КАНТАРЕЛЛИ Анна Мария (IT),МИНАРИ Стефано (IT),БАССИ Барбара (IT)
申请号：
RU2013148786/15
公开号：
RU2013148786A
申请日:
2012.04.18
申请国别(地区):
RU
年份:
2015
代理人:
摘要：
1. A propellant-free, sterile pharmaceutical composition for inhalation administration containing micronized particles of crystalline corticosteroid suspended in an aqueous solution, where i) a volume diameter of not more than 10% of said suspended particles [d (v, 0.1)] is less than 0.6 μm ； ii) a volume diameter of not more than 50% of said particles [d (v, 0.5)] is from 1.5 μm to 1.9 μm； iii) a bulk diameter of at least 90% of said particles [d (v, 0.9) is equal to or less than 4.7 μm, and where said particles have a particle size range that is described as [d (v, 0.9) -d (v, 0.1)] / d (v, 0.5) and ranges from 1.2 to 2.2 microns. 2. The composition according to claim 1, where the volumetric diameter of not more than 50% of the suspended particles is from 1 to 1.8.3. The composition according to claim 1 or 2, where the volumetric diameter of at least 90% of the suspended particles is equal to or less than 4.0 microns. The composition according to claim 3, where the range of particle size is from 1.5 to 2.1.5. The composition according to claim 1, wherein the corticosteroid is selected from the group of beclomethasone dipropionate, budesonide, flunosolid, mometasone furoate, cyclesenide, fluticasone or their esters, such as furoate or propionate. The composition according to claim 5, wherein the corticosteroid is beclomethasone dipropionate. The composition according to claim 6, wherein beclomethasone dipropionate is presented in anhydrous form. The composition according to claim 6, wherein beclomethasone dipropionate is in the form of a monohydrate. The composition of claim 1, wherein the aqueous solution comprises one or more pharmaceutically acceptable excipients selected from the group consisting of humectants, isotonicity agents, and, optionally, stabilizers and / or pH adjusting buffers. The composition according to claim 9, where the humidifier is selected from the group comprising polysorbate 20,1. Безпропеллентный стерильный фармацевтический состав для инг
