applied on backing material and intended to provide prolong contact with skin.

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Properties

Plaster was firm at room temperature But spread easily when heating Remaining soft and pliable when in contact

with the skin

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Example

Bellodana plaster Kerutolytic plaster Neocapsicum plaster Famycetin dressing

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Uses

For stiff neck Aching shoulders Back ache RheumatismBurns Abrasions

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Label

Blladona plasterFormula: active ingredient Hyoscyamine -------0.25%Duration of action: lasts upto 12 hoursCaution: for external use onlyUse: relief of aches and pain2/26/2015


16.Poultice/cataplasmsHistorically

• Preparation of thick semi-solid base which were often heated and applied to a body part or area on a cloth in order to draw infection.

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Definition

Paste like preparation used externally to reduce inflammation because they retain heat well.

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Direction for use

After heating on water bath the preparation is spread thickly on a dressingAnd applied as hot as the patient can bear it

to the effected area

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Preparation

Select a herb that you will be using for your poutice

Using a mortar and pestle, grind the herbs into a fine powder.

Add a small amount of warm water to herbs enough to make a thick paste that spreads easily

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Another method for preparation

• Poultices can also be prepared by heating and mixing the ingredients

• E.g • Kaolin poultic

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Uses

Soothing in pain and inflammationCounter-irritant To treat boils To treat acne Ued for insect stings

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LabelKaolin poultice

Formula: heavy kaolin ------------527g boric acid ---------------45g methyl salicylate ------2ml thymol -------------------500mg peppermint oil---------0.5ml glycerol ------------------425gMethod: heat and mix the ingrdientsDose: as per requiredUse: for boils for inflammatory skin conditionsStorage: away from sunlight Caution : for external use only

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17.LOZENGES/TROCHES/ COUGH SWEETS

HistoricallyLozenges were solid dosage form

dessigned to dissolve slowly and disintegrate in the

mouth Lozenges were used for drugs exerting a local action.

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Definition

A small , medicated candy intended to be dissolved slowly in the mouth to lubricate and soothe irritated tissues of throat.

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Types

1. Hard lozenges similar to hard candy2. Soft lozenges3. Chewable lozenges gummy type lozenges

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Preparation

lozenges were prepared by: mixing active substances With one of four lozenges bases (lozenges mass)METHOD: Lozenges was rolled into a flat sheet of appropriate thickness On a lozenge board Using a cylindrical roller Shaped lozenges were cut from this using a metal cutter Finished lozenges were weight, checked and dried. 2/26/2015


Example

Strepsils lozenges Halls lozenges Liquorice lozenges Bismuth lozenges

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Uses

To temporarily stop cough Nicotine lozenges: help people stop smokin Nystatin lozenges: used to treat fungal infections

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Label

STREPSILS LOZENGESFormula 2-4 dichlorobenzyl alcohol ---------1.2g Amylmetacresol -----------------------0.6gDose: not more than 12 lozenges per day Direction for use: dissolve one lozenges slowly in the mouthUse: to relief sore throat to treat mouth infections

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classical dosage form

Health & Medicine

classical dosage form

old dosage form

obsolete dosage form

semisolid dosage form

classification of dosage

liquid dosage form definition

conventional dosage

concentration syrups