Formulation development of immediate release chlorpropamide tablets using directly compressible excipients

Diabetes mellitus is a major cause of morbidity and mortality worldwide. Chlorpropamide is an oral antidiabetic drug belonging to sulphonyl urea group, frequently prescribed in the treatment of type II diabetes mellitus. The present study was aimed on adopting cost effective direct compression method for the development of immediate release tablets of chlorpropamide by employing Avicel PH 102 and pregelatinized starch as directly compressible excipients. Each batch of tablets was evaluated for different pharmacopeial and non-pharmacopeial tests. All pharmacopeial tests were within the specified limits. Disintegration time was less than 15 min, except for one formulation. Dissolution results were satisfactory and within the range of 73 to 91% for all formulations. High performance liquid chromatography (HPLC) method was used to determine the drug content of each tablet batch. Assay was within the United States Pharmacopeia (USP) limit for three formulations. The present study concluded that chlorpropamide tablets can be successfully prepared by direct compression method. This technique reduces manufacturing cost by employing least number of excipients. Formulation F3 proves to be the best immediate release formulation because of its good physical attributes and assay results predicting to have improved bioavailability.   Key Words: Chlorpropamide, immediate release tablet, directly compressible excipients, Avicel PH 102.