Assist Extemporaneous Preparations
Assist Extemporaneous Preparations
LEARNING OUTCOMES:
• Laboratory Rule
• General Laboratory Rule
1. Use all PPE
2. Clean work area
3. Calculate correctly ingredients
4. Collect all ingredients & equipment's
5. Clean equipment's
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The information on the labels of dispensed medicines should be accurate legible intelligible
adequate and relevant.
1. Accurate: the label should be checked immediately after writing and again prior to
fixing to container.
2. Legible:- the label should be type written or printed or written neatly with pen
Note that the size of the label should be related to the size of the container.
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2. Solution used in mouth and throat: - mouth washes and gargles, throat paints, throat
sprays.
3. Solution instilled into body cavities : douches, enemas, eardrops, eyes, drops, nasal
drops, nasal sprays.
4. Solution applied to body surface: Collodions, liniments, lotion and paints.
In addition to the active ingredient (medicaments), solutions also contain vehicles and
adjuncts.
The vehicle is the medium in which the ingredient of a medicine are dissolved or dispersed
for solution this is the solvent. E.g. water, aromatic waters, alcohol, glycerol, syrup, etc.
Water is the vehicle of choice for the majority of pharmaceutical solution. Because water is
generally available, relatively inexpensive, palatable and non- toxic for oral use and non
irritant for external use. It also acts as a solvent for a wide range of substances.
The adjuncts are additives that are added to improve the quality of the preparations. E.g.
chemical stabilizers, colorants, flavorings, preservatives, etc.
Aromatic water
Aromatic waters are aqueous solutions usually saturated of volatile oils or other volatile
substances that are characterized by very low water solubility. E.g. Chloroform.
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Aromatic waters are used externally as perfumes (e.g. Rose water) and internally as flavoring
agents (e.g. peppermint water, cinnamon water has been used as carminative and chloroform
water was used in expectorant preparations).
Practical
1. (a) chloroform water BP. 88
Chloroform 2.5 ml
Water FBC to 1000ml
Send 100ml
1.Peppermint water
Pepper min oil 0.2 ml
Water FBC to 100ml
Send 50ml
1. Spirits
Sprits also known as essences are alcoholic or aqueous alcoholic solutions of volatile
substances. Like the aromatic water the active ingredients in the sprits may be a solid,
liquid or gas. The volatile substance in the majority of case is volatile oils.
Some sprits are used internally for their medical value a few medically by inhalation.
But a large number are used as flavoring agents
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Practical
Peppermint spirit
Ingredient Master formula reduced formula
Peppermint oil 100ml _________________________?
Ethanol (90%) 1000ml_________________________?
Send 30 ml.
Chloroform sprit
Ingredient Master formula
Chloroform 50ml
Ethanol (90%) 1000ml
Send 40ml
Tinctures
Tinctures are alcoholic or hydro alcoholic solution of principles extracted from natural
sources or of pure chemical merely dissolved in these solvent systems an example of the
latter being iodine tincture.
Tinctures vary widely in their method of preparation the strength of their volatile
ingredients their alcoholic content and their intended use
Tinctures are prepared by a number of processes: maceration (process M) percolation
(process p) solution and dilution.
Iodine Tincture
Ingredient Master formula reduced formula
Iodine 25g -------------------------------?
Potassium iodide 25g--------------------------------?
Purified water 25mg------------------------------?
Ethanol (90%) to 1000ml----------------------------?
Send 50ml
Compounding: dissolve the potassium iodide and the iodide in the purified water and add
sufficient ethanol (90%) to produce 1000ml.
Storage condition: should store in tight, light resistance containers protected from direct sun
light and excessive heat.
Actions and uses: antiseptic.
Iodine Solution (Lugols solution)
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Ingredients Master formula Reduced formula
Iodine 50g ?
Potassium iodide 100g ?
Water up to 1000ml ?
Send 100ml
Procedure
Potassium iodide and Iodine are dissolved in small portion of purified Water by stirring
& shaking till dissolve completely.
Syrups
Syrups are concentrated aqueous solutions of sucrose other sugars or sweetening agents
to which small quantities of suitable polyhydric alcohols may be added to retard
crystallization or to increase the solubility of the other ingredients
Syrups usually contain aromatic or other flavoring materials.
