Optimizing spray drying of ciprofloxacin hydrochloride solutions for the production of inhalable powders.

RAZUC M; PIÑA J; BUCALÁ V; RAMÍREZ RIGO MV

Rosario

Congreso; 4ta Reunión Internacional de Ciencias Farmacéuticas (RICiFa 2016); 2016

Universidad de Rosario y UNC

Introduction:Ciprofloxacin hydrochloride (CIP) is a broad-spectrum antibiotic used in the treatment of respiratory infections. Dry powder inhalers (DPI) constitute an interesting alternative for the administration of high-dose drugs, like antibiotics. The DPI are obtain by different ways, including spray-drying, supercritical fluid recrystallization and controlled precipitation. Particularly, spray-drying is a rapid, continuous, cost-effective, reproducible and scalable process. In this context, the aim of this work is to rationally study the spray-drying of ciprofloxacin for DPI in order to identify the formulation and operating conditions that lead to an optimal product in terms of particle size and process yield.Materials and methods:CIP aqueous solutions were dried by using a Mini-Spray Dryer B-290, BÜCHI. A 24−1 fractional factorial design was used for subsequent optimization. The following formulation and operating factors were modified: CIP concentration (10-50mg/mL), Drying air inlet temperature (110-180°C), Feed volumetric flow rate (3.0-6.0mL/min) and Atomization air volumetric flow rate (473-670L/h). The process yield, particle size distribution, powder moisture content, product densities and estimated aerodynamic diameter were analyzed.Results:The effect of the studied factors on the moisture content was non-significant (p-value:0.0650), while on the other responses (process yield, particle size and densities) were significant (p-value