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PRACTICAL- AIM: REQUIRMENTS: Mortar pestle, spatula, butter paper, sieves, tablet punching machine, plastic bag, Disintegration apparatus, etc. REFERENCE : FORMULA: For mul ati on Parace tamol (mg) Lact ose (mg) Sta rch pas te (10 % w/v ) Starc h powde r activ ated with water (10% w/v) MCC SSG (extern al) (PVP+wa ter) SSG (Inter nal) (PVP+w ater) Ta lc Mg stea rate F1 125 375 q.s - - - - 1% 2% F2 125 375 - q.s - - - 1% 2% F3 125 375 q.s - 5% - - 1% 2% F4 125 375 - - - 2% - 1% 2% F5 125 375 - - - - 2% 1% 2% PROCEDURE: Wet granulation method:

Disintegrating Agent New 2

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Page 1: Disintegrating Agent New 2

PRACTICAL-

AIM:

REQUIRMENTS: Mortar pestle, spatula, butter paper, sieves, tablet punching machine, plastic bag,

Disintegration apparatus, etc.

REFERENCE :

FORMULA:

Formulation

Paracetamol (mg)

Lactose (mg)

Starch paste (10% w/v)

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

MCC

SSG (external)(PVP+water)

SSG (Internal)(PVP+water)

Talc

Mg stearate

F1 125 375 q.s - - - - 1% 2%F2 125 375 - q.s - - - 1% 2%F3 125 375 q.s - 5% - - 1% 2%F4 125 375 - - - 2% - 1% 2%F5 125 375 - - - - 2% 1% 2%

PROCEDURE:

Wet granulation method:

Formulation F1: Paracetamol, lactose, starch-5% as inter granular disintegrating agent were weighed accurately according to formula, mixed throughly 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.

Page 2: Disintegrating Agent New 2

Formulation F3: According to formula MCC and other ingredients and starch paste (10%) was added drop wise to get damp mass.

Formulation F4: Paracetamol, lactose were weighed accurately according to formula, mixed throughly in mortar and PVP(10%)+water was added drop wise to get damp mass. SSG-2% as external granular disintegrating agent added.

Formulation F5: Paracetamol, lactose, SSG-2% as inter granular disintegrating agent were weighed accurately according to formula, mixed throughly in mortar and PVP(10%)+water 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 60ºC.

The obtained dried granules were again passed through sieve no: 40.

For lubrication:

Dried granules were weighed. The yield was found (theoretical and practical).

The required quantity of lubricants was calculated on the basis of practical yield. The granules were tapped on 40# sieve and the fines were collected. The fines were weighed (should not be more than 15% w/w of granules).

Lubricant was mixed with fines by tumbling method.

The lubricated fines were mixed with the remaining granules by tumbling method.

Formulation of tablets:

The granules of F1, F2, F3, F4 and F5 were compressed using rotaty punch tablet machines the hardness of the tablets was adjusted to optimum levels with required amount of compression force.

Page 3: Disintegrating Agent New 2

DISINTEGRATION TIME STUDY:

The prepared tablets were put into disintegrating apparatus and note the time till no palpable mass seen.

FORMULATION

TIME(mins)

F1F2 F3F4F5

Page 4: Disintegrating Agent New 2

EVALUATION PARAMETERS:

1. Disintegration time

RESULT:

PARAMETER F1 F2 F3 F4 F5DisintegrationTime (sec)

CONCLUSION:

Page 5: Disintegrating Agent New 2

RESULT: