KR880008803A - 핵을 갖는 구형 과립 및 그의 제조방법 - Google Patents

핵을 갖는 구형 과립 및 그의 제조방법 Download PDF

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KR880008803A
KR880008803A KR1019880000707A KR880000707A KR880008803A KR 880008803 A KR880008803 A KR 880008803A KR 1019880000707 A KR1019880000707 A KR 1019880000707A KR 880000707 A KR880000707 A KR 880000707A KR 880008803 A KR880008803 A KR 880008803A
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drug
nucleus
spherical
spherical granules
granules
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KR1019880000707A
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KR960005138B1 (ko
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다다시 마끼노
데쓰로 다바따
신이찌로 히라이
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우메모또 요시마사
다께다야꾸힝고오교가부시끼가이샤
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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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug

Abstract

내용 없음.

Description

핵을 갖는 구형 과립 및 그의 제조방법
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (36)

  1. 약물 및 저치환된 히드록시프로필셀룰로오스를 함유하는 분무 분말로 피복된 핵을 갖는 구형 과립.
  2. 제1항에 있어서, 약물이 중추 신경계용 약물인 핵을 갖는 구형 과립.
  3. 제2항에 있어서, 중추 신경계용 약물이 디아제팜, 이 데베논, 아스피린, 이부프로펜, 파라세타몰, 나프록센, 피록시캄 디클로페낙, 인도메타신, 술린닥, 로라제팜, 니트라제팜, 페니토인, 아세토아미노펜, 에텐즈아미드 또는 케토프로펜인 핵을 갖는 구형 과립.
  4. 제1항에 있어서, 약물이 순환기계용 약물인 핵을 갖는 구형 과립.
  5. 제4항에 있어서, 순환기계용 약물이 몰시도민, 빈포세틴, 프로프라놀롤, 메틸도파, 디피리다몰, 푸로세미드, 트리암테렌, 니페디핀, 아테놀롤, 스피로노락톤, 메토프롤롤, 핀돌롤, 캅토프릴 또는 이소소르비드 니트레이트인 핵을 갖는 구형 과립.
  6. 제1항에 있어서, 약물이 호흡기계용 약물인 핵을 갖는 구형 과립.
  7. 제6항에 있어서, 호흡기계용 약물이 암렉사녹스, 댁스트로메토르판, 테오필린, 슈도에페드린, 살부타몰 또는 구아이페네신인 핵을 갖는 구형 과립.
  8. 제1항에 있어서, 약물이 소화기계용 약물인 핵을 갖는 구형 과립.
  9. 제8항에 있어서, 소화기계용 약물이 항궤양 활성을 갖는 벤즈이미다졸 화합물, 시메티딘, 라니티딘, 판크레아틴 또는 5-아미노살리실산인 핵을 갖는 구형 과립.
  10. 제9항에 있어서, 벤즈이미다졸 화합물을 하기 일반식으로 나타내는 핵을 갖는 구형 과립.
    [식중, R1은 수소, 알킬, 할로겐, 시아노, 카르복시, 카르보알콕시, 카르보알콕시알킬, 카르바모일, 카르바모일알킬, 히드록시, 알콕시, 히드록시알킬, 트리플루오로메틸, 아실, 카르바모일옥시, 니트로, 아실옥시, 아릴, 아릴옥시, 알킬티오 또는 알킬술피닐이고, R2는 수소, 알킬, 아실, 카르보알콕시, 카르바모일, 알킬카르바모일, 디알킬카르바모일, 알킬카르보닐메틸, 알콕시카르보닐메틸 또는 알킬술포닐이며, R3및 R5는 동일하거나 다르고, 각각 수소, 알킬, 알콕시 또는 알콕시알콕시이며, R4는 수소, 알킬, 임의로 플루오트화될 수도 있는 알콕시, 또는 알콕시알콕시이고, 및 m은 0 내지 4의 정수이다.]
  11. 제9항에 있어서, 벤즈아미다졸 화합물이 2-[(3-메틸-4(2,2,2-트리플루오로에톡시)-2-피리딜] 메틸술피닐] 벤즈이미다졸 또는 5-메톡시-2-[[4-메톡시-3,5-디메틸-2-피리딜)-메틸술피닐] 벤즈이미다졸인 핵을 갖는 구형 과립.
  12. 제1항에 있어서, 약물이 항생물질 또는 화학요법제인 핵을 갖는 구형 과립.
  13. 제12항에 있어서, 항생물질 또는 화학요법제가 세팔렉신 세팍로르, 세프라딘, 아목시실린, 피밤피실린, 바캄피실린, 디클록사실린, 에리쓰로마이신, 에리쓰로마이신 스테아레이트, 린코마이신, 독시싸이클린, 트리메토프림 또는 슐파메톡사졸린 핵을 갖는 구형 과립.
  14. 제1항에 있어서, 약물이 대사계용 약물인 핵을 갖는 구형 과립.
  15. 제14항에 있어서, 대사계용 약물이 세라펩타아제, 글리벤클라미드 또는 포타슘 클로라이드인 핵을 갖는 구형 과립.
  16. 제1항에 있어서, 약물이 비타민 약물인 핵을 갖는 구형 과립.
  17. 제16항에 있어서, 비타민 약물이 비타민B1, 비타민B2, 비타민B6, 비타민 C 또는 푸르술티아민인 핵을 갖는 구형 과립.
  18. 제1항에 있어서, 저 치환된 히드록시프로필셀룰로오스가 4 내지 20％의 히드록시프로폭실기 함량을 갖는 핵을 갖는 구형 과립.
  19. 제18항에 있어서, 함량이 5.0 내지 16.0％인 핵을 갖는 구형 과립.
  20. 제18항에 있어서, 함량이 10.0 내지 13.0％인 핵을 갖는 구형 과립.
  21. 제1항에 있어서, 저 치환된 히드록시프로필셀룰로오스의 평균 입자크기의 직경이 200㎛이하인 핵을 갖는 구형 과립.
  22. 제21항에 있어서, 평균 입자 직경이 100㎛이하인 핵을 갖는 구형 과립.
  23. 제21항에 있어서, 평균 입자 직경이 30㎛이하인 핵을 갖는 구형 과립.
  24. 제1항에 있어서, 과립이 12 메시 체를 통과하고 32 메시 체를 통과하지 않는 핵을 갖는 구형 과립.
  25. 제1항에 있어서, 과립이 장용-피복된 핵을 갖는 구형 과립.
  26. 수성 결합체를 사용하여 분무시키면서, 약물 및 저 치환된 히드록시프로필셀룰로오스를 함유된 분무 분말로 종자 핵을 피복함을 특징으로 하는 핵을 갖는 구형 과립의 제조방법.
  27. 제26항에 있어서, 종자 핵이 옥수수 전분 25중량부로 슈크로오스 75중량부를 피복함으로써 제조된 논파레일인 제조방법.
  28. 제26항에 있어서, 종자 핵이 결정 셀룰로오스로 만들어진 제조방법.
  29. 제26항에 있어서, 수성 결합체가 물 또는 에탄올이 제조방법.
  30. 제26항에 있어서, 수성 결합체가 물 또는 에탄올내에 녹은 결합체의 용액인 제조방법.
  31. 제30항에 있어서, 용액이 0.1 내지 80％(W/V)의 농도를 갖는 제조방법.
  32. 제30항에 있어서, 결합체가 슈크로오스, 히드록시프로필셀룰로오스, 히드록시프로필메틸셀룰로오스, 메틸셀룰로오스, 폴리비닐피롤리돈, 풀룰란 및 아라비아 고무로 구성된 군으로 부터 선택된 하나 또는 그 이상의 제조방법.
  33. 제26항에 있어서, 분무 분말의 입자 크기가 100㎛이하인 제조방법.
  34. 제26항에 있어서, 분무 분말이 5내지 90％(W/W)의 저 치환된 히드록시프로필셀룰로오스를 함유하는 제조방법.
  35. 제26항에 있어서, 분무 분말이 2내지 70％(W/W)의 약물을 함유하는 제조방법.
  36. 제26항에 있어서, 분무 분말에 대한 수정 결합체의 비율이 1 : 1 내지 1 : 2인 제조방법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019880000707A 1987-01-29 1988-01-28 핵을 갖는 구형 과립 및 그의 제조방법 KR960005138B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP1917887 1987-01-29
JP19178 1987-01-29
JP62-19178 1987-01-29

