Formulation and Evaluation of Colon Targeted Matrix Tablets of Mesalazine

ABSTRACT

The present work involves the formulation of colon targeted matrix tablet of Mesalazine by using direct compression method. Excipients including in the formulation are Eudragit S100, Ethyl cellulose, Lactose, Talc, Magnesium stearate. Preformulation studies have also been performed to study the nature of API and compatibility of API with excipients by physical observation and TLC studies. The result showed that API was compatible with all the excipients selected. The tablets were formulated by direct compression method using the selected excipient quantities. The formulated tablets were tested for both pre-compression parameters and post compression parameters as per requirements of standards. Pre-compression parameters such as bulk density, tapped density, compressibility index, Hausner’s ratio and compressibility index. The results obtained indicate that it has good flow property for direct compression. The formulated Mesalazine matrix tablets were coated with enteric polymer Eudragit FS 30D by pan coating method. The prepared tablets were evaluated for weight variation, hardness, thickness, friability, drug content, disintegration time and in-vitro dissolution studies. All these parameters were found to be within the standard limits. Comparative studies of coated Mesalazine tablets and uncoated Mesalazine tablets were evaluated for the hardness, thickness, in-vitro dissolution studies and disintegration time. Out of six formulations, the formulation F6 showed 98.51% drug release at 16 hrs. Since it provide greater protection to the core under acidic condition while at the same time show the fastest drug release under intestinal pH. So the formulation F6 was considered as the confirmatory trial and it was subjected for stability studies up to three months of accelerated stability 40⁰C ± 2C⁰, 75 % ± 5 % RH and found to be within limits.

Keywords: Matrix Tablet, Mesalazine, direct compression method.