Expt No: - 01

Date:-

PREPARATION AND EVALUATION OF PARACETAMOL GRANULES

AIM:- To prepare Paracetamol granules for 20 tablets and evaluate the parameters of bulk
density, angle of repose, compressibility index.
REQUIREMENTS:Paracetamol, Lactose, Starch paste, micro-crystalline cellulose, Stearic acid fine powder
Beakers, Glass rod, Mortar and pestle.
REFERENCES:1) Practical pharmaceutics by R.S.Gaud and G.D.Gupta, page No:- 242.
2) The theory and practice of industrial pharmacy by Leon Lachman, third edition, page No:
- 76 78.
3) Pharmaceutics I by R.M.Mehta, Page No :- 238 265.
PRINCIPLE:Paracetmol is chemically acetaminophen and it is non-steroidal anti-inflammatory drug
used as analgesic, lactose acts as diluents, dry starch powder acts as disintegrating agent, starch
paste or mucilage acts as binder or adhesive agent and it is used to form coherent mass. .
Several characteristics of finished granules are of major significance because they can
exert a pronounced influence on the progress of the subsequent tabletting process and the
properties of the tablets produced. Granules size distributions are best determined by test
sieving procedures. Granules should possess sufficient strength to withstand normal handling and
mixing processes without breaking down and producing large amounts of fine powder.
Bulk density plays an important role during compression of tablet whereas angle of
repose and compressibility index is used to determine the flow property of granules.

PROCEDURE:A) Preparation of aspirin granules:1) Accurately weigh the required amount of paracetmol, lactose; dry starch powder is taken
into mortar.
2) To this add the required quantity of starch paste. The adding is continued until to form a
coherent mass.
3) Pass the coherent mass through the sieve no 10 and the obtained granules are dried at 40
500 C in hot air oven.
4) The dried granules were passed through sieve no 20 to get uniform granules.
5) To this add calculated amount of talc and magnesium stearate.
6) Then the prepared granules were evaluated in the following parameters bulk density,
angle of repose and compressibility index.
S.NO
1
2
3
4
5

STANDARD
FORMULA
FOR ONE TABLET

INGEDIENTS
Paracetmol
Lactose
Micro-crystalline cellulose,
Starch paste
Stearic acid fine powder

300mg
150mg
138.35mg
Q.S
1.65mg

EVALUATION OF ASPIRIN GRANULES

A) Determination of angle of repose:1) The prepared granules were subjected for the determination of angle of repose.
2) Fix the funnel at distance of 6 cm.
3) The granules were passed through the fixed funnel and the heights, radius of the
pile were noted.
4) find out angle of repose by using formula,
= tan-1 h/r
= angle of repose
h = height of pile, cm
r = radius of pile in cm.
B) Determination of bulk density:1) Weigh the granules accurately and note down the weight.
2) The granules were transferred into 100 ml measuring cylinder, and tap the
cylinder at least 100 200 times.
3) calculate the bulk density by using formula,
Bulk density

Mass of granules
________________
Volume of granules

C) Determination of compressibility index:1) The granules were taken in 100 ml measuring cylinder and calculate fluffy
density.
Mass of granules
Fluffy Density = ---------------------------Fluffy volume
2) Tap the measuring cylinder at least 100 200 times and calculate the tapped density.
Mass of granules
Tapped density = -----------------------------Tapped volume
3) Then calculate the compressibility index by using formula.

I=

Tapped density fluffy density

----------------------------------------X 100
Tapped density

REPORT:The paracetamol granules were prepared for 20 tablets and the following parameters were
estimated.
Angle of repose
Bulk density
Compressibility index

=
=
=

Expt No: - 02
Date:-

PREPARATION AND EVALUATIONL OF PARACETAMOL TABLETS

AIM:- To prepare and evaluate paracetamol tablet by following evaluation tests;
1) Weight Uniformity
2) Content Uniformity
3) Disintegration
4) Dissolution
And some of the unofficial tests include Hardness and Friability.
REQUIREMENTS
Paracetamol, Lactose, Starch paste, micro-crystalline cellulose, Stearic acid fine
powder, single punch compression machine.
REFERENCES
1) Practical pharmaceutics by R.S.Gaud and G.D.Gupta, page No:- 242.
2) The theory and practice of industrial pharmacy by Leon Lachman, third edition, page
No :- 317 328, 346 373.
3) Pharmaceutics- I by R.M.Mehta, Page No :- 238 265.
PRINCIPLE:Tablets are the solid dosage form containing medicament of medicaments, usually
circular in shape and may be flat or biconvex. Tablets are prepared by the compression method
and are hence called the compressed tablet.
Advantages of tablets
1)
2)
3)
4)
5)
6)
7)
8)
9)

The tablets are easy to be administered.

