With recently published Product Specific Guidance Documents for Beclomethasone Dipropionate (May 2019) and Tiotropium Bromide (November 2020), The FDA has signalled a push to explore new in vitro tests to help potential generic drug developers provide supporting data to demonstrate bioequivalence for pMDI and soft mist inhaler products. Two of the proposed tests gaining the most interest as of late are Spray Velocity and Spray Duration.
The FDA has classified pMDI and soft mist inhaler products as combination products due its uniqueness of drug-device-patient usage combination. Genericizing these products has been a major challenge especially for the US market where the regulatory hurdles make it even more difficult for the generic companies to achieve approval. However, these past several years, we have seen several new key approvals that seem to be paving the way for others. In addition, The FDA’s willingness to explore new in vitro testing methods will hopefully pave a path to simplifying the generic approval process, meaning more competition in the market.
Proveris Scientific’s SprayVIEW Measurement System has long been the industry gold standard platform for measurement of spray pattern and plume geometry of spray and aerosol products. In this webinar Proveris will take you through the new features of our Viota Software update which will now allow users the ability to automatically perform Plume Front Velocity and Spray Duration measurements all within the same environment. Ian Flaherty and Lynn Jordan review the content of the recent guidance documents and explain the how they are addressed with the new SprayVIEW platform. Examples of data generated from both traditional pMDI inhalers and soft mist inhalers will be discussed in relation to the new measurement capability.
Please join us on Tuesday July 19th to learn how to take advantage of these new powerful tools to help bolster your submission packages with additional data highlighting characteristics of your combination drug products.
Key Learning Objectives
- Develop a greater understanding of the current regulatory landscape surrounding generic pMDI and soft mist inhaler products including newly proposed in vitro tests
- Learn about the Proveris SprayVIEW Measurement System and its capabilities including Plume Front Velocity and Spray Duration Measurements
- See example data highlighting how these measurements can provide key insight that will accelerate the development process with the ultimate goal of getting products to market most efficiently
