KR970705979A - Spray-dried microparticles as therapeutic vehicles as therapeutic agents - Google Patents

Spray-dried microparticles as therapeutic vehicles as therapeutic agents Download PDF

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KR970705979A
KR970705979A KR1019970702043A KR19970702043A KR970705979A KR 970705979 A KR970705979 A KR 970705979A KR 1019970702043 A KR1019970702043 A KR 1019970702043A KR 19970702043 A KR19970702043 A KR 19970702043A KR 970705979 A KR970705979 A KR 970705979A
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microparticle
water
therapeutic agent
soluble
soluble substance
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KR1019970702043A
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Korean (ko)
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앤드류 드렉 써튼
리차드 알란 존슨
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디 히스
안다리스 리미티드
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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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/22—Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations
    • A61K49/222—Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations characterised by a special physical form, e.g. emulsions, liposomes
    • A61K49/223—Microbubbles, hollow microspheres, free gas bubbles, gas microspheres
    • 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
    • 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
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 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
    • A61K9/14—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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
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Abstract

매끈하고 구형이며, 90% 이상의 질량 중앙 입자 크기가 1-10㎛이며 치료제 또는 진단제를 지니거나 또는 수가용성 물질로서 그와 같은 제제를 사용하는, 수가용성 물질의 미소입자가 상기 제제를 운반하기 위한 건조 분말 흡입기에 성공적으로 사용될 수 있다.The microparticles of the water soluble material, which are smooth and spherical, have a mass median particle size of greater than 90% of 1-10 占 퐉 and have a therapeutic or diagnostic agent or use such a preparation as a water soluble substance, Can be successfully used in dry powder inhalers.

Description

치료용 매개체로서의 분무-건조 미소입자(Spray-dried microparticles as therapeutic vehicles)Spray-dried microparticles as therapeutic vehicles as therapeutic agents

본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음Since this is a trivial issue, I did not include the contents of the text.

Claims (19)

