ONCE DAILY ORAL DOSAGE FORM COMPRISING TACROLIMUS

摘要

An extended release oral dosage form comprising as active substance tacro limus or a pharmaceutically active analogue thereof for a once daily immunos uppressive treatment of a patient in need thereof. The dosage form releases the active substance over an extended period of time defined by a release of at the most 63.5% of the content of the active substance at the 12 hours ti me point defined by in vitro dissolution and when tested according to the US P Il dissolution test (paddle) or USP I dissolution test (basket) form in a medium at pH 4.5 and comprising 0.005% hydroxypropylcellulose and a rotation of 50 rpm. The extended release dosage form provides improved pharmacokinet ic parameters due to an extended and constant in vivo release including subs tantial decreased peak concentrations despite increased bioavailability, sub stantial extended times for maximal concentration, and higher minimal concen trations when compared with conventional immediate release dosage forms and a recent modified release dosage form.