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PRACTICAL-5

AIM: To prepare and evaluate immediate release tablet formulation hydrophobic

API by wet granulation method and to study the effect of addition pattern of
disintegrating agent by key parameters disintegration time and pattern of addition
Formula: Each tablet contains Zinc oxide 125mg.
Excipients q.s.
Batch size: 20 tablets
Packaging: Aluminium foil strip of 10 tablets.
FORMULATION:
Formulation

Role
of F1
each
ingredient

F2

F3

F4

F5

Zinc oxide

Drug

125 mg

125 mg

125 mg

125 mg

125 mg

Lactose(mg)

Diluent

375 mg

375 mg

375 mg

375 mg

375 mg

Starch paste (10%w/v)

Binder/D.T

q.s

q.s

PVP+water (10%w/v)

Binder

q.s

q.s

q.s

Starch powder activated Disintegrant with water(10%w/v)

MCC

Disintegrant -

5%

SSG(external)

Disintegrant -

2%

SSG(internal)

Disintegrant -

2%

Talc

Glindant

1%

1%

1%

1%

1%

Mg stearate

Lubricant

2%

2%

2%

2%

2%

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Observation table:
DISINTEGRATION TIME STUDY:
The prepared tablets were put into disintegrating apparatus and note the time till no
palpable mass seen.
FORMULATI
ON
F1
F2
F3
F4
F5

TIME
(mins)

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PROCEDURE:
1. Wet granulation method:
Formulation F1: Zinc oxide, lactose, starch-5% as inter granular disintegrating
agent were weighed accurately according to formula, mixed thoroughly in mortar
and starch paste (10%) was added drop wise to get damp mass.
Formulation F2: Here, starch power activated with water was added drop wise in
formula to get damp mass.
Formulation F3: According to formula MCC and other ingredients and starch paste
(10%) was added drop wise to get damp mass.
Formulation F4: Zinc oxide, lactose were weighed accurately according to formula,
mixed thoroughly in mortar and PVP+water(10%w/v) was added drop wise to get
damp mass. SSG-2% as external granular disintegrating agent added.
Formulation F5: Zinc oxide, lactose, SSG-2% as inter granular disintegrating agent
were weighed accurately according to formula, mixed thoroughly in mortar and
PVP+water(10%w/v) was added drop wise to get damp mass.
This damp mass was passed through a sieve no. 16 and the obtained granules were
dried in hot air oven at 60C.

2. Lubrication of granules
Talc and magnesium stearate were weighed accurately in quantity required, and
mixed properly by tumbling method. (in dry glass beaker or in plastic bag).
The granules were tapped on 40# sieve to collect fines. The fines were mixed with
lubricant mixture by same tumbling method. The lubricated fines were mixed with
remaining granules by tumbling, ensuring complete mixing. (Gentle mixing).
The tablets were compressed from each batch of granules, with target hardness 3-4
kg and target weight of ________mg. and evaluated for key parameters like
disintegration time.

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Comment:
Disintegrating agents work by different mechanism like capillary action,
swelling, bursting, and gas adsorption etc. Addition patterns like internal
disintegrant (during granulation), external disintegrant (after granulation)
affect time of disintegrate and mechanism pattern of disintegrant.
In this practical study disintegrant agent is added in formula by different
method and effect on performance is investigated.
Observation shows external addition of SSG leads to faster disintegration as
comparison to internal addition.

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REFERENCE :
Pharmaceutical dosage forms: Tablet volume 1, edited by Herbert A Liebermann
and Leon Lachmann.