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EXTEMPORANEOUS PREPARATIONS BY SANA GHAYAS. LEARNING OBJECTIVES: At the end of this lecture, students will be able to: Know about extemporaneous dispensing. Define different dosage forms

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slide2

LEARNING OBJECTIVES:

At the end of this lecture, students will be able to:

  • Know about extemporaneous dispensing.
  • Define different dosage forms
  • Classify different dosage forms on the basis of their use with examples (solutions, suspensions, creams, emulsions, ointments, paste, gels, suppositories, pessaries, powders, granules, oral unit dosage forms)
  • Contrast different dosage forms
  • Dispense different dosage forms extemporaneously with labels.
  • Evaluate dispensed dosage forms and their labels.
  • Provide special labels and advice for patients.
slide3

Dispensed products grouped into

  • Solution
  • Suspension
  • Emulsion
  • Creams
  • Powders and oral unit-dosage forms
  • Ointments
  • Pastes & jellies
  • Suppositories & pessaries
slide4

SOLUTIONS:

  • Homogenous liquid preparations
  • Containing one or more dissolved ingredients
  • Designed for internal & external use.

FORMULATION OF SOLUTION:

Following should be determined before formulating a solution:

  • Vehicles
  • Solubility
  • additives
slide5

VEHICLES:

Medium in which ingredients of medicine are dissolved or dispersed.

  • Water
  • Syrup
  • Ethanol
  • Glycerol
  • Propylene glycol
  • Acetone
  • Solvent ether
slide6

SOLUBILITY:

  • “The no. of parts of solvent (by volume) that will dissolve one part (by weight of a solid or volume of a liquid )of the substance.
  • For oral solutions, ethanol, glycerol and propylene glycol may be used in various combinations with water as cosolvent.
  • Surfactant can be used for solubilization of poorly water soluble medicaments. E.g. polysorbates.
slide7

ADDITIVES

  • GIT can tolerate solutions with a wide range of pH values.
  • Hypertonic solutions (potassium citrate mixture BP) should be well diluted before taking orally.
  • Solutions prepared for mucosal surfaces (nasal drops) usually include sodium chloride to increase tonicity to that of body fluids.
  • Stabilizers
  • preservative
  • Colours
  • Flavours
slide8

SOLUTIONS AS ORAL DOSAGE FORMS:

  • Elixirs, mixtures & oral solutions contain one or more ingredients dissolved in a suitable vehicle.
  • If dose less than 5 ml prescribed, oral liquid usually diluted.
  • Choice of diluent is critical as their inclusion can adversely affect flavour, stability or appearance.
  • Extemporaneously dispensed products usually diluted with water or syrup, appears as last line in the formula.
slide9

SHELF LIFE:

  • SUPPLY OF PRODUCT WITH SHORT HALF LIFE:
  • Quantity of product supplied to patient must not exceed that which would be expected to be used with in the shelf life.
  • CONTAINERS, LABELS AND ADVICE FOR PATIENTS:
slide10

MOUTHWASHES AND GARGLES:

  • These are usually diluted with warm water before use
  • Most are not intended to be swallowed in significant amounts.
  • Long shelf life
  • Stable products
  • Prepared from stock.
  • Extemporaneously prepared or poured preparations are supplied in amber colored fluted bottles or medicine bottles for products intended to be swallowed.
slide11

SOLUTIONS INSTILLED INTO BODY CAVITIES:

  • Nasal drops and sprays formulated as iso osmotic with nasal secretions.
  • Buffered
  • Shelf life of extemporaneous products
  • Dispensing:
  • extemporaneous nasal drops supplied in hexagonal, amber fluted glass bottles with a rubber teat and dropper closure.
  • Nasal sprays packed in flexible plastic bottles or pressurized containers.
  • For decongestant drops, patient should “AVOID EXCESSIVE USE” and “AVOID USE IN VERY YOUNG BABIES UNLESS UNDER MEDICAL ADVICE”
slide12

EAR DROPS:

  • Water, glycerol and propylene glycol may be used as vehicles.
  • They are supplied in glass bottles with a teat and dropper closure or plastic squeeze bottles.

