PRACTICAL-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 tabletsPackaging:Aluminium foil . strip of 10 tablets.

FORMULATION: INGREDIENTSQUANTITY / TABLET)QUANTITY TAKEN Roll of each ingredients

Paracetamol300mg15g

Microcrystalline cellulose60 mg3g

Starch paste (10%w/v)q.s.q.s.

Sodium starch glycolate24mg1.2g

Talc2mg0.1g

Magnesium stearate8mg0.4g

Aerosil3mg0.15g

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.II. Lubrication of granules: Talc, magnesium stearate and Aerosil were weighed accurately in quantity required, and mixed properly by tumbling method. (in dry glss 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.Observation tables:Table 1 Granules characteristics B.noAppearanceYieldWt of finesMoisture content

Table 2 Evaluation of compressed tablets of Paracetamol

PARAMETERB1 (5 mins)B2 (10 mins)B3 (15 mins)B4 (20 min)

Hardness (kg/cm2)

DisintegrationTime (sec)

Disintegration pattern

Cumulative drug release in 30 mins

DISSOLUTION STUDY:BATCHTIME(mins)ABSORBANCECONCENTRATION(g/ml)CONCENTRATION(mg/5ml)CONCENTRATION(mg/900ml)Cumulative concentration%DRCPR

B-10

10

20

30

B-20

10

20

30

B-30

10

20

30

B-40

10

20

30

Comments: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------------------

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