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Details for Patent: 6,432,447

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Details for Patent: 6,432,447

Title: Organic compounds
Abstract:An oral dosage form comprising fluvastatin and HPMC, which oral dosage form is color-stable upon prolonged periods of storage.
Inventor(s): Kalb; Oskar Michael (Loerrach, DE), Valazza; Stephen John (Matawan, NJ)
Assignee: Novartis AG (Basel, CH)
Filing Date:May 17, 2001
Application Number:09/859,861
Claims:1. A colour-stable sustained release tablet comprising fluvastatin, a hydroxypropyl methyl cellulose polymer, and a coating material; wherein the coating material comprises a hydroxypropyl methyl cellulose polymer in an amount of less than or equal to 73 weight percent, and a colouring agent in an amount of from 18 to 30 weight percent, wherein the weight percents are based on the total weight of the coating material.

2. The tablet ac to claim 1 wherein the hydroxypropyl methyl cellulose polymer in the coating material comprises up to 12 percent hydroxypropylfunctionality and has a number average molecular weight of about 20,000 to about 170,000.

3. The tablet according to claim 2 wherein the hydroxypropyl methyl cellulose polymer has a viscosity of 100 to 100,000 centipoise as determined at a concentration of 2.0 weight percent of polymer in water.

4. The tablet according to claim 2 wherein the hydroxypropyl methyl cellulose polymer has a number average molecular weight of 20,000 to 30,000.

5. The tablet according to claim 1 wherein the colouring agent is present in an amount of 22 to 25 weight percent.

6. The tablet according to claim 1 wherein the colouring agent is a combination of titanium dioxide and iron (II) oxide.
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