HMG-COA reductase inhibitor extended release formulation

A controlled release oral solid dosage form for the reduction of serum cholesterol levels in humans comprising lovastatin and a controlled release carrier in an amount effective to provide a controlled release of the lovastatin, the dosage form providing a mean AUC0-48hr of lovastatin of from about 15 to about 90 ng·hr/ml, based on a 40 mg dose of lovastatin administered to human patients on a once-a-day basis.

A controlled release oral solid dosage form for the reduction of serum cholesterol levels in humans comprising lovastatin and a controlled release carrier in an amount effective to provide a controlled release of the lovastatin the dosage form providing a mean AUC0-48hr of lovastatin of from about 15 to about 90 ng·hr/ml, based on a 40 mg dose of lovastatin administered to human patients on a once-a-day basis, wherein said dosage form comprises

• (i) a tablet core comprising from about 3%wt to about 20%wt of the total dosage form of lovastatin, from about 10%wt to about 40%wt of the total dosage form of water swellable polymer;
• and
• (ii) a coating comprising from about 20%wt to about 80%wt of the total dosage form of osmotic agent, from about 0.05%wt to about 5%wt of the total dosage form of a blend of enteric polymer and water insoluble polymer.