Patent ID: 6143353
Filing Date: 2000-11-07
Classification: A61K

Abstract:
A method for obtaining a controlled release formulation of an active agent, comprising:preparing a solid substrate comprising an active agent;coating said substrate with a sufficient amount of an aqueous dispersion of (i) a plasticized water-insoluble acrylic polymer comprised of monomers selected from the group consisting of an ester of acrylic acid, an ester of methacrylic acid, an alkyl ester of acrylic acid, an alkyl ester of methacrylic acid, and mixtures of any of the foregoing, and (ii) a further material selected from the group consisting of a polymerizable permeability-enhancing agent, a water-soluble acrylic polymer, a pore-former, and mixtures of any of the foregoing, to provide a controlled release of said active agent when said coated substrate is exposed to an environmental fluid, andcuring said coated substrate at a temperature greater than the glass transition temperature of the plasticized water-insoluble acrylic polymer until a curing endpoint is reached at which said coated substrate upon exposure to an environmental fluid provides a band range, when comparing the dissolution profile after exposure to accelerated storage conditions of at least one month at 40.degree. C./75% RH to the dissolution profile prior to exposure of said coated substrate to said accelerated storage conditions, which is not wider than about 15% of total active agent released at any point of time during said dissolution.