Claims for Patent: 8,920,392

Summary for Patent: 8,920,392

Title:	Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions
Abstract:	The invention relates to a method for treating overactive bladders and a device for storing and administering non-occluded oxybutynin topical compositions.
Inventor(s):	Gochnour; Scott (Salt Lake City, UT), Subramanyan; Venkatesh (Salt Lake City, UT), Kimball; Michael W. (Salt Lake City, UT)
Assignee:	Watson Laboratories, Inc. (Salt Lake City, UT)
Application Number:	12/435,895
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,920,392
Patent Claims:	1. A device for storing and administering a non-occluded oxybutynin topical composition comprising: a) a non-occluded oxybutynin topical composition comprising: i) a therapeutically effective amount of oxybutynin; ii) a thickening agent and iii) 50% or more based upon the weight of the non-occluded oxybutynin topical composition of a solvent; b) a reservoir for the non-occluded oxybutynin topical composition; and c) a laminate surrounding the reservoir and non-occluded oxybutynin topical composition comprising: i) a first polymer that is in contact with the non-occluded oxybutynin topical composition; and ii) a metal foil bound to the first polymer layer; and d) a notch or partial scoring of the laminate surrounding the reservoir and non-occluded oxybutynin topical composition wherein the notch or partial scoring facilitates the opening of the device for dispensing the non-occluded oxybutynin topical composition from the device; and wherein the device can withstand 30 pounds of pressure without bursting when squeezed between two platens of a motorized test stand and when the device is stored at 25.degree. C. and 60% relative humidity for twenty-six weeks the non-occluded oxybutynin topical composition contains not more than 0.2% of phenylcyclohexyl glycolic acid ethyl ester (PCGE); not more than 2.0% phenylcyclohexylglycolic acid (PCGA) and there is not more than a 20% change in the solvent content. 2. The device of claim 1 wherein the laminate further comprises an adhesive layer between the first polymer layer and the metal foil for bonding the metal foil to the first polymer layer. 3. The device of claim 1 wherein the laminate further comprises an additional layer for embossing or printing descriptive information. 4. The device of claim 1 wherein the non-occluded oxybutynin topical composition is a gel, cream or lotion. 5. The device of claim 4 wherein the non-occluded oxybutynin topical composition is a gel. 6. The device of claim 1 wherein the non-occluded oxybutynin topical composition comprises about 2% to about 20% based upon the total weight of the composition of oxybutynin. 7. The device as defined in claim 1 wherein the oxybutynin is oxybutynin chloride. 8. The device of claim 1 wherein the solvent comprises at least 60% of the total weight of the composition. 9. The device of claim 1 that can withstand 50 pounds of pressure without bursting. 10. The device of claim 1 that can withstand 100 pounds of pressure without bursting. 11. The device of claim 1 wherein after storage at 25.degree. C. and 60% relative humidity for fifty-two weeks, the non-occluded oxybutynin topical composition contains not more than 0.17% of PCGE; not more than 1.7% of PCGA and there is not more than a 15% change in the solvent content. 12. The device of claim 11 wherein after storage at 25.degree. C. and 60% relative humidity for fifty-two weeks, the non-occluded oxybutynin topical composition contains not more than 0.15% of PCGE; not more than 1.0% of PCGA and there is not more than a 10% change in the solvent content. 13. The device of claim 1 wherein after storage at 40.degree. C. and 75% relative humidity for thirteen weeks, the non-occluded oxybutynin topical composition contains not more than 0.15% of PCGE; not more than 1.0% of PCGA and there is not more than a 15% change in the solvent content. 14. The device of claim 13 wherein after storage at 40.degree. C. and 75% relative humidity for thirteen weeks, the non-occluded oxybutynin topical composition contains not more than 0.10% of PCGE; not more than 0.50% of PCGA and there is not more than a 10% change in the solvent content. 15. The device of claim 1 wherein after storage at 40.degree. C. and 75% relative humidity for twenty-six weeks, the non-occluded oxybutynin topical composition contains not more than 0.17% of PCGE; not more than 1.7% of PCGA and there is not more than a 15% change in the solvent content. 16. The device of claim 15 wherein after storage at 40.degree. C. and 75% relative humidity for twenty-six weeks, the non-occluded oxybutynin topical composition contains not more than 0.15% of PCGE; not more than 1.0% of PCGA and there is not more than a 10% change in the solvent content. 17. The device of claim 1 wherein the reservoir is formed by sealing at least one edge of the laminate. 18. The device of claim 17 wherein the reservoir is formed by sealing more than one edge of the laminate. 19. The device of claim 17 wherein the seal is a destructive seal. 20. A device for storing and administering a non-occluded oxybutynin topical composition comprising: a) a non-occluded oxybutynin topical composition with a pH of about 4.5 to about 9 comprising: i) about 2% to about 20% based upon the weight of the non-occluded oxybutynin topical composition of oxybutynin; ii) about 0.05% to about 10% based upon the weight of the non-occluded oxybutynin topical composition of a thickening agent; and iii) 50% or more based upon the weight of the non-occluded oxybutynin topical composition of a solvent; b) a reservoir for the non-occluded oxybutynin topical composition; and c) a laminate surrounding the reservoir and non-occluded oxybutynin topical composition comprising: i) a first polymer that is in contact with the non-occluded oxybutynin topical composition; and ii) a metal foil bound to the first polymer layer wherein the reservoir is created by forming at least one destructive seal on the laminate; and d) a notch or partial scoring of the laminate surrounding the reservoir and non-occluded oxybutynin topical composition wherein the notch or partial scoring facilitates the opening of the device for dispensing the non-occluded oxybutynin topical composition from the device and wherein the device can withstand 50 pounds of pressure without bursting when squeezed between two platens of a motorized test stand; wherein when the device is stored at 25.degree. C. and 60% relative humidity for twenty-six weeks, the non-occluded oxybutynin topical composition contains not more than 0.15% of phenylcyclohexyl glycolic acid ethyl ester (PCGE), not more than 1.00% of phenylcyclohexylglycolic acid (PCGA), there is not more than a 15% change in the solvent content and not more than a 0.75 change in pH; and wherein when the device is stored for thirteen weeks at 40.degree. C. and 75% relative humidity, the non-occluded oxybutynin topical composition contains not more than 0.15% of PCGE, not more than 1.00% of PCGA, there is not more than a 15% change in the solvent content and not more than a 0.75 change in pH. 21. A method for treating human patients suffering from overactive bladder comprising the steps of a) providing a storage and administration device as defined in claim 1 to a human; b) dispensing a single or daily dose of the oxybutynin composition from the device; and c) applying the single or daily dose of the oxybutynin composition to a skin surface of the human patient. 22. A method for treating human patients suffering from overactive bladder comprising the steps of a) providing a storage and administration device as defined in claim 20 to a human; b) dispensing a single or daily dose of the oxybutynin composition from the device; and c) applying the single or daily dose of the oxybutynin composition to a skin surface of the human patient. 23. The device of claim 1 wherein the non-occluded oxybutynin topical composition does not include a backing member. 24. The device of claim 20 wherein the non-occluded oxybutynin topical composition does not include a backing member.