As you’ve previously learned:

Dispersion/ Dispersed System

“A heterogenous system consisting of two or more than two

components, one of which is dispersed as particles throughout
the other.”
2
EMULSIONS
◾ Definition
◾ Types of Emulsion
◾ Theories of emulsification
◾ Emulsifying agents and their
classification
◾ Methods of preparation
◾ Stability of emulsion.
4
EMULSION

“A thermodynamically unstable system consisting of at least two

immiscible liquid phases, one of which is dispersed as globules (the
dispersed phase) in the other liquid phase (the continuous phase),
stabilized by the presence of an emulsifying agent.”

5
O I L IN W ATER (O / W ) O R W ATER IN O I L (W/O)
EMULSION

Oil

Water

Water in Oil Oil in W ater

(W/O) Emulsion (O/W) Emulsion
6
◾ In case of emulsions,
 One liquid phase is essentially polar (e.g., aqueous), whereas the other
is relatively nonpolar (e.g., an oil).
 The dispersed phase is a liquid that is neither soluble nor miscible
with the
liquid of the dispersing phase.
 The particle diameter of the dispersed phase generally extends from
about
0.1 to 10 μm.
7

 To prepare a stable emulsion, a third phase, an emulsifying agent, is

necessary.
◾ Emulsified systems range from lotions (relatively low viscosity) to
ointments and creams (semisolid)
◾ Route of Administration: Based on the constituents and the
intended application:
 Liquid emulsions: orally, topically, or parenterally
 Semisolid emulsions: topically

8
9
10
 ADVANTAGES

◾ Emulsions possess a number of advantages over the other

liquid dosage forms;
 Poorly water soluble drugs may be easily incorporated with improved
dissolution
rate and bioavailability.
 Unpleasant taste and odor of oils can be masked partially or wholly
by emulsification.
 Absorption rate and permeation of medicament can be
controlled. 11

 Formulation and technology for organ targeted delivery is available.

TYPES OF EMULSION

A. Simple emulsion (w/o, o/w)

B. Multiple emulsion (w/o/w,
o/w/o)
C. Micro emulsion/ Nano
emulsions

12
 A. SIMPLE EMULSIONS
◾ Simple emulsions are classified as:
i. Oil-in-water (o/w) Emulsion: System in which the oil phase is dispersed as
globules throughout an aqueous continuous phase (diluted with aqueous
phase)
ii. Water-in-oil (w/o) Emulsion: System in which the aqueous phase is
dispersed as globules throughout the continuous oil phase (diluted with
oleaginous phase)

13
i. OIL-IN-WATER (O/W) E M U L S I O N

• The common daily life example is milk.

• These emulsions are used mainly for internal/oral use
(as bitter or disagreeable taste and odor of drugs
can be masked by emulsification)
• Externally these emulsions are used for formulating
non greasy creams, lotions and liniments .
• Cosmetic products prepared using o/w emulsions
can easily be removed from the surface of the
skin .
• Example: Castor oil emulsion, foundation
creams, vanishing creams. 14
ii. WATER-IN-OIL (W/O) E M U L S I O N

 They are mainly used externally as

lotions and creams as the external
layer of oil forms an occlusive layer
and prevents the evaporation of
moisture from the surface of the skin.
 They are also effective as cleansing
cream as they solubilize the oil
soluble dirt from the surface .
 Example: Cold creams, oily
calamine lotion 16
◾ Medicinal emulsions for oral
administration are usually of the
o/w Which require the use of an
o/w emulsifying agent (synthetic
nonionic surfactants like acacia,
tragacanth, and gelatin)
◾ Not all emulsions that are consumed,
however, belong to the o/w type.

17
No. Oil-in-water (o/w) Emulsion
Water: Dispersion
1 medium
Oil: Dispersed phase
2 Have non-greasy texture
3 Easily to wash from skin
They are used externally to provide
4 stratum
cooling effect
e.g. vanishing cream
Water soluble drugs are more quickly
5
released from o/w emulsions
They are preferred for formulations
6
meant for internal use as bitter taste of
oils can be masked.
7 Acceptable by consumer
Water-in-oil (w/o) Emulsion
Oil: Dispersion
medium
Water: Dispersed phase
Have greasy texture
Difficult to wash from skin
Can be use to hydrate the upper layer of
corneum (moisturizing cream)
Can be used to clean skin from dirt
Oil soluble drugs are more quickly
released from w/o emulsions
They are preferred for formulations
meant for external use like creams. 18
Not acceptable by consumer
B. MULTIPLE EMULSION
◾ Multiple emulsions are emulsions whose disperse phase contains droplets of
another phase.
◾ They are made by emulsifying a water-in-oil emulsion with a hydrophilic
surfactant to produce a water-in-oil-in-water system, or an oil-in-water system with
a low HLB surfactant to produce an oil-in-water-in-oil system.