Practical
Sucrose 850g
Purified water to 1000ml
Send 50ml
Methods of preparation
a. Hot process: place the sucrose in dish, add the water and dissolve the
sucrose by heating on a water bath stirring continuously. When
dissolution of the sucrose is complete allow the solution formed to
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cool and add sufficient boiling purified water to make up for that lost
by evaporation. Then strain the syrup while still warm to make up for
that lost by evaporation. Then strain the syrup while still warm
though a fine muslin supported in a funnel in to a bottle which is
capable of nearly filling and shake the bottle occasionally until the
content is quite coil.
b. Cold process: place the sucrose in a suitable percolator, the neck of
which is nearly filled with loosely packed cotton moistened after
packing with a few drops of water. Pour carefully about 450ml of
purified water upon the sucrose and regulate the outflow to a steady
drip of percolate. Return the percolate if necessary until all the
sucrose has dissolved. Then wash the inside and the cotton with
sufficient purified water to bring the volume of the percolate to 100
ml and mix.
c. Alternatively the sucrose may be dissolved more rapidly in the proper
amount of water by agitation in a graduated bottle.
N.B syrup made without heat is practically colorless while syrups made
with heat have pale amber color due to the laevulose formed as a result
of hydrolysis of sucrose.
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Sucrose 825g ?
Purified water to 1000ml ?
Ft. syrup send 50ml
Compounding: dissolve the ferrous sulfide water and filter the solution until clear filtrate
and add purified water to make 1000 ml mix and filter if necessary through a placed get of
cotton.
Elixir:
Are clear flavored oral liquid containing one or more active ingredient dissolved in vehicles.
That usually contains a high proportion of sucrose or a suitable polyhydric alcohol or
alcohols (glycerol’s, propylene glycol) and May also contains ethanol. Elixirs generally owe
their pleasant flavor to the presence of sugar and the volatile flavoring agents. However the
sugar contents of elixirs is lower than that of syrups.
In general elixirs are reasonable stable preparations provided they are stored in well filled
containers and are not diluted or mixed with other preparations.
Practical
Phenobarbitone elixir
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1. Phenobarbitone………………………04g--------------------- ?
4. Glycerol ………………………………..40ml-------------------- ?
Linctuses: - are viscous oral liquids that may contain one or more active ingredients in solution.
The vehicle usually contains a large amount of sucrose other sugars or suitable poly hydric
alcohols or alcohols. Linctuses are intended for use in the treatment or relief of cough being
sipped and swallowed slowly without the addition of waters.
Send 40ml
Action and use: - demulcent in the treatment of cough to be sipped swallowed slowly undiluted.
2. Mouth washes
3. Throat spray
1. Gargles: - are aqueous solution intended for use in the prevention and or treatment of throat
infection by forcing air from in the lung through the gargles which is hard in the throat.
Gargles usually contains a bactericide eg phenol or thymol and are dispensed and are
dispensed in concentrated forms with direction for dilution with warm water before use.
2. Mouth washes: - are aqueous preparations used to clean and deodoralize the
buccal cavity for the purpose of oral hygiene and to treat infections of the mouth.
Mouth washes are particularly refreshing to bed ridden patient like gargles they are usually used
after dilution with warm water and direction for diluting the mouth washes should be given on
the labels of these preparations.
Eg: compound sodium chloride mouth washes.
Ingredient master formula reduced formula
1. Sodium bicarbonate ………………………10g_______________?
2. Sodium chloride ……………………………_ 15g_____________?
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3. Concentrated peppermint emulsion … …...25ml____________?
4. Double strength chloroform water…………500ml____________?
5. Water to …………………………………………1000ml____________?
Mitt 50ml
Sig dilute with an equal volume of warm water before use.
Compounding: - dissolve the sodium bicarbonate and the sodium chloride in portion of the
water Add the concentrated peppermints emulsion and the double strength chloroform water
finally adjust to final volume with water
3. Throat paints: - are liquid preparations used for mouth and throat infection by
applying to the mucus surfaces. They are usually medicated with substance possessing
antiseptic, astringent, caustic or analgesic properties.
