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KR950703936A - 항정신병약 함유 서방성 마이크로스피어 및 이의 제조법(sustained-release microsphere containing antipsychotic and process for producing the same) - Google Patents

항정신병약 함유 서방성 마이크로스피어 및 이의 제조법(sustained-release microsphere containing antipsychotic and process for producing the same) Download PDF

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KR950703936A
KR950703936A KR1019950701853A KR19950701853A KR950703936A KR 950703936 A KR950703936 A KR 950703936A KR 1019950701853 A KR1019950701853 A KR 1019950701853A KR 19950701853 A KR19950701853 A KR 19950701853A KR 950703936 A KR950703936 A KR 950703936A
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acid
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antipsychotic
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release microsphere
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시게미 기노
도모노리 오사지마
히로아키 미즈타
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고야 마사시
요시토미 세이야쿠 가부시키가이샤
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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Abstract

본 발명은 브롬페리돌 또는 할로페리돌등의 소수성 항정신병약을 폴리락트산 또는 락트산·글리콜산 공중합체등의 생체내 조직적합성 고분자 중합물로 된 기제에 포함시켜 이루어지는 서방성 마이크로스피어 및 이의 제조법에 관한 것이다.
장기간 투여가 필요한 경우, 매일 투여하는 대신에 1내지 8주간에 1회의 주사로 소정의 약리효과를 얻을 수 있다. 그 결과, 유지요법시의 콤플라이언스의 현저한 향상이 기대될 수 있다. 또, 생체내 조직적합성 고분자 중합물을 사용하므로 매립등의 외과수술이 일체 불필요하고, 일반적인 현탁 주사제와 완전히 동일한 방식으로 용이하게 피하 및 근육내에 투여할 수 있어서, 재차 제거해낼 필요가 없다. 그밖에도 투여시의 저항감, 통증이 적다.

Description

항정신병약 함유 서방성 마이크로스피어 및 이의 제조법(SUSTAINED-RELEASE MICROSPHERE CONTAINING ANTIPSYCHOTIC AND PROCESS FOR PRODUCING THE SAME)
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
제1도는 실시예 1내지 3에서 수득한 마이크로스피어를 래트 근육내 투여한 부위에 있어서의 브롬페리돌의 잔존량을 도시한 도면이다,
제2도는 실시예4에서 수득한 할로페리돌 함유 마이크로스피어를 래트근육내 투여한 후의 혈장중 농도 추이를 도시한 도면이다,
제3도는 실시예 3에서 수득한 마이크로스피어의 시험관에서의 방출 시험 결과를 도시한 도면이다.

Claims (20)

