Abstract

Development Of Discriminating Dissolution Procedure for Artemether and Lumefantrine Tablets

Author(s): Sagar Narayankar, Manisha Phadke, Dattatray Patil, R. K. Jadhav, Ramesh S.Yamgar

In the Pharmaceutical Industry, Regulatory agencies often insist on discriminating dissolution methods. As a product development continues to multiply at increasingly faster rates , dissolution method development must be able to keep pace with increased number of products and dissolution scientists has a great challenge to develop the discriminating dissolution method especially for combination drug product. Dissolution methods developed using the slowest paddle speed (50 rpm) represent the most appropriate operating condition as they normally produce the steepest drug release profiles. Normally a steep drug release profile is assumed to provide optimum discriminating power to distinguish small variations in the tablet manufacturing process or to detect stability changes on storage. In actual practice many a times , for certain tablet formulations it has been observed that drug release profiles established at slower speed that is at 50 rpm can be steeper reflecting a system defect than a discriminatory tool. Higher paddle speeds that is 75 or 100 rpm which result in flatter drug release profiles can, in some cases ,more accurately reflect true formulation changes or manufacturing changes or process. This point is emphasized in the description of the development of a dissolution method for a compressed tablet containing two active pharmaceutical ingredients (Artemether and Lumefantrine).The selection of dissolution medium for a tablet with Artemether and Lumefantrine having very different solubility properties is detailed. The effects of paddle speed, selection of medium on system performance and method discriminating power are thoroughly evaluated.

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