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Influence of the Size of Micronized Active Pharmaceutical Ingredient on the Aerodynamic Particle Size and Stability of a Metered Dose Inhaler
Abstract:Pharmaceutical inhalers are often used to treat pulmonary diseases. Only active pharmaceutical ingredient (API) particles from these inhalers that are less than approximately 5 µm are likely to reach the lung and be efficacious. This study was designed to investigate the impact of micronized API particle size on the aerodynamic particle size distribution (PSD) profile and the particle size stability of a suspension metered dose inhaler (MDI) containing propellant HFA‐227 (1,1,1,2,3,3,3 heptafluoropropane) and a corticosteroid. The median API particle size ranged from 1.1 µm to 1.8 µm (97% to 70% of particles
Keywords:Cascade impaction  Particle size distribution (PSD)  Metered dose inhalers (MDI)  Sympatec laser diffraction  Micronization  Aerosol  Temperature cycling
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