JP6737793B2 - 錠剤コアとポリビニルアルコールコーティングとを含む経口インスリン投与のための医薬組成物 - Google Patents

錠剤コアとポリビニルアルコールコーティングとを含む経口インスリン投与のための医薬組成物 Download PDF

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Publication number
JP6737793B2
JP6737793B2 JP2017540129A JP2017540129A JP6737793B2 JP 6737793 B2 JP6737793 B2 JP 6737793B2 JP 2017540129 A JP2017540129 A JP 2017540129A JP 2017540129 A JP2017540129 A JP 2017540129A JP 6737793 B2 JP6737793 B2 JP 6737793B2
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Prior art keywords
human insulin
desb30 human
γglu
oeg
insulin
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Japanese (ja)
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JP2018508491A (ja
JP2018508491A5 (https=
Inventor
ラース・ホヴゴー
ハネ・ラフスゴー
トマス・ボーグラム・ケルスン
ペータ・マセン
ジュスティーノ・ディ・プレトーロ
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Novo Nordisk AS
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Novo Nordisk AS
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5089Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
JP2017540129A 2015-01-29 2015-01-29 錠剤コアとポリビニルアルコールコーティングとを含む経口インスリン投与のための医薬組成物 Expired - Fee Related JP6737793B2 (ja)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2015/051813 WO2016119854A1 (en) 2015-01-29 2015-01-29 Pharmaceutical composition for oral insulin administration comprising a tablet core and a polyvinyl alcohol coating

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2020082000A Division JP2020117542A (ja) 2020-05-07 2020-05-07 錠剤コアとポリビニルアルコールコーティングとを含む経口インスリン投与のための医薬組成物

Publications (3)

Publication Number Publication Date
JP2018508491A JP2018508491A (ja) 2018-03-29
JP2018508491A5 JP2018508491A5 (https=) 2019-10-03
JP6737793B2 true JP6737793B2 (ja) 2020-08-12

Family

ID=52462305

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2017540129A Expired - Fee Related JP6737793B2 (ja) 2015-01-29 2015-01-29 錠剤コアとポリビニルアルコールコーティングとを含む経口インスリン投与のための医薬組成物

Country Status (5)

Country Link
US (1) US20180000742A1 (https=)
EP (1) EP3250225A1 (https=)
JP (1) JP6737793B2 (https=)
CN (1) CN107206059A (https=)
WO (1) WO2016119854A1 (https=)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10919949B2 (en) 2017-08-17 2021-02-16 Novo Nordisk A/S Acylated insulin analogues and uses thereof
KR20210102347A (ko) 2018-12-11 2021-08-19 사노피 인슐린 수용체 결합 친화성이 감소된 인슐린 유사체
WO2021029467A1 (en) * 2019-08-14 2021-02-18 Sam Chun Dang Pharm. Co., Ltd. A solid dosage form for orally administration
CN118754967A (zh) * 2019-12-30 2024-10-11 甘李药业股份有限公司 胰岛素衍生物
WO2023012263A1 (en) 2021-08-04 2023-02-09 Novo Nordisk A/S Solid oral peptide formulations
JP2025508982A (ja) 2022-03-03 2025-04-10 サイプルメド ゲーエムベーハー 治療用ペプチドおよびタンパク質の改善された経口医薬製剤
TW202421645A (zh) 2022-11-25 2024-06-01 丹麥商諾佛 儂迪克股份有限公司 如glp—1之肽治療劑的口服投與

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3935326A (en) * 1967-06-28 1976-01-27 Boehringer Mannheim G.M.B.H. Process for coating tablets with aqueous resin dispersions
GB9414045D0 (en) * 1994-07-12 1994-08-31 Berwind Pharma Service Moisture barrier film coating composition, method, and coated form
SI21402A (sl) * 2003-02-12 2004-08-31 LEK farmacevtska dru�ba d.d. Obloženi delci in farmacevtske oblike
AU2004264958B2 (en) * 2003-08-13 2010-04-15 Biocon, Ltd Micro-particle fatty acid salt solid dosage formulations for therapeutic agents
AR049142A1 (es) * 2004-06-07 2006-06-28 Wyeth Corp Composiciones para recubrimientos de azucar,composiciones recubiertas y metodos para la fabricacion de los mismos
RU2527893C2 (ru) * 2004-07-19 2014-09-10 Биокон Лимитед Инсулин-олигомерные конъюгаты, их препараты и применения
BRPI0710503A2 (pt) * 2006-04-07 2011-08-16 Merrion Res Iii Ltd uso de uma composição farmacêutica, composição farmacêutica, e, forma de dosagem oral
RU2524150C2 (ru) * 2006-09-22 2014-07-27 Ново Нордиск А/С Аналоги инсулина, устойчивые к протеазам
RU2453332C2 (ru) * 2007-10-16 2012-06-20 Байокон Лимитид Твердая фармацевтическая композиция (варианты) и способ контроля концентрации глюкозы с ее помощью, способ получения твердой фармацевтической композиции (варианты), таблетка (варианты) и способ получения амфорных частиц
HUE032284T2 (en) * 2008-03-18 2017-09-28 Novo Nordisk As Protease-stabilized, acylated insulin analogues
AU2010339907A1 (en) * 2009-12-16 2012-07-05 Nod Pharmaceuticals, Inc. Compositions and methods for oral drug delivery
CN102335431B (zh) * 2010-07-14 2015-08-26 上海蓝心医药科技有限公司 一种给药组合物及其制备和使用方法
US20110142889A1 (en) * 2009-12-16 2011-06-16 Nod Pharmaceuticals, Inc. Compositions and methods for oral drug delivery
KR20130036290A (ko) * 2010-06-23 2013-04-11 노보 노르디스크 에이/에스 추가 이황화 결합을 함유하는 인슐린 유도체
US20140357838A1 (en) * 2011-12-21 2014-12-04 Novo Nordisk A/S N-Terminally Modified Insulin Derivatives
JP2016524617A (ja) * 2013-05-30 2016-08-18 ノヴォ ノルディスク アー/エス 糖尿病の治療のための新規な経口医薬組成物

Also Published As

Publication number Publication date
US20180000742A1 (en) 2018-01-04
JP2018508491A (ja) 2018-03-29
CN107206059A (zh) 2017-09-26
WO2016119854A1 (en) 2016-08-04
EP3250225A1 (en) 2017-12-06

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