title: Development of budesonide nanocluster dry powder aerosols: formulation and stability.
abstract: The physical and chemical stability of dry powder aerosol formulations is an essential component in the development of an inhaled therapeutic. The pharmaceutical processing methods and storage conditions are primary determinants of the stability of a dry powder inhaler (DPI) formulation. Wet milling was used to produce budesonide NanoClusters (NCs), which are agglomerates of drug nanoparticles (≈ 300 nm) with a mean aerodynamic diameter between 1 and 3 µm, capable of deep lung penetration. In this study, the reproducibility of NC processing and performance was established. The physical stability of a selected budesonide NC formulation was investigated using industry standard dose content uniformity and cascade impaction techniques. The chemical stability of the lead formulation was also determined as a function of processing parameters and storage conditions. This study confirms the reproducibility and robust stability of NC powders as a novel means to turn drug particles into high-performance aerosols.
authors.affiliation: Department of Pharmaceutical Chemistry, The University of Kansas, Lawrence, Kansas 66047, USA.
authors.forename: Nashwa
authors.initials: N
authors.lastname: El-Gendy
authors.forename: Shan
authors.initials: S
authors.lastname: Huang
authors.forename: Parthiban
authors.initials: P
authors.lastname: Selvam
authors.forename: Pravin
authors.initials: P
authors.lastname: Soni
authors.forename: Cory
authors.initials: C
authors.lastname: Berkland
mesh_terms: D000280:Administration, Inhalation; D000336:Aerosols; D019819:Budesonide / Q000008:administration & dosage / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D004355:Drug Stability; D004356:Drug Storage; D005938:Glucocorticoids / Q000008:administration & dosage / Q000737:chemistry*; D006813:Humidity; D053758:Nanoparticles; D036103:Nanotechnology; D009330:Nebulizers and Vaporizers; D010316:Particle Size; D011208:Powders; D012212:Rheology; D013678:Technology, Pharmaceutical / Q000379:methods; D013696:Temperature; D013997:Time Factors; D014867:Water / Q000737:chemistry
chemical_list: D000336:Aerosols; D005938:Glucocorticoids; D011208:Powders; D014867:Water; D019819:Budesonide