HOT MELT GRANULATION FORMULATIONS OF POORLY WATER-SOLUBLE ACTIVE AGENTS

摘要

The presently disclosed subject matter is directed to a granule, wherein the granule has an active agent and a wax dispersed therein, and the granule exhibits excellent friability when compressed to form a pharmaceutical composition. The subject matter disclosed herein is also directed to methods of preparing the granules and the pharmaceutical compositions comprising the granules. The compositions and methods disclosed provide granules and pharmaceutical compositions for immediate release of the active agent and do not substantially prolong the release of the active agent from the granule.

主权项

1. A pharmaceutical composition, comprising:
a granule, said granule comprising an active agent and a wax material, wherein said active agent has a water solubility of less than 1 mg/ml and said wax material is present in an amount below about 8% (w/w) of said granule.