18
19
◾ Route of Administration: Water-in-oil-in-water (w/o/w) emulsions in which a
water-soluble drug is dissolved in the aqueous phase may be injected by the
subcutaneous (SC) or intramuscular (IM) routes to produce a delayed
action preparation.To escape, the drug has to diffuse through the oil to reach
the tissue fluids, hence the delayed-release action.

20
C . MICRO EMULSION

◾ Microemulsions are thermodynamically stable, optically transparent

isotropic mixtures of a biphasic o/w system stabilized with surfactants.
◾ Diameter of droplets in
 microemulsion= 100 Å (10 millimicrons) to 1000 Å, ( about 10-200nm), whereas in a
macroemulsion= 5000 Å in diameter.
◾ Both o/w and w/o microemulsions may be formed spontaneously by
agitating the oil
and water phases with carefully selected surfactants.
21
◾ The type of emulsion produced depends on the properties of the oil and surfactants.
◾ An emulsifying adjunct or cosurfactant is used in the preparation of microemulsions.
◾ The surfactant and cosurfactant molecules form an adsorbed film on the microemulsion
particles to prevent coalescence.
◾ EXAMPLE: An anionic surfactant (sodium lauryl sulfate or potassium oleate), can be dispersed in
an organic liquid (such as benzene), a small measured amount of water is added, and the
microemulsion is formed by the gradual addition of a lipophilic cosurfactant (pentanol), to form a
clear solution at 30◦C.
 The addition of pentanol temporarily reduces the surface tension to approximately zero, allowing
spontaneous emulsification.
22
◾ Advantages of microemulsions in drug delivery are:
 more rapid and efficient oral absorption of drugs than through solid dosage
forms,
 enhanced transdermal drug delivery through increased diffusion into the skin,
and
 the unique potential application of microemulsions in the development of
artificial red blood cells and targeting of cytotoxic drugs to cancer cells.
23
Types of emulsions- S U M M A R Y

24
IDENTIFICATION OF TYPE OF EMULSION
◾ As it is difficult to distinguish emulsion type from naked eye, hence
different tests are used to identify the type of emulsion, the test
includes:
1) Dye solubility test
2) Dilution test
3) Electrical conductivity test
4) OTHERS

25
1. DYE SOLUBILITY TEST

◾ A small quantity of a water-soluble dye such as methylene blue

or brilliant blue FCF may be dusted on the surface of the
emulsion.
◾ If water is the external phase (i.e., if the emulsion is of the o/w type),
the dye will dissolve and uniformly diffuse throughout the water.
◾ If the emulsion is of the w/o type, the particles of dye will lie in
clumps
on the surface. 26
27
 2. DILUTION TEST
◾ A second method involves dilution of the emulsion with water. If the emulsion
mixes
freely with the water, it is of the o/w type.

28
3. ELECTRICAL C O N D U CTIVITY TEST

◾ Another test uses a pair of electrodes connected to an

external electric source and immersed in the emulsion.
◾ If the external phase is water, a current will pass through the
emulsion and can be made to deflect a voltmeter needle or cause
a light in the circuit to glow.
◾ If the oil is the continuous phase, the emulsion fails to carry the
current.
29
30
Fluorescence Test:
If an emulsion on exposure to ultraviolet radiations show:
Continuous Fluorescence-------- W/O Emulsion
Spotty Fluorescence----------------O/W Emulsion

Cobalt Chloride Test:

When a filter paper soaked in cobalt chloride solution is
dipped in an emulsion and dried.
It turns:
Blue to pink-------------------O/W Emulsion
No change in color ---------W/O Emulsion 31
32
THEORIES OF EMULSIFICATION

◾ There is no universal theory of emulsification because emulsions can be prepared

using several different types of emulsifying agent,
◾ each of which depends for its action on a different principle to achieve a stable
product.
◾ For a theory to be meaningful, it should be capable of explaining
 (a) the stability of the product and
 (b) the type of emulsion formed.

