MANUFACTURE OF BIPHASIC LIQUID

DOSAGE FORMS -
EMULSIONS AND SUSPENSIONS

IV Pharm D
Hospital Pharmacy
EMULSIONS
 DEFINITION
 An emulsion is a biphasic liquid preparation containing two immiscible
liquids, one of which is dispersed as minute globules into the other.
 The liquid which is converted into minute globules is called the
‘dispersed phase’ and the liquid in which in which the globules are
dispersed is called the ‘continuous phase’
 An emulsifying agent is used to disperse the globules in continuous
phase. It forms a film around the globules so that they are scattered in the
continuous phase and makes a stable emulsion.
 The globule size in emulsion varies from 0.25 to 25 µm in diameter.

 Emulsions having large globules: coarse emulsions

 Emulsions having globules of diameter < 5 µm : fine emulsions

 Emulsions having globules of diameter ≤ 10 nm : micro emulsions.

 ADVANTAGES
 Medicines having unpleasant odour and taste can be made palatable
for oral administration in the form of an emulsion.
 Emulsion provides stability to drugs that are prone to oxidation and
hydrolysis.
 Emulsion improves the absorption of oils when taken internally.

 Emulsions are employed for TPN.

DISADVANTAGES
 Emulsions are thermodynamically unstable .

 Difficult and time consuming procedures involved in manufacture of

emulsions.
 TYPES OF EMULSIONS
(i) Oil in water type (o/w)
(ii) Water in oil type (w/o)

(i) Oil in water type emulsion:

 The oil is in the dispersed phase and water is in the continuous phase.
 It is preferred for internal use.
 In these emulsions, gum acacia, tragacanth, methyl cellulose, saponins,
monovalent soaps, etc. are used as the emulsifying agents.

(ii) Water in oil type emulsion:

 The water is in the dispersed phase and the oil is in continuous phase.
 The w/o emulsions are used for external preparations like creams,
lotions.
 Wool fat, resins, divalent soaps, beeswax, etc. are used as emulsifying
agent.
Tests for identification of type of emulsions

(1) Dilution test

(2) Dye test
(3) Conductivity test
(4) Fluorescence test

(1) Dilution test : The emulsion is diluted with water. If the emulsion
remains stable after its dilution, it is o/w emulsion. The w/o emulsion
remains stable, when oil is added to it.

(2) Dye test: Scarlet dye (oil soluble dye) is mixed with the emulsion.
Place a drop of emulsion on a microscopic slide, cover it with a cover
slip and examine under a microscope.
If the disperse globules appear red and the ground colourless, the
emulsion is o/w type and vice versa ( water soluble dye)
(3) Conductivity test: This is performed by dipping a pair of electrodes
connected through a low voltage bulb in the emulsion.

If the bulb glows on passing the electric current, the emulsion is o/w type as
water is in the continuous phase and is a good conductor of electricity.

If the bulb doesn't glow, then the emulsion is w/o type.

(4) Fluorescence test: Certain fixed oils possess fluorescence property in

the presence of UV radiation.

When observed under microscope in the presence of UV, the whole field
fluorescence indicates that the oil is present in continuous phase (w/o type)
and droplets fluorescence indicates oil is present in the dispersed phase
(o/w type).
 CLASSIFICATION OF EMULSIONS

Emulsion

Type of Mode of
emulsifying administration
agent used
Natural
gum Oral

Gum
substitute External
Soaps, use
Saponins
Parenteral
Starch

Natural
Rectal
waxes
Synthetic
waxes
 FORMULATION OF EMULSION
(A) Emulsifying agents
 Emulsifying agents reduce the interfacial tension between the oily phase
and aqueous phase and makes them miscible thus forming a stable
emulsion.
 To prepare a stable emulsion sometimes two or more emulsifying agents
are used.
 Based on HLB (Hydrophile Lipophile Balance) method, every emulgent
is given a number in HLB scale which is divided into 18 units.
 Emulgents with higher numbers (8-18) indicates hydrophilic properties
and produces o/w type emulsions.
 Eg: Acacia (8), Tragacanth (13.2), Sodium lauryl sulphate (40)
 Emulgents with lower numbers (3-6) represents lipophilic properties and
produces w/o type emulsions.
 Eg: Glyceryl monostearate (3.8), Sorbitol monostearate (4.7)
An ideal emulsifying agent should possess the following properties:

 It should reduce the interfacial tension between the two immiscible

liquids.

