KR970703130A - 플루티카손 프로피오네이트 제제(Fluticasone Propionate Formulations) - Google Patents

플루티카손 프로피오네이트 제제(Fluticasone Propionate Formulations)

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Publication number
KR970703130A
KR970703130A KR1019960706578A KR19960706578A KR970703130A KR 970703130 A KR970703130 A KR 970703130A KR 1019960706578 A KR1019960706578 A KR 1019960706578A KR 19960706578 A KR19960706578 A KR 19960706578A KR 970703130 A KR970703130 A KR 970703130A
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South Korea
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formulation
sorbitan monolaurate
polyoxyethylene
surfactant
fluticasone propionate
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KR1019960706578A
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English (en)
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KR100361413B1 (ko
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데이비드 알렉산더 타인쉬
트레버 레슬리 일로트
도로시 질 스넬
리 퐁 람
Original Assignee
그라함 브레레톤
글락소 웰컴 오스트레일리아 리미티드
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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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

본 발명은 흡입에 의해 약물을 투여하기 위해 사용되는 제제에 관한 것이다. 특히, 본 발명은 실질적으로 모든 입자의 크기가 12미크론 미만인 플루티카손 프로피오네이트, 1종 이상의 계면 활성제, 1종 이상의 완충제 및 물을 포함하는 제제에 관한 것이다. 또한, 상기 제제의 유효량을 흡입에 의해 투여하는 것으로 이루어지는 호흡기 질환의 치료 방법이 기술된다.

Description

플루티카손 프로피오네이트 제제(Fluticasone Propionate Formulations)
[도면의 간단한 설명]
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (17)

