Issue link: https://www.e-digitaleditions.com/i/1518209
This section provides information that may be useful in research and development or manufacturing. Content is provided by the companies listed. No endorsement or preference is intended. 30 April 2024 Inhalation EXTRA FOCUS Product Development This section of Inhalation provides information that may be useful in research and development or manufacturing. Content is provided by the companies listed. No product endorsement or preference is intended. RDD 2024 workshop on generic nasal suspensions "Exploring In Vitro-Only Bioequivalence Pathways for Generic Nasal Suspensions" In 2023, the US FDA introduced new draft guidances for nasal suspension product bioequivalence (BE) requirements, provid- ing a fully "in vitro-only" approval pathway. is workshop will explore robust testing package design for such studies. We will discuss traditional in vitro spray characterization tests for generic product sub- missions (SAC, DPS, SP, DISP; DSD, PG; Priming/ Re-priming) and then address advanced techniques such as morphologically directed Raman spectros- copy (MDRS) and dissolution studies, emphasizing their relevance to establishing in vitro/in vivo cor- relation (IVIVC). Challenges and solutions for these techniques will also be highlighted. Intertek Melbourn UK: +44 1763 261648 bd.melbourn@intertek.com www.intertek.com Advances in inhaler leakage monitoring MKON has developed several unique technologies to improve the speed and accuracy of inhaler leak- age monitoring and to reduce leakage. In a video on our website, the computational fluid dynamic (CFD) simulation displays an inhaler canister with a conven- tional ferrule on the left and MKON's advanced lat- tice ferrule on the right. e illustration shows how MKON's ferrule allows for instant leak detection while the conventional ferrule waits for gas pressure to build up before any leak detection is possible. Addi- tional design work is in process to minimize leakage. MKON, LLC US: +1 512 707-9260 info@mkonllc.com www.mkonllc.com