They are easy to be dispensed.
These are more stable dosage form.
They maintain the accuracy of dosage.
Bitter and nauseous substances can be given easily in tablets form after giving a suitable
coating to the tablets.
They are the lightest and the most compact of all dosage forms.
Of all the dosage form, tablets are easiest and the cheapest regard packing and transport.
They are better suited to a large scale production as compare with any other unit oral
dosage form.
These are an economical dosage form.

Disadvantages of tablets
1) Some drugs resist compression into tablet form due to their amorphous nature or low
density character.
2) Bitter tasting drugs, drugs with objectionable odour or drugs that the sensitive to oxygen
or atmospheric moisture may require encapsulation or a special type of coating which
may increase the cost of the finished tablets.
3) Drugs with poor wetting and slow dissolution properties and difficult to convert into
tablets which provide full drug bioavailability.
Excipients used in formulation of tablets
An excipient is an inert substances which is added along with medicaments to prepare
the granules from the solid medicaments. The following are some of the excipients which are
generally required in the formulation of tablets.
1) Diluents
2) Granulating agents
3) Binding agents
4) Disintegrating agents
5) Lubricants
6) Adsorbents
7) Colouring agents, flavouring agents and sweetening agents.
Diluents
The diluents is needed in the formulation of a tablet when the quantity of medicament in
each tablet is very small and it is not possible to make a good tablet.
Ex:- Lactose
Sucrose
Sodium chloride
Dextrose,
Starch.
Granulating agents
These are used to convent the fine powder into granules. A granulating agent provided
proper moisture to convert fine powder into damp mass, which after passing through a sieve of
suitable number forms granules.
Ex:- Water,
Alcohol,
Mucilage of Starch,
Mucilage of Acacia.

Binding agents
These are used in granulation to provide proper strength to the granules, in order to keep
the tablet intact after compression.
Ex:- gelatin,
Sucrose,
Methyl cellulose,
Acacia powder.
Disintegrating agents
The substances which are added in the tablet formulation to ensure disintegrating of the
tablet into smaller particles when swallowed are called disintegrating agents.
Ex:- Potato starch,
Maize starch,
Weat starch,
Methyl cellulose and Bentonite.
Lubricants
These are added to improve the appearance of the tablet, flow properties of granules and to
prevent sticking of the materials to the dies and punches.
Ex:- Talc,
Magnesium stearate,
Calcium stearate.
Adsorbents
These substances are used to absorb volatile oils, liquid extracts and tinctures
Ex:- magnesium carbonate,
Kaolin, starch.
Colours, flavours and sweetening agents
The colours are added to the solution of the granulating agents.
Flavours are volatile oils and hence they are added into the granules just before the compression
of tablets. Sweetening agents are used to improve the taste of the tablet, these are used
chewable tablets and lozenges.
Ex:-

Sucrose,
Lactose,
Mannitol.

paracetamol is chemically acetaminophen and it is non-steroidal anti-inflammatory drug

used as analgesic, lactose acts as diluent, dry starch powder acts as disintegrating agent, starch
paste or mucilage acts as binder or adhesive agent and it is used to form coherent mass.

PROCEDURE:A) Preparation of paracetamol granules:1) Accurately weigh the required amount of paracetamol, lactose; dry starch powder is taken
into mortar.
2) To this add the required quantity of starch paste. The adding is continued until to form a
coherent mass.
3) Pass the coherent mass through the sieve no 10 and the obtained granules are dried at 40
500 C in hot air oven.
4) The dried granules were passed through sieve no 20 to get uniform granules.
5) To this add calculated amount of talc and magnesium stearate.
6) Then the prepared granules were evaluated in the following parameters bulk density,
angle of repose and compressibility index.
B) Preparation of paracetamol tablets
Prepared granules are used for the compressing the tablet by using single punch
compression machine.
EVALUATION OF PARACETAMOL TABLETS
Procedure:
Calibration curve:
1. weigh 10mg of paracetamol and dissolve in 3/4th of distilled water in 100ml volumetric
flask and make up the volume to the mark with distilled water.(100mcg/ml)
2. pipette out 0.2,0.4,0.6,..1.2ml of the above solution in 10ml volumetric flask
dilute up to 10ml distilled water to each of the above solution. Mark the above solution
2,4,6,12mcg/ml solution.
3. measure the absorbance of the above solution at 244nm in uv visible spectrophotometer
using distilled water as blank
4. Standard graph is constructed taking concentration of paracetamol on x-axis and
absorbance on y-axis.
Table -1
Calibration curve of paracetamol:
S.No
1
2
3
4
5
6