매끈하고 구형이며, 90% 이상이 질양 중앙 입자 크기가 1-10㎛인, 치료 및 진단용의 수가용성 물질인 미소입자.Soluble microparticles, which are smooth and spherical, and have a nodular median particle size of from 1 to 90%. 매끈하고 구형이며, 90% 이상이 질양 중앙 입자 크기가 1-10㎛이며, 치료제 또는 진단제를 지닌, 수가용성 물질인 미소입자.Soluble particles that are smooth and spherical, 90% or more of which have a median particle size of 1-10 占 퐉 and have a therapeutic or diagnostic agent. 제2항에 있어서, 상기 수가용성 물질 및 치료제 또는 진단제의 수성 용액을 분무-건조함으로써 얻을 수 있는 미소입자.3. The microparticle according to claim 2, which is obtained by spray-drying an aqueous solution of the water-soluble substance and the therapeutic agent or diagnostic agent. 제1항 내지 제3항 중 임의의 한 항에 있어서, 입자 크기가 1-15㎛인 미소입자.4. The microparticle according to any one of claims 1 to 3, wherein the particle size is 1-15 mu m. 제1항 내지 제4항 중 임의의 한 항에 있어서, 최대 4 분위수간의 범위가 3㎛인 미소입자.5. The microparticle according to any one of claims 1 to 4, wherein the range between the maximum quartiles is 3 占 퐉. 제5항에 있어서, 최대 4 분위수간 범위가 2㎛인 미소입자.6. The microparticle of claim 5, wherein the range between the maximum quartiles is 2 [mu] m. 제1항 내지 제6항 중 임의의 한 항에 있어서, 무균상태인 미소입자.7. The microparticle according to any one of claims 1 to 6, which is sterile. 제1항 내지 제7항 중 임의의 한 항에 있어서, 적어도 부분적으로 수불용성 물질로 피복된 미소입자.8. The microparticle of any one of claims 1 to 7, wherein the microparticle is at least partially coated with a water insoluble material. 제1항 내지 제8항 중 임의의 한 항에 있어서, 수용체-결합성분을 또한 지니고 있는 미소입자.9. The microparticle according to any one of claims 1 to 8, further comprising a receptor-binding component. 제1항 내지 제9항 중 임의의 한 항에 있어서, 수가용성 물질이 탄수화물인 미소입자.10. The microparticle according to any one of claims 1 to 9, wherein the water-soluble substance is a carbohydrate. 제1항 내지 제9항 중 임의의 한 항에 있어서, 수가용성 물질이 아미노산 또는 폴리아미노산인 미소입자.10. Microparticles according to any one of claims 1 to 9, wherein the water-soluble substance is an amino acid or a polyamino acid. 제1항 내지 제9항 중 임의의 한 항에 있어서, 수가용성 물질이 지방산 또는 그 에스테르인 미소입자.10. The microparticle according to any one of claims 1 to 9, wherein the water-soluble substance is a fatty acid or an ester thereof. 제1항 내지 제9항 중 임의의 한 항에 있어서, 수가용성 물질이 단백질, 펩티드 또는 효소인 미소입자.10. Microparticles according to any one of claims 1 to 9, wherein the water-soluble substance is a protein, a peptide or an enzyme. 제13항에 있어서, 수가용성 물질이 천연 또는 재조합 형태의 인체 단백질 또는 단편인 미소입자.14. The microparticle of claim 13, wherein the water soluble material is a human protein or fragment in natural or recombinant form. 제14항에 있어서, 수가용성 물질이 인체혈청 알부민인 미소입자.15. The microparticle of claim 14, wherein the water-soluble material is human serum albumin. 제1항 내지15항 중 임의의 한 항에 있어서, 수가용성 물질이 미소입자 형성전에 화학적으로 또는 효소적으로 수식되는 미소입자.The microparticles according to any one of claims 1 to 15, wherein the water-soluble substance is chemically or enzymatically modified before microparticle formation. 제1항 내지16항 중 임의의 한 항에 의한 미소입자의 형태로 치료제를 포함하고 있는, 폐의 기로를 통하여 치료제를 운반하는데 적응되는 흡입기.An inhaler adapted for delivery of a therapeutic agent through a lung tract, comprising a therapeutic agent in the form of a microparticle according to any one of claims 1 to 16. 치료제가 폐의 기로를 통하여 복용하게 되는 병의 치료를 위한 약제의 제조를 위하여 치료제를 사용하는 방법에 있어서, 치료제가 제1항 내지 16항 중 임의의 한 항에 의한 미소입자의 형태로 존재하는 것을 특징으로 하는 방법.A method for the use of a therapeutic agent for the manufacture of a medicament for the treatment of a disease in which the therapeutic agent is taken via a cardiac route, wherein the therapeutic agent is present in the form of a microparticle according to any one of claims 1 to 16 ≪ / RTI > 병을 치료하기 위하여 폐의 기로를 통하여 작용하는 유효량의 치료제를 환자에게 투여함으로써 환자를 치료하는 방법에 있어서, 제 1항 내지 16항 중 임의의 한 항에 의함 미소입자 형태의 치료제를 복용하는 방법을 포함하는 개선된 치료방법.A method of treating a patient by administering to a patient an effective amount of a therapeutic agent that acts through a cardiac tract to treat a disease, comprising: administering a therapeutic agent in the form of a microparticle according to any one of claims 1 to 16 Lt; / RTI > ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.※ Note: It is disclosed by the contents of the first application.
KR1019970702043A 1994-09-29 1995-09-26 Spray-dried microparticles as therapeutic vehicles as therapeutic agents KR970705979A (en)

Applications Claiming Priority (3)

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EP94307126 1994-09-29
EP94307126.6 1994-09-29
PCT/GB1995/002279 WO1996009814A1 (en) 1994-09-29 1995-09-26 Spray-dried microparticles as therapeutic vehicles

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EP (1) EP0783298A1 (en)
JP (1) JPH10506406A (en)
KR (1) KR970705979A (en)
AU (1) AU701440B2 (en)
BR (1) BR9509171A (en)
CA (1) CA2199954A1 (en)
CZ (1) CZ92497A3 (en)
FI (1) FI971332A (en)
HU (1) HUT77373A (en)
MX (1) MX9702357A (en)
NO (1) NO971438D0 (en)
NZ (1) NZ292980A (en)
PL (1) PL319600A1 (en)
RU (1) RU2147226C1 (en)
WO (1) WO1996009814A1 (en)
ZA (1) ZA958239B (en)

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