 It should be compatible with other ingredients of the preparation.

 It should be non-toxic.

 It should produce and maintain the required consistency of the

emulsion.

 It should be chemically stable.

 It should indefinitely distribute the globules of dispersion liquid

throughout the dispersion medium
CLASSIFICATION OF EMULSIFYING AGENTS
1.Natural sources
(a) Vegetable sources:
 These are carbohydrates which includes gums and mucilaginous
substances and produces o/w type emulsions.
 The emulsions prepared from these sources need preservative as
carbohydrate acts as a medium for bacterial growth.
Examples:
 Acacia: Emulsions prepared from gum acacia are attractive in
appearance, palatable and stable over a wide range of pH (2 to 10).
Emulsions have low viscosity and creaming occurs rapidly.
Gum acacia is used in the following ration for preparing emulsion from
various types of oils:
Name of the oil Oil Gum
Fixed oil 4 1
Volatile oil 2 1
Mineral oil 3 1
 Tragacanth: Tragacanth alone is rarely used an emulgent as it produces
thick and coarse emulsion.
The appearance and stability of emulsion is improved by passing it
through homogeniser.
A stable emulsion is also prepared by adding acacia to tragacanth.

 Agar: It not a good emulgent as it forms a very coarse and viscous

emulsion. It is used as a 2% mucilage in water.

 Pectin: It is used 1% mucilage in water.

 Starch: It is rarely used as it forms very coarse emulsions. It is generally

used to prepare enemas.

 Irish moss: It is used as thickening agent.

It is used along with acacia in the emulsification of cod liver oil and to
mask the unpleasant odour and taste of the oil.
(b) Animal sources:

 Wool fat: Used in emulsions for external use. It produces o/w type

emulsions and can absorb about 50% of water.

 Egg yolk: Used in extemporaneous preparations for internal use as it get

spoiled during transportation. Emulsions prepared from egg yolk

requires proper preservation and storage in refrigerator.

 Gelatin: Used in the concentration of 1%. It is mainly used for the

emulsification of liquid paraffin. Emulsion prepared from gelatin

requires preservation.
2. Semisynthetic polysaccharides:
 Methyl cellulose: It is a synthetic derivative of cellulose. It is widely
used as emulsifying, suspending and thickening agent in the
concentration of 2%.
 Sodium carboxymethyl cellulose: It is used as an emulsion stabilizer in
the concentration of 0.5 to 1.0%. It is soluble in both hot and cold water.

3. Synthetic emulsifying agents:

 Anionic: This includes alkali soaps, metallic soaps, sulphated alcohols
(sodium lauryl sulphate) and sulphonates. Soap emulsions are used for
external application.
 Cationic: This include benzalkonium chloride, benzethenium chloride,
cetrimide. They are mainly used in the preparation of emulsions for
external use.
 Non-ionic: Include glyceryl esters such as glyceryl monostearate,
sorbitan fatty acid such as sorbitan monopalmitate. Emulsions prepared
from them remain stable over a wide pH ranges.
4. Inorganic emulsifying agents
 Milk of magnesia (10-20%), magnesium oxide (5-10%) and magnesium
aluminium silicate (1%) used to prepare coarse o/w emulsions.
 Bentonite (5%) is used to prepare both o/w and w/o emulsions.