ENEMAS:

  • Used for cleansing, therapeutic or diagnostic purposes.
  • shelf life
  • Amber fluted glass bottles used for enemas and disposable bags sealed to a rectal nozzle are for commercial use.
  • Label is marked as “FOR RECTAL USE ONLY”
slide13

SOLUTIONS FOR EXTERNAL USE:

  • Liniments, lotions and paints are usually stable.
  • Shelf-life of liniments, lotions and paints
  • Containers for liniments, lotions and paints
  • Special labels and advice for patients .
  • Antiseptic and disinfectant solutions
  • Shelf-life of antiseptic and disinfectant solutions
  • Containers for antiseptic and disinfectant solutions
  • Special labels and advice for patients
slide14

PHARMACEUTICAL SUSPENSION:

  • Suspensions are classified as:
  • Coarse suspensions.
  • Colloidal suspensions.

FORMULATION OF SUSPENSION:

  • Water is usually vehicle of choice.
  • Non aqueous vehicle like fractionated coconut oil are occasionally used.
  • Other additives are buffers, stabilizers, preservatives, colors and flavors.

PROPERTIES OF A GOOD PHARMACEUTICAL SUSPENSION

slide15

FACTORS AFFECTING PROPERTIES OF A PHARMACEUTICAL SUSPENSION:

  • Diffusible solids
  • Stokes law
  • Control of particle size
  • Flocculation
  • poorly wettable solids
  • In diffusible solids

THICKENING AGENTS:

  • Polysaccharides i.e. acacia gum, tragacanth, sodium alginate, starch.
  • Water soluble celluloses i.e. methyl cellulose, hydroxyethyl cellulose, sodium carboxymethyl cellulose.
  • Clays i.e. bentonite, aluminium magnesium silicate, hectorite.
  • Synthetic thickeners i. e. carbomers, colloidal silicon dioxide.
slide16

BASIC TECHNIQUES FOR PREPARING PHARMACEUTICAL SUSPENSIONS

SUSPENSIONS AS ORAL DOSAGE FORMS

  • MIXTURES:
  • Advantages of suspensions as oral dosage forms
  • Disadvantages of suspensions as oral dosage forms
  • Shelf life of oral suspensions
  • Containers for oral suspensions
  • Special labels and advice for patients
slide17

SUSPENSIONS FOR EXTERNAL USE

  • LOTIONS:
  • containers for lotions
  • Special labels and advice for patients
  • INHALATIONS
  • Containers for inhalations
  • Special labels and advice for patients
  • OTHER TYPES OF DISPENSED PRODUCT
  • SUSPENSIONS AS 'EMERGENCY' FORMULATIONS
slide18

EMULSION:

  • An emulsion is a disperse system consisting of two immiscible liquids, one of which(disperse phase) is finely divided and distributed through the other (continuous phase).
  • DETERMINATION OF EMULSION TYPE
  • To distinguish between O/W and W/O emulsions, following tests may be used:
  • Miscibility test
  • Microscopic examination after staining with a oil soluble dye
  • Microscopic observation under UV radiation
  • Conductivity measurements
slide19

FORMULATION

  • Emulsifying agents facilitate the production of a dispersion by reducing interfacial tension and maintain the separation of the droplets of the dispersed phase by forming a barrier at the interfaces.
  • For oral/parenteral administration, O/W emulsions are required
  • For external use both O/W and W/O systems may be used.
  • TYPES OF EMULSIFYING AGENTS
  • Synthetic or semi synthetic substances
  • Natural products
  • Finely divided solids
  • Many of the substances described as thickening agents also act as amulgents.
slide20

SYNTHETIC OR SEMI SYNTHETIC SUBSTANCES

  • They are further classified depending on their ionization in aqueous solution as follows:
  • Anionic surfactants e.g. alkali metal and ammonium soaps, amine soaps, soaps of divalent & tri valent metals, alkyl phosphate and alkyl sulphates.
  • Cationic surfactants e.g. quarternary ammonium compounds like cetrimide
  • Non ionic surfactants e.g. glycol and glycerol esters, sorbitan esters, polysorbates, macrogol ethers and esters
  • Ampholytic or amphoteric surfactants which are not widely used as emulsifiers in pharmacy.
  • NATURAL PRODUCTS
  • FINELY DIVIDED SOLIDS
slide22

Choice of an emulsifying agent

  • Selection of appropriate emulsification system depends on active ingredients incorporated into product and on use of final product and based on theoretical con­siderations and on experience.