33
THEORIES OF EMULSIFICATION

A.Surface tension theory

B.O riented-wedge theory
C.Interfacial film (Plastic)
theory

34
35
Surface tension
◾ The molecules at the surface of water are not completely surrounded by
other molecules as they are in the bulk of the water.
◾ As a result there is a net inward force of attraction exerted on a molecule at
the surface from the molecules in the bulk solution, which results in a tendency
for the surface to contract.
◾ This contraction is spontaneous and represents a minimum free energy
state.
◾ We express the “strength of contraction by the work required to increase 38

the surface area by 1 meters square; this is referred to as the surface

◾ Surface tension is the force per unit length
existing at the surface of a liquid and Interfacial
tension is the force per unit length existing at
the interface between two immiscible liquid
phases.
◾ Units of surface and interfacial tension: N/ m .
◾ The attractive force exerted upon
the surface molecules of a liquid by the molecules
beneath that tends to draw the surface molecules
into the bulk of the liquid and makes the liquid 39

assume the shape having the least surface area.

A. SURFACE TENSION THEORY OF EMULSIFICATION

◾ According to the surface tension theory of emulsification, the use of

emulsifiers and stabilizers :
◾ lowers the interfacial tension of the two immiscible liquids
◾ reducing the repellent force between the liquids and
◾ diminishing each liquid’s attraction for its own molecules.
◾ Thus, the surface-active agents facilitate the breaking up of large
globules into smaller ones, which then have a lesser tendency to
reunite or coalesce.
40
 B. ORIENTED-WEDGE THEORY
◾ The oriented-wedge theory assumes :
◾ monomolecular layers of emulsifying agent curved around a droplet of the internal
phase of the emulsion.
◾ The theory is based on the presumption that certain emulsifying agents orient themselves
about and within a liquid in a manner reflective of their solubility in that particular liquid.
(wedge shape)
◾ Generally, an emulsifying agent having :
◾ a greater hydrophilic character will promote an o/w emulsion and a greater hydrophobic
character will promote w/o emulsion.
◾ In other words, the phase in which the emulsifying agent is more soluble will become the
41
continuous or external phase of the emulsion.
C .THE PLASTIC O R INTERFACIAL FILM THEORY

◾ The plastic or interfacial film theory places the emulsifying agent at the
interface between the oil and water, surrounding the droplets of the internal
phase as a thin layer of film adsorbed on the surface of the internal phase.
◾ The film prevents contact and coalescing of the dispersed phase.
◾ The tougher and more pliable the film, the greater the stability of the emulsion.
◾ The formation of an o/w or a w/o emulsion depends on the degree of solubility
of the agent in the two phases, with water-soluble agents encouraging o/w
emulsions and vice versa.

41
◾ In actual, it is unlikely that a single theory of emulsification can
explain the means by which the many and varied emulsifiers
promote emulsion formation and stability.
◾ Lowering of the interfacial tension is important in the initial formation
of an emulsion, but the formation of a protective wedge of molecules
or film of emulsifier is important for continued stability.
◾ No doubt certain emulsifiers are capable of both tasks.

42
Theories of emulsification- S U M M A R Y

43
PREPARATION OF EMULSIONS

The initial step in preparation of an

emulsion is selection of the Emulsifying
Agent….
44
45
 2

What happen when two immiscible liquids are agitated

together?
1. Failure of the two liquids to remain mixed, because:
 The cohesive force between the molecules of each separate liquid
is greater than the adhesive force between the two liquids.

46
 What happen when two immiscible liquids are agitated
together?
2. The increase in the surface energy makes the system
thermodynamically unstable,
 Hence the droplets have a tendency to coalesce.

51
 3

To prevent this coalescence:

◾ Introduce third material (Emulsifying agent), which form
a film around the dispersed globules and prevent them
from coming close to each other and form larger
globules.