5. Alcohols:
 Carbowaxes: Mainly used in the preparation of creams and ointments.
Depending upon the molecular weight, it is used for maintaining desired
consistency in other preparations.
 Cholesterol: Includes cetyl alcohol, stearyl alcohol, cholesterol and
glyceryl monostearate. They are only used with other emulgents.
 Lecithins: It forms w/o emulsion. It is rarely used as it darkens when
exposed to the light and so the emulsion.
(B) Preservatives
 Emulsions prepared from emulsifying agents such as carbohydrates,
proteins, sterol and non-ionic surfactants may lead to the growth of
bacteria, fungi and moulds in the presence of water.
 The contamination of emulsions by these microorganism cause
unpleasant odour, taste and discolouration.
 The following steps can minimize the contamination:
- Use thoroughly cleaned equipment.
- Use ingredients of high quality.
- Maintain the prescribed ratio of oil, water and gum during preparation.
- Use freshly boiled and cooled water.
- Maintain the prescribed pH of the emulsion.
 Benzoic acid (0.1-0.2%), methyl paraben and propyl paraben (0.1-0.2%),
chloroform (0.25%), cholecresol (0.1%), etc. are some of the
preservatives used.
(C) Antioxidants:
 During storage of emulsions, the fats and emulsifying agents undergo
oxidation by atmospheric oxygen.
 This is prevented by adding antioxidants such as tocopherol, gallic acid,
propyl gallate and ascorbic acid.
 Qualities of good antioxidant:
- It should be non-toxic and non-irritant.
- It should be readily soluble or dispersible in the medium.
- It should be compatible with other ingredients in the medium.
- It should be effective in low concentrations.

(D) Flavours:
 Vanillin is used for liquid paraffin emulsion.
 Benzaldehyde for cod-liver oil emulsion
 A combination of flavouring and sweetening agent increases the
palatability of the emulsion.
 PREPARATION OF EMULSIONS

(1) Dry gum method

(2) Wet gum method

(3) Bottle method

(4) Other methods

(1) Dry gum method:
 Measure the required quantity of oil in a dry measure and transfer it into
a dry mortar.
 Add the calculated quantity of gum into it and triturate rapidly to form a
uniform mixture.
 Add required quantity of water and triturate vigorously till a clicking
sound is produced and the product becomes white or nearly white due
internal reflection of light.
 The emulsion produced at this stage is known as primary emulsion.
 Other liquid formulative ingredients that are miscible with the external
phase are added to the primary emulsion.
 Preservatives, stabilizers, colorants, flavouring agents are dissolved in a
suitable volume of external phase and added to primary emulsion.
 The emulsion is the transferred to a graduated cylinder and made to
volume with external phase .
The proportion of oil, water and gum for dry gum method:

Type of oil Examples Oil:Water:Gum

Fixed oil Castor oil 4:2:1
Almond oil
Arachis oil
Cod-liver oil
Volatile oil Turpentine oil 2:2:1
Peppermint oil
Cinnamon oil

Mineral oil Liquid paraffin 3:2:1

Example: Prepare and dispense 200 ml of arachis oil emulsion using dry
method.
Ingredients:
Arachis oil 50.0 ml
Purified water add to 200 ml

*Arachis oil is fixed oil and the proportion of oil:water:gum is 4:2:1.

Formula for primary emulsion:
Arachis oil 50.0 ml
Water 25.0 ml
Gum 12.5 g

Calculation:
Approximate volume of primary emulsion: 87.5 ml
Total volume of emulsion: 200 ml
Volume of water required : 200-87.5 = 112.5 ml
Method: Measure the required quantity of arachis oil in a dry measure

and transfer to a dry mortar. Add calculated quantity of gum acacia

powder and triturate rapidly to from a uniform mixture. Add required

quantity of water and triturate vigorously until a clicking sound is

produced and the product turns white. Add remaining water to produce

the required volume. Transfer the emulsion into a bottle, label and

dispense.
(2) Wet gum method:
 In this method, the same proportions of oil, water and gum are used as in
the dry gum method, but the order of mixing is different.
 Calculate the quantity of oil, water and gum required for preparing the
primary emulsion.
 Powder the gum in a mortar. Add water and triturate it with gum to form
a mucilage.
 Add the required quantity of oil in small portions with rapid trituration
until a clicking is produced and the product turns white or nearly white.
So, the primary emulsion is formed.
 Add more of water in small portions to the primary emulsion with
trituration to produce the required volume.
 Stir thoroughly to form a primary emulsion.
Example: Prepare and dispense 120 ml of castor oil emulsion.
Ingredients:
Castor oil 8 ml
Water add upto 120 ml
*Castor oil is a fixed oil. Hence, the proportion of oil, water and gum is
4:2:1.

