CA3070082A1 - Efficacy of a gastro-retentive bile acid sequestrant dosage form - Google Patents

Efficacy of a gastro-retentive bile acid sequestrant dosage form Download PDF

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Publication number
CA3070082A1
CA3070082A1 CA3070082A CA3070082A CA3070082A1 CA 3070082 A1 CA3070082 A1 CA 3070082A1 CA 3070082 A CA3070082 A CA 3070082A CA 3070082 A CA3070082 A CA 3070082A CA 3070082 A1 CA3070082 A1 CA 3070082A1
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CA
Canada
Prior art keywords
patient
dosage form
tablet
study
weeks
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CA3070082A
Other languages
English (en)
French (fr)
Inventor
Mark G. Currie
Ahmad Hashash
Bernard Joseph Lavins
Michael Hall
Silva Karasik
Original Assignee
Ironwood Pharmaceuticals Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ironwood Pharmaceuticals Inc filed Critical Ironwood Pharmaceuticals Inc
Publication of CA3070082A1 publication Critical patent/CA3070082A1/en
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/74—Synthetic polymeric materials
    • A61K31/785—Polymers containing nitrogen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/04—Drugs for disorders of the respiratory system for throat disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • G01N33/743—Steroid hormones
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2560/00—Chemical aspects of mass spectrometric analysis of biological material

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Pulmonology (AREA)
  • Urology & Nephrology (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Nutrition Science (AREA)
  • Biomedical Technology (AREA)
  • Microbiology (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Otolaryngology (AREA)
  • Food Science & Technology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Endocrinology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CA3070082A 2017-07-19 2018-07-19 Efficacy of a gastro-retentive bile acid sequestrant dosage form Pending CA3070082A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201762534591P 2017-07-19 2017-07-19
US62/534,591 2017-07-19
US201862681633P 2018-06-06 2018-06-06
US62/681,633 2018-06-06
PCT/US2018/042904 WO2019018656A1 (en) 2017-07-19 2018-07-19 EFFICACY OF A DOSAGE FORM OF BILIARY ACID SEQUESTERING AGENT WITH GASTRIC RETENTION

Publications (1)

Publication Number Publication Date
CA3070082A1 true CA3070082A1 (en) 2019-01-24

Family

ID=65015306

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3070082A Pending CA3070082A1 (en) 2017-07-19 2018-07-19 Efficacy of a gastro-retentive bile acid sequestrant dosage form

Country Status (9)

Country Link
US (2) US20200138854A1 (https=)
EP (1) EP3654953A4 (https=)
JP (1) JP2020527580A (https=)
CN (2) CN111050755A (https=)
AU (1) AU2018302255A1 (https=)
BR (1) BR112020001071A2 (https=)
CA (1) CA3070082A1 (https=)
MA (1) MA49653A (https=)
WO (2) WO2019018639A1 (https=)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110579541B (zh) * 2019-08-29 2022-04-08 北京悦康科创医药科技股份有限公司 一种兰索拉唑有关物质的检测方法
CN110596295A (zh) * 2019-10-21 2019-12-20 上海百趣生物医学科技有限公司 一种检测胆汁酸的方法
CN111005074A (zh) * 2019-12-19 2020-04-14 江西海普洛斯医学检验实验室有限公司 一种基于illumina测序平台的DNA文库构建试剂盒、文库构建方法和应用
CN111060643B (zh) * 2020-01-16 2021-04-02 博莱克科技（武汉）有限公司 一种含有同分异构体胆汁酸代谢组分分离方法
CN111812264B (zh) * 2020-07-09 2021-06-15 苏州旭辉检测有限公司 一种去氧胆酸类化合物的生物样品分析方法
CN114146184A (zh) * 2021-12-03 2022-03-08 成都施桂行医药科技有限责任公司 阳离子聚合物在制备药物中的应用
CN114235995A (zh) * 2021-12-03 2022-03-25 天津国科医工科技发展有限公司 检测血清中15种胆汁酸的方法
CN115201357A (zh) * 2022-06-17 2022-10-18 陕西盘龙医药研究院 一种小儿咽扁颗粒中猪去氧胆酸的限量检测方法
WO2025043046A1 (en) * 2023-08-22 2025-02-27 GlycosBio, INC. Latex-compatible oil-based compositions

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009158625A2 (en) * 2008-06-26 2009-12-30 Ironwood Pharmaceuticals, Inc. Compositions and methods for treating or preventing gastrointestinal disorders and gerd-related respiratory disorders
US20120009130A1 (en) * 2010-05-06 2012-01-12 Nanoaxis Viral Therapy and Prophylaxis Using Nanotechnology Delivery Techniques
WO2011157655A1 (en) * 2010-06-15 2011-12-22 Biocrates Life Sciences Ag Use of bile acids for prediction of an onset of sepsis
WO2012027331A1 (en) * 2010-08-27 2012-03-01 Ironwood Pharmaceuticals, Inc. Compositions and methods for treating or preventing metabolic syndrome and related diseases and disorders
MX346224B (es) * 2011-02-04 2017-03-10 Biocopea Ltd Composiciones y metodos para el tratamiento de inflamacion cronica y enfermedades inflamatorias.
CN102729224B (zh) * 2012-07-05 2016-04-27 南京德朔实业有限公司 具有辅助弹出电池包功能的电动工具
CA2898362C (en) * 2013-01-15 2020-09-01 Ironwood Pharmaceuticals, Inc. Gastro-retentive sustained-release oral dosage form of a bile acid sequestrant
US20180015118A1 (en) * 2015-02-03 2018-01-18 Ironwood Pharmaceuticals, Inc. Methods of treating upper gastrointestinal disorders in ppi refractory gerd
WO2017070114A2 (en) * 2015-10-18 2017-04-27 Wei Jia Diabetes-related biomarkers and treatment of diabetes-related conditions

Also Published As

Publication number Publication date
WO2019018639A1 (en) 2019-01-24
AU2018302255A1 (en) 2020-02-06
US20200138854A1 (en) 2020-05-07
EP3654953A4 (en) 2021-05-19
CN111050755A (zh) 2020-04-21
MA49653A (fr) 2021-05-19
BR112020001071A2 (pt) 2020-07-14
CN114767646A (zh) 2022-07-22
US20230190662A1 (en) 2023-06-22
JP2020527580A (ja) 2020-09-10
WO2019018656A1 (en) 2019-01-24
EP3654953A1 (en) 2020-05-27

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