EMULSIONS
Mr. Pranjal D.Chougule
Assistant Professor
Ashokrao Mane Institute of
Pharmacy, Ambap
EMULSIONS
1) Definition
2) Types of Emulsion
3) Pharmaceutical Applications of Emulsion
4) Formulation of Emulsion
5) Theory of Emulsion
6) Preservation of Emulsion
7) Preparation of Emulsion
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8) Stability of Emulsion
DEFINITION
The word "emulsion" comes from the Latin word for "to milk“.
An emulsion is a mixture of two or more liquids that are
normally immiscible (nonmixable or unblendable) OR
An emulsion is a two phase system consisting of two
incompletely miscible liquids, one of which is dispersed as finite
globules in the other.
The particle size of the globules range from 0.25 to 25 μm. An
emulsifying agent and mechanical energy are needed to join the
phases. 3
TYPES OF EMULSION
A. Based on dispersed phase
1. Oil in Water (O/W): Oil droplets dispersed in water
2. Water in Oil (W/O):Water droplets dispersed in oil
3. Multiple Emulsions: (e.g. w/o/w emulsions)
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SINGLE EMULSION
MULTIPLE EMULSIONS:
1. Oil-in-Water-in-Oil: (O/W/O)
In O/W/O systems an aqueous phase (hydrophilic) separates internal and
external oil phase. In other words, O/W/O is a system in which water
droplets may be surrounded in oil phase, which in true encloses one or
more oil droplets.
2. Water-in-Oil-In-Water: (W/O/W)
SUSPENSIONS
In W/O/W systems, an organic phase (hydrophobic) separates internal
and external aqueous phases. In other words, W/O/W is a system in
which oil droplets may be surrounded by an aqueous phase, which in
turn encloses one or several water droplets. These systems are the most
studied among the multiple emulsions.
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B. Based on size of liquid droplets
1. 0.2–50 mm Macroemulsions
2. 0.01–0.2 mm Microemulsions
3. 50–1000 nm Nanoemulsions
PHARMACEUTICAL EMULSIONS
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PHARMACEUTICAL APPLICATIONS OF
EMULSIONS
1. Oral, rectal and topical administration of oils and oil-soluble
drugs.
2. The unpleasant taste or odor can be masked by emulsification.
3. The absorption and penetration of medicament are enhanced
by emulsification.
4. Intramuscular injections of water-soluble drugs or vaccine to
provide slow release.
5. The use of sterile stable i.v emulsion containing fats,
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carbohydrates and vitamins as a potential nutrition.
FORMULATION OF EMULSION
Selection of Emulsifying agents (emulsifiers):
1. An emulsifying agent is any material that enhances the stability of
an emulsion (i.e. Prevention of coalescence and reducing creaming).
2. The ideal emulsifying agent is colorless, odourless, tasteless,
nontoxic, non-irritant and able to produce stable emulsions at low
concentrations.
Examples of Emulsifying agent
1. Carbohydrate Materials:
- Acacia, Tragacanth, Agar, Pectin. o/w emulsion.
2. Protein Substances:
- Gelatin, Egg yolk, Caesin o/w emulsion.
3. High Molecular Weight Alcohols:
- Stearyl Alcohol, Cetyl Alcohol, Glyceryl Mono stearate o/w emulsion,8
cholesterol w/o emulsion.
4.Wetting Agents:
-Anionic, Cationic, Nonionic
-o/w emulsion
-w/o emulsion
5. Finely divided solids
- Bentonite, Magnesium Hydroxide, Aluminum Hydroxide
o/w emulsion.
Choice of emulgent
Selection is based on
1. Toxicity
2. Chemical incompatibility
3. The cost
4. Types of emulsion desired
5. Shelf life 9
OTHER ADDITIVES
1. Viscosity Builders: To build up the viscosity of external
phase Ex: Hydrocolloids
2. Antimicrobials: To protect against microbial degradation
Ex: Benzoic acid, Methyl paraben
3. Antioxidants: To protect against rancidity
Ex: BHT,BHA, Gallic acid, Propylgallate, Tocopherols
4. Organoleptic additives: To improve palatabilty of emulsion
Colors, Flavors and Sweeteners
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IDENTIFICATION/DETECTION TESTS
1. Dilution Test (emulsion can be diluted only with external phase)
2. Conductivity Test (o/w emulsions conduct electric current)
3. Dye Solubility Test (using water or oil soluble dyes)
4. Fluorescence Test (some oils fluoresce under UV light)
5. Cobalt chloride paper test (CoCl2 blue paper turns pink when
hydrated)
6. Depending on the direction of creaming
At least two tests should be done to reach a conclusive11
decision about the identity of the emulsion
IDENTIFICATION/DETECTION TESTS
Dilution Test:
Based on the solubility of external phase of emulsion
- o/w emulsion can be diluted with water
- w/o emulsion can be diluted with oil
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Conductivity
Test
Water is good conductor of electricity whereas oil
is nonconductor. Therefore, continuous phase of
water runs electricity more than continuous phase
of oil.
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Dye-Solubility 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
•if the scattered globules appear red and continuous phase
colorless, then it is w/o type.
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FLUORESCENCE TEST
Oils give fluorescence.
Under UV light, while water doesn’t.
Therefore, O/W emulsion shows spotty pattern while W/O
emulsion fluoresces.
Many oils show Fluorescence when
exposed to UV light
Method:
An emulsion is observed against UV Light
Under Microscope fluorescence of entire field
indicates oil as External phase and spotty
fluorescence is observed when water remains 15
as External Phase
FLUORESCENCE TEST
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COBALT CHLORIDE PAPER TEST
Anhydrous Cobalt is Blue and Hydrated Cobalt is
Red.
