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Pharmaceutical composition containing sugar and lipid composite particles for inhalation and method for manufacturing same
The invention relates to a pharmaceutical composition containing composite particles with a controlled aerodynamic particle size distribution, wherein the composite particles comprise one or more active pharmaceutical ingredients (API), at least one sugar and at least one lipid, a process for manufacturing the pharmaceutical composition comprises the steps of (1) blending API and one or more excipients comprising at least one sugar or at least one lipid, or both at least one sugar and at least one lipid, into a homogeneous powder; and (2) reducing the particle size distribution of the blend, the micronized pharmaceutical composition allows for the delivery of crystalline stable API with better aerodynamic properties than the micronized API alone, as well as improved downstream processing and stability properties.