Joshua Houlden1, Miles Jeanneret1 Davide Cunha1 & Mervin Ramjeeawon1
1Intertek Melbourn, Saxon Way, Melbourn, Herts, SG8 6DN, UK
Summary
There has been increased focus on the generic pharmaceutical industry when embarking on in-vitro only bio-equivalence testing of inhaled products, using a weight of evidence based approach to submission. In the draft product specific guidance document for beclomethasone dipropionate issued in May 2019, the FDA proposed additional supportive in-vitro studies. These included the characterisation of Plume Front Velocity (PFV) profiles of the test and reference product to support the weight of evidence approach to negate the need for resource consuming comparative clinical endpoint bioequivalence studies [1].
Plume Velocity analysis is a technique that permits the movement of the plume generated from the inhalers to be visually captured over time from which data can be extracted and extrapolated to determine the velocity of the plume emitted.
Two different commercially available metered dose inhalers (pMDI) and one commercially available soft mist inhaler (SMI) were selected to demonstrate this novel approach to device characterisation. The differences in the plume velocity between the two different device types (pMDI/SMI) was investigated and the comparison of plume velocities between a generic pMDI device and its reference listed drug (RLD). The force to actuate, and plume duration times, for both pMDIs were also investigated.
Key Message
Development of Plume Front Velocity and Force to Actuate methodologies for the characterisation of pMDI and SMI devices using the Proveris SprayVIEW were shown to be highly effective for the evaluation of emitted aerosol devices and in-vitro bioequivalence studies between generic and reference listed drug products.