Practical no.
4:
Comparison of paracetamol tablets prepared by direct
compression and wet granulation technique
Aim: To prepare and evaluate the paracetamol tablets by direct compression and wet
granulation.
Apparatus: Mortar and pestle, compression machine, digital balance, Monsanto hardness
tester, roche friabilator.
Chemicals:Paracetamol, lactose, starch, starch paste, talc & magnesium stearate.
Principle: Tablets are solid unit dosage forms containing drug substance with (or) without
suitable diluents and are prepared by either compression or moulding methods. Tablets
frequently are discoid in shape. They also may be round, oval and oblong, cylindrical. In
general tablets are prepared by
- Wet granulation
- Direct compression
- Dry granulation
Procedure:
Preparation of paracetamol tablets by direct compression:
1. Weigh the required ingredients and pass paracetamol, lactose through 40 mesh and
magnesium stearate through 80 mesh.
2. Mix the paracetamol, lactose in a polyethylene bag for 10 min then pass through 40 mesh.
3. Lubricate the blend with magnesium stearate and glidant talc is added for 5min. then
compresses the tablets using single punch machine by adjusting the die cavity.
Preparation of paracetamol tablets by wet granulation:
1. Pass paracetamol and lactose through 100 mesh and magnesium stearate through 80 mesh.
2. Granulate mix paracetamol and lactose in a polyethylene bag and transfer into a mortar.
3. Granulate by using starch paste. Then dry the granules at a temperature of 50-60 C for 45
min in a tray dryer.
4. After by using the granules obtained were passed through the sieve 16/18 mesh to remove
the lumps on the granules. Then the granules were mixed with required quantities of talc and
magnesium stearate.
5. Then formed mixture powder is weighed into individual tablet weight using this weighed
powder or the tablets were compressed using single punch machine.
Evaluation tests for tablets:
These are also called as quality control tests for tablets. The various evaluation tests for
tablets are:
- General appearance
- Size appearance
- Organoleptic characteristics
- Hardness
- Unique identification method
- Friability
- Drug content and release
- Weight variation
- Disintegration
- Dissolution
a. Hardness: hardness is defined as the force required to break a tablet in a diametric
compression test. The hardness of tablet is indicative of its tensile strength and is measured in
terms of pressure required to crush it when placed on the edge. Different hardness tester that
are commercially available are
- Monsanto hardness tester
- Pfizer tester
- Strong-cobb tester
- Erweka tester
Monsanto hardness tester: it consists of a barrel consisting of compressible spring held
between two plungers. The lower plunger is placed in contact with a tablet and ‘0’ readings
are taken. The upper plunger is then forced against the spring by forming threaded bolt unit
the tablet fracture. As the spring is compressed a rigid pointer along with the barrel indicates
the force of fracture is recorded and this ‘0’ force reading.
b. Weight variation: It’s desirable that every individual tablet in a batch is uniform weight.
The weight variation if any is in permissible limits, non-uniformity in weights can lead to
variation in dosing.
Some of the basic causes for weight variation of tablets are faulty incorporation of glidants
and resulting poor flow of granules, difference in lower punch length proper lubricants.
Procedure: It is done by weighing 20 tablets individually and correctly. Then calculate the
average weight based on average weight apply limits and compare whether the individual
tablets fall within the limits or not.
The tablets meet the USP limit if not more than 2 tablets are outside the % limit. If tablet
meet the IP limit if not more than 6 tablets are outside the % limit.
Based on the average weight the % of deviation as mentioned in IP are as follows:
Avg. wt % limits
<130mg + 10%
130-320mg + 7.5%
>320mg + 5%
c. Friability: Defined as mechanical strength to withstand mechanical shocks of handling in
manufacturing packaging and shipping.In generally reflects that poor cohesion tablet
ingredients standard deviations have been fabricated.
Roche friability tester: In this number of tablets are subjected to combine effect and
visualized by utilizing plastic chambers that resolves at 25 rpm dropping the tablet from
distance per height of 6 inches in each revolution.
Pre-weighed tablets are placed in friabilator and operated for 100 revolutions. Then the
tablets are reweighed conventional tablets that Acceptable range is <0.5-1%.
OBSERVATIONS AND CALCULATIONS
