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AssigneeVeloxis Pharmaceuticals A/S
InventorsRobert D. Gordon, Per Holm, Anne-Marie Lademann, Tomas Norling
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An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.
1-95. (canceled)
A method of suppressing kidney rejection in a kidney transplant patient comprising orally administering once daily in the evening to the kidney transplant patient an extended release pharmaceutical composition comprising tacrolimus, wherein the in vivo release of the extended release pharmaceutical composition after oral administration takes place substantially in the colon.
A method of suppressing kidney rejection in a kidney transplant patient comprising prescribing an extended release pharmaceutical composition comprising tacrolimus for once daily oral administration without restriction as to the time of day of administration, wherein the in vivo release of the extended release pharmaceutical composition after oral administration takes place substantially in the colon.
A method of suppressing kidney rejection in a kidney transplant patient comprising orally administering once daily an extended release pharmaceutical composition comprising tacrolimus without restriction as to the time of day of administration, wherein
Dependencies are inferred from the claim text.