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Claims for Patent: 8,574,634

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Claims for Patent: 8,574,634

Title:Compositions and methods of treatment with proanthocyanidin polymer antidiarrheal compositions
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 Pharmaceutcials, Inc. (South San Francisco, CA)
Application Number:12/175,131
Patent Claims: 1. A method of treating secretory diarrhea in an animal, comprising: orally administering, to the animal, an enteric coated pharmaceutical composition comprising a therapeutically effective amount of an aqueous soluble proanthocyanidin polymer composition isolated from a Croton species or a Calophyllum species, and a pharmaceutically acceptable carrier.

2. The method of claim 1, wherein the secretory diarrhea is caused by enteric bacteria.

3. The method of claim 2, wherein the enteric bacteria is selected from the group consisting of E. coli, a Vibrio species, a Campylobacter species, a Salmonella species, a Aeromonas species, a Plesiomonas species, a Shigella species, a Klebsiella species, a Citrobacter species, a Yersinia species, a Clostridium species, a Bacteroides species, a Staphylococcus species, and a Bacillus species.

4. The method of claim 1, wherein the secretory diarrhea is caused by protozoa.

5. The method of claim 4, wherein the protozoa is selected from the group consisting of a Giardia species, a Cryptosporidium species, and Cryptosporidium parvum.

6. The method of claim 1, wherein the secretory diarrhea is caused by non-infectious etiologies.

7. The method of claim 6, wherein the non-infectious etiologies is selected from the group consisting of inflammatory bowel syndrome, ulcerative colitis, cancer and AIDS.

8. The method of claim 1, wherein the Croton species is Croton lechleri.

9. The method of claim 1, wherein the Calophyllum species is Calophyllum inophylum.

10. The method of claim 1, wherein the proanthocyanidin polymer composition is formulated as a capsule.

11. The method of claim 1, wherein the method further comprises administering the proanthocyanidin polymer composition in combination with a substance able to reduce the secretion of stomach acid.

12. The method of claim 1, wherein the method further comprises administering the proanthocyanidin polymer composition in combination with a composition able to inactivate or inhibit the action of stomach enzymes.

13. The method of claim 12, wherein the composition able to inactivate or inhibit the action of stomach enzymes is a protease inhibitor.

14. The method of claim 13, wherein the protease inhibitor is aprotinin.

15. The method of claim 1, wherein the secretory diarrhea is caused by rotavirus.

16. The method of claim 3, wherein the Vibrio species is Vibrio cholerae.
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