Study of Pharmaceutical Quality of Some Marketed Tablet Dosage Forms of Paracetamol and Metformin

Rau. B. S.1* and Vijaya Ratna. J2

The purpose of the study is to ascertain whether dosage forms in the market, are all meeting the requirements with respect to pharmaceutical quality. Conventional paracetamol and metformin tablet dosage forms, produced by different manufacturing concerns, were collected from the market, in a random manner, and were subjected to pharmaceutical quality tests. The objective was to determine whether the tablets conformed with the specifications of Indian Pharmacopoeia. Ten among forty paracetamol tablets tested and one among the seventeen metformin tablets tested were found to be not of standard quality. One paracetamol tablet failed in drug content assay and nine and one each of paracetamol and metformin tablets respectively, failed to release the minimum percent of drug in the required time. Deficiencies in excipients and lacunae in manufacturing procedures may be responsible for this result.
Pharmaceutical quality is a vital parameter of formulations and determines their safety and efficacy. Indian generic pharmaceutical industry, especially the small scale sector, releases formulations into the market, which imitate the branded products, without going through bougainvilleas studies, when the drug is in use in India since more than four years. This is permitted by the Drugs and Cosmetics Act 1940, under Part X A, which defines the new drug. Rule 122 E of Part X A of the Act specifies that a drug need not be considered as new, if it is included in the Indian Pharmacopoeia or it is in use in India for more than four years; whichever is earlier. Bougainvilleas studies are necessary by the Act in India, only for new drugs. Compliance to the specification in Indian Pharmacopoeia is necessary and sufficient, for drugs to be marketed in India. Since different companies use different manufacturing procedures and exceptions, the products may be differing in quality.
The objective of the study is to find out whether marketed formulations are of quality as per Indian Pharmacopoeia1 specifications. Paracetamol2, 3 is selected for the study, as it is a widely used over the counter drug and metformin is chosen as it is the drug of choice for first line4 treatment of type II diabetes.
Materials And Methods
Conventional paracetamol and metformin tablets were collected from the market in a random manner from different medical shops in Andhra Pradesh and Tamilnadu. All the chemicals used were of analytical reagent grade and methods used for quality analysis were as per Indian Pharmacopoeia.
Forty different samples of paracetamol and seventeen different samples of metformin tablets were collected from market, in a random manner and subjected to quality control test as per Indian Pharmacopoeia specifications. Results of quality of tablets relating to weight variation, assay, dissolution, friability, hardness and disintegration were compiled and shown in Table 1 for paracetamol and in Table 2 for metformin.



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