Method:
Trest Filter Paper with cobalt chloride solution
and dry it. Dip the dry treated paper in an
Emulsion.
The change in colour of Paper from Blue to Pink
Red indicates O/W Emulsion.
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COBALT CHLORIDE PAPER TEST
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DEPENDING ON THE DIRECTION
OF CREAMING
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METHODS OF PREPARATION
The methods commonly used to prepare emulsions can
be
divided into two categories
A) Trituration Method
This method consists of dry gum method and wet gum
method.
1. Dry Gum Method
•In this method the oil is first triturated with gum with a
little amount of water to form the primary emulsion.
•The Trituration is continued till a characteristic
‘clicking’ sound is heard and a thick white cream is
formed.
• Once the primary emulsion is formed, the remaining 20
quantity of water is slowly added to form the final
emulsion.
This method contain- "4:2:1" formula
4 parts (volumes) of oil
2 parts of water
1 part of gum
2.Wet Gum Method
•As the name implies, in this method first gum and water are
triturated together to form a mucilage.
•The required quantity of oil is then added gradually in small
proportions with thorough trituration to form the primary
emulsion.
Once the primary emulsion has been formed remaining quantity of
water is added to make the final emulsion.
"4:2:1" formula
4 parts (volumes) of oil
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2 parts of water
1 part of gum
B. BOTTLE METHOD
•This method is employed for preparing emulsions containing
volatile and other non-viscous oils. Both dry gum and wet
gum methods can be employed for the preparation.
•As volatile oils have a low viscosity as compared to fixed
oils, they require comparatively large quantity of gum for
emulsification.
•In this method, oil or water is first shaken thoroughly and
vigorously with the calculated amount of gum. Once this has
emulsified completely, the second liquid (either oil or water)
is then added all at once and the bottle is again shaken
vigorously to form the primary emulsion. More of water is
added in small portions with constant agitation after each
addition to produce the final volume.
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MECHANICAL EQUIPMENT FOR
EMULSIFICATION
Mechanical stirrers
Propeller type mixers
-Turbine mixers
- Homogenizers
Colloid mills
Ultrasonifiers
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THEORIES OF EMULSIFICATION
1. By Lowering the Interfacial Tension
(preventing the coalescence of droplets)
2. By formation of rigid interfacial film
(Monomolecular film, Multimolecular film and Solid
particle film)
3. By forming electrical double layer
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EMULSION INSTABILITY
An emulsion is said to be stable if it remains as such after its
preparation , that is the dispersed globules are uniformly
distributed through out the dispersion medium during its
storage.
The emulsion should be chemically stable and there should
not be any bacterial growth during it shelf life.
The instability of pharmaceutical emulsions may be classified
as following:
1. Cracking (irreversible instability)
2) Flocculation
3) Creaming
4) Phase inversion 25
EMULSION STABILITY
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CRACKING
•When an emulsion cracks during preparation. i.e the
primary emulsion does not become white but acquires
an oily translucent appearance.
•In such a case it is impossible to dilute the emulsion
nucleus with water and the oil separates out.
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Cracking of emulsion can be due to:
1 Addition of an incompatible emulsifying agent:
e.g. monovalent soap + divalent soap
2 Chemical or microbial decomposition of
emulsifying agent:
e.g. alkali soap decompose by acid.
3 Exposure to increased or reduced temperature
4-addition of common solvent
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EMULSION STABILITY
FLOCCULATION:
The small spheres of oil join together to form clumps or flocks
which rise or settle in the emulsion more rapidly than
individual particles.
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CREAMING
It is the concentration of the floccules of the internal phase
form upward or downward layer according to the density of
internal phase.
Stokes equation included the factors that affect the
creaming process:
dx/dt=D2 (pi-pe)g/18n
dx/dt=rate of setting
D=diameter particle
p=density of internal phase and external phase
g=gravitational constant
n=viscosity of medium
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Factors affect creaming:
Globule size:
↑globule size ↑creaming
The density of the internal phase and External phases:
pi-pe=0 dx/dt=0
pi-pe=-ve[i.e.-ve velocity upward creaming]
pi-pe=+ve [downward creaming]
Gravity:
Constant, however centrifugation is applied
Velocity:
↑ ↓creaming
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COALESCENCE
It is the process by which emulsified particles merge with each
to form large particles.
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BREAKING
Due to coalescence and creaming combined, the oil separates
completely from water so that it floats at the top in a single,
continuous layer.
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PHASE INVERSION
In phase inversion o/w type emulsions changes into w/o type
and vice versa.
It is a physical instability.
It may be brought about by:
• the addition of an electrolyte e.g. addition of calcium chloride
into o/w emulsion formed by sodium stearate can be inverted
to w/o.
• by changing the phase volume ratio.
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• by temperature changes.
Phase inversion can be minimized by:
• using the proper emulsified agent in adequate
concentration.
•keeping the concentration of dispersed phase between
30 to 60%.
• storing the emulsion in a cool place.
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STORAGE AND PACKAGING
Depending on the use, emulsions should be packed in
suitable containers.
› For oral use : usually packed in well filled bottles having
an air tight closure.
› Light sensitive products : packed in amber colored bottles.
› For viscous emulsions : wide mouth bottles should be used.
The label on the emulsion should mention that these
products have to be shaken thoroughly before use.
› External use products should clearly mention on their label
that they are meant for external use only.
› Emulsions should be stored in a cool place but refrigeration
should be avoided as this low temperature can adversely
effect the stability of preparation. 36
THANK
YOU
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