KR960703004A - 혈장 약물 농도의 신속한 초기 증가량을 시현하는 24시간 경구용 오피오이드 제형을 투여함으로써 통증을 치료하는 방법 - Google Patents

혈장 약물 농도의 신속한 초기 증가량을 시현하는 24시간 경구용 오피오이드 제형을 투여함으로써 통증을 치료하는 방법 Download PDF

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KR960703004A
KR960703004A KR1019950705603A KR19950705603A KR960703004A KR 960703004 A KR960703004 A KR 960703004A KR 1019950705603 A KR1019950705603 A KR 1019950705603A KR 19950705603 A KR19950705603 A KR 19950705603A KR 960703004 A KR960703004 A KR 960703004A
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opioid
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새클러 리차드
골든하임 폴
카이코 로버트
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마틴 그리네
유로셀티크, 에스.에이.
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Abstract

환자들은 투여시 오피오이드의 최저 유효진통농도가 보다 빨리 달성되도록 초기의 신속한 오피오이드 흡수를 제공하는 24시간 경구용 지속방출성 오피오이드 제형으로 치료된다. 이러한 지속방출성 오피오이드 제형들은 사람 환자에 있어서 경구 투여후 최소 24시간 동안 진통효과를 제공하는 유효속도로 오피오이드 진통진통제를 방출시키는 유효량의 적어도 하나의 지연물질을 포함하고, 1시간 부터 약 8시간 까지의 흡수반감기를 제공하는 것을 특징으로 한다. 이러한 지속방출성 오피오이드 제형을 이용하여 사람 환자를 적정하는 방법도 본원에 개시되어 있다.

Description

혈장 약물 농도의 신속한 초기 증가량을 시현하는 24시간 경구용 오피오이드 제형을 투여함으로써 통증을 치료하는 방법
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
제1도는 실시예 1(공복)에 대한 평균 진정(sedation)대 시간 곡선 그래프이다,
제2도는 실시예 2(공복)에 대한 평균 진정(sedation)대 시간 곡선 그래프이다,
제3도는 실시예 1(공복)에 대한 평균 호흡률 대 시간 곡선 그래프이다.

Claims (26)

