Hot melt granulation formulations of poorly water-soluble active agents
AssigneeMylan Laboratories Limited
InventorsChaoju Xiao, Boyong Li
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Abstract
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.
Claims7
An immediate release pharmaceutical composition consisting of granules and extragranular excipients, wherein
- the granules consist of disulfiram, a wax material, microcrystalline cellulose, and lactose;
- the wax material is present in an amount of about 2% (w/w) to about 7% (w/w) of the granules;
- and
- the disulfiram and the wax material are distributed throughout the granules.
Dependencies are inferred from the claim text.