LO3:Manufacture/

compound products

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 Formulation of dosage forms
 Dosage forms are the means by which drug molecules are delivered
to sites of action within the body.
Types of dosage forms
 Base on the physical nature of the products dosage forms are
classified into four groups
1.Liquid dosage forms: - solution, suspension and emulsions.
2.Semi –solid dosage forms: - ointments, pastes, creams, jellies.
3.Solid dosage forms: - powders, granules capsules, tablets,
suppositories
4.Gases:-aerosols
Formulation of liquid dosage forms
1. 1. Solutions-are homogenous liquid preparation containing one or
more dissolved ingredients and are used for a variety of purposes as
both internal and external dosage forms.
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 Solutions…
 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.

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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.
 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).

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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 Spirits…
 Most spirits are prepared by simple solution in alcohol although some
can be prepared by distillation, maceration and chemical rxn
methods.
 In preparing spirits it must kept in mind that the oils dissolved in
alcohols are precipitated causing turbidity when the solution are
mixed with water. In order to avoid this turbidity water except as
specified in the formula should be avoided.
 Graduated and other equipments used should be thoroughly dry, filter
paper should be moistened with alcohol.
 Storage: spirit should keep in well closed containers and stored at
temperature not exceeding 250c good storage condition prevent
evaporation and volatilities of either the alcohol or active principles.
 Action and uses: the spirit is an effective carminative.
 Also, mixed with other drugs or preparation, it may be used as a
flavor

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 A. Solution taken orally
Elixirs -is a liquid oral preparation that usually contains either potent or unpleasant-
tasting drugs.
 The formulation is clear and generally contains a high proportion of sugar or
other sweetening agent included to mask offensive or nauseating tastes.
 Paediatric elixirs are usually formulated with a fruit syrup as a base flavouring
agent.
 In general, non-aqueous solvents (alcohol, glycerin or propylene glycol) form a
significant proportion of the vehicle used in elixirs, or alternatively solubilising
agents are included.
Preparations of elixirs: prepared by simple solution with agitation and or by the
admixture of two or more ingredients. Alcohol soluble and water soluble
components are generally dissolved separately in alcohol and purified water
respectively. Then the aqueous solution is added to the alcoholic solution rather
than the reverse in order to maintain the highest possible alcoholic strength at all
times so that minimal separation of the alcoholic soluble components occurs. When
the two solutions are completely mixed the mixture is made to volume with the
specified solvent or vehicles.
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 Elixirs…
Practical example
Phenobarbitone elixir
• Ingredient master formula Rduced form

• Phenobarbitone………………………04g--------------------- ?
• Ethanol (90) ………………………….40ml-------------------- ?
• Compound organic spirit ………….2.5ml------------------- ?
• Glycerol ………………………………..40ml-------------------- ?
• Amaranth solution ………………….1ml---------------------- ?
• Purified water to …………………….1000ml------------------ ?
• Ft elixir send 50ml
• Sig 2 tsp.h.s store in dark place.
• Compounding: dissolve the Phenobarbitone in the ethanol (90) and
add the compound orange spirit before adding the glycerol. The
amaranth solution and water to volume.
• Action
06/10/2025 and use: anti convulsant
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 Linctuses
 A linctus is viscous a liquid oral preparation contain sugars chiefly used for a demulcent,
expectorant or sedative purpose, principally in the treatment of cough.
 As such, a linctus is intended to be sipped slowly and allowed to trickle down the throat
in an undiluted form. Consequently, linctuses are formulated as viscous solutions which
Example, Simple linctuses B.P
•Ingredients Master formula reduced formula
1. Concentrated anise water………………10ml----------------------------?
2. Amaranth solution 1% …………………15ml----------------------------?
3. Citric acid monohydrate ……………… 25g------------------------------?
4. Chloroform spirit …………………………60ml---------------------------?
5. Syrup to ……………………………………1000ml-------------------------?
• Send 40ml

 Compounding:-the citric acid should be dissolved in the chloroform spirit concentrated

anise water and amaranth solution before adding the syrups to volume.

•Action and use: - demulcent in the treatment of cough to be sipped swallowed slowly
undiluted.
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 Tinctures
• Tinctures are alcoholic or hydro alcoholic solution of principles extracted from
natural sources or of pure chemical merely dissolved in these solvent systems.
• 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.
• Example 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
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 Oral solutions….
Iodine Solution (Lugols solution)

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.

