Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
2006-09-19
2006-09-19
Tran, S. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S452000, C424S457000, C424S458000, C424S465000, C424S468000, C424S469000
Reexamination Certificate
active
07108866
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 Cmaxof 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.
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Albert Kenneth Stephen
Maes Paul José
Biovall Laboratories International SRL
Hunton & Williams
Teskin Robin L.
Tran S.
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