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Manufacturing and Evaluation of Paracetamol Tablets

Method · April 2017

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Kailas K Mali Remeth J Dias

Adarsh College of Pharmacy, Vita Government Polytechnic, Jalgaon
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Vishwajeet Ghorpade
Krishna Institute Of Medical Sciences University
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 Manufacturing of Paracetamol Tablets
Aim
To manufacture and submit paracetamol tablets from prepared paracetamol
granules
Learning objectives
1. To understand working of single punch machine.
2. To understand stages involved in manufacturing of tablets.
Theory
Tablets are prepared by forcing particles into close proximity to each other by
powder compression, which enables the particles to cohere into a porous, solid specimen
of defined geometry. The compression takes place in a die by the action of two punches,
the lower and the upper, by which the compressive force is applied. Powder compression
is defined as the reduction in volume of a powder owing to the application of a force.
Because of the increased proximity of particle surfaces accomplished during compression,
bonds are formed between particles which provide coherence to the powder, i.e. a
compact is formed. Compaction is defined as the formation of a solid specimen of
defined geometry by powder compression.
Process of tablet formation can be divided into three stages
Die filling
This is normally accomplished by gravitational flow of the powder from a hopper
via the die table into the die. The die is closed at its lower end by the lower punch.
Tablet formation
The upper punch descends and enters the die and the powder is compressed until a
tablet is formed. During the compression phase, the lower punch can be stationary or can
move upwards in the die. After maximum applied force is reached, the upper punch
leaves the powder, i.e. the decompression phase.
Tablet ejection
During this phase the lower punch rises until its tip reaches the level of the top of
the die. The tablet is subsequently removed from the die table by a pushing device.

Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao

Department of Pharmaceutics, Yashoda Technical Campus, Satara
Single punch tablet machine
A single-punch press possesses one die and one pair of punches. The powder is
held in a hopper which is connected to a hopper shoe located at the die table. The hopper
shoe moves to and fro over the die, by either a rotational or a translational movement.
When the hopper shoe is located over the die, the powder is fed into the die by
gravitational powder flow. The amount of powder filled into the die is controlled by the
position of the lower punchy. When the hopper shoe is located beside the die, the upper
punch descends and the powder is compressed. The lower punch is stationary during
compression and the pressure is thus applied by the upper punch and controlled by the
upper punch displacement. After ejection, the tablet is pushed away by the hopper shoe as
it moves back to the die for next tablet.
Prerequisite
1. Compression
2. Compaction
3. Consolidation
4. Deformation
Requirements
Chemicals: Paracetamol granules
Equipments: Single punch tablet machine/ KBR Press, balance
Procedure
1. Weigh granules equivalent to 500 mg of paracetamol.
2. Check setting for the tablet machine.
3. Fill weighed granules into the die cavity.
4. Apply optimum pressure on upper punch so as to granules gets compressed.
5. After compression eject the prepared tablet and subjected to hardness test.
6. If tablet have sufficient hardness then repeat the procedure to prepare next tablet.

Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao

Department of Pharmaceutics, Yashoda Technical Campus, Satara
Calculation for weight of granules equivalent to 500 mg Paracetamol

Sr. Quantity given Quantity taken Qty for

Ingredients
No. (1 tablet) 20 tab one tablet
1 Paracetamol IP 500 mg 10 g 500 mg
2 Starch Paste 10 % qs  5 ml (0.5g) 25 mg
3 Starch Powder 12.5 mg 0.25 g 12.5 mg
Total 537.5 mg
4 Starch powder 5% 26.87 mg
5 Magnesium stearate 5% 26.87 mg
6 Talc 1% 5.37 mg
7 Methyl paraben 0.1 % 0.573 mg
8 Weight for one tablet 597.21 mg
600 mg granules contains 500 mg of paracetamol

Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao

Department of Pharmaceutics, Yashoda Technical Campus, Satara
 Evaluation of Paracetamol Tablets: Thickness and Diameter
Aim
To determine thickness and diameter of paracetamol tablets
Learning objective
1. To understand importance of thickness measurement.
Theory
Tablet thickness should be controlled within 5% or less of a standard value. The
crown thickness of individual tablets is measured with a micrometer. The crown
thickness of individual tablets is also determined for the purpose of determining the
density of tablet compacts. Mostly tablet have uniform diameter unless they have
prepared by using different dies. Small variation in tablet thickness and diameter
significantly affects hardness and dissolution profile of tablet. The tablet diameter and
thickness is measured by using vernier calliper. Least count of measuring instrument is
the ratio of smallest division on main scale and total number of divisions on vernier scale
or thimble scale.

