CN115803020A - 含有苯磺酸米洛巴林的口腔崩解片剂 - Google Patents

含有苯磺酸米洛巴林的口腔崩解片剂 Download PDF

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Publication number
CN115803020A
CN115803020A CN202180049600.5A CN202180049600A CN115803020A CN 115803020 A CN115803020 A CN 115803020A CN 202180049600 A CN202180049600 A CN 202180049600A CN 115803020 A CN115803020 A CN 115803020A
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China
Prior art keywords
orally disintegrating
disintegrating tablet
weight
besylate
granules
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Pending
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CN202180049600.5A
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English (en)
Chinese (zh)
Inventor
吉永真治
中桥俊之
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Daiichi Sankyo Co Ltd
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Daiichi Sankyo Co Ltd
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Publication of CN115803020A publication Critical patent/CN115803020A/zh
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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
    • A61K9/2072—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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (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)
CN202180049600.5A 2020-07-27 2021-07-26 含有苯磺酸米洛巴林的口腔崩解片剂 Pending CN115803020A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2020-126311 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 (1)

Publication Number Publication Date
CN115803020A true CN115803020A (zh) 2023-03-14

Family

ID=80036359

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CN202180049600.5A Pending CN115803020A (zh) 2020-07-27 2021-07-26 含有苯磺酸米洛巴林的口腔崩解片剂

Country Status (6)

Country Link
JP (1) JPWO2022024979A1 (enrdf_load_stackoverflow)
KR (1) KR20230044355A (enrdf_load_stackoverflow)
CN (1) CN115803020A (enrdf_load_stackoverflow)
BR (1) BR112023000403A2 (enrdf_load_stackoverflow)
TW (1) TWI883230B (enrdf_load_stackoverflow)
WO (1) WO2022024979A1 (enrdf_load_stackoverflow)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024248079A1 (ja) * 2023-06-02 2024-12-05 第一三共株式会社 ミロガバリンを含有する医薬組成物
CN116966158A (zh) * 2023-08-14 2023-10-31 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

Citations (12)

* 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
US20090148524A1 (en) * 2005-12-28 2009-06-11 Shigehiro Higuchi Method of producing solid preparation disintegrating in the oral cavity
JP2009215235A (ja) * 2008-03-11 2009-09-24 Nitta Gelatin Inc マンゴー抽出物
CN102006861A (zh) * 2008-02-13 2011-04-06 大日本住友制药株式会社 口腔崩解片
CN102190736A (zh) * 2010-03-18 2011-09-21 信越化学工业株式会社 低取代羟丙基纤维素以及包含低取代羟丙基纤维素的固体制剂
CN104244930A (zh) * 2012-04-24 2014-12-24 第一三共株式会社 口腔崩解片及其制造方法
CN104334169A (zh) * 2013-04-04 2015-02-04 第一三共株式会社 包含氨基羧酸盐的固体组合物
JP2019014666A (ja) * 2017-07-05 2019-01-31 日本ケミファ株式会社 口腔内崩壊錠及びその製造方法
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
CN109996542A (zh) * 2016-12-01 2019-07-09 第一三共株式会社 包含二胺衍生物的口腔崩解片
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 (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
JP6630343B2 (ja) 2015-03-19 2020-01-15 第一三共株式会社 抗酸化剤を含有する固形製剤
BR112017019920B1 (pt) 2015-03-19 2023-11-07 Daiichi Sankyo Company, Limited Preparação sólida farmacêutica, e, método para estabilização de uma preparação sólida farmacêutica
WO2019021957A1 (ja) * 2017-07-25 2019-01-31 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 (13)

* 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
US20090148524A1 (en) * 2005-12-28 2009-06-11 Shigehiro Higuchi Method of producing solid preparation disintegrating in the oral cavity
CN102006861A (zh) * 2008-02-13 2011-04-06 大日本住友制药株式会社 口腔崩解片
JP2009215235A (ja) * 2008-03-11 2009-09-24 Nitta Gelatin Inc マンゴー抽出物
CN102190736A (zh) * 2010-03-18 2011-09-21 信越化学工业株式会社 低取代羟丙基纤维素以及包含低取代羟丙基纤维素的固体制剂
CN104244930A (zh) * 2012-04-24 2014-12-24 第一三共株式会社 口腔崩解片及其制造方法
CN106913553A (zh) * 2012-04-24 2017-07-04 第三共株式会社 口腔崩解片及其制造方法
CN104334169A (zh) * 2013-04-04 2015-02-04 第一三共株式会社 包含氨基羧酸盐的固体组合物
CN109996542A (zh) * 2016-12-01 2019-07-09 第一三共株式会社 包含二胺衍生物的口腔崩解片
JP2019014666A (ja) * 2017-07-05 2019-01-31 日本ケミファ株式会社 口腔内崩壊錠及びその製造方法
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

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
张俊杰;王伟;李晨;周四元;张邦乐;: "口腔崩解片制剂新技术及其研究进展", 中国新药杂志, no. 07, 15 April 2020 (2020-04-15), pages 22 - 27 *
金云隆;冯松浩;张铁军;白明学;: "中药口腔崩解片的研究进展", 中草药, no. 22, 28 November 2018 (2018-11-28), pages 231 - 237 *

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TW202220643A (zh) 2022-06-01
JPWO2022024979A1 (enrdf_load_stackoverflow) 2022-02-03
TWI883230B (zh) 2025-05-11
KR20230044355A (ko) 2023-04-04
BR112023000403A2 (pt) 2023-02-07
WO2022024979A1 (ja) 2022-02-03

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