JP6888091B2 - スルホニル尿素系薬の医薬組成物及びその調製方法 - Google Patents

スルホニル尿素系薬の医薬組成物及びその調製方法 Download PDF

Info

Publication number
JP6888091B2
JP6888091B2 JP2019532920A JP2019532920A JP6888091B2 JP 6888091 B2 JP6888091 B2 JP 6888091B2 JP 2019532920 A JP2019532920 A JP 2019532920A JP 2019532920 A JP2019532920 A JP 2019532920A JP 6888091 B2 JP6888091 B2 JP 6888091B2
Authority
JP
Japan
Prior art keywords
cyclodextrin
concentration
pharmaceutical composition
composition according
additive
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
JP2019532920A
Other languages
English (en)
Japanese (ja)
Other versions
JP2020511417A (ja
JP2020511417A5 (https=
Inventor
ウー チョン
ウー チョン
チュンション カオ
チュンション カオ
ウェイ コン
ウェイ コン
ソン リー
ソン リー
ホンユイ チェン
ホンユイ チェン
Original Assignee
チアンスー アオサイカン ファーマシューティカル カンパニー，リミティド
チアンスー アオサイカン ファーマシューティカル カンパニー，リミティド
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
Publication date
Application filed by チアンスー アオサイカン ファーマシューティカル カンパニー，リミティド, チアンスー アオサイカン ファーマシューティカル カンパニー，リミティド filed Critical チアンスー アオサイカン ファーマシューティカル カンパニー，リミティド
Publication of JP2020511417A publication Critical patent/JP2020511417A/ja
Publication of JP2020511417A5 publication Critical patent/JP2020511417A5/ja
Application granted granted Critical
Publication of JP6888091B2 publication Critical patent/JP6888091B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • 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
    • A61K47/26—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
    • A61K47/40—Cyclodextrins; Derivatives 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0006—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
    • C08B37/0009—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid alpha-D-Glucans, e.g. polydextrose, alternan, glycogen; (alpha-1,4)(alpha-1,6)-D-Glucans; (alpha-1,3)(alpha-1,4)-D-Glucans, e.g. isolichenan or nigeran; (alpha-1,4)-D-Glucans; (alpha-1,3)-D-Glucans, e.g. pseudonigeran; Derivatives thereof
    • C08B37/0012—Cyclodextrin [CD], e.g. cycle with 6 units (alpha), with 7 units (beta) and with 8 units (gamma), large-ring cyclodextrin or cycloamylose with 9 units or more; Derivatives thereof
    • C08B37/0015—Inclusion compounds, i.e. host-guest compounds, e.g. polyrotaxanes
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Obesity (AREA)
  • Dermatology (AREA)
  • Materials Engineering (AREA)
  • Polymers & Plastics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2019532920A 2016-12-14 2017-12-13 スルホニル尿素系薬の医薬組成物及びその調製方法 Active JP6888091B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201611149802.4A CN108210501B (zh) 2016-12-14 2016-12-14 一种磺酰脲类药物的注射用药物组合物及其制备方法
CN201611149802.4 2016-12-14
PCT/CN2017/115993 WO2018108111A1 (zh) 2016-12-14 2017-12-13 一种磺酰脲类药物的药物组合物及其制备方法

Publications (3)

Publication Number Publication Date
JP2020511417A JP2020511417A (ja) 2020-04-16
JP2020511417A5 JP2020511417A5 (https=) 2021-02-25
JP6888091B2 true JP6888091B2 (ja) 2021-06-16

Family

ID=62558059

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2019532920A Active JP6888091B2 (ja) 2016-12-14 2017-12-13 スルホニル尿素系薬の医薬組成物及びその調製方法

Country Status (5)

