Pharma Middle East

Biography

Biography: Liljana Makraduli

Abstract

The purpose of this study is to apply experimental design in order to determine the influence of the formulation factors and their interactions on the dissolution of the active substance mesalamine (mesalazine) from the mesalazine film-coated tablets 500 mg. The delayed release of the active substance from the film-coated tablets at pH 1.2 during 120 minutes; at pH 6.8 during 60 minutes and at pH 7.2 during 90 minutes was analyzed according to USP/NF monograph for mesalamine delayed-release tablets. The formulation for achieving the best dissolution profile was chosen. The desired dissolution profile is as follows: maximum 1% of dissolved mesalamine/ film–coated tablet expressed as a percentage of the declared content at pH 1.2 in 120 minutes and at pH 6.8 in 60 minutes; and minimum 80% (Q) dissolved mesalamine/ film–coated tablet expressed as a percentage of the declared content at pH 7.2 during 90 minutes. With the study it was shown that design of experiments could be successfully used in planning the experimental design, performing series of well-selected experiments and gaining the most informative combination out of the given factors. It is a science based and effective approach to analyze and optimize a given formulation; in contrast to the most frequently used “trial and error” approach when the experiments are first performed and the gained data are analyzed afterwards.