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KR19990035795A - 호르몬 패치 - Google Patents

호르몬 패치 Download PDF

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KR19990035795A
KR19990035795A KR1019980700454A KR19980700454A KR19990035795A KR 19990035795 A KR19990035795 A KR 19990035795A KR 1019980700454 A KR1019980700454 A KR 1019980700454A KR 19980700454 A KR19980700454 A KR 19980700454A KR 19990035795 A KR19990035795 A KR 19990035795A
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drug formulation
acrylate
estradiol
gestagen
oleic acid
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귄터 코르데스
마르틴 시그문트
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파퀘스, 파우쓰-베르구스
그뤼넨탈 게엠베하
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    • 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
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • 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
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • 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
    • A61K47/06—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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal 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
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • A61K9/7061—Polyacrylates

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Steroid Compounds (AREA)
  • Power Steering Mechanism (AREA)
  • Surgical Instruments (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)

Abstract

본 발명은 약물로서의 에스트로겐 및 게스타겐, 또는 게스타겐 또는 안드로겐, 아크릴레이트 접착제 및 흡수 증진제로서 올레산과 2-(2-에톡시에톡시)에탄올의 2개 물질을 포함하는 경피 치료 시스템(TTS)에 관한 것이다.

Description

호르몬 패치
본 발명은 3개 이하의 약물이 포함되어 있고, 이러한 약물이 경피 치료 시스템(transdermal therapeutic system; TTS)으로부터 피부를 통해 사람 또는 동물의 체내(전신계적 순환)로 방출되는, TTS라고도 불리는 피부에 적용시키는 패치(patch)에 관한 것이다. 피부 패치는 배면 필름 및 약물과 기타 물질(예: 흡수 촉진제)이 존재하는 감압성 접착제를 포함한다. 또한, 추가의 접착층은 패치가 사용되기 전에 잡아당겨 제거하는 보호 필름으로서 임의로 제공된다.
약물의 경피 투여용 피부 패치는 공지되어 있다. 이러한 제제와 관련된 한가지 문제는 국소 제제중 피부상에 침적되거나 쌓이는 많은 약물의 충분한 양이 피부를 통과하지 않기 때문에 단위 면적 및 단위 시간당 다량의 활성 성분이 충분히 흡수되도록 하는데 있다.
이러한 이유로 인하여, 침투 개선제, 흡수 증진제 또는 향상제라고 불리는 소위 흡수 촉진제가 연구되어 왔고 피부 패치내에 혼입되었다. 이러한 방식으로, 바람직한 약리학적 효과를 우선적으로 달성하는 것이 가능하다. 흡수 촉진제의 예는 프로필렌 글리콜, 저 분자량의 폴리에틸렌 글리콜, 올레산, 이소프로필 미리스테이트, 미리스톨, "가트포세(Gattefosse)" 트랜스큐톨, "헨켈(Henkel)" 유타놀, 글리세롤 모노라우레이트(="Huls" Imvitor 312), 리시놀산의 부분 글리세라이드(="Huls" Softigen 701), 불포화된 폴리글리콜화 글리세라이드(="Gattefosse" Labrafil M1944CS), "가트포세" 라브라팍 하이드로 WL1219(Labrafac Hydro WL1219), 에스타산 GT60, 포화된 폴리글리콜화 글리세라이드(="Gattefosse" Labrasol), 인지질 등을 포함한다[참조: Rieg-Falson, F. et al. 1989, Watkinson, A. C. et al. 1991, and Hadgraft, J. and Guy, R. H. (eds): Marcel Dekker Inc. N.Y. 1989).
본 발명은 에스트로겐(예: 에스트라디올 및 에티닐 에스트라디올), 게스타겐(예: 노르에티스테론 아세테이트, 레보노르게스트렐 또는 클로르마디논 아세테이트) 및/또는 안드로겐(예: 테스토스테론)에 대한 향상제로서 TTS중에서 2개의 물질, 즉 올레산과 2-(2-에톡시에톡시)에탄올의 혼합물을 함께 사용하는 것에 관한 것이다.
상이한 약물을 포함하는 피부 패치를 개발하기 위한 본 발명자의 연구에 있어, 다수의 침투 개선제가 제형중에 혼입되고, 활성 성분의 방출이 시험되었다. 활성 성분의 방출은 USP 패들 장치(USP paddle apparatus: United States Pharmacopoeia XXIII에 기술)내에서 시험되었고, "털이 없는 마우스 피부"를 통한 침투가 프란츠 셀 모델[Franz cell model : Franz cell: Franz, T.J., J. Invest. Dermatol. 1975 (64), pages 191-195]을 사용하여 시험되었으며, 사람 각질층을 통한 침투가 또한 프란츠 셀내에서 시험되었다. 침투-증진 물질은 올레산 DAB 10, 2-(2-에톡시에톡시)에탄올, 유타놀 G(DAB 10), 라브라팍(Labrafac) 및 라브라필(Labrafil)과 올레산/2-(2-에톡시에톡시)에탄올, 올레산/라브라필, 및 올레산/라브라팍을 대략 1:1의 비율로 포함하는 혼합물을 포함한다.
USP 패들 장치내에서 시간에 따른 활성 성분의 방출은 큰 차이를 나타내지 않는다. 그러나, 동물 피부 및 특히 사람 각질층을 통한 침투의 측정시, 향상제로서 올레산과 2-(2-에톡시에톡시)에탄올의 대략 1:1의 혼합물을 사용하여 제조된 피부 패치가 향상제 각각을 첨가하거나 향상제를 첨가하지 않고 관측한 것보다 현저히 높은 침투율을 제공함이 밝혀졌다. 올레산과 2-(2-에톡시에톡시)에탄올의 혼합물이 올레산과 기타 향상제의 혼합물을 사용한 경우에 수득된 침투율보다 더욱 높은 침투율을 제공한다는 사실은 놀라운 것이다. 올레산과 2-(2-에톡시에톡시)에탄올의 혼합물은 특수한 흡수-촉진 특성에 의해 명백히 구별된다.
또한, 이들 물질은 2개 모두 공지된 것이고, 약제학적 제제중에서 부형 물질로서 통상적이고 무해한 것이며, 부작용의 위험을 포함하고 이들이 사람용 의약에 사용될 수 있기전에 장기간의 독성 실험에서 시험되어야만 하는 신규의 화학 물질이 아니라는 것이 장점으로서 강조된다.
하기 실시예에 본 특허원에 따른 피부 패치 및 비교용 피치가 제조될 수 있는 방법을 제공한다. 또한, 활성 성분의 방출에 있어서의 결과 및 침투 시험 결과가 기술되어 있다. 당해 분야의 숙련가에게 친숙한 HPLC 방법은 촉진제 매질중 활성 성분 함량의 분석을 위해 사용되었다.

