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KR920700762A - 향상된 피낭 제조 방법 및 그의 체형 - Google Patents

향상된 피낭 제조 방법 및 그의 체형

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KR920700762A
KR920700762A KR1019910701573A KR910701573A KR920700762A KR 920700762 A KR920700762 A KR 920700762A KR 1019910701573 A KR1019910701573 A KR 1019910701573A KR 910701573 A KR910701573 A KR 910701573A KR 920700762 A KR920700762 A KR 920700762A
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medium
solvent
drug
solubility
well
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KR0162660B1 (en
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토마스 알 티스
리차드 엠 길리
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원본미기재
써던 리서취 인스티튜트
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J13/00—Colloid chemistry, e.g. the production of colloidal materials or their solutions, not otherwise provided for; Making microcapsules or microballoons
    • B01J13/02—Making microcapsules or microballoons
    • B01J13/06—Making microcapsules or microballoons by phase separation
    • B01J13/12—Making microcapsules or microballoons by phase separation removing solvent from the wall-forming material solution
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/5089—Processes

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  • Medicinal Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
  • Medicinal Preparation (AREA)
  • Extrusion Moulding Of Plastics Or The Like (AREA)
  • Glass Compositions (AREA)
  • Surgical Instruments (AREA)
  • Crystals, And After-Treatments Of Crystals (AREA)
  • Electron Tubes For Measurement (AREA)
  • Injection Moulding Of Plastics Or The Like (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
  • Processes Of Treating Macromolecular Substances (AREA)
  • Separation By Low-Temperature Treatments (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Superconductors And Manufacturing Methods Therefor (AREA)
  • Press Drives And Press Lines (AREA)

Abstract

내용 없음

Description

향상된 피낭 제조 방법 및 그의 체형
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (68)

