JP2023541827A - Glp-1受容体アゴニストの改善された医薬製剤 - Google Patents

Glp-1受容体アゴニストの改善された医薬製剤 Download PDF

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JP2023541827A
JP2023541827A JP2023515289A JP2023515289A JP2023541827A JP 2023541827 A JP2023541827 A JP 2023541827A JP 2023515289 A JP2023515289 A JP 2023515289A JP 2023515289 A JP2023515289 A JP 2023515289A JP 2023541827 A JP2023541827 A JP 2023541827A
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copolymer
coating
mol
repeat units
pharmaceutical composition
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JP2023541827A5 (enExample
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フロリアン フェーガー,
マルティン ヴェルレ,
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サイプルメド ゲーエムベーハー
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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
    • A61K9/20—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
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • 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
    • 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
    • A61K9/4816—Wall or shell material
    • 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
    • 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
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Emergency Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
JP2023515289A 2020-09-07 2021-09-07 Glp-1受容体アゴニストの改善された医薬製剤 Pending JP2023541827A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP20194828 2020-09-07
EP20194828.8 2020-09-07
EP20208628 2020-11-19
EP20208628.6 2020-11-19
PCT/EP2021/074625 WO2022049310A1 (en) 2020-09-07 2021-09-07 Improved pharmaceutical formulations of glp-1 receptor agonists

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JP2023541827A true JP2023541827A (ja) 2023-10-04
JP2023541827A5 JP2023541827A5 (enExample) 2024-09-13

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US (1) US20240041983A1 (enExample)
EP (1) EP4210680A1 (enExample)
JP (1) JP2023541827A (enExample)
CN (1) CN116419750A (enExample)
WO (1) WO2022049310A1 (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20190060A1 (ar) 2016-09-26 2019-03-26 Chugai Pharmaceutical Co Ltd مشتق بيرازولو بيريدين له تأثير مساعد لمستقبل glp-1
CA3237751A1 (en) 2021-11-10 2023-05-19 Tyler Brown Ionic liquid compositions
WO2023166179A1 (en) * 2022-03-03 2023-09-07 Cyprumed Gmbh Improved oral pharmaceutical formulations of therapeutic peptides and proteins
TW202400219A (zh) * 2022-04-29 2024-01-01 香港商鵬躍醫藥科技有限公司 用於鼻內給藥的索馬魯肽及其鹽的藥物組合物
KR20250057847A (ko) 2022-08-29 2025-04-29 일라이 릴리 앤드 캄파니 경구 전달용 조성물
WO2024134493A1 (en) * 2022-12-19 2024-06-27 Quisitive Therapeutics Drug delivery system for tirzepatide
US12605427B2 (en) * 2023-05-15 2026-04-21 Red Mountain Med Spa, LLC Sublingual semaglutide-BPC 157 combination for weight loss
CN122376711A (zh) * 2024-06-03 2026-07-14 深圳奥礼生物科技有限公司 口服的多肽组合物
WO2026084427A1 (ko) * 2024-10-16 2026-04-23 국민대학교산학협력단 세마글루티드 및 흡수촉진제를 유효성분으로 포함하는 경구투여용 제제 및 이의 제조방법

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014533656A (ja) * 2011-11-30 2014-12-15 武田薬品工業株式会社 有核錠
JP2016500682A (ja) * 2012-10-17 2016-01-14 ノヴォ ノルディスク アー/エス 経口ペプチドデリバリーのための脂肪酸アシル化アミノ酸
JP2018505172A (ja) * 2015-01-29 2018-02-22 ノヴォ ノルディスク アー/エス Glp−1アゴニスト及び腸溶コーティングを含む錠剤
US20200237875A1 (en) * 2019-01-30 2020-07-30 Synlev Pharmaceuticals Corporation Formulations and methods for treatment of fibromyalgia and related myofascial pain disorders

