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Claims for Patent: 6,262,115

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Claims for Patent: 6,262,115

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 Coporation (Mountain View, CA)
Application Number:09/280,309
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 a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt, that is administered once-a-day at a release rate of 0.05 mg per hour up to 0.850 mg per hour for the management of incontinence in the patient.

2. The method for the management of incontinence in a patient according to claim 1, wherein the dosage form is a sustained-release dosage form and the pharmaceutically acceptable salt is a member selected from the group consisting of acetate, bitartrate, citrate, edetate, chloride, edisylate, estolate, esylate, fumarat, , gluceptate, gluconate, glutamate, bromide, lactate, malate, maleate, mandelate, mesylate, methyinitrate, mucate, napsylate, nitrate, pamoate, pantothenate, phosphate, salicylate, stearate, succinate, sulfate, tannate, and tartrate.

3. The method for the management of incontinence in a patient according to claim 1, wherein the dosage form is a controlled-release dosage form and the oxybutynin is present as a racemate.

4. The method for the management of incontinence in a patient according to claim 1, wherein the dosage form is a member selected from the group consisting of a tablet, capsule, caplet, bead, and matrix and the oxybutynin is present as the R-enantiomer.

5. The method for the management of incontinence in a patient according to claim 1, wherein the dosage form is a member selected from the group consisting of a tablet, capsule, caplet, bead and matrix and the oxybutynin is present as the S-enantiomer.

6. A method for treating incontinence in a patient exhibiting the symptoms of incontinence, wherein the method comprises admitting orally into the patient a sustained release dosage form comprising 240 ng to 650 mg of a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt that is administered once-a-day at a incontinence-managing rate of 10 ng per hour to 20 mg per hour for the management of incontinence.

7. The method for treating incontinence in a patient according to claim 6, wherein the method administers the pharmaceutically acceptable salt oxybutynin chloride over 24 hours.

8. A method for the management of incontinence and for the management of hormone replacement therapy in a patient, wherein the method comprises administering once-a-day a sustained-release therapeutically effective dose of a member selected from the group consisting oxybutynin and its pharmaceutically acceptable salt for the management of incontinence, and administering a therapeutically effective dose of an estrogenic steroid for the management of hormone replacement therapy to the patient in need of both therapies.

9. The method for the management of incontinence and for the management of hormone replacement therapy according to claim 8, wherein the oxybutynin and the estrogenic steroid are administered at the same time.

10. The method for the management of incontinence and for the management of hormone replacement therapy according to claim 8, wherein a progestin is administered with the estrogenic steroid.

11. The method for the management of incontinence and for the management of hormone replacement therapy according to claim 8, the oxybutynin and the estrogenic steroid are administered at a different time.

12. The method for the management of incontinence and for the management of hormone replacement therapy according to claim 8, wherein the administration of the estrogenic steroid is accompanied by the administration of a progestin steroid as a steroid pair and at a different time from the administration of the oxybutynin.

13. The method for the management of incontinence and for hormone replacement therapy according to claim 8, wherein the estrogenic steroid is a conjugated equine estrogen.

14. A method for treating involuntary incontinence in a patient, wherein the method comprises admitting orally into the patient a sustained release once-a-day dosage form comprising 240 ng to 650 mg of a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt, that is administered in a sustained rate to provide in the plasma of the patient a higher oxybutynin/desethylmetabolite ratio than about 0.18 to 1 for treating involuntary incontinence in the patient.

15. A method for managing the concentrations of oxybutynin (OXY) and its desethylmetabolite (DESOXY) in the plasma of a patient, and for managing incontinence in the patient, wherein the method comprises admitting orally into the patient a once-a-day dosage form comprising 240 ng to 650 mg of a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt, that is administered at a controlled rate to provide higher OXY/DESOXY ratio than about 0.18 to 1 for managing the plasma concentrations and for managing incontinence in the patient.

16. A method for the management of overactive bladder and for increasing compliance in a patient in need of said management and compliance wherein the method comprises admitting orally into the patient a once-a-day dosage form comprising 240 ng to 650 mg of a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt that is administered in a sustained-release dosage of 0.10 ng per hour to 25 mg per hour for increasing patient compliance for the management of overactive bladder in the patient.

17. The method according to claim 16, wherein the dosage form comprises a polymer selected from the group consisting of an erodible, nonerodible, diffusion, ion-exchange, and porous polymers.

