Extended release formulation of diltiazem hydrochloride

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Capsules

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Details

424489, 424470, 424457, 424468, 424464, 424456, 424400, A61K 948

Patent

active

061624632

ABSTRACT:
An extended release formulation of diltiazem which is suitable for once-daily oral administration comprises a quantity of a quick release preparation of diltiazem or a pharmaceutically active salt thereof, mixed with a quantity of a slow release (or delayed release) preparation of diltiazem or a pharmaceutically active salt thereof. The quick release preparation used obtains a maximal release of diltiazem within approximately 1-2 hours after administration, and then falls toward baseline levels. The delayed release preparation individually shows a maximal release of diltiazem at between approximately 6-8 hours after administration. The formulation containing the two preparation achieves a maximal release of diltiazem approximately within 1-2 hours after administration, and the levels of released diltiazem remain near these maximal levels for approximately another 12 hours after administration, compared to other extended release formulations of diltiazem (referred to herein as slow or delayed release preparations) which achieve maximal release approximately 9 hours after oral administration. The preferred embodiment is a capsule containing the formulation, which, based upon the total quantity of drug in the formulation rather than total weight of the formulation, comprises up to approximately 25 percent by weight of the quick release preparation of diltiazem, and up to 75 percent by weight of the slow (or delayed) release preparation of diltiazem. The present invention has application for combinations of other preparations of quick release and slow or delayed release pharmaceuticals.

REFERENCES:
patent: 4894240 (1990-01-01), Geoghegan et al.
patent: 5028664 (1991-07-01), Ohmura et al.
patent: 5252338 (1993-10-01), Jao et al.
patent: 5472710 (1995-12-01), Klokkens-Bethke et al.
patent: 5578322 (1996-11-01), Shiozawa et al.

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