JP7530173B2 - 活性薬剤の経口投与のための製剤 - Google Patents

活性薬剤の経口投与のための製剤 Download PDF

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Publication number
JP7530173B2
JP7530173B2 JP2019508963A JP2019508963A JP7530173B2 JP 7530173 B2 JP7530173 B2 JP 7530173B2 JP 2019508963 A JP2019508963 A JP 2019508963A JP 2019508963 A JP2019508963 A JP 2019508963A JP 7530173 B2 JP7530173 B2 JP 7530173B2
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unit dosage
dosage forms
active agent
dosage form
therapeutically active
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JP2019524836A5 (enExample
JP2019524836A (ja
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グレゴリー バーシュテイン
アリエル ロスナー
フィリップ エム シュワルツ
ヒレル ガリッツァー
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エンテラ バイオ エルティーディー．
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Publication of JP2019524836A5 publication Critical patent/JP2019524836A5/ja
Priority to JP2022099609A priority Critical patent/JP7546622B2/ja
Priority to JP2024016436A priority patent/JP7736834B2/ja
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Priority to JP2025076671A priority patent/JP2025114692A/ja
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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
    • A61K9/2004—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
    • 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
    • A61K38/29—Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
    • 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
    • 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
    • A61K9/20—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
    • A61K9/2095—Tabletting processes
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Endocrinology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2019508963A 2016-08-17 2017-08-17 活性薬剤の経口投与のための製剤 Active JP7530173B2 (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2022099609A JP7546622B2 (ja) 2016-08-17 2022-06-21 活性薬剤の経口投与のための製剤
JP2024016436A JP7736834B2 (ja) 2016-08-17 2024-02-06 活性薬剤の経口投与のための製剤
JP2025076671A JP2025114692A (ja) 2016-08-17 2025-05-02 活性薬剤の経口投与のための製剤

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662375989P 2016-08-17 2016-08-17
US62/375,989 2016-08-17
PCT/IL2017/050920 WO2018033927A1 (en) 2016-08-17 2017-08-17 Formulations for oral administration of active agents

Related Child Applications (2)

Application Number Title Priority Date Filing Date
JP2022099609A Division JP7546622B2 (ja) 2016-08-17 2022-06-21 活性薬剤の経口投与のための製剤
JP2024016436A Division JP7736834B2 (ja) 2016-08-17 2024-02-06 活性薬剤の経口投与のための製剤

Publications (3)

Publication Number Publication Date
JP2019524836A JP2019524836A (ja) 2019-09-05
JP2019524836A5 JP2019524836A5 (enExample) 2020-09-17
JP7530173B2 true JP7530173B2 (ja) 2024-08-07

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Family Applications (4)

Application Number Title Priority Date Filing Date
JP2019508963A Active JP7530173B2 (ja) 2016-08-17 2017-08-17 活性薬剤の経口投与のための製剤
JP2022099609A Active JP7546622B2 (ja) 2016-08-17 2022-06-21 活性薬剤の経口投与のための製剤
JP2024016436A Active JP7736834B2 (ja) 2016-08-17 2024-02-06 活性薬剤の経口投与のための製剤
JP2025076671A Pending JP2025114692A (ja) 2016-08-17 2025-05-02 活性薬剤の経口投与のための製剤

Family Applications After (3)

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JP2022099609A Active JP7546622B2 (ja) 2016-08-17 2022-06-21 活性薬剤の経口投与のための製剤
JP2024016436A Active JP7736834B2 (ja) 2016-08-17 2024-02-06 活性薬剤の経口投与のための製剤
JP2025076671A Pending JP2025114692A (ja) 2016-08-17 2025-05-02 活性薬剤の経口投与のための製剤

Country Status (14)

Country Link
US (2) US12239691B2 (enExample)
EP (1) EP3500291A4 (enExample)
JP (4) JP7530173B2 (enExample)
KR (4) KR20230088854A (enExample)
CN (4) CN109862906A (enExample)
AU (2) AU2017311698B2 (enExample)
BR (1) BR112019003136A2 (enExample)
CA (1) CA3033259A1 (enExample)
IL (3) IL312218B2 (enExample)
MX (1) MX2019001850A (enExample)
NZ (1) NZ751668A (enExample)
SG (1) SG11201901070YA (enExample)
WO (1) WO2018033927A1 (enExample)
ZA (1) ZA201901370B (enExample)

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WO2016128972A1 (en) * 2015-02-09 2016-08-18 Entera Bio Ltd. Formulations for oral administration of active agents with controlled absorption profile
MX2019001850A (es) * 2016-08-17 2019-05-15 Entera Bio Ltd Formulaciones para administracion oral de principios activos.
US12303487B2 (en) * 2018-11-19 2025-05-20 Spoke Sciences, Inc. N-acylated fatty amino acids to reduce absorption variability in cannabinoid based compositions
CN115209910A (zh) * 2020-03-18 2022-10-18 四川海思科制药有限公司 口服药物组合物
AU2023226092A1 (en) * 2022-02-24 2024-10-03 Entera Bio Ltd. Formulations comprising acid-neutralizing polymer for oral administration of parathyroid hormone
WO2023161936A1 (en) * 2022-02-24 2023-08-31 Entera Bio Ltd. Formulations comprising acid-neutralizing polymer for oral administration of growth hormone-releasing hormone
KR20240152915A (ko) * 2022-02-24 2024-10-22 엔테라 바이오 리미티드 활성제의 경구 투여를 위한 산 중화 중합체를 포함하는 제형
WO2025046589A1 (en) * 2023-08-30 2025-03-06 Entera Bio Ltd. Formulations comprising a combination of acid-neutralizing polymeric and non-polymeric substances for oral administration of active agents

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ＬＯＰＥＳ，Ｃ．Ｍ．ｅｔ ａｌ．，Ｉｎｔ Ｊ Ｐｈａｍ，Ｖｏｌ．５１０，ｐｐ．１４４－１５８
Ｍｕｌｔｉｐｌｅ Ｕｎｉｔ Ｔａｂｌｅｔｓ，Ｐｈａｒｍａ Ｔｉｐｓ，２０１１年，ｐｐ．１－５，Ｒｅｔｒｉｅｖｅｄ ｆｒｏｍ ｔｈｅ Ｉｎｔｅｒｎｅｔ：＜ｈｔｔｐ：／／ｗｗｗ．ｐｈａｒｍａｔｉｐｓ．ｉｎ／Ａｒｔｉｃｌｅｓ／Ｐｈａｒｍａｃｅｕｔｉｃｓ／Ｔａｂｌｅｔ／Ｍｕｌｔｉｐｌｅ－Ｕｎｉｔ－Ｔａｂｌｅｔｓ．ａｓｐｘ＞
ＳＡＮＤＢＥＲＧ，Ａ．ｅｔ ａｌ．，Ｐｈａｒｍ Ｒｅｓ，Ｖｏｌ．１０，Ｎｏ．１，ｐｐ．２８－３４
杉原正久、「経口製剤投与後の薬物血中濃度の変動要因の解析に関する研究」、２０１６年３月、岡山大学大学院 医歯薬学総合研究科 博士後期課程創薬生命科学専攻 博士論文
矢野正生、「インスリン測定について」、ＣＤＥＪ Ｎｅｗｓ Ｌｅｔｔｅｒ 第３０号、２０１１年４月

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