JP2024516110A - 細菌を含有する医薬組成物 - Google Patents

細菌を含有する医薬組成物 Download PDF

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JP2024516110A
JP2024516110A JP2023562191A JP2023562191A JP2024516110A JP 2024516110 A JP2024516110 A JP 2024516110A JP 2023562191 A JP2023562191 A JP 2023562191A JP 2023562191 A JP2023562191 A JP 2023562191A JP 2024516110 A JP2024516110 A JP 2024516110A
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Prior art keywords
bacterium
cryoprotectant
bacteria
pharmaceutical
sucrose
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JP2023562191A
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English (en)
Japanese (ja)
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JP2024516110A5 (enExample
Inventor
ジャヒク，メフメダリヤ
マッケンナ，コリン
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エヴェロ バイオサイエンシズ，インコーポレーテッド
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/745—Bifidobacteria
    • 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
    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K9/4858—Organic 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2023562191A 2021-04-08 2022-04-08 細菌を含有する医薬組成物 Pending JP2024516110A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202163172370P 2021-04-08 2021-04-08
US63/172,370 2021-04-08
US202163197000P 2021-06-04 2021-06-04
US63/197,000 2021-06-04
PCT/US2022/023979 WO2022217030A1 (en) 2021-04-08 2022-04-08 Pharmaceutical composition containing bacteria

Publications (2)

Publication Number Publication Date
JP2024516110A true JP2024516110A (ja) 2024-04-12
JP2024516110A5 JP2024516110A5 (enExample) 2025-04-15

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ID=81581166

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JP2023562191A Pending JP2024516110A (ja) 2021-04-08 2022-04-08 細菌を含有する医薬組成物

Country Status (6)

Country Link
US (1) US20250073285A1 (enExample)
EP (1) EP4319723A1 (enExample)
JP (1) JP2024516110A (enExample)
KR (1) KR20240006543A (enExample)
TW (1) TW202304415A (enExample)
WO (1) WO2022217030A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3102263A1 (en) * 2018-06-07 2019-12-12 Artugen Therapeutics Ltd. Methods and compositions for the treatment of c. difficile

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012525122A (ja) * 2009-04-30 2012-10-22 アクトジェニックス・エヌブイ 乳酸菌のフリーズドライのための凍結保護剤
WO2019157003A1 (en) * 2018-02-06 2019-08-15 Evelo Biosciences, Inc. Compositions and methods for treating cancer and immune disorders using veillonella bacteria
CN110251474A (zh) * 2019-07-15 2019-09-20 北京工商大学 一种淀粉基大肠靶向双层益生菌片的制备方法
WO2019230183A1 (ja) * 2018-05-31 2019-12-05 株式会社ホクコン 乳酸菌及びその用途
US10576111B2 (en) * 2017-07-05 2020-03-03 Evelo Biosciences, Inc. Method of treating cancer using Bifidobacterium animalis ssp. lactis strain PTA-125097
JP2020527688A (ja) * 2017-07-14 2020-09-10 フォーディー ファーマ レオン エス．エル．ユー．４Ｄ Ｐｈａｒｍａ Ｌｅｏｎ， Ｓ．Ｌ．Ｕ． 製品を真空凍結乾燥するためのプロセス
WO2020257390A1 (en) * 2019-06-21 2020-12-24 Evelo Biosciences, Inc. Compositions and methods of treating a th2-mediated condition using prevotella