Country Link
US (1) US10966993B2 (https=)
EP (1) EP3556371B1 (https=)
JP (1) JP6888091B2 (https=)
CN (2) CN108210501B (https=)
WO (1) WO2018108111A1 (https=)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108553428A (zh) * 2018-05-29 2018-09-21 昆药集团股份有限公司 格列本脲制剂及其制备方法
CN109432031A (zh) * 2018-12-24 2019-03-08 扬子江药业集团广州海瑞药业有限公司 一种格列美脲片剂及其制备方法
CN111759323B (zh) * 2020-07-08 2021-06-29 刘明明 一种多模块微循环功能测评装置及基于其的生物组织微循环可视化方法
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans
CN116648251A (zh) * 2020-11-16 2023-08-25 江苏先声药业有限公司 一种格列本脲的经鼻给药的药物组合物
WO2022103638A1 (en) 2020-11-16 2022-05-19 Orcosa Inc. Cannabinoids in the treatment of autism spectrum disorder
CN114642673A (zh) * 2020-12-21 2022-06-21 江苏奥赛康药业有限公司 格列本脲组合物在制备治疗脑含水量升高药物中的应用
CN114642671A (zh) * 2020-12-21 2022-06-21 江苏奥赛康药业有限公司 格列本脲组合物在制备治疗脊髓出血药物中的应用
CN114642672A (zh) * 2020-12-21 2022-06-21 江苏奥赛康药业有限公司 格列本脲组合物在制备治疗脊髓神经元减少药物中的应用
CN114642674A (zh) * 2020-12-21 2022-06-21 江苏奥赛康药业有限公司 格列本脲组合物在制备治疗神经细胞凋亡药物中的应用
JP2024512310A (ja) * 2021-03-04 2024-03-19 バイオジェン チェサピーク エルエルシー 低吸着グリブリド製剤および方法
CN113413389B (zh) * 2021-07-19 2024-03-15 成都赜灵生物医药科技有限公司 一种组蛋白去乙酰化酶抑制剂的制剂及其制备方法和用途
EP4486304A1 (en) * 2022-03-03 2025-01-08 Remedy Pharmaceuticals, Inc. Low-sorbing glyburide kit, formulation and methods

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1269578B (it) 1994-04-22 1997-04-08 Chiesi Farma Spa Complessi di inclusione multicomponente ad elevata solubilita' costituiti da un farmaco di tipo acido, una ciclodestrina e una base.
US6555139B2 (en) * 1999-06-28 2003-04-29 Wockhardt Europe Limited Preparation of micron-size pharmaceutical particles by microfluidization
US6464988B1 (en) * 2001-05-09 2002-10-15 Usv Limited Glipizide-cyclodextrin inclusion complexes and their pharmaceutical composition
GB0205253D0 (en) * 2002-03-06 2002-04-17 Univ Gent Immediate release pharmaceutical granule compositions and a continuous process for making them
US8980952B2 (en) * 2002-03-20 2015-03-17 University Of Maryland, Baltimore Methods for treating brain swelling with a compound that blocks a non-selective cation channel
US20030219482A1 (en) * 2002-03-21 2003-11-27 Chaudhari Sunil Sudhakar Multiparticulate compositions for once-a-day administration
JP2003321364A (ja) * 2002-05-07 2003-11-11 Eisai Co Ltd シクロデキストリンにより可溶化及び安定化された抗腫瘍剤含有組成物
DE10341414A1 (de) * 2003-09-05 2005-03-31 Boehringer Ingelheim Pharma Gmbh & Co. Kg Oral zu applizierende Darreichungsform für schwerlösliche saure und amphotere Wirkstoffe
CN1267488C (zh) * 2003-09-26 2006-08-02 清华大学 格列吡嗪－环糊精包合物的制备方法
WO2006038552A1 (ja) * 2004-10-01 2006-04-13 Eisai R & D Management Co., Ltd. 微粒子含有組成物およびその製造方法
CN101189003B (zh) * 2005-05-13 2012-02-08 托波塔吉特英国有限公司 Hdac抑制剂的药物制剂
CN1872231B (zh) * 2005-06-01 2011-10-05 天津天士力制药股份有限公司 一种治疗糖尿病的滴丸及其制备方法
CN1823755A (zh) * 2006-01-11 2006-08-30 宛六一 那格列奈软胶囊及其制备方法
PT2868315T (pt) 2007-12-04 2017-09-04 Remedy Pharmaceuticals Inc Formulações melhoradas e métodos para liofilização e liofilizados assim produzidos
US20110034560A1 (en) 2008-01-29 2011-02-10 Sven Jacobson Liquid formulations of compounds active at sulfonylurea receptors
CN101658487B (zh) * 2008-08-28 2011-10-05 北京天川军威医药技术开发有限公司 格列美脲水溶液给药系统及其制备方法
US20130131089A1 (en) 2010-04-30 2013-05-23 Portola Phamaceuticals Inc. Dosage forms of elinogrel and methods of injectable administration thereof
CN104644591A (zh) * 2013-11-25 2015-05-27 天津市汉康医药生物技术有限公司 一种沙格列汀药物组合物及其制备方法

