GOCHNOUR, Scott,SUBRAMANYAN, Venkatesh,KIMBALL, Michael
申请号：
ES10772664
公开号：
ES2650611T3
申请日:
2010.05.04
申请国别(地区):
ES
年份:
2018
代理人:
摘要：
A device for preserving and administering a topical solution of non-occluded oxybutynin comprising: a) A topical composition of non-occluded oxybutynin comprising: (a) a therapeutically active amount of oxybutynin； (b) a thickening agent selected from the group consisting of synthetic polymers, vinyl polymers, cellulosic polymers, natural gelling agents, polyethylene compounds, polysaccharides, acrylic acid esters, alkoxybutynin polymers, polyethylene oxide polymers, polyethers, gelatin succinate , colloidal magnesium aluminum silicate, petrolatum and mixtures of the foregoing； and (c) 50% or more of the weight of the topical solution of non-occluded oxybutynin of a solvent selected from the group consisting of C1-C6 hydrocarbons, water and mixtures thereof； b) a reservoir for the topical composition of non-occluded oxybutynin； c) a laminate surrounding the reservoir and the topical composition of non-occluded oxybutynin, comprising； i) a first polymer that is in contact with the topical composition of non-occluded oxybutynin； and ii) a metal sheet bonded to the first polymer layer； and d) a notch or partial mark of the laminate surrounding the reservoir and the topical composition of non-occluded oxybutynin, where the notch or partial mark facilitates the opening of the device for dispensing the topical composition of non-occluded oxybutynin from the device； and where the device can withstand 206.84 kPa (30 pounds, 13.60 kg) of unexploded pressure when compressed between two rollers of a motorized test bench, and when the device is stored at 25 ° C and 60% of relative humidity for twenty-six weeks the topical composition of non-occluded oxybutynin does not contain more than 0.2% ethyl ester of phenylcyclohexyl glycolic acid (PCGE)； no more than 2.0% phenylcyclohexyl glycolic acid (GAAP) and there is no more than 20% change in solvent content.Un dispositivo para conservar y administrar una solución tópica de oxibutinina no ocluida comprendiendo: a) Una composición t
