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Claims for Patent: 7,985,418

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Claims for Patent: 7,985,418

Title:Aliphatic amine polymer salts for tableting
Abstract: The tablets, compositions and methods of the present invention, comprising a carbonate salt of an aliphatic amine polymer and s monovalent anion can prevent or ameliorate acidosis, in particular acidosis in patients with renal disease. The tablets and compositions of the present invention maintain a disintegration time of no greater than 30 minutes at 37.degree. C. and at pH of at least 1 for a period of at least ten weeks at 60.degree. C. Furthermore, the tablets are stable for extended periods of time without the need for specialized storage conditions.
Inventor(s): Bhagat; Hitesh R. (Wayland, MA), Goldberg; Jeffrey M. (Framingham, MA), Harianawala; Abizer I. (Lexington, MA), Brenner; Louis (Brookline, MA)
Assignee: Genzyme Corporation (Cambridge, MA)
Application Number:11/262,291
Patent Claims: 1. A tablet comprising sevelamer carbonate and sodium chloride, wherein the chloride of the sodium chloride is present in a range of between 0.1 to 1% by weight relative to the combined weights of the sevelamer carbonate and the sodium chloride.

2. The tablet of claim 1, wherein the sodium chloride is sodium chloride powder.

3. The tablet of claim 1, wherein the chloride is present in a range of between 0.1 to 0.5% by weight relative to the combined weights of the sevelamer carbonate and the sodium chloride.

4. The tablet of claim 1, wherein the chloride is present in a range of between 0.1 to 0.3% by weight relative to the combined weights of the sevelamer carbonate and the sodium chloride.

5. The tablet of claim 1, further comprising one or more excipients.

6. The tablet of claim 5, wherein the one or more excipients includes binders, glidants, and lubricants.

7. The tablet of claim 5, wherein the one or more excipients are selected from the group consisting of: colloidal silicon dioxide, stearic acid, magnesium silicate, calcium silicate, sucrose, cellulose, calcium stearate, glyceryl behenate, magnesium stearate, talc, zinc stearate, sodium stearylfumarate, carboxymethyl cellulose, microcrystalline cellulose, hydroxypropyl cellulose, acacia, tragacanth, pectin, gelatin, and polyethylene glycol.

8. The tablet of claim 5, wherein the one or more excipients includes hypromellose.

9. The tablet of claim 5, wherein the one or more excipients includes diacetylated monoglyceride.

10. The tablet of claim 5, wherein the one or more excipients includes colloidal silicon dioxide.

11. The tablet of claim 5, wherein the one or more excipients includes stearic acid.

12. The tablet of claim 5, wherein the one or more excipients includes zinc stearate.

13. The tablet of claim 5, wherein the one or more excipients includes carboxymethyl cellulose.

14. The tablet of claim 5, wherein the one or more excipients includes microcrystalline cellulose.

15. The tablet of claim 5, wherein the one or more excipients includes hydroxylpropyl cellulose.

16. The tablet of claim 1, wherein the tablet is coated with a coating composition.

17. The tablet of claim 16, wherein the coating composition comprises a cellulose derivative.

18. The tablet of claim 17, wherein the cellulose derivative is hydroxypropylmethylcellulose.

19. The tablet of claim 18, wherein the hydroxypropylmethylcellulose includes hydroxypropylmethylcellulose low viscosity and/or hydroxypropylmethylcellulose high viscosity.

20. The tablet of claim 16, wherein the coating composition further comprises a plasticizing agent.

21. The tablet of claim 20, wherein the plasticizing agent comprises an acetylated monoglyceride.

22. The tablet of claim 21, wherein the acetylated monoglyceride is diacetylated monoglyceride.

23. The tablet of claim 1, wherein the tablet is an oval, film coated, compressed tablet.

24. The tablet of claim 23, wherein the tablet comprises 800 mg of sevelamer carbonate on an anhydrous basis.

25. The tablet of claim 23, wherein the tablet comprises 400 mg of sevelamer carbonate on an anhydrous basis.

26. A coated tablet, comprising: i) a coating composition; and ii) a tablet core, comprising sevelamer carbonate and sodium chloride, wherein the chloride of the sodium chloride is present in a range of between 0.1 to 1% by weight relative to the combined weights of the sevelamer carbonate and the sodium chloride.

27. The coated tablet of claim 26, wherein the coating composition comprises an amount ranging from about 3% to about 6% by weight, relative to the weight of the tablet core.

28. The tablet of claim 27, wherein the sodium chloride is sodium chloride powder.

29. The tablet of claim 28, wherein the chloride is present in a range of 0.1 to 0.3% by weight relative to the combined weights of the sevelamer carbonate and the sodium chloride.

30. The tablet of claim 29, further comprising one or more excipients.

31. The tablet of claim 30, wherein the one or more excipients includes diacetylated monoglyceride.

32. The tablet of claim 31, wherein the one or more excipients includes zinc stearate.

33. The tablet of claim 32, wherein the one or more excipients includes microcrystalline cellulose.

34. The tablet of claim 33, wherein the one or more excipients includes hydroxylpropyl cellulose.

35. The tablet of claim 33, wherein the one or more excipients includes hypromellose.

36. The tablet of claim 33, wherein the one or more excipients includes hydroxypropylmethylcellulose.

37. The coated tablet of claim 33, wherein the coating composition includes hydroxypropylmethylcellulose.

38. The coated tablet of claim 35, wherein the coated tablet comprises 800 mg of sevelamer carbonate on an anhydrous basis.

39. The coated tablet of claim 35, wherein the coated tablet comprises 400 mg of sevelamer carbonate on an anhydrous basis.

40. The coated tablet of claim 37, wherein the coated tablet comprises 800 mg of sevelamer carbonate on an anhydrous basis.

41. The coated tablet of claim 37, wherein the coated tablet comprises 400 mg of sevelamer carbonate on an anhydrous basis.
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