JP7404381B2 - Tbn、又はその塩もしくは水和物を含む薬物組成物及びその製造方法 - Google Patents

Tbn、又はその塩もしくは水和物を含む薬物組成物及びその製造方法 Download PDF

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JP7404381B2
JP7404381B2 JP2021550131A JP2021550131A JP7404381B2 JP 7404381 B2 JP7404381 B2 JP 7404381B2 JP 2021550131 A JP2021550131 A JP 2021550131A JP 2021550131 A JP2021550131 A JP 2021550131A JP 7404381 B2 JP7404381 B2 JP 7404381B2
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tbn
weight ratio
enteric
layer
composition according
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JP2022522005A5 (enExample
JP2022522005A (ja
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ウェイ リウ
イェウェイ スン
ユーチァン ワン
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Guangzhou Magpie Pharmaceuticals Co Ltd
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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
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4965—Non-condensed pyrazines
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
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    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
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    • 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
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    • 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
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    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A—HUMAN NECESSITIES
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    • A61K9/2806—Coating materials
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
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    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
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    • A—HUMAN NECESSITIES
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    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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  • Animal Behavior & Ethology (AREA)
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  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Psychology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Immunology (AREA)
  • Psychiatry (AREA)
  • Urology & Nephrology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Hospice & Palliative Care (AREA)
  • Pain & Pain Management (AREA)
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  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2021550131A 2019-02-27 2019-07-31 Tbn、又はその塩もしくは水和物を含む薬物組成物及びその製造方法 Active JP7404381B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201910143739.0A CN111617047B (zh) 2019-02-27 2019-02-27 一种含tbn或其盐或其水合物的药物组合物及其制备方法
CN201910143739.0 2019-02-27
PCT/CN2019/098709 WO2020173046A1 (zh) 2019-02-27 2019-07-31 一种含tbn或其盐或其水合物的药物组合物及其制备方法

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JP2022522005A JP2022522005A (ja) 2022-04-13
JP2022522005A5 JP2022522005A5 (enExample) 2023-10-10
JP7404381B2 true JP7404381B2 (ja) 2023-12-25

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US (1) US20220168299A1 (enExample)
EP (1) EP3932407B1 (enExample)
JP (1) JP7404381B2 (enExample)
CN (1) CN111617047B (enExample)
AU (1) AU2019431238B2 (enExample)
CA (1) CA3131558A1 (enExample)
IL (1) IL285865A (enExample)
WO (1) WO2020173046A1 (enExample)

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Publication number Priority date Publication date Assignee Title
CN109893511B (zh) * 2017-12-11 2022-07-12 湖北舒邦药业有限公司 一种地红霉素肠溶片肠溶包衣、其制备方法以及一种地红霉素肠溶片
CN111763178B (zh) * 2019-04-01 2023-02-03 广州喜鹊医药有限公司 硝酮嗪晶型、制备方法及应用
CN112516100A (zh) * 2020-12-31 2021-03-19 珠海润都制药股份有限公司 一种艾司奥美拉唑镁肠溶片及其制备方法
CN116650411A (zh) * 2022-02-25 2023-08-29 广州喜鹊医药有限公司 一种注射用硝酮嗪药物组合物及其制备方法

Citations (1)

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Publication number Priority date Publication date Assignee Title
JP2011518789A (ja) 2008-04-25 2011-06-30 曁南大学 ニトロン化合物、その製造方法およびその医薬用途

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CN1683345A (zh) * 2005-02-28 2005-10-19 杨喜鸿 川芎嗪的协同增效药用酸盐及其制备方法
CN101269049B (zh) * 2008-04-25 2012-01-25 广东药学院 磷酸川芎嗪微孔渗透泵控释片及其制备方法
CN101987081B (zh) * 2010-07-16 2012-08-08 钟术光 一种控释制剂
SI2659881T1 (en) * 2012-04-30 2018-03-30 Tillotts Pharma Ag Formulation of the delayed release medicinal product
CN104922086B (zh) * 2015-06-21 2018-01-16 珠海润都制药股份有限公司 一种质子泵抑制剂肠溶片的制备方法
CN105963298B (zh) * 2016-05-06 2019-07-09 广州喜鹊医药有限公司 川芎嗪衍生物硝酮嗪在预防和治疗脑损伤疾病中的应用
CN108653236B (zh) * 2017-03-31 2025-03-25 上海惠永药物研究有限公司 一种生物膜包载药物纳米晶体的制备方法及其用途
CN107417631A (zh) * 2017-08-04 2017-12-01 广州喜鹊医药有限公司 一种氘代硝酮嗪化合物及其制备方法和在制药中的应用
CN108815128B (zh) * 2018-05-25 2022-01-07 广东药科大学 一种磷酸-川芎嗪微孔渗透泵控释片的制备方法

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
JP2011518789A (ja) 2008-04-25 2011-06-30 曁南大学 ニトロン化合物、その製造方法およびその医薬用途

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
Eur J Drug Metab Pharmacokinet,2011年,Vol.36,pp.95-101
樋口商会 医薬事業 製品一覧(医薬品添加剤)のページ(抜粋),<URL:https://www.higuchi-inc.co.jp/business-products/pharmaceuticals/excipient/>,[検索日 2023. 03. 27]

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CA3131558A1 (en) 2020-09-03
US20220168299A1 (en) 2022-06-02
JP2022522005A (ja) 2022-04-13
CN111617047A (zh) 2020-09-04
CN111617047B (zh) 2021-06-22
IL285865A (en) 2021-10-31
WO2020173046A1 (zh) 2020-09-03
EP3932407A4 (en) 2022-06-29
AU2019431238A1 (en) 2021-10-28
AU2019431238B2 (en) 2023-09-28
EP3932407C0 (en) 2023-10-18
EP3932407B1 (en) 2023-10-18
EP3932407A1 (en) 2022-01-05

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