Details for Patent: 9,895,315

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:	Dec 14, 2016
Application Number:	15/378,320
Claims:	1. A tablet, comprising: i) sevelamer carbonate; ii) sodium chloride, wherein the amount of chloride of the sodium chloride present in the tablet is in a range of between 0.1-1 wt. %, relative to the combined weights of the sevelamer carbonate and the sodium chloride; and iii) optionally, one or more excipients; wherein the tablet has a disintegration time of no greater than 60 minutes at a temperature of 37.+-.2.degree. C. 2. The tablet of claim 1, wherein the tablet comprises particles of the sevelamer carbonate. 3. The tablet of claim 2, wherein at least 95% by volume of the sevelamer carbonate particles have a diameter of at least 45 microns. 4. The tablet of claim 1, wherein the disintegration time of said tablet is maintained for a period of at least 1 week, 2 weeks, 1 month, 5 weeks, 2 months, 10 weeks, 3 months, 6 months, 1 year, or two years, when stored in a sealed, water impervious container, at 60.degree. C. 5. The tablet of claim 1, wherein the tablet maintains the disintegration time at a temperature of 37.+-.2.degree. C. and a pH range in the range of between 1-5. 6. The tablet of claim 1, wherein the tablet comprises 400 mg or 800 mg of the sevelamer carbonate on an anhydrous basis. 7. The tablet of claim 1, wherein the optional one or more excipients is(are) present in said tablet. 8. The tablet of claim 1, wherein the one or more excipients includes binders, glidants, and lubricants. 9. The tablet of claim 1, wherein the one or more excipients includes hypromellose. 10. The tablet of claim 1, wherein the one or more excipients includes diacetylated monoglyceride. 11. The tablet of claim 1, wherein the one or more excipients includes colloidal silicon dioxide. 12. The tablet of claim 1, wherein the one or more excipients includes stearic acid. 13. The tablet of claim 1, wherein the one or more excipients includes zinc stearate. 14. The tablet of claim 1, wherein the one or more excipients includes carboxymethyl cellulose. 15. The tablet of claim 1, wherein the one or more excipients includes microcrystalline cellulose. 16. The tablet of claim 1, wherein the one or more excipients includes hydroxylpropyl cellulose. 17. The tablet of claim 1, wherein the tablet is coated with a coating composition comprising hydroxypropylmethylcellulose and optionally a plasticizing agent. 18. The tablet of claim 1, wherein the tablet is coated with a coating composition comprising hydroxypropylmethylcellulose and diacetylated monoglyceride. 19. The tablet of claim 1, wherein the tablet is an oval, film coated, compressed tablet. 20. A method of treating hyperphosphatemia in a patient in need thereof, comprising administering the tablet of claim 1. 21. The tablet of claim 4, wherein the disintegration time of said tablet is no greater than 20 minutes at a temperature of 37.+-.2.degree. C., and said disintegration time of said tablet is maintained for a period of at least 1 week, when stored in a sealed, water impervious container, at 60.degree. C.