Sachet Formulation for Amine Polymers

Patent metadata

Field	Value
Publication number	US-2016113961-A1
Application number	US-201514750459-A
Country	US
Kind code	A1
Filing date	Jun 25, 2015
Priority date	Sep 15, 2005
Publication date	Apr 28, 2016
Grant date	—

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.

First claim

1 - 39 . (canceled)

40 . A method of treating a patient suffering from a disorder of phosphate metabolism, comprising:
administering to the patient a therapeutically effective amount of powder formulation comprising a mixture of: a) a pharmaceutically acceptable anionic stabilizer comprising an esterified alginate; b) carbonate salt of sevelamer mixed with the anionic stabilizer; and c) sodium chloride;
wherein:
i) 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.

41 . The method of treating of claim 40 , wherein the esterified alginate is a propylene glycol alginate

42 . The method of treating of claim 40 , wherein the amount of the sevelamer carbonate is 800 mg on an anhydrous basis

43 . The method of treating of claim 40 , wherein the amount of the sevelamer carbonate is 2.4 g on an anhydrous basis

44 . The method of treating of claim 40 , 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.

45 . The method of treating of claim 40 , wherein the chloride of the sodium chloride is present in a range of between 0.05-1 wt. % relative to the combined weights of the sevelamer carbonate and the sodium chloride.

46 . The method of treating of claim 40 , wherein the chloride of the sodium chloride is present in a range of between 0.08-0.5 wt % relative to the combined weights of the sevelamer carbonate and the sodium chloride.

47 . The method of treating of claim 40 , 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.

48 . The method of treating of claim 40 , wherein the powder formulation further comprises one or more of a pharmaceutically acceptable flavoring agent, sweetener, or coloring agent

49 . The method of treating of claim 48 , wherein the powder formulation further comprises a pharmaceutically acceptable flavoring agent.

50 . The method of treating of claim 49 , 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.

51 . The method of treating of claim 50 , wherein the at least one pharmaceutically acceptable flavoring agent is lemon flavor.

52 . The method of treating of claim 48 , wherein the powder formulation further comprises a pharmaceutically acceptable sweetener.

53 . The method of treating of claim 52 , 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.

54 . The method of treating of claim 53 , wherein the at least one pharmaceutically acceptable sweetener is sucralose.

55 . The method of treating of claim 48 , wherein the powder formulation further comprises a pharmaceutically acceptable coloring agent.

56 . The method of treating of claim 55 , wherein the pharmaceutically acceptable coloring agent is yellow iron oxide.

57 . The method of treating of claim 40 , wherein the disorders of phosphate metabolism is hyperthyroidism.

58 . The method of treating of claim 40 , wherein the disorders of phosphate metabolism is inadequate renal function.

59 . The method of treating of claim 40 , wherein the disorders of phosphate metabolism is hyperphosphatemia.

60 . The method of treating of claim 40 , wherein the subject has a serum phosphate level of greater than about 4.5 mg/dL.

61 . The method of treating of claim 40 , wherein the therapeutically effective amount of the powder formulation is orally administered to the patient.

62 . The method of treating of claim 40 , wherein the powder formulation is packaged in a unit-dose container or a multi-dose container.

63 . The method of treating of claim 40 , wherein the container is a tub or sachet.

Assignees

• Genzyme Corp

Inventors

• Bhagat Hitesh R
• Goldberg Jeffrey M

Classifications

• A61P7/00

  Drugs for disorders of the blood or the extracellular fluid · CPC title

• A61P3/06

  Antihyperlipidemics · CPC title

• A61P3/12

  for electrolyte homeostasis · CPC title

• A61P3/14

  for calcium homeostasis (vitamin D A61P3/02; parathyroid hormones A61P5/18; calcitonin A61P5/22; osteoporosis A61P19/10; bone metastasis A61P35/04) · CPC title

• A61P3/00

  Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00) · CPC title