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Claims for Patent: 6,919,092

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Claims for Patent: 6,919,092

Title: Method for the management of incontinence
Abstract:A composition and a dosage form are disclosed comprising oxybutynin alone/or accompanied by another drug indicated for therapy. A method is disclosed for administering oxybutynin alone/or accompanied by a different drug or for administering oxybutynin and a different drug according to a therapeutic program for the management of incontinence alone, and for other therapy.
Inventor(s): Guittard; George V. (Cupertino, CA), Jao; Francisco (San Jose, CA), Marks; Susan M. (San Jose, CA), Kidney; David J. (Palo Alto, CA), Gumucio; Fernando E. (San Jose, CA)
Assignee: ALZA Corporation (Mountain View, CA)
Application Number:09/785,805
Patent Claims: 1. A method for the management of incontinence in a patient, wherein the method comprises admitting orally into the patient a dosage form comprising 240 ng to 650 mg of a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt, that releases the member at a controlled and sustained, substantially zero order rate of 0.05 mg per hour up to 0.850 mg per hour for about 24 hours.

2. A pharmaceutical dosage form comprising 240 ng to 650 mg of a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salts, the dosage form being adapted to release the member at a controlled and sustained, substantially zero order release rate for about 24 hours.

3. A dosage form comprising 5 mg to 250 mg of a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt, wherein (i) said dosage form provides a maximum plasma oxybutynin concentration of about 0.28 ng/ml to about 0.45 ng/ml per mg of said member in said dosage form and (ii) wherein said dosage form delivers said member from said dosage form over a period of about 24 hours.

4. The dosage form according to claim 3, wherein said salt is oxybutynin hydrochloride.

5. The dosage form of claim 4, wherein said dosage form delivers at a substantially zero order rate of release.

6. The dosage form according to claim 3, wherein said dosage form further comprises a member selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylethylcellulose, hydroxypropylbutylcellulose, and hydroxypropylpentylcellulose.

7. The dosage form according to claim 4, wherein said dosage form further comprises a member selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylethylcellulose, hydroxypropylbutylcellulose, and hydroxypropylpentylcellulose.

8. The dosage form of claim 3, wherein said dosage form delivers at a substantially zero order rate of release.

9. The dosage form according to claim 3, wherein said dosage form is a tablet.

10. The dosage form according to claim 4, wherein said dosage form is a tablet.

11. The dosage form according to claim 6, wherein said dosage form is a tablet.

12. The dosage form according to claim 7, wherein said dosage form is a tablet.

13. A method for the management of incontinence in a patient comprising administration to a subject of a dosage form comprising 5 mg to 250 mg of a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt, wherein (i) said dosage form provides a maximum plasma oxybutynin concentration of about 0.28 ng/ml to about 0.45 ng/ml per mg of said member in said dosage form and (ii) wherein said dosage form delivers said member from said dosage form over a period of about 24 hours.

14. The method according to claim 13, wherein said salt is oxybutynin hydrochloride.

15. The method according to claim 13, wherein said dosage form further comprises a member selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylethylcellulose, hydroxypropylbutylcellulose, and hydroxypropylpentylcellulose.

16. The dosage form of claim 13, wherein said dosage form delivers at a substantially zero order rate of release.

17. The method according to claim 14, wherein said dosage form further comprises a member selected from the group consisting of hydroxypropylmethylcellulose, hydroxypropylethylcellulose, hydroxypropylbutylcellulose, and hydroxypropylpentylcellulose.

18. The dosage form of claim 17, wherein said dosage form delivers at a substantially zero order rate of release.

19. The method according to claim 13, wherein said dosage form is a tablet.

20. The method according to claim 14, wherein said dosage form is a tablet.

21. The method according to claim 15, wherein said dosage form is a tablet.

22. The method according to claim 17, wherein said dosage form is a tablet.

23. The method according to any one of claim 13, 14, 15, 17, 19, 20, 21 or 22 wherein the incidence of side effects associated with oxybutynin treatment is reduced.
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