Pharmaceutical compositions comprising fluvastatin
OwnerOskar Kalb, Stephen Valazzainventors
Life of this patent
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Abstract
Pharmaceutical compositions comprising fluvastatin, HPMC and optionally other pharmaceutical excipients which are colour-stable upon prolonged periods of storage.
Claims15
A pharmaceutical composition comprising fluvastatin and HPMC which is colour-stable upon prolonged periods of storage.
A pharmaceutical composition comprising compressed granules comprising fluvastatin and HPMC, wherein said granules have a mean particle size of less than 200 microns.
Granules comprising fluvastatin and HPMC wherein the granules have a mean particle size of less than 200 microns.
A pharmaceutical composition or granules according to any preceding claim additionally comprising a coating wherein said coating comprises up to 73% by weight of a colouring agent based on the total weight of the coating, more particularly 17 to 30%.
A pharmaceutical composition or granules according to any of the preceding claims wherein the HPMC comprises up to 12 percent hydroxypropyl functionality and has a number average molecular weight of about 20,000 to 170,000.
A pharmaceutical composition or granules according to any of the preceding claims wherein the HPMC is present in amounts of from 15 to 50% by weight based on the total weight of the composition.
A pharmaceutical composition or granules according to any of the preceding claims additionally comprising a non-ionic hydrophilic polymer selected from hydroxyethyl cellulose or hydroxypropyl cellulose.
A pharmaceutical composition or granules according to any of the preceding claims wherein the ratio of HPMC to non-hydrophilic polymer is about 10:1 to 3:11.
A pharmaceutical composition or granules wherein the fluvastatin is fluvastatin sodium.
A method of preventing or substantially reducing the formation of gels of hydrated HPMC in a pharmaceutical composition or in granules comprising a fluvastatin and HPMC comprising the step of storing the pharmaceutical composition or granules at a relative humidity not exceeding 75% and at a temperature of between 25° C. and 40° C.
A method of preventing or substantially reducing the formation of gels of hydrated HPMC in a pharmaceutical composition comprising fluvastatin and HPMC comprising the step of compressing granules comprising fluvastatin and HPMC, wherein said granules have a mean granule particle size of less than 200 microns.
Dependencies are inferred from the claim text.