Patent ID: 8664239
Filing Date: 2014-03-04
Classification: A61K,A61P,Y10S

Abstract:
1. 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 (i) the pharmaceutical composition provides a substantially zero order release profile, (ii) at least 8% of the tacrolimus in the composition is released at the 4 hour time point, (iii) at least 15% of the tacrolimus in the composition is released at the 8 hour time point, and (iv) less than 62% of the tacrolimus in the composition is released within 15 hours, when subjected to an in vitro dissolution test using the USP II Paddle method at a rotation speed of 50 ppm in a 900 mL aqueous dissolution medium at pH 4.5 with 0.005% hydroxypropylcellulose.