WO2008108286A1 - 経皮吸収医薬組成物、医薬組成物貯蔵ユニットおよびこれを利用する経皮吸収製剤 - Google Patents

経皮吸収医薬組成物、医薬組成物貯蔵ユニットおよびこれを利用する経皮吸収製剤 Download PDF

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Publication number
WO2008108286A1
WO2008108286A1 PCT/JP2008/053597 JP2008053597W WO2008108286A1 WO 2008108286 A1 WO2008108286 A1 WO 2008108286A1 JP 2008053597 W JP2008053597 W JP 2008053597W WO 2008108286 A1 WO2008108286 A1 WO 2008108286A1
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WIPO (PCT)
Prior art keywords
transdermal absorption
medicinal composition
active ingredient
preparation
hours
Prior art date
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PCT/JP2008/053597
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English (en)
French (fr)
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WO2008108286A9 (ja
Inventor
Takahito Kimura
Masahiro Orihashi
Shigeto Fujishita
Koichi Takabatake
Tatsuhisa Kato
Satoshi Shiota
Yuichiro Shima
Original Assignee
Teika Pharmaceutical Co., Ltd.
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 EP08721045.6A priority Critical patent/EP2123274B1/en
Priority to BRPI0807290A priority patent/BRPI0807290A2/pt
Priority to US12/529,191 priority patent/US9326979B2/en
Priority to JP2009502553A priority patent/JP5313868B2/ja
Priority to ES08721045.6T priority patent/ES2591278T3/es
Priority to KR1020157002750A priority patent/KR101612901B1/ko
Application filed by Teika Pharmaceutical Co., Ltd. filed Critical Teika Pharmaceutical Co., Ltd.
Priority to KR1020097020394A priority patent/KR101521989B1/ko
Priority to CA2679316A priority patent/CA2679316C/en
Priority to CN2008800068257A priority patent/CN101621999B/zh
Publication of WO2008108286A1 publication Critical patent/WO2008108286A1/ja
Publication of WO2008108286A9 publication Critical patent/WO2008108286A9/ja
Priority to HK10102133.2A priority patent/HK1134041A1/xx

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/28Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7084Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Emergency Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

 モルヒネの有効レベルの血中濃度を少なくとも48時間にわたって持続可能である経皮吸収製剤等を提供することを目的とする。該経皮吸収製剤は、モルヒネまたはその塩から選択される有効成分を、ヒト皮膚表面温度付近の温度において流動性を有する有効成分保持媒体中に、飽和溶解度以上の配合量で配合し、かつ該有効成分の少なくとも一部を結晶型で保持した経皮吸収医薬組成物であって、前記経皮吸収医薬組成物を製剤化し、これをバリカンで毛刈り処理を行った白色家兎の無傷の背中の皮膚に72時間適用した際の製剤一投与単位あたりの該有効成分の利用可能量が、モルヒネ塩基換算で10mg~400mgであり、かつ、上記条件において、製剤適用後24時間の時点および48時間の時点での、該有効成分の血漿中濃度が少なくともモルヒネ塩基換算で40ng/mLであることを特徴とする経皮吸収医薬組成物等を含むものである。  
PCT/JP2008/053597 2007-03-02 2008-02-29 経皮吸収医薬組成物、医薬組成物貯蔵ユニットおよびこれを利用する経皮吸収製剤 WO2008108286A1 (ja)

Priority Applications (10)

Application Number Priority Date Filing Date Title
BRPI0807290A BRPI0807290A2 (pt) 2007-03-02 2008-02-29 "composição medicinal para absorção transdérmica, unidade de armazenamento de composição medicinal e prepraração de absorção transdérmica usando a mesma"
US12/529,191 US9326979B2 (en) 2007-03-02 2008-02-29 Medicinal composition for transdermal absorption, medicinal composition storing unit and transdermal absorption preparation using the same
JP2009502553A JP5313868B2 (ja) 2007-03-02 2008-02-29 経皮吸収医薬組成物、医薬組成物貯蔵ユニットおよびこれを利用する経皮吸収製剤
ES08721045.6T ES2591278T3 (es) 2007-03-02 2008-02-29 Composición medicinal para absorción transdérmica, unidad de almacenamiento de composición medicinal y preparación para absorción transdérmica que usa la misma
KR1020157002750A KR101612901B1 (ko) 2007-03-02 2008-02-29 경피흡수 의약조성물, 의약조성물 저장유닛 및 이것을 이용하는 경피흡수제제
EP08721045.6A EP2123274B1 (en) 2007-03-02 2008-02-29 Medicinal composition for transdermal absorption, medicinal composition storing unit and transdermal absorption preparation using the same
KR1020097020394A KR101521989B1 (ko) 2007-03-02 2008-02-29 경피흡수 의약조성물, 의약조성물 저장유닛 및 이것을 이용하는 경피흡수제제
CA2679316A CA2679316C (en) 2007-03-02 2008-02-29 Morphine composition for transdermal absorption, morphine composition storing unit and transdermal absorption preparation using the same
CN2008800068257A CN101621999B (zh) 2007-03-02 2008-02-29 经皮吸收医药组合物、医药组合物储存单元以及利用了该储存单元的经皮吸收制剂
HK10102133.2A HK1134041A1 (en) 2007-03-02 2010-03-01 Medicinal composition for transdermal absorption, medicinal composition storing unit and transdermal absorption preparation using the same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2007053102 2007-03-02
JP2007-053102 2007-03-02

