HMG-CoA reductase inhibitor extended release formulation
AssigneeAndrx Labs, LLC
InventorsChih-Ming Chen, Joseph Chou, David Wong
Life of this patent
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Abstract
Controlled release oral solid dosage form for the reduction of serum cholesterol levels in humans include a drug comprising an alkyl ester of hydroxy substituted naphthalenes (e.g., lovastatin) and a controlled release carrier, such that the dosage form provides a mean time to maximum plasma concentration (Tmax) of the drug which occurs at about 10 to about 32 hours after oral administration on a once-a-day basis to human patients. The dosage form provides a therapeutically effective reduction in serum cholesterol levels. Methods of reducing serum cholesterol levels in humans are also disclosed.
Claims28
1-75. (canceled)
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 maximum plasma concentration (Cmax) of lovastatin of from about 1 to about 8 ng/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 maximum plasma concentration (Cmax) of lovastatin of about 5.5±2.5 ng/mL measured after 28 days of treatment, 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 maximum plasma concentration (Cmax) of lovastatin of from about 1 to about 8 ng/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.
Dependencies are inferred from the claim text.