CONTROLLED-RELEASE FORMULATION COATED WITH AQUEOUS DISPERSION OF ETHYL CELLULOSE

PROBLEM TO BE SOLVED: To provide a dosage form that retains stable elution of medicine under the controlled conditions same as the original conditions, causing no change, even when it is exposed to a variety of temperature and humidity conditions for a long period of time, the pharmaceutical formulation thereof and methods for producing the same. SOLUTION: A stabilized solid controlled release formulation having a coating derived from an aqueous dispersion of a hydrophobic polymer is obtained by overcoating a substrate including an active agent selected from the group consisting of a systemically active therapeutic agent, a locally active therapeutic agent, a disinfecting and sanitizing agent, a cleansing agent, a fragrance agent and a fertilizing agent, with an aqueous dispersion of the plasticized hydrophobic polymer and then curing the coated substrate at a temperature above the glass transition temperature of the plasticized hydrophobic polymer, until a curing endpoint is reached at which the coated substrate provided a stabilized elution of the active agent which is unchanged after exposure to accelerated storage conditions, the end point being determined by comparing the elution profile of the formulation immediately after curing to the elution profile of the formulation after exposure to accelerated storage conditions of at least one month at a temperature of 37°C and at a relative humidity of 80%. COPYRIGHT: (C)2006,JPO&NCIPI