Method for treatment of diarrhea-predominant irritable bowel syndrome

Inactive Publication Date: 2007-11-01
NAPO PHARMA INC
View PDF3 Cites 47 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0009]The present invention relates to methods for treating at least one symptom of diarrhea-predominant irritable bowel syndrome (d-IBS) by administering a molecule that inhibits secretion of chloride ions from a cell (inhibitor molecule). Exemplary inhibitor molecules are those that inhibit secretion of chloride ions through the cystic fibrosis transmembrane conductance regulator chloride-ion channel (CFTR). Other exemplary inhibitor molecules include potassium ion channel openers. Exemplary symptoms of d-IBS include pain, abdominal discomfort, diarrhea, abnormal stool frequency, abnormal stool consistency and the presence of urgency. Thus, in one embodiment, the invention provides a method for the treatment of one or more symptoms of d-IBS comprising administering to a patient in need of such treatment, an amount of a molecule that inhibits secretion of chloride ions from a cell (inhibitor molecule) effective to treat the one or more symptoms of d-IBS. In

Problems solved by technology

In addition, patients diagnosed with IBS are at increased risk for other, non-gastrointestinal functional disorders such as fibromyalgia and interstitial cystitis.
Thus, IBS accounts for a large proportion of annual healthcare costs in the U.S.
Since abdominal pain is one of the defining characteristic of IBS, ant

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Method for treatment of diarrhea-predominant irritable bowel syndrome
  • Method for treatment of diarrhea-predominant irritable bowel syndrome
  • Method for treatment of diarrhea-predominant irritable bowel syndrome

Examples

Experimental program
Comparison scheme
Effect test

example 1

Preparation of Pharmaceutical Formulations

[0109]Described below are illustrative methods for the manufacture and packaging for different preferred pharmaceutical formulations of the proanthocyanidin polymer composition from C. lechleri according to the present invention.

[0110]1A. Encapsulated Enteric Coated Beads

[0111]Detailed descriptions of the batch formula and methods used to prepare the encapsulated enteric coated proanthocyanidin polymer composition bead formulation based on sugar spheres are provided below. Each hard-shell gelatin capsule contained 250 mg proanthocyanidin polymer composition enteric coated beads. Capsules were packaged in HDPE bottles containing sixteen (16) 250 mg caps each. The formulation for enteric coated proanthocyanidin polymer composition beads contained 17.3% (w / w) of nonpareil seeds (sugar spheres 40 / 60 mesh, Paulaur, lot #60084060), 64.5% proanthocyanidin polymer composition from C. lechleri, 1.5% hydroxypropylmethylcellulose (Methocel E5 Premium,...

example 2

Isolation of Directly Compressible Proanthocyanidin Polymer Composition

[0134]A directly compressible proanthocyanidin polymer composition (used to prepare the formulations in Examples 1E and 1F above) was isolated from the latex of the Croton lechleri plant as follows:

[0135]460 liters of Croton lechleri latex was mixed with 940 liters purified water for ten minutes and then allowed to stand overnight (12 hours) at 4° C. The red supernatant was pumped into a holding tank and the residue discarded. The supernatant was then extracted with 200 liters n-butanol by mixing for ten minutes and then allowing the phases to separate. The n-butanol phase was discarded, and the aqueous phase was extracted two more times with 200 liters n-butanol each time. After extraction, the aqueous phase was concentrated by ultrafiltration using a 1 kD cut-off membrane (a low protein binding cellulose membrane), and then the retentate was dried in a tray dryer at approximately 37° C. (±2° C.).

[0136]For pur...

example 3

Components, Composition, and Manufacturing of a Drug Product

[0138]3A. Drug Product

[0139]The drug product, crofelemer, consists of an enteric-coated 125 mg tablet(s) over-encapsulated in a Size 00, opaque Swedish orange gelatin capsule and backfilled with microcrystalline cellulose. Each capsule contains 1, 2, or 4 enteric-coated tablets. The tablet core consists of 99.93% crofelemer and 0.07% magnesium stearate and is coated with a methacrylic acid copolymer.

[0140]3B. Components of Drug Product

[0141]Crofelemer is supplied by Napo Pharmaceuticals, Inc., and is manufactured under current Good Manufacturing Practices (cGMP). Magnesium stearate is manufactured by Mallinckrodt (or equivalent) and meets the specifications for magnesium stearate as described in 27 USP / NF. The magnesium stearate is certified by the manufacturer to be derived from vegetable sources. Microcrystalline cellulose is manufactured by FMC (or equivalent) and meets the specifications for microcrystalline cellulose...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

PropertyMeasurementUnit
Fractionaaaaaaaaaa
Mass flow rateaaaaaaaaaa
Mass flow rateaaaaaaaaaa
Login to view more

Abstract

The present invention provides methods for treating diarrhea-predominant irritable bowel syndrome comprising administering to a patient in need thereof, an inhibitor of chloride-ion transport in an amount sufficient to treat diarrhea-predominant irritable bowel syndrome (d-IBS). Treatment of d-IBS includes the treatment of the diarrhea component of d-IBS as well as the pain, abdominal discomfort and other symptoms associated with d-IBS. In one embodiment, the inhibitor of chloride-ion transport is crofelemer.

Description

BACKGROUND OF THE INVENTION[0001]Irritable bowel syndrome (IBS) is a common functional disorder of the bowel that has a pronounced effect on quality of life. A defining characteristic of IBS is abdominal discomfort or pain. The Rome II Diagnostic Criteria (a system for diagnosing functional gastrointestinal disorders based on symptoms) for IBS is as follows: at least 12 weeks or more, which need not be consecutive, in the preceding 12 months of abdominal discomfort or pain that is accompanied by at least two of the following features: (1) it is relieved with defecation, and / or (2) onset is associated with a change in frequency of stool, and / or (3) onset is associated with a change in form (appearance) of stool.[0002]Other symptoms that support the diagnosis of IBS include pain; abnormal stool passage (straining, urgency, or feeling of incomplete evacuation); passage of mucus; and bloating or feeling of abdominal distension. Patients can be sub-divided by their underlying bowel habit...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
IPC IPC(8): A61K36/47A61K31/426A61K31/365A61K9/28
CPCA61K31/365A61K31/426A61K31/353A61K36/47A61K9/28A61K36/38A61P1/00A61P1/04A61P1/12A61P3/12A61P25/00A61P25/04A61P29/02A61P43/00A61K36/185
Inventor QUART, BARRY D.ROSENBAUM, DAVID P.NEENAN, THOMAS X.BLANKS, ROBERT C.
Owner NAPO PHARMA INC
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap