Method for the management of incontinence

• US 20040043943A1
• Filed: 08/20/2003
• Published: 03/04/2004
• Est. Priority Date: 05/22/1995
• Status: Abandoned Application

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Kidney, David J., Jao, Francisco, Guittard, George V., Gumucio, Fernando E., Marks, Susan M.
• Application Number:
  US10/645,715
• Publication Number:
  US 20040043943A1
• Time in Patent Office: Days
• US Class Current: 514/23
• 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 a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt, that is administered 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, methylnitrate, 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 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 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 then 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 then 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 into the patient a dosage form comprising a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt that is administered 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 to the patient a member selected from a group consisting of oxybutynin and its pharmaceutically acceptable salt at a sustained release rate for the management of the overactive bladder, and orally administering to the patient a composition comprising 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, 17α

-ethinyl estradiol, 17α

-ethinyl estradiol esters, 17α

-ethinyl estradiol acetate, 17α

-ethinyl estradiol benzoate, 17α

-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, 17α

-ethinyltestosterone, 17α

-ethinyl-19-nor-testosterone, d-17β

-acetoxy-13β

-ethyl-17α

-ethinyl-17β

-hydroxygon4-en-3-one, 13β

-ethyl-17β

-hydroxygon4-en-3-one, 13β

-17α

-diethyl-17β

-hydroxygon-4-en-3-one, chlormadione acetate, dimethistrone, 17α

-ethinyl-β

-acetoxy-19-norandrost4-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.