Oil

Wate
r
52 52
 EMULSIFYING AGENTS
These agents helps in the production of
stable dispersion by reducing interfacial
tension and maintaining the separation of
droplets by forming a barrier at oil water
interface.
Effective emulsifying agents are surface
active agents these have:
Hydrophilic heads/group----- Oriented
towards water
Hydrophobic tail/lipophilic ------ Oriented 53

towards oil 53
EMULSIFYING AGENTS

◾ Emulsion type is determined by the solubility of the emulsifying agent:

 if the emulsifying agent is more soluble in water, (i.e. hydrophilic)

then
water will by the continuous phase and O / W emulsion will formed

 If the emulsifying agent is more soluble in oil, (i.e. hydrophobic)

then
oil will by the continuous phase and W / O emulsion will formed
54

◾ If some material is added which alters the solubility of the

 Selection of Emulsifier
◾ An ideal emulsifier must be:
 Compatible with the other ingredients
 Stable and not deteriorate in the preparation.
 Nontoxic with respect to its intended use and the amount to be
consumed by the patient.
 Possess little odor, taste, or color.
 Must not interfere with the stability or efficacy of the therapeutic agent.
 Possess the capability to promote emulsification and to maintain the
stability of the emulsion for the intended shelf life of the product.
Shelf life : “shelf life” generally means the length of time you can expect a
product to look and act as expected and to stay safe for use
 CLASSIFICATION OF EMULSIFYING AGENTS

◾There are different ways to classify emulsifiers or

emulgents; like on the basis of:
a. Type of film the emulsifiers form
b. Chemical nature of the emulsifier

57
a. Type of film the emulsifiers
form

58
a.Type of film the emulsifiers form
TYPE 1: SURFACE ACTIVE AGENTS
These agents are adsorbed at oil–water interfaces:
 to form monomolecular films
 to reduce interfacial tension

TYPE 2: HYDROPHILIC COLLOIDS

These agents form a multimolecular film around the dispersed droplets
of oil in an o/w emulsion.

TYPE 3: FINELY DIVIDED SOLID PARTICLES

These solids are adsorbed at the interface between two immiscible liquid
phases and form what amounts to a film of particles around the dispersed
globules.
They form Particulate film
HYDROPHILE-LIPOPHILE BALANCE (HLB)

◾ The hydrophile– lipophile balance (H L B) number is a

measure of the balance between hydrophobic and hydrophilic
portions of a surfactant.
◾ In selecting a surfactant for emulsion stabilization, it is
essential that there is a degree of surfactant hydrophilicity
and hydrophobicity.
55
 1
0
HYDROPHILE-LIPOPHILE BALANCE (HLB)
◾ The usual range of H L B is between 1 to 20.
◾ Material that are highly polar or hydrophilic have higher number
of H L B than materials that are less polar or lipophilic which have
low number of HLB.

◾ Materials having an:

H L B value (3-6) are lipophilic & produce W/O.
H LB value (9-12) are hydrophilic and produce O/W .
62

62
57
58
 11

RULE OF BANCROFT

◾ The type of emulsion is a function of the relative

solubility of the surfactant, the phase in which it is more
soluble being the
continuous phase.
◾ Emulsifying agent with a high HLB is soluble in water and results in
the formation of an (O/W) emulsion.
◾ The reverse situation is true with surfactant of low HLB, which tend
to form (W/O) emulsions. 65
 12

H L B VA L U E S O F EMULSIFYIN G
A G E N Emulsifying
TS agent H L B value
Acacia 8.0
Sorbitan monolaurate 8.6

Sorbitan monostearate 4.7

Polysorbate 20 16.7
Polysorbate 60 14.9
Polysorbate 80 15.0
Sodium lauryl sulphate 40.0

Sodium oleate 18.0

Tragacanth 13.2
Triethanolamine oleate 12 66

66
b. Chemical nature of the
emulsifier a)
Carbohydrate
1. Materials
N ATURAL
EMULGENTS b) Protein
Substances

a) Non-
EMULSIFIERS Emulgent
ionic
2. s
SYNTHETIC
EMULGENTS b) Ionic
Emulgents

Finely
3. Divided
67

OTHERS Solids
1) NATURAL EMULGENTS OR
N ATURALLY OCCURRING EMULSIFYING AGENTS

a) Carbohydrate Materials
Example: Pectin ,Acacia, Agar, Tragacanth (Pnemonic: PAAT)
◾ They form hydrophilic colloids (i.e. multimolecular film) when
added to water and generally give O/W emulsion.
◾ Acacia- commonly used in the preparation of
Extemporaneous emulsions
◾ Tragacanth and agar- Thickening agents in acacia- emulsified
products
◾ Microcrystalline cellulose (semi-synthetic
polysaccharides)- Viscosity regulator 68
1) NATURAL EMULGENTS OR
N ATURALLY OCCURRING EMULSIFYING AGENTS

b) Protein substances
Example: Gelatin, Egg yolk,
Casein
“Pnemonic: GEC”

