EXTEMPORANEOUS DISPENSING

OF:

EMULSIONS
By:
R.Ph Dr. SABA INAYAT ALI
LECTURER
DCOP 24.03.2018
LEARNING OBJECTIVES
At the end of this topic, students will be able to:

 Define Emulsions
 Discuss properties, importance and types of emulsions
 Determine the preparation of emulsions
 Discuss the problems associated with emulsions
 List the commonly used emulsifying agents
 Give the examples of official oral emulsions
 EMULSIONS
 An emulsion is a disperse system
consisting of two immiscible liquids, one
of which (the disperse phase) is finely
divided and distributed through the
other (the continuous phase).

 The dispersed phase is referred to as the

Internal phase

 The dispersion medium as the External or

Continuous phase
 Generally, to prepare a stable emulsion, an
emulsifying agent is necessary

 Because the external phase of an emulsion is

continuous, an O/W emulsion may be diluted with
water or an aqueous preparation, and W/O
emulsion with an oleaginous or oil miscible liquid
 Emulsions
Phase A

Phase B

A B C D

A.: Two immiscible liquids not emulsified

B. An emulsion of phase A dispersed in Phase B
C. Unstable emulsion slowly separates.
D. The emulsifying agent places it self on the interface between phase A and phase B
and stabilizes the emulsion.
 The aqueous phase may contain water-soluble drugs,
preservatives, coloring and flavoring agents

 The oil phase frequently consists of fixed oil or volatile

and drugs that exist as oil, such as oil-soluble vitamins
and antiseptic

 It is necessary to add antioxidant to prevent autoxidation

of the oil and rancidity/and or destruction of any vitamin
present
Advantages
 to deliver drugs that exhibit a low aqueous solubility.
 Pharmaceutical emulsions may be used to mask the taste
of therapeutic agents, in which the drug is dissolved in the
internal phase of an o/w emulsion.
 Emulsions may be commonly used to administer oils that
may have a therapeutic effect. e.g. liquid paraffin
 Pharmaceutical emulsions may be employed to administer
drugs to patients who have difficulty swallowing solid-
dosage forms.
Disadvantages
 Pharmaceutical emulsions are
thermodynamically unstable and therefore
must be formulated to stabilize the
emulsion from separation of the two
phases.
Types of emulsions
 Simple emulsions
(Macro 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)
Types of emulsions
w/o/w o/w/o

Multiple emulsions
 EMULSIFYING AGENTS

Natural • Acacia is most Carbohydrates

Emulsifying frequently use.  acacia,
Agents Tragacanth and Agar  tragacanth
- thickening agents in  agar
Acacia - emulsified  pectin
products. Proteins
 gelatin,
 egg yolk
 casein
Finely • These materials Colloidal clays including
Divided generally form O/W  Bentonite
Solids emulsions  Magnesium hydroxide
 Aluminum hydroxide
 EMULSIFYING AGENTS

Synthetic  (wetting agents), which may be  Anionic

Anionic, Cationic, Nonionic • Triethanolamine oleate
• Sodium lauryl sulfate

 Cationic
• Benzalkonium chloride

 Nonionic
• Sorbitan esters (span)
• Polyethylene glycol 400
monostearate
• Polyoxyethylene sorbitan esters
(Tweens)
OTHER ADDITIVES

 Antioxidants
 Preservatives
 Coloring agent
 Flavoring agent
 Qualities Required for
Emulsifiers
 Must be compatible with other ingredients in the
formula
 Must not interfere with the stability and efficacy of
the therapeutic agent
 Must be stable to microorganisms
 Must be non-toxic
 Must possess little or no odor, taste or color
 Must promote emulsification and maintain stability
of the emulsion for intended shelf-life
 PREPARATION OF EMULSIONS

 On small scale
 mortar and pestle can
be used

 For large scale

production
 mechanical stirrers ,
homegenizers, colloidal
mill are used
Methods of Preparation
1. Continental or Dry gum method
2. English or wet gum method
3. Bottle or Forbes bottle method
Continental or Dry gum method
(G+O+W)
 The method is also referred to as the
“4:2:1” method because for every 4 parts
(volumes) of oil, 2 parts of water and 1 part of
gum are added in preparing the initial or
primary emulsion.

