Beruflich Dokumente
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Page no.
PRACTICAL: 10
Aim:To prepare stable oral suspension of API with low dose and high dose and
to study the effect of solid content on dose uniformity and stability and compare
with marketed formulation.
Formula:Each 5 ml contains
Ingredients
Quantit Quantity
y given taken (A)
Role of ingredients
Barium sulphate
100 gm
31.25
20
40
API
Poly
vinyl 5
pyrrolidone (pvp)
1.56
1.56
1.56
0.125
0.125 0.125
Suspending agent
0.125
0.125 0.125
Antioxidant
Methyl paraben
1.2
0.2
0.2
0.2
Preservative
Propyl paraben
0.12
0.02
0.02
0.02
Preservative
Water
320 ml
100 ml
100
ml
100 ml
Vehicle
Date
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Observation table:
1. Particle Size Distribution:
Calibration Factor:
No. of divisions of stage micrometer= 10(y)
No. of divisions of eye piece micrometer=7.1(x)
(y/x)*10= 10/7.1*10
= 14.08m
MEAN(d)
NO.
OF f*d
PARTICLES(f)
Date
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Ingredients
Qty given
Paracetamol
0.5 gm
Citric acid
0.5 gm
Sodium citrate
0.5 gm
Polyvinyl pyrrolidone
5 gm
Orange flavor
0.1 ml
Dextrose
30 gm
Water
58.9 ml
Qty taken
Marketed formulation:
Paracetamol suspension:
Content:
Volume: 100 ml
Company Name:
Procedure:
1.Method of preparation:
For high dose formulation:
Methyl paraben, propyl paraben and sodium cmc was dissolved in hot water.
PVP and sodium bisulfite was added to obtain the clear solution.
Barium sulphate was lastly suspended in the above solution.
Date
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RANGE
MEAN(d)
NO.
OF f*d
PARTICLES(f)
Time
(min)
Paracetamol 0
suspension
10
20
30
40
50
60
Initial
Ultimate
SVR
Average
Height
Height(Hu)
SVR
(H0)
LF MF LF
MF LF MF LF MF
Date
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2. Method of characterization:
i.
Redispersibility:
It was performed by keeping the suspension in 10 ml measuring
cylinder and keeping it untouched for 4-5 hours.
The number of strokes needed to redisperse the suspension was noted.
ii.
iii.
iv.
Pourability:
It was performed by allowing the suspension to pour from bottle.
v.
Aspect:
It was done to visualize overall aspects of the suspension.
vi.
Viscosity:
It was measured by brookefield viscometer.
vii.
Colour:
Colour was determined by visual inspection.
viii.
Density:
It was measured using specific gravity bottle.
Date
TIME(MINS) H0
Page no.
HU
0
10
20
30
40
50
60
EVALUATION
PARAMETER
Low dose preparation
Colour
Odour
Flavor
pH
Viscosity
No.of inversions
High dose preparation
Colour
Odour
Flavor
pH
No.of inversions
Viscosity
OBSERVATION
SVR
Date
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Comment:
1. Oral suspension having potent drug should ensure uniformity of dose
throughout the shelf life.Low amount of solids is to be kept in well
distributed form.This is achieved by complete and efficient
deflocculation.This is also facilitated by use of structured vehicle but the
viscosity of the formulation should not be affected throughout the shelf-life
and should not affect the pourability of the dosage form.
2. Oral suspension having high amount of solids should have minimum
sedimentation throughout the shelf-life to ensure dose uniformity and
elegance.This is achieved by controlled flocculation in structured vehicle or
controlled deflocculation in structured vehicle.
3. In present study, attempt is made to prepare efficient stable suspension of
high dose API and potent API.
Reference:
1.Modern dispensing pharmacy by R.S.Gaud; page no:175
2.Industrial pharmacy by Leon Lachman, Herbert Lieberman; special Indian
edition 2009; page no:498.