KR960003720A - 플루옥세틴 약제학적 제형 - Google Patents

플루옥세틴 약제학적 제형 Download PDF

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KR960003720A
KR960003720A KR1019950021265A KR19950021265A KR960003720A KR 960003720 A KR960003720 A KR 960003720A KR 1019950021265 A KR1019950021265 A KR 1019950021265A KR 19950021265 A KR19950021265 A KR 19950021265A KR 960003720 A KR960003720 A KR 960003720A
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멘디자발 아르체
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레르난도 레니즈 마르티네즈
릴리, 에스. 에이.
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Abstract

본 발명은 플루옥세틴 하이드로클로라이드 이외에 붕해제, 희석제, 활탁제, 잡착방지제, 감미제, 풍미제 및 임의로는 착색제 중에서 선택된 적절한 부형제 및 공보조제를 포함하며, 직접 압착법에 의해 분산성 정제를 제조하는데 적합한 플루옥세핀 하이드로클로라이드의 약제학적 제형에 관한 것이다. 위에서 언급한 제형은 19 내지 21℃의 수중에서 3분 이내에 붕해되는 분산성 정제의 제조에 적합하며, 우울증 치료에 적합하다.

Description

플루옥세틴 약제학적 제형
내용없음

Claims (25)

  1. 적절한 부형제 및 공보조제와 함께, 제형의 총 중량을 기준으로 하여, 활성 성분으로서의 플루옥세틴 하이드로 클로라이드를 4 내지 7.5중량% 함유하는, 직접 압착시켜 분산성 정제를 제조하기에 적합한 약제학적 제형.
  2. 제1항에 있어서, 적절한 부형제 및 공보조제가 붕해제, 희석제, 활탁제, 접착방지제, 감미제 및 풍미제로 이루어진 약제학적 제형.
  3. 제2항에 있어서, 혼입된 붕해제가 나트륨 전분 글리콜레이트, 아크릴산의 중합체성 유도체 및, 바람직하게는, 크로스포비돈인 약제학적 제형.
  4. 제3항에 있어서, 나트륨 전분 글리콜레이트가, 제형의 총 중량을 기준으로 하여, 9.5 내지 17중량%의 양으로 함유되는 약제학적 제형.
  5. 제3항에 있어서, 아크릴산 유도체가, 제형의 총 중량을 기준으로 하여, 10 내지 21중량%의 양으로 함유되는 제형.
  6. 제3항에 있어서, 크로스포비돈이, 제형의 총 중량을 기준으로 하여, 9 내지 13중량%의 양으로 함유되는 제형.
  7. 제2항에 있어서, 미세결정성 셀룰로즈, 락토오즈, 하이드록시프로필 셀룰로즈(HPC). 예비젤라틴화 전분, 무수 유동 전분 및 이들의 배합물과 혼합물을 희석제로서 함유하는 제형.
  8. 제7항에 있어서, 하이드록시프로필 셀룰로즈, 바람직하게는 L－HPC가, 제형의 총 중량을 기준으로 하여, 5 내지 25중량%의 양으로 함유되는 제형.
  9. 제7항에 있어서, 예비젤라틴화 전분과 하이드록시프로필 세룰로즈, 바람직하게는 L－HPC가 약 5중량%의 양으로 함유되는 제형.
  10. 제7항에 있어서, 미세결정성 셀룰로즈가, 제형의 총 중량을 기준으로 하여, 62 내지 76중량%의 양으로 함유되는 제형.
  11. 제10항에 있어서, 미세결정성 셀룰로즈의 평균 입자 크기가 50 내지 90μ인 제형.
  12. 제7항에 있어서, 제형의 총 중량을 기준으로 하여, 15 내지 27중량%의 무수 유동 전분과 46 내지 58중량%의 미세결정성 셀룰로즈를 함유하는 미세결정성 셀룰로즈와 무수 유동 전분의 배합물을 포함하는 제형.
  13. 제2항에 있어서, 활탁제로서의 스테아릴 나트륨 푸마레이트가, 제형의 총 중량을 기준으로 하여, 1 내지 2.5중량%의 양으로 함유되는 제형.
  14. 제2항에 있어서, 접착방재제로서의 콜로이드성 이산화규소가, 제형의 총 중량을 기준으로 하여, 1 내지 2중량%의 양으로 함유되는 제형.
  15. 제2항에 있어서, 인공 또는 천연 감미제 또는 이들의 혼합물을 함유하는 제형.
  16. 제15항에 있어서, 제형의 총 중량을 기준으로 하여, 인공 감미제로서의 나트륨 사카린이 0.4 내지 5ㅍ 또는 아스파탐이 약 1.6중량% 함유되는 제형.
  17. 제15항에 있어서, 천연 감미제로서 만니톨, 소르비톨, 암모늄 글리시리세이트 또는 이들의 혼합물을 함유하는 제형.
  18. 제17항에 있어서, 만니톨이, 제형의 총 중량을 기준으로 하여 2.5 내지 5중량%의 양으로 함유되는 제형.
  19. 제17항에 있어서, 소르비톨이, 제형 총 중량을 기준으로 하여, 1.5 내지 4중량%의 양으로 함유되는 제형.
  20. 제17항에 있어서, 암모늄 글리시리시네이트가, 제형의 총 중량을 기준으로 하여, 0.5 내지 1중량% 양으로 함유되는 제형.
  21. 제15항에 있어서, 제형의 총 중량을 기준으로 하여, 0.5 내지 4.5중량%의 나트륨 사카린과 2.5 내지 5중량%의 만니톨을 함유하는 나트륨 사카린과 만니톨의 혼합물을 포함하는 제형.
  22. 제15항에 있어서, 풍미제로서의 민트향, 페파민트향, 오렌지향, 복숭아향, 살구향, 라즈베리향, 레몬향, 코코넛향 및 파인애플향 또는 이들의 혼합물이, 제형의 총 중량을 기준으로 하여 1.4 내지 12.5중량%의 양으로 포함되는 제형.
  23. 제15항에 있어서, 감미제로서 만니톨 및 소르비톨을 함유하며, 풍미제로서, 제형의 총 중량을 기준으로 하여, 10 내지 12중량%의 딸기향, 0.6 내지 0.7중량%의 아니시드 또는 약 0.3중량%의 페파민트향의 또는 아니시드와 페파민트향의 혼합물을 함유하는 제형.
  24. 제1항 내지 제23항 중의 어느 한 항에 따르는 약제학적 제형을 직접 압착시켜 수득할 수 있는, 플루옥세틴 하이드로클로라이드를 함유하는 분산성 정제.
  25. 제1항 내지 제23항 중의 어느 한 항에 있어서 언급한 약제학적 제형을 직접 압착시킴을 포함하여, 플루옥세틴 하이드로클로라이드를 함유하는 분산성 정제를 제조하는 방법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019950021265A 1994-07-20 1995-07-20 플루옥세틴약제학적제제 KR100360130B1 (ko)

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ES09401593A ES2082723B1 (es) 1994-07-20 1994-07-20 Formulacion farmaceutica de fluoxetina en forma dispersable.
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ATE200733T1 (de) 2001-05-15
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