Organic compounds
AssigneeNovartis AG
InventorsOskar Michael Kalb, Stephen John Valazza
Life of this patent
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Abstract
An oral dosage form comprising fluvastatin and HPMC, which oral dosage form is color-stable upon prolonged periods of storage.
Claims11
An oral dosage form comprising a core of fluvastatin, HPMC polymers and optionally other pharmaceutical excipients which dosage for is colour-stable upon prolonged periods of storage.
Granules comprising fluvastatin, HPMC polymers and optionally other pharmaceutically acceptable excipients.
An oral dosage form according to any of the preceding claims wherein the HPMC comprises up to 12 percent hydroxypropylfunctionality and has a number average molecular weight of about 20,000 to 170,000.
An oral dosage form according to any of the preceding claims wherein the HPMC is present in amounts of from 15 to 50% by weight.
An oral dosage form according to any of the preceding claims additionally comprising a non-ionic hydrophilic polymer selected from hydroxyethyl cellulose or hydroxypropyl cellulose.
An oral dosage form according to any of the preceding claims wherein the ratio of HPMC to non-hydrophilic polymer is about 10:1 to 3:1.
An oral dosage form according to any of the preceding claims wherein the active agent is a HMG CoA reductase inhibitor.
A method of preventing or substantially reducing the formation of gels of hydrated HPMC in an oral dosage form comprising a fluvastatin and HPMC comprising the step of storing the oral dosage form at a relative humidity not exceeding 75% and at a temperature of between 25 and 40 degrees centigrade.
A method of preventing or substantially reducing the formation of gels of hydrated HPMC in an oral dosage form comprising a fluvastatin and HPMC comprising the step of compressing granules comprising fluvastatin and HPMC, wherein said granules have a mean particle size of less than 125 microns.
Dependencies are inferred from the claim text.