Patent ID: 8685998

Claim:
An extended release oral dosage form for once daily immunosuppressive treatment of a patient in need thereof, comprising tacrolimus as an active substance, wherein (a) at least 8% of the active substance is released at the 4 hour time point, (b) less than 25% of the active substance is released at the 5 hour time point, (c) 40% of the active substance is released within 10 to 14 hours, (d) 63.5% or less of the active substance is released at the 12 hour time point, and (e) the dosage form releases the active substance with a substantial zero order release profile over an extended period of time defined by the release from the 8 hours time point to the 15 hours time point, the substantial zero order release being defined as a linear release profile with a deviation of at the most +/âˆ’15%, 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.