Publications (2)

Publication Number Publication Date
WO2008108286A1 true WO2008108286A1 (ja) 2008-09-12
WO2008108286A9 WO2008108286A9 (ja) 2009-10-08

Family

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PCT/JP2008/053597 WO2008108286A1 (ja) 2007-03-02 2008-02-29 経皮吸収医薬組成物、医薬組成物貯蔵ユニットおよびこれを利用する経皮吸収製剤

Country Status (11)

Country Link
US (1) US9326979B2 (ja)
EP (1) EP2123274B1 (ja)
JP (2) JP5313868B2 (ja)
KR (2) KR101521989B1 (ja)
CN (1) CN101621999B (ja)
BR (1) BRPI0807290A2 (ja)
CA (1) CA2679316C (ja)
ES (1) ES2591278T3 (ja)
HK (1) HK1134041A1 (ja)
RU (1) RU2428186C2 (ja)
WO (1) WO2008108286A1 (ja)

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CA2730340C (en) 2008-07-14 2017-02-07 Polypid Ltd. Sustained-release drug carrier composition
ES2732149T3 (es) 2009-07-14 2019-11-20 Polypid Ltd Composición de vehículos de fármacos de liberación mantenida
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CA2783001C (en) 2010-01-19 2017-12-12 Polypid Ltd. Sustained-release nucleic acid matrix compositions
US9272044B2 (en) 2010-06-08 2016-03-01 Indivior Uk Limited Injectable flowable composition buprenorphine
GB2481017B (en) 2010-06-08 2015-01-07 Rb Pharmaceuticals Ltd Microparticle buprenorphine suspension
DE102011076653A1 (de) * 2011-05-27 2012-11-29 Acino Ag Transdermales therapeutisches System enthaltend Buprenorphin und eine alpha-Hydroxysäure
BR112014024382B1 (pt) 2012-04-18 2022-08-09 SpecGx LLC Composições farmacêuticas de contenção de abuso de liberação imediata e seu processo de preparação
ES2644935T3 (es) * 2012-04-18 2017-12-01 Mallinckrodt Llc Composiciones farmacéuticas de liberación inmediata con propiedades disuasorias del abuso
PL2872121T3 (pl) 2012-07-12 2019-02-28 SpecGx LLC Kompozycje farmaceutyczne o przedłużonym uwalnianiu, zniechęcające do nadużywania
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011111384A1 (ja) * 2010-03-11 2011-09-15 株式会社メドレックス パーキンソン病治療薬を含有する経皮用組成物

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KR101612901B1 (ko) 2016-04-15
US20100074943A1 (en) 2010-03-25
EP2123274A1 (en) 2009-11-25
KR20150017390A (ko) 2015-02-16
RU2428186C2 (ru) 2011-09-10
KR20090116816A (ko) 2009-11-11
BRPI0807290A2 (pt) 2016-10-11
US9326979B2 (en) 2016-05-03
CA2679316A1 (en) 2008-09-12
WO2008108286A9 (ja) 2009-10-08
EP2123274B1 (en) 2016-08-24
HK1134041A1 (en) 2010-04-16
ES2591278T3 (es) 2016-11-25
JP2013189451A (ja) 2013-09-26
CN101621999A (zh) 2010-01-06
JPWO2008108286A1 (ja) 2010-06-17
CA2679316C (en) 2016-11-29
EP2123274A4 (en) 2013-05-29
JP5313868B2 (ja) 2013-10-09
KR101521989B1 (ko) 2015-05-28
RU2009136444A (ru) 2011-04-10
CN101621999B (zh) 2012-09-26

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