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Claims for Patent: 6,488,963

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Claims for Patent: 6,488,963

Title: Hot-melt extrudable pharmaceutical formulation
Abstract:The present invention relates to pharmaceutical formulations comprising a hot-melt extrudable mixture of a therapeutic compound and a high molecular weight poly(ethylene oxide) in an essentially non-film like preparation. In some embodiments, the formulation further comprises poly(ethylene glycol). The present invention also includes efficient methods for hot-melt extruding pharmaceutical formulations in essentially non-film preparations.
Inventor(s): McGinity; James W. (Austin, TX), Zhang; Feng (Austin, TX)
Assignee: The University of Texas System (Austin, TX)
Application Number:09/260,694
Patent Claims: 1. A non-film controlled release pharmaceutical formulation comprising an effective amount of a therapeutic compound and a high molecular weight poly(ethylene oxide), wherein the poly(ethylene oxide) has a molecular weight of about 1,000,000 to about 10,000,000 Daltons, and wherein the poly(ethylene oxide) and the therapeutic compound comprise a ratio of poly(ethylene oxide) to therapeutic compound of from about 99.99:.01 weight percent to about 50:50 weight percent.

2. The non-film controlled release pharmaceutical formulation of claim 1 further comprising a plasticizer.

3. The non-film controlled release formulation of claim 2 wherein the plasticizer is selected from the group consisting of: an oligomer, a copolymer, an oil, a organic molecule, a polyol having aliphatic hydroxyls, an ester-type plasticizer, a glycol ether, poly(propylene glycol), a multi-block polymer, a single block polymer, and a poly(ethylene oxide) having a molecular weight less than about 500,000 Daltons.

4. The non-film controlled release pharmaceutical preparation of claim 3, wherein the polyethythene oxide is further defined as polyethylene oxide having a molecular weight less than about 500,000 Daltons.

5. The non-film controlled release pharmaceutical formulation of claim 4, further comprising poly(ethylene glycol).

6. The non-film controlled release pharmaceutical formulation of claim 1 wherein said formulation is prepared by a process of hot-melt extrusion.
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