CN100589796C - 高效输送大量治疗性气雾剂 - Google Patents
高效输送大量治疗性气雾剂 Download PDFInfo
- Publication number
- CN100589796C CN100589796C CN01812533A CN01812533A CN100589796C CN 100589796 C CN100589796 C CN 100589796C CN 01812533 A CN01812533 A CN 01812533A CN 01812533 A CN01812533 A CN 01812533A CN 100589796 C CN100589796 C CN 100589796C
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- Prior art keywords
- granule
- powder
- medicament
- administration
- particulate
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
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Classifications
-
- 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
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
-
- 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
-
- 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
Abstract
Description
粉末 | Dg(微米) | P(克/毫升) |
微米级硫酸舒喘宁(1) | 2.5 | 0.26 |
喷雾干燥型硫酸舒喘宁(2) | 8.0 | 0.20 |
喷雾干燥型人体生长激素(3) | 14.5 | 0.07 |
试样标号 | 凯特普罗芬的加入量(毫克) | 固体总量(克/升) | %凯特普罗芬 |
第一次试验 | 0 | 1.000 | 0 |
第二次试验 | 8.0 | 1.016 | 1.6 |
第三次试验 | 15.1 | 1.030 | 3.0 |
第四次试验 | 30.1 | 1.060 | 5.7 |
第五次试验 | 46.0 | 1.092 | 8.4 |
第六次试验 | 63.0 | 1.126 | 11.2 |
试样标号 | 收集重量(毫克) | 理论产量(毫克) | 实际产率(%理论产量) |
第一次试验 | 186 | 500 | 37.2 |
第二次试验 | 195 | 508 | 38.4 |
第三次试验 | 147 | 515 | 28.5 |
第四次试验 | 127 | 530 | 24.0 |
第五次试验 | 89 | 546 | 16.3 |
第六次试验 | 67 | 563 | 11.9 |
试样标号 | 空气动力学平均直径(微米) | 标准偏差 | 体积平均几何直径(微米,2巴压力下) |
第一次试验 | 3.11 | 1.48 | 9.0 |
第二次试验 | 3.01 | 1.37 | 9.3 |
第三次试验 | 2.83 | 1.40 | 10.3 |
第四次试验 | 2.84 | 1.41 | 10.4 |
第五次试验 | 2.65 | 1.39 | 9.8 |
第六次试验 | 2.83 | 1.38 | 8.8 |
0级 | 1.33毫克 |
2级 | 2.75 |
F级 | 3.17 |
胶囊装入量 | 12.37 |
直径小于5.6微米部分的重量 | 5.92 |
直径等于5.6微米部分的重量 | 0.479 |
直径小于3.4微米部分的重量 | 3.17 |
直径等于3.4微米部分的重量 | 0.256 |
时间分钟 | 口服给药平均值(ug/ml) | 组标准偏差 | 肺部给药平均值(ug/ml) | 给药组标准偏差 | P值 |
0 | 1.0 | 无 | 1.0 | 无 | |
5 | 1.7 | 0.75 | 9.6 | 1.27 | 0.0003 |
15 | 2.1 | 0.76 | 7.6 | 0.28 | 0.0000 |
30 | 1.9 | 0.12 | 5.5 | 0.76 | 0.0012 |
60 | 2.0 | 0.13 | 4.5 | 0.60 | 0.0002 |
120 | 1.7 | 0.31 | 2.4 | 0.44 | 0.0929 |
240 | 1.4 | 0.05 | 1.8 | 0.63 | 0.2554 |
360 | 1.0 | 0.06 | 1.8 | 0.35 | 0.0224 |
480 | 1.0 | 0.00 | 1.3 | 0.47 | 0.2174 |
加载量(%)标记左旋多巴/卡比多巴 | 产率(%) | 2巴压力下的体积平均几何直径(微米) | 体积平均几何直径比率0.5/4.0巴 | 堆平均空气动力学直径(微米) | 细粒级(%)5.6/3.4 |
20/0 | >40 | 9.9 | 无 | 2.7 | 无 |
40/0 | >40 | 8.0 | 1.2 | 3.3 | 42/17 |
20/5 | 42 | 10 | 1.6 | 3.1 | 64/38 |
40/10 | >20 | 7.4 | 1.6 | 3.8 | 40/14 |
粉末的配方组成 | 萃取回收率% | 实际加载量(%) |
20/0 | 100±4.5 | 17.3±0.2 |
40/0 | 101±2.8 | 35.0±5.4 |
重量% | 沙美特罗 | 二棕榈酰卵磷脂 | 二棕榈酰卵磷脂乙醇胺 | 柠檬酸钠 | 氯化钙 | 乳糖 |
F-1 | 1 | 69 | - | 20 | 10 | - |
不含沙美特罗的F-1 | 0 | 70 | - | 20 | 10 | - |
F-2 | 1 | 29.5 | 29.5 | 20 | - | 20 |
不含沙美特罗的F-2 | 0 | 30 | 30 | 20 | - | 20 |
Claims (8)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/591,307 US6858199B1 (en) | 2000-06-09 | 2000-06-09 | High efficient delivery of a large therapeutic mass aerosol |
US09/591,307 | 2000-06-09 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1441670A CN1441670A (zh) | 2003-09-10 |
CN100589796C true CN100589796C (zh) | 2010-02-17 |
Family
ID=24365965
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN01812533A Expired - Fee Related CN100589796C (zh) | 2000-06-09 | 2001-06-08 | 高效输送大量治疗性气雾剂 |
Country Status (21)
Country | Link |
---|---|
US (6) | US6858199B1 (zh) |
EP (2) | EP1767196A3 (zh) |
JP (2) | JP2004503482A (zh) |
KR (1) | KR100697479B1 (zh) |
CN (1) | CN100589796C (zh) |
AT (1) | ATE357222T1 (zh) |
AU (2) | AU7536801A (zh) |
CA (1) | CA2412561C (zh) |
DE (1) | DE60127407T2 (zh) |
DK (1) | DK1296663T3 (zh) |
ES (1) | ES2283417T3 (zh) |
HK (1) | HK1051139A1 (zh) |
IL (1) | IL153281A0 (zh) |
MX (1) | MXPA02012023A (zh) |
NO (1) | NO20025873L (zh) |
NZ (1) | NZ523254A (zh) |
PL (1) | PL360287A1 (zh) |
PT (1) | PT1296663E (zh) |
RU (1) | RU2275900C2 (zh) |
SI (1) | SI1296663T1 (zh) |
WO (1) | WO2001095874A2 (zh) |
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