Crystallization induced flower-like lactose as potential carriers for dry powder inhaler application

The study documents the flower-like lactose particles as potential carriers to improve Dry Powder Inhaler (DPI) efficiency. The lactose particles (LM x , LM f ) are prepared by anti-solvent crystallization and compared with commercial lactose carriers (Inhalac 251; LM c ). Formulations of 1.48% w/w drug loading are prepared using salbutamol sulfate (model drug) and different lactose carriers. The carrier properties are correlated with %FPF using principal component analysis. The analytical results confirm LM x is α-lactose monohydrate, LM f comprises α and β-lactose. Time-resolved crystal growth shows that the LM x particle is agglomerated structure while, LM f particle appear as flower-like structure of size (~45.37–63.92 μm) with high surface and aerodynamic properties compared to LM c . The in-vitro aerosolization studies resulted in higher fine particle fraction (%FPF) for formulations with LM x (~33.23%) and LM f (~44.85%) compared to LM c (~23.40%). The high %FPF is mainly attributed to the higher surface roughness, amorphicity, surface energy of engineered lactose carriers. • Crystallization induced flower-like lactose gives high %FPF than commercial lactose. • Flower-like lactose particles are potential inhalable carriers for DPI application. • Particle, bulk property and %FPF are correlated using principal component analysis. • High %FPF is due to higher surface roughness, energy and % fine lactose particles.