The effect of ethanol on the habit and in vitro aerodynamic results of dry powder inhalation formulations containing ciprofloxacin hydrochloride

Dry powder inhalation (DPI) formulations containing ciprofloxacin hydrochloride (CIP) as a model drug were prepared by spray-drying in the presence of different ethanol concentrations. The role of ethanol on the habit and aerodynamics of the DPI samples was examined in detail. The roughness, depth and width of the dimples were uniquely expressed. A new correlation was determined between the mass median aerodynamic diameter (MMAD)/D (0.5) ratio and cohesion work (Wc). DPI formulation containing 30% ethanol in the stock solution had the best in vitro aerodynamic results. [Display omitted] In the case of dry powder inhalation systems (DPIs), the development of carrier-free formulations has gained increased attention. Thereby, spray-drying is a promising technology and is widely used to produce carrier-free DPIs. Numerous works have been published about the co-spray-drying of active ingredients with various solid excipients and their effect on the physicochemical characteristics and aerodynamic properties of the formulations. However, only a few studies have been reported about the role of the solvents used in the stock solutions of spray-dried formulations. In the present work, DPI microcomposites containing ciprofloxacin hydrochloride were prepared by spray-drying in the presence of different ethanol concentrations. The work expresses the roughness, depth and width of the dimples for particle size as a novel calculation possibility, and as a correlation between the MMAD/D0.5 ratio and correlating it with cohesion work, these new terms and correlations have not been published – to the best of our knowledge – which has resulted in gap-filling findings. As a result, different proportions of solvent mixtures could be interpreted and placed in a new perspective, in which the influence of different concentrations of ethanol on the habit of the DPI formulations, and thus on in vitro aerodynamic results. Based on these, it became clear why we obtained the best in vitro aerodynamic results for DPI formulation containing 30% ethanol in the stock solution.