МОРТОН Дэвид (IT),ЦИ ЧЖОУ Тони (IT),МУЗА Росселла (IT)
申请号:
RU2012126507/15
公开号:
RU2012126507A
申请日:
2010.11.24
申请国别(地区):
RU
年份:
2014
代理人:
摘要:
1. A composition in the form of a dry powder for pulmonary administration, containing mechanically synthesized microparticles consisting of particles of an antibiotic belonging to the aminoglycoside group in an amount of 90% mass / mass or more and magnesium stearate in an amount of 10% mass / mass or less where magnesium stearate covers at least 50% of the entire surface of the particles of the drug. The composition of claim 1, wherein the antibiotic is selected from the group consisting of tobramycin, kanamycin A, dibecacin, amikacin and arbekacin. The composition of claim 2, wherein the antibiotic is tobramycin. The composition according to claim 3, where the amount of tobramycin is from 90 to 99.9%, and the amount of magnesium stearate is from 0.1 to 10% mass / mass. The composition according to claim 4, wherein the amount of tobramycin is from 95 to 99%, and the amount of magnesium stearate is from 1 to 5% w / w. The composition of claim 5, wherein the amount of tobramycin is from 99 to 99.5%, and the amount of magnesium stearate can also be from 0.5 to 1.0% w / w. The composition of claim 1, wherein the amount of residual water in the microparticles is less than 5% w / w. A composition according to any one of claims 1 to 7, further comprising a physiologically acceptable pharmacologically inert carrier. Mechanically synthesized microparticles consisting of particles of an antibiotic belonging to the aminoglycoside group in an amount of 90% mass / mass or more and magnesium stearate in an amount of 10% mass / mass or less, where magnesium stearate covers at least 50% of the entire surface drug particles. 10. Microparticles according to claim 9, wherein the antibiotic is tobramycin. Capsule for use with a dry powder inhaler filled with the composition in1. Композиция в форме сухого порошка для легочного введения, содержащая механо-синтезированные микрочастицы, состоящие из частиц антибиотика, принадлежащего к группе аминогликозидов, в количестве 90% масс/масс, и