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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

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

QUANTITY
PER
TABLET
300 mg
60 mg
q.s.
24 mg
2 mg
8 mg
3 mg
397 mg

QUANTITY
PER
20
TABLET
15 g
3g
q.s.
1.2 g
0.1 g
0.4 g
0.15 g
19.85 g

Role of each
ingredients
API
Diluent
Binder
Superdisintegrant
Glidant
Lubricant
Glidant

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

B2 (10 mins)

B3 (15 mins)

B4 (20 min)

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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:
BAT
CH

TIM
E
(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

ABS
ORB
ANC
E

CONC
ENTR
ATIO
N
(g/ml)

CONC
ENTR
ATIO
N
(mg/5
ml)

CONCE
NTRATI
ON
(mg/900
ml)

Cumulative %D
concentrati R
on

CPR

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