Requirements
Paracetamol tablets, vernier calliper, etc
Procedure
1. Determine the least count of vernier calliper. Calculate least count by dividing
smallest division on main scale by total number of divisions on vernier scale.
2. Place tablet between measuring jaws and record main scale and vernier scale
reading.
3. Measure thickness for ten tablets.
4. Complete the calculations and calculate average thickness for tablet.
5. Calculate 5 % deviation from average thickness.

Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao

Department of Pharmaceutics, Yashoda Technical Campus, Satara
 6. Calculate range and check whether individual thickness of tablet lies in it.

Calculations
1. Percent deviation
Percent deviation = 5 x average thickness/100
2. Upper limit
UL = Avg thickness + Percent deviation
3. Lower limit
LL = Avg thickness - Percent deviation
4. Thickness range
Thickness range = (LL to UL)

Observations
Least Count (C) of vernier caliper = 0.01 cm
Sr. No. MSR VSR Total
(A) (B) A + (B x C)
1
2
3
4
5
6
7
8
9
10
Average
Upper limit
Lower limit

Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao

Department of Pharmaceutics, Yashoda Technical Campus, Satara
Result
1. Thickness of tablet is found to be _____ cm.
2. Upper limit is found to be _______ cm
3. Lower limit is found to be _______ cm
4. Thickness of all tablets is found within 5% range from average.

Conclusion
From above result it can be concluded that given tablet complies/ does not
complies with standards.

Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao

Department of Pharmaceutics, Yashoda Technical Campus, Satara
 Evaluation of Paracetamol Tablets: Hardness
Aim
To determine hardness of given tablet of paracetamol IP
Learning objective
1. To understand working of hardness tester.
2. To study importance of tablet hardness.
Theory
The test measures crushing strength property defined as the compressional force
applied diametrically to a tablet which just fractures it. Hardness is a property which is
dependent on density and porosity of the material on one hand and pressure of the
compression on the other. The resistance of tablet to chipping, abrasion or breakage
under condition of storage, transportation and handling factor before use depends on
hardness of tablet. Hardness adjustments are made throughout tablet run to determine the
need for pressure adjustment for tableting machine. If tablet is too hard, it will into
disintegrate, will require period of time or meet the dissolution specification. If too soft, it
will not withstand during subsequent processing such as coating, packaging and
transportation.

Figure 1. Monsanto hardness tester

There are no hard and fast rules about hardness of tablets but from practical point
of view degree of hardness that does not interfere with their disintegration time is
considered suitable. Generally a hardness of 5 kg is taken as minimum of uncoated
tablets for insuring mechanical stability. Among a large number of measuring devices,
the most favored ones are Monsanto tester, Pfizer tester, and Strong cobb hardness tester.
The principle of measurement involves subjecting the tablet to an increasing load until
Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao
Department of Pharmaceutics, Yashoda Technical Campus, Satara
the tablet breaks or fractures. The load is applied along the radial axis of the tablet. Oral
tablets normally have a hardness of 4 to 8 or 10 kg; however, hypodermic and chewable
tablets are much softer (3 kg) and some sustained release tablets are much harder (10-20
kg).
Requirements:
Paracetamol tablets, Monsanto hardness tester.
Procedure
1. Place the tablet diametrically on fixed anvil of the Monsanto hardness tester.
2. Rotate the top screw of the tester so as to tablet holds between fixed and moving
anvil of tester.
3. Adjust the scale suitably to zero.
4. Again rotate top screw of the tester so as to pressure gets applied on tablet.
5. Continue the rotation of screw till tablets breaks.
6. At this stage, record the reading on scale.
7. Repeat the procedure for next tablet.
Result
The hardness of given paracetamol tablet is found to be ____ kg/cm2.