  1. 오피오이드 진통제, 및 사람 환자에 있어서 경구 투여후 최소 24시간 동안 진통효과를 제공하는 유효속도로 오피오이드 진통제를 방출시키는 유효량의 적어도 하나의 지연물질을 포함하며, 사람 환자에게 투여될 때 상기 오피오이드의 혈장농도의 초기의 신속한 증가율을 제공하는 경구용 지속방출성 오피오이드 제형으로서, 공복상태에서 투여될 때 1시간 부터 8시간 까지의 흡수반감기를 제공하는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  2. 제1항에 있어서, 상기 지속방출성 오피오이드 제형이 1시간 부터 약6시간 까지의 흡수반감기를 제공하는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  3. 제1항에 있어서, 상기 지속방출성 오피오이드 제형이 1시간 부터 약 3시간 까지의 흡수반감기를 제공하는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  4. 제1항 내지 제3항중 어느 하나의 항에 있어서, 상기 오피오이드 진통제가 히드로모르폰, 옥시코돈, 디히드로코데인, 코데인, 디히드로모르핀, 모르핀, 부프레노르핀, 전술한 것들의 염들 및 전술한 것들중 임의의 것의 혼합물로 구성되는 군으로부터 선택되는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  5. 제1항 내지 제3항중 어느 하나의 항에 있어서, 상기 오피오이드 진통제가 알펜타닐, 알릴프로딘, 알파프로딘, 이닐레리딘, 벤질모르핀, 벤지트라미드, 부프레노르핀, 부토르파놀, 클로니타젠, 코데인, 시클라조신, 데소모르핀, 덱스트로모르아미드, 데조신, 디암프로미드, 디히드로코데인, 디히드로모르핀, 디메녹사들, 디메펩타놀, 디메틸티암부텐, 디옥사페닐 부틸레이트, 디피파논, 엡타조신, 에토헵타진, 에틸메틸티암부텐, 에틸모르핀, 에토니타젠, 펜타닐, 헤로인, 히드로코데인, 히드로모르폰, 히드록시페티딘, 이소메타돈, 케토베미돈, 레발로르판, 레보르파놀, 레보펜아실모르판, 로펜타닐, 메페리딘, 멥타지놀, 메타조신, 메타돈, 메토폰, 모르핀, 미로핀, 날부핀, 나르세인, 니코모르핀, 노르레보르파놀, 노르메타돈, 날로르핀, 노르모르핀, 노르피파논, 오피움, 옥시코돈, 옥시모르폰, 파파베레툼, 펜타조신, 페나독손, 페노페리딘, 피미노딘, 피리트라미드, 프로펩타진, 프로메톨, 프로페리딘, 프로피람, 프로폭시핀, 수펜타닐, 트라마톨, 틸리딘, 그의 염, 전술한 것들중 임의의 것들의 혼합물로 구성되는 군으로부터 선택되는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  6. 제1항 내지 제3항중 어느 하나의 항에 있어서, 상기 오피오이드가 모르핀이고, 상기 오피오이드의 최고 혈장농도가 30mg 도스의 모르핀 황산염을 기준으로 할 때 약 2ng/㎖부터 약 14ng/㎖ 까지인 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  7. 제1항 내지 제3항중 어느 하나의 항에 있어서, 상기 오피오이드가 모르핀이고, 상기 오피오이드의 최고 혈장농도가 30mg 도스의 모르핀 황산염을 기준으로 할 때 약 3ng/㎖부터 약 8ng/㎖ 까지인 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  8. 제1항 내지 제3항중 어느 하나의 항에 있어서, 상기 오피오이드 진통제가 약 2mg 내지 약 64mg까지의 히드로모르폰으로 구성되는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  9. 제1항 내지 제3항중 어느 하나의 항에 있어서, 상기 오피오이드 진통제가 약 5mg 내지 약 800mg까지의 모르핀으로 구성되는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  10. 제1항 내지 제3항중 어느 하나의 항에 있어서, 상기 오피오이드 진통제가 약 5mg 내지 약 400mg까지의 옥시코돈으로 구성되는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  11. 제1항 내지 제10항중 어느 하나의 항에 있어서, 상기 제형이 투여후 약 2시간 및 약 10시간 사이에 오피오이드의 생체내에서의 최고 혈장농도를 제공하는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  12. 제1항 내지 제11항중 어느 하나의 항에 있어서, 상기 지연물질이 아크릴폴리머, 알킬셀룰로오스, 쉘락, 제인, 수소첨가 식물성유, 수소첨가 캐스터오일, 및 전술한 것들의 임의의 혼합물로 구성되는 군으로부터 선택되는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  13. 제1항 내지 제12항중 어느 하나의 항에 있어서, 상기 제형이 상기 오피오이드를 포함하고 약 0.5mm부터 약 2mm까지의 직경을 갖는 다수의 기질을 포함하는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  14. 제13항에 있어서, 상기 지연물질이 상기 기질의 표면에 코팅되는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  15. 제13항에 있어서, 상기 기질이 상기 오피오이드 진통제로 코팅된 불활성 비드를 포함하고, 더 나아가 상기 제형에 지속방출 특성을 부여하고 지연물질을 함유 하는 것을 특징으로 하는 외측 코팅제를 포함하는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  16. 제13항에 있어서, 상기 기질이 상기 오피오이드 진통제와 상기 지연물질의 실질상 균일한 혼합물의 매트릭스를 포함하는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  17. 제1항 내지 제16항중 어느 하나의 항에 있어서, 상기 오피오이드의 도스의 일부분이 상기 제형내에 즉방성 형태로 포함되는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  18. 제1항 내지 제17항중 어느 하나의 항에 있어서, 상기 제형이 투여후 약 2시간 및 약 10시간 사이에 상기 오피오이드의 생체내에서의 최고 혈장농도를 제공하는 것을 특징으로 하는 경구용 지속방출성 오피오이드 제형.
