WO2017018818A1 - Pharmaceutical composition with improved storage stability and method for preparing the same - Google Patents

Pharmaceutical composition with improved storage stability and method for preparing the same Download PDF

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Publication number
WO2017018818A1
WO2017018818A1 PCT/KR2016/008267 KR2016008267W WO2017018818A1 WO 2017018818 A1 WO2017018818 A1 WO 2017018818A1 KR 2016008267 W KR2016008267 W KR 2016008267W WO 2017018818 A1 WO2017018818 A1 WO 2017018818A1
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
weight
amount
composition according
formula
Prior art date
Application number
PCT/KR2016/008267
Other languages
English (en)
French (fr)
Inventor
Bong Oh Kim
Kyu Jin Kyung
Ji Yeong Kim
Hye Rim Kim
Bum Chan MIN
Yoo Jeong YOON
Min Hyo Seo
Yil Woong Yi
Original Assignee
Samyang Biopharmaceuticals Corporation
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
Priority to CN201680001948.6A priority Critical patent/CN106659681A/zh
Priority to AU2016299546A priority patent/AU2016299546B2/en
Priority to EP16830851.8A priority patent/EP3328435A4/en
Priority to BR112018001725A priority patent/BR112018001725A2/pt
Priority to MX2018001221A priority patent/MX2018001221A/es
Priority to CA2993925A priority patent/CA2993925A1/en
Application filed by Samyang Biopharmaceuticals Corporation filed Critical Samyang Biopharmaceuticals Corporation
Priority to RU2018107057A priority patent/RU2018107057A/ru
Priority to JP2018504241A priority patent/JP2018521103A/ja
Publication of WO2017018818A1 publication Critical patent/WO2017018818A1/en
Priority to IL257188A priority patent/IL257188A/en
Priority to ZA2018/01188A priority patent/ZA201801188B/en
Priority to HK18109127.7A priority patent/HK1249442A1/zh

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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)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
PCT/KR2016/008267 2015-07-28 2016-07-28 Pharmaceutical composition with improved storage stability and method for preparing the same WO2017018818A1 (en)

Priority Applications (11)

Application Number Priority Date Filing Date Title
AU2016299546A AU2016299546B2 (en) 2015-07-28 2016-07-28 Pharmaceutical composition with improved storage stability and method for preparing the same
EP16830851.8A EP3328435A4 (en) 2015-07-28 2016-07-28 PHARMACEUTICAL COMPOSITION WITH IMPROVED STORAGE STABILITY AND METHOD FOR THE MANUFACTURE THEREOF
BR112018001725A BR112018001725A2 (pt) 2015-07-28 2016-07-28 composição farmacêutica com micela polimérica.
MX2018001221A MX2018001221A (es) 2015-07-28 2016-07-28 Composicion farmaceutica con estabilidad de almacenamiento mejorada y metodo para prepararla.
CA2993925A CA2993925A1 (en) 2015-07-28 2016-07-28 Pharmaceutical composition with improved storage stability and method for preparing the same
CN201680001948.6A 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
RU2018107057A RU2018107057A (ru) 2015-07-28 2016-07-28 Фрамацевтическая композиция с улучшенной устройчивостью при хранении и способ ее получения
JP2018504241A JP2018521103A (ja) 2015-07-28 2016-07-28 保存安定性が向上した医薬組成物及びその製造方法
IL257188A IL257188A (en) 2015-07-28 2018-01-28 Pharmaceutical composition with improved storage stability and method for preparing the same
ZA2018/01188A ZA201801188B (en) 2015-07-28 2018-02-21 Pharmaceutical composition with improved storage stability and method for preparing the same
HK18109127.7A HK1249442A1 (zh) 2015-07-28 2018-07-13 具有改善的儲存穩定性的藥物組合物及其製備方法

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2015-0106627 2015-07-28
KR20150106627 2015-07-28

Publications (1)

