Controlled absorption diltiazen pharmaceutical formulation

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

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424462, 424468, 424473, 424490, 424497, 514965, A61K 950, A61K 958

Patent

active

047216190

ABSTRACT:
A controlled absorption diltiazem formulation for oral administration comprises a pellet having a core of diltiazem or a pharmaceutically acceptable salt thereof in association with an organic acid and a lubricant, and an outer membrane which permits release of diltiazem in an aqueous medium at a controlled rate which is substantially pH independent. The pellet has a dissolution rate in vitro, which when measured according to the Paddle Method of U.S. Pharmacopoeia XX, is not more than 10% of the total diltiazem after 2 hours of measurement in a buffered medium. Not more than 30% of the total diltiazem is released after a total of 4 hours measurement and not more than 40% of the total diltiazem is released after a total of 6 hours. 100% release is achieved after 12 hours, with a maximum of 80% of the total diltiazem being released after 8 hours.

REFERENCES:
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patent: 4499066 (1985-02-01), Moro et al.
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patent: 4600645 (1986-07-01), Ghebre-Sellassie et al.
patent: 4609542 (1986-09-01), Panoz et al.
patent: 4610870 (1986-09-01), Jain et al.
Chemical Abstracts, vol. 100, No. 18, Apr. 30, 1984, p. 367.

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