IN VITRO BIOEQUIVALENCE STUDY OF FOUR BRANDS OF NIMESULIDE TABLETS MARKETED IN INDIA

The availability of numerous brands of nimesulide in our drug market today places clinicians and pharmacists in a difficult situation of choice of a suitable brand or the possibility of alternative use. The aim of the present study was to predict the bioequivalence of four brands of nimesulide tablets marketed in India using in vitro tests. The in vitro dissolution study was carried out on the four brands of nimesulide tablets using the paddle method according to US Pharmacopoeia(USP) guidelines. Other general quality assessment tests like hardness and disintegration time were also determined and all these generic tablets passed compendial specifications. All the brands tested passed the standard for disintegration time. There were slight differences in the dissolution profiles of the four brands. All the brands except NM1, however, released >45% of nimesulide within 30 min. Based on the in vitro tests, NM2, NM3 and NM4 are consideredbioequivalent and interchangeable. NM1 has very low dissolution rate, which will likely result in poor bioavailability. The results show the need for constant monitoring of new brands of nimesulide introduced into the drug market to ascertain bioequivalence and conformity with pharmacopoeia standards.