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Claims for Patent: 9,095,509

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Claims for Patent: 9,095,509

Title:Sachet formulation for amine polymers
Abstract: A powder formulation comprises a pharmaceutically acceptable anionic stabilizer and an aliphatic amine polymer or a pharmaceutically acceptable salt thereof mixed with the anionic stabilizer. The powder formulation is conveniently packaged in a container, such as a sachet. A method of treating a subject with hyperphosphotemia with the powder formulation is also disclosed.
Inventor(s): Bhagat; Hitesh R. (Wayland, MA), Goldberg; Jeffrey M. (Framingham, MA)
Assignee: Genzyme Corporation (Cambridge, MA)
Application Number:11/519,982
Patent Claims: 1. A powder in a container, the powder comprising a mixture of: a) a pharmaceutically acceptable anionic stabilizer comprising propylene glycol alginate; b) carbonate salt of sevelamer mixed with the anionic stabilizer, wherein the amount of the sevelamer carbonate is 800 mg on an anhydrous basis; and c) sodium chloride; wherein: i) the container is a sachet and the ratio of the anionic stabilizer to sevelamer carbonate is 0.005-1:1; and ii) the only pharmaceutically active ingredient in the powder is the sevelamer carbonate.

2. The powder of claim 1, wherein the powder is uncapsulated and free-flowing, and wherein the powder contains less than 5 wt % of particles having a particle size more than 300 microns and less than 5 wt % of particles having a particle size less than 10 microns.

3. The powder of claim 1, wherein the powder further comprises a pharmaceutically acceptable flavoring agent.

4. The powder of claim 1, wherein the powder further comprises a pharmaceutically acceptable sweetener.

5. The powder of claim 4, wherein the pharmaceutically acceptable sweetener includes at least one member selected from the group consisting of sucralose, sucrose, xylose, mannitol, maltitol, maltol, sorbitol and xylitol.

6. The powder of claim 3, wherein the pharmaceutically acceptable flavoring agent includes at least one member selected from the group consisting of grape, cherry, peppermint, menthol, vanilla flavor, orange vanilla flavor, lemon flavor, spearmint, wintergreen, cinnamon, and menthone flavors.

7. The powder of claim 4, wherein the pharmaceutically acceptable sweetener is sucralose.

8. The powder of claim 1, wherein the powder further comprises a pharmaceutically acceptable coloring agent.

9. The powder of claim 8, wherein the pharmaceutically acceptable coloring agent is yellow iron oxide.

10. A powder in a container, the powder comprising a mixture of: a) a pharmaceutically acceptable anionic stabilizer comprising propylene glycol alginate; b) carbonate salt of sevelamer mixed with the anionic stabilizer, wherein the amount of the sevelamer carbonate is 2.4 g on an anhydrous basis; and c) sodium chloride; wherein: i) the container is a sachet and the ratio of the anionic stabilizer to sevelamer carbonate is 0.005-1:1; and ii) the only pharmaceutically active ingredient in the powder is the sevelamer carbonate.

11. The powder of claim 10, wherein the powder is uncapsulated and free-flowing, and wherein the powder contains less than 5 wt % of particles having a particle size more than 300 microns and less than 5 wt % of particles having a particle size less than 10 microns.

12. The powder of claim 10, wherein the powder further comprises a pharmaceutically acceptable flavoring agent.

13. The powder of claim 12, wherein the pharmaceutically acceptable flavoring agent includes at least one member selected from the group consisting of grape, cherry, peppermint, menthol, vanilla flavor, orange vanilla flavor, lemon flavor, spearmint, wintergreen, cinnamon, and menthone flavors.

14. The powder of claim 10, wherein the powder further comprises a pharmaceutically acceptable sweetener, comprising at least one member selected from the group consisting of sucralose, sucrose, xylose, mannitol, maltitol, maltol, sorbitol and xylitol.

15. The powder of claim 14, wherein the pharmaceutically acceptable sweetener is sucralose.

16. The powder of claim 10, wherein the powder further comprises a pharmaceutically acceptable coloring agent.

17. The powder of claim 16, wherein the pharmaceutically acceptable coloring agent is yellow iron oxide.

18. A powder in a container, the powder comprising a mixture consisting essentially of: a) a pharmaceutically acceptable anionic stabilizer comprising propylene glycol alginate and glycerol alginate; b) carbonate salt of sevelamer mixed with the anionic stabilizer; c) sodium chloride; and d) optionally one or more of a pharmaceutically acceptable flavoring agent, sweetener, or coloring agent; wherein: i) the container is a sachet and the ratio of the anionic stabilizer to sevelamer carbonate is 0.005-1:1; and ii) the only pharmaceutically active ingredient in the powder is the sevelamer carbonate.

19. The powder of claim 18, wherein the powder is uncapsulated and free-flowing, and wherein the powder contains less than 5 wt % of particles having a particle size more than 300 microns and less than 5 wt % of particles having a particle size less than 10 microns.

20. The powder of claim 18, wherein the powder comprises a pharmaceutically acceptable flavoring agent.

21. The powder of claim 20, wherein the pharmaceutically acceptable flavoring agent includes at least one member selected from the group consisting of grape, cherry, peppermint, menthol, vanilla flavor, orange vanilla flavor, lemon flavor, spearmint, wintergreen, cinnamon, and menthone flavors.

22. The powder of claim 18, wherein the powder comprises a pharmaceutically acceptable sweetener, comprising at least one member selected from the group consisting of sucralose, sucrose, xylose, mannitol, maltitol, maltol, sorbitol and xylitol.

23. The powder of claim 22, wherein the pharmaceutically acceptable sweetener is sucralose.

24. The powder of claim 18, wherein the powder comprises a pharmaceutically acceptable coloring agent.

25. The powder of claim 24, wherein the pharmaceutically acceptable coloring agent is yellow iron oxide.

26. The powder of claim 1, wherein the chloride of the sodium chloride is present in a range of between 0.01-2 wt. % relative to the combined weights of the sevelamer carbonate and the sodium chloride.

27. The powder of claim 10, wherein the chloride of the sodium chloride is present in a range of between 0.01-2 wt. % relative to the combined weights of the sevelamer carbonate and the sodium chloride.

28. The powder of claim 18, wherein the chloride of the sodium chloride is present in a range of between 0.01-2 wt. % relative to the combined weights of the sevelamer carbonate and the sodium chloride.
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