OPTIMIZING SPRAY DRYING OF CIPROFLOXACIN HYDROCHLORIDE SOLUTIONS FOR THE PRODUCTION OF INHALABLE POWDERS

V. BUCALÁ; J. PIÑA; M. F. RAZUC; M. V. RAMIREZ RIGO

Rosario

Congreso; 4ta. Reunión Internacional de Ciencias Farmacéuticas; 2016

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 spraydrying 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 (pvalue:0.0650), while on the other responses (process yield, particle size and densities) were significant (p-value