Formula for primary emulsion

Castor oil 32.0 ml
Water 16.0 ml
Gum acacia powder 8.0 g

Calculation
Approximate volume of primary emulsion: 56 ml
Total volume of emulsion: 120 ml
Required of volume of water to make: 120-56 = 64 ml
Method: Powder the gum acacia in a mortar. Add water and triturate to

form a mucilage. Add required quantity of castor oil in small portions with

rapid trituration until a clicking sound is produced and the product turns

white or nearly white. Add more of water in small portions to the primary

emulsion with trituration to produce the required volume. Transfer the

emulsion to a bottle, label and dispense.

(3) Bottle method:
 Bottle method is used for preparation of emulsions containing volatile

and non-viscous oils.

 The proportion of oil:water:gum is 2:2:1.

 Measure the required quantity of oil and transfer into a large bottle. Add

the required quantity of powdered gum.

 Shake the bottle vigorously, until the oil and um are mixed thoroughly.

 Add the calculated amount of water all at once.

 Shake the mixture vigorously to form a primary emulsion.

 Add more of water in small portions with constant agitation to produce

the required volume.

(4) Other methods:
 Various blenders and homogenisers are used for preparing emulsions.
 Hand homogeniser, Silverson mixer homogeniser, colloidal mill are
used for the preparation of emulsions.
 Principle: Large globules in coarse emulsions are broken into smaller
globules by passing them under pressure through a narrow orifice.

Hand homogeniser
 The homogeniser is hand operated.
 The emulsion is placed in the hopper of the homogeniser .
 The up and down movement of the handle causes coarse emulsion to
draw in through inlet valve and pass through homogenising valve.
 In this way the emulsion is forced to pass through the orifice.
 The oil globules are broken into fine globules of uniform size.
Silverson mixer homogeniser
 It consists of an emulsifier head which is covered with fine meshed
stainless sieve.
 The emulsifier head consists of a number of blades which rotate at a very
high speed inorder to produce a powerful shearing action.
 The blades are rotated by an electric motor fitted at the top.

 The emulsifier head is placed in a vessel containing immiscible liquids.

 When the motor is started, the liquids are sucked through fine holes and the
oil is reduced to fine globules due to rotation of blades.

Colloidal mill
Colloidal mills are used to produce very fine emulsions having particle size
less than one micron on a large scale manufacture.
Hand homogeniser Silverson mixer homogeniser
 STABILITY OF EMULSIONS

 An emulsion is said to be stable if it remains as such after its

preparation, i.e. the dispersed globules are uniformly distributed

throughout the dispersion medium during its storage.

 The following three changes usually occurs during the storage of an

emulsion:

(1) Cracking

(2) Creaming

(3) Phase inversion

(1) Cracking :
 Cracking means the separation of two layers disperse and continuous
phase, due to the coalescence of disperse phase globules which are
difficult to redisperse by shaking.
 Cracking may occur due to following reasons:
- By addition of emulsifying agent of opposite type: When monovalent
soaps are added to w/o type and divalent soaps to o/w type leads to
cracking of emulsion.
- By decomposition or precipitation of emulsifying agents: When an acid
is added to an alkali soap emulsion, it causes decomposition of
emulgent.
When sodium chloride is added to sodium or potassium soap emulsion,
it leads to precipitation of emulsion and leads to cracking.
- By addition of a common solvent: When a solvent is added to an
- emulsion, and the dispersed phase, continuous phase and emulsifying
agent is miscible in that solvent which leads to a clear solution.
- By microorganisms: Improper storage of emulsions develops bacterial

and mould growth. This leads to destruction of emulgent and cause

cracking of emulsion.

- Changes in temperature: When emulsions are stored for longer time, an

increase in temperature may reduce the viscosity of the emulsion and

improves cracking.

- By creaming: A creamy emulsion is more liable to crack than a

homogenous emulsion.
(2) Creaming :
 Creaming may be defined as the upward movement of dispersed
globules to form a thick layer at the surface of the emulsion.
 Creaming is a temporary phase because it can be redistributed by mild
shaking or stirring to get again a homogenous emulsion.
 According to Stoke’s law, the rate of creaming depends on the number
of factors which can be explained by:

