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PRACTICAL-13
AIM- To Prepare and Evaluate Stable topical Suspension Of given
API & study effect of different humectants.
FormulaEach 5 ml of topical suspension contains API Precipitated sulphur
Excipients - q.s.,
Batch size- 40 ml
Packaging- Narrow mouth glass bottle with metal screw cap.
FormulationFORMULA:
Ingredients
Precipitated
sulphur
Humectant
Quantity
for 30 ml
1.5 gm
1.5 ml
Sodium lauryl 0.075 gm
Sulphate
Alcohol (95%) 4.5 ml
Rose Water
30 ml
Quantity for 40 ml
Glycerine
4.5 gm
PG
4.5 gm
Sorbitol
4.5 gm
15%(4.5
ml)
0.075
10%(3
ml)
0.075
12%(3.6
ml)
0.075
humectant
4.5
26.42 ml
4.5
27.92 ml
4.5
27.32 ml
co solvent
Vehicle
Ideal Humectant Concentration:
Glycerin-30%
Propylene Glycol-15%
Sorbitol-3-15%
Role of ingredients
API
Suspending agent
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Observations:
1. Appearance2. pH value:
Humectant
pH
Glycerine
PG
Sorbitol
3. Sedimentation Parameters:
a.) Sedimentation volume ratio
Humectant Time(min)
Initial
height(ml)
Glycerine
10
20
30
40
50
60
PG
10
20
30
40
50
60
Sorbitol
10
20
30
40
50
60
Final
height(ml)
Ratio
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METHOD OF PREPARATION-
Ingredients such as zinc stearate, sodium lauryl sulphate were weighed and
transferred into mortar.
Humectant and alcohol were added as per quantity into mortar.
They all were triturated with continuous stirring with pastel.
Rose Water was added as quantity sufficient and mixed uniformly.
Prepared suspension was transferred to glass bottles.
Labelling was done.
Method of characterization1. Appearance
2. pH value
3. Sedimentation parameters
a.)Sedimentation volume ratio
b.)Sedimentation rate
c.)Redispersibility
4. Viscosity
5. Particle size distribution
6. Spreadbility
7. Occlusivity Test for water transdermal loss:
Specified volume of water was taken in preweighed bottle.
Formulation was applied on whattmann filter paper which permeable to
water.
Bottle was covered with cap.
At regular interval bottle was weighed & loss of water was determined.
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b.)Sedimentation rate:
Humectants
Glycerin
PG
Sorbitol
Sedimentation rate
4. Redispersibility:
Humectants
[Link] strokes
Glycerine
PG
Sorbitol
5. viscosity: [Brooke field viscometer]
Humectants
Rpm
Centipoises
Glycerin
PG
Sorbitol
6. Particle size distribution:
Factor calculation:
Humectant
Size range
Mean size
[Link]
particles(f)
fd
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COMMENT:
Humectant plays an important role in maintaining skin moisture. It prevents loss of
moisture from skin by forming occlusive layer on skin.
Skin moisture is essential in preventing skin dryness & prevent occurrence of
diseases like psoriasis, dermatitis, etc. The main objective of humectant is to
absorb water from high humidity surrounding atmosphere.
Various humectants like sorbitol, propylene glycol, glycerine etc. are used as
humectant in topical suspension formulations which maintains Occlusivity of skin
by preventing transdermal water loss.
In present study, Occlusivity test was done by using these humectants & results
were affected by various humectants with different concentration.
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Humectant
Size range
Mean size
[Link]
particles(f)
Fd
Humectant
Size range
Mean size
[Link]
particles(f)
Fd
Humectant
Size range
Mean size
[Link]
particles(f)
Fd
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REFERENCEPharmaceutical Dosage Forms: Disperse System Vol-2; Second Edition,
[Link], Leon Lachman and Joseph [Link]; Pg no.205,423
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7. Spreadibility
Humectant
Spreadbility
Glycerine
PG
Sorbitol
[Link]
Humectant
Glycerin
PG
Sorbitol
Humectant
Glycerin
PG
Sorbitol
Weight of bottle
After 3 days
After 5 days
% Transdermal water loss
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