CN106659681A - 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
CN106659681A
CN106659681A CN201680001948.6A CN201680001948A CN106659681A CN 106659681 A CN106659681 A CN 106659681A CN 201680001948 A CN201680001948 A CN 201680001948A CN 106659681 A CN106659681 A CN 106659681A
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CN
China
Prior art keywords
pharmaceutical composition
medicine
soluble
formula
poorly water
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.)
Pending
Application number
CN201680001948.6A
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English (en)
Chinese (zh)
Inventor
金峰五
庆奎真
金志英
金寭林
闵范赞
尹裕晶
徐敏孝
李雄
李一雄
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.)
Samyang Biopharmaceuticals Corp
Original Assignee
Samyang Biopharmaceuticals Corp
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 Samyang Biopharmaceuticals Corp filed Critical Samyang Biopharmaceuticals Corp
Publication of CN106659681A publication Critical patent/CN106659681A/zh
Pending legal-status Critical Current

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    • 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
    • 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
    • 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
    • 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
    • A61K47/06—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
    • 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
    • A61K9/14—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CN201680001948.6A 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 CN106659681A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR10-2015-0106627 2015-07-28
KR20150106627 2015-07-28
PCT/KR2016/008267 WO2017018818A1 (fr) 2015-07-28 2016-07-28 Composition pharmaceutique à stabilité au stockage améliorée, et son procédé de préparation

Publications (1)

Publication Number Publication Date
CN106659681A true CN106659681A (zh) 2017-05-10

Family

ID=57885186

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201680001948.6A Pending CN106659681A (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) EP3328435A4 (fr)
JP (1) JP2018521103A (fr)
KR (1) KR101787451B1 (fr)
CN (1) CN106659681A (fr)
AU (1) AU2016299546B2 (fr)
BR (1) BR112018001725A2 (fr)
CA (1) CA2993925A1 (fr)
HK (1) HK1249442A1 (fr)
IL (1) IL257188A (fr)
MX (1) MX2018001221A (fr)
RU (1) RU2018107057A (fr)
WO (1) WO2017018818A1 (fr)
ZA (1) ZA201801188B (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102144479B1 (ko) * 2018-05-24 2020-08-13 주식회사 덱스레보 조직 수복용 조성물 및 이의 제조방법
KR102251192B1 (ko) * 2020-08-07 2021-05-13 주식회사 덱스레보 조직 수복용 조성물 및 이의 제조방법

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1571816A (zh) * 2001-10-18 2005-01-26 株式会社三养社 具有改进稳定性的聚合物胶束组合物
CN101910274A (zh) * 2007-12-31 2010-12-08 株式会社三养社 含紫杉烷的两亲嵌段共聚物胶束组合物及其制备方法
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
CN102218027A (zh) * 2011-04-22 2011-10-19 上海谊众生物技术有限公司 一种包载难溶性抗肿瘤药物的聚合物胶束冻干制剂
CN102264351A (zh) * 2008-12-26 2011-11-30 株式会社三养社 包含水溶性差的药物的聚合胶束组合物的制备方法
CN103768013A (zh) * 2014-01-17 2014-05-07 丽珠医药集团股份有限公司 以精制两亲性嵌段共聚物为载体的紫杉醇聚合物胶束

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7550157B2 (en) * 2000-05-12 2009-06-23 Samyang Corporation 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
ATE487134T1 (de) 2007-03-06 2010-11-15 Cell Therapeutics Europe Srl Verfahren zur bestimmung der menge konjugierten taxans in polyglutaminsäure-taxan-konjugaten
US9801818B2 (en) * 2007-12-31 2017-10-31 Samyang Biopharmaceuticals Corporation Method for stabilizing amphiphilic block copolymer micelle composition containing poorly water-soluble drug

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1571816A (zh) * 2001-10-18 2005-01-26 株式会社三养社 具有改进稳定性的聚合物胶束组合物
CN101910274A (zh) * 2007-12-31 2010-12-08 株式会社三养社 含紫杉烷的两亲嵌段共聚物胶束组合物及其制备方法
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
CN102264351A (zh) * 2008-12-26 2011-11-30 株式会社三养社 包含水溶性差的药物的聚合胶束组合物的制备方法
CN102218027A (zh) * 2011-04-22 2011-10-19 上海谊众生物技术有限公司 一种包载难溶性抗肿瘤药物的聚合物胶束冻干制剂
CN103768013A (zh) * 2014-01-17 2014-05-07 丽珠医药集团股份有限公司 以精制两亲性嵌段共聚物为载体的紫杉醇聚合物胶束

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
CIUTARU ET AL: ""A HPLC validated assay of paclitaxel"s related impurities in pharmaceutical forms containing Cremophor® EL"", 《JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS》 *
KUMAR ET AL: ""Isolation and characterization of degradation impurities in docetaxel drug substance and its formulation"", 《JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS》 *
潘帅奇: ""紫杉醇mPEG-PLA共聚物胶束治疗脑胶质瘤的研究"", 《中国优秀硕士论文全文数据库 医药卫生科技辑》 *

Also Published As

Publication number Publication date
RU2018107057A3 (fr) 2019-08-28
AU2016299546A1 (en) 2018-03-08
RU2018107057A (ru) 2019-08-28
AU2016299546B2 (en) 2019-05-02
WO2017018818A1 (fr) 2017-02-02
JP2018521103A (ja) 2018-08-02
KR20170015199A (ko) 2017-02-08
HK1249442A1 (zh) 2018-11-02
BR112018001725A2 (pt) 2018-09-18
EP3328435A1 (fr) 2018-06-06
IL257188A (en) 2018-03-29
ZA201801188B (en) 2018-12-19
CA2993925A1 (fr) 2017-02-02
EP3328435A4 (fr) 2019-03-13
MX2018001221A (es) 2018-04-24
KR101787451B1 (ko) 2017-10-19

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