Observations
Tablet No. Hardness
Kg/cm2
1
2
3
4
5
6
Average

Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao

Department of Pharmaceutics, Yashoda Technical Campus, Satara
 Evaluation of Paracetamol Tablets: Weight variation
Aim
To determine weight variation of given paracetamol tablets.
Learning objectives
1. To understand weight variation test for tablets.
Theory
The test ensures that all the tablets in a batch are of same potency, within
reasonable limits. Weight variation may basically occur due to the depth of the die cavity,
bulk density of granules or powder, uniformity of particulate flow, wide variation in
granule size and improper lubrication. Even with a proper granulation having uniform
flow, a volume fill is not as accurate as a fill based on weight. Therefore, tablet weight
variations must fall within certain specifications established by the IP.
Each tablet in a batch should be uniform in weight and the weight variation if any,
should be generally within 10% for tablets weighing 80 mg or less, 7.5% for tablets
weighing more than 80 mg and up to 250 mg, and 5 % for tablets weighing 250mg or
more. Hence, all finished batches, 20 tablets are weighed collectively and individually.
From the collective weight average weight per tablet is calculated. The weights of
individual tablets are the compared to ascertain whether they are within permissible limits
or not.
Requirements
Paracetamol tablets and weighing balance.
Procedure
1. Take 20 tablets of paracetamol IP.
2. Weigh individually paracetamol tablets and record weight in observation table.
3. Again take weight of 20 tablets collectively.
4. From collective weight calculate average weight per tablet.
5. As weight of individual tablet is more than 250 mg so consider 5% variation.
6. Calculate 5% variation from average value.
7. Calculate upper limit and lower limit.
8. Compare weights of individual tablet to ascertain whether they are within
permissible limits or not.
Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao
Department of Pharmaceutics, Yashoda Technical Campus, Satara
Calculations
1. Average weight per tablet
Average weight per tablet = Collective weight of 20 tablets/ 20
2. 5 % deviation from average weight
Percent deviation = 5 x average weight of tablet/100
3. Upper limit
Upper limit = Average weight per tablet + 5 % deviation from average
4. Lower limit
Lower limit = Average weight per tablet + 5 % deviation from average

Observations
Tablet No. Weight Tablet No. Weight
(mg) (mg)
1 11
2 12
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Collective weight of 20 tablets
Average weight per tablet
5 % deviation from average
Upper limit
Lower limit

Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao

Department of Pharmaceutics, Yashoda Technical Campus, Satara
Results
Average weight per tablet is found to be ____ mg.
5 % deviation from average is ____ mg.
The weights of individual tablets are lies within permissible limits.

Conclusion
From above results it can be concluded that the given paracetamol tablets
complies with IP standards.

Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao

Department of Pharmaceutics, Yashoda Technical Campus, Satara
 Evaluation of Paracetamol Tablets: Friability test
Aim
To determine friability of given paracetamol tablets.
Learning objectives
1. To understand friability test for tablets.
Theory
This test is designed to measure the ability of the tablet to withstand abrasion in
packaging, handling and transportation. Friability generally refers to loss in weight of
tablets in the containers due to removal of fine particles from their surfaces. Test is
performed to assess the effect of friction and shock which may often cause tablets to chip,
cap or break. It generally reflects poor cohesion of tablet ingredients.
The equipment most commonly used for friability test is the Roche Friabilator. It
consists of a circular plastic chamber divided into 2 or 3 compartments. This chamber
rotates at 25 rpm and drops the tablets from a height of 15cm with each revolution. For
tablet with unit mass equal to or less than 650mg take a sample of whole tablet
corresponding to 6.5g and for a tablet with unit mass of more than 650mg take sample of
10 whole tablets. Preweighed tablets are placed in the apparatus and the friabilator is
operated for 100 revolutions and the tablets are weighed again. The difference in the two
weights represents friability. The weight loss should not be more than one percent.

Fig. 1: Roche Friability Test Apparatus

Requirements
Paracetamol tablets, friability tester and weighing balance.

Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao

Department of Pharmaceutics, Yashoda Technical Campus, Satara
Procedure
1. Collect paracetamol tablets, dedust and check individual weight.
2. If weight of one tablet less than 650 mg then take a sample of whole tablet
corresponding to weigh 6.5 g. Record the weight of tablets as W0.
3. Remove drug from friabilator and clean properly.
4. Place the tablets in drum and fix it to friabilator.
5. Operate the friabilator for 100 revolutions.
6. Once again remove drum and dedust tablets.
7. Check tablets for capping, lamination and chipping.
8. Again take weight for tablets and record it as W1.
9. Calculate the percent friability.

