CN111574702A - 具有改善的储存稳定性的药物组合物及其制备方法 - Google Patents

具有改善的储存稳定性的药物组合物及其制备方法 Download PDF

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Publication number
CN111574702A
CN111574702A CN202010292397.1A CN202010292397A CN111574702A CN 111574702 A CN111574702 A CN 111574702A CN 202010292397 A CN202010292397 A CN 202010292397A CN 111574702 A CN111574702 A CN 111574702A
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China
Prior art keywords
pharmaceutical composition
paclitaxel
block copolymer
less
weight
Prior art date
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Pending
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CN202010292397.1A
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English (en)
Chinese (zh)
Inventor
金峰五
闵范赞
金志英
金寭林
徐敏孝
李思元
李一雄
赵重雄
崔仁子
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Sanyang Holding Co
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Samyang Biopharmaceuticals Corp
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Application filed by Samyang Biopharmaceuticals Corp filed Critical Samyang Biopharmaceuticals Corp
Publication of CN111574702A publication Critical patent/CN111574702A/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
    • A61K9/14—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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G63/00—Macromolecular compounds obtained by reactions forming a carboxylic ester link in the main chain of the macromolecule
    • C08G63/88—Post-polymerisation treatment
    • C08G63/90—Purification; Drying
    • 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
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • 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
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G63/00—Macromolecular compounds obtained by reactions forming a carboxylic ester link in the main chain of the macromolecule
    • C08G63/66—Polyesters containing oxygen in the form of ether groups
    • C08G63/664—Polyesters containing oxygen in the form of ether groups derived from hydroxy carboxylic acids
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G63/00—Macromolecular compounds obtained by reactions forming a carboxylic ester link in the main chain of the macromolecule
    • C08G63/78—Preparation processes
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G63/00—Macromolecular compounds obtained by reactions forming a carboxylic ester link in the main chain of the macromolecule
    • C08G63/78—Preparation processes
    • C08G63/82—Preparation processes characterised by the catalyst used
    • C08G63/823—Preparation processes characterised by the catalyst used for the preparation of polylactones or polylactides
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08G—MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G63/00—Macromolecular compounds obtained by reactions forming a carboxylic ester link in the main chain of the macromolecule
    • C08G63/78—Preparation processes
    • C08G63/82—Preparation processes characterised by the catalyst used
    • C08G63/85—Germanium, tin, lead, arsenic, antimony, bismuth, titanium, zirconium, hafnium, vanadium, niobium, tantalum, or compounds thereof

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CN202010292397.1A 2015-07-28 2016-07-28 具有改善的储存稳定性的药物组合物及其制备方法 Pending CN111574702A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR10-2015-0106626 2015-07-28
KR20150106626 2015-07-28
CN201680001936.3A CN106559983A (zh) 2015-07-28 2016-07-28 具有改善的储存稳定性的药物组合物及其制备方法

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN201680001936.3A Division CN106559983A (zh) 2015-07-28 2016-07-28 具有改善的储存稳定性的药物组合物及其制备方法

Publications (1)

Publication Number Publication Date
CN111574702A true CN111574702A (zh) 2020-08-25

Family

ID=57884841

Family Applications (2)

Application Number Title Priority Date Filing Date
CN202010292397.1A Pending CN111574702A (zh) 2015-07-28 2016-07-28 具有改善的储存稳定性的药物组合物及其制备方法
CN201680001936.3A Pending CN106559983A (zh) 2015-07-28 2016-07-28 具有改善的储存稳定性的药物组合物及其制备方法

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CN201680001936.3A Pending CN106559983A (zh) 2015-07-28 2016-07-28 具有改善的储存稳定性的药物组合物及其制备方法

Country Status (13)

