Morphine controlled release system
First Claim
1. An oral pharmaceutical composition for controlled release of at least one opioid, comprising:
- an erodible matrix composition comprising a mixture of (a) a polymer or a mixture of polymers comprising a polyethylene glycol, a polyethylene oxide and/or a block copolymer of ethylene oxide and propylene oxide, (b) an opioid, and optionally, (c) one or more pharmaceutically acceptable excipients, wherein the erodible matrix composition does not comprise polyethylene glycol 2000 monostearate or polyethylene glycol 400 monostearate; and
a single coating on the erodible matrix having two openings exposing at least one surface of the matrix, wherein the coating is substantially insoluble in and impermeable to aqueous media and comprises one or more polymers selected from the group consisting of ethylcellulose, cellulose acetate, polyamide, polyethylene, polyethylene terephthalate, polypropylene, polyurethane, polyvinyl acetate, polyvinyl chloride, silicone rubber, latex, polyhydroxybutyrate, polyhydroxyvalerate, teflon, polylactic acid or polyglycolic acid and copolymers thereof, ethylene vinyl acetate (EVA), styrene-butadienestyrene (SBS) and styrene-isoprene-styrene (SIS),wherein the composition exhibits controlled release of the opioid by erosion of the matrix and exhibits a zero order release profile wherein about 75% w/w of the opioid is released from the composition within 4-10 hours when tested in a Dissolution Test in accordance with USP 24, NF 19, (711), Dissolution, apparatus 2, equipped with a paddle, in 1000 mL of 0.1 N hydrochloric acid and a paddle rotation of 120 rpm for the first 120 minutes, and thereafter substituting a pH 6.8 buffer solution and using a paddle rotation of 50 rpm.
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Accused Products
Abstract
A oral pharmaceutical composition for controlled release of an opioid from a pharmaceutical composition is described that comprises (i) an erodible matrix composition comprising a mixture of (a) a polymer or a mixture of polymers (b) an opioid, and optionally, (c) one or more pharmaceutically acceptable excipients; and (ii) a single, substantially insoluble in and impermeable coating having two openings exposing at least one surface of the matrix, and comprising one or more polymers. The composition exhibits controlled release of the opioid by erosion of the matrix and exhibits a zero order release profile wherein about 75% w/w of the opioid is released from the composition within 4-10 hours when tested in a dissolution test as described herein.
382 Citations
34 Claims
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1. An oral pharmaceutical composition for controlled release of at least one opioid, comprising:
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an erodible matrix composition comprising a mixture of (a) a polymer or a mixture of polymers comprising a polyethylene glycol, a polyethylene oxide and/or a block copolymer of ethylene oxide and propylene oxide, (b) an opioid, and optionally, (c) one or more pharmaceutically acceptable excipients, wherein the erodible matrix composition does not comprise polyethylene glycol 2000 monostearate or polyethylene glycol 400 monostearate; and a single coating on the erodible matrix having two openings exposing at least one surface of the matrix, wherein the coating is substantially insoluble in and impermeable to aqueous media and comprises one or more polymers selected from the group consisting of ethylcellulose, cellulose acetate, polyamide, polyethylene, polyethylene terephthalate, polypropylene, polyurethane, polyvinyl acetate, polyvinyl chloride, silicone rubber, latex, polyhydroxybutyrate, polyhydroxyvalerate, teflon, polylactic acid or polyglycolic acid and copolymers thereof, ethylene vinyl acetate (EVA), styrene-butadienestyrene (SBS) and styrene-isoprene-styrene (SIS), wherein the composition exhibits controlled release of the opioid by erosion of the matrix and exhibits a zero order release profile wherein about 75% w/w of the opioid is released from the composition within 4-10 hours when tested in a Dissolution Test in accordance with USP 24, NF 19, (711), Dissolution, apparatus 2, equipped with a paddle, in 1000 mL of 0.1 N hydrochloric acid and a paddle rotation of 120 rpm for the first 120 minutes, and thereafter substituting a pH 6.8 buffer solution and using a paddle rotation of 50 rpm. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
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Specification