Date Page no.PRACTICAL-4

AIM: To study effect of lubrication time in formulation of oral tablet prepared by wet granulation, using Paracetamol as model drug.

Formula: Each tablet contains Paracetamol IP 300mg.

Excipients q.s.

Batch size: 50 tablets

Packaging:Aluminum foil strip of 10 tablets.

FORMULATION:

INGREDIENTS QUANTITY PER TABLET

QUANTITY PER 20 TABLET

Role of each ingredients

Paracetamol 300 mg 15 g APIMicrocrystalline cellulose 60 mg 3 g DiluentStarch paste (10%w/v) q.s. q.s. BinderSodium starch glycolate 24 mg 1.2 g SuperdisintegrantTalc 2 mg 0.1 g GlidantMagnesium stearate 8 mg 0.4 g LubricantAerosil 3 mg 0.15 g GlidantTotal **

Expression isfaulty **

19.85 g

PROCEDURE:I. Wet granulation of Paracetamol IP. Paracetamol, sodium starch glycolate and microcrystalline cellulose were

mixed thoroughly and sifted through 40 # sieve. A 10%w/v starch paste was prepared and weighed quantity was added to dry

mixture, gradually to prepare desired wet mass, which was granulated through 10 # sieve and granules were dried in tray drier.

The dried granules were sized through 20# sieve and checked for yield, appearance and quantity of fines. The results were reported.

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Observation tables:

Table 1 Granules characteristics

B.no Appearance Yield Wt of fines Moisture content

Table 2 Evaluation of compressed tablets of Paracetamol

PARAMETER B1 (5 mins) B2 (10 mins) B3 (15 mins) B4 (20 min)Hardness (kg/cm2)DisintegrationTime (sec)Disintegration patternCumulative drug release in 30 mins

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II. Lubrication of granules: Talc, magnesium stearate and Aerosil 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,

varying mixing time 5min,10 min, 15,20 and 30 min. 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 and dissolution tests.

The results were compiled and commented upon. Graph: Dissolution profiles.

CONCLUSION:Paracetamol is sparingly soluble drug having slight hydrophobic nature. This characteristic may hinder the rate of de-aggregation after disintegration of tablets.

The function of lubricants in tablet are:

To decrease friction between tablet and the die wall. To coat each granule properly to facilitate the distribution of compression

force evenly. To impart bonding between the particles upon compression.

But excessive lubrication (either higher concentration or prolonged lubrication ) impart hydrophobicity to the granules which affects disintegration , de-aggregation and consequently dissolution time of the tablets, the time may be extended, which is not desired. The present experiment evaluates the effect of lubrication time on disintegration and dissolution time of compressed tablets.

The results show that

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DISSOLUTION STUDY:

BATCH

TIME(mins)

ABSORBANCE

CONCENTRATION(µg/ml)

CONCENTRATION(mg/5ml)

CONCENTRATION(mg/900ml)

Cumulative concentration

%DR

CPR

B-1 0102030

B-2 0102030

B-3 0102030

B-4 0102030

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REFERENCE :Pharmaceutical dosage forms: Tablet volume 1, edited by Herbert A Liebermann and Leon Lachmann, pg no. 136.