  1. (1)웰형성 물질이 용해되어 있는 용매에 유효량의 약품을 분산시켜 분산액을 형성시킨 후, (2) 상기 분산액을 유효량의 연속진행 매체와 조합시켜 상기 진행매체와 상기 약품, 상기 용매 및 상기 웰형성 물질로 이루어진 미세소적을 함유하는 에멀션을 형성시킨 다음, (3)상기 에멀션을 즉시 유효량의 추출매체에 첨가시켜 상기 미세소적으로 부터 상기 용매를 추출시켜 미세피낭된 제형을 얻는 것으로 이루어진 약품의 미세피낭 방법.
  2. 제1항에 있어서, 상기 첨가공정은 3분 이내에 상기 에멀션을 상기 추출매체에 첨가시키는 것인 약품의 미세피낭방법.
  3. 제1항에 있어서, 상기 첨가공정은 상기 에멀션이 형성된 후, 즉시 상기 에멀션을 상기 추출매체에 첨가시키는 것인 약품의 미세피낭방법.
  4. 제1항에 있어서, 상기 분산공정은 상기 약품을 상기 용매에 용해시키는 것이 약품의 미세피낭방법.
  5. 제1항에 있어서, 상기 용매는 상기 진행매체와 불혼화성인 것인 약품의 미세피낭방법.
  6. 제1항에 있어서, 상기 용매는 상기 추출매체에서 약 100당 1부 내지 약 100당 25부의 용해도를 갖는 것인 약품의 미세피낭방법.
  7. 제1항에 있어서, 상기 진행매체는 물인 것인 약품의 미세피낭방법.
  8. 제1항에 있어서, 상기 진행매체는 유기용매인 것인 약품의 미세피낭방법.
  9. 제1항에 있어서, 상기 진행매체는 오일인 것인 약품의 미세피낭방법.
  10. 제1항에 있어서, 상기 진행매체는 계면활성제를 함유하는 것인 약품의 미세피낭방법.
  11. 제10항에 있어서, 상기 계면활성제는 진행매체에서 약0.1중량% 내지 약 20중량%로 존재하는 것인 약품의 미세피낭방법.
  12. 제1항에 있어서, 상기 분산액을 상기 연속 진행매체에 첨가시키는 공정이전에 상기 진행매체를 상기 용매로 포화시키는 공정이 추가되어 이루어진 약품의 미세피낭방법.
  13. 제1항에 있어서, 상기 미세소적으로 부터 상기 용매의 증발을 방지시키는 공정이 추가 되어 이루어진 약품의 미세피낭방법.
  14. 제1항에 있어서, 상기 추출매체는 물인 것인 약품의 미세피낭방법.
  15. 제1항에 있어서, 상기 추출매체는 유기용매인 것인 약품의 미세피낭 방법.
  16. 제1항에 있어서, 상기 추출매체는 오일인 것인 약품의 미세피낭방법.
  17. 제1항에 있어서, 상기 추출매체에 그의 이온농도를 조절하기 위하여 유효량의 염을 용해시키는 공정이 추가되어 이루어진 약품의 미세피낭방법.
  18. 제1항에 있어서, 산 또는 염기를 첨가함으로써 상기 추출매체의 pH를 조절하는 공정이 추가되어 이루어진 약품의 미세피낭방법.
  19. 제1항에 있어서, 상기 추출매체로 부터 상기 미세피낭된 생성물을 분리시키는 공정이 추가되어 이루어진 약품의 미세피낭방법.
  20. 제1항에 있어서, 상기 약품은 고수용성 화합물인 것인 약품의 미세피낭방법.
  21. 제1항에 있어서, 상기 약품은 상기 연속진행 매체에서 밀리리터당 10밀리그람 이상의 용해도를 갖는 것인 미세피낭방법.
  22. 제1항에 있어서, 상기 약품은 상기 추출매체에서 밀리리터당 10밀리그람 이상의 용해도를 갖는 것인 약품의 미세피낭방법.
  23. 제1항에 있어서, 상기 분산액에서 상기 웰형성 물질에 대한 상기 약품의 비가 커서 고다공도를 갖는 상기 미세피낭된 생성물을 얻는 것은 약품의 미세피낭방법.
  24. 제1항에 있어서, 상기 분산액에서 상기 웰형성 물질에 대한상기 약품의 퍼센트 20중량%이상인 것인 약품의 미세피낭방법.
  25. 제1항에 있어서, 상기 분산액에서 상기 웰형성 물질에 대한 상기 약품의 퍼센트는 약20중량% 내지 약80중량%인 것인 약품의 미세피낭방법.
  26. 제1항에 있어서, 상기 분산액에서 상기 웰형성 물질에 대한 상기 약품의 비가 낮아 저다공도를 갖는 상기 미세피낭된 생성물은 얻는 것인 약품의 피낭방법.
  27. 제1항에 있어서, 상기 분산액에서 상기 웰형성 물질에 대한 상기 약품의 퍼센트는 20중량% 미만인 것인 약품의 미세피낭방법.
  28. 제1항에 있어서, 상기 연속 진행매체는 상기 용매에 대해 높은 용해도를 가져 고다공도를 갖는 상기 미세피낭 생성물을 얻는 것인 약품의 미세피낭방법.
  29. 제1항에 있어서, 상기 연속 진행매체는 상기 용매에서 약2%내지 약 25%의 용해도를 가져 고다공도를 갖는 상기 미세피낭된 생성물을 얻는 것인 약품의 미세피낭방법.
  30. 제1항에 있어서, 상기 연속 진행매체는 상기 용매에 대해 낮은 용해도를 가져 저다공도를 갖는 상기 미세피낭된 생성물을 얻는 것인 약품의 미세피낭방법.