They are usually viscous (so wide mouthed container should be used). Throat paints are applied
by means of throat brush.
Compounding:
Put the water into a 50ml conical measure. Dissolve the potassium iodide (it dissolves very
readily in water and need not be powdered). Add the iodine and stir until complete dissolved.
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Although iodine is only slightly soluble n water it is readily soluble in aqueous solution of
iodine. In a small measure dissolve the peppermint oil in the alcohol and transfer it to the iodine
solution and mix well. Make up to the volume with glycerol and mix toughly. If the iodine
solution is not well. Mixed with the glycerol the preparation is streaky.
Note: because of the high viscosity of the vehicle this preparation is best made entirely in a
measure. For the same reason an excess should be prepared since it is impossible to transfer the
entire contents of the measure to a bottle. A glass or a counterbalanced watch glass and a
vulcanite spatula must be used for weighing the iodine
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Labeling: - for external use only
Suspension
Dispersed system = dispersed phase + dispersing phase.
The particles of the dispersed phase re usually solid material that is insoluble in the dispersion
media.
Flocculated and non flocculated suspensions
The suspension are said to be flocculated when the individual particles are in contact
with each other and from a net work like structures.
Non- flocculated when the individual particles exist as a separate entity.
Flocculated suspensions
1. Particles form loosely aggregates and form a net work like structures.
2. The rate of sedimentation is high.
3. Sedimentation is rapidly formed.
4. Sedimentation is easy to redisperse.
5. Sediment is loosely packed and does not form a hard cake.
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6. Supernatant liquid is clear.
7. The flocculate sticks to the sides of the bottle.
8. Suspension is not pleasing in appearance.
Non – flocculated suspension
1. Particles exist as separate entity.
2. The rate of sedimentation is low.
3. Sedimentation is slowly formed.
4. Sediment is difficult to redisperse.
5. Sediment is very closely packed and a hard cake is formed.
6. Supernatant liquid is not clear.
7. The flocculate does not stick to the sides of the bottles.
8. Suspension is glassing in appearance.
Reasons for suspensions.
1. Certain drugs are chemically unstable when in solution but stable in suspension.
2. Easy of swallowing.
3. Flexibility of administration.
4. Easy of incorporation flavoring and sweetening agent.
Properties of ideal suspension.
1. It should settle slowly and should be readily re – dispersed on gentle shaking of the
container.
2. The suspension should pour readily and evenly from its container.
3. It should be chemically inert.
4. The suspended particle should not form a cake.
5. It should be free from large particles which spoil its appearance.
6. It should be free from gritty taste.
7. It should not cause irritation.
Ingredients which may be added to suspension.
1. Flocculating agents:-in suspension the solid particles are well dispersed in dispersion
medium ie. Vehicle. The dispersion can be improved by adding a surfactant which act as a
flocculating agent. The flocculating agents acts by reducing the surface tension and thereby
improving the dispersion of solid and minimize flocculation. Eg – sodium lauryl sulphate
_ tweens, spans, carbowaxes
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2. Thickening agents: - these are hydrophilic colloids which form colloidal dispersion with
water and increase the viscosity of continuous phase. So that the solid particle remain
suspended in it for sufficient long time to measure a uniform accurate dose. Eg acacia,
tragacanth, starch, sodium alginate, methyl cellulose, sodium carboxy methyl cellulose, clay,
aluminum hydroxide.
3. Wetting agents: - these are substance which reduce the interfacial tension b/n the solid
particles and the liquid medium. Thus producing a suspension of required quality. The
excessive use of wetting agent may cause foaming or may give bad tastes or odors to the
suspension. Eg alcohol in tragacanth mucilage, glycerin in sodium alginate, polysorbate in
oral and parentral suspensions.
4. Preservatives:- preservative selected should be effective against a wide range of micro
organisms. Eg benzoic acid, sodium benzoate, methyl paraben, propyl praben.
5. Organoleptic additive:- coloring agent, sweetening agents and flavoring agents are
generally incorporated in oral suspension. Suitable perfumes and color is incorporated in
suspension which is meant for external use.
