Claims for Patent: 8,618,160

Summary for Patent: 8,618,160

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 (Rowville, AU), Houlden; Robert James (Rowville, AU)
Assignee:	Rose U (Palo Alto, CA)
Application Number:	12/738,168
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,618,160
Patent Claims:	1. An individually packaged wipe for the treatment of hyperhidrosis comprising about 0.25 to about 6% w/w of a glycopyrrolate compound, a buffering agent, and an alcohol and water in a weight ratio of about 50:50 to about 70:30, wherein said wipe is individually packaged and contained within a pouch resistant to leakage and the glycopyrrolate compound degrades by less than 0.5% when stored at 40.degree. C. for 3 months, wherein the buffering agent maintains a pH at about 4.5, and wherein the buffering agent is at about 10 mM to about 20 mM. 2. The individually packaged wipe of claim 1, wherein the pouch comprises an inner lining of linear low density polyethylene (LLDPE). 3. The individually packaged wipe of claim 1, further comprising propylene glycol. 4. The individually packaged wipe of claim 1, wherein the buffering agent comprises citric acid and sodium citrate. 5. The individually packaged wipe of claim 1, wherein the buffering agent comprises citric acid and tromethamine. 6. The individually packaged wipe of claim 1, wherein the alcohol is at about 53.7 to about 57.3% w/w and water is in the weight ratio of about 40:60 to about 60:40. 7. The individually packaged wipe of claim 1, wherein the alcohol is at about 53.7 to about 57.3% w/w, the buffering agent is at about 0.2 to about 0.5% w/w and the water is added to 100% w/w. 8. The individually packaged wipe of claim 3, wherein the alcohol is at about 53.7 to about 57.3 w/w, the propylene glycol is at about 2 to about 4% w/w, the buffering agent is at about 0.2 to about 0.5% w/w; and the water is added to 100% w/w. 9. A method for alleviating hyperhidrosis in a mammal comprising the topical administration of the wipe of claim 1 to an area of the body such that the hyperhidrosis is substantially reduced. 10. The individually packaged wipe of claim 1, wherein the alcohol comprises ethanol. 11. The individually packaged wipe of claim 1 further comprising a preservative. 12. The individually packaged wipe of claim 1 further comprising an additive. 13. The individually packaged wipe of claim 1, wherein the wipe is selected from a group consisting of nonwoven material, paper material, woven material, knitted material, tufted material, stitched-bonded and material felted by wet-milling material.