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Mineral Oil Emulsion

REVIEW OF BASIC CONCEPTS

Dispersed Liquid preparation


Official Title Mineral Oil Emulsion, USP System containing undissolved or
immiscible drugs distributed
Category Cathartic throughout a vehicle.
Synonyms Liquid Petrolatum Emulsion,
Emulsion Two-phase systems in which
Liquid paraffin Emulsion
one liquid is dispersed
Uses Laxative for oral throughout another liquid in
administration, treat the form of droplets.
constipation
Primary The initial emulsion formed
Official Mix the Mineral Oil with Emulsion after incorporating all the
Definition the Powdered Acacia in a appropriate amounts of
dry mortar, add 250 mL of oil, water, and gum
Purified Water all at once, depending on the method
and emulsify the mixture. used.
Then add, in divided Emulsion Another name for primary
portions, triturating after Nucleus emulsion
each addition, a mixture
of the Syrup, 50 mL of
Purified Water, and the 3 SMALL SCALE EXTEMPORANEOUS
METHODS OF PRIMARY EMULSION
Vanillin dissolved in the
alcohol. Continental/ · Trituration with the gum.
Finally add Purified Water Dry Gum
to make the product Method · 4 parts of oil is first
measure 1000 mL, and mixed with 1 part of gum
mix.
· 2 parts of water is
The Vanillin may be then added all at once
replaced by not more
than 1 percent of any · Triturate the mixture
other official flavoring immediately, rapidly, and
substance or any mixture continuously until a creamy
of official flavoring white primary emulsion is
substances. Sixty mL of formed
sweet orange peel · Crackling sound to
tincture or 2 g of benzoic the movement of the
acid may be used as a pestle is heard.
preservative in place of
the Alcohol. English/ Wet · Triturate mucilage with
Gum Method the oil

· Trituration with the


gum
· 1 part of the gum is
first mixed with 2 parts of
water.
AGGREGATION of the
Flocculation dispersed droplets due to
intermolecular attraction.
· The 4 parts of oil is
then added slowly in
parts and the mixture is
triturated to make the
emulsion.
DOWNWARD movement of
Bottle/ Forbes Triturate mucilage with
· Sedimentation the dispersed droplets
Bottle Method the oil.
due to a difference in
· Trituration with the gum.
density between the
· Like the Dry Gum
internal and external
Method but instead 1-part
phase.
of the gum is first mixed
with 2 parts of water.
· The 4 parts of oil is
then added slowly in
parts and the mixture is SEPARATION of the
triturated to make the Coalescence dispersed and continuous
emulsion. phase.
REASONS FOR IMPORTANT STEPS

1. Why is an emulsifying agent needed in


the formulation of an emulsion?
- An emulsifying agent (emulsifier) Change of an emulsion
will reduce the interfacial tension Phase from one type to
between the two immiscible Phases and Inversion another.
form a stable emulsion.
2. Why are the spans and tweens used in - (ex. adding oil to the point that
blends, rather than as a single emulsifying o/w becomes w/o)
agent?
- To achieve required HLB value
to stabilize the emulsion.
3. What does levigation do? FORMULA
- Levigation forms a paste, generates
friction which reduces particle size.

TERMINOLOGIES

UPWARD movement of
Creaming the dispersed droplets
due to a difference in
density between the
internal and external
phase.
INGREDIENTS
Packaging Preserve in tight containers;
15 mL clean flint bottle

Mineral Oil Active ingredients


Labeling Shake well before use

Acacia Emulsifying agent


Container 15 mL flint bottle (clean)
PROCEDURE
Syrup Sweetener
1. Mix 5.0 mL Mineral Oil with 1.25
g Powdered Acacia in a dry mortar.
Alcohol Preservative
2. Add 250 mL of Purified Water all
at once, and emulsify the mixture until it
Purified Water External phase
is creamy white and produces a
QUALITY CONTROL/ PACKAGING crackling sound to the movement of the
Vanillin Flavorant pestle.

RFIS: Purified water is added all at once


Official Title Mineral Oil Emulsion, USP to ensure uniform distribution. Water
should be swirled in the mortar to
remove the remaining portions of the
Appearance White, milky opaque, emulsion.
homogenous mixture 3. Add, in divided portions, triturating
after each addition, a mixture of the 1
mL Syrup, 0.5 mL of Purified Water, and
pH 4.5-5
Vanillin dissolved in the alcohol.

Pourability easily pourable RFIS: Other ingredients soluble in the


external phase are then added with
trituration to disperse them evenly.
Redistribution Easily dispersed upon
shaking 4. Finally add Purified Water to make
the product measure 10.00 mL, and mix

Particle Size >1um: Milky IDENTIFICATION TEST FOR DETECTION

Physical No creaming, DILUTION TEST It can be diluted with


Stability sedimentation, flocculation, water
coalescence, and phase
inversion
CONDUCTIVITY Lamp will glow’
TEST

DYE-SOLUBILITY Colorless globules


against a colored
background

CoCl2 FILTER Blue filter paper turns


PAPER TEST pink

FLUORESCENCE Spotty fluorescence


TEST

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