General methods of preparation of suspension
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12. Make up to volume with the vehicle and shake thoroughly
The drug particles (dispersed phase) is suspension could be
o Diffusible solids
o In diffusible solids or
o Poorly wet table solids
Methods of dispensing suspension.
The suspensions are divided in to four (4) types according to its methods of dispensing.
There are certain insoluble powders substances which are light in weight and readily mix with
waters and remain suspended throughout the liquid for sufficient long time after shaking. Such
substances are known as diffusible solids. No needs of adding thickening agent.
Eg – calcium carbonate.
- Mg carbonate.
- Rhubarb powder.
- Light kaolin.
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Compounding: first tare the final container because if the syrup and a little of the chloroform
water. Add the amaranth solution and mix well.
If the dye is added at a later stage in the preparation it will not penetrate in to the powder and
white specks will be visible in the final product. Dilute the suspension until pourable and while
specks will be visible in the final product. Dilute the suspension until pourable and transfer to
the bottle. Although it is advisable to add volatile ingredients such as chloroform water before
making up to volume with water Add the benzoic acid solution to the bottle and make up to
volume and shake thoroughly.
Storage and shelf life: unless the kaolin has been sterilized the preparation should be recently
prepared.
Container: amber medicine bottle.
Advice for patients when dispensed: shake the bottle.
Maintain fluid intake in diarrhea. If the product is counter prescribed the patient should seek
medical advice if the condition persists.
Actions and uses: anti diarrhea mixture for children.
Ingredient Master formula Scaled quantities
Magnesium sulfate 400 g
light magnesium carbonate 50g
Concentrated peppermint emulsion 25g
Double strength chloroform water 300ml
Water FBC sufficient to produce 1000ml
Mitt 50ml
Sig. 10 ml t.i.d. shake the bottle before use
Magnesium sulfate mixture BP.88 (magnesium sulfate oral suspension)
Compounding: first tare the final container and select a mortar of sufficient size to
allow for adequate mixing of the product. Mix the magnesium sulfate and light magnesium
carbonate in the mortar. This method is to be preferred to making a separate solution of the
magnesium sulfated which is time consuming. Add enough vehicle to make a smooth paste and
dilute with the vehicle unit sufficiently pour able to transfer to the bottle. The volatile peppermint
emulsion should be added to the bottle before making up to final volume.
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The mixture may also be prepared from a pre packed mix of the two powder ingredients with the
addition of the appropriate amount of peppermint emulsion and chloroform water.
Method of dispensing.
1. Finely powder ali the ingredients.
2. Mix then together in a mortar and add compound tragacanth powders.
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3. Measure ¾ of the vehicles and triturate to form a smooth cream.
4. Examine the suspension carefully and if it contains any foreign particles. Strains through the
muslin piece into a tarred bottle.
5. Rinse the mortars with small quantity of vehicle to clean it. Transfer rinsing to the bottle.
6. Add any liquid ingredient.
7. Add more of the vehicles to produce the required volume.
Procedure:
1. Dissolve Sodium Citrate in 35ml Purified Water
2. Weigh Calamine, Zinc Oxide and Bentonite & triturate it with Sodium. Citrate solution.
3. Add Liquid phenol, the Glycerin and sufficient quantity of water to make up the required
volume.
4. Write Label
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Zinc oxide 80g
Bentonite 20g
Glycerin 20ml
Liquefied phenol 10ml
Calcium hydroxide solution to 1000ml
Mitt. 50ml
Strong and shelf life: the preparation is stable cool storage is advised because of the
volatile preservative.
Advice for patients when dispensed: shake the bottle for external use only. The
lotion is applied to the skin as required and allowed to dry. Action and uses: cooling lotion
They contain resinous matter and when it is mixed with water. It leads to precipitation of resin
and may stick to the sides of the bottle which will be difficult to rediffuse by shaking.
To prevent this protective colloid is dispersed in the vehicle before tincture is added.
Tragacanth mucilage (1/4th of the total volume) is commonly used as protective colloid. Needs
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4. Suspension produced by chemical reaction.
