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ECSP21072161A - Composiciones de liberación retardada de linaclotida - Google Patents

Composiciones de liberación retardada de linaclotida

Info

Publication number
ECSP21072161A
ECSP21072161A ECSENADI202172161A ECDI202172161A ECSP21072161A EC SP21072161 A ECSP21072161 A EC SP21072161A EC SENADI202172161 A ECSENADI202172161 A EC SENADI202172161A EC DI202172161 A ECDI202172161 A EC DI202172161A EC SP21072161 A ECSP21072161 A EC SP21072161A
Authority
EC
Ecuador
Prior art keywords
delayed release
release compositions
linaclotide
linaclotide delayed
compositions
Prior art date
Application number
ECSENADI202172161A
Other languages
English (en)
Inventor
Mark Currie
Anil Chhettry
Ritesh Sanghvi
Angelika Fretzen
Mohammad Bari
Ahmad Hashash
Matthew Miller
Mahendra Dedihiya
Andreas Grill
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=52293217&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ECSP21072161(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ironwood Pharmaceuticals Inc filed Critical Ironwood Pharmaceuticals Inc
Publication of ECSP21072161A publication Critical patent/ECSP21072161A/es

Links

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
    • A61K38/10—Peptides having 12 to 20 amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61K9/1617—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
    • A61K9/14—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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
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    • 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
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    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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    • 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
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    • 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
    • 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
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    • A61K9/2846—Poly(meth)acrylates
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
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    • A—HUMAN NECESSITIES
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • A—HUMAN NECESSITIES
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
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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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nutrition Science (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Endocrinology (AREA)
  • Zoology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)

Abstract

La presente invención se refiere a composiciones farmacéuticas de liberación retardada que comprenden linaclotida o sales farmacéuticamente aceptables de esta, así como a varios métodos y procesos para la preparación y uso de las composiciones.
ECSENADI202172161A 2013-12-11 2021-09-28 Composiciones de liberación retardada de linaclotida ECSP21072161A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361914951P 2013-12-11 2013-12-11
US201361914952P 2013-12-11 2013-12-11

Publications (1)

Publication Number Publication Date
ECSP21072161A true ECSP21072161A (es) 2021-11-18

Family

ID=52293217

Family Applications (2)

Application Number Title Priority Date Filing Date
ECIEPI201659106A ECSP16059106A (es) 2013-12-11 2016-07-08 Composiciones de liberación retardada de linaclotida
ECSENADI202172161A ECSP21072161A (es) 2013-12-11 2021-09-28 Composiciones de liberación retardada de linaclotida

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ECIEPI201659106A ECSP16059106A (es) 2013-12-11 2016-07-08 Composiciones de liberación retardada de linaclotida

Country Status (29)

Country Link
US (7) US20160310559A1 (es)
EP (2) EP3821881A1 (es)
JP (4) JP6964380B2 (es)
KR (3) KR102337809B1 (es)
CN (3) CN106659687A (es)
AU (3) AU2014362220B2 (es)
CA (1) CA2933587C (es)
CL (1) CL2016001424A1 (es)
CY (1) CY1123953T1 (es)
DK (1) DK3079669T3 (es)
EA (1) EA201691216A1 (es)
EC (2) ECSP16059106A (es)
ES (1) ES2838007T3 (es)
HR (1) HRP20201753T1 (es)
HU (1) HUE052981T2 (es)
IL (2) IL246155A0 (es)
LT (1) LT3079669T (es)
MX (2) MX386584B (es)
NZ (2) NZ759512A (es)
PE (2) PE20161373A1 (es)
PH (1) PH12016501122B1 (es)
PL (1) PL3079669T3 (es)
PT (1) PT3079669T (es)
RS (1) RS61133B1 (es)
SG (2) SG11201604729QA (es)
SI (1) SI3079669T1 (es)
SM (1) SMT202000686T1 (es)
UA (1) UA119335C2 (es)
WO (2) WO2015089335A1 (es)