Formulation by the HLB method

  • emulgents with high numbers (8-18) produce o/w emulsions and with low numbers (3—6) give w/o emulsions.
slide24

OTHER ADDITIVES

Antioxidants:

e.g. butylatedhydroxyanisole (BHA) or butylatedhydroxytoluene (BHT). Ethyl, propyl or dodecylgallate may also used.

Preservatives

Desirable properties of a preservative for emulsions

Preservatives commonly used in emulsions

  • Organic acids.
  • Parahydroxybenzoic acid esters.
  • Chlorocresol.
  • Phenethyl alcohol.
  • Quaternary ammonium compounds.
  • Chloroform.

Colour and flavor

  • Additional color is rarely necessary.
  • Flavors are used for oral emulsions.
slide25

STABILITY OF EMULSIONS :

The main difficulties encountered in practice are listed here.

Creaming

  • This is separation of the emulsion into two regions, one containing more of the disperse phase, e.g. cream on milk.

Cracking

  • This involves coalescence of dispersed globules and separation of the disperse phase as a separate layer.

Phase inversion

  • The most stable range of disperse phase concentrations is 30-60%.
  • If amount of disperse phase increased until it approaches or exceeds the theoretical maximum of 74% of the total volume then phase inversion may occur, i.e. from o/w to w/o, or from w/o to o/w.
slide26

COMPOUNDING OF EMULSIONS AND CREAMS

  • Basic techniques are:
  • Weighing
  • Measuring of liquids
  • Mixing
  • On small scale mortar and pestle are used producing globule size larger than 10 µm.
  • Homogenizers are used for extemporaneously prepared emulsions.

EMULSIONS AS ORAL DOSAGE FORMS

  • Shelf-life of oral emulsions
  • Containers for oral emulsions
  • Special labels and advice for patients
slide27

EMULSIONS FOR EXTERNAL USE:

  • Liniments and lotions are liquid or semi liquid emulsions designed for application to skin.
  • Shelf-life of applications, liniments and lotions
  • Containers for applications, liniments and lotions
  • Special labels and advice for patients
slide28

CREAMS:

  • They are viscous semi solids for external use.
  • They may be W/O or O/W emulsions.
  • GENERAL COMPOUNDING PROCEDURE FOR CREAMS
  • DILUTED CREAMS
  • SHELF-LIFE OF CREAMS
  • CONTAINERS FOR CREAMS
  • SPECIAL LABELS AND ADVICE FOR PATIENTS
slide29

OINTMENTS PASTES AND GELS:

  • Ointments are greasy preparations.
  • Gels are transparent or translucent, non greasy, aqueous preparations.
  • Pastes contain a higher proportion of finely powdered medicament than ointments or gels

BASES FOR OINTMENTS AND OINTMENT TYPE PASTES

They may be classified into four main groups:

  • HYDROCARBON BASES
  • ABSORPTION BASES
  • WATER MISCIBLE BASES
  • WATER SOLUBLE BASES
slide31

OTHER ADDITIVES FOR OINTMENTS AND PASTES

  • These include:
  • Antioxidants like BHT, BHA, EDTA and must be compatible with the medicaments incorporated into the base.
  • Preservatives, which may not be required in anhydrous ointments. Examples are sorbic acid, quaternary ammonium compounds etc.
slide32

FORMULATION OF GELS:

  • Gelling agents are either organic hydrocolloids or hydrophilic inorganic substances.
  • Slightly viscous gels may be used as replacement solutions for body secretions i.e. artificial saliva and tears.
  • More viscous gels may be used as lubricants for catheters, examination gloves and surgical instruments.
  • Those designed for surgical or ophthalmic use must be supplied sterile.
slide33

TRAGACANTH GELS:

Concentration of tragacanth from 2%-5% produce gels of increasing viscosity.

