JP7744908B2 - ミロガバリンベシル酸塩を含有する口腔内崩壊錠 - Google Patents

ミロガバリンベシル酸塩を含有する口腔内崩壊錠

Info

Publication number
JP7744908B2
JP7744908B2 JP2022540284A JP2022540284A JP7744908B2 JP 7744908 B2 JP7744908 B2 JP 7744908B2 JP 2022540284 A JP2022540284 A JP 2022540284A JP 2022540284 A JP2022540284 A JP 2022540284A JP 7744908 B2 JP7744908 B2 JP 7744908B2
Authority
JP
Japan
Prior art keywords
orally disintegrating
disintegrating tablet
weight
mirogabalin
besylate
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
JP2022540284A
Other languages
English (en)
Japanese (ja)
Other versions
JPWO2022024979A1 (https=
Inventor
眞治 吉永
俊之 中橋
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Daiichi Sankyo Co Ltd
Original Assignee
Daiichi Sankyo Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
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Publication of JPWO2022024979A1 publication Critical patent/JPWO2022024979A1/ja
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Publication of JP7744908B2 publication Critical patent/JP7744908B2/ja
Active legal-status Critical Current
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Classifications

    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biochemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2022540284A 2020-07-27 2021-07-26 ミロガバリンベシル酸塩を含有する口腔内崩壊錠 Active JP7744908B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2020126311 2020-07-27
JP2020126311 2020-07-27
PCT/JP2021/027505 WO2022024979A1 (ja) 2020-07-27 2021-07-26 ミロガバリンベシル酸塩を含有する口腔内崩壊錠

Publications (2)

Publication Number Publication Date
JPWO2022024979A1 JPWO2022024979A1 (https=) 2022-02-03
JP7744908B2 true JP7744908B2 (ja) 2025-09-26

Family

ID=80036359

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2022540284A Active JP7744908B2 (ja) 2020-07-27 2021-07-26 ミロガバリンベシル酸塩を含有する口腔内崩壊錠

Country Status (6)

Country Link
JP (1) JP7744908B2 (https=)
KR (1) KR20230044355A (https=)
CN (1) CN115803020A (https=)
BR (1) BR112023000403A2 (https=)
TW (1) TWI883230B (https=)
WO (1) WO2022024979A1 (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPWO2024248079A1 (https=) * 2023-06-02 2024-12-05
CN116966158B (zh) * 2023-08-14 2025-10-21 四川制药制剂有限公司 一种富马酸丙酚替诺福韦片的制备方法
CN118948808B (zh) * 2024-08-07 2025-11-25 山东大学 一种苯磺酸米洛巴林口溶膜剂及其制备方法
CN120437109B (zh) * 2025-07-09 2025-09-26 湖南一格制药有限公司 一种稳定性优异的苯磺酸美洛加巴林制剂组合物
CN121221543A (zh) * 2025-11-26 2025-12-30 华润双鹤利民药业（济南）有限公司 一种苯磺酸美洛加巴林口崩片制剂及其制备方法

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009102038A1 (ja) 2008-02-13 2009-08-20 Dainippon Sumitomo Pharma Co., Ltd. 口腔内崩壊錠
WO2013161823A1 (ja) 2012-04-24 2013-10-31 第一三共株式会社 口腔内崩壊錠及びその製造方法
WO2014163132A1 (ja) 2013-04-04 2014-10-09 第一三共株式会社 アミノカルボン酸の塩の固形組成物
WO2018101373A1 (ja) 2016-12-01 2018-06-07 第一三共株式会社 ジアミン誘導体を含む口腔内崩壊錠
JP2019034935A (ja) 2017-08-17 2019-03-07 第一三共株式会社 プラスグレルを含む口腔内崩壊錠
WO2020027019A1 (ja) 2018-07-30 2020-02-06 第一三共株式会社 安定化剤を含有する医薬品の固形製剤

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003034655A (ja) * 2001-05-15 2003-02-07 Takeda Chem Ind Ltd 速崩壊性固形製剤
US7390503B1 (en) * 2003-08-22 2008-06-24 Barr Laboratories, Inc. Ondansetron orally disintegrating tablets
US8486450B2 (en) * 2005-12-28 2013-07-16 Takeda Pharmaceutical Company Limited Method of producing solid preparation disintegrating in the oral cavity
JP5295506B2 (ja) * 2006-02-21 2013-09-18 第一三共株式会社 レボフロキサシン含有錠剤
JP5308042B2 (ja) * 2008-03-11 2013-10-09 新田ゼラチン株式会社 マンゴー抽出物
JP5031054B2 (ja) * 2010-03-18 2012-09-19 信越化学工業株式会社 低置換度ヒドロキシプロピルセルロース及びこれを含む固形製剤
BR112017019920B1 (pt) 2015-03-19 2023-11-07 Daiichi Sankyo Company, Limited Preparação sólida farmacêutica, e, método para estabilização de uma preparação sólida farmacêutica
BR112017019918B1 (pt) 2015-03-19 2023-11-07 Daiichi Sankyo Company, Limited Preparação sólida farmacêutica, e, método para produzir uma preparação sólida farmacêutica para estabilizar uma preparação sólida farmacêutica
JP7182356B2 (ja) * 2017-07-05 2022-12-02 日本ケミファ株式会社 口腔内崩壊錠及びその製造方法
JPWO2019021957A1 (ja) * 2017-07-25 2020-07-09 第一三共株式会社 点鼻用乾燥粉末医薬組成物
CN110742868A (zh) * 2019-11-20 2020-02-04 合肥拓锐生物科技有限公司 一种Mirogabalin Besilate口腔崩解片

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009102038A1 (ja) 2008-02-13 2009-08-20 Dainippon Sumitomo Pharma Co., Ltd. 口腔内崩壊錠
WO2013161823A1 (ja) 2012-04-24 2013-10-31 第一三共株式会社 口腔内崩壊錠及びその製造方法
WO2014163132A1 (ja) 2013-04-04 2014-10-09 第一三共株式会社 アミノカルボン酸の塩の固形組成物
WO2018101373A1 (ja) 2016-12-01 2018-06-07 第一三共株式会社 ジアミン誘導体を含む口腔内崩壊錠
JP2019034935A (ja) 2017-08-17 2019-03-07 第一三共株式会社 プラスグレルを含む口腔内崩壊錠
WO2020027019A1 (ja) 2018-07-30 2020-02-06 第一三共株式会社 安定化剤を含有する医薬品の固形製剤

Also Published As

Publication number Publication date
KR20230044355A (ko) 2023-04-04
JPWO2022024979A1 (https=) 2022-02-03
TWI883230B (zh) 2025-05-11
WO2022024979A1 (ja) 2022-02-03
BR112023000403A2 (pt) 2023-02-07
CN115803020A (zh) 2023-03-14
TW202220643A (zh) 2022-06-01

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