  31. 제1항에 있어서, 상기 연속 진행매체는 상기 용매에서 약2%미만의 용해도를 갖는 것인 약품의 미세피낭방법.
  32. 제1항에 있어서, 상기 용매는 에틸 아세테이트, 디에틸카보네이트, 클로로포롬과 메틸 클로라이드로 이루어진 그룹으로 부터 선택된 것이며, 상기 진행매체는 물인 것인 약품의 미세피낭방법.
  33. 제1항에 있어서, 상기 약품은 상기 연속 진행매체에서 충분한 용해도를 가져 상기 에멀션 형성동안에 상기 미세소적으로 상기 연속진행 매체를 끌어당기는 것인 약품의 미세피낭방법.
  34. 제1항에 있어서, 상기 약품은 상기 연속 진행매체에서 100㎎/㎖이상의 용해도를 갖는 것인 약품의 미세피낭방법.
  35. 제1항에 있어서, 상기 약품은 상기 추출매체에서 100㎎/㎖이상의 용해도를 갖는 것인 약품의 미세피낭방법.
  36. 제1항에 있어서, b)공정 이전에 고수용성 보조화합물을 상기 약품과 혼합시키는 공정을 추가하여, 상기 혼합물이 상기 연속 진행매체에서 충분한 용해도를 가져 상기 연속 진행매체를 상기 미세소적으로 끌어당기는 것인 약품의 미세피낭방법.
  37. 제36항에 있어서, 상기 보조화합물은 상기 연속 진행매체에서 100㎎/㎖이상의 용해도를 갖는 것인 약품의 미세피낭방법.
  38. 제36항에 있어서, 상기 보조화합물은 상기 연속 추출매체에서 100㎎/㎖이상의 용해도를 갖는 것인 약품의 미세피낭방법.
  39. 제36항에 있어서, 상기 보조화합물은 상기 연속 진행매체에서 1gram/㎖이상의 용해도를 갖는 것인 약품의 미세피낭방법.
  40. 제36항에 있어서, 상기 보조화합물은 상기 추출매체에서 1gram/㎖이상의 용해도를 갖는 것인 약품의 미세피낭방법.
  41. 제1항에 있어서, 상기 약품은 고체화합물이며, 상기 미세피낭된 생성물은 마이크로스피어인 것은 약품의 미세피낭방법.
  42. 제1항에 있어서, 상기 약품은 액체이며, 상기 미세피낭된 생성물은 마이크로캡슐인 것인 약품의 미세피낭방법.
  43. 제1항에 있어서, 상기 약품은 고체화합물이며, 상기 미세피낭된 생성물은 마이크로캡슐인 것인 약품의 미세피낭방법.
  44. 제41항에 있어서, 상기 마이크로스피어는 일차 방출운동에너지를 나타낸 것인 약품의 미세피낭방법.
  45. 제42항에 있어서, 상기 마이크로캡슐은 영차 방출운동에너지를 나타낸 것인 약품의 미세피낭방법.
  46. 제43항에 있어서, 상기 마이크로캡슐은 영차 방출운동에너지를 나타낸 것인 약품의 미세피낭방법.
  47. 제1항에 있어서, 상기 분산액에서 용매에 대한 웰형성 물질의 퍼센트는 약3중량% 내지 40중량%인 것인 약품의 미세피낭방법.
  48. 제1항에 있어서, 상기 용매를 상기 미세소적로 부터 추출하는 동안 또는 후에 상기 약품을 상기 미세피낭된 생성물로 부터 제거하여 마이크로버블을 얻는 것인 약품의 미세피낭방법.
  49. 제48항에 있어서, 상기 약품은 상기 연속 진행매체에서 1gram/㎖의 용해도를 갖는 고체인 것이 약품의 미세피낭방법.
  50. 제48항에 있어서, 상기 약품은 상기 추출 진행매체에서 1gram/㎖의 용해도를 갖는 고체인 것인 약품의 미세피낭방법.
  51. 제48항에 있어서, 상기 약품은 액체인 것인 약품의 미세피낭방법.
  52. 제51항에 있어서, 상기 액체는 물에 용해된 마니돌인 것인 약품의 미세피낭방법.
  53. 제1항에 있어서, 상기 웰-형성물질은 상기 용매에서 높은 농도로 존재하여 저다공도와 낮은 약품방출속도를 갖는 상기 미세피낭 생성물을 얻는 것인 약품의 미세피낭방법.
  54. 제1항에 있어서, 상기 웰-형성물질은 상기 용매에서 저농도로 존재하여 고다공도와 높은 약품방출속도를 갖는 상기 미세피낭된 생성물을 얻는 것인 약품의 미세피낭 방법.
  55. a)약품의 웰 형성물질이 용해되어 있는 용매에 분산시켜 분산액을 형성시키되, 상기 웰 형성물질에 대한 상기 약품의 퍼센트는 20중량% 이상으로 하며, b)상기 분산액을 유효량의 연속진행매체와 조합시켜 상기 제조매체와 상기 약품, 상기 용매 및 상기 웰 형성물지롤 이루어진 미세소적을 함유하는 에멀션을 형성시킨 다음, c)상기 (b)공정 후 상기 에멀션을 즉시 유효량의 추출매체에 첨가시켜 상기 미세소적으로 부터 상기 용매를 추출하며 미세피낭된 생성물을 얻는 것으로 이루어진 고다공도를 나타내는 피낭웰을 가지는 미세피낭 제형의 제조방법.
  56. 제55항에 있어서, 상기 연속 진행매체는 상기 용매에서 용해성이 높은 것인 미세피낭 제형의 제조방법.
