CN1138531C - 分散性大分子组合物及其制备方法和用途 - Google Patents
分散性大分子组合物及其制备方法和用途 Download PDFInfo
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- CN1138531C CN1138531C CNB971944709A CN97194470A CN1138531C CN 1138531 C CN1138531 C CN 1138531C CN B971944709 A CNB971944709 A CN B971944709A CN 97194470 A CN97194470 A CN 97194470A CN 1138531 C CN1138531 C CN 1138531C
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- 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
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/28—Insulins
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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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
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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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1658—Proteins, e.g. albumin, gelatin
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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
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0086—Inhalation chambers
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- Proteomics, Peptides & Aminoacids (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
Description
药物 | 适应症 |
降钙素血红蛋白(EPO)因子IX粒细胞集落刺激因子(G-CSF)粒细胞巨噬细胞集落刺激因子(GM-CSF)生长激素肝素肝素(低分子量)胰岛素α干扰素β干扰素γ干扰素白细胞介素-2促黄体激素释放激素(LHRH)生长激素释放抑制因子类似物加压素类似物滤泡刺激激素(FSH)淀粉不溶素睫状向神经因子生长激素释放因子(GRF)胰岛素类生长因子促胰岛素 | 骨质疏松预防佩吉特病血钙过多贫血血友病B中性血细胞减少骨髓接枝/移植失败身材矮小肾衰竭血结块哮喘血结块I型和II型糖尿病B型和C型肝炎毛细胞性白血病卡波济肉瘤多发性硬化慢性肉芽肿病肾癌前列腺癌子宫内膜异位胃肠癌尿崩症尿床生育力I型糖尿病Lou Gehrig疾病身材矮小骨质疏松营养不良II型糖尿病B型和C型肝炎 |
β干扰素γ干扰素白细胞介素-1受体拮抗剂白细胞介素-3白细胞介素-4白细胞介素-6巨噬细胞集落刺激因子(M-CSF)神经生长因子甲状旁腺激素生长激素释放抑制因子类似物α-I胸腺素IIb/IIIa抑制剂α-I抗胰蛋白酶抗-RSV抗体囊纤维化转膜调节剂(CFTR)基因脱氧核糖核酸酶(DNase)杀菌剂/渗透性增加蛋白(BPI)抗-CMV抗体白细胞介素-1受体白细胞介素-1受体拮抗剂 | 类风湿性关节炎类风湿性关节炎化学疗法佐剂免疫缺陷症血小板减少症真菌病癌症血胆固醇过多末梢性神经病骨质疏松不应性腹泻B型和C型肝炎不稳定咽峡炎囊纤维变性呼吸多核病毒囊纤维变性慢性支气管炎成人呼吸窘迫综合症巨细胞病毒哮喘哮喘 |
属性/方法 | 单位 | 收集器1 | 收集器2 | 收集器3 | 收集器4 |
水分Karl Fisher | H2Owt% | 3.4% | 2.8% | 2.8% | 3.0% |
颗粒粒度Horiba Capa 700 | MMD%<5微米 | 1.80m100 | 1.4μm100 | 1.6μm100 | 1.40μm100 |
气溶胶颗粒粒度Cascade impactor | MMAD | 3.3μm68% | ND | ND | ND |
给药剂量效率吸入装置,重力 | %±SD | 83±3 | 84±5 | 84±4 | 81±6 |
表面积 | m2/g | 11.3 | 11.7 | ND | ND |
粗糙度 | 3.8 | 3.9 | ND | ND |
属性/方法 | 单位 | 收集器1人口空气70℃ | 收集器2人口空气75℃ | 收集器3人口空气80℃ |
水分Karl Fisher | H2Owt% | 2.28 | 2.02 | 1.63 |
颗粒粒度Horiba Capa 700 | MMD%<5微米 | 2.41μm100 | 2.69μm82.3 | 2.43μm100 |
给药剂量效率 | %±SD | 71±3 | 73±3 | 71±2 |
平均表面积测微计Gemini | m2/g±SD | 6.76±.19 | 6±.02 | 8.07±.12 |
粗糙度 | 3.6 | 3.9 | 3.8 |
属性/方法 | 单位 | 收集器 |
水分Karl Fisher | H2Owt% | 4.8% |
颗粒粒度Horiba Capa 700 | MMD%<5微米%<1.4微米%<1.0微米 | 1.34μm100%62%44% |
给药剂量效率干粉装置,重力 | %±SD | 73±2 |
Claims (15)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/644,681 US6051256A (en) | 1994-03-07 | 1996-05-08 | Dispersible macromolecule compositions and methods for their preparation and use |
US08/644,681 | 1996-05-08 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1218394A CN1218394A (zh) | 1999-06-02 |
