JP2023510158A - 細菌及び微生物細胞外小胞を含有する固形剤形 - Google Patents

細菌及び微生物細胞外小胞を含有する固形剤形 Download PDF

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JP2023510158A
JP2023510158A JP2022539136A JP2022539136A JP2023510158A JP 2023510158 A JP2023510158 A JP 2023510158A JP 2022539136 A JP2022539136 A JP 2022539136A JP 2022539136 A JP2022539136 A JP 2022539136A JP 2023510158 A JP2023510158 A JP 2023510158A
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bacterium
dosage form
solid dosage
mev
bacteria
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JP2023510158A5 (https=
JPWO2021133904A5 (https=
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ジェイ．エイチ． ダビット，クリストファー
グッドマン，ブライアン
アルタフ，サイド
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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
    • 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
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • 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
    • A61K9/2813—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. 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
    • A61K9/28—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
    • A61K9/2846—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
    • A61K9/20—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
    • 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
    • A61K9/4883—Capsule finishing, e.g. dyeing, aromatising, polishing
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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
    • A61K2035/11—Medicinal preparations comprising living procariotic cells
    • A61K2035/115—Probiotics

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2022539136A 2019-12-27 2020-12-23 細菌及び微生物細胞外小胞を含有する固形剤形 Pending JP2023510158A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962954153P 2019-12-27 2019-12-27
US62/954,153 2019-12-27
PCT/US2020/066828 WO2021133904A1 (en) 2019-12-27 2020-12-23 Solid dosage forms containing bacteria and microbial extracellular vesicles

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JP2023510158A true JP2023510158A (ja) 2023-03-13
JP2023510158A5 JP2023510158A5 (https=) 2024-01-05
JPWO2021133904A5 JPWO2021133904A5 (https=) 2024-01-05

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US (1) US20230355689A1 (https=)
EP (1) EP4081195A1 (https=)
JP (1) JP2023510158A (https=)
KR (1) KR20220128362A (https=)
CN (1) CN114945357A (https=)
AR (1) AR122353A1 (https=)
AU (1) AU2020413225A1 (https=)
BR (1) BR112022012514A2 (https=)
CA (1) CA3165418A1 (https=)
CO (1) CO2022010242A2 (https=)
MX (1) MX2022007943A (https=)
TW (1) TW202135783A (https=)
WO (1) WO2021133904A1 (https=)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021252861A1 (en) * 2020-06-11 2021-12-16 Evelo Biosciences, Inc. Compositions and methods for treating diseases and disorders using megasphaera sp
KR20230053609A (ko) * 2020-07-21 2023-04-21 에벨로 바이오사이언시즈, 인크. 신경염증성 질환에 대한 경구 요법으로서의 베일로넬라 파르불라 균주
US20250114411A1 (en) * 2021-09-24 2025-04-10 Evelo Biosciences, Inc. Solid dosage forms containing bacteria and microbial extracellular vesicles
JP2024542749A (ja) * 2021-12-16 2024-11-15 エンテロバイオーム インコーポレイテッド がん又は炎症性疾患予防又は治療用薬学的組成物
CN115252651B (zh) * 2022-06-08 2024-06-07 广州知易生物科技有限公司 嗜粘蛋白阿克曼菌在制备防治高血压的组合物中的应用和含有其的组合物
CA3266547A1 (en) * 2022-08-29 2024-03-07 Eli Lilly And Company COMPOSITIONS FOR ORAL ADMINISTRATION
CN116509900B (zh) * 2022-12-01 2023-11-10 佛山科学技术学院 益生菌或其细胞外囊泡在制备防治胃溃疡产品中的应用

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003506481A (ja) * 1999-08-12 2003-02-18 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフトング 経口投与形態物
JP2015537042A (ja) * 2012-11-23 2015-12-24 セレス セラピューティクス インコーポレイテッド 相乗的細菌組成物並びにその生成及び使用の方法
WO2019152667A1 (en) * 2018-01-31 2019-08-08 Evelo Biosciences, Inc. Compositions and methods for treating immune disorders using lachnospiraceae bacteria

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4775536A (en) 1986-02-24 1988-10-04 Bristol-Myers Company Enteric coated tablet and process for making
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
DE69924735T2 (de) 1998-07-28 2006-01-19 Tanabe Seiyaku Co., Ltd. Zur wirkstoffabgabe an zielorten im darm fähige zubereitung
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
US20070065513A1 (en) 2003-10-31 2007-03-22 Avi Avramoff 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
CN101209247B (zh) * 2006-12-27 2011-12-14 天津中新药业集团股份有限公司 一种结肠靶向制剂的制备方法
CN101757042A (zh) * 2009-05-25 2010-06-30 北京诚创康韵医药科技有限公司 一种益生菌微丸制剂及其制备
US8906668B2 (en) * 2012-11-23 2014-12-09 Seres Health, Inc. Synergistic bacterial compositions and methods of production and use thereof
CA2903375C (en) 2013-03-01 2020-11-24 Bpsi Holdings, Llc. Delayed release film coatings containing calcium silicate and substrates coated therewith
AU2014239883B2 (en) * 2013-03-14 2019-01-17 Therabiome, Llc Targeted gastrointestinal tract delivery of probiotic organisms and/or therapeutic agents

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003506481A (ja) * 1999-08-12 2003-02-18 メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフトング 経口投与形態物
JP2015537042A (ja) * 2012-11-23 2015-12-24 セレス セラピューティクス インコーポレイテッド 相乗的細菌組成物並びにその生成及び使用の方法
WO2019152667A1 (en) * 2018-01-31 2019-08-08 Evelo Biosciences, Inc. Compositions and methods for treating immune disorders using lachnospiraceae bacteria

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US20230355689A1 (en) 2023-11-09
AU2020413225A1 (en) 2022-06-23
CA3165418A1 (en) 2021-07-01
CO2022010242A2 (es) 2022-10-21
EP4081195A1 (en) 2022-11-02
AR122353A1 (es) 2022-09-07
BR112022012514A2 (pt) 2022-09-06
WO2021133904A1 (en) 2021-07-01
MX2022007943A (es) 2022-07-27
TW202135783A (zh) 2021-10-01
KR20220128362A (ko) 2022-09-20
CN114945357A (zh) 2022-08-26

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