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Claims for Patent: 6,733,780

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Claims for Patent: 6,733,780

Title: Direct compression polymer tablet core
Abstract: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.
Inventor(s): Tyler; Joseph (Somerville, MA), Petersen; John S. (Acton, MA)
Assignee: Genzyme Corporation (Cambridge, MA)
Application Number:09/691,429
Patent Claims: 1. A tablet comprising a core and a coating thereof, wherein at least about 95% by weight of the core is an aliphatic amine polymer selected from the group consisting of unsubstituted and N-substituted poly(allylamine), poly(diallylamine), and poly(vinylamine).

2. The tablet of claim 1 wherein the N-substituents are selected from the group consisting of substituted and unsubstituted C.sub.1 -C.sub.24 -alkyl groups.

3. The tablet of claim 2 wherein the alkyl substituents are trialkylammonioalkyl groups.

4. The tablet of claim 1 wherein the aliphatic a polymer is cross-linked.

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

6. A tablet comprising a core and a coating therefor, wherein at least about 95% by weight of the core is a linear or cross-linked poly(allylamine) or a pharmaceutically acceptable salt thereof.

7. The tablet of claim 6 wherein the poly(allylamine) is hydrated.

8. The tablet of claim 7 wherein the poly(allylamine) comprises from about 3% to about 10% water.

9. The tablet of claim 8 wherein thee poly(allylamine) comprises from about 5% to about 8% water.

10. The tablet of claim 9 wherein the polyallylamine is from about 1% to about 10% cross-linked.

11. A tablet comprising a core and a coating therefor, wherein at least about 95% by weight of the core is a hydrated cross-linked poly(allylamine hydrochloride).

12. The tablet of claim 1 wherein the coating is a water-based coating.

13. The tablet of claim 6 wherein the coating is a water-based coating.

14. The tablet of claim 13 wherein said water-based coating comprises hydroxypropylmethylcellulose and a plasticizer.

15. The tablet of claim 14 wherein said water-based coating comprises hydroxypropylmethylcellulose low viscosity, hydroxypropylmethylcellulose high viscosity, and diacetylated monoglyceride.

16. The tablet of claim 1 wherein said polymer is polydiallylamine.

17. The tablet of claim 16 wherein said tablet further comprises a water-based coating.

18. A tablet comprising a core and a coating therefor, wherein at least about 95% by weight of the core is a linear or cross-linked poly(allylamine) or a pharmaceutically acceptable salt thereof, wherein the moisture content of the poly(allylamine) is from about 5% to about 9% by weight, wherein the hardness of the tablet is at least about 150 N and wherein the friability of the tablet is no more than 0.8%.

19. A tablet comprising a core and a coating therefor, wherein the core comprises 98% by weight sevelamer hydrochloride with a moisture content of 6% by weight, 1% by weight colloidal silicon dioxide and 1% by weight stearic acid, and wherein the coating is a mixture comprising 38.5% w/w low viscosity hydroxypropylmethylcellulose, 38.5% high viscosity hydroxypropylmethylcellulose and 23% w/w diacetylated monoglyceride.
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