IN-VITRO DISSOLUTION STUDY OF MELOXICAM IMMEDIATE RELEASE PRODUCTS USING FLOW THROUGH CELL (USP APPARATUS 4) UNDER DIFFERENT OPERATIONAL CONDITIONS

Abstract

Objective: To evaluate and compare the in-vitro dissolution profiles of five generic immediate release (IR) products of Meloxicam (MX) available in Egyptian market with the innovator reference product (Mobic ® , R) using different operational conditions of the flow through dissolution cell (FTC, USP Apparatus 4), in phosphate buffer (pH=7.5). Methods: The comparative in-vitro dissolution studies were performed under different FTC operational conditions such as cell size, tablet position within the cell, open and closed loops setup and type of flow (laminar and turbulent) on MX dissolution rate from different IR products. Results: The study showed that two generic products, out of five, gave similar dissolution profiles with R using a specified well controlled condition of FTC. A selected generic product (Mobitil, G1) was tested versus R under different operational conditions of the FTC such as cell size, type of flow, tablet position and open & closed loops setup. The dissolution profile of MX from R was highly affected by changing the tablet position, slightly affected by the open & closed loops setup and not affected by cell size and type of flow. On the other hand, the dissolution profile of MX from G1 was affected by all the previous operational conditions. Comparing ƒ 2 values between G1 against R among the different operational conditions proposed, only one in-vitro dissolution test showed similar dissolution profile of G1 with respect to R. Conclusion: Three generic products of MX might not be interchangeable with the innovator product (Mobic ® ).