In this type of preparation of suspensions the highly diluted solutions or reactants are mixed
together so as to form very finely divided precipitates that can be easily distributed
throughout the liquid by shaking. The precipitates so formed are diffusible in nature. Hence
Emulsion
Are biphasic liquid dosage forms of medicament in which two immiscible are made miscible
by addition of a third substance known as emulsifying agent.
Also defined as mixtures of two immiscible liquids in which one liquid is dispersed as
minute’s globules in to the others.
The liquid that is broken up into the liquids is called dispersed phase or internal phase and
the liquid in which the globules are dispersed is known as continuous phase or dispersion
medium (external phase).
Types of emulsions: - the emulsions are of two types.
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Tastes for identification of types of emulsion.
The quantities of oil, gum and water required for primary emulsion
are as follows.
Portion of oil : water : gum
Fixed oils 4 : 2 : 1
Volatile oils 2 : 2 : 1
The most common used fixed oil includes caster oils, cod liver oils, olive oils and liquid
paraffin(minerals oil)
The most common volatile oils include turpentine oils, cinnamon oil and peppermint oil.
- Practical 1
Castor oil emulsions (o/w)
Ingredient Master Formula reduced formula
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a dry mortar. To this add the calculated quantity of acacia and triturate rapidly so as to
mix them. To this incorporate water required for primary emulsion and triturate rapidly
till clicking sound is produced and the product become white or nearly white then add
more water to produce the required volume.
2. Wet gum methods:-wet gum method is a procedure to formulate this formulation 4: 2: 1
ratio of oil, water and gum acacia respectively will be used for preparation of primary
emulsion. Triturate 2g of gum acacia and 4ml of water in mortar and to form mucilage.
8ml of caster oil will gradually add with simultaneous mixing. Add about 10ml of more
vehicle small quantities at a time with constant triturating so as to get homogenous
product. Add more vehicles to produce the desired volume.
i. Bottles method (volatile methods)
In this method is generally used for volatile oil as volatile oils are less viscous therefore they
require greater amount of gum acacia for their emulsion. (4 : 4 : 2) or 2 : 2 : 1
Procedures: - put the oil in the bottle adds gum acacia to it bottles is shaken vigorously for
some time.
Add calculated amount of water all at once mixture is shaken vigorously to form a primary
emulsion.
Add more of water with constant agitation to produce the required volume.
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2. Semi solid dosage forms
Are mainly meant for external application e.g. ointments, creams,
jelly, paste and suppository.
OINTEMENTS
Ointments are semisolid preparations intended for external application to the skin or mucous
membranes. E.g. the rectum, vaginal, eyes
Ointments may be medicated or none typically medicated ointments are used for the treatment of
infection, inflammation and pruritus.
None medicated ointment is used for physical effect that they provide as protecting, emollients
or lubricating properties.
Ointment bases may be used for their physical effects or as vehicles in the preparation of
medicated ointments.
Advantages of ointments
Easily spread on skin, being retained at the site of application as an occlusive layer thereby
preventing moisture loss from the skin.
Are persists at the site of application.
Disadvantages of ointments
Pharmaceutically ointments are generally greasy and are difficult to remove and are therefore
cosmetically unacceptable.
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Similarly liniments and lotions may also be cosmetically unacceptable to the patient and difficult
to use.
Pastes are generally applied as a thick layer at the required site and are therefore considered to be
cosmetically unacceptable.
Staining of clothes is often associated with the use of pharmaceutical pastes and ointments.
Pharmaceutically ointments may not be applied to exuding sites this does not hold for pastes.
Liniments may not be applied to broken skin.
Properties
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A. Hydrocarbon bases are hydrophobic and those immiscible with water.
- Rubbing in to the surface and removal after treatment is difficult.
B. They are not absorbed from the skin and they remain on the surface as an occlusive layer
that
1. Restrict loss of moisture and therefore keep the skin soft but may lead to water
logging with consequent maceration of the skin.
2. Retain body heat which may produce uncomfortable feeling of warmth. They are
mainly used for their protective and emollient effect or when superficial medication is
adequate.
C. They are sticky
Ensures prolonged contact b/n the skin and medicament but makes application unpleasant
and leads to other contamination.
D. Their constituents are readily available and cheap.
E.G. includes
I. soft paraffin for epidermal ointments
II. Hard paraffin’s to harden or soften the ointment base
III. Liquid paraffin’s to get a desired consistency of the ointment and to levigate the
substances.
