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Claims for Patent: 7,276,250

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Claims for Patent: 7,276,250

Title:Sustained release formulations of oxymorphone
Abstract:Sustained release formulations of oxymorphone or pharmaceutically acceptable salts thereof; methods for making the sustained release formulations of oxymorphone or pharmaceutically acceptable salts thereof; and methods for using the sustained release formulations of oxymorphone or pharmaceutically acceptable salts thereof to treat patients suffering from pain are provided.
Inventor(s): Baichwal; Anand R. (Wappingers Falls, NY), Kao; Huai-Hung (Syosset, NY), McCall; Troy W. (Germantown, TN)
Assignee: Penwest Pharmaceuticals Company (Danbury, CT)
Application Number:10/189,932
Patent Claims: 1. An oral sustained release formulation comprising from about 5 mg to about 80 mg oxymorphone hydrochloride and from about 80 mg to about 360 mg of a granulated sustained release delivery system, wherein the granulated sustained release delivery system comprises from about 8.3% to about 41.7% by weight locust bean gum, from about 8.3% to about 41.7% by weight xanthan gum, from about 20% to about 55% by weight dextrose, from about 5% to about 20% by weight calcium sulfate dihydrate, and from about 2% to about 10% ethyl cellulose.

2. The oral sustained release formulation of claim 1, comprising about 20 mg oxymorphone hydrochloride.

3. The oral sustained release formulation of claim 1, comprising about 160 mg of the granulated sustained release delivery system.

4. An oral sustained release formulation comprising from about 5 to about 80 mg oxymorphone hydrochloride and from about 80 mg to about 360 mg of a granulate sustained release delivery system, wherein the granulated sustained release delivery system comprises about 25% locust bean gum, about 25% xanthan gum, about 35% dextrose, about 10% calcium sulfate dihydrate, and about 5% ethyl cellulose.

5. The oral sustained release formulation of claim 1, further comprising an outer coating.

6. A method for treating a patient suffering from pain comprising administering an effective amount of the oral sustained release formulation of any one of claims 1-5.

7. An oral sustained release formulation comprising from about 5 mg to about 80 mg oxymorphone hydrochloride and from about 300 mg to about 420 mg of a granulated sustained release delivery system, wherein the granulated sustained release delivery system comprises from about 8.3% to about 41.7% by weight locust bean gum, from about 8.3% to about 41.7% by weight xanthan gum, from about 20% to about 55% by weight dextrose, from about 5% to about 20% by weight calcium sulfate dihydrate, and from about 2% to about 10% ethyl cellulose.

8. The oral sustained release formulation of claim 7, comprising about 20 mg oxymorphone hydrochloride.

9. The oral sustained release formulation of claim 7, comprising about 360 mg of the granulated sustained release delivery system.

10. The oral sustained release formulation of claim 7, wherein the granulated sustained release delivery system comprises about 25% locust bean gum, about 25% xanthan gum, about 35% dextrose, about 10% calcium sulfate dihydrate, and about 5% ethyl cellulose.

11. The oral sustained release formulation of claim 7, further comprising an outer coating.

12. A method for treating a patient suffering from pain comprising administering an effective amount of the oral sustained release formulation of any one of claims 7-11.

13. A solid dosage formulation comprising the oral sustained release formulation of any one of claims 1-5.

14. The solid dosage formulation of claim 13, wherein the solid dosage formulation is a tablet.

15. A solid dosage formulation comprising the oral sustained release formulation of anyone of claims 7-11.

16. The solid dosage formulation of claim 15, wherein the solid dosage formulation is a tablet.
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