  1. 소수성 향정신병약을 생체내 조직적합성 고분자 중합물로 된 기제에 포함시켜 이루어진 항정신병약 함유서방성 마이크로스피어.
  2. 제1항에 있어서, 소수성 항정신병약이 할로페리돌, 브롬페리돌, 플루페나진, 클로르프로마진, 설피리드, 칼피프라민, 클로카프라민, 모사프라민, 라스페리돈, 클로자핀, 오란자핀 셀틴돌 또는 이들의 의약으로서 허용되는 산 부가염으로부터 선택되는 항정신병약 함유 서방성 마이크로스피어.
  3. 제1항 또는 제2항에 있어서, 소수성 항정신병약이 할로페리돌, 브롬페리돌, 말레이산 플루페나진, 클로르프로마진, 히벤즈산 클로르프로마진, 설피리드, 염산 칼피프라민, 말레이산 칼피프라민, 염산 클로카프라민, 염산 모사프라민, 리스페리돈, 클로자핀, 오란자핀 및 셀틴돌로부터 선택되는 항정신병약 함유 서방성 마이크로스피어.
  4. 제1항에 있어서, 소수성 항정신병약이 할로페리돌 및 브롬페니돌로부터 선택되는 항정신병약함유 서방성 마이크로피어.
  5. 제1항에 있어서, 생체내 조직적합성 고분자 중합물이 지방상 에스테르의 중합체 또는 이의 공중합체, 폴리아크릴산 에스테르류, 폴리히드록시부티르산류, 폴리알킬렌 옥살레이트류, 폴리오르토에스테르, 폴리카르보네이트 및 폴리아미노산류중 1종 또는 2종 이상으로부터 선택되는 향정신병약 함유 서방성 마이크로스피어.
  6. 제1항 내지 제5항중 어느 한 항에 있어서, 생체내 조직적합성 고분자 중합물이 폴리락트산, 폴리글리콜산, 폴리시트르산, 폴리말산 및 락트산·글리콜산 공중합체중 1종 또는 2종 이상으로부터 선택되는 지방산 에스테르의 중합체 또는 공중합체인 항정신병약 함유 서방성 마이크로스피어.
  7. 제1항 내지 제6항중 어느 한 항에 있어서, 생체내 조직적합성 중합물이 폴리락트산, 폴리글리콜산, 폴리시트르산, 폴리말산, 락트산·글리콜산 공중합체, 폴리 α-시아노아크릴산 에스테르, 폴리 β-히드록시부티르산, 폴리트리메틸렌 옥살레이트, 폴리오르토에스테르, 폴리오르타르보네이트, 폴리에틸렌 카르보네이트, 폴리 γ-벤질-L-글루타민산 및 폴리 L-알라닌중 1종 또는 2종 이상으로부터 선택되는 항정신병약 함유 서방성 마이크로스피어.
  8. 제1항 내지 제7항중 어느 한 항에 있어서, 소수성 항정신병약이 평균 입자 직경 5㎛이하의 미결정인 항정신병약 함유 서방성 마이크로스피어.
  9. 제1항 내지 제8항중 어느 한 항에 있어서, 항정신병약 함유 서방성 마이크로스피어가 수성 현택제인 항정신병약 함유 마이크로스피어.
  10. 소수성 항정신병약을 포함하는 생체내 조직적합성 고분자 중합물의 용액을 유층으로 하여, 이 유층을 수층중에 첨가하고, 이어서 유화조작을 수행하여 0/W형 유화물을 만들고, 그 후 유층중의 용액을 액중건조법에 의해 탈리시키는 것을 특징으로 하는 항정신병약 함유 서방성 마이크로스피어.
  11. 제10항에 있어서, 소수성 항정신병약이 할로페리돌, 브롬페리돌, 플로페나진, 클로르프로마진, 설피리드, 칼피프라민, 클로카프라민, 모사프라민, 리스페리돈, 클로자핀, 오란자핀 및 셀틴돌또는 이들의 의약으로서 허용되는 산 부가염으로부터 선택되는 항정신병약 함유 서방성 마이크로스피어 제조법.
  12. 제10항 또는 제11항에 있어서, 소수성 항정신병약이 할로페리돌, 브롬페리돌, 말레인산 플루페나진, 클로르프로마진, 히벤즈산 클로로프마진, 설피리드, 염산 칼피프라민, 말레인산 칼피프라민, 염산 클로카프라민, 염산 모사프라민, 리스페리돈, 클로자핀, 오란자핀 및 셀틴돌로부터 선택되는 항정신병약 함유 서방성 마이크로스피어의 제조법.
  13. 제10항에 있어서, 소수성 항정신병약이 할로페리돌 및 브롬페리돌로부터 선택되는 항정신병약 함유 서방성 마이크로스피어의 제조법.
  14. 제10항에 있어서, 생체내 조직적합성 고분자 중합물이 지방산 에스테르의 중합체 또는 이의 공중합체, 폴리아크릴산 에스테르류, 폴리히드록시부티르산류, 폴리알킬렌 옥살레이트류, 폴리오트로에스테르, 폴리카르보네이트 및 폴리아미노산류중 1종 또는 2종 이상으로부터 선택되는 항정신병약 함유 서방성 마이크로스피어의 제조법.
  15. 제10항 내지 제14항중 어느 한 항에 있어서, 생체내 조직적합성 고분자 중합물이 폴리락트산, 폴리글리콜산, 폴리리시트르산, 폴리말산 및 락트산·글리콜산 공중합체중 1종 또는 2종 이상으로 부터 선택되는 지방산 에스테르의 중합체 또는 공중합체인 항정신병약 함유 서방성 마이크로스피어의 제조법.
  16. 제10항 내지 제15항중 어느 한 항에 있어서, 생체내 조직적합성 중합물이 폴리락트산, 폴리글리콜산, 폴리시트르산, 폴리말산, 락트산·글리콜산 공중합체, 폴리 α-시아노아크릴산 에스테르, 폴리 β-히드록시부티르산, 폴리트리메틸렌 옥살레이트, 폴리오르토에스테르, 폴리오르토카르보네이트, 폴리에틸렌 카르보네이트, 폴리 γ-벤질-L-글루타민산 및 폴리 L-알라닌중 1종 또는 2종 이상으로부터 선택되는 항정신병약 함유 서방성 마이크로스피어의 제조법.
  17. 제10항 내지 제16항중 어느 한 항에 있어서, 소수성 항정신병약이 평균 입자 직경 5㎛이하의 미결정인 항정신병약 함유 서방성 마이크로스피어의 제조법.
  18. 제10항 내지 제17항중 어느 한 항에 있어서, 생체내 조직적합성 고분자 중합물의 용액의 용매가 비등점 120℃ 이하이고 물과 혼화되지 않는 용매인 항정신병약 함유 서방성 마이크로스피어제조법.
  19. 제10항 내지 제18항중 어느 한 항에 있어서, 수층에 유화제로서 음이온성 계면활성제, 비이온성 계면활성제, 폴리비닐피롤리돈, 폴리비닐알코올, 카르복시메틸셀룰로오스, 레시틴 및 젤라틴으로 부터 선택된 1종 도는 2종 이상의 화합물을 첨가하는 것을 포함하는 항정신병약 함유 서방성 마이크로스피어의 제조법.
  20. 제10항 내지 제19항중 어느 한 항에 있어서, 항정신병약 함유 서방성 마이크로스피어가 수성 현탁제인 항정신병약 함유 서방성 마이크로스피어의 제조법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019950701853A 1992-11-17 1993-11-15 항정신병약함유서방성마이크로스피어및이의제조방법 KR100333115B1 (ko)

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