MATRIX MESALAMINE EXTENDED RELEASE MINITABLETS AND ITS PROCESS THEREOF

摘要

Compositions for development of matrix type extended release mesalamine minitablets without use of any modified release coating, comprising a) mesalamine or its prodrug or derivatives thereof having a weight percentage in a range of 65-85 weight percentage with respect to the composition; b) at least one intragranular excipient having a weight percentage in a range of 3.5-22.5 weight percentage with respect to the composition; c) at least one binder having a weight percentage in a range of 2-6.5 weight percent with respect to the composition; and d) at least one extra granular excipient having a weight percentage in a range of 2-5 weight percentage with respect to the composition such that largest dimension in the minitablet is range of 1.00 mm to 2.8 mm. In another aspect of the present disclosure provides for a process of preparation of composition.