Assessing the Performance of a New Apparatus for Orally Inhaled Product Dissolution Testing in the Differentiation of Alternative Commercial Products for the Delivery of Fluticasone Propionate

Ben Bradley¹, Richard Postlethwaite¹, Jamie Clayton¹ & Mark Copley¹

¹Copley Scientific Ltd, Colwick Quays Business Park, Rd 2, Colwick, Nottingham, NG2 4JY, UK

Summary

Experiments were carried out to compare the dissolution characteristics of Flixotide (fluticasone propionate (FP)) delivered by dry powder inhaler (Flixotide DPI, Accuhaler, GSK) and metered dose inhaler (Flixotide MDI, Evohaler, GSK), using a novel apparatus for orally inhaled product (OIP) dissolution testing (Inhaled Dissolution Apparatus (IDA), Copley Scientific).

The results clearly differentiate the dissolution behaviour of the fine particle dose (<5 µm) from each device type. With the MDI, t₅₀ values are 2.5 to 3 times longer than with the DPI (where t₅₀ is the dissolution half-life, the time taken for 50% of the test dose to dissolve), for example, 11.64 +/-0.07 min c.f. 4.11 +/- 0.35 min (data for 5 dose actuations). These results are consistent with previously reported dissolution data for different types of FP OIPs.

This preliminary testing highlights the potential of the apparatus to produce reproducible data   for routine OIP dissolution testing for QC applications or to support a claim of bioequivalence (BE) in the development of generics.