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AssigneeVeloxis Pharmaceuticals, Inc.
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.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein (i) the initial dose of tacrolimus is 0.14 mg/kg/day, and (ii) the Tmax on day 1, when administered under fasting conditions, is between 4 hours and 24 hours.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein (i) the initial dose of tacrolimus is 0.14 mg/kg/day, (ii) the Tmax on day 1, when administered under fasting conditions, is between 4 hours and 24 hours, and (iii) the patient is concomitantly treated with mycophenolate mofetil.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein (i) the initial dose of tacrolimus is 0.14 mg/kg/day, (ii) the Tmax on day 1, when administered under fasting conditions, is between 4 hours and 24 hours, and (iii) the patient is concomitantly treated with a corticosteroid.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein (i) the initial dose of tacrolimus is 0.14 mg/kg/day, (ii) the Tmax on day 1, when administered under fasting conditions, is between 4 hours and 24 hours, and (iii) the patient is African-American.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein (i) the initial dose of tacrolimus is 0.14 mg/kg/day, (ii) the Tmax on day 1, when administered under fasting conditions, is between 4 hours and 24 hours, and (iii) the plasma concentration of tacrolimus in the patient is maintained at a therapeutically effective amount without inducing nephrotoxicity or neurotoxicity.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein (i) the initial dose of tacrolimus is 0.14 mg/kg/day, (ii) the target trough concentration for the tacrolimus is 5-10 ng/mL, (iii) at least 8% of the tacrolimus in each extended release composition is released at the 4 hour time point, (iv) 40% of the tacrolimus is released within 10 to 14 hours, and the Tmax on day 1, when administered under fasting conditions, is between 4 hours and 24 hours, when tested according to the USP II dissolution test (paddle) or USP I dissolution test (basket) method at a rotation of 50 rpm in a medium at pH 4.5 comprising 0.005% hydroxypropylcellulose.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein (i) the initial dose of tacrolimus is 0.14 mg/kg/day, (ii) the target trough concentration for the tacrolimus is 5-10 ng/mL, (iii) at least 8% of the tacrolimus in each extended release composition is released at the 4 hour time point, (iv) the Tmax on day 1, when administered under fasting conditions, is between 4 hours and 24 hours, and (v) the patient is concomitantly treated with mycophenolate mofetil.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein (i) the initial dose of tacrolimus is 0.14 mg/kg/day, (ii) the target trough concentration for the tacrolimus is 5-10 ng/mL, (iii) at least 8% of the tacrolimus in each extended release composition is released at the 4 hour time point, (iv) the Tmax on day 1, when administered under fasting conditions, is between 4 hours and 24 hours, and (v) the patient is concomitantly treated with a corticosteroid.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein (i) the initial dose of tacrolimus is 0.14 mg/kg/day, (ii) the target trough concentration for the tacrolimus is 5-10 ng/mL, (iii) at least 8% of the tacrolimus in each extended release composition is released at the 4 hour time point, (iv) the Tmax on day 1, when administered under fasting conditions, is between 4 hours and 24 hours, and (v) the patient is African-American.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein the initial dose of tacrolimus is 0.14 mg/kg/day, and the target trough concentration for the tacrolimus is 5-10 ng/mL.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein (i) the initial dose of tacrolimus is 0.14 mg/kg/day, (ii) the target trough concentration for the tacrolimus is 5-10 ng/mL, and (iii) the in vivo release of each composition after oral administration takes place substantially in the colon.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein (i) the initial dose of tacrolimus is 0.14 mg/kg/day, (ii) the target trough concentration for the tacrolimus is 5-10 ng/mL, and (iii) the patient is concomitantly treated with mycophenolate mofetil.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein (i) the initial dose of tacrolimus is 0.14 mg/kg/day, (ii) the target trough concentration for the tacrolimus is 5-10 ng/mL, and (iii) the patient is concomitantly treated with a corticosteroid.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein (i) the initial dose of tacrolimus is 0.14 mg/kg/day, (ii) the target trough concentration for the tacrolimus is 5-10 ng/mL, and (iii) the patient is African-American.
A method of prophylaxis of organ rejection in a de novo kidney transplant patient comprising once daily orally administering to the patient an effective amount of tacrolimus in the form of one or more extended release compositions comprising tacrolimus, wherein (i) the initial dose of tacrolimus is 0.14 mg/kg/day, (ii) the target trough concentration for the tacrolimus is 5-10 ng/mL, and (iii) the plasma concentration of tacrolimus in the patient is maintained at a therapeutically effective amount without inducing nephrotoxicity or neurotoxicity.
Dependencies are inferred from the claim text.