Also Published As

Publication number Publication date
US10966993B2 (en) 2021-04-06
EP3556371B1 (en) 2024-06-12
CN111093674B (zh) 2023-03-28
WO2018108111A1 (zh) 2018-06-21
CN108210501A (zh) 2018-06-29
CN108210501B (zh) 2019-03-08
EP3556371A4 (en) 2020-08-12
EP3556371A1 (en) 2019-10-23
JP2020511417A (ja) 2020-04-16
EP3556371C0 (en) 2024-06-12
CN111093674A (zh) 2020-05-01
US20200022993A1 (en) 2020-01-23

Similar Documents

Publication Publication Date Title
JP6888091B2 (ja) スルホニル尿素系薬の医薬組成物及びその調製方法
KR100607391B1 (ko) 시클로덱스트린 및 탁소이드를 함유하는 약제학적 조성물
CN109906077B (zh) 依达拉奉与(+)-2-莰醇的舌下用药物组合物
ES3058386T3 (es) Composiciones farmacéuticas de furosemida
JP5413998B2 (ja) シクロデキストリンまたはその誘導体によるピノセンブリンの封入複合体
US11318115B2 (en) Oral pharmaceutical composition of Tecovirimat and preparation method thereof
JP2012167132A (ja) Ｎ−［ｏ−（ｐ−ピバロイルオキシベンゼンスルホニルアミノ）ベンゾイル］グリシン・モノナトリウム塩・４水和物の凍結乾燥製剤
US20150119440A1 (en) Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof
US20250170151A1 (en) Low-sorbing glyburide kit, formulation and methods
EP2968575B1 (en) Parenteral diclofenac composition
AU2017315757A1 (en) Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof
WO2007124668A1 (fr) Composition pharmaceutique comportant un concentré élevé de polydatine
CA3210407A1 (en) Low-sorbing glyburide formulation and methods
JP2006008684A (ja) ジクロフェナクナトリウムとβ−シクロデキストリンとを有する注入可能薬学組成物
CN101199530A (zh) 伊曲康唑纳米混悬剂冻干组合物及其制备和使用方法
EP3906020B1 (en) Pharmaceutical compositions of torsemide and their uses
WO2025113679A1 (zh) 药物组合物、制剂、美托拉宗冻干粉制剂及其制备方法与用途
ES3024636T3 (en) Parenteral formulation comprising siponimod
MX2014013556A (es) Formulacion parenteral de esmolol.
WO2023209731A1 (en) Injectable liquid or lyophilized powder dosage forms of selexipag and their method of preparation
CN101366701A (zh) N，n-二甲基甘氨酸-2，6-二异丙基苯酯盐类注射剂

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20190625

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20191223

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20201005

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20201013

A524 Written submission of copy of amendment under article 19 pct

Free format text: JAPANESE INTERMEDIATE CODE: A524

Effective date: 20210113

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20210511

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20210519

R150 Certificate of patent or registration of utility model

Ref document number: 6888091

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250