A. Soft paraffin’s/petrolatum
Is a purified mixtures of semisolid hydrocarbons obtained from petrolatum.
There are two varieties of soft paraffin’s yellow and white soft paraffin’s
Yellow soft paraffin’s
Is a pale yellow translucent soft mass free or almost free from odor and taste?
Has melting point of 38 – 560c
Used when medicament is white or colorless.
Both yellow and white soft paraffin
Have no noticeable action on the skin and are not absorbed
Are suitable for epidermal types of preparation
Because of hydrophobic nature aqueous liquids cannot be mixed with soft paraffin but wool fat
and waxes are included to incorporate aqueous and liquids in it.
B. Hard paraffin
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Is a purified mixture of solid hydrocarbons obtained by distillation from petrolatum or shale
oils?
Is a colorless or white translucent odorless, tasteless mass and is used to harden or stiffen the
ointment base. Its melting point is b/n 47 and 650c and when solid it is used to enhance the
rheological properties of ointment bases (to harden and stiffen the ointment bases).
C. Liquid paraffin
- Also known as liquid petrolatum or white mineral oils
- Consists of liquid hydrocarbon and may be obtained from petrolatum by distillation.
- Varies in composition according to the source of petrolatum. Is colorless, transparent,
tasteless and odorless oily liquid.
- Is insoluble in water but soluble in organic solvent like chloroform. Is used along with hard
paraffin and soft paraffin to get a desired consistency of the ointment.
E. ABSORPTION BASES
The term is used to denote the hydrophilic character of the bases.
Unlike the hydrocarbon bases they are hydrophilic.
Can absorb considerable amount of water or aqueous solutions but they are immiscible with
large amount of water.
Are difficult to wash of from the skin.
Unlike hydrocarbon bases, absorption base may be formulated to contain significant amounts
of aqueous phase. These may be either non – aqueous formulations to which an aqueous
phase may be added to produce water in oil emulsion (termed none emulsified bases) or
water in oil emulsions that can facilitate the incorporation of an aqueous phase (with out
phase inversion or cracking).
The key properties of both none emulsified bases and water in oil emulsions that are relevant
to the formulations of ointment is detailed below.
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Typically none emulsified base are commonly composed of (1) one or more paraffin’s. And
(2) a sterol based emulsifying agent.
E.G. of emulsifying agent used in absorption bases include:-
Lanoline (wool fat), lanoline alcohols (wool alcohols), bees wax (white or yellow),
hydrous wool fat and cholesterol.
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Is purified fat like substances obtained from wool sheep?
Is yellow wish white ointment like mass with a characteristics odor?
Is insoluble in water but soluble in ether and chloroform.
Is a mixture of 70% w/w wool fat and purified waters.
Is a w/o type emulsion.
Aqueous liquid can be emulsified with it.
Used as emollient alone.
B. Wool alcohol.
Is obtained from wool fat by treating it with alkali and separating the fraction containing
cholesterol and other alcohols.
Contain not less than 30% of cholesterol.
Used as emulsifying agent for the preparations of w/o emulsion and used to absorb water in
ointment bases.
Also used to improve the texture, stability and emollient property of the o/w emulsions.
C. Bees wax
Is obtained from honey comb of bees it is of two types.
a. Yellow bees wax
b. White bees wax obtained by bleaching and purifying the yellow bees wax.
Used to as stiffening agents in pastes, ointment and other preparation.
D. Cholesterol
Is widely distributed in animal in animal organisms.
Wool fat is also used as source of cholesterol
Used to increase the incorporation of substances in oils and fats.
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It incorporated into paraffin’s and oils to produce a base that can incorporate the
subsequent addition of an aqueous phase.
The water contents of base that have been formulated using hydrous lanolin are
significant.
E.g. Oily cream BP is water in oil emulsion ointment base that is composed of wool
alcohols (50%w/w) and water (50%w/w).
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- are emollient, occlusive, contain water, some absorbs additional water and greasy.
- E.G. hydrous wool fat, cod cream.
