Candidate Device Selection for pMDI In-Vitro only Bioequivalence focussing on Spray Pattern and Plume Geometry Analysis

Miles Jeanneret¹, Michael Kurowski¹, Joe Woodcock¹ & Mervin Ramjeeawon¹

¹Intertek Melbourn, Saxon Way, Melbourn, Herts, SG8 6DN, UK

Summary

In-Vitro only bioequivalence (IVBE) submissions for orally inhaled and nasal drug products (OINDP) have become an increased focus for the generic pharmaceutical industry in recent years. Spray pattern (SP) and plume geometry (PG) testing can be included as in-vitro studies to facilitate a weight of evidence‑based approach to submission for a pMDI product. SP and PG are well-established techniques for OINDP characterisation and are good indicators of spray performance and therefore the likely bioavailability of delivered drug product.

Two different commercially available pressurized metered dose inhalers (pMDIs) were selected to investigate performance – these devices were a generic pMDI device and its’ reference listed drug (RLD). Three additional commercially available actuators were also investigated using the canister from the generic pMDI device to examine the impact of actuator selection on product performance. SP and PG were analysed for a full range of actuator/canister combinations along with force to actuate, plume duration and spray intensity. The change in actuator with identical canisters was seen to alter the spray characteristics such as for the SP area.

Key Message

SP and PG analysis can be used as a fast and effective screening tool for actuator candidate selection for a generic pMDI or as preliminary analysis to characterize an OINDP product and act as an indicator of device performance and demonstrating in vitro equivalence.