Dissolution testing of tablets within and beyond expiration date with olanzapine as pharmaceutical ingredient

Abstract

The expiration date is a guarantee from the manufacturer that a drug product will remain chemically stable - and thus maintain its full potency and safety - prior to that date. Authors of this study have checked whether tested drug product has a similar dissolution profile beyond and within expiration date. In this paper, dissolution study of Zyprexa (Olanzapine as an Active Pharmaceutical Ingredient) 10 mg tablets was conducted in three different mediums, in the same way as comparison in-vitro and in-vivo tests during investigation of bioavailability and bioequivalence at clinical trials phase. Obtained results demonstrated that dissolution profiles of tested and reference product are essentially similar, which was statistically confirmed by means of similarity factor.