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US 5,470,584 AGranted
Diltiazem formulation
AssigneeCarderm Capital L.P.
InventorsDennis L. Hendrickson, Dan C. Dimmitt, Mark S. Williams, Paul F. Skultety, Michael J. Baltezor
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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.
Claims9
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 more elements
Dependencies are inferred from the claim text.