WOMEN INSTITUTE OF LEARNING ABBOTTABAD

PREPARED BY: Riddah Syed

ROLLNO: 55

CLASS: Second professional

TOPIC: Emulsion

SUBMITTED TO: Anum Shahzadi

 EMULSIONS
DEFINITION:
An emulsion is a thermodynamically unstable system consisting of at least two
immiscible liquid phases one of which is dispersed as globules in the other liquid phase stabilized by a
third substance called emulsifying agent.

OR

An emulsion may be defined as a preparation consisting of two immiscible liquids, usually

water and oil, one of which is dispersed as small globules in other unless a third component(emulsifying
agent) is present, the dispersion is unstable, and the globules undergo coalescence to form two separate
layers of water and oil.

FIGURE SHOWING DISPERSED PHASE AND CONTINOUS PHASE:

 INTRODUCTION:
AQUEOUS PHASE:
It may contain water soluble drugs, preservatives, and coloring and flavoring
agents.It is desirable to use distilled or deionized water , since calcium and magnesium ions, found in
hard water,can have an adverse effect on the stability of some emulsions, particularly those containing
fatty acid soaps as the emulsifying agent.Care must be takento ensure that flavors and preservatives
which may have some oil solubility are present in the aqueous phase in a concentration sufficient to
elict their desrire effect.

OIL PHASE:
The oil phase of an emulsion frequently consists of fixed or volatile oils and drugs
that exist as oil, such as oil-soluble vitamins and antiseptics. It is frequently necessary to add an
antioxidant to prevent autoxidation of the oil and consequent rancidity and/or destruction of any
vitamin present. Oils used in the preparation of emulsion should also be kept free of micro-organism,
since these too can cause rancidity. The emulsifying agent is the most important component of an
emulsion in term of achieving stability.

CLASSIFICATION OF EMULSIONS

Based on dispersed phase

- Simple emulsions

Oil in Water (O/W)

Water in Oil (W/O)

- Multiple emulsions

Oil-in-water-in-oil (O/W/O)
 Water-in-oil-in-water (W/O/W)

- Micro emulsions

(Globule size is less than 120 nm, they appear to be transparent.)

Based on size of liquid droplets

0.2 – 50 mm Macro emulsions (Kinetically Stable)

0.01 – 0.2 mm Micro emulsions (Thermodynamically Stable)

GENERAL TYPES OF PHARMACEUTICAL EMULSIONS

 1) Lotions

 2) Liniments

 3) Creams

 4) Ointments

 5) Vitamin drops

SIMPLE EMULSIONS
 MULTIPLE EMULSIONS

 Also called emulsion within emulsion

 They are developed with a view to delay the release of an active ingredient. They have three
phases.

 They may be oil-in-water-in-oil (o/w/o) or of water-in-oil-in-water (w/o/w).

PREPARATION OF MULTIPLE EMULSIONS

 MICRO EMULSION

They may be defined as dispersions of insoluble liquids in a second liquid that

appears clear and homogenous to the naked eye. They are frequently called solubilised systems
because on a macroscopic basis they seem to behave as true solutions.

As in micro emulsions the globule size is less than 120 nm, they appear to be transparent.

Ex. Etoposide micro emulsion

methotraxate micro emulsion

IDENTIFICATION OF EMULSIONS

Dilution test:

 In this test the emulsion is diluted either with oil or water. If the emulsion is o/w type
and it is diluted with water, it will remain stable as water is the dispersion medium"
but if it is diluted with oil, the emulsion will break as oil and water are not miscible
with each other.

Conductivity Test:
 Water is good conductor of electricity whereas oil is non-conductor. Therefore, continuous
phase of water runs electricity more than continuous phase of oil.
 DYE SOLUBILITY TEST

 Water soluble dye (methylene blue) will be taken up by the aqueous phase where as
oil soluble dye will be taken by oily phase. When microscopically it is observed that
water soluble dye is taken up by the continuous phase , it is o/w emulsion. If the dye
is not taken up by the continuous phase , test is repeated with oil soluble dye..
Coloring of continuous phase confirms w/o emulsion. This test can fail if ionic
emulsions are present.
 Water soluble dyes will dissolve in aqueous phase.
 Oil soluble dyes will dissolve in oil phase.
Oil-soluble dye (e.g. Scarlet) Water-soluble dye (e.g. Amaranth dye)

FLUORESCENCE TEST:
 Oils give fluorescence under UV light, while water doesn’t.
 Therefore, O/W emulsion shows spotty pattern when observed under UV.
 while W/O emulsion fluoresces

COBALT CHLORIDE TEST:

 Principle: Cobalt Chloride solution is used for identification of Emulsion. It is water

soluble so it changes colour when encountered by O/W emulsion.
 Procedure: Filter paper is Dipped in Emulsion. Filter paper changes its color from blue to
Pink
 Result: Emulsion is O/W otherwise not.

