DDS lab

CGSabroso
Emulsion
l A thermodynamically unstable two-
phase system consisting of at least two
immiscible liquids, one of which is
dispersed in the form of small droplets
throughout the other, and an emulsifying
agent.
Emulsion
•  a dispersed system containing at least two
immiscible liquid phases. The
majority of conventional emulsions in
pharmaceutical use have dispersed
particles ranging in diameter from 0.1 to
100 um.
Phases of Emulsion
•  The dispersed liquid - internal or
discontinuous phase
•  The dispersion medium - external or
continuous phase
Types of Emulsion
1. oil-in-water (o/w) emulsions
–  oils, petroleum hydrocarbons, and / or waxes
are the dispersed phase, and water or an
aqueous solution is the continuous phase
Types of Emulsion
–  Oil is dispersed as droplets in an aqueous
medium.
–  formed if the aqueous phase constitutes
>45% of the total weight and hydrophilic
emulsifier is used
Types of Emulsion
–  O/W emulsions are used topically, orally, or
parenterally.
Types of Emulsion
2. water-in-oil (w/o) emulsion
-  Water is dispersed as droplets in an oil or
oleaginous medium
-  Used for external preparations when
emollient, lubricating, or protective properties
are desired.
Types of Emulsion
3. Multiple emulsions
o/w/o or w/o/w

4. Microemulsion
- appear as translucent or transparent and
have droplet diameter in the nanometer
range
Theories of emulsification

•  surface tension theory

•  oriented-wedge theory
•  plastic or interfacial film theory.
Preparing an emulsion

•  Select the suitable emulsifier

–  Compatible with the other ingredients
–  Stable and do not deteriorate
–  Non toxic
–  Little odor, taste or color
–  Capable of emulsifying
Emulsifying agents
1.  Natural emulsifying agents –
substances derived either form animal
or plant sources
Example:
gelatin, casein, eggyolk, wool fat,
cholesterol, acacia, tragacanth,
pectin, alginates, starch
Emulsifying agents

2. High–molecular-weight alcohols
•  Stearyl alcohol, cetyl alcohol, and glyceryl
monostearate

•  Employed primarily as thickening agents

and stabilizers for o/w emulsions of certain
lotions and ointments used externally.
Emulsifying agents
3. Finely divided solids – substances
adsorbed in the water interface to form a
coherent film.
Example:
Bentonite, veegum, magnesium
hydroxide, aluminum hydroxide and
magnesium trisilicate
Emulsifying agents
4. Synthetic emulsifying agents – or surface
active agents, they contain both the
lipophilic and hydrophilic groups.
•  Anionic
•  Cationic
•  Non-ionic
Synthetic emulsifying agents
-  Anionic agents – these are organic salts
which are ionized in the presence of water.
-  They are widely used in external preparations
as o/w emulsifying agents
-  Ex. Sodium lauryl sulfate
Synthetic emulsifying agents
-  Cationic surfactants – these are quaternary
ammonium compounds, which are inactivated
by the presence of soaps.
-  Emulsions which used these type are
generally stable at acidic pH
-  Ex. Benzalkonium chloride
Synthetic emulsifying agents
–  Non-ionic surfactants – these are the
polysorbates and sorbitan series which tend
to be of low order toxicity, non-irritating,
tasteless and chemically stable and are
compatible with ionic, anionic and non-ionic
drugs or adjuvant
–  Ex. PEG 400, SPANS (sorbitan), TWEENS
(polyoxyethylene derivatives)
HLB values

•  The type of emulsion formed is

based on the hydrophilic-
lipophilic balance (HLB).
HLB values

•  HLB system – logical means of selecting

emulsifying agents based on balance
between the hydrophilic and lipophilic
portions of an emulsifying agent.
HLB VALUES
HLB values
–  HLB number usually between 1 and 20 are
used as emulsifying agents
–  with values 8 –18 indicates hydrophilic
molecule and will produce o/w type of
emulsion
–  lower numbers in the range of 3 to 6
indicates lipophilic molecules and will
produce w/o emulsions
Methods of Preparation

