WO2015148474A1 - Compositions for the treatment of autodigestion - Google Patents

Compositions for the treatment of autodigestion Download PDF

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Publication number
WO2015148474A1
WO2015148474A1 PCT/US2015/022198 US2015022198W WO2015148474A1 WO 2015148474 A1 WO2015148474 A1 WO 2015148474A1 US 2015022198 W US2015022198 W US 2015022198W WO 2015148474 A1 WO2015148474 A1 WO 2015148474A1
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WO
WIPO (PCT)
Prior art keywords
peg
glucose
shock
tranexamic acid
compositions disclosed
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.)
Ceased
Application number
PCT/US2015/022198
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English (en)
French (fr)
Inventor
Thomas HALLAM
Robin JACKMAN
John Rodenrys
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.)
Leading Biosciences Inc
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Leading Biosciences 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 Leading Biosciences Inc filed Critical Leading Biosciences Inc
Priority to ES15767838T priority Critical patent/ES2906262T3/es
Priority to CN202110088870.9A priority patent/CN112641771B/zh
Priority to DK15767838.4T priority patent/DK3122349T3/da
Priority to CA2942358A priority patent/CA2942358C/en
Priority to JP2017502766A priority patent/JP6648106B2/ja
Priority to MX2016012248A priority patent/MX376176B/es
Priority to EP15767838.4A priority patent/EP3122349B1/en
Priority to KR1020227015575A priority patent/KR20220068266A/ko
Priority to AU2015236283A priority patent/AU2015236283B2/en
Priority to KR1020167027915A priority patent/KR102397379B1/ko
Priority to PL15767838T priority patent/PL3122349T3/pl
Priority to CN201580020501.9A priority patent/CN106572987B/zh
Publication of WO2015148474A1 publication Critical patent/WO2015148474A1/en
Anticipated expiration legal-status Critical
Ceased 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
    • 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
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • 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
    • 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
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
    • 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
    • A61K31/765—Polymers containing oxygen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/08—Solutions
    • 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
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/06—Antiarrhythmics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Definitions

  • compositions disclosed herein comprise about 7.8 g of tranexamic acid, about 50.3 g of PEG 3350, about 40 g of glucose, about 5.7 g of sodium sulfate, about 1.7 g of sodium bicarbonate, about 1.5 g of sodium chloride, and about 0.7 g of potassium chloride. In some embodiments, compositions disclosed herein comprise about 7.8 g of tranexamic acid and about 40 g of glucose. In some embodiments, compositions disclosed herein are formulated as aqueous solutions. In certain specific embodiments, the volume of the aqueous solution is 1000 mL.
  • compositions disclosed herein are formulated as aqueous solutions comprising about 2.5 wt%, about 2.6 wt%, about 2.7 wt%, about 2.8 wt%, about 2.9 wt%, about 3.0 wt%, about 3.1 wt%, about 3.2 wt%, about 3.3 wt%, about 3.4 wt%, about 3.5 wt%, about 3.6 wt%, about 3.7 wt%, about 3.8 wt%, about 3.9 wt%, about 4.0 wt%, about 4.1 wt%, about 4.2 wt%, about 4.3 wt%, about 4.4 wt%, about 4.5 wt%, about 4.6 wt%, about 4.7 wt%, about 4.8 wt%, about 4.9 wt%, about 5.0 wt%, about 5.1 wt%, about 5.2 wt%, about 5.3 wt%
  • compositions disclosed herein are formulated as aqueous solutions comprising about 0.06 wt%, about 0.07 wt%, or about 0.08 wt% of potassium chloride. In a specific embodiment, compositions disclosed herein are formulated as aqueous solutions comprising about 0.07 wt% of potassium chloride. In some embodiments, compositions disclosed herein are formulated as aqueous solutions comprising about 0.06 wt% to about 0.08 wt% of potassium chloride.
  • Figure 3 shows the mean percentage of villi intact per rat after administration of the formulations and shock induction. 92.6% of villi were intact across all rats that received Representative Formulation 1 , whereas only 52.8% of the villi were intact across all rats that received Comparative Formulation 1. These results are consistent with the mean values calculated from the total villi observed in Table 5.
  • Comparative Formulation 3 via a direct injection into the middle of the stomach.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Dermatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Virology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Vascular Medicine (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
PCT/US2015/022198 2014-03-25 2015-03-24 Compositions for the treatment of autodigestion Ceased WO2015148474A1 (en)

Priority Applications (12)