Observations
1. Weight of tablets before friability test (W0) _____ g.
2. Weight of tablets after friability test (W0) _____ g.

Calculations
1. Friability
Percent friability = [W0-W1] x 100/W0

Result
Friability of given paracetamol tablet is found to be _______ %.

Conclusion
From above results it can be concluded that the given paracetamol tablets
complies/ does not with IP standards.

Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao

Department of Pharmaceutics, Yashoda Technical Campus, Satara
 Evaluation of Paracetamol Tablets: Disintegration test
Aim
To perform disintegration test for paracetamol tablets as per IP.
Learning objectives
1. To understand concept and importance of disintegration.
Theory
Boavailability of a drug depends in absorption of the drug, which is affected by
solubility of the drug in gastrointestinal fluid and permeability of the drug across
gastrointestinal membrane. The drugs solubility mainly depends on physical – chemical
characteristics of the drug. However, the rate of drug dissolution is greatly influenced by
disintegration of the tablet.
The drug will dissolve at a slower rate from a nondisintegrating tablet due to
exposure of limited surface area to the fluid. The disintegration test is an official test and
hence a batch of tablet must meet the stated requirements of disintegration.
Disintegrants, an important excipient of the tablet formulation, are always added
to tablet to induce breakup of tablet when it comes in contact with aqueous fluid and this
process of desegregation of constituent particles before the drug dissolution occurs, is
known as disintegration process and excipients which induce this process are known as
disintegrants.
Disintegration is defined as the state in which any residue of the tablet, except
fragments of insoluble coating remaining on the screen of the test apparatus consists of a
soft mass having no palpably firm, unmoistened core.
This disintegration test is provided to determine whether tablets disintegrate
within a prescribed time when placed in a liquid medium under the prescribed
experimental conditions. The apparatus consists of a basket rack assembly supporting six
glass tubes. These tubes are held vertically by two superimposed transparent plastic
plates with six holes having same diameter as the tubes. Woven wire gauge made os
stainless steel is attached to the underside of the lower plate. The upper and the lower
plates are held in position by vertical metal rods at the periphery and a metal rod in the
centre of the upper plate for attachment to mechanical device. The assembly should be
raised and lowered between 28 to 32 times per minute in the liquid at 37oC.

Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao

Department of Pharmaceutics, Yashoda Technical Campus, Satara
 One tablet is placed in each of six tubes of the basket and a disc is added to each
tube. The apparatus is operated using water at 37oC as the immersion liquid. The tablets
pass the test if all six have disintegrated in not more than 15 minutes (for uncoated
compressed tablets). If one or two tablets fail to disintegrate, the test is repeated on 12
additional tablets and not less than 16 of the total of 18 tablets must disintegrate.
Requirements
Paracetamol tablets, disintegration test apparatus.
Procedure
1. Remove basket assembly from the apparatus.
2. Place required quantity of water (800 to 900 ml) into beaker provided with
apparatus.
3. Place beaker on its position and switch on the temperature knob to attain
temperature of medium to 37oC.
4. Add one tablet in each tube of basket assembly and put discs if necessary.
5. Suspend assembly in liquid and operate equipment for 15 minutes.
6. Observe continuously each tablet till disintegration. Record disintegration time for
all tablets.
7. At the end of 15 minutes remove basket assembly and observe each tube for any
residue of tablet.
Observation
Tablet No. Disintegration time Residue on screen*
(min) (yes/no)
1
2
3
4
5
6
Average DT
* at the end of 15 min

Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao

Department of Pharmaceutics, Yashoda Technical Campus, Satara
 Result
Disintegration time of given paracetamol tablet is found to be _______ %.
No any residue found on screen of basket assembly at the end of 15 min.
Conclusion
From above results it can be concluded that the given paracetamol tablets
complies/does not with disintegration test as per IP standards.

Mali Kailas Krishnat, Dias Remeth Jacky, Ghorpade Vishwajeet Sampatrao

Department of Pharmaceutics, Yashoda Technical Campus, Satara

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