DIAZEPAM TABLETS I.P. - EXPERIMENT

EXPT NO: 03                                                                                                            DATE:

DIAZEPAM TABLETS I.P.

AIM: To prepare and submits 10 Tablets of Diazepam I.P

FORMULA:

S. No.	Ingredients	Qty for 1 Tab	Qty for ____ Tab
1	Diazepam	5 mg
2	Lactose	95 mg
3	Starch Powder	10 mg
4	Starch Paste (10% w/w)	Q.S
5	Magnesium Stearate	1 mg
6	Talc	1 mg

PRINCIPLE:

Method involved in manufacturing of Diazepam tablet IP is wet granulation. In this process the powder is converted to granules using granulating agent. This is done in order to provide good flow properties & compressibility to powders. Thus the granules obtained are subjected to drying & thereafter passed through a sieve no.22 to achieve granules of uniform size. Thus process of wet granulation can be given as.

Drug + Diluents + Granulating agent  à wet mass à wet screening

Drying à dry screening à  mixing of excipients à compression

In Diazepam tablet P. Lactose is used as diluents, as the quantity of drug is too small. Starch paste is used as binders or adhesive (which is used to prepare wet mass) or granulating agent. Starch powder is used a disintegrating agent and Magnesium stearate & Talc used as lubricant, glidant & anti-adherent.

PROCEDURE:

Method used is wet granulation. Required quantity of Diazepam is taken with lactose and starch powder in dry mortar. Mix well by trituration, to this adds sufficient quantity of starch paste. Mix well until it is converted to coherent mass. This mass is passed through # no. 12 to get wet granules. Dry the granules in hot air oven at temperature not more than 60°C. Passing through sieve no.223 over 44 regranulates the dried granules.

The fines that have passed are collected and amount equivalent to 15% of weight of granules is added to granules. Total weight of granules so obtained is found out. The required quantities of talc (1%) are mixed with granules in geometric progression. These granules are then compressed into tablet.

USE: As sedative, Hypnotic, Anxiolytic and CNS depressant.

STORAGE: Store in a cool place in airtight container.

STRENGTH: Each tablet contains 5mg of Diazepam I.P.

DOSE: As directed by physician

REFERENCE: The theory & practice of industrial pharmacy by Lachmann & Liberman III Edition.