|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|
|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.