◾ These substances give O / W

emulsion. 69
 2) SYNTHETIC EMULSIFIERS

a) Non-ionic emulsifiers Example: Sorbitan esters “Spans”,

Polyoxyethylene derivatives “Tweens” “Pnemonic: SP”
◾ Non-ionic surfactants are effective over a pH range= 3-10
◾ Sorbitan esters are supplied commercially as Spans and are mixtures
of the partial esters of sorbitol and its mono- and di-anhydrides with
oleic acid.
◾ They are generally insoluble in water (low HLB value and are used
as W/0 emulsifiers and as wetting agents*.
70
◾ Wetting agents are substances that reduce the surface tension of water to allow it to spread
drops onto a surface, increasing the spreading abilities of a liquid.
◾ Polyoxyethylene derivatives OR Polysorbates are
complex mixtures of partial esters of sorbitol and its mono
and di- anhydrides condensed with an approximate
number of moles of ethylene oxide.They are supplied
commercially as Tweens.
◾ The polysorbates are miscible with water, as reflected in
their
o/w higher HLB values, and are used as emulsifying agents 71

emulsions.
for
b) Ionic
emulsifiers
i. Anionic surfactants (negatively charged)
Example: various monovalent, polyvalent and organic soaps e.g. Sodium
lauryl sulfate (o/w), Sodium stearate (o/w), Calcium oleate (w/o),
Triethanolamine (TEA) oleate (o/w).
 Anionic surfactants require pH greater than 8

ii. Cationic surfactant (positively charged)

Example: benzalkonium chloride (bactericidal properties)
 Cationic surfactants are effective over pH=
72

3-7
3) OTHERS
Finely divided
solids
◾ Finely divided solid particles, which are adsorbed at the interface
between two immiscible liquid phases and form a film of
particles around the dispersed globules.
◾ Example: colloidal clays, including, magnesium
hydroxide, bentonite and aluminum hydroxide.
◾ Generally, these form o/w emulsions when the insoluble
material is preferentially added to the aqueous phase if there is
a greater volume of the aqueous phase than of the oleaginous
phase.
◾ If the powdered solid is added to the oil and the oleaginous
phase volume predominates, a substance such as bentonite is 73

capable of forming a w/o emulsion.

They form emulsions with good stability which are less prone
to microbial contamination than those formed with other
naturally derived agents
eg: Bentonite, Aluminium magnesium silicate and colloidal
silicon dioxide.
Colloidal Aluminium and magnesium hydroxides are used for
Internal preparations eg:
“Liquid paraffin and magnesium hydroxide oral emulsion is
stabilized by the Magnesium hydroxide”

74
PREPARATION OF EMULSIONS

◾ Emulsions may be prepared by several methods,

Fig. 14.9 Hand
depending upon the nature of the components and the
Homogenizer
equipment.
◾ O n a small scale, as in the laboratory or
pharmacy, emulsions may be prepared using
 a dry Wedgwood or porcelain mortar and pestle,
 a mechanical blender or mixer, such as a Waring blender
or a milkshake mixer,
 a hand or bench-type homogenizer (Fig. 14.9), (Fig.
45
14.10),
 or sometimes a simple prescription bottle. Fig. 14.10 Bench-type
◾ On a large scale,
◾ Large mixing tanks (Fig. 14.5) may be used to form the
emulsion
through the action of a high speed impeller.
◾ As desired, the product may be rendered finer by passage
through colloid mill, in which the particles are sheared
between the small gap separating a high-speed rotor and the
stator,
◾ or by passage through a large industrial homogenizer
(Capacity=100,000 L of product per hour), in which the
liquid is forced under great pressure through a small valve 46

opening.
Fig. 14.5 Mixing
 Impellers

Colloidal Industrial
mill homogenize r
47
METHODS OF PREPARATION OF EMULSIONS

◾ In the small-scale extemporaneous preparation of emulsions, three

(3) methods may be used:
i. Continental or D ry gum method
ii. English or Wet gum method
iii.Bottle or Forbes bottle method.