 For instance, if 40 mL of oil are to be

emulsified, 20 mL of water and 10 g of
gum would be employed, with additional
water or other formulation ingredients
being added afterward to the primary
emulsion
Continental or Dry Gum Method ( G + O + W )
Emulsifier is triturated with the oil in perfectly dry porcelain mortar

two parts of water then added at once

triturate immediately, rapidly and continuously (until get a clicking sound and
thick white cream is formed, this is primary emulsion)

Other liquid formulative ingredients that are soluble in or miscible with the
external phase may then be added to the primary emulsion with mixing.

the remaining quantity of water is slowly added to form the final emulsion
English or Wet Gum method ( G + W + O )

triturate gum with water in a mortar to form a mucilage

oil is added slowly in portions

the mixture is triturated

after adding all of the oil, thoroughly mixed for several minute to form the
primary emulsion

Once the primary emulsion has been formed remaining quantity of water is
added to make the final emulsion
Bottle or Forbes Bottle Method
(G+O+W)
 For the extemporaneous preparation
of emulsions from volatile oils or
oleaginous substances of low
viscosities, the bottle method is used.
 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.
 gum + oil (dry bottle)

Shake

water (volume equal to oil) is added in portions with vigorous shaking

to form primary emulsion

remaining quantity of water is added to make the final emulsion

PROBLEMS
 Flocculation
 Creaming
 Coalescence and breaking
 Deterioration by Microorganism
 Miscellaneous Physical and Chemical Change
FLOCCULATION
 is the joining together of
globules to form large
clumps or floccules which
rise or settle in the
emulsion more rapidly
than do the individual
particles
 CREAMING
 is the rising (upward creaming) or
settling (downward creaming) of
globules or floccules to form a
concentrated layer at the surface
or to the bottom of the emulsion
 In creaming, the globules are still
surrounded by a protective coating or
sheath of emulsifying agent and may
redispersed simply by agitating the
product
COALESCENCE AND
BREAKING
 unlike creaming, the
coalescence of globules and
the subsequent breaking of
an emulsion are irreversible
processes.
Deterioration by Molds, yeast and bacteria may bring about decomposition and
Microorganism contamination of the emulsion. Preservatives should be more
fungistatics than bacteriostatic

Miscellaneous Light and rancidity affect the color and the odor of oils and may destroy
Physical and their vitamin content. Freezing and thawing and high temperature
Chemical result in the coarseness and breaking of an emulsion.
Change
Emulsion Stability
A stable emulsion is characterized by the following:

1. Absence of flocculation and creaming

2. Absence of coalescence of globules and
separation of the layers
3. Absence of deterioration due to microorganisms
4. Maintenance of elegance with respect to
appearance, odor, color and consistency
 Test for identification of emulsion type:
 Dilution test (miscibility test)
 Staining test (dye solubility test)
 Conductivity measurement
Conductivity Test
This test is based on the basic principle that water is a good conductor of
electricity. Therefore in case of o/w emulsion , this test will be positive as
water is the external phase. In this test. An assembly consisting of a pair
of electrodes connected to a lamp is dipped into an emulsion. If the emulsion
is o/w type, the lamp glows.
Dye Solubility Test
In this test, when an emulsion is mixed with a water soluble dye such as
amaranth and observed under the microscope, if the continuous phase
appears red, then it means that the emulsion is o/w type as water is the
external phase and the dye will dissolve in it to give color but if the scattered
globules appear red and continuous phase colorless, then it is w/o type.
Similarly if an oil soluble dye such as Scarlet red C or Sudan III is added to an
emulsion and the continuous phase appears red, then it w/o emulsion.
SHELF LIFE OF ORAL EMULSIONS

 Unpreserved emulsions deteriorate rapidly

but stabilized and preserved systems may
be stored
CONTAINERS FOR ORAL
EMULSIONS
 Emulsions should be
supplied in well-filled
containers with air
tight closures

 For viscous
preparations, wide-
mouthed amber glass
bottles are more
appropriate
SPECIAL LABELS AND ADVICE FOR
PATIENTS

SHAKE THE BOTTLE

STORE IN A COOL
PLACE BUT AVOID
FREEZING
Examples
 Oral use
 Cod-liver oil emulsions
 Liquid paraffin oral emulsion
 Castor oil emulsions
EMULSIONS FOR EXTERNAL USE

Applications
Liniments
Lotions
Creams
Applications, Liniments &
Lotions
 These are liquid or semi-solid emulsions
designed for application to the skin.
 Preparations intended for use on broken
skin should be free from microbial
contamination.
Shelf-life of Applications,
Liniments & Lotions
 These are generally stable preparations
 Diluted lotions should not be stored for
long periods (maximum 1 month)
Containers for Applications,
Liniments & Lotions
 Amber fluted bottles or jars are used for
extemporaneously prepared products.
 Some manufactured products may be
packed in plastic containers.
SPECIAL LABEL AND ADVICE FOR
PATIENTS

SHAKE THE BOTTLE

 Advise the patient that product should not
be applied to broken skin.
REFERENCE
 Pharmaceutical practice by D.M. Collette
 Ch # 13