18. The method according to claim 16, wherein the dosage form is an osmotic dosage form.

19. The method according to claim 16, wherein the dosage form comprises tiny pills.

20. The method according to claim 16, wherein the patient is administered a member selected from the group consisting of an estrogen and a progestin.

21. The method according to claim 16, wherein the dosage form comprises drug releasing beads.

22. A method for treating an overactive bladder in a female patient, wherein the method comprises admitting orally once-a-day into the patient a dosage form comprising 240 ng to 650 mg a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt that is administered once-a-day in a controlled release dose of 0.05 mg per hour to 0.850 mg per hour for treating the overactive bladder in the female patient.

23. The method for treating the overactive bladder according to claim 22, wherein the dosage form comprises a member selected from the group consisting of poly(amide), poly(amino acid), poly(ester), poly(lactic acid), poly(glycolic acid), poly(orthoester), poly(orthocarbonate), poly(acetyl), poly(anhydride), poly(dehydropyran), poly(carbohydrate), and poly(dioxinone).

24. The method for treating the overactive bladder according to claim 22, wherein the dosage form comprises a member selected from the group consisting of an olefin, vinyl, condensation, addition, carbohydrate, and silicon polymer.

25. The method for treating the overactive bladder according to claim 22, wherein the dosage form comprises a member selected from the group consisting of hydroxypropylalkylcellulose, and hydroxyalkylcellulose.

26. The method for the management of overactive bladder and hormone replacement therapy in a female patient, wherein the method comprises orally administering once-a-day to the patient a member selected from a group consisting of oxybutynin and its pharmaceutically acceptable salt at a therapeutically-effective, sustained release rate for the management of the overactive bladder, and orally administering to the patient a composition comprising a therapeutically-effective amount of a steroid selected from the group an estrogen and a progestin for hormone replacement therapy.

27. The method for the management of overactive bladder and hormone replacement therapy according to claim 26 wherein the oxybutynin and the steroid are administered at the same time.

28. The method for the management of overactive bladder and hormone replacement therapy according to claim 26, wherein the oxybutynin and the steroid are administered at different times.

29. The method for the management of overactive bladder and hormone replacement therapy according to claim 26, wherein the estrogen is a member selected from the group consisting of estradiol, estradiol valerate, estradiol benzoate, estradiol cypionate, estradiol propionate, estradiol dipropionate, estradiol acetate, ethinyl estradiol, 17.alpha.-ethinyl estradiol, 17.alpha.-ethinyl estradiol esters, 17.alpha.-ethinyl estradiol acetate, 17.alpha.-ethinyl estradiol benzoate, 17.alpha.-ethinyl estradiol ethers, estrone, estrone acetate, estrone sulfate, estriol, estriol succinate, estriol triacetate, conjugated equine estrogens, and estradiol esters.

30. The method for the management of overactive bladder and hormone replacement therapy according to claim 26, wherein the progestin is a member selected from the group consisting of progesterone, medroxyprogesterone, medroxyprogesterone acetate, hydroxyprogesterone, hydrogesterone caproate, norethindrone, norethindrone acetate, megestrol, megestrol acetate, progestin, progestogin, norgestrel, norethisterone, norethisterone acetate, levonorgestrel, norgestimate, norethynodrel, 17-hydroxyprogesterone esters, 19-nor-17-hydroxyprogesterone, 19-nor-17-hydroxyprogesterone esters, 17.alpha.-ethinyltestosterone, 17.alpha.-ethinyl-19-nor-testosterone, d-17.beta.-acetoxy- 13.beta.-ethyl-17.alpha.-ethinyl-17.beta.-hydroxygon-4-en-3-one, 13.beta.-ethyl-17.beta.-hydroxygon-4-en-3-one, 13.beta.-17.alpha.-diethyl-17.beta.-hydroxygon-4-en-3-one, chlormadione acetate, dimethistrone, 17.alpha.-ethinyl-.beta.-acetoxy-19-norandrost-4-en-3-one oxime, 3-ketodesogestrel, desogestrel, gestodine, and gestodene acetate.

31. The method for the management of overactive bladder and hormone replacement therapy according to claim 26, wherein the oxybutynin is administered from a dosage form selected from the group consisting of osmotic, diffusion, erodible, nonerodible, and ion-exchange dosage forms.
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