V= 2r2 (d1 - d2) g

9ᶯ
Where, V = rate of creaming
r = radius of globules
d1= density of dispersed phase
d2= density of dispersed medium
g= gravitational constant
ᶯ = viscosity of the dispersion medium
(i) Radius of globules: The rate of creaming is directly proportional to the
radius of globules. Larger the size of globules, more will be creaming
and vice versa.
(ii) Difference in density of disperse phase and continuous phase: Greater
the difference between the density of disperse phase and continuous
phase, more will be creaming.
(iii) Viscosity of the dispersion medium: The rate of creaming is inversely
proportional to the viscosity of the dispersion medium. Viscosity can
be increased by adding tragacanth and methyl cellulose. Too much
viscosity should be avoided as it become difficult to redisperse the
material.
(iv) Storage condition: The emulsion should be stored in a cool place
because the rise in temperature reduces the viscosity which may lead
to creaming.
(3) Phase inversion:
 Phase inversion means the change of one type of emulsion into the
other type, i.e. o/w type changes to w/o type and vice versa.
 It may be due to following reasons:

- By the addition of an electrolyte

- By changing the phase-volume ratio
- By temperature change
- By changing the emulsifying agent
 The phase inversion can be minimized by :

- keeping the concentration of disperse phase between 30 to 60%

- Storing the emulsion in a cool place
- By using a proper emulsifying agent in adequate concentration
 CONTAINERS
 The emulsions should be packed in containers having an adequate air
space above the emulsion, so as to permit adequate shaking before its
use.
 Emulsions for internal use should be packed in wide mouthed bottle to
remove it easily.
 Metallic closures should be avoided.
 Wide mouthed amber glass bottles are most appropriate for storage of
emulsions.

LABELLING
A secondary label ‘shake well before use’ is required in addition to other
requirements.

STORAGE
Emulsions should be stored in air tight container protected from light,
freezing and high temperature and store in a cool place.
SUSPENSIONS
 DEFINITION
 Suspensions are the biphasic liquid dosage form in which the finely
divided solid particles ranging from 0.5 to 5.0 micron are dispersed in a
liquid or semisolid vehicle.
 The solid particles act as disperse phase whereas liquid vehicle acts as
the continuous phase.
 The particle size of the disperse phase is very important in the
formulation of suspensions.
 Suspensions for external application should have small particle size to
avoid gritty feeling to the skin and to cover greater area of the
application.
 Suspensions for parenteral administration should have a particle size
that can pass through the needle.
 Suspensions to be instilled into the eye should be free from gritty
particles to avoid irritation, pain and discomfort.
 CLASSIFICATION OF SUSPENSIONS

(1) Oral suspensions

(2) Parenteral suspensions

(3) Ophthalmic suspensions

(4) Suspension for external use

(1) Oral suspensions
 These are consumed by oral route.
 They generally contain flavouring agent and sweetening agent to mask
the bitter taste of the drug.
 Nowadays suspensions are readily available in the market in dry
powder form and these are reconstituted by adding a specified quantity
of freshly boiled and cooled water before use.

Advantages Disadvantages

It is easy to swallow the suspended soluble All suspensions are required to be shaken
medicaments. before use.

Insoluble derivatives in suspensions is The accuracy of dosage is less reliable as

more palatable than soluble derivatives in compared to solution.
solution

Bulky insoluble powders can be added that Storage of suspension may lead to changes
acts as adsorbents of toxins or to reduce in disperse system, especially when there is
excess acidity in the GIT. fluctuations in temperature.
(2) Parenteral suspensions
 These suspensions are administered by parenteral route.

 These suspensions should fulfil the required qualities:

- The particle size of the suspension should be such that it can be

easily pass through the needle of the syringe.
- There should not be any crystal growth in the suspension during its
storage.
- the concentration of solid particles in the suspension should be
between 0.5 to 30%.
- the viscosity of the suspension should not interfere with its flow
through the syringe needle.
- The suspensions should be sterilised.
(3) Ophthalmic suspensions
 Compared to eye drops, these are not commonly used.

 These are prepared when the drug is insoluble in the desired solvent or
unstable in liquid form.
 These suspensions must fulfil the following conditions:

- The particle size of eye-suspensions should be fine so that it should

be non-irritating to the eye.
- The suspensions should be sterilised.
- The suspensions should be isotonic.
- These should have desired viscosity.
- The suspensions should be packed in a suitable container, so that it
can be easily instilled into the eye.
(4) Suspensions for external use
 These are meant for external use. Eg: lotions, inhalations, drops etc.