SODIUM ALGINATE GELS:

A concentration of 1.5% produces fluid gels and 5-10% gels are suitable as dermatological vehicles.

PECTIN GELS

CELLULOSE DERIVATIVES:

POLYVINYL ALCOHOLS:

The required concentration is usually between 10% and 20%, depending on the grade of PVA and the desired viscosity.

slide34

OTHER ADDITIVES FOR GELS:

  • HUMECTANTS: Like glycerol, propylene glycol or sorbitol solution may be added to retain water, otherwise skin formation may occur.
  • PRESERVATIVES: like methyl and propylhydroxybenzoates either alone or in combination are suitable for gels containing pectin, carmellose sodium, sodium alginate, tragacanth, etc.
  • CHELATING AGENTS: like EDTA may be used for protection against heavy metals.
slide35

COMPOUNDING OF OINTMENTS AND PASTES

  • The basic techniques are weighing, measuring of liquids, size reduction, size separation and mixing.
  • MIXING BY FUSION
  • PREPARATION OF MEDICATED OINTMENT AND PASTES BY FUSION
  • MIXING BY TRITURATION
slide36

SHELF LIFE OF OINTMENTS, PASTES AND GELS

  • CONTAINERS FOR OINTMENTS, PASTES AND GELS
  • Extemporaneously prepared ointments and pastes are usually packed in screw capped amber glass or plastic pots.
  • SPECIAL LABELS FOR OINTMENTS, PASTES AND GELS
  • Store in a cool place.
  • Sterile.
  • The labels for collapsible tubes should be fixed to the upper(nozle) end of the tube.
slide37

SUPPOSITORIES:

  • They are solid medicated preparations designed for insertion into rectum.
  • They melt, dissolve or disperse and exerts a local or systemic effect.
  • Pessaries similar solid medicated preparations designed for insertion into the vagina.
  • Usually used to provide local effect.
  • FORMULATION OF SUPPOSITORIES AND PESSARIES:
  • There are two main classes of suppository base:
  • Fatty bases designed to melt at body temperature.
  • Water soluble or water miscible bases designed to dissolve or disperse within the body.
slide38

PROPERTIES OF IDEAL SUPPOSITORY BASE:

  • FATTY BASES:
  • Theobroma oil (cocoa butter):
  • Advantages of theobroma oil include:
  • Disadvantages of theobroma oil include:
  • Polymorphism
  • Adherence to the mould
  • Softening point too low for hot climates
  • Melting point reduced by soluble ingredients
  • Rancidity on storage
  • Poor water-absorbing ability
  • Leakage from the body
  • expense
slide39

(b) Synthetic hard fat:

  • They include mixture of mono-, di- and tri-glycerides of saturated fatty acids.

Advantages of these bases over theobroma oil:

Disadvantages of synthetic bases include:

slide40

(2)Water soluble and water miscible bases:

  • glycero-gelatin
  • Mixture of glycerol and water gelled by the addition of gelatin.

(b)Gelatin

  • Two type of gelatin are used in pharmaceutical preparations:
  • Type A which behaves as a cationic agent and most effective at pH 3.2.
  • Type B which behaves as a anionic agent and most effective at pH 7-8.

(c) Macrogols (polyethylene glycols)

  • Mixtures of macrogols can be used as bases for suppositories and pessaries.
slide41

OTHER ADDITIVES

  • Antioxidants can be added to prevent oxidation which must be compatible with the medicament.
  • Water miscible or water soluble bases should include preservative which must be challenged with appropriate micro organisms to test its efficacy.
  • Emulsifying agents (wool fat, macrogols) may be included to facilitate incorporation of aqueous solutions or polar liquids but with caution.
  • Hardening agents are added to the base to raise the melting point.
  • Viscosity modifiers reduce the sedimentation rate.
slide42

CHOICE OF SUPPOSITORY OR PESSARY BASE

  • COMPOUNDING OF SUPPOSITORY OR PESSARY BASE
slide43

SUPPOSITORY OR PESSARY MOULDS

  • For small scale, metal moulds are used having 6 cavities usually.
  • Normal capacities of commonly used moulds include 1, 2, 4 and 8 g.
slide44

DISPLACEMENT VALUES

Use of displacement values (Method for determining displacement value)