Country Link
EP (1) EP3328434A4 (ja)
JP (1) JP6605706B2 (ja)
KR (1) KR101748191B1 (ja)
CN (2) CN111574702A (ja)
AU (1) AU2016299544A1 (ja)
BR (1) BR112018001736A2 (ja)
CA (1) CA2993920A1 (ja)
HK (1) HK1249439A1 (ja)
IL (1) IL257185A (ja)
MX (1) MX2018001219A (ja)
RU (1) RU2018107052A (ja)
WO (1) WO2017018816A1 (ja)
ZA (1) ZA201801189B (ja)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116670232A (zh) * 2020-12-10 2023-08-29 三养控股公司 可缩短重构时间的聚合物胶束纳米颗粒的制备方法

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113424057B (zh) * 2019-04-19 2024-04-05 海正生物制药有限公司 组合物中泊洛沙姆188的检测方法

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101910246A (zh) * 2007-12-31 2010-12-08 株式会社三养社 包含源自α-羟酸的疏水嵌段的高纯两亲共聚物及其制备方法
CN104098780A (zh) * 2007-12-31 2014-10-15 株式会社三养生物制药 含紫杉烷的两亲嵌段共聚物胶束组合物及其制备方法

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KR0180334B1 (ko) 1995-09-21 1999-03-20 김윤 블럭 공중합체 미셀을 이용한 약물전달체 및 이에 약물을 봉입하는 방법
KR100360827B1 (ko) * 1999-08-14 2002-11-18 주식회사 삼양사 난용성 약물을 가용화하기 위한 고분자 조성물 및 그의 제조방법
NZ522442A (en) 2000-05-12 2004-04-30 Samyang Corp Method for the preparation of polymeric micelle via phase separation of block copolymer
US7217770B2 (en) * 2000-05-17 2007-05-15 Samyang Corporation Stable polymeric micelle-type drug composition and method for the preparation thereof
MXPA04003621A (es) * 2001-10-18 2004-07-30 Samyang Corp Composicion de micela polimerica con estabilidad mejorada.
US9801818B2 (en) * 2007-12-31 2017-10-31 Samyang Biopharmaceuticals Corporation Method for stabilizing amphiphilic block copolymer micelle composition containing poorly water-soluble drug
EP2201935B1 (en) * 2008-12-26 2020-07-08 Samyang Biopharmaceuticals Corporation Polymeric micelle composition containing a poorly soluble drug and preparation method of the same
CN101444510B (zh) 2008-12-31 2011-03-09 南京卡文迪许生物工程技术有限公司 含有伏立康唑的药物制剂及其制备方法
CN104758256B (zh) * 2014-02-14 2016-05-04 苏州海特比奥生物技术有限公司 一种多西他赛纳米聚合物胶束冻干制剂及其制备方法

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101910246A (zh) * 2007-12-31 2010-12-08 株式会社三养社 包含源自α-羟酸的疏水嵌段的高纯两亲共聚物及其制备方法
CN104098780A (zh) * 2007-12-31 2014-10-15 株式会社三养生物制药 含紫杉烷的两亲嵌段共聚物胶束组合物及其制备方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116670232A (zh) * 2020-12-10 2023-08-29 三养控股公司 可缩短重构时间的聚合物胶束纳米颗粒的制备方法

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Publication number Publication date
JP2018521094A (ja) 2018-08-02
AU2016299544A1 (en) 2018-03-08
MX2018001219A (es) 2018-04-24
ZA201801189B (en) 2019-01-30
BR112018001736A2 (pt) 2018-09-11
HK1249439A1 (zh) 2018-11-02
RU2018107052A (ru) 2019-08-28
EP3328434A4 (en) 2019-03-13
CN106559983A (zh) 2017-04-05
CA2993920A1 (en) 2017-02-02
JP6605706B2 (ja) 2019-11-13
KR101748191B1 (ko) 2017-06-19
KR20170015198A (ko) 2017-02-08
IL257185A (en) 2018-03-29
EP3328434A1 (en) 2018-06-06
WO2017018816A1 (en) 2017-02-02
RU2018107052A3 (ja) 2019-08-28

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Address after: Seoul, South Kerean

Applicant after: Sanyang holding Co.

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Applicant before: SAMYANG BIOPHARMACEUTICALS Corp.

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Application publication date: 20200825

RJ01 Rejection of invention patent application after publication