Conference Talk | Plume Front Velocity and Force to Actuation Characterisation of pMDIs and Soft Mist Inhalers
Authors: Joshua Houlden, Miles Jeanneret Davide Cunha & Mervin Ramjeeawon
Intertek Melbourn, Saxon Way, Melbourn, Herts, SG8 6DN, UK
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.
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.
Please complete the form to request our conference presentation slides. Our team will be happy to send these after the conference (Dec 8-10, 2021).
Intertek Melbourn, Saxon Way, Melbourn, Herts, SG8 6DN, UK
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.
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.
Please complete the form to request our conference presentation slides. Our team will be happy to send these after the conference (Dec 8-10, 2021).