Floroiu states that, “More work is needed for setting the basis for a pulmonary BCS but . . . its principles once defined will be useful tools for formulation, development and quality control. Having a pulmonary BCS in place could be a tool in setting product specifications for OIDPs.”
In addition, Jan Olof Svensson’s poster on “In-vitro Dissolution Testing Of Aerosolized Powders Using The USP Dissolution Apparatus 7” was one of the posters selected for the Posters on the Podium session. Svensson, of AstraZeneca, describes a method using a modified Andersen cascade impactor with the USP dissolution apparatus 7 and concludes that the apparatus is “robust and well suited for testing of aerosolized, micronized drug substances with good repeatability.”
Advances in delivery devices
Besides the poster presentation by Jeff Weers on the Respira AOS device, and a talk by Worth Longest of VCU a session on “Reviving Positive Pressure DPI Devices for Efficient and Reproducible Aerosol Delivery to Infants and Children” in the session on “New DPI Theory and Practice,” most of the delivery-device related talks at Digital RDD 2020 center around regulatory issues and/or connected devices.
In the Aptar Pharma sponsor seminar “Decoding Article 117 of Medical Device Regulation 2017/745: Known Information and Future Challenges for Drug-Device Combination Products,” presented by Krystel Limouzin, Global Regulatory Affairs Director, Limouzin reviews issues related to the EU MDR General Safety and Performance Requirements. Among the topics she reviews are challenges raised by industry, including supply chain complexity and the continuing need to answer basic questions such as what risk classification rules are applicable to drug device combinations and what is the meaning of “substantial change.” At the time of the talk, implementation of the new MDR was still set for May 2020 but was up in the air due to the COVID-19 pandemic. The EC has since announced that implementation of most of the provisions will be delayed until May 2021.
A session coordinated with International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) on “The Impact of New Technology & Regulation on Inhaler Design, Development & Product Lifecycle” focuses on connected devices and includes papers on development of the a number of such devices, including connected Turbuhaler, Ellipta, and Nexthaler DPIs, as well as Teva’s Digihaler.
In her talk on “Personalized Aerosol Therapies: Understanding The Data Privacy Barrier,” Mary Devlin Capizzi of Faegre Drinker reviews the approaches to medical device data regulations in the US, Europe, China, and India, noting that the regulatory frameworks have been expanding and will likely continue to expand. In response to a question about whether the industry should adopt a common platform for connected inhalers, Capizzi, who serves as counsel to IPAC-RS, pledged to present the idea to the consortium’s Devices Working Group.