  1. (a) 실질적으로 모든 입자의 크기가 12미크론 미만인 플루티카손 프로피오네이트, (b) 1종 이상의 계면활성제, (c) 1종 이상의 완충제 및 (d) 물을 포함하는, 분무에 적합한 제제.
  2. 제1항에 있어서, 플루티카손, 프로피오네이트의 입자 크기가 1 내지 6미크론인 제제.
  3. 제1항 또는 2항에 있어서, 플루티카손 프로피오네이트가 제제의 고상 성분의 총 중량을 기준으로 하여 0.5 내지 10%(w/w)의 양으로 존재하는 제제.
  4. 제1항 내지 3항 중 어느 한 항에 있어서, 계면 활성제가 제제의 고상 성분의 총 중량을 기준으로 하여 0.25 내지 0.75%(w/w)의 양으로 존재하는 제제.
  5. 제1항 내지 4항 중 어느 한 항에 있어서, 계면 활성제가 소르비탄 트리올레에이트, 소르비탄 모노-올레에이트, 소르비탄 모노라우레이트, 폴리옥시에틸렌(20) 소르비탄 모노라우레이트, 폴리옥시에틸렌(20) 소르비나 모노-올레에이트, 천연 레시틴, 올레일 폴리옥시에틸렌(2)에테르, 스테아릴 폴리옥시에틸렌(2)에테르, 라우릴 폴리옥시에틸렌(4)에테르, 옥시에틸렌과 옥시프로필렌과의 블록 공중합체, 합성 레시틴, 디에틸렌 글리콜 디올레에이트, 테트라히드로푸르푸릴 올레에이트, 에틸올레에이트, 글리세릴 모노-올레에이트, 폴리에틸렌 글리콜 400 및 글리세릴 모노라우레이트로 이루어지는 군으로부터 선택되는 제제.
  6. 제5항에 있어서, 계면 활성제가 소르비탄 모노라우레이트 및 폴리옥시에틸렌(20) 소르비탄 모노라우레이트인 제제.
  7. 제6항에 있어서, 소르비탄 모노라우레이트 및 폴리옥시에틸렌(20) 소르비탄 모노라우레이트가 1：7.5 내지 1：8.25의 비율로 존재하는 제제.
  8. 제1항 내지 7항 중 어느 한 항에 있어서, 약 5 내지 약 7의 pH로 완충된 제제.
  9. 제1항 내지 8항 중 어느 한 항에 있어서, 등장성인 제제.
  10. 제1항 내지 9항 중 어느 한 항에 있어서, (a) 플루티카손 프로피오네이트(미세 분쇄됨) 0.25 내지 1.1mg/mℓ; (b) 폴리옥시에틸렌(20) 소르비탄 모노라우레이트 0.06 내지 0.09mg/mℓ; (c) 소르비탄 모노라우레이트 0.0075 내지 0.0125mg/mℓ; (d) 인산일나트륨 이수하물 9.25 내지 9.5mg/mℓ; (e) 이염기 인산나트륨 무수물1.6 내지 1.85mg/mℓ; (f) 염화나트륨 4.7 내지 4.9mg/mℓ; 및 (g) 물로 이루어지는 제제.
  11. 제10항에 있어서, (a) 플루티카손 프로피오네이트(미세 분쇄됨) 약 0.26mg/mℓ; (b) 폴리옥시에틸렌(20) 소르비탄 모노라우레이트 약 0.07mg/mℓ; (c) 소르비탄 모노라우레이트 약 0.009mg/mℓ; (d) 인산일나트륨 이수하물 약 9.4mg/mℓ; (e) 이염기 인산나트륨 무수물 약 1.75mg/mℓ; (f) 염화나트륨 약 4.8mg/mℓ; 및 (g) 물로 이루어지는 제제.
  12. 제10항에 있어서,(a) 플루티카손 프로피오네이트(미세 분쇄됨) 약 1.05mg/mℓ; (b) 폴리옥시에틸렌(20) 소르비탄 모노라우레이트 약 0.08mg/mℓ; (c) 소르비탄 모노라우레이트 약 0.01mg/mℓ; (d) 인산일나트륨 이수화물 약 9.4mg/mℓ; (e) 이염기 인산나트륨 무수물 약 1.75mg/mℓ; (f) 염화나트륨 약 4.8mg/mℓ; 및 (g) 물로 이루어지는 제제.
  13. 플루티카손 프로피오네이트를 계면 활성제 용액과 접촉시키고 생성되는 약물/계면 활성제 용액을 제제의 다른 성분과 혼합하는 것으로 이루어지는, 전항 중 어느 한 항에 따른 제제의 제조 방법.
  14. 제1항 내지 12항 중 어느 한 항에 따른 제제를 포함하는 용기.
  15. 소적이 흡입에 적합한 것인 제제의 다량의 소적을 제조하기 의한 분무기 중의 제1항 내지 12항 중 어느 한 항에 따른 제제의 용도.
  16. (a) 실질적으로 모든 입자의 크기가 12미크론 미만인 플루티카손 프로피오네이트, (b) 1종 이상의 계면 활성제, (c) 1종 이상의 완충제 및 (d) 물을 포함하는 제제의 유효량을 흡입에 의해 투여하는 것으로 이루어지는 호흡기 질환의 치료 방법.
  17. ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019960706578A 1994-05-21 1995-05-19 플루티카손 프로피오네이트 제제 KR100361413B1 (ko)

Applications Claiming Priority (2)

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GB9410222.5 1994-05-21
GB9410222A GB9410222D0 (en) 1994-05-21 1994-05-21 Medicaments

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KR970703130A true KR970703130A (ko) 1997-07-03
KR100361413B1 KR100361413B1 (ko) 2003-02-19

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KR1019960706578A KR100361413B1 (ko) 1994-05-21 1995-05-19 플루티카손 프로피오네이트 제제
KR1019960706549A KR970703132A (ko) 1994-05-20 1995-05-19 듀오카르마이신 유도체의 안정화 방법(method for stabilizing duocarmycin derivatives)

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ZA954101B (en) 1996-01-29
TW438604B (en) 2001-06-07
BR9507746A (pt) 1997-08-19
AU2614595A (en) 1995-12-18
US5993781A (en) 1999-11-30
DE69523587D1 (de) 2001-12-06
ES2164767T3 (es) 2002-03-01
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WO1995031964A1 (en) 1995-11-30
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