“COMPARATIVE STUDY OF MARKETED PARACETAMOL TABLET”

A

Dissertation of minor project submitted to Chhattisgarh swami vivekanand technical university, Bhilai,

In partial fulfillment of the requirement for the degree of

BACHELOR OF PHARMACY 2010

Supervised By; Submitted By;

Mr.Shekhar Verma Jayanti Tiwari M.pharm. (pharmaceutics) Roll No.3124107025

Institute of Pharmacy, RIT, Chhatauna, Mandir Hasaud,

Raipur, C.G. 492101

Comparative Study Of Marketed Paracetamol Tablets

Introduction A tablet is a pharmaceutical dosage form. It comprises a

mixture of active substances and excipients, usually in powder form, pressed or compacted into a solid.

The compressed tablet is the most popular dosage form in use today. About two-thirds of all prescriptions are dispensed as solid dosage forms, and half of these are compressed tablets.

Advantages of Tablet Medication: They offer the greatest capabilities of all oral dosage

forms for the greatest dose precision and least content variability.

Low cost among all oral dosage forms. They are the easiest and cheapest to package and ship. Easy large scale production than other oral dosage forms.

Fever Fever (also known as pyrexia or controlled

hyperthermia) is a common medical sign characterized by an elevation of body temperature above the normal range of 36.5–37.5 °C(98-100°F).

Pyrogens:• A pyrogen is a substance that induces fever.• These can be either internal (endogenous) or external

(exogenous) to the body. Medications:• The antipyretic ibuprofen is effective in treating a fever. • It is more effective than acetaminophen / paracetamol

in children however both may be used together, safely.

Profile Of Paracetamol Paracetamol or acetaminophen is a widely used over-

the-counter analgesic (pain reliever) and antipyretic (fever reducer).

Mechanism of action of Paracetamol The main mechanism of action of paracetamol is

considered to be the inhibition of cyclooxygenase(COX), and paracetamol is highly selective for COX2.

Paracetamol reduces the oxidized form of the COX enzyme, preventing it from forming pro-inflammatory chemicals.

This leads to a reduced amount of Prostaglandin E2 in the CNS, thus lowering the hypothalamic set point in the thermoregulatory centre.

Evaluation Parameters of tablet To design tablets and later monitor tablet production quality,

quantitative evaluations and assessments of a tablet’s chemical, physical, and bioavailability properties must be made. The following are the important evaluation parameters of tablets:

o Hardness• Tablet hardness has been defined as the force required to break

a tablet in a diametric compression test. • This test normally consists of breaking or crushing the tablet by

application of a compressive load. • Several devices operating in this manner to test tablet

hardness: Monsanto tester, the Strong-Cobb tester, the Pfizer tester, the Erweka tester, and the Schleuniger tester.

• The hardness of the tablet must not be more than 4 kg.

o Friability• The tablets may be subjected to a tumbling motion,

during coating, packaging, or transport, which may cause small particles to abrade from the surface of the tablet.

• To examine this, friability test or test to measure the resistance to abrasion is done.

• The Roche Friabilator is the most frequently used friability tester.

• Conventional compressed tablets that lose less than 0.5 to 1.0% of their weight are generally considered acceptable or the loss of weight should not be more than 1%.

% friability=(initial wt.-final wt.)*100/initial wt.

o Weight Variation• The volumetric fill of the die cavity determines the

weight of the compressed tablet. • The weight of the tablets being made is routinely

measured to help ensure that a tablet contains the proper amount of drug.

• The USP weight variation test is run by weighing 20 tablets individually, calculating the average weight, and comparing the individual tablet weights to the average.

• The tablets meet the USP test if no more than 2 tablets are outside the percentage limit and if no tablet differs by more than 2 times the percentage limit.

• The USP provide tolerances for the average weight of uncoated compressed tablets.

o Disintegration• Disintegration is defined as that state in which no

residue of the tablet or capsule remains on the screen of the apparatus or, if a residue remains, it consists of fragments of insoluble coating of the tablet or of capsule shells.

• The time that it takes a tablet to disintegrate is measured in a device described in the USP/NF.

• This test determines whether tablet or capsules disintegrate within a prescribed time when placed in a liquid medium under the prescribed experimental conditions.

• If 1 or 2 tablets failed to disintegrate, repeat the test on 12 additional tablets; not less than 16 of the total of 18 tablet tested disintegrate.

o Dissolution• The dissolution test measures the amount of time required

for a given percentage of the drug substance in a tablet to go into solution under a specified set of condition.

• In vitro dissolution test is used as an indirect measurement of drug availability.

• Two objectives in the development of in vitro dissolution tests are to show:

That the release of the drug from the tablet is as close as possible to 100%

That the rate of drug release is uniform batch to batch and is the same as the release rate from those batches proven to be bio-available.

• The USP/NF specifies that either of two apparatuses be used for determining dissolution rate/dissolution time:

1. Type-1 apparatus(Basket type)2. Type-2 apparatus(Paddle type)

RESULT The comparative study of marketed Paracetamol tablets

has been done using two different brands of Paracetamol tablets:

• Calpol (GSK)• Crocin (Remidex Pharma)

S. no.

Brand Hardness(kg)

Friability (%)

Dissolution time(min)

Disintegra-tion time

1. Calpol 5 kg 0.31% 8 min 10 min

2. Crocin 4.5kg 0.33% 10 min 12 min

Conclusion The overall conclusion of the comparative study of two

different brands of paracetamol tablet is that the Calpol is having more withstand capacity than Crocin.

The importance of this test is due to the fact that tablets are carried from one place to another by transport, hence this parameter informed about the capacity of the tablets.

The disintegration and dissolution test of two tablet showed comparative analysis of release and bioavailability; and the bioavailability of Calpol is faster than Crocin in all the aspect.

Calpol also showed better hardness and weight variation test than Crocin.

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