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UA119335C2 (uk) * 2013-12-11 2019-06-10 Айронвуд Фармасьютикалз, Інк. Композиції лінаклотиду з затриманим вивільненням
WO2016020901A1 (en) 2014-08-07 2016-02-11 Acerta Pharma B.V. Methods of treating cancers, immune and autoimmune diseases, and inflammatory diseases based on btk occupancy and btk resynthesis rate
CA2936740C (en) 2014-10-31 2017-10-10 Purdue Pharma Methods and compositions particularly for treatment of attention deficit disorder
US20180008547A1 (en) * 2015-02-02 2018-01-11 Aurobindo Pharma Ltd Stable Compositions comprising Linaclotide
WO2016197042A1 (en) * 2015-06-05 2016-12-08 Ironwood Pharmaceuticals, Inc. Modified or targeted release formulations of linaclotide
WO2017156214A1 (en) * 2016-03-11 2017-09-14 Gateway Pharmaceutical LLC Pharmaceutical compositions for colon-specific delivery
US10588864B2 (en) 2016-03-11 2020-03-17 Gateway Pharmaceuticals LLC Pharmaceutical compositions for colon-specific delivery
JP6957610B2 (ja) * 2016-10-06 2021-11-02 スキャンポ・アーゲーＳｕｃａｍｐｏ ＡＧ 医薬品用途のための多層ビーズ
MA47112A (fr) * 2016-12-21 2019-10-30 Ironwood Pharmaceuticals Inc Procédés de traitement du syndrome du côlon irritable avec des formulations à libération modifiée ou retardée de linaclotide
KR102227486B1 (ko) * 2017-06-30 2021-03-12 롯데정밀화학 주식회사 프로톤 펌프 저해제를 포함하는 경구용 고형제제 조성물, 이를 포함하는 경구용 고형제제 및 그 제조방법
KR102743821B1 (ko) * 2018-03-23 2024-12-18 팔라틴 테크놀로지스 인코포레이티드 멜라노코르틴 수용체-특이적 펩티드 제형 및 위장관-특이적 전달을 위한 방법
US10722473B2 (en) 2018-11-19 2020-07-28 Purdue Pharma L.P. Methods and compositions particularly for treatment of attention deficit disorder
US20220241367A1 (en) * 2019-06-10 2022-08-04 Ironwood Pharmaceutical, Inc. Treatment of Abdominal Pain Associated with Diarrhea-Predominant Irritable Bowel Syndrome
KR102104507B1 (ko) * 2019-08-23 2020-04-24 브릿지바이오테라퓨틱스(주) 팔미토일-l-프롤릴-l-프롤릴-글리실-l-타이로신 나트륨을 포함하는 약제학적 제제 및 이의 제조방법
CN110935007B (zh) * 2019-12-12 2023-06-23 烟台大学 利那洛肽复方组合物、制剂及其用途和制备方法
GB202017863D0 (en) * 2020-11-12 2020-12-30 Intract Pharma Ltd Novel compositions
WO2022245650A1 (en) * 2021-05-19 2022-11-24 Alberto Paz Orally administered compositions for cancer treatment
TW202426473A (zh) * 2022-10-03 2024-07-01 全福生物科技股份有限公司 包含pedf衍生短肽(pdsp)之組合物及其用途
CN120418354A (zh) * 2022-12-28 2025-08-01 中外制药株式会社 含有待分散的物质的固体分散体、含有其的药物组合物及其生产方法

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US7371727B2 (en) 2003-01-28 2008-05-13 Microbia, Inc. Methods and compositions for the treatment of gastrointestinal disorders
US7304036B2 (en) 2003-01-28 2007-12-04 Microbia, Inc. Methods and compositions for the treatment of gastrointestinal disorders
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JP5964589B2 (ja) * 2008-12-03 2016-08-03 シナジー ファーマシューティカルズ インコーポレイテッド グアニル酸シクラーゼｃアゴニストの製剤およびその使用方法
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