1. Continental or dry gum method.

•  “4:2:1”method
•  O+G+W
2. English or wet gum method.
•  same proportions of oil, water, and gum
but the order of mixing is different.
•  Mucilage is prepared
•  G+W+O
Methods of Preparation

3. Bottle or Forbes bottle method.

•  For the extemporaneous preparation of
emulsions from volatile oils or oleaginous
substances of low viscosities
•  3:2:1 or 2:2:1
Methods of Preparation

4. Auxiliary Methods.
•  An emulsion prepared by either the wet
gum or the dry gum methods using hand
homogenizer to facilitate emulsification
Methods of Preparation

•  Auxiliary Methods
•  The hand homogenizer is less efficient in
reducing the particle size of very thick
emulsions, and it should not be employed
for emulsions containing a high proportion
of solid matter because of possible
damage to the valve
Methods of Preparation

5. In situ soap method.

The two types of soaps developed by this
method are calcium soaps and soft soaps.
Calcium soaps are water-in-oil emulsions,
which contain certain vegetable oils, e.g.,
oleic acid, in combination with limewater,
and are prepared simply by mixing equal
volumes of the oil and limewater.
Identification of emulsion type
•  O/W and W/O
–  Miscibility test
–  Conductivity test
–  Dye-solubility test (amaranth water soluble,
sudan III or Scarlet red soluble in oil)
–  Fluorescence test
Phenomena associated with the
physical stability are:
l Creaming
–  Creaming is the upward movement of
dispersed droplets relative to the continuous
phase
–  Downward creaming
–  These phenomena are based on the densities
of the dispersed and continuous phase
Phenomena associated with the
physical stability are:
l Aggregation and coalescence.
–  Aggregation (flocculation) is the coming
together of the dispersed droplets which
results to creaming.
–  Coalescence is the complete fusion of
droplets. Aggregation precedes coalescence.
Phenomena associated with the
physical stability are:
l Cracking
–  The coalescence of droplets results to
separation of the dispersed phase as a
separate layer
Causes of emulsion to crack or cream

•  Incorporation of excess dispersed phase

•  Globule size
•  Storage temperature
•  Potential for globule coalescence
•  Changes which affect the interfacial film
formed by the emulsifying agent
Phenomena associated with the
physical stability are:
•  Phase inversion – when an emulsion
change from o/w to w/o.
•  the most stable range of dispersed phase
concentration is 30% to 60%.
•  If the amount of the dispersed phase
approaches or exceeds a theoretical
maximum of 74% of the total volume,
then phase inversion may occur.
Dispensing of emulsion

•  Emulsions can be extemporaneously

prepared on a small scale using mortar
and pestle in such cases, proper labeling
should be observed during dispensing.
Dispensing of emulsion

•  Emulsions are packed using tight, amber-

colored containers, preferably wide mouth
for easy pouring.
•  Emulsions should be stored at room
temperature, special labeling such as
“shake well before use” should be
attached to the container
•  Emulsions are affected by heat, cold, light,
air and microorganisms
 EMULSION
q  Method of Identifying Emulsion
ü 1. Drop Dilution Test
q  add water (drop) àhomogenous à o/w
ü  2. Dye Solubility Test
q  oil soluble à sudan red à w/o
q  water soluble à amaranth green à o/w
ü  3. Electronic Conductivity Test
q  water conduct electricity à o/w
ü  4. Fluorescence Test
q  oil can absorb UV light à w/o
PREPARATION 12
MINERAL OIL EMULSION
q  Category
ü  Oral Emulsion
PREPARATION 12
MINERAL OIL EMULSION
q  Synonym
ü  Liquid Petrolatum Emulsion
PREPARATION 12
MINERAL OIL EMULSION
q  Description of Final Product
ü  It is a whitish yellow color
PREPARATION 12
MINERAL OIL EMULSION
q  Use
ü  employed as lubricating
cathartic with a usual dose of
30 mL
PREPARATION 12
MINERAL OIL EMULSION
q  Formulation
Ingredients OA CA

