EP3328437A4 - 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

Info

Publication number
EP3328437A4
EP3328437A4 EP16830853.4A EP16830853A EP3328437A4 EP 3328437 A4 EP3328437 A4 EP 3328437A4 EP 16830853 A EP16830853 A EP 16830853A EP 3328437 A4 EP3328437 A4 EP 3328437A4
Authority
EP
European Patent Office
Prior art keywords
preparing
pharmaceutical composition
same
storage stability
improved storage
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.)
Withdrawn
Application number
EP16830853.4A
Other languages
German (de)
French (fr)
Other versions
EP3328437A1 (en
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
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 EP3328437A1 publication Critical patent/EP3328437A1/en
Publication of EP3328437A4 publication Critical patent/EP3328437A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • 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
    • A61K9/10—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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
EP16830853.4A 2015-07-28 2016-07-28 Pharmaceutical composition with improved storage stability and method for preparing the same Withdrawn EP3328437A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20150106629 2015-07-28
PCT/KR2016/008270 WO2017018820A1 (en) 2015-07-28 2016-07-28 Pharmaceutical composition with improved storage stability and method for preparing the same

Publications (2)

Publication Number Publication Date
EP3328437A1 EP3328437A1 (en) 2018-06-06
EP3328437A4 true EP3328437A4 (en) 2019-03-20

Family

ID=57884713

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16830853.4A Withdrawn EP3328437A4 (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) EP3328437A4 (en)
JP (1) JP2018521105A (en)
KR (1) KR101787453B1 (en)
CN (1) CN107466231A (en)
AU (1) AU2016299548A1 (en)
BR (1) BR112018001737A2 (en)
CA (1) CA2993928A1 (en)
HK (1) HK1249441A1 (en)
IL (1) IL257187A (en)
MX (1) MX2018001223A (en)
RU (1) RU2018107055A (en)
WO (1) WO2017018820A1 (en)
ZA (1) ZA201801187B (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001085216A1 (en) * 2000-05-12 2001-11-15 Samyang Corporation Method for the preparation of polymeric micelle via phase separation of block copolymer
WO2001087345A1 (en) * 2000-05-17 2001-11-22 Samyang Corporation Stable polymeric micelle-type drug composition and method for the preparation thereof
US20100280214A1 (en) * 2007-12-31 2010-11-04 Samyang Corporation Highly pure amphiphilic copolymer comprising hydrophobic block from alpha-hydroxy acid and process for the preparation thereof
US20130345297A1 (en) * 2007-12-31 2013-12-26 Samyang Biopharmaceuticals Corporation Method for stabilizing amphiphilic block copolymer micelle composition containing poorly water-soluble drug

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6020507A (en) 1998-03-02 2000-02-01 Bristol-Myers Squibb Company Synthesis of paclitaxel from baccatin III by protection of the 7-hydroxyl of baccatin III using a strong base and an electrophile
CA2463172C (en) * 2001-10-18 2009-08-18 Samyang Corporation Polymeric micelle composition with improved stability
WO2005037840A1 (en) 2003-10-16 2005-04-28 Mayne Pharma (Usa), Inc. Method for inverting the c2’ hydroxyl group of taxane esters
KR101024742B1 (en) * 2007-12-31 2011-03-24 주식회사 삼양사 Amphiphilic Block Copolymer Micelle Composition Containing Taxane and Manufacturing Process of The Same
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

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001085216A1 (en) * 2000-05-12 2001-11-15 Samyang Corporation Method for the preparation of polymeric micelle via phase separation of block copolymer
WO2001087345A1 (en) * 2000-05-17 2001-11-22 Samyang Corporation Stable polymeric micelle-type drug composition and method for the preparation thereof
US20100280214A1 (en) * 2007-12-31 2010-11-04 Samyang Corporation Highly pure amphiphilic copolymer comprising hydrophobic block from alpha-hydroxy acid and process for the preparation thereof
US20130345297A1 (en) * 2007-12-31 2013-12-26 Samyang Biopharmaceuticals Corporation Method for stabilizing amphiphilic block copolymer micelle composition containing poorly water-soluble drug

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
KIM S C ET AL: "In vivo evaluation of polymeric micellar paclitaxel formulation: toxicity and efficacy", JOURNAL OF CONTROLLED RELEASE, ELSEVIER, AMSTERDAM, NL, vol. 72, no. 1-3, 14 May 2001 (2001-05-14), pages 191 - 202, XP027296131, ISSN: 0168-3659, [retrieved on 20010514] *
See also references of WO2017018820A1 *
ZHU K J ET AL: "PREPARATION, CHARACTERIZATION, AND PROPERTIES OF POLYLACTIDE (PLA)-POLY(ETHYLENE GLYCOL) (PEG) COLOYMERS: A POTENTIAL DRUG CARRIER", JOURNAL OF APPLIED POLYMER SCIENCE, JOHN WILEY & SONS, INC, US, vol. 39, no. 1, 1 January 1990 (1990-01-01), pages 1 - 09, XP000650366, ISSN: 0021-8995, DOI: 10.1002/APP.1990.070390101 *

Also Published As

Publication number Publication date
RU2018107055A3 (en) 2019-08-28
JP2018521105A (en) 2018-08-02
IL257187A (en) 2018-03-29
CA2993928A1 (en) 2017-02-02
BR112018001737A2 (en) 2018-09-11
EP3328437A1 (en) 2018-06-06
CN107466231A (en) 2017-12-12
KR20170015200A (en) 2017-02-08
MX2018001223A (en) 2018-11-09
WO2017018820A1 (en) 2017-02-02
RU2018107055A (en) 2019-08-28
KR101787453B1 (en) 2017-10-19
ZA201801187B (en) 2018-12-19
AU2016299548A1 (en) 2018-02-22
HK1249441A1 (en) 2018-11-02

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