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AssigneeBiovail Laboratories International S.R.L.
InventorsKenneth Albert, Paul Maes
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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.
A chronotherapeutic extended release tablet dosage form comprising a dosage effective amount of diltiazem hydrochloride, which tablet dosage form is suitable for once-daily administration and which tablet dosage form when administered once daily provides for a Cmax of diltiazem in the blood to be attained between 10 and 15 hours after administration and wherein said extended release tablet dosage form comprises the following:
An extended release tablet containing an effective amount of diltiazem hydrochloride comprising:
An extended release tablet containing an effective amount of diltiazem hydrochloride comprising:
Dependencies are inferred from the claim text.