 These suspensions contain very small particles to avoid grittiness.

 Lotion containing suspended particles evaporate when applied to the

skin leaving a light deposit of medicament on the surface.

 Lotions are easier to apply than many other semi-solid preparations.

 Calamine lotion is a suspension type preparation which provides

protective effect.

 Lotions meant for application on broken or inflamed skin should be free

from harmful microorganisms.

Flocculated and non-flocculated suspensions

Flocculated suspension Non-flocculated suspension

Particles form loose aggregates and Individual particles exists as
form a net work like structure. separate entity.
The rate of sedimentation is high. The rate of sedimentation is low.

Sediment is rapidly formed and Sediment is slowly formed and

easy to redisperse. difficult to redisperse.
Sediment is loosely packed and sediment is very closely packed
doesnot form a hard cake. and a hard cake is formed.
Sediment liquid is clear. Sediment liquid is not clear.

The floccule stick to the sides of the The floccule does not stick to the
bottle. sides of the bottle
Suspension is not pleasing in Suspension is pleasing in
appearance. appearance .
 FORMULATION OF SUSPENSION

(1) Flocculating agents

 The dispersion of solid particles in the dispersion medium or vehicle

can be improved by adding flocculating agents such as surfactants or

protective colloid.

 The flocculating agent acts by reducing the surface tension and thereby

improving the dispersion of solids and minimise flocculation.

 Eg: Sodium lauryl sulphate, Tweens, Spans, Carbowaxes, etc.

2. Thickening agents
 These are hydrophilic colloids which form colloidal dispersions with
water and increases viscosity of the continuous phase,.
 The thickening agents used to stabilize suspensions are classified into
three major groups- polysaccharides, inorganic agents and synthetic
compounds.

(A) Polysaccharides: There are two types of polysaccharides.

(a) Natural polysaccharides:
(i) Gum acacia: It is a good protective colloid and suspending agent.
It is more effective when it is used as compound tragacanth powder.
Compound tragacanth powder contains acacia 20%, tragacanth 15%,
starch 20% and sucrose.
Acacia contains an enzyme oxidase which cause deterioration of easily
oxidisable medicament. So benzoic acid and parahydroxy benzoic acid are
added as antimicrobial agents to preserve the suspension.
(ii) Tragacanth: It’s a better thickening agent than acacia. It is used as
compound tragacanth powder or tragacanth mucilage to suspend heavy
indiffusible substances. Tragacanth mucilage is used when the vehicle is
water or chloroform water.

(iii) Starch: It is sometimes used with other suspending agents because of

the high viscosity of its mucilage. It is an ingredient of compound
tragacanth powder.

(iv) Sodium alginate: It forms a viscous solution when dissolved in water.

Its 1% solution have the same suspending power as that of tragacanth
mucilage.
(b) Semisynthetic:

(i) Methyl cellulose: It is used in the concentration of 0.5 to 2% for both

internal and external preparations.

(ii) Sodium carboxymethyl cellulose: It is used in the concentration of

0.25 to 1% for suspending powders in oral, parenteral and external use.

(iii) Microcrytalline cellulose: It is prepared from wood cellulose by acid

hydrolysis. It produces colloidal dispersions.

(B) Inorganic agents

(a) Clay: Bentonite and aluminium magnesium silicate is used.

Bentonite: Its creamy and hygroscopic. 2% suspension is used in

external preparations.

Aluminum magnesium silicate: Its creamy, colourless, odourless and

tasteless powder used in boith internal and external preparations.

(b) Aluminium hydroxide: It is used as suspending agent in suspension

containing barium sulphate, calamine, sulphonamide and sulphur.
(C) Synthetic compounds
(a) Carbomer: It is used in the concentration of 0.1 to 0.4% for internal
and external preparations.
(b) Colloidal silicon dioxide: It is a white non-gritty powder used in the
concentration of 1.5 to 4%.

3. Wetting agents
 These reduces the interfacial tension between the solid particles and

liquid medium.

 When adding wetting agent, he affinity of the particles for the

surrounding medium is increased and the interparticular forces are

decreased.

 Excessive use of wetting agent may cause foaming or may give bad taste

or odour to the suspension.

