CN105338958A - 胆汁酸螯合剂的胃内滞留缓释口服剂型 - Google Patents

胆汁酸螯合剂的胃内滞留缓释口服剂型 Download PDF

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Publication number
CN105338958A
CN105338958A CN201480015783.9A CN201480015783A CN105338958A CN 105338958 A CN105338958 A CN 105338958A CN 201480015783 A CN201480015783 A CN 201480015783A CN 105338958 A CN105338958 A CN 105338958A
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CN
China
Prior art keywords
dosage form
oral dosage
gastric
hours
retentive oral
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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
CN201480015783.9A
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English (en)
Chinese (zh)
Inventor
V·塞瑟拉曼
D·B·赫登
K·M·莱斯科
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ironwood Pharmaceuticals Inc
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Ironwood Pharmaceuticals Inc
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Application filed by Ironwood Pharmaceuticals Inc filed Critical Ironwood Pharmaceuticals Inc
Priority to CN201711090819.1A priority Critical patent/CN108057028A/zh
Publication of CN105338958A publication Critical patent/CN105338958A/zh
Pending legal-status Critical Current

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    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10—Peptides having 12 to 20 amino acids
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nutrition Science (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Physiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Otolaryngology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CN201480015783.9A 2013-01-15 2014-01-14 胆汁酸螯合剂的胃内滞留缓释口服剂型 Pending CN105338958A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201711090819.1A CN108057028A (zh) 2013-01-15 2014-01-14 片剂形式的肠溶包衣的胃内滞留口服剂型及其应用和药物组合物

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201361752726P 2013-01-15 2013-01-15
US61/752,726 2013-01-15
US201361914804P 2013-12-11 2013-12-11
US61/914,804 2013-12-11
PCT/US2014/011450 WO2014113377A1 (en) 2013-01-15 2014-01-14 Gastro-retentive sustained-release oral dosage form of a bile acid sequestrant

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN201711090819.1A Division CN108057028A (zh) 2013-01-15 2014-01-14 片剂形式的肠溶包衣的胃内滞留口服剂型及其应用和药物组合物

Publications (1)

Publication Number Publication Date
CN105338958A true CN105338958A (zh) 2016-02-17

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CN201480015783.9A Pending CN105338958A (zh) 2013-01-15 2014-01-14 胆汁酸螯合剂的胃内滞留缓释口服剂型
CN201711090819.1A Pending CN108057028A (zh) 2013-01-15 2014-01-14 片剂形式的肠溶包衣的胃内滞留口服剂型及其应用和药物组合物

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CN201711090819.1A Pending CN108057028A (zh) 2013-01-15 2014-01-14 片剂形式的肠溶包衣的胃内滞留口服剂型及其应用和药物组合物

Country Status (11)

Country Link
US (6) US20160015644A1 (https=)
EP (2) EP3991719A1 (https=)
JP (2) JP6716255B2 (https=)
CN (2) CN105338958A (https=)
AU (1) AU2014207680B2 (https=)
BR (1) BR112015016917B1 (https=)
CA (1) CA2898362C (https=)
EA (1) EA201591338A1 (https=)
ES (1) ES2906114T3 (https=)
MX (1) MX383752B (https=)
WO (1) WO2014113377A1 (https=)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110475564A (zh) * 2016-12-21 2019-11-19 硬木药品公司 用利那洛肽的修饰的或延迟释放制剂治疗肠易激综合征的方法
CN111110647A (zh) * 2018-10-31 2020-05-08 浙江京新药业股份有限公司 含盐酸考来维仑的药物组合物及其制备方法

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CA2898362C (en) * 2013-01-15 2020-09-01 Ironwood Pharmaceuticals, Inc. Gastro-retentive sustained-release oral dosage form of a bile acid sequestrant
WO2014131024A2 (en) 2013-02-25 2014-08-28 Synergy Pharmaceuticals Inc. Agonists of guanylate cyclase and their uses
TW201618783A (zh) 2014-08-07 2016-06-01 艾森塔製藥公司 以布魯頓(Bruton)氏酪胺酸激酶(BTK)佔據和BTK再合成速率為基礎之治療癌症、免疫和自體免疫疾病及發炎性疾病之方法
US20180015118A1 (en) 2015-02-03 2018-01-18 Ironwood Pharmaceuticals, Inc. Methods of treating upper gastrointestinal disorders in ppi refractory gerd
CN105362244A (zh) * 2015-11-26 2016-03-02 青岛海之源智能技术有限公司 考来烯胺缓释片及制备方法
CN105456219A (zh) * 2015-12-28 2016-04-06 青岛海之星生物科技有限公司 一种考来替泊缓释片及制备方法
CN105520919A (zh) * 2015-12-28 2016-04-27 青岛海之星生物科技有限公司 一种考来替泊缓释胶囊及制备方法
JP2020527580A (ja) * 2017-07-19 2020-09-10 アイアンウッド ファーマシューティカルズ インコーポレイテッド 胃滞留性胆汁酸捕捉剤剤形の有効性
EP3501503A1 (en) * 2017-12-22 2019-06-26 Cosmo Technologies Ltd. Solid delivery composition

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US20070196396A1 (en) * 2004-02-11 2007-08-23 Rubicon Research Private Limited Controlled release pharmaceutical compositions with improved bioavailability
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

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110475564A (zh) * 2016-12-21 2019-11-19 硬木药品公司 用利那洛肽的修饰的或延迟释放制剂治疗肠易激综合征的方法
CN111110647A (zh) * 2018-10-31 2020-05-08 浙江京新药业股份有限公司 含盐酸考来维仑的药物组合物及其制备方法

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JP2016508992A (ja) 2016-03-24
AU2014207680B2 (en) 2018-09-06
NZ709924A (en) 2021-02-26
US20220370367A1 (en) 2022-11-24
HK1214529A1 (zh) 2016-07-29
JP2018203787A (ja) 2018-12-27
EP2945614A1 (en) 2015-11-25
JP6716255B2 (ja) 2020-07-01
US20170266116A1 (en) 2017-09-21
BR112015016917B1 (pt) 2022-08-30
AU2014207680A1 (en) 2015-08-27
US20210267903A1 (en) 2021-09-02
MX383752B (es) 2025-03-11
WO2014113377A1 (en) 2014-07-24
ES2906114T3 (es) 2022-04-13
CA2898362C (en) 2020-09-01
CA2898362A1 (en) 2014-07-24
US20220110876A1 (en) 2022-04-14
EP3991719A1 (en) 2022-05-04
EP2945614B1 (en) 2021-11-24
US20210015754A1 (en) 2021-01-21
EA201591338A1 (ru) 2016-01-29
US20160015644A1 (en) 2016-01-21
CN108057028A (zh) 2018-05-22
JP6755920B2 (ja) 2020-09-16
MX2015009055A (es) 2016-05-16
BR112015016917A2 (https=) 2017-08-15

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Application publication date: 20160217