Claims for Patent: 9,744,105

Summary for Patent: 9,744,105

Title:	Topical glycopyrrolate formulations
Abstract:	Individually packaged topical formulations comprising about 0.25 to about 6% w/w of glycopyrrolate for the treatment of hyperhidrosis, wherein said wipe is contained within a pouch resistant to leakage. The formulations may further comprise ethanol, a buffering agent and water. In addition, the formulations may further comprise a polymer system comprising a hydrophobic polymer in combination with a hydrophilic polymer.
Inventor(s):	Johnston; Michael (Yarraville, AU), Houlden; Robert James (Kilsyth, AU)
Assignee:	ROSE U, LLC (Palo Alto, CA)
Application Number:	14/084,010
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,744,105
Patent Claims:	1. A glycopyrrolate base solution comprising: about 0.5 to about 4.0% w/w of a glycopyrrolate compound having the following formula: ##STR00003## wherein X.sup.- is a pharmaceutically acceptable counter ion salt; ethanol and water in a weight ratio of about 50:50 to about 60:40; and a buffering agent, comprising citric acid and a base selected from the group consisting of sodium citrate and tromethamine, said acid and base at a total concentration of about 0.2 to about 0.5% w/w and at an acid:base ratio sufficient to maintain a pH of the glycopyrrolate base solution of about 3.5 to about 6 for at least nine months at 25.degree. C. 2. The glycopyrrolate base solution of claim 1, wherein the buffering agent maintains a pH of the base solution of 4.0+/-0.5. 3. The glycopyrrolate base solution of claim 1, wherein the buffering agent maintains a pH of the base solution of about 4.0. 4. The glycopyrrolate base solution of claim 1, wherein the glycopyrrolate compound degrades by less than 1% when stored at 0 to 25.degree. C. for at least one month, two months, six months or one year. 5. The glycopyrrolate base solution of claim 4, wherein the glycopyrrolate compound degrades by up to 0.2% when stored at 0 to 25.degree. C. for at least three months. 6. The glycopyrrolate base solution of claim 1, further comprising propylene glycol. 7. The glycopyrrolate base solution of claim 1, wherein the base is sodium citrate. 8. The glycopyrrolate base solution of claim 7, wherein the buffering agent maintains a pH of the base solution of 4.0+/-0.5. 9. The glycopyrrolate base solution of claim 7, wherein the buffering agent maintains a pH of the base solution of about 4.0. 10. The glycopyrrolate base solution of claim 7, wherein the buffering agent is about 0.15% citric acid and about 0.06% sodium citrate. 11. The glycopyrrolate base solution of claim 7, wherein the ethanol to water weight ratio is about 60:40. 12. The glycopyrrolate base solution of claim 10, wherein the ethanol and water are in a weight ratio of about 60:40. 13. The glycopyrrolate base solution of claim 10, comprising about 59% ethanol and about 39% water. 14. The glycopyrrolate base solution of claim 1, wherein the base is tromethamine. 15. The glycopyrrolate base solution of claim 1, wherein the buffering agent maintains a pH of the base solution of about 4.5. 16. The glycopyrrolate base solution of claim 1, wherein the ethanol is at about 53.7 to about 57.3% w/w, and the water is added to 100% w/w. 17. The glycopyrrolate base solution of claim 1, further comprising a polymer system comprising a hydrophobic polymer in combination with a hydrophilic polymer. 18. The glycopyrrolate base solution of claim 17, wherein the polymer system comprises a polyvinyl pyrrolidone and a butyl ester of polyvinylmethylether/maleic anhydride copolymer. 19. The glycopyrrolate base solution of claim 1, wherein the ethanol and water are in a weight ratio of about 60:40. 20. An individually packaged wipe for the treatment of hyperhidrosis comprising a wipe loaded with the glycopyrrolate base solution of claim 1 contained within a pouch resistant to leakage. 21. The individually packaged wipe of claim 20, wherein the wipe is selected from the group consisting of nonwoven material, paper material, woven material, knitted material, tufted material, stitched-bonded material, and material felted by wet-milling material. 22. A method for alleviating hyperhidrosis in a mammal comprising the topical administration of the wipe of claim 20, following removal from the pouch, to an area of the body such that the hyperhidrosis is reduced. 23. An individually packaged wipe for the treatment of hyperhidrosis comprising a wipe loaded with the glycopyrrolate base solution of claim 13 contained within a pouch resistant to leakage. 24. The individually packaged wipe of claim 23, wherein the wipe is selected from the group consisting of nonwoven material, paper material, woven material, knitted material, tufted material, stitched-bonded material, and material felted by wet-milling material. 25. A method for alleviating hyperhidrosis in a mammal comprising the topical administration of the wipe of claim 23, following removal from the pouch, to an area of the body such that the hyperhidrosis is reduced. 26. An individually packaged wipe for the treatment of hyperhidrosis comprising a wipe loaded with the glycopyrrolate base solution of claim 16 contained within a pouch resistant to leakage. 27. The individually packaged wipe of claim 26, wherein the wipe is selected from the group consisting of nonwoven material, paper material, woven material, knitted material, tufted material, stitched-bonded material, and material felted by wet-milling material. 28. A method for alleviating hyperhidrosis in a mammal comprising the topical administration of the wipe of claim 26, following removal from the pouch, to an area of the body such that the hyperhidrosis is substantially reduced. 29. A glycopyrrolate base solution, consisting essentially of about 0.5 to about 4.0% w/w of a glycopyrrolate compound having the following formula: ##STR00004## wherein X.sup.- is a pharmaceutically acceptable counter ion salt; ethanol and water in a weight ratio of about 50:50 to about 60:40; and a buffering agent, comprising citric acid and a base selected from the group consisting of sodium citrate and tromethamine, said acid and base at a total concentration of about 0.2 to about 0.5% w/w and at an acid:base ratio sufficient to maintain a pH of the glycopyrrolate base solution of about 3.5 to about 6 for at least nine months at 25.degree. C.