Claims (8)

  1. 약물로서 에스트로겐과 게스타겐, 또는 게스타겐 또는 안드로겐, 아크릴레이트계 감압성 접착제 및 흡수 증진제로서 올레산과 2-(2-에톡시에톡시)에탄올의 2개 물질을 포함하는 경피 치료 시스템(transdermal therapeutic system: TTS).
  2. 제1항에 있어서, 에스트로겐이 에스트라디올 또는 에티닐 에스트라디올이고 게스타겐이 노르에티스테론 아세테이트, 레보노르게스트렐, 프로게스테론 또는 클로르마디논 아세테이트이며 안드로겐이 테스토스테론이고, 여기서 염 또는 에스테르, 또는 염기가 또한 사용될 수 있는 약물 제제.
  3. 제1항 또는 제2항에 있어서, 아크릴레이트계 감압성 접착제가 부틸 아크릴레이트, 2-에틸헥실 아크릴레이트, 메타크릴레이트, 비닐 아세테이트, 아크릴산 및 하이드록시에틸 아크릴레이트의 라디칼 중합에 의해, 또는 이들 단량체 일부 또는 모두의 혼합물로부터 수득되고/되거나 가교 결합제 및/또는 기타 부형 물질이 2% 미만의 양으로 가해짐을 특징으로하는 약물 제제.
  4. 제1항 내지 제3항중 어느 한 항에 있어서, 올레산 대 2-(2-에톡시에톡시)에탄올의 중량비가 2:1 내지 1:2, 바람직하게는 1.5:1 내지 1:1.5이고, 이 혼합물의 양이 모든 활성 성분과 부형제 물질을 포함하나 배면 필름과 같은 필름 및 방출 라이너는 제외된 패치 중량에 대해 1 내지 10중량%임을 특징으로하는 약물 제제.
  5. 제1항 내지 제4항중 어느 한 항에 있어서, 에스트라디올 및 노르에티스테론 아세테이트를 포함함을 특징으로하는 약물 제제.
  6. 제1항 내지 제4항중 어느 한 항에 있어서, 에스트라디올 및 레보노르게스트렐을 포함함을 특징으로하는 약물 제제.
  7. 제1항 내지 제4항중 어느 한 항에 있어서, 에티닐 에스트라디올 및 레보노르게스트렐을 포함함을 특징으로하는 약물 제제.
  8. 제1항 내지 제4항중 어느 한 항에 있어서, 테스토스테론을 포함함을 특징으로하는 약물 제제.
KR1019980700454A 1995-07-22 1996-07-22 호르몬 패치 Withdrawn KR19990035795A (ko)

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JP (1) JPH11504038A (ko)
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CN (1) CN1195994A (ko)
AT (1) ATE212234T1 (ko)
AU (1) AU6786696A (ko)
BR (1) BR9609794A (ko)
CA (1) CA2227538A1 (ko)
CZ (1) CZ20498A3 (ko)
DE (3) DE19526864A1 (ko)
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HU (1) HUP9900301A3 (ko)
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NO (1) NO980277D0 (ko)
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CA2227538A1 (en) 1997-02-06
ATE212234T1 (de) 2002-02-15
NO980277L (no) 1998-01-21
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DE19526864A1 (de) 1997-01-23
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HUP9900301A2 (hu) 1999-06-28
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