Extended release form of diltiazem
AssigneeGalephar P.R., Inc., Ltd.
InventorsArthur M. Deboeck, Philippe R. Baudier
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Abstract
An extended-release galenical form of Diltiazem or a pharmaceutically acceptable salt thereof, which comprises beads containing said Diltiazem or a pharmaceutically acceptable salt thereof as an active ingredient and a wetting agent, said beads being coated with a microporous membrane comprising at least a water-soluble or water-dispersible polymer or copolymer and a pharmaceutically acceptable adjuvant.
Claims15
An extended-release galenical composition of Diltiazem or one or more pharmaceutically-acceptable salts thereof, which comprises beads, said beads consisting essentially of in admixture together:
- a) an effective amount of Diltiazem or said one or more salts thereof as an active ingredient, and
- b) an effective amount of a wetting agent, wherein said wetting agent is selected from the group consisting of a sugar, a C.sub.12 -C.sub.20 fatty acid ester of sucrose or xylose, a glyceride of sucrose, a fatty acid ester of polyoxyethylene, an ether of fatty alcohols and polyoxyethylene, an ester of sorbitan, an ester of polyoxyethylene sorbitan, a glyceride-polyglycide, an alcohol-polyglycide ester, lecithins and a combination thereof,
- wherein said beads are coated with a microporous membrane constituted by an aqueous dispersion of a neutral copolymer of ethyl acrylate and methyl acrylate, and a pharmaceutically-acceptable adjuvant.
A pharmaceutical composition, comprising an extended-release galenical composition of Diltiazem or one or more pharmaceutically-acceptable salts thereof, which comprises in capsule form:
- a) beads consisting essentially of an effective amount of each of Diltiazem or said one or more salts thereof and a wetting agent in admixture together, wherein said wetting agent is selected from the group consisting of a sugar, a C.sub.12 -C.sub.20 fatty acid ester of sucrose or xylose, a glyceride of sucrose, a fatty acid ester of polyoxyethylene, an ether of fatty alcohols and polyoxyethylene, an ester of sorbitan, an ester of polyoxyethylene sorbitan, a glyceride-polyglycide ester, an alcohol-polyglycide ester, lecithins and a combination thereof,
- wherein said beads are coated with a microporous membrane constituted by an aqueous dispersion of a neutral copolymer of ethyl acrylate and methyl methacrylate, and a pharmaceutically-acceptable adjuvant, and
- b) one or more other pharmaceutically active ingredients which are pharmaceutically compatible with Diltiazem or said one or more salts thereof.
A method for treating angina pectoris or hypertension or both in a mammal, which comprises administering to said mammal an effective amount of an extended-release galenical composition consisting essentially of Diltiazem or one or more pharmaceutically-acceptable salts thereof and a wetting agent in admixture together in the form of beads, wherein the wetting agent is selected from the group consisting of a sugar, a C.sub.12 -C.sub..degree. fatty acid ester of sucrose or xylose, a glyceride of sucrose, a fatty acid ester of polyoxyethylene, an ether of fatty alcohols and polyoxyethylene, an ester of sorbitan, an ester of polyoxyethylene sorbitan, an alcohol-polyglycide ester, a glyceride-polyglyceride lecithins and a combination thereof, and
- wherein the beads are coated with a microporous membrane constituted by an aqueous dispersion of a neutral copolymer of ethyl acrylate and methyl methacrylate, and a pharmaceutically-acceptable excipient.
Dependencies are inferred from the claim text.