Clinical Pharmacology & Biopharmaceutics
Open Access

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/filmâ�?�?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/filmâ�?�?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 â�?�?trial and errorâ�? approach when the experiments are first performed and the gained data are analyzed afterwards.

Biography

Liljana Makraduli is currently completing her PhD thesis at the “Ss Cyril and Methodius University” Skopje, Macedonia. She is R&D Director at Replek Farm Ltd., Skopje, Macedonia. She is an expert in Pharmaceutical Technology with specialization at the “Faculty of Pharmacy”, “Ss Cyril and Methodius University” Skopje, Macedonia. She participated in two scientific projects financed by the Ministry of Education of Republic of Macedonia and by the NATO Science for Peace Program. She participated in more than 20 Workshops, Forums, Congresses and Symposia with published scientific work. Her paper “Factorial design analysis and optimization of alginate-Ca-chitosan microspheres” was published in Journal of Microencapsulation.

Email: Liljana.Makraduli@replek.com.mk