HLB VALUE OF EMULSIONS

1~3 Anti-foaming agent.

3~6 w/o emulsifying agents.

7~9 Wetting agents.

8 ~ 18 O/w emulsifying agents.

13 ~15 Detergents.

15 ~18 Solubilizing Agents

APPLICATION OF EMULSIONS

• For prolonged action

• Taste masking

• Improved stability

• Parenteral preparation

• Enzyme entrapment

• Increased Oral bioavailability

ADVANTAGES OF EMULSIONS

• Mask the unpleasant taste O/W is convenient means of oral administration of water-insoluble
liquids.

• Oil-soluble drugs can be given parentrally in form of oilin water emulsion. (e.g Taxol).

• Emulsion can be used for external application in cosmetic and therapeutic Application because
of Better and faster absorption.

• Sustained release medication. Nutritional supplement. Inert and chemically non-reactive.

Reasonably odorless and cost Effective.

• Radiopague agents for diagnostic purposes.

• Intravenous Nutrition (maintenanceof debilitated patients)- Intralipid, Nutralipid).

• Fluorocarbon Emulsions- fluorocarbons have high capacities for dissolving gases like O2 and
CO2and serve as blood substitutes for a short period of time

DIS ADVANTAGES OF EMULSIONS

• Emulsions are thermodynamically unstable and have short shelf-life.

• Improper formulation of emulsions leads to creaming and cracking of emulsion.
• Improper selection of emulsifying agent leads to phase inversion and some times
it may also lead to

FORMULATION OF EMULSIONS

 aqueous phase:

purified water

 organic phase:

arachis oil,cod liver oil,sesame oil,castor oil

 Emulsifier:

acacia,SLS,tween,bentonite

 Antioxidant:

sodium bisulphite,sodium nitrite

 Preservatives:

methyl and propyl paraben

PREPARATION OF EMULSION

Commercially, emulsions are prepared in large volume mixing tanks and refined and
stabilized by passage through a colloid mill or homogenizer. Extemporaneous production is
more concerned with small scale methods.

1) Dry Gum Methods

2) Wet Gum Methods

3) Bottle Method

4) Beaker Method

. 5) In situ Soap Method.

DRY GUM METHOD FOR PREPARATION OF EMULSIONS:

Dry gum method is used to prepare the initial or primary emulsion from oil, water, and a
hydrocolloid or "gum" type emulsifier.

Procedure:

Take mortar, 1 part gum is levigated with the 4 parts oil until the powder is thoroughly wetted;
then the 2 parts water are added all at once, and the mixture is vigorously triturated until the
primary emulsion formed is creamy white and produces a "crackling" sound as it is triturated.

Active ingredients, preservatives, color, flavors are added as a solution to the primary
emulsion.

When all agents have been incorporated, the emulsion should be transferred to a calibrated
vessel, brought to final volume with water.
WET GUM METHOD
Methodology (Oil 4 parts + Water 2 parts + Emulsifier 1 parts)

Procedure: In this method, the proportions of oil, water, and emulsifier are the same (4:2:1),
but the order and techniques of mixing are different. The 1 part gum is triturated with 2 parts
water to form a mucilage; then the 4 parts oil is added slowly, in portions, while triturating.
After all the oil is added, the mixture is triturated for several minutes to form the primary
emulsion. Then other ingredients may be added as in the continental method. Generally
speaking, the English method is more difficult to perform successfully, especially with more
viscous oils, but may result in a more stable emulsion.

BOTTLE METHOD
This method may be used to prepare emulsions of volatile oils, Oleaginous substances of very
low viscosities.

This method is a variation of the dry gum method.

One part powdered acacia (or other gum) is placed in a dry bottle and four parts oil are added.
The bottle is capped and thoroughly shaken. To this, the required volume of water is added all
at once, and the mixture is shaken thoroughly until the primary emulsion forms. Reference:
http://pharmlabs.unc.edu/labs/emulsions/beaker.htm

BEAKER METHOD
The most appropriate method. Dividing components into water soluble and oil soluble
components. All oil soluble components are dissolved in the oily phase in one beaker and all
water soluble components are dissolved in the water in a separate beaker. Oleaginous
components are melted and both phases are heated to approximately 70°C over a water bath.
The internal phase is then added to the external phase with stirring until the product reaches
room temperature.

