Effect of gastric retentive bile acid chelating agent dosage form

A technology of bile acid chelating agent and gastric retention, which is applied in the direction of drug combination, pill delivery, inorganic non-active ingredients, etc., and can solve the problem of incomplete response to PPI treatment

Pending Publication Date: 2022-07-22
IRONWOOD PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Some GERD patients do not fully respond to PPI therapy

Method used

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  • Effect of gastric retentive bile acid chelating agent dosage form
  • Effect of gastric retentive bile acid chelating agent dosage form
  • Effect of gastric retentive bile acid chelating agent dosage form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0186] Example 1: A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging discovery trial to determine oral administration for 8 weeks in symptomatic gastroesophageal reflux disease patients with bile acid sequestering formulations that did not respond completely to proton pump inhibitors safety and efficacy.

[0187] This case presents the protocol and results of a multicenter (approximately 60-80 centers in the United States), randomized, double-blind, placebo-controlled, parallel-group, 8-week study consisting of 3 distinct periods (screening period up to 28 days; preconditioning period 14-21 days; treatment period 57 days). like figure 1 , the study included patients with gastroesophageal reflux disease who continued to experience gastroesophageal reflux disease symptoms while receiving once-daily treatment with a standard-dose proton pump inhibitor that the investigators believed had been optimized. Eligible patients continued to take proton pump in...

Embodiment 2

[0796]Example 2: Single-center, open-label, randomized, single-dose, 3-lane scintillation imaging study in healthy subjects with 3 periods, each with a difference designed to evaluate the in vivo performance of IW-3718 The in vivo performance of the breakfast composition, IW-3718, was compared to the performance of the immediate release bile acid sequestrant in the fed state.

[0797] The purpose of this study was to compare the gastroprotective properties of a 500 mg tablet of IW-3718 in the fed state compared to an immediate release formulation (comparison product immediate release Cholestagel [bile acid sequestrant; 625 mg]) . The gastrointestinal maintenance properties of the two drugs were studied after breakfast using two drugs with different fat and calorie contents.

[0798] The recommended cholesterol dose is 6 x 625 mg tablets per day; the dose selected in this study was 1 x 625 mg tablet for each of the 3 periods. This dose was well within the recommended daily do...

Embodiment 3

[1107] Example 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging Exploratory Trial to Determine the Safety and Efficacy of an Oral Bile Acid Sequestrant Dosage Form for Up to 8 Weeks of Administration to Patients with Gastroesophageal Reflux Disease

[1108] Eligibility Criteria

[1109] Inclusion criteria

[1110] Each patient must meet all of the following criteria to be eligible to participate in this study:

[1111] Patients had signed the ICF prior to performing any study-specific procedures.

[1112] Patients were non-hospitalized male or female (if female, not pregnant) and at least 18 years of age at the time of the screening visit.

[1113] Patients had a diagnosis of GERD and reported experiencing GERD symptoms (heartburning or reflux) on average ≥4 days per week during the last 8 weeks prior to the screening visit.

[1114] For at least 8 weeks prior to screening, patients had received standard labeled dose, QD, PPI therapy (which, in ...

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Abstract

Methods or formulations for reducing one or more symptoms of gastroesophageal reflux disease (GERD) in symptomatic GERD patients that do not fully respond to proton pump inhibitors (PPIs). A patient takes an enteric gastric retentive oral dosage form in the form of a therapeutically effective amount of a bile chelating agent tablet dispersed in a polymer matrix consisting essentially of a poly (alkylene) oxide and one or more one or more fillers or compressing agents, the patient thus obtains one or more relief of GERE symptoms of clinical significance.

Description

technical field [0001] The present invention, in particular, relates to a method of treating, eg, GERD, using a gastroretentive oral dosage form comprising a bile acid sequestrant. Background technique [0002] Bile reflux occurs when bile travels up (backflow) from the small intestine into the stomach and then into the esophagus. When the lower esophageal sphincter (LES), which separates the esophagus from the stomach, malfunctions, bile acids can back up into the esophagus. [0003] Many diseases and / or symptoms are associated with bile reflux alone or in combination with bile reflux and acid reflux; among them, these diseases and / or symptoms include gastroesophageal reflux disease or GERD, heartburn, indigestion, dyspepsia , erosive esophagitis, peptic ulcer, gastric ulcer, esophageal ulcer, esophagitis, laryngitis, pharyngitis, rough or hoarse voice, GERD-related pulmonary dysfunction (eg, cough and / or asthma), Barrett's esophagus, Esophageal cancer (eg adenocarcinoma)...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/32A61K31/785A61K47/38A61K47/26A61K47/02A61K47/10A61K47/36A61K47/14A61P1/00A61P1/04A61P1/14A61P1/16A61P11/04A61P35/00
CPCA61K9/284A61K9/2031A61K9/2054A61K9/2018A61K9/2059A61K9/2013A61K9/2009A61K31/785A61P1/04A61P1/16A61P11/04A61P1/14A61P35/00A61P1/00A61K45/06G01N33/743G01N2560/00A61K9/0065A61K2300/00A61K9/28
Inventor 马克·G·科里阿玛德·哈沙什伯纳德·约瑟夫·拉文斯迈克尔·霍尔席尔瓦·卡拉西克
Owner IRONWOOD PHARMA
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