PRACTICALAIM: 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
Batch size:

q.s.

50 tablets

Packaging: Aluminium foil . strip of 10 tablets.

FORMULATION:
INGREDIENTS

Paracetamol
Microcrystalline
cellulose
Starch paste
(10%w/v)
Sodium starch
glycolate
Talc
Magnesium stearate
Aerosil

QUANTITY
/ TABLET)

QUANTITY
TAKEN

300mg
60 mg

15g
3g

q.s.

q.s.

24mg

1.2g

2mg
8mg
3mg

0.1g
0.4g
0.15g

Roll of
each
ingredien
ts

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.no

Appearance

Yield

Wt of fines

Moisture
content

Table 2 Evaluation of compressed tablets of Paracetamol

PARAMETER
Hardness
(kg/cm2)
Disintegration
Time (sec)
Disintegration
pattern
Cumulative
drug release
in 30 mins

B1 (5 mins)

B2 (10 mins)

B3 (15 mins)

B4 (20 min)

DISSOLUTION STUDY:
BATC
H

TIME
(mins
)

B-1

0
10
20
30
0
10
20
30
0
10
20
30
0
10
20
30

B-2

B-3

B-4

ABSO
RBAN
CE

CONCE
NTRATI
ON
(g/ml)

CONCE
NTRATI
ON
(mg/5
ml)

CONCENT
RATION
(mg/900
ml)

Cumulative
concentrati
on

%D
R

CPR

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.