Family Cites Families (39)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3219656A (en) 1963-08-12 1965-11-23 Rohm & Haas Alkylpolyalkoxyalkyl glucosides and process of preparation therefor
US3839318A (en) 1970-09-27 1974-10-01 Rohm & Haas Process for preparation of alkyl glucosides and alkyl oligosaccharides
AT382381B (de) 1984-10-02 1987-02-25 Oesterr Zuckerfab Evidenz Verfahren zur herstellung neuer grenzfl|chenaktiver kohlenhydrat-derivate
DK39892D0 (da) 1992-03-25 1992-03-25 Bernard Thorens Peptid
US5661130A (en) 1993-06-24 1997-08-26 The Uab Research Foundation Absorption enhancers for drug administration
US5869602A (en) 1995-03-17 1999-02-09 Novo Nordisk A/S Peptide derivatives
US5866536A (en) 1995-03-31 1999-02-02 Emisphere Technologies, Inc. Compounds and compositions for delivering active agents
DE122009000079I2 (de) 1996-08-30 2011-06-16 Novo Nordisk As Novo Alle Glp-1 derivate
US5773647A (en) 1997-02-07 1998-06-30 Emisphere Technologies, Inc. Compounds and compositions for delivering active agents
DE69916811T2 (de) 1998-02-27 2005-04-14 Novo Nordisk A/S Glp-1 derivate mit einem helix-gehalt über 25 %, die partiell strukturierte mizellenartige aggregate bilden
EP1060191B1 (en) 1998-02-27 2010-04-28 Novo Nordisk A/S Derivatives of glp-1 analogs
AU2610899A (en) 1998-02-27 1999-09-15 Novo Nordisk A/S N-terminally modified glp-1 derivatives
AU3247799A (en) 1998-02-27 1999-09-15 Novo Nordisk A/S Glp-1 derivatives of glp-1 and exendin with protracted profile of action
NZ534409A (en) 1999-04-05 2006-03-31 Emisphere Tech Inc Disodium salts, monohydrates, and ethanol solvates for delivering active agents
EP1670515A2 (en) 2003-09-19 2006-06-21 Novo Nordisk A/S Albumin-binding derivatives of therapeutic peptides
JP2007537141A (ja) 2003-12-18 2007-12-20 ノボ ノルディスク アクティーゼルスカブ 新規なglp−1化合物
CN101665538A (zh) 2003-12-18 2010-03-10 诺沃挪第克公司 与白蛋白样物质相连的新glp-1类似物
ES2542228T3 (es) 2004-07-08 2015-08-03 Novo Nordisk A/S Marcas de prolongación polipeptídica que comprenden un resto de tetrazol
US20060046962A1 (en) 2004-08-25 2006-03-02 Aegis Therapeutics Llc Absorption enhancers for drug administration
JP5107713B2 (ja) 2004-10-07 2012-12-26 ノヴォ ノルディスク アー/エス 遅延性のエキセンディン−4化合物
JP2008515856A (ja) 2004-10-07 2008-05-15 ノボ ノルディスク アクティーゼルスカブ 遅延性glp−1化合物
ES2484796T3 (es) 2005-03-18 2014-08-12 Novo Nordisk A/S Compuestos de GLP-1 extendidos
TWI362392B (en) 2005-03-18 2012-04-21 Novo Nordisk As Acylated glp-1 compounds
US20090318353A1 (en) 2006-08-25 2009-12-24 Novo Nordisk A/S Acylated Exendin-4 Compounds
US20100261637A1 (en) 2007-09-05 2010-10-14 Novo Nordisk A/S Peptides derivatized with a-b-c-d- and their therapeutical use
US20100292133A1 (en) 2007-09-05 2010-11-18 Novo Nordisk A/S Truncated glp-1 derivaties and their therapeutical use
EP2190872B1 (en) 2007-09-05 2018-03-14 Novo Nordisk A/S Glucagon-like peptide-1 derivatives and their pharmaceutical use
AU2010250452B2 (en) 2009-05-20 2014-06-05 Toray Industries, Inc. Cell membrane-permeable peptides
CN102596253B (zh) 2009-09-30 2013-11-06 蒂奥迈里克斯研究与指导有限公司 含有维生素b 亚结构的粘膜粘着聚合物
KR20130100897A (ko) 2010-04-21 2013-09-12 나노메가 메디컬 코포레이션 나노입자의 약제학적 조성물
WO2012112319A1 (en) 2011-02-04 2012-08-23 Aegis Therapeutics, Llc Orally bioavailable peptide drug compositions and methods thereof
CN103458873B (zh) 2011-04-14 2016-04-13 诺沃—诺迪斯克有限公司 用于口服肽递送的脂肪酸酰化的氨基酸
CA2872314C (en) 2012-05-03 2021-08-31 Zealand Pharma A/S Gip-glp-1 dual agonist compounds and methods
US20150174076A1 (en) 2012-06-14 2015-06-25 Entrega, Inc. Mucoadhesive devices for delivery of active agents
WO2015086728A1 (en) 2013-12-13 2015-06-18 Sanofi Exendin-4 peptide analogues as dual glp-1/gip receptor agonists
TW201609797A (zh) 2013-12-13 2016-03-16 賽諾菲公司 雙重glp-1/升糖素受體促效劑
TW201625668A (zh) 2014-04-07 2016-07-16 賽諾菲公司 作為胜肽性雙重glp-1/昇糖素受體激動劑之艾塞那肽-4衍生物
JP2017525656A (ja) 2014-06-04 2017-09-07 ノヴォ ノルディスク アー/エス 医療用のglp−1/グルカゴン受容体コアゴニスト
CN105832691B (zh) * 2016-05-31 2018-10-02 深圳市健元医药科技有限公司 一种度拉糖肽结肠定位缓释制剂及其制备方法

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014533656A (ja) * 2011-11-30 2014-12-15 武田薬品工業株式会社 有核錠
JP2016500682A (ja) * 2012-10-17 2016-01-14 ノヴォ ノルディスク アー/エス 経口ペプチドデリバリーのための脂肪酸アシル化アミノ酸
JP2018505172A (ja) * 2015-01-29 2018-02-22 ノヴォ ノルディスク アー/エス Glp−1アゴニスト及び腸溶コーティングを含む錠剤
US20200237875A1 (en) * 2019-01-30 2020-07-30 Synlev Pharmaceuticals Corporation Formulations and methods for treatment of fibromyalgia and related myofascial pain disorders

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
AAPS PHARMASCI, vol. 3, no. 2, JPN6025041297, 2001, pages 14, ISSN: 0005920712 *
INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 357, JPN6026032161, 2008, pages 219 - 227, ISSN: 0005920714 *
粉砕, JPN6025041299, 2006, pages 3 - 10, ISSN: 0005920713 *

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WO2022049310A1 (en) 2022-03-10
EP4210680A1 (en) 2023-07-19
US20240041983A1 (en) 2024-02-08

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