(4) Preservatives

 A suitable preservative is needed to preserve suspensions against

bacterial growth.

 They should be effective against wide range of organism.

 Benzoic acid, sodium benzoate, methyl paraben, propyl paraben are

commonly used as preservatives in suspensions.

(5) Organoleptic additives

 Colouring agents, sweetening agents and flavouring agents are

generally incorporated in oral suspensions.

 METHODS OF PREPARATION OR DISPENSING OF
SUSPENSIONS

(1) Suspensions containing diffusible solids

(2) Suspensions containing indiffusible solids

(3) Suspensions containing precipitate forming liquids

(4) Suspensions produced by chemical reactions.

(1)Suspensions containing diffusible solids
 Diffusible solids are light weight, insoluble powdered substances , mix
with water and remain suspended throughout the liquid for sufficient long
time after shaking.
 Eg: Calcium carbonate, light magnesium carbonate, magnesium trisilicate.

General method of dispensing

 Finely powder the solid ingredients.
 Mix the insoluble powders in a mortar and add enough vehicle to make a
smooth cream.
 Add more vehicle to make it pourable.
 Examine the suspension and if foreign particles are present and strain it
through a muslin cloth to a bottle.
 Rinse the mortar and pestle with some amount of vehicle and transfer the
rinsings to the bottle.
 Add any liquid ingredient and more of vehicle to produce the required
volume
 Mix thoroughly by shaking the bottle.
Example: Preparation of 90 ml of the following suspension.

Ingredients:
Light kaolin 12.0 g
Light magnesium carbonate 3.0 g
Sodium bicarbonate 3.0 g
Peppermint water to make 90 ml

Method: Mix the weighed quantities of light kaolin, light magnesium

carbonate, sodium bicarbonate in a mortar. Measure 3/4th of peppermint
water and add this to the mortar. Triturate thoroughly until a smooth paste
is formed. Then dilute it with remaining amount of peppermint water,
strain it through muslin piece. Add more of peppermint water to produce
the required volume. Transfer the suspension to a bottle, label and
dispense.
(2) Suspensions containing indiffusible solids
 Indiffusible solids are those which do not dissolve in water and do not
remain evenly distributed in the vehicle for sufficient long time to
ensure uniformity of dose .
 Examples: Calamine, Hydrocortisone, Aspirin, Chalk, etc.

General method of dispensing (compound tragacanth powder)

 Finely powder all the ingredients.
 Mix them together in a mortar and add compound tragacanth powder.
 Measure 3/4th of vehicle and triturate to form a smooth cream.
 Add more vehicle to make it pourable.
 Examine the suspension and if foreign particles are present and strain it
through a muslin cloth to a bottle.
 Rinse the mortar and pestle with some amount of vehicle and transfer
the rinsings to the bottle.
 Add any liquid ingredient and more of vehicle to produce the required
volume.
 Mix thoroughly by shaking the bottle.
Example: Prepare and dispense 30 ml of the following suspension.
Ingredients:
Bismuth carbonate 1.0 g
Prepared chalk 1.0 g
Kaolin 4.0 g
Tincture catechu 2.0 ml
Water to make 30 ml

Method: Mix the weighed quantities of bismuth carbonate, prepared chalk

and kaolin. To this, incorporate calculated quantity of compound powder
of tragacanth and mix thoroughly. Measure 3/4th of water. Add small
amount of water and triturate to form a smooth cream. Add the remaining
portion of water. Strain through a muslin cloth. Add tincture catechu in the
centre of cream with continuous trituration. Add more of water to produce
the required volume. Transfer the suspension into bottle, label and
dispense.
(3) Suspensions containing precipitate forming liquids
 Liquid preparations like compound benzoin tincture, tolu tincture etc,
gets precipitated when water is added to them.
 These are insoluble in water and forms indiffusible precipitates in
presence of salts.
 They contains resinous matter and when it is mixed with water, it leads
to precipitation of resin and may stick to the sides of the bottle and is
difficult to rediffuse by shaking.
 To prevent this, a protective colloid is dispersed in the vehicle before
tincture is added.
 Tragacanth mucilage or compound tragacanth powder is commonly
used as protective colloid.
General method of dispensing (tragacanth mucilage)
 Mix the tragacanth mucilage with equal volume of the vehicle.

