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Claims for Patent: 6,242,003

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Claims for Patent: 6,242,003

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)
Application Number:09/549,222
Patent Claims: 1. A color-stable sustained release tablet comprising granules comprising fluvastatin and a hydroxypropyl methyl cellulose polymer; wherein the granules have a mean particle size of less than 200 microns; and the hydroxypropyl methyl cellulose polymer comprises up to 12 percent hydroxypropyl functionality, has a number average molecular weight of about 20,000 to about 170,000, and is present in an amount of from 15 to 50 weight percent, based on the total weight of the composition.

2. The tablet according to claim 1 wherein the granules have a mean particle size of less than 125 microns.

3. The tablet according to claim 1 wherein the granules have a mean particle size of 100 to 125 microns.

4. The tablet according to claim 1 wherein the hydroxypropyl methyl cellulose polymer comprises from 7 to 12 percent hydroxypropyl functionality.

5. The tablet according to claim 1 wherein the hydroxypropyl methyl cellulose polymer has a normal viscosity of 100 to 100,000 centipoise as determined at a concentration of 2.0 weight percent of polymer in water.

6. The tablet according to claim 1 wherein the hydroxypropyl methyl cellulose polymer has a number average molecular weight of 20,000 to 30,000.

7. A color-stable sustained release tablet comprising granules comprising fluvastatin, a hydroxypropyl methyl cellulose polymer, a coating material, and a coloring agent; wherein the coloring agent is present in an amount of less than or equal to 73 weight percent, based on the total weight of the coating; and the hydroxypropyl methyl cellulose polymer comprises up to 12 percent hydroxypropyl functionality, has a number average molecular weight of about 20,000 to about 170,000, and is present in an amount of from 15 to 50 weight percent, based on the total weight of the composition.

8. The tablet according to claim 7 wherein the coloring agent is present in an amount of 17 to 30 weight percent.

9. The tablet according to claim 8 wherein the coloring agent is present in an amount of 22 to 25 weight percent.

10. The tablet according to claim 7 wherein the coloring agent is selected from the group consisting of titanium dioxide, iron oxide, and combinations thereof.

11. The tablet according to claim 7 wherein the coloring agent is a combination of titanium dioxide and iron (II) oxide.

12. The tablet according to claim 7 wherein the tablet additionally comprises a non-ionic hydrophilic polymer selected from the group consisting of hydroxyethyl cellulose, hydroxypropyl cellulose, poly(ethylene)oxide, and combinations thereof.

13. The tablet according to claim 12 wherein the ratio of the hydroxypropyl methyl cellulose polymer to non-ionic hydrophilic polymer is from about 10:1 to 3:1.

14. The tablet according to claim 13 wherein the ratio of the hydroxypropyl methyl cellulose polymer to non-ionic hydrophilic polymer is from 7:1 to 5:1.

15. The tablet according to claim 13 wherein the ratio of the hydroxypropyl methyl cellulose polymer to non-ionic hydrophilic polymer is about 6.1.

16. The tablet according to claim 12 wherein the hydroxyethyl cellulose has a number average molecular weight of from 90,000 to 1,300,000.

17. The tablet according to claim 12 wherein the hydroxypropyl cellulose has a number average molecular weight of from 370,000 to 1,500,000.

18. The tablet according to claim 12 wherein the poly(ethylene)oxide has a number average molecular weight of from 100,000 to 500,000.

19. The tablet according to claim 12 wherein the non-ionic hydrophilic polymer is present in the tablet in an amount of from 1 to 20 weight percent, based on the total weight of the tablet.

20. The tablet according to claim 19 wherein the non-ionic hydrophilic polymer is present in the tablet in an amount of from 3 to 12 weight percent.

21. A method for preparing a color-stable sustained release oral dosage pharmaceutical composition comprising fluvastatin and a hydroxypropyl methyl cellulose polymer, said method comprising storing the composition at a relative humidity not exceeding 75% and at a temperature of 25.degree. C. to 40.degree. C., wherein said method prevents or reduces the formation of gel in the hydroxypropyl methyl cellulose polymer.

22. The method according to claim 21 wherein the composition is stored at a relative humidity not exceeding 60%.

23. The method according to claim 21 wherein the composition is formed of compressed granules.

24. The method according to claim 23 wherein the granules have a mean particle size of less than 200 microns.

25. The method according to claim 24 wherein the granules have a mean particle size of less than 125 microns.

26. The method according to claim 21 wherein the granules have a mean particle size of 100 to 125 microns.

27. The method according to claim 21 wherein the hydroxypropyl methyl cellulose polymer comprises up to 12 percent hydroxypropylfunctionality and has a number average molecular weight of about 20,000 to about 170,000.

28. The method according to claim 22 wherein the hydroxypropyl methyl cellulose polymer is present in amounts of from 15 to 50% by weight.

29. The method according to claim 21 wherein the composition additionally comprises a non-ionic hydrophilic polymer selected from the group consisting of hydroxyethyl cellulose, hydroxypropyl cellulose, poly(ethylene)oxide, and combinations thereof.

30. The method according to claim 29 wherein the ratio of the hydroxypropyl methyl cellulose polymer to non-ionic hydrophilic polymer is from about 10:1 to 3:1.
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