Sufficient Water is added to make the required volume

Actions and Use: -Goiter

Syrups
 Syrups are concentrated aqueous solutions of sucrose or other sugars 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.

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 Syrups….
Practical

Simple syrup, USP

Ingredient Master Formula Reduced Formula

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 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.

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 Syrup…
a. 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.
b. 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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 Ferrous sulfate syrup USP
Ingredients Master formula Reduced formula

Ferrous sulfate 40g ?

Citric acid hydrous 2.1g ?

Peppermint spirit 2ml ?

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.

Actions and uses: Heamatnic/Anemia.

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 2- Solution used for mouth and throat:

Gargles

Mouth washes

Throat spray

Throat paints (mandls paints)

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.
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 Example, phenol gargles (carbolic acid gargles)

• Ingredient. Master formula reduced formula Phenol

glycerin ………………………50ml---------------------------------?
Amaranth solution …………………10ml-----------------------------------?
Water to ………………………………1000ml---------------------------------?
Mitt 50ml
Sig dilute with one equal volume of warm water before use note to be swallowed in large amount.
 Compounding: - mix the phenol glycerin and the amaranth solution with portion of the water.
Agitate and add water to final volume.
•Action and use: - antibacterial and anesthetic.

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
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labels of these preparations.
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 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.

Example,Compound iodine paint (mand’l paint)

Ingredient Master formula Reduced formula
Potassium Iodide 25.0g
Iodine 12.5g
Alcohol 90% 40.01ml
Water 25.0ml
Peppermint Oil 4.0ml
Glycerol to 1000ml
Mitt. 40 ml.
Sig store in cool place. Shake the bottle before use.
Not to be swallowed in large quantities.
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 Throat paints …
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. Although iodine is only slightly soluble in 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 miixed with the glycerol the
preparation is treaky.

•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

•Actions and used: Antiseptic in the treatment of pharyngitis and tonstillis

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 3. Solutions installed into body cavity
Douches Eye drops
Enema Nasal drops
Ear drops Nasal sprays
Douches: are aqueous solutions used for rinsing a body cavity and function as cleaning agent. e.g isotonic
sodium chloride solution, Antiseptic eg mercury chloride (0.001%), (0.02%) potassium permanganate
(0.025%), lactic acid (0.5 to 2%) Or astringent egalun (1%)

 The word douches in most often used vaginal solutions but it is sometimes applied to solution for the
bladder (usually called irrigations) or the rectum (usually called enemas).

 Douches usually are directed to the appropriate body part by using bulb syringes.

 Douches are often supplied as liquid concentrated or powders to be diluted or dissolved in the appropriate
amount of warm water to the correct the strength and suitable volume (usually 1-2 litters) prior to use,
however tablets for preparing solutions are also available.

 If powders or tablets are supplied they must be free from insoluble materials in order to produce a clear
solution.

 Tablets are produced by usually processes but any lubricants or diluents used must be readily soluble in
water.

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 Solutions installed into body cavity…
 Boric acid may be used as lubricants and sodium chloride normally is used
as a diluents.
 Tablets deteriorate on exposure to moist air and should be stored in air tight
containers.
•Container: - douches are supplied in narrow mouthed, colored, fluted bottles.
•Labeling: - for external use only
4. Solution applied to body surfaces/applied on the skin.

• Collodions

• Paints

• Liniments
• Lotions and

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 4. Solution applied to body surfaces/applied on the skin…

Collodions-These are principally solutions of pyroxylin in a vehicle of ether

and alcohol that are intended to be painted onto the skin and left to dry.
 When dry, the collodion leaves a flexible film of cellulose on the skin
which may be used to seal minor injuries or retain a dissolved drug in
contact with the skin for an extended period.
 Collodions are highly volatile and highly flammable and care should be
taken to label any preparation appropriately.
Paints-
Liniment- is a liquid preparation intended to be rubbed with friction and
massaged onto the skin to obtain analgesic, rubefacient or generally
stimulating effects.
 Liniments should not be used on broken skin.
 They are usually solutions of oils, alcohols or soaps, but may be
formulated as emulsions.
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 Lotions
 Lotions are solutions, but may also be suspensions or emulsions, that
are intended to be applied to the skin without friction on a carrier
fabric such as lint and covered with a waterproof dressing.
 In some cases lotions are applied to the scalp, where the vehicle for
the medication is alcohol based, allowing for rapid drying of the hair
and thus making the product more acceptable to the patient (e.g.
Salicylic Acid Lotion 2%).

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