High drug load mesalazine sachet

摘要

The present invention is directed to a high drug formulation having desirable properties in terms of ease of manufacture and visual appearance as well as a sachet for the formulation.

主权项

1. A pharmaceutical dosage form suitable for oral administration and in the form of flowable, coated granules comprising:
granules comprising 90 to 98% by weight of mesalazine or a pharmaceutically acceptable salt thereof and 2 to 10% by weight of polyvinylpyrrolidone; wherein the granules are coated with a coating comprising ethylcellulose such that the ratio of the weight of the coating to the weight of the mesalazine or pharmaceutically acceptable salt thereof is from 0.3-3%; wherein the flowable, coated granules of the dosage form are adapted to be contained in a sachet or capsule.