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Claims for Patent: 5,288,505

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Claims for Patent: 5,288,505

Title: Extended release form of diltiazem
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.
Inventor(s): Deboeck; Arthur M. (Gurabo, PR), Baudier; Philippe R. (Waterloo, BE)
Assignee: Galephar P.R., Inc., Ltd. (Carolina, PR)
Application Number:07/721,396
Patent Claims: 1. 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.

2. The extended-release galenical composition of claim 1, wherein said salt is the hydrochloride salt.

3. The extended-release galenical composition of claim 1, wherein the weight of the microporous membrane is about 2 to 35% by weight of that of the uncoated beads.

4. The extended-release galenical composition of claim 3, wherein the weight of the microporous membrane is about 5 to 22% by weight of that of the uncoated beads.

5. The extended-release galenical composition of claim 1, wherein the weight of the Diltiazem salt is about 20 to 95% by weight.

6. 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.

7. The pharmaceutical composition of claim 6, wherein said one or more other pharmaceutically active ingredients comprise-.beta.-adrenoceptor or diuretic compounds or compositions containing the same.

8. The pharmaceutical composition of claim 6, wherein the weight of the microporous membrane is about 2 to 35% by weight of that of the uncoated beads.

9. The pharmaceutical composition of claim 6, wherein said salt is the hydrochloride salt.

10. The pharmaceutical composition of claim 6, wherein the weight of the microporous membrane is about 5 to 22% by weight of that of the uncoated beads.

11. 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.

12. The method of claim 11, wherein said administration is orally and once per day.

13. The method of claim 11, wherein said mammal is a human.

14. The method of claim 12, wherein from about 120 mg to about 480 mg of said one or more Diltiazem salts are administered in total per day.

15. The method of claim 11, wherein said salt is the hydrochloride salt.
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