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; a device for storing and administering non-occluded oxybutynin topical compositions and a method for preparing the device for storing and administering non-occluded oxybutynin topical compositions.

1 . A method for preparing a flexible packaging system for a non-occluded oxybutynin composition comprising:
 a) combining two sheets of a laminate or folding a single sheet of a laminate to form a reservoir for the non-occluded oxybutynin composition wherein the laminate comprises:
 i) a first polymer layer that is in contact with the non-occluded oxybutynin topical composition in the reservoir and wherein the first polymer layer is a polyethylene or acrylic based polymer or copolymer; and 
 ii) a metal foil bound to the first polymer layer; 
   b) filling the reservoir formed in step (a) with 0.25 g to 5 g of the non-occluded oxybutynin composition wherein the non-occluded oxybutynin topical composition comprises:
 i) 2% by weight to 20% by weight of the topical composition of oxybutynin; 
 ii) 0.05% by weight to 10% by weight of the topical composition of a thickening agent selected from the group consisting of synthetic polymers, vinyl polymers, cellulose polymers, naturally occurring gelling agents, polyethylene compounds; polysaccharides, acrylic acid esters, alkoxybutynin polymers, polyethylene oxide polymers, polyethers, gelatin succinate, colloidal magnesium aluminum silicate, petroleum jelly and mixtures thereof; and 
 iii) 50% by weight or more of the topical composition of a solvent selected from the group consisting of C 1 -C 6  hydrocarbons, water and mixtures thereof; and 
   c) sealing the reservoir to create the flexible packaging system that can withstand 20 pounds of pressure without bursting when squeezed between two platens of a motorized test stand.   
     
     
         2 . The method of  claim 1  further comprising the step of forming a notch or score in the laminate surrounding the reservoir and non-occluded oxybutynin topical composition wherein the notch or score facilitates the opening of the packaging system for dispensing the non-occluded oxybutynin topical composition from the packaging system. 
     
     
         3 . The method 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. 
     
     
         4 . The method of  claim 1  wherein the laminate further comprises an additional layer for embossing or printing descriptive information on the packaging system. 
     
     
         5 . The method of  claim 1  wherein the metal foil is aluminum foil with a thickness of 0.2 mil to 0.5 mil. 
     
     
         6 . The method of  claim 1  wherein the first polymer layer is a polyethylene polymer selected from the group consisting of low density polyethylene and linear low density polyethylene, with a thickness of 0.5 mil to 2.5 mil. 
     
     
         7 . The method of  claim 1  wherein the first polymer layer is an acrylonitrile-methyl acrylate copolymer with a thickness of 0.5 mil to 2.5 mil. 
     
     
         8 . The method of  claim 1  wherein the first polymer layer is linear low density polyethylene with a thickness of 0.5 mil to 2.5 mil. 
     
     
         9 . The method of  claim 3  wherein the adhesive is a urethane or ethylene/acrylic acid copolymer with a thickness of 0.3 mil to 0.75 mil. 
     
     
         10 . The method of  claim 1  wherein the non-occluded oxybutynin topical composition is a gel, cream or lotion. 
     
     
         11 . The method of  claim 10  wherein the non-occluded oxybutynin topical composition is a gel. 
     
     
         12 . The method of  claim 1  wherein the solvent is a mixture of the C 1 -C 6  hydrocarbon and water. 
     
     
         13 . The method of  claim 1  wherein the flexible packaging system can withstand 25 pounds of pressure without bursting. 
     
     
         14 . The method of  claim 1  wherein the non-occluded oxybutynin topical composition has a pH of 4.5 to 9. 
     
     
         15 . The method of  claim 1  wherein when the packaging system is stored at 40° C. and 75% relative humidity for thirteen 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. 
     
     
         16 . The method of  claim 1  wherein when the packaging system is stored at 40° C. and 75% relative humidity for thirteen weeks, the non-occluded oxybutynin topical composition contains not more than 0.15% of phenylcyclohexyl glycolic acid ethyl ester (PCGE); not more than 1.0% phenylcyclohexylglycolic acid (PCGA) and there is not more than a 15% change in the solvent content. 
     
     
         17 . The method of  claim 1  wherein when the packaging system is stored at 25° 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. 
     
     
         18 . The method of  claim 1  wherein when the packaging system is stored at 25° 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 1.0% phenylcyclohexylglycolic acid (PCGA) and there is not more than a 15% change in the solvent content. 
     
     
         19 . The method of  claim 1  wherein when the packaging system is stored at 25° C. and 60% relative humidity for fifty-two weeks, the non-occluded oxybutynin topical composition exhibits a total leachable concentration from the laminate in contact with the non-occluded topical system of not more than 300 ppm. 
     
     
         20 . The method of  claim 1  wherein when the packaging system is stored at 25° C. and 60% relative humidity for fifty-two weeks, the non-occluded oxybutynin topical composition exhibits a total leachable concentration from the laminate in contact with the non-occluded topical system of not more than 200 ppm. 
     
     
         21 . The method of  claim 19  wherein the first polymer layer is a polyethylene polymer selected from the group consisting of low density polyethylene and linear low density polyethylene, with a thickness of 0.5 mil to 2.5 mil and the total leachable concentration in the non-occluded oxybutynin topical composition is not more than 200 ppm. 
     
     
         22 . The method of  claim 19  wherein the first polymer layer is an acrylonitrile-methyl acrylate copolymer with a thickness of 0.5 mil to 2.5 mil and the total leachable concentration in the non-occluded oxybutynin topical composition is not more than 100 ppm. 
     
     
         23 . A flexible packaging system prepared according to the method of  claim 1 .