Publication Number Publication Date
WO2017018818A1 true WO2017018818A1 (en) 2017-02-02

Family

ID=57885186

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2016/008267 WO2017018818A1 (en) 2015-07-28 2016-07-28 Pharmaceutical composition with improved storage stability and method for preparing the same

Country Status (13)

Country Link
EP (1) EP3328435A4 (ja)
JP (1) JP2018521103A (ja)
KR (1) KR101787451B1 (ja)
CN (1) CN106659681A (ja)
AU (1) AU2016299546B2 (ja)
BR (1) BR112018001725A2 (ja)
CA (1) CA2993925A1 (ja)
HK (1) HK1249442A1 (ja)
IL (1) IL257188A (ja)
MX (1) MX2018001221A (ja)
RU (1) RU2018107057A (ja)
WO (1) WO2017018818A1 (ja)
ZA (1) ZA201801188B (ja)

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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003033592A1 (en) * 2001-10-18 2003-04-24 Samyang Corporation Polymeric micelle composition with improved stability
US20110251269A1 (en) * 2008-12-26 2011-10-13 Samyang Corporation Preparation method of polymeric micelles composition containing a poorly water-soluble drug
US8853351B2 (en) * 2007-12-31 2014-10-07 Samyang Biopharmaceuticals Corporation Highly pure amphiphilic copolymer comprising hydrophobic block from alpha-hydroxy acid and process for the preparation thereof

Family Cites Families (7)

* 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
ES2353653T3 (es) 2007-03-06 2011-03-03 Cell Therapeutics Europe S.R.L. Método para determinar la cantidad de taxano conjugado en conjugados de ácido poliglutámico-taxano.
US9801818B2 (en) * 2007-12-31 2017-10-31 Samyang Biopharmaceuticals Corporation Method for stabilizing amphiphilic block copolymer micelle composition containing poorly water-soluble drug
KR101024742B1 (ko) * 2007-12-31 2011-03-24 주식회사 삼양사 탁산 함유 양친성 블록 공중합체 미셀 조성물 및 그 제조방법
CN102218027B (zh) * 2011-04-22 2014-07-02 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

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003033592A1 (en) * 2001-10-18 2003-04-24 Samyang Corporation Polymeric micelle composition with improved stability
US8853351B2 (en) * 2007-12-31 2014-10-07 Samyang Biopharmaceuticals Corporation Highly pure amphiphilic copolymer comprising hydrophobic block from alpha-hydroxy acid and process for the preparation thereof
US20110251269A1 (en) * 2008-12-26 2011-10-13 Samyang Corporation Preparation method of polymeric micelles composition containing a poorly water-soluble drug

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
CIUTARU, D. ET AL.: "A HPLC validated assay of paclitaxel's related impurities in pharmaceutical forms containing Cremophor EL.", JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, vol. 34, 2004, pages 493 - 499, XP055350129 *
KUMAR, D. ET AL.: "Isolation and characterization of degradation impurities in docetaxel drug substance and its formulation.", JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, vol. 43, 2007, pages 1228 - 1235, XP005901637 *
See also references of EP3328435A4 *

Also Published As

Publication number Publication date
KR101787451B1 (ko) 2017-10-19
HK1249442A1 (zh) 2018-11-02
BR112018001725A2 (pt) 2018-09-18
CA2993925A1 (en) 2017-02-02
EP3328435A4 (en) 2019-03-13
AU2016299546B2 (en) 2019-05-02
EP3328435A1 (en) 2018-06-06
RU2018107057A3 (ja) 2019-08-28
ZA201801188B (en) 2018-12-19
JP2018521103A (ja) 2018-08-02
IL257188A (en) 2018-03-29
CN106659681A (zh) 2017-05-10
MX2018001221A (es) 2018-04-24
RU2018107057A (ru) 2019-08-28
AU2016299546A1 (en) 2018-03-08
KR20170015199A (ko) 2017-02-08

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