72
METHODS OF PREPARATION OF EMULSIONS
◾ In these methods,
 The emulsifying agent (usually acacia) is mixed with the oil before the addition
of water, that is, dry gum.
 The emulsifying agent is added to the water (in which it is soluble) to
form a mucilage, and then the oil is slowly incorporated to form the
emulsion, that is, wet gum.
 The bottle method is reserved for volatile oils or less viscous oils and is
a
variation of the dry gum method.
73
i. CONTINENTAL OR DRY GUM METHOD

◾ The method is also referred to as the 4:2:1

(Oil-Water-Gum).
In this method:
1. The acacia or O/W emulsifier is triturated with the oil in a dry
wedgewood or porcelain mortar, until mixed.
 A rough surface should be used, for good grinding to reduce
the globules size.
2. Then the two parts of water are added all at once.
74
3. The mixture triturated immediately, rapidly and continuously until the
primary emulsion is formed.
- Creamy white and produces a crackling
sound.
4. Other liquid ingredients that are soluble in the external phase may then
be added.
5. Solid substances such as preservatives, stabilizers colorants, and any
flavoring material usually dissolved in a water then added to an emulsion.
6. Any substances that may interfere with the stability of emulsion (e.g. alcohol)
may added at the end.
7. When all necessary agents have been added, the emulsion is transferred
to a graduating cylinder and made to volume with water.
78
ii. ENGLISH O R WET GUM METHOD
 The same proportion of water, gum and oil is used but the order of mixing is different.
In this method:
1. Triturating of emulsifier (acacia) with water in a mortar.
2. The oil then is added slowly in portions.
3. The mixture is triturated to emulsify the oil.
4. The mixture is thoroughly mixed for several minutes to insure uniformity of
the emulsion.
5. Then, as with the continental or dry gum method, the other formulative
materials are
added.
6. The emulsion is then transferred to a graduating cylinder and brought to volume
iii. BOTTLE OR FORBES BOTTLE METHOD

It is used for volatile oils or oleaginous substances of low viscosity. (2:2:1)

1. The emulsifier (powder acacia) is placed in a dry bottle.
2. Two parts of oil then added.
3. The bottle is then shaken in a caped container.
4. A water is then added in portions.
5. When a primary emulsion is formed the other ingredients is added.
 It is not suitable for viscous oils.
6. When all of the water has been added, the primary emulsion thus formed may be
diluted
to the proper volume with water or an aqueous solution of other formulative agents.
 isWhen
generally 80
the intended dispersed phase is a mixture of fixed oil and volatile oil, the dry gum
employed.
method
Methods of preparation of emulsions-
SUMMARY

78
AUXILIARY METHOD :
◾ To increase the quality of emulsion prepared by any
of the pervious methods:
 The emulsion is passed through a hand
homogenizer.
 The emulsion is forced to pass through a very small
orifice which reduces the globules of the internal
phase to about 5 µm.
IN-SITU S O A P METHOD :
◾ A special type of emulsion preparation method by
which two types of soaps are developed i.e. 79

calcium soaps and soft soaps.

• In chemistry, in situ typically means "in the reaction mixture."

• There are numerous situations in which chemical intermediates

are synthesized in situ in various processes.

• This may be done because the species is unstable, and cannot be isolated, or
simply out of convenience.

• Latin, literally "in its (original) place or position" .

• in the original place instead of being moved to another place.

80
• Calcium soaps are w/o emulsions
• Contain certain vegetable oils, such as oleic acid, in combination
with limewater
• (synonym: Calcium Hydroxide Solution, USP).
• They are prepared simply by mixing equal volumes of the oil and limewater.
• The emulsifying agent in this instance is the calcium salt of the free fatty acid
formed from the combination of the two entities.
• In the case of olive oil, the free fatty acid is oleic acid and the
resultant emulsifying agent is calcium oleate.
• As oil phase is the external phase, this formulation is ideal
• where occlusion and skin softening are desired, such as for itchy, dry skin
or sunburned skin.
• example is calamine liniment
81
STABILITY OF EMULSIONS
◾ One of the most important characteristics of emulsions is their inherent instability.
◾ Even though the dispersed drops are small, gravity exerts a measurable force on them and
over time they coalesce to form larger drops which tend to either settle to the bottom or
rise to the top of the mixture. This process ultimately causes the internal and external
phases to separate into the two original components.
◾ Depending on how the emulsion is formulated and the physical environment to which it is
exposed, this separation may take minutes, months, or millennia.
◾ The stability of a pharmaceutical emulsion is characterized by:
 the absence of coalescence of the internal phase,
 absence of creaming, and
 maintenance of elegance with respect to appearance, odor, color, and other
physical properties.
STABILITY OF EMULSIONS

◾ The instability of pharmaceutical emulsions may be classified

as follows:
a) Creaming
b) Cracking and breaking
c) Phase inversion
INSTABILITY OF E M U L S I O N S
a) CREAMING
“Concentration or aggregation of the globules of the
dispersed phase at the top or bottom of the
system.”

