Method for the management of incontinence

• US 6,919,092 B2
• Filed: 02/16/2001
• Issued: 07/19/2005
• Est. Priority Date: 05/22/1995
• Status: Expired due to Fees

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Kidney, David J., Gumucio, Fernando E., Marks, Susan M., Jao, Francisco, Guittard, George V.
• Primary Examiner(s): Dodson, Shelley A.
• Assistant Examiner(s): George, Konata M
• Application Number:
  US09/785,805
• Publication Number:
  US 20010005728A1
• Time in Patent Office: 1,614 Days
• Field of Search: 424/464, 424/468, 424/474, 424/475, 424/479, 424/480, 424/484, 424/486, 514/534, 514/579, 514/646, 514/663, 514/727, 514/729, 514/730
• US Class Current: 424/464
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/221 with compounds having an amino group, e.g. acetylcholine, acetylcarnitine
• CPC Class Codes: A61K 31/24 having an amino or nitro group
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer
• CPC Class Codes: A61P 13/10 of the bladder

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.

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.