Characterisation and deposition studies of recrystallised lactose from binary mixtures of ethanol/butanol for improved drug delivery from dry powder inhalers.

摘要: Dry powder inhaler formulations comprising commercial lactose–drug blends can show restricted detachment of drug from lactose during aerosolisation, which lead to poor fine particle fractions (FPFs) are suboptimal. The aim the present study was investigate whether crystallisation different ethanol/butanol co-solvent mixtures could be employed as a method altering FPF salbutamol sulphate blends. Lactose particles were prepared by an anti-solvent recrystallisation process using various ratios two solvents. Crystallised or mixed with and in vitro deposition studies performed multistage liquid impinger. Solid-state characterisation results showed that primarily composed α-anomer whilst crystallised samples comprised α/β mixture containing lower number moles water per mole compared lactose. also less elongated more irregular shape rougher surfaces. Formulation better aerosolisation performance dose uniformity when highest (38.0 ± 2.5%) obtained for (20:60) 19.7 1.9% Engineered carriers modified anomer content physicochemical properties, grade, produced generated high FPF.