Formulation, Development and Evaluation of Dry Powder for Inhalation of Tiotropium Bromide

Abstract

A Dry powder inhaler (DPI) is a device that delivers medication to the lungs in the form of a dry powder. Dry powder inhalers (DPIs) for Tiotropium Bromide were developed with a view to treat bronchospasm associated with chronic bronchitis and emphysema. The formulations were prepared with different grades of Lactose monohydrate like Respitose SV010, Respitose ML006, Micronized Respitose SV010, and Lactohale LH300 and evaluated for physical characterization like bulk density, tapped density, flow property, particle size distribution, and also evaluated chemical characterization like assay, related substances, emitted dose and fine particle dose. The influence of composition of DPI and overages on performance of DPI was studied. The better emitted dose and fine particle dose was obtained from the DPIs formulated with 25:75 ratio of fine lactose (Respitose ML006) and coarse lactose (Respitose SV001) having 10% w/w overages of API. The selected batch was kept in stability chamber and sample were withdraw periodically after 1 month, 2 month, and 3 month, and evaluated the emitted dose and fine particle dose and compared the marketed formulation (Spiriva).