WO2016190712A3 - 안정화된 약학 조성물 및 그의 제조방법 - Google Patents

안정화된 약학 조성물 및 그의 제조방법 Download PDF

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Publication number
WO2016190712A3
WO2016190712A3 PCT/KR2016/005653 KR2016005653W WO2016190712A3 WO 2016190712 A3 WO2016190712 A3 WO 2016190712A3 KR 2016005653 W KR2016005653 W KR 2016005653W WO 2016190712 A3 WO2016190712 A3 WO 2016190712A3
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WO
WIPO (PCT)
Prior art keywords
preparation
preparing same
pharmaceutical composition
stabilized pharmaceutical
composition
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PCT/KR2016/005653
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English (en)
French (fr)
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WO2016190712A2 (ko
Inventor
조중웅
김경해
서민효
이사원
Original Assignee
주식회사 삼양바이오팜
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Application filed by 주식회사 삼양바이오팜 filed Critical 주식회사 삼양바이오팜
Priority to JP2017561639A priority Critical patent/JP6873923B2/ja
Priority to EP16800351.5A priority patent/EP3305283B1/en
Priority to US15/561,118 priority patent/US10456362B2/en
Publication of WO2016190712A2 publication Critical patent/WO2016190712A2/ko
Publication of WO2016190712A3 publication Critical patent/WO2016190712A3/ko
Priority to PH12017501828A priority patent/PH12017501828B1/en

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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
    • A61K9/08—Solutions
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

페메트렉시드와 같이 산화에 의한 분해가 쉽게 일어나는 약물을 포함하는 조성물의 제조에 있어서 제조공정상에서 산소를 제거하여 안정성을 높인 조성물 및 그 제조방법이 개시된다. 상기 제조방법은 밀폐된 챔버 내에서 동결 및 탈기하여 제조의 용이성을 높인 제조방법이며, 산화에 블안정한 약물의 안정성을 획기적으로 높인 조성물을 제공할 수 있다.
PCT/KR2016/005653 2015-05-28 2016-05-27 안정화된 약학 조성물 및 그의 제조방법 WO2016190712A2 (ko)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2017561639A JP6873923B2 (ja) 2015-05-28 2016-05-27 安定化された薬学組成物およびその製造方法
EP16800351.5A EP3305283B1 (en) 2015-05-28 2016-05-27 Stabilized pharmaceutical composition and method for preparing same
US15/561,118 US10456362B2 (en) 2015-05-28 2016-05-27 Stabilized pharmaceutical composition and method for preparing same
PH12017501828A PH12017501828B1 (en) 2015-05-28 2017-10-06 Stabilized pharmaceutical composition and method for preparing same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2015-0074540 2015-05-28
KR1020150074540A KR101919436B1 (ko) 2015-05-28 2015-05-28 안정화된 약학 조성물 및 그의 제조방법

Publications (2)

Publication Number Publication Date
WO2016190712A2 WO2016190712A2 (ko) 2016-12-01
WO2016190712A3 true WO2016190712A3 (ko) 2017-02-02

Family

ID=57392877

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2016/005653 WO2016190712A2 (ko) 2015-05-28 2016-05-27 안정화된 약학 조성물 및 그의 제조방법

Country Status (6)

Country Link
US (1) US10456362B2 (ko)
EP (1) EP3305283B1 (ko)
JP (2) JP6873923B2 (ko)
KR (1) KR101919436B1 (ko)
PH (1) PH12017501828B1 (ko)
WO (1) WO2016190712A2 (ko)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101919436B1 (ko) * 2015-05-28 2018-11-16 주식회사 삼양바이오팜 안정화된 약학 조성물 및 그의 제조방법
JP6837895B2 (ja) * 2017-04-04 2021-03-03 日本化薬株式会社 医薬品溶液製剤の製造方法

