Aysu Yurdasiper Erdem
Ege University, Turkey
Title: Development of fluticasone propionate spray dried powder formulation containing different carriers as an excipient for the treatment of asthma
Biography
Biography: Aysu Yurdasiper Erdem
Abstract
Statement of the Problem: Asthma is a heterogenic disease occurring in both adults and children worldwide. Over the past decade, orally inhaled fixed-dose agents have emerged as an important therapeutic class for treatment of asthma. Current guidelines recommend inhaled corticosteroids as the basis of initial controller treatment. Several factors such as correct use of inhalers and adherence to the treatment affect the outcome of the disease and have been described to be major barriers for successful treatment.
Objective: The objective of this study was to develop Fluticasone Propionate (FP) Dry Powder Inhalers (DPI) containing different carriers using spray drying technique and characterize the powder in terms of aerosolization, flow properties in order to determine which formulations could be the most suitable for pulmonary delivery.
Materials & Methods: Trehalose, Mannitol and Leucine were used as carriers. The mixtures were spray-dried with constant stirring using a Buchi Nanospray Dryer B-90. A simple, rapid, accurate and sensitive method was developed for quantitative analysis of FP using High Performance Liquid Chromatography (HPLC) with UV detection. The chromatography parameters were Thermo Scientific Hypersil ODS C18, (5 μm, 4,6x250 mm). The isocratic mobile phase was acetonitrile:water (65:35; v/v) at a flow rate of at 1.0 mL.min-1. The determinations were performed using UV-V is detector set at 238 nm. The in vitro aerosolization performance was investigated using Next Generation Impactor (Copley).
Results & Discussion: SEM images of DPI formulations showed almost spherical structures with particle size 1-5 μm. Also the sizes of the particles were determined by laser diffraction with a dry sampling system (Mastersizer 3000 Malvern instruments). Process yield values were higher than 86.±2.8% and encapsulation efficiency values were above 81.±3.2%. The optimized formulation developed in this study exhibited good in vitro aerosolization properties. The Carr’s Index is higher for the formulation with trehalose.