Using a nominal 1 g mould, Prepare and weigh six suppositories of unmedicated base = ag

Prepare base containing 30% medicament, fill six moulds and weigh six suppositories = bg

Calculate the amount of base, cg and medicament d g in the six suppositories c = 70% b and d = 30% b

Therefore the amount of base displaced by

displacement value = __d______

a-c

For example:

Weight of six unmedicatedsuppos. = 6.0 gWeight of six suppos. Containing 30% drug = 7.5 g

Base = 70% of 7.5 = 5.25

Drug = 30% of 7.5 = 2.25

Base displaced by 2.25 g = 6 - 5.25 = 0.75 g

Therefore the displacement value of the drug = 2.25/0.75 =3

Method for using displacement value

Required: to prepare for 8 suppositories each containing 300 mg drug of displacement value 3 using a nominal 1 g mould.

Total amount of drugs required = 8 x 300 mg = 2.4 g

This will displace 2.4/3= 0.8 g of base

Therefore amount of base required = 8-0.8 = 7.2 g

slide45

MOULD LUBRICATION

Preparation of suppositories with a fatty base

  • Calculate the quantities required.
  • Prepare the mould.
  • Prepare the base.
  • Prepare the medicament.
  • Melt the base.
  • Incorporate the medicament.
  • Fill the mould.
  • Remove the excess.
  • Open the mould.

Preparation of suppositories with a macrogol base

slide46

Preparation of suppositories with a glycero-gelatin base

  • Calculate the quantities required.
  • Prepare the mould.
  • Prepare the medicament.
  • Prepare the base.
  • Heat treatment of the base.
  • Adjustment of base to weight.
  • Incorporate any medicament.
  • Fill the mould.
slide47

SHELF LIFE:

  • Stable preparations if the packaging provides adequate protection and that the storage temperature is low.

CONTAINERS

LABEL AND ADVICE

  • Store in a cool place.
  • For rectal use only.
  • For vaginal use only.

EXAMPLES

  • Compound bismuth subgallate suppositories BP
  • Dimenhydrinate suppositories
  • Glycerol suppositories BP
slide48

POWDERS:

  • Undivided oral powders.
  • Divided oral powders.
  • Granules for oral administration.
  • Dusting powders for external use.
  • FORMULATION OF POWDERS AND GRANULES:
  • COMPOUNDING:
  • Basic techniques of compounding of powders and granules are:
  • Weighing
  • Size reduction
  • Size separation
  • Mixing
slide49

PREPARATION OF UNDIVIDED ORAL POWDERS:

  • PREPARATION OF DIVIDED ORAL POWDERS:
  • WRAPPING DIVIDED POWDERS:
  • PREPARATION OF GRANULES:

On small scale, granules are made with a mortar and pestle and suitable sieves.

  • PREPARATION OF DUSTING POWDERS:

They are prepared using method as for undivided oral powders.

Sieve size should be 180 µm.

slide50

ORAL POWDERS AS DOSAGE FORMS:

1. UNDIVIDED POWDERS AS ORAL DOSAGE FORMS:

  • Relatively few medicaments are formulated as undivided/divided powders.
  • ADVANTAGES AND DISADVANTAGES OF UNDIVIDED POWDERS:
  • SHELF LIFE OF UNDIVIDED POWDERS:
  • Undivided powder are suitably packaged and stored.
  • Remain stable over a long period.
  • CONTAINERS OF UNDIVIDED POWDERS:
  • Plain glass jars with close fitting closures and a 5 ml measuring spoon should be supplied for undivided powders.
  • SPECIAL LABEL AND ADVICE FOR PATIENTS:

2. DIVIDED POWDERS AS ORAL DOSAGE FORMS:

  • SHELF LIFE OF DIVIDED POWDERS:
  • CONTAINERS OF DIVIDED POWDERS:
  • SPECIAL LABEL AND ADVICE FOR PATIENTS:
slide51

3. GRANULES AS ORAL DOSAGE FORMS:

  • Bulk granules can be used to deliver medicaments of low potency.
  • Granules packed in individual sachets.
  • SHELF LIFE OF GRANULES
  • CONTAINERS OF GRANULES
  • SPECIAL LABEL AND ADVICE FOR PATIENTS:
  • GRANULES FOR MIXTURES:
  • Some antibiotics are unstable in solution or suspension, which are formulated by manufacturers as dry granules containing medicaments and various adjuncts.