  57. 제56항에 있어서, 상기 연속 진행매체는 상기 용매에서 약2% 내지 약25%의 용해도를 갖는 것인 미세피낭제형의 제조방법.
  58. 제55항에 있어서, 상기 분산액에서 상기 웰 형성물질에 대한 상기 약품의 퍼센트는 약20중량% 내지 약 80중량%인것인 미세피낭 제형의 제조방법.
  59. a)약품을 웰 형성물질이 용해되어 있는 용매에 분산시켜 분산액을 형성시키되, 상기 웰 형성물질에대한 상기 약품의 퍼센트는 20중량% 미만상으로 하며, b)상기 분산액을 유효량의 연속진행매체와 조합시켜 상기 제조매체와 상기 약품, 상기 용매 및 상기 웰 형성물질로 이루어진 미세소적을 함유하는 에멜션을 형성시킨 다음 c)상기 (b)공정 후 상기 에멀션을 즉시 유효량의 추출매체에 첨가시켜 상기 미세소적으로 부터 상기 용매를 추출하며 미세피낭 된 생성물을 얻는 것으로 이루어진 저다공성을 나타내는 피낭웰을 갖는 미세피낭제형의 제조방법.
  60. 제59항에 있어서, 상기 연속 진행매체는 상기 용매에서 용해성이 낮은 것인 미세피낭 제형의 제조방법.
  61. 제60항에 있어서, 상기 연속 진행매체는 상기 용매에서 약 2%미만의 용해도를 갖는 것인 미세피낭 제형의 제조방법.
  62. a)웰 형성물질이 용해되어 있는 용매에 유효량의 약품을 분산시켜 분산액을 형성시킨 다음, b)상기 분산액을 유효량의 연속진행매체와 조합시켜 상기 진행매체와 상기 약품, 상기 용매 및 상기 웰 형성물질로 이루어진 미세소적을 포함하는 에멀션을 형성시키되, 상기 연속 진행매체는 상기 용매에서 약2% 내지 약25%의 용해도를 가지며, c)상기 (b)공정 후, 즉시 상기 에멀션을 유효량의 추출매체에 첨가시켜 상기 미세소적으로 부터 상기 용매를 추출시켜 상기 미세피낭 된 생성물을 얻는 것으로 이루어진 고다공성을 나타내는 피낭웰을 갖는 미세피낭 제형의 제조방법.
  63. a)웰 형성물질이 용해되어 있는 용매에 유효량의 약품을 분산시켜 분산액을 형성시킨 다음, b)상기 분산액을 유효량의 연속진행매체와 조합시켜 상기 진행매체와 상기 약품, 상기 용매 및 상기 웰 형성물질로 이루어진 미세조적을 포함하는 에멀션을 형성시키되, 상기 연속 진행매체는 상기 용매에서 약2% 미만의 용해도를 가지며, c)상기 (b)공정 후, 즉시 상기 에멀션을 유효량의 추출매체에 첨가시켜 상기 미세소적으로 부터 상기 용매를 추출시켜 상기 미세피낭 된 생성물을 얻는 것으로 이루어진 저다공성을 나타내는 피낭웰을 갖는 미세피낭 제형의 제조방법.
  64. 제1항의 방법에 따라 제조된 미세피낭된 제형.
  65. 제55항의 방법에 따라 제조된 미세피낭된 제형.
  66. 제59항의 방법에 따라 제조된 미세피낭된 제형.
  67. 제62항의 방법에 따라 제조된 미세피낭된 제형.
  68. 제63항의 방법에 따라 제조된 미세피낭된 제형.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
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US5407609A (en) 1995-04-18
ES2084698T3 (es) 1996-05-16
IE901616L (en) 1990-11-04
EP0471036A1 (en) 1992-02-19
DE69024953T2 (de) 1996-08-14
EP0471036B2 (en) 2004-06-23
IL94296A (en) 1995-10-31
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DE69024953D1 (de) 1996-02-29
DK0471036T4 (da) 2004-07-19
IE69313B1 (en) 1996-09-04
CA2050911C (en) 1997-07-15
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AU5741590A (en) 1990-11-29
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IL94296A0 (en) 1991-03-10
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WO1990013361A1 (en) 1990-11-15
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CA2050911A1 (en) 1990-11-05
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