Application Number Priority Date Filing Date Title
ES15767838T ES2906262T3 (es) 2014-03-25 2015-03-24 Composiciones para el tratamiento de la autodigestión
CN202110088870.9A CN112641771B (zh) 2014-03-25 2015-03-24 用于治疗自身消化的组合物
DK15767838.4T DK3122349T3 (da) 2014-03-25 2015-03-24 Sammensætninger til behandling af autodigestion
CA2942358A CA2942358C (en) 2014-03-25 2015-03-24 Compositions for the treatment of autodigestion
JP2017502766A JP6648106B2 (ja) 2014-03-25 2015-03-24 自己消化の治療用組成物
MX2016012248A MX376176B (es) 2014-03-25 2015-03-24 Composiciones para el tratamiento de autodigestion.
EP15767838.4A EP3122349B1 (en) 2014-03-25 2015-03-24 Compositions for the treatment of autodigestion
KR1020227015575A KR20220068266A (ko) 2014-03-25 2015-03-24 자가소화의 치료용의 조성물
AU2015236283A AU2015236283B2 (en) 2014-03-25 2015-03-24 Compositions for the treatment of autodigestion
KR1020167027915A KR102397379B1 (ko) 2014-03-25 2015-03-24 자가소화의 치료용의 조성물
PL15767838T PL3122349T3 (pl) 2014-03-25 2015-03-24 Kompozycje do leczenia samotrawienia
CN201580020501.9A CN106572987B (zh) 2014-03-25 2015-03-24 用于治疗自身消化的组合物

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201461970247P 2014-03-25 2014-03-25
US61/970,247 2014-03-25
US201462019007P 2014-06-30 2014-06-30
US62/019,007 2014-06-30

Publications (1)

Publication Number Publication Date
WO2015148474A1 true WO2015148474A1 (en) 2015-10-01

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PCT/US2015/022198 Ceased WO2015148474A1 (en) 2014-03-25 2015-03-24 Compositions for the treatment of autodigestion

Country Status (14)

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US (4) US9314442B2 (enExample)
EP (1) EP3122349B1 (enExample)
JP (1) JP6648106B2 (enExample)
KR (2) KR102397379B1 (enExample)
CN (3) CN106572987B (enExample)
AU (1) AU2015236283B2 (enExample)
CA (1) CA2942358C (enExample)
DK (1) DK3122349T3 (enExample)
ES (1) ES2906262T3 (enExample)
MX (1) MX376176B (enExample)
PL (1) PL3122349T3 (enExample)
PT (1) PT3122349T (enExample)
TW (2) TWI554269B (enExample)
WO (1) WO2015148474A1 (enExample)

Cited By (2)

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Publication number Priority date Publication date Assignee Title
US9775821B2 (en) 2014-03-25 2017-10-03 Leading BioSciences, Inc. Compositions for the treatment of autodigestion
US10772861B2 (en) 2010-09-23 2020-09-15 Leading Biosciences, LLC Administration of serine protease inhibitors to the stomach

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CN108883086B (zh) * 2016-01-11 2021-10-26 恒翼生物医药科技(上海)有限公司 用于治疗和预防粘连及肠梗阻的组合物和方法
US20200323803A1 (en) * 2017-10-24 2020-10-15 Leading BioSciences, Inc. Compositions and methods for glucose control
BE1025996A9 (fr) 2018-01-19 2020-05-11 Hyloris Dev Sa Solution orale d’acide tranexamique
CN110730413A (zh) * 2018-06-29 2020-01-24 阿里巴巴集团控股有限公司 一种终端定位方法和装置
US10980757B2 (en) 2018-09-06 2021-04-20 RTU Pharma SA Ready-to-use tranexamic acid intravenous solution

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CN112641771B (zh) 2022-04-15
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US20180000765A1 (en) 2018-01-04
JP2017515888A (ja) 2017-06-15
KR102397379B1 (ko) 2022-05-13
KR20220068266A (ko) 2022-05-25
US20150272914A1 (en) 2015-10-01
TW201538154A (zh) 2015-10-16
TWI554269B (zh) 2016-10-21
DK3122349T3 (da) 2022-02-14
EP3122349A4 (en) 2017-10-11
US9314442B2 (en) 2016-04-19
TWI669114B (zh) 2019-08-21
PT3122349T (pt) 2022-02-07
US20220054439A1 (en) 2022-02-24
US9775821B2 (en) 2017-10-03
JP6648106B2 (ja) 2020-02-14
CN112807325A (zh) 2021-05-18
CA2942358A1 (en) 2015-10-01
CN106572987B (zh) 2021-02-12
CN112641771A (zh) 2021-04-13
EP3122349B1 (en) 2021-12-22
AU2015236283B2 (en) 2020-05-07
MX376176B (es) 2025-03-07
AU2015236283A1 (en) 2016-09-29
CA2942358C (en) 2023-03-28
US20160263064A1 (en) 2016-09-15
CN106572987A (zh) 2017-04-19
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TW201707697A (zh) 2017-03-01
US11123317B2 (en) 2021-09-21

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