Patent ID: 8679534

Claim:
A method for reducing serum cholesterol levels in humans comprising orally administering to a human on a once a day basis a controlled release lovastatin tablet comprising 10 to 80 mg of lovastatin and formulated with a core comprising the lovastatin and a water swellable polymer and a coating surrounding the core wherein the coating comprises a water insoluble polymer and a pH sensitive polymer that dissolves at a pH above 3 to release less than 20% of the lovastatin after 2 hours of in vitro testing and between 20% and 70% of the lovastatin after 5 hours of in vitro testing wherein the in vitro testing is conducted using a USP XXII, Type II dissolution apparatus in 2% sodium lauryl sulfate, pH 7.0 NaH 2 PO 4 buffer at 37° C. and 50 rpms, so that a mean time to maximum plasma concentration of lovastatin after a single dose administration in the morning without food is at least about 12 hours and the ratio of AUC 0-48hr of lovastatin for the controlled release dosage form to AUC 0-48hr of lovastatin for an immediate release oral lovastatin tablet is greater than unity following the single dose administration of the controlled release tablet and immediate release tablet.