Method for treatment of constipation-predominant irritable bowel syndrome
Inventors
Quart, Barry D. • Rosenbaum, David P.
Assignees
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Publication Number
US-9138450-B2
Publication Date
2015-09-22
Expiration Date
Abstract
The present invention provides methods for treating constipation-predominant irritable bowel syndrome comprising administering to a patient in need thereof, a polymeric proanthocyanidin composition from a Croton species or Calophyllum species in an amount sufficient to treat constipation-predominant irritable bowel syndrome (c-IBS). Treatment of c-IBS includes the treatment of the constipation component of c-IBS as well as the pain and abdominal discomfort associated with c-IBS. In one embodiment, the polymeric proanthocyanidin compound is crofelemer. The present invention in an alternative embodiment also provides methods for treating alternating constipation-predominant/diarrhea-predominant irritable bowel syndrome.
Core Innovation
The disclosed subject matter relates to treating alternating constipation-predominant/diarrhea-predominant irritable bowel syndrome (a-IBS) by administering an extract or latex isolated from Croton spp. or Calophyllum spp. The administration amount is effective to treat a-IBS and is bioequivalent to an orally administered dose of about 50 mg per day to about 500 mg per day of crofelemer.
The disclosed subject matter also relates to treating a-IBS by administering a polymeric proanthocyanidin composition isolated from Croton spp. or Calophyllum spp. The administration amount is effective to treat a-IBS and is bioequivalent to an orally administered dose of about 50 mg per day to about 500 mg per day of crofelemer.
The document describes delivery and formulation considerations directed toward non-systemic absorption, including enteric-protected delivery such as enteric coated or delayed release crofelemer. In addition, co-administration is described with non-systemically absorbed analgesic/anti-inflammatory agents, and the disclosure includes characterization and mechanistic or toxicity-related summaries that discuss inhibition of COX-1 and COX-2 and inhibition of cytokine release, alongside noted cytotoxicity observations and diarrhea observations in animal and human contexts.
Claims Coverage
The partial content provides two independent claims focused on treating alternating constipation-predominant/diarrhea-predominant irritable bowel syndrome (a-IBS). Each independent claim defines treatment by bioequivalent dosing to orally administered crofelemer, using either a Croton/Calophyllum-derived extract/latex or a Croton/Calophyllum-derived polymeric proanthocyanidin composition.
Bioequivalent crofelemer dosing using Croton/Calophyllum extract or latex for a-IBS
A method of treating alternating constipation-predominant/diarrhea-predominant irritable bowel syndrome (a-IBS) by administering to a patient an extract or latex isolated from Croton spp. or Calophyllum spp. effective to treat a-IBS, wherein the amount is bioequivalent to an orally administered dose of about 50 mg per day to about 500 mg per day of crofelemer.
Bioequivalent crofelemer dosing using Croton/Calophyllum polymeric proanthocyanidin composition for a-IBS
A method of treating alternating constipation-predominant/diarrhea-predominant irritable bowel syndrome (a-IBS) by administering to a patient a polymeric proanthocyanidin composition isolated from Croton spp. or Calophyllum spp. effective to treat a-IBS, wherein the amount is bioequivalent to an orally administered dose of about 50 mg per day to about 500 mg per day of crofelemer.
Across both independent claims, the core coverage is a-IBS treatment using Croton spp. or Calophyllum spp. derived materials (extract/latex or polymeric proanthocyanidin composition) administered in amounts that are bioequivalent to oral crofelemer dosing of about 50 mg/day to about 500 mg/day.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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