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Claims for Patent: 7,323,195

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Claims for Patent: 7,323,195

Title:Enteric formulations of 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 Pharmaceuticals, Inc. (South San Francisco, CA)
Application Number:10/919,969
Patent Claims: 1. A pharmaceutical composition comprising an aqueous soluble isolated proanthocyanidin polymer composition from a Croton spp. or from a Calophyllum spp., formulated with an enteric coating to protect the proanthocyanidin polymer composition from the stomach environment; and a pharmaceutically acceptable carrier.

2. A pharmaceutical composition comprising an with aqueous soluble isolated proanthocyanidin polymer composition from a Croton species or a Calophyllum species, formulated to protect the proanthocyanidin polymer composition from the stomach environment in a controlled release preparation for oral administration, and a pharmaceutically acceptable carrier.

3. The pharmaceutical composition of claim 1, in which the Croton spp. is Croton lechleri.

4. The pharmaceutical composition of claim 2, in which the Croton spp. is Croton lechleri.

5. The pharmaceutical composition of claim 1, in which the enteric coating is comprised of a methacrylic acid-methacrylic acid ester copolymer with acid ionizable groups.

6. The pharmaceutical composition of claim 1, which is formulated as a compressed tablet.

7. The pharmaceutical composition of claim 1, which is formulated as an enteric-coated capsule.

8. The pharmaceutical composition of claim 1, formulated as a capsule, in which the capsule contains beads, each bead comprising a core of the proanthocyanidin polymer composition, and the beads further comprising a layer of enteric coating.

9. The pharmaceutical composition of claim 1, which further comprises a lubricant.

10. The pharmaceutical composition of claim 2, which further comprises a lubricant.

11. The pharmaceutical composition of claim 9, in which the lubricant is magnesium stearate.

12. The pharmaceutical composition of claim 1, in which the isolated proanthocyanidin polymer composition is formulated as enteric coated granules or powder.
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