Aliphatic Amine Polymer Salts for Tableting
AssigneeGenzyme Corporation
InventorsHitesh R. Bhagat, Jeffrey M. Goldberg, Abizer I. Harianawala, Louis Brenner
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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° C. and at pH of at least 1 for a period of at least ten weeks at 60° C. Furthermore, the tablets are stable for extended periods of time without the need for specialized storage conditions.
Claims21
1-48. (canceled)
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 maintains a disintegration time of no greater than 60 minutes at a temperature of 37±2° C.
Dependencies are inferred from the claim text.