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AssigneeAethos Pharmaceuticals, Inc.
InventorsBrian Robert MCMILLAN, Todd Roland DAVIAU, John Michael CRONAN, JR., James Franklin DAVIS, III, Mark James LICARDE, Saurabh Sudhir TRIVEDI, Ian W. COTTRELL
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A process is described for preparing stabilized tablet formulations for temperature and moisture sensitive active drugs. Water soluble polyvinyl alcohol is processed with drugs such as angiotensin converting enzyme (ACE) inhibitors and compressed into solid form once excess water is removed. Low dose polyvinyl alcohol ramipril tablets prepared by this process are stable under conditions of high humidity and heat for periods of at least up to six months with less than 8% hydrolysis of the prodrug to the active metabolite diketopiperazine (DKP).
A stabilized compressed pharmaceutical formulation, comprising an admixture of a highly granulated pharmaceutical agent coated with polyvinyl alcohol wherein the polyvinyl alcohol provides a long-term stabilized moisture and temperature protective coating on the granulated pharmaceutical agent.
A 1-25 mg ramipril tablet comprising polyvinyl alcohol coated ramipril particles.
Polyvinyl alcohol coated ramipril particulates comprised within 1.0 to 2.5 mg ramipril tablets which degrade to less than 8% diketopiperazine (DKP) during storage time of at least 12 months in containers exposed to relative humidity up to at least 75%.
Dependencies are inferred from the claim text.