Concentration (g / ml)
2
4
6
8
10
12

Absorbance
0.18
0.38
0.55
0.75
0.92
1.10

Determination of weight Uniformity:1) This test is not applicable to coated tablets other than film, coated tablets.
2) Weight 20 tabs, selected at random and calculate the average weight.
3) Not more than 2 -3 weights deviate from average weight by more than 3% shown below
(as per I.P)
Average weight of tablets
% deviation
80mg or less
10 %
>80mg<250mg
7.5%
>250mg
5.0%
Determination of content Uniformity
1) This test is not applicable for tablets containing multivitamins and trace elements.
2) Take 20 tablets randomly and triturate the 20 tablets to make fine powder.
3) Weigh 100 mg of equivalent and make up to 100ml in suitable solvent measure the
absorbance at 244 nm by using spectrophotometer. This is considered as test absorbance.
4) 100mg of paracetamol is weighed and make necessary dilution, make up the volume to
100ml
5) The absorbance is measured at 244 nm using U.V.Spectrometer.
6) The tablets comply with test if not more than one of the individual values thus obtained is
outside limits. 85 115% of avg value and none is outside the limits 75 125 % of avg
value. If 2 or 3 of the individual values are outside the limits 85 115% of avg value and
none is outside the limits 75- 125%. Repeat the experiment using another 20 tablets. The
tablets comply with test with total sample of 20 tablets, 3 of individual values are outside
the limits 85 115% and none is outside limits 75 125% of avg value.
7) The content uniformity of tablet is find out by using the formula,
Test absorbance
------ ------------------------X dilution factor X average weight
Stand absorbance

Determination of disintegration:This test determines whether tablets disintegrate within time and placed in liquid medium
under prescribed experimental conditions. Disintegration is defined as the state in which no
residue of the tablet remains on the screen of apparatus or if the residue remains, it consists of
fragments of insoluble coating of tablet.
1) a rigid basket rack assembly supporting 6 cylindrical glass tubes, 77.5 2.5mm long,
21.5mm inner diameter and with a wall thickness of about 2mm disintegration apparatus
is used.
2) One tablet is placed in each tube and basket rack is positioned in 1 lit beaker of water,
simulated gastric fluid or simulated intestinal fluid.
3) Thermostatic arrangements for heating the liquid and maintaining temperature at 37 0
20C.
4) Tablet remains 2.5 cm below surface of liquid and upper movement at distance of 2.5 cm
from bottom of beaker.
5) A standard motor driven device is used to move basket assembly containing tablets up
and down having distance of 5 6 cm at frequency of 28 32 cpm.
Determination of Hardness:This test is carried out by using Pfizer (or) Monsanto apparatus.
Determination of friability:This test is carried out by using Roche Friabilator.
1) Drop 10 tab individually at distance of 15cm
2) The plastic chamber revolves at 25rpm, friability apparatus used to rotate 100 revolutions
for 4mnts.
3) Weigh 10 tabs individually and calculate average weight.
4) Reweigh tablets after 4 min and % deviation of weight is calculated. The % deviation
should not exceed 1%.
Dissolution test:a) Invitro dissolution studies.
In vitro release rate studies were carried out using USP - XXIV dissolution apparatus

Type II. Water was used as dissolution medium (900 ml) and was maintained at 37
0.50C The paddle speed was controlled at 50 rpm. Aliquots of 5 ml were withdrawn at
different time intervals up to 1 hr and a 5 ml of fresh medium was added to replace the
sample that was withdrawn. Drug content of the paracetamol tablet was determined by
UV/Visible spectroscopy at 244 nm, after suitable dilution of the samples. Calculate the
amounts of drug release from the formulation were calculated by using the standard
graph of paracetamol.
Plot the graph by taking cumulative percentage drug dissolved on y-axis and time on x-axis.

Amount present = concentration X dilution factor X conversion factor

Amount of drug release

Cumulative percentage of drug release = -------------------------------- X 100
Amount of drug loaded
In-Vitro dissolution profile:
S.NO TIME ABSORBANCE
(hr)
(244nm)
1
2
3
4
5
6
7
8
9
10

CONCENTRATION
(g/ml)

5
10
15
20
25
30
35
40
45
50

REPORT:paracetamol tablets were evaluated for following tests,

7) Weight uniformity
8) Content uniformity
9) Disintegration time
10) Dissolution profile
11) Hardness
12) Friability

AMOUNT
PRESENT
(mg)

CUMULATIVE
%
DRUG
RELEASE