Granules for pharmaceutical preparations, methods and apparatus for their production

摘要

Disclosed are improved granular pharmaceutical preparations, together with improved methods and apparatus for preparation of granules for use in such preparations. Such methods are especially useful for making granules for solid oral dose pharmaceutical preparations, and are particularly suited to the production of granules comprising 5-aminosalicylic acid (5-ASA) for the treatment of inflammatory bowel disease. The granules exhibit a more sharply peaked length distribution, and hence aspect ratio distribution, and have a consequently much sharper dissolution profile after further processing.

主权项

1. A pharmaceutical composition comprising coated non-spherical extruded granules comprising 5-aminosalicylic acid, prepared by applying a pharmaceutically acceptable coating to uncoated, non-spherical extruded granules comprising 5-aminosalicylic acid and having a length along an axis of extrusion and a cross-sectional dimension of extrusion, wherein said uncoated granules are selected for coating such that at least 80% by number of said uncoated granules have an aspect ratio of said length to said cross-sectional dimension of greater than 0.7 and less than 2.2.