Abstract
This paper addresses an alternative method to the evaluation of similarity factor f 2 as a criterion for assessment of similarity between two in-vitro dissolution profiles as proposed in the SUPAC-IR Guidance (1995). Diltiazem hydrochloride Sustained-Release (SR) tablets were tested and the following independent-model dissolution parameters were used: t 10% dissolution time, t 25% dissolution time, t 50% dissolution time, mean dissolution time (MDT), dissolution efficiency (DE) at t 120, and at t 360. To compare the dissolution profiles, several release models were tested such as Higuchi, zero order, first order, Baker-Lonsdale, Hixson-Crowell, Weibull and Korsmeyer-Peppas. The similarities between two in-vitro dissolution profiles were assessed by pair-wise independent-model procedures such as difference factor ( f 1), similarity factor ( f 2) and Rescigno index ( ξ 1 and ξ 2). The in vitro release kinetics of diltiazem hydrochloride sustained release tablets were evaluated using USP apparatus 2.
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