Some additional amount of water can be incorporated in both types of o/w or w/o bases and still
retain soft cream like consistency.
Advantage of PEG
Water solubility
Good solvent properties
Freedom from greasiness
Disadvantage of PEG
Limited up take of water
Less blend/ not inert/ paraffin waxes.
Reduce the activity of a number of anti microbial substances.
Preparation of ointment
The formulation of ointments involves the dispersal or dissolution of the selected therapeutic
agent into an ointment base and there fore in addition to the physical properties of the
dispersed/dissolved drugs the physicochemical properties of ointment bases are fundamental to
the clinical and none clinical performance of this types of dosage form.
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On small scale pharmacist mix the components by using the following materials.
7. Mixing by fusion
All or some of the components of ointments are combined by being melted together and cooled
with Constance stirring until congealed.
Components not melted are added to the congealing mixtures as it is being cooled and stirred.
Naturally heat labile substances and any volatile components are added last when the
temperature of the mixture is low enough not be cause decomposition or volatilization of the
components.
On small scale the fusion process may be conducted in a porcelain dish or glass beaker.
Fusion is necessary when waxes, hard paraffin, fatty alcohols, fatty acids or any hard wax- like
material is included in the formula.
By this process the materials with the highest melting points are heated to the lowest requires
required temperature to produce a melt.
8. Packaging
Ointments are dispensed in either ointment or collapsible tube. However ointments prepared
extemporaneously are usually packed in ointment jar.
The ointment should be packed and the top surface should be smoothed neatly.
Ointments jars should be closed tightly when not in use particularly if the ointment consisting
water to prevent loss though operation.
9. Storage
Ointments should be stored in a cool place to prevent softening and eventually liquefiable in the
base
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Insoluble medicament may settle to the bottom of the container if the ointment is permit to
liquefy.
Excessive heat or cold may cause an emulsion base to separate into two phases.
Practical
Calamine ointments
Ingredients Master formula R.F
1. Calamine finely sifted ……….. 15gm__________________?
2. White soft paraffin ………………85gm_________________?
Procedures
Pass the calamine through a very fine sieve to get a fine powder. Triturate the calamine with a
portion of white soft paraffin on an ointment slab with ointment spatula. Until smooth gradually
add the remainder of remainder of white soft paraffin with a continuous triturating until a
uniform ointment is obtained.
Pack the ointment in wide mouth container jar, labeled dispense the container must be labeled
with direction for external use only.
Uses calamine has amild astringentaction on the skin and is used in ointments for relief
discomfort of dermatitis.
Formulation:
Simple ointment is an absorption base prepared by fusion.
Yellow or white soft paraffin is chosen according to the color of the finished product.
In this case there is no dark colored ingredient to be added.
White soft paraffin should be used.
Compounding:
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Melt hard paraffin and Cetostearyl alcohol on water bath to this incorporate wool fat and white
soft paraffin. Stir until all ingredients are melted.
Examine the content for foreign particles.
Stir gently to aid melting and to mix the ingredients. When homogenous, remove from the beat
and continue to stir gently until cold.
NB. Weigh the wool fat and the soft paraffin using waxed papers to allow full recovery of the
materials.
Storage: store in cool places
Action and use: ointment base.
Procedures
Melt emulsifying wax to this incorporate liquid paraffin and white soft paraffin stir until
homogeneous.
Allow to cool slowly with continuous stirring till a uniform mass is obtained pack in wide mouth
container and label.
Uses it forms oil in water emulsions and is used as water soluble ointment base.
a. Whitfield’s Ointment
Ingredients Master formula Reduced formula
1. Benzoic acid, in fine powder 60 g ________________________?
2. Salicylic Acid, in fine powder 30g__________________________?
3. Emulsifying ointment 910 g ________________________?
Send 20gm
Compounding:
Sift the medicament through separate 180µm sieves. Note that salicylic acid very irritant to the
respiratory tract and precautions should be taking to avoid inhalation. Weigh the powders after
sifting and mix them. Then place them on an ointment tile and levigate with two or three times
their weight of the base until homogenous. Gradually incorporate the reaming base.
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Storage shelf life: store in a cool place.
Container: wide – mouthed amber jar with a greaseproof paper disc.