◾ Depending upon the density of the continuous phase relative to that

of the dispersed phase, creaming can be:
 UPWARD creaming- If dispersed phase is less dense than the continuous
phase (o/w)
 D O W N W A R D creaming (Sedimentation)- If dispersed phase is more dense
than
Rate of creaming:
◾ It depends upon the factors present in Stoke’s
equation:
𝒅𝟐 (pi−pe)g
v=
18η
Where,
V = rate of sedimentation
D = diameter of particles
p = density of internal phase and external phase
g = gravitational constant
η = viscosity of medium
◾ Hence, in order to increase the stability of an emulsion according to
the Stoke’s equation:
 globule or particle size should be Reduced (Homogenization)
 density difference between the internal and external phases should be
Minimal,
 viscosity of the external should be reasonably High.
◾ Creaming increases the risk of coalescence of globules of the
internal phase which then leads to the separation of that phase
into a layer….
b) CRACKING A N D BREAKING

“Separation of internal phase from emulsion is called breaking and

the emulsion is said as being cracked or broken.”

◾ The breaking or phase separation of emulsion occurs because the

protective sheath around the dispersed phase globules no longer
exists.
◾ Cracked or broken emulsion can not be reestablished on simple agitation
and additional emulsifying agents and reprocessing (through
appropriate machinery) is required to reproduce the emulsion.
 CREAMING
• Concentration or aggregation of
the globules of the dispersed
phase at the top or bottom of
the system is referred as
creaming
• Reversible process
• Reform emulsion on shaking
• Globules of dispersed phase
still surrounded by protective
sheath of emulsifying agent
CRACKING
• Separation of internal phase
from emulsion is called
breaking or cracking
• Irreversible process
• Do not form emulsion on shaking
• Film of emulsifying agents
surrounding the particles no
longer exists
c) PHASE INVERSION

“Change of emulsion type from o/w to w/o and vice versa.”

◾ Phase inversion can be brought about by:

i. By adding electrolytes
ii. By changing phase volume ratio

i. By adding electrolytes
If sufficient amount of electrolyte is added, salting out can occur, which may
invert emulsion from o/w to w/o.
e.g. when CaCl2 is added to o/w emulsion containing Na-stearate as emulgent,
it
ii. By changing phase volume
ratio
 Phase volume ratio is the relative volume of the internal and
external phase.
 As the internal phase concentration of an emulsion increases, there is an
increase in viscosity of an emulsion to certain point after which it decreases.
At this point inversion occurs.
 The concentration of the internal phase above which the emulsifier can
not produce a stable emulsion of desired type is called Critical point.
 Generally, a phase volume ratio of 50/50 results in most stable emulsion.
 However, a general emulsion may be prepared without inversion with as
much as
75% of volume of the internal phase.
P H A S E IN V ERSIO N - B Y C H A N G I N G P H A S E VO L U M E
RAT IO
◾ The procedure of phase inversion is sometimes used in the
preparation of commercial emulsions, and it is the principle of the
continental method used in compounding practice.
◾ When controlled properly during the preparation of an emulsion,
phase inversion often results in a finer product.
OTHER FAC TORS TO BE CONSIDERED RELATED TO
EMULSION STABILITY

1.Emulsifier type and concentration:

2. Particle size and size distribution:
3. pH:
4. Temperature
EXAMPLES OF ORAL EMULSIONS

1. Mineral oil emulsion- as a lubricating cathartic

2. Simethicone Emulsion- used as a defoaming agent for the relief of
painful symptoms of excessive gas in the gastrointestinal tract.
3. Castor oil emulsion- used as a laxative for isolated bouts of constipation and
in preparation of the colon for radiography and endoscopic examination.

99
References:
Emulsions: Types, theories of emulsification, Emulsifying agents their classification and stability of
emulsion.
-Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems (9th Edition)