Direct compression polymer tablet core
The present invention provides a tablet core which comprises at least about 95% by weight of an aliphatic amine polymer. The invention also provides a method of producing a tablet core comprising at least about 95% by weight of an aliphatic amine polymer resin The method comprises the step of compressing the aliphatic amine polymer to form the tablet core. The tablet core can further include one or more excipients. In this embodiment, the method of producing the tablet core comprises the steps of: (1) hydrating the aliphatic amine polymer to the desired moisture level; (2) blending the aliphatic amine polymer with the excipients in amounts such that the polymer comprises at least about 95% by weight of the resulting blend; and (3) compressing the blend to form the tablet core. The present invention further relates to a coated tablet comprising an aliphatic amine polymer core wherein the coating is a water based coating.
1. A method of removing phosphate from a patient in need thereof, comprising administering to said patient a tablet, comprising:
i) a hydrophilic, compressed core consisting essentially of:
a) at least 95 wt. % sevelamer hydrochloride; and
b) one or more excipients, comprising stearic acid or colloidal silicon dioxide; and
ii) a water-based coating, comprising hydroxypropylmethylcellulose or diacetylated monoglyceride.
2. The method of claim 1 , wherein the sevelamer hydrochloride is hydrated.
3. The method of claim 1 , wherein the sevelamer hydrochloride comprises a moisture content of about 5 wt. % or greater.
4. The method of claim 1 , wherein the sevelamer hydrochloride has a moisture content of about 5 wt. % to about 9 wt. %.
5. The method of claim 4 , wherein the water-based coating comprises hydroxypropylmethylcellulose and diacetylated monoglyceride.
6. The method of claim 5 , wherein the total amount of excipients is from 0 wt. % to about 5 wt. % of the hydrophilic, compressed core.
7. The method of claim 6 , wherein the tablet is a compressed tablet.
8. The method of claim 7 , wherein the hydrophilic, compressed core has a hardness of at least 150 N.
9. The method of claim 7 , wherein the hydrophilic, compressed core has a hardness of 150-170 N.
10. The method of claim 9 , wherein the hydrophilic, compressed core has a friability of no more than 0.8%.
11. The method of claim 10 , wherein the hydrophilic, compressed core comprises 400 mg or 800 mg of the sevelamer hydrochloride on an anhydrous basis.
12. The method of claim 11 , wherein the largest dimension of the hydrophilic, compressed core is at least 0.3125 inches.
13. The method of claim 11 , wherein the largest dimension of the hydrophilic, compressed core is at least 0.620 inches.
14. The method of claim 11 , wherein the largest dimension of the hydrophilic, compressed core is 0.750 inches.
15. The method of claim 11 , wherein the hydrophilic, compressed core is formed from a 0.3125 in.×0.750 in. punch.
16. The method of claim 11 , wherein the hydrophilic, compressed core comprises 400 mg of the sevelamer hydrochloride on an anhydrous basis.
17. The method of claim 11 , wherein the hydrophilic, compressed core comprises 800 mg of the sevelamer hydrochloride on an anhydrous basis.
18. The method of claim 11 , wherein the patient suffers from hyperphosphatemia.