CN1138531C true CN1138531C (zh) | 2004-02-18 |
Family
ID=24585923
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB971944709A Expired - Fee Related CN1138531C (zh) | 1996-05-08 | 1997-05-07 | 分散性大分子组合物及其制备方法和用途 |
Country Status (30)
Country | Link |
---|---|
US (5) | US6051256A (zh) |
EP (1) | EP0948317A4 (zh) |
JP (2) | JP2000510471A (zh) |
CN (1) | CN1138531C (zh) |
AP (1) | AP987A (zh) |
AU (1) | AU730059B2 (zh) |
BG (1) | BG64113B1 (zh) |
BR (1) | BR9709057A (zh) |
CA (1) | CA2253393C (zh) |
CZ (1) | CZ295644B6 (zh) |
EA (1) | EA000956B1 (zh) |
EE (1) | EE03591B1 (zh) |
GE (1) | GEP20012345B (zh) |
HK (1) | HK1020319A1 (zh) |
IL (1) | IL126754A (zh) |
IS (1) | IS4879A (zh) |
LT (1) | LT4553B (zh) |
LV (1) | LV12231B (zh) |
NO (1) | NO985196L (zh) |
NZ (1) | NZ332480A (zh) |
OA (1) | OA10914A (zh) |
PL (1) | PL190732B1 (zh) |
RO (1) | RO118523B1 (zh) |
SI (1) | SI9720031A (zh) |
SK (1) | SK285400B6 (zh) |
TR (1) | TR199802247T2 (zh) |
TW (1) | TW550089B (zh) |
UA (1) | UA65538C2 (zh) |
WO (1) | WO1997041833A1 (zh) |
YU (1) | YU49206B (zh) |
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1997
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- 1997-05-07 GE GEAP19974599A patent/GEP20012345B/en unknown
- 1997-05-07 EP EP97926420A patent/EP0948317A4/en not_active Withdrawn
- 1997-05-07 CA CA002253393A patent/CA2253393C/en not_active Expired - Fee Related
- 1997-05-07 TR TR1998/02247T patent/TR199802247T2/xx unknown
- 1997-05-07 PL PL97329870A patent/PL190732B1/pl not_active IP Right Cessation
- 1997-05-07 JP JP09540191A patent/JP2000510471A/ja not_active Withdrawn
- 1997-05-07 BR BR9709057A patent/BR9709057A/pt not_active Application Discontinuation
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- 1997-05-07 IL IL12675497A patent/IL126754A/xx not_active IP Right Cessation
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- 1997-05-07 WO PCT/US1997/007779 patent/WO1997041833A1/en active Application Filing
- 1997-05-07 AP APAP/P/1998/001369A patent/AP987A/en active
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- 1997-05-07 CZ CZ19983599A patent/CZ295644B6/cs not_active IP Right Cessation
- 1997-06-14 TW TW086108261A patent/TW550089B/zh not_active IP Right Cessation
- 1997-07-05 UA UA98126441A patent/UA65538C2/uk unknown
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1998
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- 1998-11-05 OA OA9800212A patent/OA10914A/en unknown
- 1998-11-06 NO NO985196A patent/NO985196L/no not_active Application Discontinuation
- 1998-11-09 LT LT98-157A patent/LT4553B/lt not_active IP Right Cessation
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1999
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2000
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2001
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2003
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2006
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