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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

Batch size:100 ml.

Packaging: Narrow mouth glass bottle with metal screw cap.
Pack size: 60 ml.
Formulation:
(a)

High dose preparation

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

Stabilizer and thickner

Sodium carboxy 0.4

methyl cellulose

0.125

0.125 0.125

Suspending agent

Sodium bisulphite 0.4

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

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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

a) For low dose formulation:

RANGE

MEAN(d)

NO.
OF f*d
PARTICLES(f)

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(b) low dose preparation :

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.

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b) For high dose formulation:

RANGE

MEAN(d)

NO.
OF f*d
PARTICLES(f)

SVR of low dose formulation

Suspension

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

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For low dose formulation:

Solution of dextrose was prepared in water.
Citric acid, sodium citrate, PVP, PCM, orange flavour were added with
continuous stirring in the same sequence as mentioned above.
White suspension was obtained.

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.

Sedimentation volume ratio:

It was performed by keeping the suspension in 10 ml measuring
cylinder and noting the volume of sediment at regular time interval.

iii.

Particle size analysis:

It was done using ocular disk and stage micrometer.

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.

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TIME(MINS) H0

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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

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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.