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Details for Patent: 8,808,738

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Details for Patent: 8,808,738

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)
Filing Date:Jul 14, 2011
Application Number:13/183,079
Claims:1. A tablet, comprising: a tablet core having a length and a width and the largest dimension of the tablet core is about 0.748 inches, wherein the table core comprises: i) sevelamer carbonate; and ii) 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 tablet core diameter is no greater than 0.748 inches.

3. The tablet of claim 1, wherein the tablet core diameter is 0.748 inches.

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

5. 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.

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

7. The tablet of claim 6, 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 6, wherein the one or more excipients includes hypromellose.

9. The tablet of claim 6, wherein the one or more excipients includes diacetylated monoglyceride.

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

11. The tablet of claim 10, wherein the coating composition comprises hydroxypropylmethylcellulose.

12. The tablet of claim 10, wherein the coating composition further comprises a plasticizing agent.

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

14. The tablet of claim 13, wherein the tablet comprises 800 mg of sevelamer carbonate on an anhydrous basis.

15. The tablet of claim 13, wherein the tablet comprises 400 mg of sevelamer carbonate on an anhydrous basis.

16. A coated tablet, comprising: i) a coating composition; and ii) a tablet core having a length and a width and the largest dimension of the tablet core is about 0.748 inches, wherein the table core comprises: a) sevelamer carbonate; and b) 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.

17. The coated tablet of claim 16, wherein the tablet core diameter is no greater than 0.748 inches.

18. The coated tablet of claim 16, wherein the tablet core diameter is 0.748 inches.

19. The coated tablet of claim 16, wherein the coating composition comprises an amount ranging from about 3% to about 6% by weight, relative to the weight of the tablet core.

20. The coated tablet of claim 16, further comprising one or more excipients.

21. The tablet of claim 20, 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.

22. The coated tablet of claim 16, wherein the one or more excipients includes diacetylated monoglyceride.

23. The coated tablet of claim 20, wherein the coated tablet comprises 800 mg of sevelamer carbonate on an anhydrous basis.

24. The coated tablet of claim 20, wherein the coated tablet comprises 400 mg of sevelamer carbonate on an anhydrous basis.
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