RU2018107057A - FRAMACEUTICAL COMPOSITION WITH IMPROVED STABILITY AT STORAGE AND METHOD FOR PRODUCING IT - Google Patents

FRAMACEUTICAL COMPOSITION WITH IMPROVED STABILITY AT STORAGE AND METHOD FOR PRODUCING IT Download PDF

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RU2018107057A
RU2018107057A RU2018107057A RU2018107057A RU2018107057A RU 2018107057 A RU2018107057 A RU 2018107057A RU 2018107057 A RU2018107057 A RU 2018107057A RU 2018107057 A RU2018107057 A RU 2018107057A RU 2018107057 A RU2018107057 A RU 2018107057A
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pharmaceutical composition
mass parts
composition according
formula
amount
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RU2018107057A
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Russian (ru)
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RU2018107057A3 (en
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Бонг Ох КИМ
Киу Дзин КИУНГ
Дзи Йеонг КИМ
Хие Рим КИМ
Бум Чан МИН
Йоо Дзеонг ЙООН
Мин Хио СЕО
Йил Воонг ЙИ
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Самьянг Байофармасьютикалз Корпорейшн
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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
    • 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
    • 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

Claims (21)

1. Полимерная мицеллярная фармацевтическая композиция, содержащая 1. A polymer micellar pharmaceutical composition comprising очищенный амфифильный блоксополимер, содержащий гидрофильный блок (A) и гидрофобный блок (B), иpurified amphiphilic block copolymer containing a hydrophilic block (A) and a hydrophobic block (B), and одно или более плохо растворимых в воде лекарственных средств, выбранных из группы, включающей паклитаксел и доцетаксел,one or more poorly water-soluble drugs selected from the group consisting of paclitaxel and docetaxel, где фармацевтическая композиция содержит, при хранении при 40°C в течение 6 месяцев, сопутствующую примесь, представленную следующей формулой 1, в количестве менее 0,17 массовых частей, по отношению к 100 массовым частям исходного количества плохо растворимого в воде лекарственного средства:where the pharmaceutical composition contains, when stored at 40 ° C for 6 months, the concomitant impurity represented by the following formula 1, in an amount of less than 0.17 mass parts, relative to 100 mass parts of the original amount of poorly water-soluble drug: [Формула 1][Formula 1]
Figure 00000001
Figure 00000001
 гдеWhere R1 является H или COCH3, и R2 является фенилом или O(CH3)3.R 1 is H or COCH 3 , and R 2 is phenyl or O (CH 3 ) 3 . 2. Фармацевтическая композиция по п. 1, где соединение формулы 1 включает соединение следующей формулы 1a:2. The pharmaceutical composition according to claim 1, wherein the compound of formula 1 comprises a compound of the following formula 1a: [Формула 1a][Formula 1a]
Figure 00000002
Figure 00000002
 3. Фармацевтическая композиция по п. 1, которая содержит сопутствующую примесь формулы 1 в количестве 0,15 массовых частей или менее, по отношению к 100 массовым частям исходного количества плохо растворимого в воде лекарственного средства.3. The pharmaceutical composition according to claim 1, which contains a concomitant admixture of formula 1 in an amount of 0.15 mass parts or less, relative to 100 mass parts of the initial amount of a poorly water-soluble drug. 4. Фармацевтическая композиция по п. 3, которая содержит сопутствующую примесь формулы 1 в количестве 0,1 массовых частей или менее, по отношению к 100 массовым частям исходного количества плохо растворимого в воде лекарственного средства.4. The pharmaceutical composition according to claim 3, which contains a concomitant impurity of formula 1 in an amount of 0.1 mass parts or less, relative to 100 mass parts of the initial amount of a poorly water-soluble drug. 5. Фармацевтическая композиция по п. 4, которая содержит родственное соединение формулы 1 в количестве 0,08 массовых частей или менее, по отношению к 100 массовым частям исходного количества плохо растворимого в воде лекарственного средства.5. The pharmaceutical composition according to claim 4, which contains a related compound of formula 1 in an amount of 0.08 mass parts or less, relative to 100 mass parts of the initial amount of a poorly water-soluble drug. 6. Фармацевтическая композиция по п. 5, которая содержит родственное соединение формулы 1 в количестве 0,04 массовых частей или менее, по отношению к 100 массовым частям исходного количества плохо растворимого в воде лекарственного средства.6. The pharmaceutical composition according to claim 5, which contains a related compound of formula 1 in an amount of 0.04 mass parts or less, relative to 100 mass parts of the initial amount of a poorly water-soluble drug. 7. Фармацевтическая композиция по п. 1, которая содержит, при хранении при 80°C в течение 3 недель, сопутствующую примесь формулы 1 в количестве менее 0,76 массовых частей, по отношению к 100 массовым частям исходного количества плохо растворимого в воде лекарственного средства.7. The pharmaceutical composition according to claim 1, which contains, when stored at 80 ° C for 3 weeks, a concomitant admixture of formula 1 in an amount of less than 0.76 mass parts, relative to 100 mass parts of the initial amount of a poorly water-soluble drug . 8. Фармацевтическая композиция по п. 1, где гидрофильный блок (A) содержит одно или более соединений, выбранных из группы, состоящей из полиэтиленгликоля или его производных, поливинилпирролидона, поливинилового спирта, полиакриламида и их сочетаний.8. The pharmaceutical composition according to claim 1, wherein the hydrophilic block (A) contains one or more compounds selected from the group consisting of polyethylene glycol or its derivatives, polyvinylpyrrolidone, polyvinyl alcohol, polyacrylamide, and combinations thereof. 9. Фармацевтическая композиция по п. 1, где гидрофобный блок (B) содержит одно или более соединений, выбранных из группы, состоящей из полилактида, полигликолида, полиминдальной кислоты, поликапролактона, полидиоксан-2-она, полиаминокислоты, полиортоэфира, полиангидрида, поликарбоната и их сочетаний.9. The pharmaceutical composition according to claim 1, wherein the hydrophobic block (B) contains one or more compounds selected from the group consisting of polylactide, polyglycolide, polymindic acid, polycaprolactone, polydioxan-2-one, polyamino acid, polyorthoester, polyanhydride, polycarbonate and their combinations. 10. Фармацевтическая композиция по п. 1, где гидрофильным блоком (A) является полиэтиленгликоль или монометоксиполиэтиленгликоль, и гидрофобным блоком (B) является полилактид.10. The pharmaceutical composition according to claim 1, wherein the hydrophilic block (A) is polyethylene glycol or monomethoxypolyethylene glycol and the hydrophobic block (B) is polylactide. 11. Фармацевтическая композиция по п. 1, где гидрофильный блок (A) имеет среднечисленную молекулярную массу от 200 до 20000 Дальтонов, и гидрофобный блок (B) имеет среднечисленную молекулярную массу от 200 до 20000 Дальтонов.11. The pharmaceutical composition according to claim 1, wherein the hydrophilic block (A) has a number average molecular weight of 200 to 20,000 Daltons, and the hydrophobic block (B) has a number average molecular weight of 200 to 20,000 Daltons. 12. Фармацевтическая композиция по п. 1, где амфифильным блоксополимером является блоксополимер, очищенный сублимацией при температуре 80°C или выше и ниже 120°C и степени вакуумирования 10 торр или менее, в течение от 10 до 74 часов.12. The pharmaceutical composition according to claim 1, wherein the amphiphilic block copolymer is a block copolymer purified by sublimation at a temperature of 80 ° C or higher and below 120 ° C and a vacuum of 10 torr or less for 10 to 74 hours.
RU2018107057A 2015-07-28 2016-07-28 FRAMACEUTICAL COMPOSITION WITH IMPROVED STABILITY AT STORAGE AND METHOD FOR PRODUCING IT RU2018107057A (en)