  19. (1)도스의 오피오이드 진통제, 및 사람 환자에 있어서 경구 투여후 최소 24시간 동안 진통효과를 제공하는 유효속도로 오피오이드 진통제를 방출시키는 유효량의 적어도 하나의 지연물질을 포함하며, 사람 환자에게 투여될 때 상기 오피오디의 혈장농도의 초기의 신속한 증가율을 제공하는 경구용 지속방출성 오피오이드 제형으로서, 공복상태에서 투여될 때 1시간부터 약 8시간 까지의 흡수반감기를 제공하는 것을 특징으로 하는 단위 도스의 지속방출성 오피오이드 제형을 사람 환자에게 1일-1회 기초로 투여하는 단계; (2)사람 환자내에서 상기 제형이 시현하는 약력학 및 약동학 파라미터를 모니터하여 반복적으로 상기 약력학 및/또는 약동학 파라미터가 상기 환자의 치료에 적합한지 아닌지 여부를 결정하는 단계; (3)상기 약력학 및/또는 약동학 파라미터가 만족스럽지 못하다고 판단되는 경우 서로 상이한 양의 오피오이드 진통제를 함유하는 단위 도스의 상기 지속방출성 오피오이드진통제 제형을 환자에게 투여함으로써 환자에게 투여되는 상기 지속방출성 오피오이드 진통제 제형의 도스를 조절함에 의해 또는 상기 약력학 및/또는 약동학 파라미터가 적당한 것으로 생각되는 경우에 이전에 투여되었던 양의 단위 도스로 상기 오피오이드 진통제의 도스를 유지함에 의해 환자를 적정하는 단계; (4)상기 환자에게서 적당한 정상상태 약력학 및/또는 약동학 파라미터가 달성될 때 까지 상기 오피오이드 진통제의 도스를 조절함으로써 단계(3)적정을 계속하는 단계; 및 (5)치료가 끝날 때가지 1일-1회 기초로 도스의 상기 경구용 지속방출성 제형내의 오피오이드 진통제의 투여를 계속하는 단계를 포함하는 것을 특징으로 하는 지속방출성 경구용 오피오이드 제형으로 사람 환자를 적정하는 방법.
  20. 도스의 오피오이드 진통제, 및 사람 환자에 있어서 경구 투여후 최소 24시간 동안 진통효과를 제공하는 유효속도로 오피오이드 진통제를 방출시키는 유효량의 적어도 하나의 지연물질을 포함하며, 사람 환자에게 투여될 때 상기 오피오이드의 혈장농도의 초기의 신속한 증가율을 제공하는 경구용 지속방출성 오피오이드 제형으로서, 공복상태에서 투여될 때 1시간부터 약 8시간 까지의 흡수반감기를 제공하는 것을 특징으로 하는 단위 도스의 지속방출성 오피오이드 제형을 포함하는 1일-1회 투여용 경구용 지속방출성 오피오이드 제형의 제조방법.
  21. 제19항 또는 제20항에 있어서, 상기 지속방출성 오피오이드 제형이 1시간 부터 약 6시간 까지의 흡수반감기를 제공하는 특징으로 하는 방법.
  22. 제19항 또는 제20항에 있어서, 상기 지속방출성 오피오이드 제형이 1시간 부터 약 3시간 까지의 흡수반감기를 제공하는 특징으로 하는 방법.
  23. 직경이 약 0.1mm부터 약 3mm이고 약 24시간 이상 동안 상기 오피오이드 진통제의 치료유효 혈중농도를 제공하도록 지속방출성 형태로 제조된 단위 도스의 오피오이드 진통제를 포함하는 다수의 기질을 제조하는 단계 및 상기 단위 소스를 환자에게 투여하여 약 24시간 동안 극심한 통증을 경감시키는 단계를 포함하는 환자를 1일-1회 경구투여용 생체이용성 지속-방출성 오피오이드 진통제 적량형태로 치료하는 방법.
  24. 제23항에 있어서, 상기 기질을 구상체, 비드, 미소구체, 종자, 펠렛, 이온교환수지비드, 과립 및 이들의 혼합으로 구성되는 군으로부터 선택된 형태로 제조하는 단계를 추가로 포함하는 방법.
  25. 제23항에 있어서, 상기 방법이 상기 기질을 불황성 비드를 상기 오피오이드 진통제로 코팅한 다음 아크릴폴리머, 알킬셀룰로오스, 쉘락, 제인, 수소첨가 식물성유, 수소첨가 캐스터오일, 및 전술한 것들의 임의의 혼합물로 구성되는 군으로부터 선택되는 소수성 물질로 오버코팅하는 단계를 추가로 포함하는 방법.
  26. 제23항에 있어서, 상기 방법이 상기 기질을 상기 오피오이드 진통제와 소수성 물질의 실질상 균일한 혼합물의 매트릭스로 제조하는 단계를 제조하는 단계를 추가로 포함하는 방법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019950705603A 1993-11-23 1994-11-22 혈장 약물 농도의 신속한 초기 증가량을 시현하는 24시간 경구용 오피오이드 제형을 투여함으로써 통증을 치료하는 방법 KR100201767B1 (ko)

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US08/156,468 US5478577A (en) 1993-11-23 1993-11-23 Method of treating pain by administering 24 hour oral opioid formulations exhibiting rapid rate of initial rise of plasma drug level
PCT/US1994/013606 WO1995014460A1 (en) 1993-11-23 1994-11-22 Opioid formulations for treating pain

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