Publications (2)

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KR880008803A true KR880008803A (ko) 1988-09-13
KR960005138B1 KR960005138B1 (ko) 1996-04-22

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Country Link
US (2) US5026560A (ko)
EP (2) EP0277741B1 (ko)
KR (1) KR960005138B1 (ko)
AT (1) ATE150963T1 (ko)
CA (1) CA1312548C (ko)
DE (2) DE3855852T2 (ko)
ES (2) ES2052697T3 (ko)
GR (1) GR3006170T3 (ko)
HU (1) HU198396B (ko)

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ATE150963T1 (de) 1997-04-15
KR960005138B1 (ko) 1996-04-22
HU198396B (en) 1989-10-30
US5516531A (en) 1996-05-14
DE3874360D1 (de) 1992-10-15
EP0475536A1 (en) 1992-03-18
EP0277741A1 (en) 1988-08-10
ES2099130T3 (es) 1997-05-16
DE3874360T2 (de) 1993-01-14
ES2052697T3 (es) 1994-07-16
GR3006170T3 (ko) 1993-06-21
US5026560A (en) 1991-06-25
EP0475536B1 (en) 1997-04-02
CA1312548C (en) 1993-01-12
HUT46238A (en) 1988-10-28
EP0277741B1 (en) 1992-09-09
DE3855852T2 (de) 1997-07-17
DE3855852D1 (de) 1997-05-07

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