Chronotherapeutic diltiazem formulations and the administration thereof

US7108866B1 · kind B1 · utility

Assignee

• Biovail Laboratories International S.R.L. · BB

Inventors

• Kenneth Stephen Albert · Campion Road, US
• Paul Maes · Grimbergen, BE

Key dates

• Filing date: May 8, 2000
• Grant date: Sep 19, 2006
• Expiry date: May 8, 2020

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K9/1635
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

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 120 mg to about 540 mg or more (as desired) of the form of Diltiazem associated with excipients to provide controlled (sustained) release of the form of Diltiazem for providing a Cmax of Diltiazem in the blood at between about 10 hours and about 15 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.