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PRACTICAL-9

AIM: To prepare stable oral suspension of wettable/non wettable API and

to study the effect on stability of suspension.
a) Wettable solids
b) Non wettable solids
A.) WETTABLE SOLIDS:

Formula: each 5ml contains Barium sulphate 1.56g,

base

.q.s.

Batch size: 100 ml.

Packaging: Narrow mouth clear glass bottle with metal screw cap.
Formula:
INGREDIENTS

QUANTITY/ml QUANTITY
ROLE
OF
TAKEN (100 ml) EXCEPIENT

Barium sulphate

0.31g

31.25 g

API

F 0.0156g

1.56 g

Stabilizer and
thickner

Kollidon
(PVP)

90

Sodium CMC

0.00125g

0.125 g

Suspending
agent

Sodium bisulfite

0.00125g

0.125 g

Antioxidant

Methyl paraben

0.002g

0.2 g

preservative

Propyl paraben

0.0002g

0.02 g

preservative

Water

q.s. 1ml

q.s. 100 ml

Vehicle

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Observation table:
1) Organoleptic properties:
Type of API

Color

Odor

Wettable
Non-wettable
Gelusil
(marketed
preparation)
Ulgel
(marketed
preparation)

2) pH:
Type of API

pH

Wettable
Non-wettable
Gelusil (marketed preparation)
Ulgel (marketed preparation)

3.) Density:
Type of API
Wettable
Non-wettable

Density (gm/L)

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Procedure:
Methyl paraben, sodium CMC, propyl paraben were dissolved in hot
water.
Kollidon and sodium bisulphite were added to it and was stirred till clear
solution was obtained.
Barium sulphate was added to the above solution.

B.) NON-WETTABLE SOLIDS:

Formula: Each 5ml contains Ibuprofen 0.2g,
base

.q.s.

Batch size: 100 ml.

Packaging: Narrow mouth clear glass bottle with metal screw cap.
Formula:
INGREDIENTS QUANTITY/ml

QUANTITY
TAKEN(100 ml)

ROLE
OF
EXCEPIENTS

Ibuprofen

0.04g

4g

API

Sucrose

0.25g

25 g

Sweetner

10 g

Stabilizer
thickner

Kollidon
M(PVP)

Cl- 0.1g

Sodium citrate

0.02g

2g

Suspending
agent

Water

q.s. 1ml

q.s. 100 ml

Vehicle

PROCEDURE:
Sucrose, 8g kollidon, sodium citrate were dissolved in 40ml water.
2g kollidon and ibuprofen were suspended in this solution and stirred.
Water as added to make up the volume.

and

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4.) Sedimentation parameter:

Type of API

Wettable

Non-wettable

Gelusil
(marketed
preparation)

Time
(min)

Initial
height(cm)
H0

Final height
(cm)Hu

Ratio
(Hu/H0)

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Evaluation parameters:
1.
2.
3.
4.
5.

Organoleptic properties: colour and odour were observed visually.

pH: With pH strip
particle size distribution: By microscopy method
Density: With pycnometer.
Sedimentation parameters:
10 ml of suspension was filled in a measuring cylinder of 10 ml.
It was allowed to stand for 60 minutes.
Height of sediment was measured at time interval of 5,10, 20, 30, 40, 50
and 60 minutes.
The obtained values were kept in the formula to get sedimentation
volume ratio and sedimentation rate.
Redispersibility was checked by redispersing the suspension after 60
minutes and number of inversions required for redispersion was checked.

Conclusion:
1.) In oral suspension formulation dose uniformity is to be ensured by
uniform dispersion of API throughout the shelf life. The nature of API
like hydrophilicity /hydrophobicity affects the uniform dispersion and
requires the use of wetting agents.
2.) The wetting agents are surfactants which displace the air around the
particle, reduces the contact angle, reduces the interfacial tension and
facilitates the wetting of particles. The wetting can be immersion wetting
or surface wetting
3.) The poorly wettable substances after made hydrophilic b surfactant also
needs to be in deflocculaed form, to ensure complete dispersion
throughout the shelf life.
4.) Wettable drug is better stabilized by controlled flocculation in structured
vehicle. In present study the stability of oral suspension formulation of
wettable and non wettable drug is investigated by key parameters like
degree of flocculation, SVR, nature of sediment, redispersibility and
particle size distribution.

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Ulgel
(marketed
preparation)

5.) Redispersibility:
Type of API
Wettable
Non-wettable
Gelusil (marketed preparation)
Ulgel (marketed preparation)

No. of inversion

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REFERENCE: Generic drug formulation, Volker Buhler, 2nd edition;

Pharmaceutical dosage forms: disperse system by Herbert A libermann, Martin
M Rieger and Gilbert S Banker, 2nd edition, volume-2, Pg no- 26

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3.) Particle size distribution:

TYPE OF API
Wettable

Non-wettable

Gelusil
(marketed
preparation)

Total
Ulgel (marketed
preparation)

Total

SIZE
MEAN
SIZE No.
OF f*d
RANGE RANGE(d m) PARTICLES (f) (m)