DK2603232T3 - Stabile formuleringer af linaclotid - Google Patents

Stabile formuleringer af linaclotid Download PDF

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Publication number
DK2603232T3
DK2603232T3 DK11745896T DK11745896T DK2603232T3 DK 2603232 T3 DK2603232 T3 DK 2603232T3 DK 11745896 T DK11745896 T DK 11745896T DK 11745896 T DK11745896 T DK 11745896T DK 2603232 T3 DK2603232 T3 DK 2603232T3
Authority
DK
Denmark
Prior art keywords
linaclotid
stable forms
stable
forms
Prior art date
Application number
DK11745896T
Other languages
English (en)
Inventor
Angelika Fretzen
Brian Cali
Mahendra Dedhiya
Yun Mo
Original Assignee
Ironwood Pharmaceuticals Inc
Forest Laboratories Holdings Ltd
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, Forest Laboratories Holdings Ltd filed Critical Ironwood Pharmaceuticals Inc
Application granted granted Critical
Publication of DK2603232T3 publication Critical patent/DK2603232T3/da

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Classifications

    • 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
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; 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
    • A61K9/1676—Agglomerates; 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
    • 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
    • A61P1/10—Laxatives

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
DK11745896T 2010-08-11 2011-08-11 Stabile formuleringer af linaclotid DK2603232T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US37280410P 2010-08-11 2010-08-11
PCT/US2011/047434 WO2012021715A2 (en) 2010-08-11 2011-08-11 Stable formulations of linaclotide

Publications (1)

Publication Number Publication Date
DK2603232T3 true DK2603232T3 (da) 2019-12-09

Family

ID=44630493

Family Applications (1)

Application Number Title Priority Date Filing Date
DK11745896T DK2603232T3 (da) 2010-08-11 2011-08-11 Stabile formuleringer af linaclotid

Country Status (16)

Country Link
US (7) US20140005128A1 (da)
EP (2) EP2603232B1 (da)
JP (2) JP5921545B2 (da)
CA (2) CA2808091C (da)
CY (1) CY1122853T1 (da)
DK (1) DK2603232T3 (da)
ES (2) ES2919136T3 (da)
HR (1) HRP20192207T1 (da)
HU (1) HUE046922T2 (da)
LT (1) LT2603232T (da)
MX (1) MX348823B (da)
PL (1) PL2603232T3 (da)
PT (1) PT2603232T (da)
RS (1) RS59978B1 (da)
SI (1) SI2603232T1 (da)
WO (1) WO2012021715A2 (da)

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Also Published As

Publication number Publication date
JP2013535505A (ja) 2013-09-12
CY1122853T1 (el) 2021-05-05
US20140378393A1 (en) 2014-12-25
EP3626253B8 (en) 2022-04-20
CA2808091A1 (en) 2012-02-16
PL2603232T3 (pl) 2020-05-18
LT2603232T (lt) 2020-01-27
PT2603232T (pt) 2020-01-09
EP3626253B1 (en) 2022-03-16
JP2016065105A (ja) 2016-04-28
ES2919136T3 (es) 2022-07-22
EP3626253A2 (en) 2020-03-25
JP5921545B2 (ja) 2016-05-24
US20190209644A1 (en) 2019-07-11
CA3040415A1 (en) 2012-02-16
RS59978B1 (sr) 2020-03-31
MX2013001677A (es) 2013-07-22
EP2603232A2 (en) 2013-06-19
WO2012021715A2 (en) 2012-02-16
US20230346881A1 (en) 2023-11-02
US20200009216A1 (en) 2020-01-09
US20220233635A1 (en) 2022-07-28
MX348823B (es) 2017-06-30
US10702576B2 (en) 2020-07-07
ES2763404T3 (es) 2020-05-28
US10675325B2 (en) 2020-06-09
EP2603232B1 (en) 2019-09-25
WO2012021715A3 (en) 2012-05-18
HRP20192207T1 (hr) 2020-02-21
US20200030407A1 (en) 2020-01-30
SI2603232T1 (sl) 2020-03-31
CA2808091C (en) 2019-05-21
HUE046922T2 (hu) 2020-03-30
US20140005128A1 (en) 2014-01-02
EP3626253A3 (en) 2020-07-29

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