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US5292522A (en) 1989-06-20 1994-03-08 Rohm Gmbh Aqueous film coating agent for solid medicaments
US5047258A (en) 1989-07-14 1991-09-10 Sterling Drug Inc. Aqueous spray-coating process
US6623759B2 (en) 1996-06-28 2003-09-23 Astrazeneca Ab Stable drug form for oral administration with benzimidazole derivatives as active ingredient and process for the preparation thereof
DE19631084A1 (de) 1996-08-01 1998-02-05 Basf Ag Verwendung von (Meth)acrylsäure-Copolymeren zur Erhöhung der Permeabilität der Schleimhaut
US6312728B1 (en) 1998-07-07 2001-11-06 Cascade Development, Inc. Sustained release pharmaceutical preparation
EP1101490B1 (en) 1998-07-28 2005-04-13 Tanabe Seiyaku Co., Ltd. Preparation capable of releasing drug at target site in intestine
US20040028737A1 (en) 2002-08-12 2004-02-12 Kopran Research Laboratories Limited Enteric coated stable oral pharmaceutical composition of acid unstable drug and process for preparing the same
DE10260919A1 (de) 2002-12-20 2004-07-01 Röhm GmbH & Co. KG Verfahren zur Herstellung von überzogenen Arzneiformen und Nahrungsergänzungsmitteln mit Konzentrationsgradienten im Überzug
CA2543172A1 (en) 2003-10-31 2005-05-19 Dexcel Ltd. Stable lansoprazole formulation
US9149439B2 (en) 2005-03-21 2015-10-06 Sandoz Ag Multi-particulate, modified-release composition
DE102005032806A1 (de) 2005-07-12 2007-01-18 Röhm Gmbh Verwendung eines teilneutralisierten, anionischen (Meth)acrylat-Copolymers als Überzug für die Herstellung einer Arzneiform mit einer Wirkstofffreisetzung bei erniedrigten pH-Werten
CN105142616B (zh) 2013-03-01 2018-02-13 Bpsi控股有限责任公司 含有硅酸钙的延迟释放薄膜包衣及其包被的底物
JP2020523326A (ja) 2017-06-14 2020-08-06 フォーディー ファーマ リサーチ リミテッド４Ｄ Ｐｈａｒｍａ Ｒｅｓｅａｒｃｈ Ｌｉｍｉｔｅｄ 細菌株を含む組成物
CA3102263A1 (en) 2018-06-07 2019-12-12 Artugen Therapeutics Ltd. Methods and compositions for the treatment of c. difficile
WO2020120714A1 (en) 2018-12-12 2020-06-18 4D Pharma Research Limited Compositions comprising bacterial strains
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WO2021252861A1 (en) * 2020-06-11 2021-12-16 Evelo Biosciences, Inc. Compositions and methods for treating diseases and disorders using megasphaera sp

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012525122A (ja) * 2009-04-30 2012-10-22 アクトジェニックス・エヌブイ 乳酸菌のフリーズドライのための凍結保護剤
US10576111B2 (en) * 2017-07-05 2020-03-03 Evelo Biosciences, Inc. Method of treating cancer using Bifidobacterium animalis ssp. lactis strain PTA-125097
JP2020527688A (ja) * 2017-07-14 2020-09-10 フォーディー ファーマ レオン エス．エル．ユー．４Ｄ Ｐｈａｒｍａ Ｌｅｏｎ， Ｓ．Ｌ．Ｕ． 製品を真空凍結乾燥するためのプロセス
WO2019157003A1 (en) * 2018-02-06 2019-08-15 Evelo Biosciences, Inc. Compositions and methods for treating cancer and immune disorders using veillonella bacteria
WO2019230183A1 (ja) * 2018-05-31 2019-12-05 株式会社ホクコン 乳酸菌及びその用途
WO2020257390A1 (en) * 2019-06-21 2020-12-24 Evelo Biosciences, Inc. Compositions and methods of treating a th2-mediated condition using prevotella
CN110251474A (zh) * 2019-07-15 2019-09-20 北京工商大学 一种淀粉基大肠靶向双层益生菌片的制备方法

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WO2022217030A1 (en) 2022-10-13
US20250073285A1 (en) 2025-03-06
TW202304415A (zh) 2023-02-01
EP4319723A1 (en) 2024-02-14
KR20240006543A (ko) 2024-01-15

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