A method of making an aggregate particles suitable for powder aerosol composition, to form a dispersion of nanoparticulate excipient particles and the nanoparticulate drug particles and / or in (a) non-aqueous liquid (here , the excipient particles and / or the drug particles have a solubility of 10mg / mL than with respect to the liquid dispersion medium are the nanoparticulate drug particles have a crystal form which is pre-selected when the nanoparticles are dispersed in the dispersion and does not include an excipient, non-aqueous liquid, no suspension homogenizing surfactant dissolved therein) It is by spray drying a dispersion of nanoparticulate excipient particles and / or (b) the nanoparticulate drug particles, to produce a set particles comprising a nanoparticulate excipient particles and the nanoparticulate drug particles and / or (Here, it maintains a crystalline form which is pre-selected for them, to the collection, nanoparticles of the excipient has a mass median aerodynamic diameter of about 100 microns or less, and the drug and / or , when the nanoparticles are dispersed in the dispersion and does not include an excipient) is substantially free of homogenizing surfactant the aggregate particles including methods, such methods particles formed by, and pharmaceutical compositions thereof. [Selection] Figure Figure 1粉末エアゾール組成物に適した集合粒子を作製する方法であって、(a)非水性液体中でナノ粒子状薬物粒子及び/又はナノ粒子状賦形剤粒子の分散液を形成すること(ここで、前記薬物粒子及び/又は前記賦形剤粒子は、前記液状分散媒質に対して10mg/mL未満の溶解度を有し該ナノ粒子状薬物粒子は、前以て選択された結晶形態を有し且つ前記分散液中に分散されたナノ粒子が賦形剤を含まないときは、該非水性液体は、その中に溶解された懸濁液均質化用界面活性剤を有さない)(b)ナノ粒子状薬物粒子及び/又はナノ粒子状賦形剤粒子の分散液を噴霧乾燥して、ナノ粒子状薬物粒子及び/又はナノ粒子状賦形剤粒子を含む集合粒子を生成させること(ここで、該薬物及び/又は賦形剤のナノ粒子は、それらの前以て選択された結晶形態を維持し、該集合粒子は、約100ミクロン以下の空気力学的質量中央径を有し、且つ前記分散液中に分散されたナノ粒子が賦形剤を含まないときは、該集合粒子は、均質化用界面活性剤を実質的に含まない)を含む、方法、このような方法によって形成される粒子、並びにその医薬組成物。【選択図】図1
