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Claims for Patent: 7,341,744

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Claims for Patent: 7,341,744

Title:Method of treating secretory diarrhea with enteric formulations of proanthocyanidin polymer
Abstract: Pharmaceutical compositions containing a proanthocyanidin polymer composition which are useful for the treatment and prevention of secretory diarrhea are provided. The invention specifically relates to pharmaceutical formulations of a proanthocyanidin polymer composition which has been isolated from a Croton spp. or a Calophyllum spp. In particular, the invention relates to a formulation of a proanthocyanidin polymer composition which protects the composition from the effects of stomach acid after oral administration, particularly to those formulations which are enteric coated. The invention also relates to methods of producing a directly compressible proanthocyanidin polymer composition, as well as compositions containing the directly compressible proanthocyanidin polymer composition.
Inventor(s): Rozhon; Edward James (El Granada, CA), Khandwala; Atul S. (San Carlos, CA), Sabouni; Akram (Fairport, NY), Balwani; Gul P. (Fremont, CA), Chan; Jody Wai-Han (Mountain View, CA), Sesin; David F. (San Carlos, CA)
Assignee: Napo Pharmaceuticals, Inc. (South San Francisco, CA)
Application Number:09/712,033
Patent Claims: 1. A method of treatment for secretory diarrhea in animals, including humans, said method comprising: administering, via the oral route of administration to a non-human animal selected from the group consisting of bovine, ovine, swine, poultry, equine, canine and feline animals or a human suffering from secretory diarrhea, a dosage of from 0.1 to 100 mg/kg/day of a pharmaceutical composition comprising an aqueous soluble proanthocyanidin polymer composition isolated from a Croton species or a Calophyllum species, said aqueous soluble proanthocyanidin polymer composition being in an amount effective to treat secretory diarrhea and formulated to protect the aqueous soluble proanthocyanidin polymer composition from the stomach environment in a controlled release preparation, and a pharmaceutically acceptable carrier.

2. The method of claim 1, in which the Croton species is Croton lechleri.

3. The method of claim 1, in which the pharmaceutical composition is formulated as a compressed tablet.

4. The method of claim 1, in which the pharmaceutical composition further comprises a lubricant.

5. The method of claim 4, in which the lubricant is magnesium stearate.

6. The method of claim 1, in which the pharmaceutical composition is formulated as a capsule, which capsule is enteric coated.

7. The method of claim 6, in which the capsule contains beads, each bead comprising a core of the proanthocyanidin polymer composition and a layer of the enteric coating.

8. The method of claim 1, in which the secretory diarrhea is caused by a bacterium.

9. The method of claim 1, in which the secretory diarrhea is caused by a non-infectious etiology.

10. The method of claim 9, in which the non-infectious etiology is selected from the group consisting of non-specific diarrhea, ulcerative colitis, and irritable bowel syndrome.

11. The method of claim 1, in which the human suffering from secretory diarrhea is an infant or a child.

12. The method of claim 1, in which the human is treated for HIV-Associated Chronic Diarrhea.

13. The method of claim 1, in which the human is treated for diarrhea caused by cholera.

14. The method of claim 1, in which a non-human animal is treated for secretory diarrhea.

15. The method of claim 14 in which the pharmaceutical composition is administered in animal feed.

16. The method of claim 1, in which dosage is between 0.1 and 40 mg/kg/day of the aqueous soluble proanthocyanidin polymer composition.

17. The method of claim 1, in which the pharmaceutical composition further comprises a pharmaceutically acceptable carrier.

18. A method of treatment for secretory diarrhea in animals, including humans, said method comprising: administering, via the oral route of administration, to a non-human animal or human suffering from secretory diarrhea, a dosage of from 0.1 to 100 mg/kg/day of a pharmaceutical composition comprising an aqueous soluble proanthocyanidin polymer composition isolated from a Croton species or from a Calophyllum species, said aqueous soluble proanthocyanidin polymer composition being in an amount effective to treat secretory diarrhea and coated with an enteric coating.

19. The method of claim 18, in which the Croton species is Croton lechleri.

20. The method of claim 18, in which the enteric coating is comprised of a methacrylic acid-methacrylic acid ester copolymer with acid ionizable groups.

21. The method of claim 18, in which the pharmaceutical composition is formulated as a compressed tablet.

22. The method of claim 18, in which the pharmaceutical composition further comprises a lubricant.

23. The method of claim 22, in which the lubricant is magnesium stearate.

24. The method of claim 18, in which the pharmaceutical composition is formulated as a capsule, which capsule is enteric coated.

25. The method of claim 24, in which the capsule contains beads, each bead comprising a core of the proanthocyanidin polymer composition and a layer of the enteric coating.

26. The method of claim 18, in which the secretory diarrhea is caused by a bacterium.

27. The method of claim 18, in which the secretory diarrhea is caused by a non-infectious etiology.

28. The method of claim 27, in which the non-infectious etiology is selected from the group consisting of non-specific diarrhea, ulcerative colitis, and irritable bowel syndrome.

29. The method of claim 18, in which the human suffering from secretory diarrhea is an infant or a child.

30. The method of claim 18, in which the human is treated for HIV-Associated Chronic Diarrhea.

31. The method of claim 18, in which the human is treated for diarrhea caused by cholera.

32. The method of claim 18, in which a non-human animal is treated for secretory diarrhea.

33. The method of claim 32, in which the non-human animal is selected from the group consisting of bovine, swine, ovine, poultry, equine, canine and feline animals.

34. The method of claim 32 in which the pharmaceutical composition is administered in animal feed.

35. The method of claim 18, in which said dosage of between 0.1 and 40 mg/kg/day of the aqueous soluble proanthocyanidin polymer composition.

36. The method of claim 18, in which the pharmaceutical composition further comprises a pharmaceutically acceptable carrier.

37. A method of treatment for secretory diarrhea in animals, including humans, said method comprising: administering, via the oral route of administration to a non-human animal selected from the group consisting of bovine, ovine, swine, poultry, equine, canine and feline animals or a human suffering from secretory diarrhea, a dosage of from 0.1 to 100 mg/kg/day of a pharmaceutical composition comprising an aqueous soluble proanthocyanidin polymer composition isolated from a Croton species or a Calophyllum species, said aqueous soluble proanthocyanidin polymer composition being in an amount effective to treat secretory diarrhea and formulated to protect the aqueous soluble proanthocyanidin polymer composition from the acidic conditions of the stomach in a controlled release preparation, and a pharmaceutically acceptable carrier.
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