Therapeutic dosage form for delivering oxybutynin

• US 20020160045A1
• Filed: 06/04/2002
• Published: 10/31/2002
• Est. Priority Date: 06/05/1998
• Status: Abandoned Application

• Current Assignee: Halle Treanor, Michael A. Desjardin, Paul M. Hwang
• Original Assignee: Halle Treanor, Michael A. Desjardin, Paul M. Hwang
• Inventors: Treanor, Halle, Hwang, Paul M., Desjardin, Michael A.
• Application Number:
  US10/164,138
• Publication Number:
  US 20020160045A1
• Time in Patent Office: Days
• US Class Current: 424/468
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• 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

Abstract

A dosage form, a therapeutic composition, and the use thereof is disclosed for administering a therapeutic agent accompanied by a pharmaceutically acceptable means administered for an indicated therapy.

Claims

1. A therapeutic composition comprising a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt and a pharmaceutically acceptable surfactant for providing a sustained-release dosage form for the treatment of a patient with an overactive bladder accompanied with symptoms of urinary frequency.

2. A therapeutic composition comprising 240 mg to 650 mg of an oxybutynin selected from the group consisting of the racemate, the R-enantiomer and the S-enantiomer and a pharmaceutically acceptable surfactant, which composition is indicated for the manufacture of an oral sustained-release dosage form for the management of bladder instability associated with incontinence.

3. A therapeutic composition comprising 240 mg to 650 mg of a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt, and a pharmaceutically acceptable surfactant selected from the group consisting of amphoteric, anionic, cationic and nonionic surfactants.

4. A therapeutic composition comprising 240 mg to 650 mg of a member selected from the group consisting of oxybutynin and its pharmaceutically acceptable salt, and 0.01 mg to 25 mg of a pharmaceutically acceptable surfactant selected from the group consisting of polyoxyethylenated sorbital monolaurate, polyoxyethylenated sorbitan monopalmitate, polyoxyethylenated sorbitan monostearate, polyoxyethylenated sorbitan tristearate, polyoxyethylenated sorbitan monooleate, polyoxyethylenated sorbitan trioleate, and polyoxyethylenated stearic acid.

5. A therapeutic composition comprising a member selected from the group consisting of 240 mg to 650 mg of oxybutynin, 0.01 mg to 25 mg of a surfactant, and 10 mg to 250 mg of a pharmaceutically acceptable hydrophilic polymer.

6. A therapeutic composition comprising 240 mg to 650 mg of oxybutynin, 0.01 to 25 mg of a surfactant, and 10 mg to 250 of a polyalkylene oxide.

7. A therapeutic composition comprising 240 mg to 650 mg of oxybutynin, 0.01 to 25 mg of a surfactant, and 0.5 to 50 mg a hydroxypropylalkylcellulose

8. A method for the management of bladder instability associated with incontinence in a patient, wherein the method comprises administering an oral sustained-release dosage form comprising oxybutynin and a surfactant for the management over a sustained-release period up to twenty-four hours.

9. A method for the treatment of a patient with an overactive bladder accompanied with symptons of urinary frequency, wherein the method comprises admitting orally into the patient a sustained-release dosage from comprising oxybutynin, a surfactant, and a binder that imparts cohesiveness to the composition, for providing sustained-release oxybutynin therapy up to twenty-four hours.

10. A method for treating a patient with urge incontinence, wherein the method comprises administering orally to the patient a sustained-release dosage form comprising oxybutynin, a surfactant and a hydroxypropylalkylcellulose that is administered over a prolonged period for treating the patient.

11. A method for treating a patient with urge incontinence, wherein the method comprises administering orally to the patient a sustained-release dosage form comprising oxybutynin, a surfactant, and a hydrophilic polymer that is administered over a prolonged period up to twenty-four hours for treating the patient.

18. The dosage form according to claim 17, wherein the therapeutic composition comprises an osmotically effective solute.

19. The dosage form according to claim 17, wherein the therapeutic composition comprises a hydrophilic polymer.

20. The dosage form according to claim 17, wherein the therapeutic composition comprises a polyalkylene oxide.

21. The dosage form according to claim 17, wherein the surfactant is a member selected from the group consisting of an amphoteric, anionic, cationic, and nonionic surfactant.

22. The dosage form according to claim 17, wherein the expandable composition comprises an osmotically active solute.

23. The dosage form according to claim 17, wherein hydrophilic member in the expandable composition is a hydrogel.

24. The dosage form according to claim 17, wherein the hydrophilic member in the expandable composition is polyethylene oxide.

25. The dosage form according to claim 17, wherein the surfactant is selected from the group consisting of polyoxyethylenated sorbitol monolaurate, polyoxyethylenated sorbitan monopalmitate, polyoxyethylenated sorbitan monostearate, polyoxyethylenated sorbitan tristearate, polyoxyethyleneated sorbitan monooleate, polyoxyethylenated sorbitan trioleate, and polyoxyethylenated stearic acid.

12. A method for providing antispasmodic therapy in a patient with uninhibited neurogenic and reflex neurogenic bladder, wherein the method comprises administering to the patient a sustained-release dosage form comprising the antispasmodic oxybutynin in a therapeutic range that avoids a toxic dose and avoids an ineffective dose over a prolonged time up to twenty-four hours for providing antispasmodic therapy in the patient with uninhibited neurogenic and reflex neurogenic bladder.

13. A method for providing antispasmodic therapy in a patient with uninhibited neurogenic and reflex neurogenic bladder, wherein the method comprises administering to the patient a composition comprising the antispasmodic oxybutynin and means for enhancing the administration of the antispasmodic oxybutynin over a prolonged time for providing the antispasmodic therapy.

14. A dosage form comprising:

a wall;

a therapeutic composition comprising oxybutynin and a surfactant; and

means in the dosage form for delivering the composition from the dosage form.

15. A dosage form comprising:

a therapeutic composition comprising oxybutynin, a surfactant, and a polyalkylene oxide;

a semipermeable wall that surrounds the therapeutic composition; and

, an exit in the dosage form for delivering the oxybutynin from the dosage form.

16. A dosage form comprising:

a therapeutic composition comprising oxybutynin, a surfactant, and a hydrophilic polymer;

a wall at least in part permeable to the passage of fluid that surrounds the therapeutic composition; and

, an exit in the dosage form for the release of oxybutynin from the dosage form.

17. A dosage form comprising:

a therapeutic composition comprising oxybutynin and a surfactant;

an expandable composition comprising a hydrophilic member;

a wall in at least a part permeable to the passage of fluid that envelops the therapeutic and the expandable compositions; and

an exit in the dosage form for releasing the oxybutynin from the dosage form.