Morphine polymer release system
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0 Petitions
Accused Products
Abstract
A pharmaceutical composition for controlled release of an active substance is provided. The active substance is released into an aqueous medium by erosion of at least one surface of the composition. The composition comprises i) a matrix comprising a) polymer or a mixture of polymers, b) an active substance and, optionally, c) one or more pharmaceutically acceptable excipients, and ii) a coating.
140 Citations
100 Claims
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1-59. -59. (canceled)
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60. A pharmaceutical composition for controlled release of at least one therapeutically, prophylactically and/or diagnostically active substance into an aqueous medium by erosion of at least one surface of the composition, the composition comprising
a matrix composition comprising a) a substantially water soluble or crystalline polymer or a mixture of substantially water soluble and/or crystalline polymers, the polymer being a polyglycol in the form of one of i) a homopolymer having a MW of from at least about 100,000 daltons to at least about 700,000 and ii) a copolymer having a MW of from about 5,000 to about 30,000 daltons, or a mixture thereof, b) an opiod as active substance, and optionally, c) one or more pharmaceutically acceptable excipients, with the proviso that the matrix composition does not contain a water dispersible or water soluble surface active agent that has at least one domain, which is compatible with the polymer in the matrix composition, and which substantially eliminates water diffusion between the interface between the polymer crystals, and the matrix having a coating that has at least one opening exposing at the one surface of said matrix, the coating being substantially insoluble in and impermeable to fluids and comprising a polymer, and wherein any matrix surface exposed to the aqueous medium erodes at a substantially constant rate, so that a zero order release is obtained of at least about 60% w/w of the active substance from the pharmaceutical composition when subject to an in vitro dissolution test according to USP 24, NF 19, 711 Dissolution, employing Apparatus 2 equipped with a paddle, the composition having a cylindrical shape optionally with one or more tapered ends.
Specification