CN103702678A - 便秘型肠易激综合征的治疗 - Google Patents

便秘型肠易激综合征的治疗 Download PDF

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Publication number
CN103702678A
CN103702678A CN201180054408.1A CN201180054408A CN103702678A CN 103702678 A CN103702678 A CN 103702678A CN 201180054408 A CN201180054408 A CN 201180054408A CN 103702678 A CN103702678 A CN 103702678A
Authority
CN
China
Prior art keywords
linaclotide
patient
symptoms
week
administration
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
CN201180054408.1A
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English (en)
Chinese (zh)
Inventor
J.约翰斯顿
B.J.莱文斯
H.施奈尔
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
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 CN103702678A publication Critical patent/CN103702678A/zh
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic 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
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10Peptides having 12 to 20 amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/485Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10Laxatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CN201180054408.1A 2010-09-11 2011-09-09 便秘型肠易激综合征的治疗 Pending CN103702678A (zh)

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
US38193610P 2010-09-11 2010-09-11
US61/381,936 2010-09-11
US38246910P 2010-09-13 2010-09-13
US61/382,469 2010-09-13
US39426710P 2010-10-18 2010-10-18
US61/394,267 2010-10-18
US40850910P 2010-10-29 2010-10-29
US61/408,509 2010-10-29
US40899410P 2010-11-01 2010-11-01
US61/408,994 2010-11-01
PCT/US2011/051080 WO2012034068A1 (en) 2010-09-11 2011-09-09 Treatment of constipation-predominant irritable bowel syndrome

Publications (1)

Publication Number Publication Date
CN103702678A true CN103702678A (zh) 2014-04-02

Family

ID=44654514

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201180054408.1A Pending CN103702678A (zh) 2010-09-11 2011-09-09 便秘型肠易激综合征的治疗

Country Status (7)

Country Link
US (9) US20140162963A1 (https=)
EP (1) EP2613794A1 (https=)
JP (1) JP2013540732A (https=)
CN (1) CN103702678A (https=)
CA (1) CA2811001A1 (https=)
MX (1) MX2013002747A (https=)
WO (1) WO2012034068A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105412904A (zh) * 2014-06-17 2016-03-23 深圳翰宇药业股份有限公司 利那洛肽肠溶缓释微丸胶囊制剂及其制备方法和用途

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA119335C2 (uk) * 2013-12-11 2019-06-10 Айронвуд Фармасьютикалз, Інк. Композиції лінаклотиду з затриманим вивільненням
WO2016024291A1 (en) * 2014-08-11 2016-02-18 Sun Pharmaceutical Industries Ltd. Linaclotide stable composition
US20180008547A1 (en) * 2015-02-02 2018-01-11 Aurobindo Pharma Ltd Stable Compositions comprising Linaclotide
US20220241367A1 (en) * 2019-06-10 2022-08-04 Ironwood Pharmaceutical, Inc. Treatment of Abdominal Pain Associated with Diarrhea-Predominant Irritable Bowel Syndrome

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010019266A2 (en) * 2008-08-15 2010-02-18 Ironwood Pharmaceuticals, Inc. Stable solid formulation of a gc-c receptor agonist polypeptide suitable for oral administration

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL115592A (en) * 1994-10-13 2000-07-26 Novo Nordisk As Stabilized pharmaceutical formulation comprising a growth hormone and leucine
US7304036B2 (en) * 2003-01-28 2007-12-04 Microbia, Inc. Methods and compositions for the treatment of gastrointestinal disorders
CA2770334A1 (en) * 2009-08-12 2011-02-17 Forest Laboratories Holdings Limited Orally disintegrating compositions of linaclotide
WO2011020054A1 (en) * 2009-08-13 2011-02-17 Ironwood Pharmaceuticals Inc. Method for modulating the pharmacodynamic effect of orally administered guanylate cyclase receptor agonists
US8933030B2 (en) * 2010-02-17 2015-01-13 Ironwwod Pharmaceuticals, Inc. Treatments for gastrointestinal disorders

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010019266A2 (en) * 2008-08-15 2010-02-18 Ironwood Pharmaceuticals, Inc. Stable solid formulation of a gc-c receptor agonist polypeptide suitable for oral administration

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
JM JOHNSTON ET AL.: "Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation", 《GASTROENTEROLOGY》 *
V ANDRESEN ET AL.: "Effect of 5 days linaclotide on transit and bowel function in females with constipation-predominant irritable bowel syndrome", 《GASTROENTEROLOGY》 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105412904A (zh) * 2014-06-17 2016-03-23 深圳翰宇药业股份有限公司 利那洛肽肠溶缓释微丸胶囊制剂及其制备方法和用途

Also Published As

Publication number Publication date
US20190282655A1 (en) 2019-09-19
US20170281722A1 (en) 2017-10-05
JP2013540732A (ja) 2013-11-07
US20180147253A1 (en) 2018-05-31
US20160206686A1 (en) 2016-07-21
WO2012034068A1 (en) 2012-03-15
US20230263854A1 (en) 2023-08-24
US20190022173A1 (en) 2019-01-24
CA2811001A1 (en) 2012-03-15
US20140162963A1 (en) 2014-06-12
US20240115656A1 (en) 2024-04-11
US20220111001A1 (en) 2022-04-14
MX2013002747A (es) 2013-10-25
EP2613794A1 (en) 2013-07-17

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C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C02 Deemed withdrawal of patent application after publication (patent law 2001)
WD01 Invention patent application deemed withdrawn after publication

Application publication date: 20140402