Chronotherapeutic diltiazem formulations and the...

Details Chronotherapeutic diltiazem formulations and the... Chronotherapeutic diltiazem formulations and the...

2008-03-25

2008-03-25

Sheikh, Humera N (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

C424S490000, C424S464000, C424S468000

Reexamination Certificate

active

07348028

ABSTRACT:
A method of treating or preventing myocardial ischemia in a patient in need thereof comprising administration of a controlled-release Galenical preparation of pharmaceutically acceptable Diltiazem including the pharmaceutically acceptable salts thereof, suitable for evening dosing every 24 hours containing from about 180 mg to about 420 mg of the form of Diltiazem associated with excipients to provide controlled (sustained) release of the form of Diltiazem for providing a Cmaxof Diltiazem in the blood at between about 10 hours and about 17 hours after administration, the preparation comprising the form of Diltiazem in oral sustained-release dosage form in which the Diltiazem is adapted to be released after administration over a prolonged period of time and exhibits when given to humans(i) a higher bioavailability when given at night compared to when given in the morning without food according to FDA guidelines or criteria and(ii) bioequivalence when given in the morning with and without food according to the same FDA guidelines or criteria.

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patent: WO 01/41744 (2001-06-01), None

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