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Claims for Patent: 5,470,584

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Claims for Patent: 5,470,584

Title: Diltiazem formulation
Abstract:The present invention is directed to a diltiazem formulation suitable for one a day administration. The formulation contains a blend of diltiazem beads having two differing dissolution profiles.
Inventor(s): Hendrickson; Dennis L. (Overland Park, KS), Dimmitt; Dan C. (Belton, MO), Williams; Mark S. (Kansas City, MO), Skultety; Paul F. (Leawood, KS), Baltezor; Michael J. (Lees Summit, MO)
Assignee: Carderm Capital L.P. (Thalwil, CH)
Application Number:08/394,573
Patent Claims: 1. A delayed release diltiazem formulation suitable for oral administration comprising:

a) a central core containing an effective amount of diltiazem or a pharmaceutically acceptable salt thereof, optionally in association with pharmaceutically acceptable excipients, and;

b) a sufficient quantity of a suitable polymeric coating material which substantially envelops said diltiazem core so that said diltiazem bead exhibits the following in-vitro dissolution profile when measured in a type 2 dissolution apparatus (paddle), according to U.S. Pharmacopoeia XXII, at 37.degree. C. in 0.1NHCl at 100 rpm:

a) from 0-15% of total diltiazem is released after 12 hours in said apparatus;

b) from 0-45% of total diltiazem is released after 18 hours of measurement in said apparatus, and;

c) not less than 45% of total diltiazem is released after 24 hours of measurement in said apparatus.

2. A diltiazem formulation according to claim 1 in which said polymeric coating contains from 10-75 w/w % of polymerized acrylate based upon the total weight of the formulation.

3. A diltiazem formulation according to claim 2 in which said polymeric coating comprises from 15-50 w/w % of the total weight of the formulation.

4. A diltiazem formulation according to claim 3 in which said polymeric acrylate is a copolymer of ethyl acrylate and methyl methacrylate which contains trimethylammoniumethyl methacrylate in a range of about 1:40 relative to the neutral monomers.

5. A diltiazem formulation according to claim 4 in which said polymeric coating contains a plasticizer in the range of 5-15 w/w % based upon the total weight of the polymeric coating.

6. A diltiazem formulation according to claim 5 in which said plasticizer is selected from the group consisting of tributyl citrate and acetyl tributyl citrate.

7. A diltiazem formulation according to claim 6 in which said polymeric coating comprises about 25 w/w % of the total weight of the formulation.

8. A diltiazem formulation according to claim 7 in which said polymeric coating contains

a) a copolymer of ethyl acrylate and methyl methacrylate which contains trimethylammoniumethyl methacrylate in a range of about 1:40 relative to the neutral monomers and

b) a copolymer of ethyl acrylate and methyl methacrylate which contains trimethylammoniumethyl methacrylate in a range of about 1:20 relative to the neutral monomers wherein the ratio of copolymer a) to copolymer b) is 95:5.

9. A diltiazem formulation according to claim 1 wherein said formulation exhibits the following in-vitro dissolution profile:

a) from 0-5% of total diltiazem is released after 6 hours of measurement in said apparatus,

b) from 0-10% of total diltiazem is released after 12 hours of measurement in said apparatus,

c) from 0-35% of total diltiazem is released after 18 hours of measurement in said apparatus, and,

d) from 50-90% of total diltiazem is released after 24 hours of measurement in said apparatus.
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