Merck + Co., Inc.

Mandana Asgharnejad

Feng Xu

Paul J Reider

Richard D Tillyer

Michael J Kaufman

Colin R Gardner

David C Dubost

Edward J J Grabowski

Jerome P Draper

Prafull K Shiromani

David Storey

Jose M Vega

The instant invention provides methods and pharmaceutical compositions for inhibiting HMG-CoA reductase, as well as for treating and/or reducing the risk for diseases and conditions affected by inhibition of HMG-CoA reductase, comprising orally administering a therapeutically effective amount of a compound selected from a dihydroxy open acid statin and a pharmaceutically acceptable salt or ester thereof in a delayed-release pharmaceutical dosage form to a patient in need of such treatment wherein substantial release of the compound from the dosage form is delayed until after passage of the dosage form through the stomach.

Dihydroxy open-acid and salts of HMG-CoA reductase inhibitors

The invention is a pharmaceutical composition for oral administration to a patient comprising pharmaceutically effective amount of [3(R)-[2-Piperidin-4-yl)ethyl]-2-piperidone-1]acetyl-3(R)-methyl-.beta.-al anine, or a pharmaceutically acceptable salt thereof; pharmaceutically acceptable amounts of a polymeric binder; and pharmaceutically acceptable amounts of pharmaceutically acceptable excipients. The invention is also a process for making a pharmaceutical composition comprising [3(R)-[2-Piperidin-4-yl)ethyl]-2-piperidone-1]acetyl-3(R)-methyl-.beta.-al anine, which comprises the steps of

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An oral drug dosage unit, for administration to a patient, having active drug, and an effective diameter and surface composition sufficient for the unit to be transported from the stomach into the duodenum following substantially complete emptying of chyme from the stomach into the intestine and prior to release of active drug from the unit, wherein the active drug has an absorption rate that is substantially affected by the coinciding presence of food in the stomach, the effective diameter of the unit prevents gastric emptying of the unit prior to gastric emptying of chyme, and the surface composition is an enteric coating which prevents release of the active drug in the stomach and allows release of the active drug in the intestine.

Oral coated active drugs

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Lansdale, PA, United States of America

Mandana Asgharnejad