Formulation Development and Evaluation of Fluticasone Propionate Dry Powder Inhaler

Abstract

Dry powder inhaler (DPI) has become widely known and attractive platform for pulmonary drug delivery. DPIs are commonly used to treat asthma and other pulmonary diseases. The effectiveness of a powdered drug to inhale depends on the inspiratory flow rate generated by the patient. DPI is chiefly composed of micronized drug admixed with the carrier particles of larger size which serve as a flow avail. The desired aerodynamic particle size for the drug to get settled in alveoli(the main target site) is 1-5 μm. The formulations were prepared with different grades of Lactose monohydrate like Inhalac 230 and inhalac 400 and evaluated for physical characterization like bulk density, tapped density, flow property and chemical characterization like assay, content uniformity and fine particle fraction. The effect of parameters like mixing time, course to fine lactose ratio and type of device were studied. The coarse to fine lactose (inhalac 230 and inhalac 400) ratio of 95:5, 15 min mixing time and Rotahaler® as device were selected. The optimized batch showed 8.9% fine particle fraction measured using eight stage non viable cascade impactor. The developed formulation showed required characteristics and can deliver drug effectively to lungs.