Mineral oil 500 mL 15 mL

Acacia 125 g 3.75g

Syrup 100 mL 3mL

Vanillin 40 mg 1.2g

Alcohol 60 mL 1.8

Purified water, qs ad 1000 mL 30mL

 MINERAL OIL EMULSION
Procedure: what method is
used here?
1.  Triturate mineral oil
2.  Add emulsifying agent in portion and
triturate
3.  Add water and triturate
4.  Add syrup in portion in trituration
5.  Add vanillin, previously dissolved in
alcohol, in portion with trituration
6.  Add enough water to 30 mL
 MINERAL OIL EMULSION
q  Procedure: what method is
used here?
1.  Triturate emulsifying agent
2.  Add water (all at once) and continue
triturating
3.  Add oil in portion with trituration
4.  Add syrup in portion with trituration
5.  Add vanillin previously dissolved in
alcohol in portion with trituration
6.  Add enough water to make 30 mL
 MINERAL OIL EMULSION
q  Label
White, with Shake Well instruction

q  Container
30 mL wide mouth, amber bottle
 MINERAL OIL EMULSION
q  Remarks
ü  Mineral oil as cathartic, acacia,
as suspending or an emulsifying
agent, syrup as a sweetening
agent, vanillin as a flavorant and
alcohol as preservative.
PREPARATION 13

LOTION
q  Lotion
•  Are aqueous liquid or sometimes alcoholic
preparation containing insoluble materials
in the form of suspension or emulsion
intended for external application without
rubbing.

•  an o/w emulsion with a high water content

to give the preparation a liquid consistency
can be considered a lotion
LOTIONS
•  Contain one or more active ingredients and a
suitable vehicle and are used for the treatment
of skin diseases, or as an antiseptics, anti-
pruritics, astringents or protectives.
•  most lotions are aqueous or
hydroalcoholic systems; small amounts of
alcohol are added to aid solubilization of
the active ingredient(s) and to hasten
evaporation of the solvent from the skin
surface
 LOTION
Methods of Preparation
1.Dispersion – Triturating the ingredients
to a smooth paste (Levigation) and then
cautiously adding the remaining liquid phase
(with the use of high speed mixers and
homogenizers)

Example: Calamine Lotion

 LOTION
q  Method Preparation
2. By Chemical Interaction

Example: White Lotion

ZnSO4 + Sulfurated potash (K2S3) à
ZnS + 2S + K2SO4
 LOTION
q  Method Preparation
3.Simple Solution in which the active
ingredient is a water soluble substance

Example: Dimethisoquin hydrochloride

lotion
PREPARATION 13
CALAMINE TOPICAL LOTION
q  Synonyms
•  Lotio Calaminae
•  Calamine is Zinc oxide and
0.5% Ferric oxide(Fe2O3)
•  The lotion is described as liquid
suspension or dispersion that is
pink in color
 CALAMINE TOPICAL LOTION
q  Use/s
ü  astringent
ü  antipruritic
ü  topical protectant and soothing
lotion sunburn
ü  treatment for ivy poisoning
ü  skin protectant
q  Formulation
Ingredients OA CA
Calamine 80 g
Zinc oxide 80 g
Glycerin 20 mL
Bentonite magma 250 mL
Calcium hydroxide, qs ad 1000 mL 30mL

•  Dilute bentonite magma with an equal volume of calcium

hydroxide topical solution
•  Mix calcium and zinc oxide alternately with glycerin to form a
smooth paste
•  Add 7.5 mL of diluted magma
•  Triturate and add the remaining magma
•  Add enough calcium hydroxide topical solution to complete
volume
 CALAMINE TOPICAL LOTION
q  Label
RED label with SHAKE Well
instruction
q  Container
30 mL wide mouth, amber bottle
 CALAMINE TOPICAL LOTION
USES
ü  Method à levigation and trituration
ü  Ferric oxide à characteristics of pink color
ü  Calamine à skin protectant, astringent, antiseptic
ü  Zinc oxide à skin protectant, astringent antiseptic
ü  Glycerin à humectant, wetting agent, levigating agent
ü  Bentonite à suspending agent
ü  Calcium hydroxide - astringent