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KR10-2015-0106627 2015-07-28
KR20150106627 2015-07-28
PCT/KR2016/008267 WO2017018818A1 (en) 2015-07-28 2016-07-28 Pharmaceutical composition with improved storage stability and method for preparing the same

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EP (1) EP3328435A4 (en)
JP (1) JP2018521103A (en)
KR (1) KR101787451B1 (en)
CN (1) CN106659681A (en)
AU (1) AU2016299546B2 (en)
BR (1) BR112018001725A2 (en)
CA (1) CA2993925A1 (en)
HK (1) HK1249442A1 (en)
IL (1) IL257188A (en)
MX (1) MX2018001221A (en)
RU (1) RU2018107057A (en)
WO (1) WO2017018818A1 (en)
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KR102144479B1 (en) * 2018-05-24 2020-08-13 주식회사 덱스레보 Composition for tissue repair treatment and methods of manufacturing the same
KR102251192B1 (en) * 2020-08-07 2021-05-13 주식회사 덱스레보 Composition for tissue repair treatment and methods of manufacturing the same

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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
CA2463172C (en) * 2001-10-18 2009-08-18 Samyang Corporation Polymeric micelle composition with improved stability
ES2353653T3 (en) 2007-03-06 2011-03-03 Cell Therapeutics Europe S.R.L. METHOD FOR DETERMINING THE AMOUNT OF CONJUGATED TAXAN IN POLYGLUTAMIC ACID-TAXAN CONJUGATES.
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 (en) * 2007-12-31 2011-03-24 주식회사 삼양사 Amphiphilic Block Copolymer Micelle Composition Containing Taxane and Manufacturing Process of The Same
BRPI0821619B1 (en) * 2007-12-31 2018-12-18 Samyang Biopharmaceuticals Method for Preparation of an Amphiphilic Block Copolymer
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
CN102218027B (en) * 2011-04-22 2014-07-02 上海谊众生物技术有限公司 Polymer micelle lyophilized agent encapsulating insoluble antitumor drug
CN103768013A (en) * 2014-01-17 2014-05-07 丽珠医药集团股份有限公司 Paclitaxel polymer micelle by using refined amphiphilic block copolymer as carrier

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HK1249442A1 (en) 2018-11-02
BR112018001725A2 (en) 2018-09-18
CA2993925A1 (en) 2017-02-02
EP3328435A4 (en) 2019-03-13
AU2016299546B2 (en) 2019-05-02
WO2017018818A1 (en) 2017-02-02
EP3328435A1 (en) 2018-06-06
RU2018107057A3 (en) 2019-08-28
ZA201801188B (en) 2018-12-19
JP2018521103A (en) 2018-08-02
IL257188A (en) 2018-03-29
CN106659681A (en) 2017-05-10
MX2018001221A (en) 2018-04-24
AU2016299546A1 (en) 2018-03-08
KR20170015199A (en) 2017-02-08

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