 Measure the precipitate forming liquid in a dry measure and pour

slowly into the centre of the mucilage with constant stirring.
 Dissolve the solid substance if any, in about 1/4th of vehicle and mix it
with above mixture.
 Examine the contents of the mortar critically for foreign particles. If
these are present, strain the suspension through muslin cloth into a
bottle.
 Add more of vehicle to rinse the mortar and transferring the rinsing to
the bottle.
 Add more of the vehicle to produce required volume.
Example: Prepare and dispense 90 ml of the following suspension

Ingredients:
Potassium iodide 2.0 g
Tincture of lobelia ether 8.0 ml
Tincture of stramonium 16.0 ml
Chloroform water to make 90 ml

Method: Mix the tragacanth mucilage with an equal volume of chloroform

water. Measure the calculated quantity of tincture lobelia ether and
tincture of stramonium in a dry measure and pour slowly into the centre of
the mucilage with continuous stirring. Dissolve the potassium iodide in
about 1/4th of the chloroform water and mix it with above mixture, strain if
necessary , through muslin cloth. Add more of chloroform water to
produce the final volume. Transfer to a bottle, label and dispense.
(4) Suspensions produced by chemical reactions
 In this, the highly diluted solutions of reactants are mixed together so as
to form very finely divided precipitates that can be easily distributed are
diffusible in nature.
 Hence, there is no need of adding any suspending agent.

Example: Preparation of 100 ml of the following suspension.

Ingredients:
Sulphurated potash 5.0 g
Zinc sulphate 5.0 g
Concentrated camphor water 2.5 ml
Water to make 100 ml
Method: Dissolve sulphurated potash and zinc sulphate separately in small
volume of water. Add sulphated potash solution to zinc sulphate solution
with constant stirring. Transfer to a tared bottle. Add camphor water with
vigorous shaking to redissolve precipitated camphor. Mix it well and make
up the volume.
 STABILITY OF SUSPENSIONS
 A stable suspension can be redisperse homogeneously with moderate
shaking and can be easily poured throughout its shelf.
 The most stable pharmaceutical suspensions are flocculated i.e, the
suspended particles are bonded together physically to form a loose,
semi-rigid structure.
 The non-flocculated suspensions can be made stable by decreasing the
particle size of the suspended material or by increasing the density and
viscosity of the vehicle.

EVALUATION OF THE STABILITY OF SUSPENSIONS

(1) Sedimentation method
(2) Rheological method
(3) Electrokinetic method
(4) Micromeritic method
(1) Sedimentation method
 In this, measurement of sedimentation volume is measured.

 It is determined by keeping a measured volume of the suspension in a

graduated cylinder in an undisturbed position for a definite period of
time and noted the ultimate height (Hu) of the sediment and initial
height of the total suspension.
 The sedimentation volume F is the ratio of the ultimate height and
initial height (Hu/Ho).
 The sedimentation volume can be plotted against time.

 The graph indicates the sedimentation pattern of suspension on storage.

 A stable suspension shows a horizontal or loss steep curve.

 The evaluation of redispersibility can also be determined by shaking

the suspension and again find out the sedimentation volume (Hu/Ho).
(2) Rheological method
 The viscosity of the suspension is determined by using a viscometer.

(3) Electrokinetic method

 In this, the surface electric charge or zeta potential of suspension is
determined .
 Zeta potential can be calculated from the migration velocities of the
particles measured by the electrophoretic method.

(4) Micromeritic method

 The stability of a suspension depends on the particle size of the
dispense phase.
 The size of the particle in a suspension may grow and may lead to
lumps and caking.
 Change in particle size distribution and crystal habit may be studied by
microscopy and coulter counter method.
 CONTAINERS
Suspensions should be packed in containers which are having adequate air
space above the liquid to permit adequate shaking.
The oral suspensions should be packed in wide mouth bottles to permit
prompt removal of the suspension.

LABELLING
A secondary label ‘shake well before use’ to be fixed on the label.
In case of dry suspension powders, the specified amount of vehicle to be
mixed may be indicated clearly on the label.

STORAGE
Suspensions should be stored in a cool place but should not be kept in a
refrigerator.
Freezing at a very low temperatures should be avoided which may lead to
aggregation of the suspended particles.