COMPARATIVE IN VITRO QUALITY AND DISSOLUTION ASSESSMENT OF DIFFERENT BRANDS OF PARACETAMOL TABLETS MARKETED IN SUDAN: IMPLICATIONS FOR BIOWAIVER ELIGIBILITY

Bioequivalence studies are the usually accepted methods to determine the therapeutic equivalence of two drug products or more. Because in-vivo bioequivalence studies are time consuming and expensive to conduct, major regulatory authorities have introduced biowaivers for some selected medicines belonging to BCS class I and III drugs. Comparative dissolution tests are used in biowaiver procedure to waiver the bioequivalence requirement. The objectives of this research were to determine the quality of three brands of Paracetamol (500 mg) tablets (B, C, and D) available in Sudanese market and to compare with the innovator brand drug product (A) through measurement of different physiochemical parameters under biowaiver condition. different tablets from each brand (A,B,C, and D) were taken from the market and were determined by the quality control parameters including weight variation, friability, hardness, disintegration test and dissolution test. The dissolution profiles were obtained in three different pH media (1.2, 4.5, and 6.8) for each brand. The percentage released of paracetamol in all dissolution media were determined by UV spectrophotometric method and the brand tablets were evaluated to check if they are complying with the specification of BP. Result: all brands were passed the test when compared with the specification and all brands B, C, and D released paracetamol with 90% and more within 30 min in all the three media. Conclusion: The tablets met with specification, they had the desired and optimum therapeutic efficacy.