Advice for patients when dispensed: the ointment should be applied sparingly to the affected
area. Is should not be applied to the broken or inflamed skin.
Actions and uses: topical anti fungal preparation
a. Sulfur ointment BP
Ingredients Master formula reduced formula
1. Precipitated sulphur, finely sifted 100g ___________________?
2. Simple ointment 900g ____________________?
Send 25 g
Compounding:
weigh out the amount of precipitate sulphur required and place it on the center ointment tile,
weigh the required amount of simple ointment (using a piece of waxed paper) and place it on
side of the tile Take a portion of the base (about two to three times the weight of the powder) and
levigate it with the sulphur until there is no sign of any gritty particles (this can checked for by
spreading a thin layer on the tile). Gradually incorporate the reaming base in geometrically and
continue levigation until uniformly mixed. Finally, collect the ointment to gather the center of
the tile using the spatula and pack into an ointment jar.
Storage and shelf life: store in a cool place .An expire date of 4 weeks is appropriate. For
external use only.
Container: wide – mounted amber jar with a grease proof paper disc
Advice for patient when dispensed: the skin should be cleansed prior to application and
ointment applied sparingly to the affected area.
Action and uses: mild antiseptic used in the treatment of fungicidal ointment.
Methyl salicylate ointment BP 1988
Ingredient master formula reduced formula
1. Methyl salicylate ……………………50gm________________________?
2. Hard paraffin…………………………25gm________________________?
3. Hydrous wool fat…………………… 25gm________________________?
Make an ointment send 25gm
Procedures
Melt hard paraffin and hydrous wool fat over water bath cool, add methyl salicylate and stir
continuously until a uniform mass is formed transfer to a suitable container label and dispense.
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Use it is used in sciatica and rheumatic pains.
Pastes
Are ointment-like preparations intended for external application to the skin?
They do not melt at ordinary temperature and this form protective coating over the area where
they are applied.
They are stiff and thick, less greasy and 60% solid ingredients such as zinc oxide, starch, calcium
carbonate.
They form porous in nature helps in perspiration can easily escape.
Do not apply on hair part of the body b/c they are difficult to remove and other dressings.
Most paste differ from ointments in containing large amounts of finely powdered solids, thus
they are usually stiffer than ointments, less greasy and more absorptive.
They are applied generously, either with a spatula or spread on lint or other dressing and are not
removed for long periods.
Storages of pastes
The pastes should be placed in well closed container and in cool place so as to prevent
evaporation of moisture present in the pastes.
For all practical purposes, pastes are prepared in the same manner as ointments
Pastes are generally packed in glass ointment jars. They are often too viscous for easy extrusion
from tubes.
Practical
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Zinc oxide paste. U.S.P
Ingredients master formula R.F
1. Zinc oxide, finely sifted 25gm__________________?
2. Starch, finely sifted 25gm__________________?
3. White petrolatum 50gm__________________?
Send 25gm
Type:-paste with semisolid base prepared by fusion and triturating method
Compounding: Separately pass the zinc oxide and starch through sieve no 120; melt the
white soft paraffin on water bath mix the required weight of a powders in warm mortars.
Add small amount of melted base and mix until cold and uniform pastes is obtained pack in
ointment jar label and dispense.
NB. The paste is much easier to manipulate in a warm mortar
Storage: store in a cool place
Container: wide – mouthed amber jar with grease proof paper disc.
Advice for patient when dispensed: the paste should be spread thickly on white lint and applied
to the affected area.
Actions and uses: it is used as an antiseptic paste.
Procedures
Pass separately the resorcinol, precipitated sulphur and zinc oxide through sieve no 120 and
mix the weighed quantity of the substances with a portion of emulsifying ointment until
smooth. Gradually add the remainder of the emulsifying ointment with through triturating
until smooth.
Pack in suitable container, label and dispense.
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Action and use: - it is used in the treatment of acne and other chronic skin disease.
Procedures
Melt the white soft paraffin on water bath incorporate the starch, zinc oxide and salicylic acid
which has been previously sifted through sieve no 120 stir until cold and homogeneous paste is
obtained , pack label and dispense.
Action and use: - it is used as antifungal paste.
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