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101069128B1 (ko) * 2011-03-10 2011-09-30 건일제약 주식회사 페메트렉시드 또는 그의 염을 포함하는 항산화제-비함유 주사용 용액 형태의 약학적 제제의 제조방법
CN103006584A (zh) * 2012-12-26 2013-04-03 哈药集团技术中心 一种注射用培美曲塞二钠的制备方法
WO2013179248A1 (en) * 2012-05-30 2013-12-05 Fresenius Kabi Oncology Ltd. Pharmaceutical compositions of pemetrexed
CN103432086A (zh) * 2013-08-28 2013-12-11 南京正大天晴制药有限公司 一种注射用培美曲塞二钠冻干粉针剂及其制备方法
WO2014198337A1 (en) * 2013-06-14 2014-12-18 Synthon B.V. Stable and water soluble pharmaceutical compositions comprising pemetrexed
WO2015102315A1 (ko) * 2013-12-30 2015-07-09 주식회사 삼양바이오팜 항산화제를 함유하지 않는 약학 조성물 및 그의 제조방법

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ES2527760T3 (es) * 1998-07-23 2015-01-29 Yeda Research And Development Co., Ltd. Tratamiento de enfermedad de Crohn con copolímero 1 y polipéptidos
DK1265612T3 (da) 2000-02-04 2004-08-09 Lilly Co Eli Farmaceutisk præparat omfattende pemetrexed samt monothioglycerol, l-cystein eller thioglycolsyre
US20070213411A1 (en) * 2003-11-05 2007-09-13 The Australian National University Dispersions And Methods Of Preparing Them
US20070077303A1 (en) * 2005-09-30 2007-04-05 Azaam Alli Methods for providing oxidatively stable ophthalmic compositions
EP2055953B1 (en) * 2007-11-01 2018-08-15 Danfoss Power Solutions Aps Fluid working machine
CN101260636A (zh) * 2008-04-29 2008-09-10 刘全祥 倒刺道钉
WO2014060962A1 (en) 2012-10-17 2014-04-24 Shilpa Medicare Limited Pemetrexed dipotassium formulations
KR101260636B1 (ko) 2012-11-29 2013-05-13 씨제이제일제당 (주) 안정화된 페메트렉시드 제제
KR101485243B1 (ko) * 2013-05-08 2015-01-21 씨제이헬스케어 주식회사 안정화된 페메트렉시드 제제
EP3040074B1 (en) * 2013-10-03 2018-07-25 Fujifilm Corporation Injection preparation and method for producing same
KR101919436B1 (ko) * 2015-05-28 2018-11-16 주식회사 삼양바이오팜 안정화된 약학 조성물 및 그의 제조방법

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101069128B1 (ko) * 2011-03-10 2011-09-30 건일제약 주식회사 페메트렉시드 또는 그의 염을 포함하는 항산화제-비함유 주사용 용액 형태의 약학적 제제의 제조방법
WO2013179248A1 (en) * 2012-05-30 2013-12-05 Fresenius Kabi Oncology Ltd. Pharmaceutical compositions of pemetrexed
CN103006584A (zh) * 2012-12-26 2013-04-03 哈药集团技术中心 一种注射用培美曲塞二钠的制备方法
WO2014198337A1 (en) * 2013-06-14 2014-12-18 Synthon B.V. Stable and water soluble pharmaceutical compositions comprising pemetrexed
CN103432086A (zh) * 2013-08-28 2013-12-11 南京正大天晴制药有限公司 一种注射用培美曲塞二钠冻干粉针剂及其制备方法
WO2015102315A1 (ko) * 2013-12-30 2015-07-09 주식회사 삼양바이오팜 항산화제를 함유하지 않는 약학 조성물 및 그의 제조방법

Also Published As

Publication number Publication date
JP2018516253A (ja) 2018-06-21
JP2020097570A (ja) 2020-06-25
PH12017501828A1 (en) 2018-04-11
EP3305283A4 (en) 2019-01-09
US10456362B2 (en) 2019-10-29
EP3305283B1 (en) 2020-09-02
KR101919436B1 (ko) 2018-11-16
JP6873923B2 (ja) 2021-05-19
KR20160139514A (ko) 2016-12-07
PH12017501828B1 (en) 2018-04-11
EP3305283A2 (en) 2018-04-11
WO2016190712A2 (ko) 2016-12-01
US20180125786A1 (en) 2018-05-10

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