4. BULK POWDERS FOR EXTERNAL USE

  • SHELF LIFE OF DUSTING POWDERS
  • CONTAINERS OF DUSTING POWDERS
  • SPECIAL LABEL AND ADVICE FOR PATIENTS
slide52

ORAL UNIT DOSAGE FORMS have accurately measured amount of medicaments in a single dosage unit

  • Easily handled by the patient.
  • Major oral unit dosage forms are tablets and capsules.

ADVANTAGES OF ORAL UNIT DOSAGE FORMS:

  • Accurate release
  • Release characteristics of drug can be controlled
  • Uniform product
  • Stable & attractive product
  • Easy to administer
  • Unpleasant tastes can be masked
  • Simple to pack, Convenient to carry

DISADVANTAGES OF ORAL UNIT DOSAGE FORMS:

  • Difficult to swallow
  • Unsuitable for the young
  • Excipients may produce unwanted effects
  • Release characteristics may not be ideal
slide53

DISPENSING OF TABLETS:

  • Mostly packaged by manufacturer into unit packs suitable to issue to the patient with out re-packing by the pharmacist.
  • Role of pharmacist in dispensing of these tablets

SUPPLY OF TABLETS FROM BULK PACK:

  • Required number of tablets must be counted from the bulk container.
  • Tablets must remain untouched by hands.
  • Cross contamination of different tablets must not occur.
  • Counting devices must be cleaned after each usage.

CONTAINERS FOR TABLETS

SPECIAL LABELS FOR TABLETS AND ADVICE FOR PATIENTS:

slide54

CAPSULES:

  • These are dosage forms in which the medicaments are enclosed within a hard or soft gelatin shell.
  • Soft gelatin capsules
  • Hard gelatin capsules
  • Hard gelatin capsules are available in a range of sizes.
  • Approximate capacities of hard gelatin capsule shells, based on lactose:

Cap. 000 00 0 1 2 3 4 5

Content 950 650 450 300 250 200 150 100

ADVANTAGES OF HARD GELATIN CAPSULE:

  • Mask unpleasant taste.
  • Easy to swallow.
  • Require fewer excipients and can be made light resistant.
  • Give rapid & uniform release of medicaments.
slide55

FORMULATION OF CAPSULES:

  • COMPOUNDING OF CAPSULES:
  • Hand filling of hard gelatin capsules is rarely carried out in a community pharmacy but can be done in hospital pharmacy.
  • Two methods are suggested:
  • (a)filling from a powder mass
  • (b)filling with weighed aliquots
  • SHELF LIFE OF CAPSULES
  • CONTAINERS FOR CAPSULES AND ADVICE FOR PATIENTS
slide57

OTHER PRODUCTS IN CAPSULE SHELLS:

  • INSUFFLATIONS:
  • They are fine powders prepared for inhalation from a suitable insufflators.
  • EYE OINTMENTS AND RECTAL OR VAGINAL DOSAGE FORMS:
slide58

REFERENCES:

  • Pharmaceutical Practice by D M Collett and M E Aulton.
  • Solutions - Pg: 87
  • Suspensions - Pg: 99
  • Emulsions/Creams - Pg: 109
  • Ointments, pastes, gels - Pg: 125
  • Suppositories and pessaries - Pg: 135
  • Powders and granules - Pg: 145
  • oral unit dosage forms - Pg: 151
slide59

EXTRA REFERENCES:

  • COOPER & GUNN’S, DISPENSING FOR PHARM. STUDENTS BY S. J. CARTER-12TH EDITION.
  • Dispensed preparations - Pg: 8
  • Solutions - Pg: 67
  • Suspensions - Pg: 100
  • Emulsions/Creams - Pg: 120
  • Powders and oral unit dosage forms - Pg: 168
  • Ointments, pastes, jellies - Pg: 192
  • Suppositories and pessaries - Pg: 232