IN SITU SOAP METHOD:

Two types of Soaps developed by this Methods: 1) Calcium Soaps 2 ) Soft Soaps 1) Calcium
Soaps: W/O type Emulsions. E.g. Oleic acid + Lime water. Prepared by simple mixing of equal
volumes of Oil and Lime water.
 Emulsifying agent used is Calcium salt of free fatty acids. E.g. Olive Oil + Oleic acid (FAA) =
calcium Oleate. Advantage: O/W is external Phase used frequently on dry skin and sun burned
skin.

INSTRUMENTS USED

1. Mixing & storage tanks [jacketed kettle / SS tank (steam, gas or electrically heated)]

2. Portable mixer

3. Colloid mill or suitable emulsifier / homogenizers or any other suitable equipment.

4. Semi automatic / automatic bottle filling machine

5. Cap sealing machine

6. Water still or deionizer

7. Clarity testing inspection table

SMALL SCALE PROCESSING:

The Wedgehood or porcelain mortar and pestle are used most frequently in the
laboratory or prescription department for the emulsification of fixed sometimes volatile oils.

The kitchen type mixer and blenders have also been used for the preparation of small
batches of emulsions.

care must be taken to ensure that excessive amounts of air are not whipped into the product.s.
 LARGE SCALE PROCESSING:

Large scale emulsions are prepared using large tank or vessels provided with jackets that permit
heating and cooling of the ingredients and a high speed propeller or turbine impeller.

Another type of homogenizer is commercially available which utilizes high frequency

radiations(ultra sonic) to disrupt the liquid and achieve droplet dispersion. It is not used to any great
extent by the pharmaceutical industries.

PROPERTIES OF EMULSIFYING AGENT

o It should be surface active, at least to the extent that the interfacial tension is reduced to
less that 10 dynes/cm.
o It should be rapidly adsorbed around the dispersed droplets and form a coherent film
capable of preventing coalescence.
o It should result in formation of an electrical potential at the droplet surface adequate to
ensure repulsion between approaching droplets.
o It should increase viscosity of the emulsion as a mean of enhancing stability.
o It should be affective in fairly low concentration.

CHARACTERISTICS OF GOOD QUALITY EMULSIONS

o It should not damage the fibre

o It should be colorless
o It should be stable for a certain period of time
o Its softening quality should be high
o The emulsion droplets should be small
o One of the most important characteristics of emulsions is their inherit
instability.even though the dispersed drops are small.

THE REASON WHY EMULSIONS ARE USED

o To make the jute fibre soft

o To increase cohesiveness of fibre
o To increase flexibility
o To make it move easily through different parts of the machines
o To reduce fibre stiffness and brittleness
ADVANCE TECHNIQUES:
NANO EMULSION:

Nanoemulsion are thermodynamically stable system in which the two immisible liquid (water and oil)
are mix to form a single phase by means of appropriate surfactant.

Diameter of the droplets in a nanoemulsion is in the range of 20 to 200 nm.

APPLICATION OF NANO EMULSIONS:

 High surface area and free energy then macro emulsion that make them effective transport
system.

 NEs do not show the problem of creaming, flocculation, coalescence and sedimentation which
are associated with macro emulsion.

 It can be formulated in variety of formulation such as foam, spray,cream,liquid etc.

 NEs are non toxic and non irritant so they can be easily applied to skin and mucous membrane.

 NEs are formulated by the surfactants which are approved by the GRAAS, so they can be given
by the enteric route.

NEs do not damage the animal and human cells hence are suitable for human and veterinary purpose
REFERENCES:
BOOKS:

• The Theory & Practice of Industrial pharmacy by Leon Lachman.

• How to practice GMP by P.P. Sharma.

• CVS Subrahmanyam , Textbook of Physical Pharmaceutics,edition2007,Vallabh Prakashan,PP-

395-426

• Alton, Michael E., ed (2007). Alton’s Pharmaceutics: The Design and Manufacture of
Medicines (3rd ed.). Churchill Livingstone. pp. 92–97, 384, 390–405, 566–69, 573–74, 589–96,
609–10, 611.ISBN 9780443101083.

• Ansell’s Pharmaceutical Dosage Forms and Drug Delivery Systems, 9th edition, pg no. 376

• http://pharmlabs.unc.edu/labs/emulsions/beaker.htm

• Validation of Disperse System: Pharmaceutical Dosage Form: Disperse Systems: Volume

3 (Part B).

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