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The Biopharmaceutics Focus Group of the Academy of Pharmaceutical Sciences (APS) of Great Britain presented a workshop on nasal biopharmaceutics at the 2022 Drug Delivery to the Lungs Conference (DDL2022) in December 2022 in Edinburgh, UK. The aim was to bring together the scientific community to discuss challenges in the development of nasally administered therapies. BACK PAGE Inhalation April 2023 39 Research focus on nasal biopharmaceutics: A workshop by the Biopharmaceutics Focus Group of the APS Lucy Goodacre a , Ben Forbes a , Alison Lansley b , Claire Patterson c and Chris Roe d On behalf of the APS Biopharmaceutics Focus Group a King's College London, Institute of Pharmaceutical Science, London, UK b University of Brighton, School of Applied Sciences, Brighton, UK c SEDA Pharmaceutical Development, Cheadle, UK d Quotient Sciences, Nottingham, UK e Biopharmaceutics Focus Group of e Academy of Phar- maceutical Sciences (APS) of Great Britain presented a work- shop on nasal biopharmaceutics at the 2022 Drug Delivery to the Lungs Conference (DDL2022) in December 2022 in Edinburgh, UK. e aim was to bring to- gether the scientific community to discuss challenges in the devel- opment of nasally administered therapies. e workshop featured thought-provoking talks on topics ranging from research and devel- opment through clinical studies. e speakers summarized how bio- pharmaceutics and performance of nasal products are currently eval- uated and shared their thoughts on new developments and unmet needs. e workshop concluded with a facilitated panel discus- sion that explored opportunities and challenges in these areas. A summary of workshop content is provided below. Nasal drug product characterization Regina Scherließ, Kiel University (Germany), summarized current guidance from the European Phar- macopoeia (Ph.Eur), United States Food and Drug Agency (FDA) [1] and European Medicines Agency (EMA) [2] including the Ph.Eur monograph "Nasal Preparations" (Ph.Eur. 11.0/0676), which stip- ulates tests for the uniformity of delivered dose. e FDA has guid- ance on the general characteristics such as pH, osmolarity and viscos- ity, plus guidance on nasal spray product performance: plume ge- ometry, dose uniformity and spray pattern. Both the FDA and EMA empha- size the need to determine the proportion of nasal spray droplets below 10 µm, a safety consider- ation to control lower respiratory tract exposure. However, differ- ent apparatus and configurations for impactor methods to measure mass fraction below 10 µm result in significantly different outcomes. In response, Regina's group has developed a new "realistic" nasal inlet for use with impactors. Physiologically-based biopharmaceutics modeling (PBBM) Claire Patterson, SEDA (UK), discussed potential applications and the status of physiologically based biopharmaceutics model- ing (PBBM) for nasal delivery. PBBM combines drug metabo- lism and physiologically- based pharmacokinetic (PBPK) soft- ware with models of dissolution and other dynamic processes relevant to nasal drug delivery. Mathematical descriptors linked by differential equations are used to predict concentration-time profiles at a target site, whether it be drug concentration locally within the nasal cavity, in the sys- temic circulation or in the brain. Such simulations can guide formulation and device develop- ment and inform dose selection. PBBM is well established for oral drug delivery and has potential for similar impact in nasal delivery. e commercial software platform GastroPlus ® (Simulations Plus, Lancaster, CA) contains a pulmo- nary/intranasal absorption model in its Additional Dosage Routes Module, although there is little reported regarding its use or effi- cacy. Building a PBBM model for nasal drug delivery relies on iden- tification of input parameters and generation of datasets (perhaps requiring new methodology) re- quired to build and validate the models. is requires more ad- vanced mechanistic understanding of processes involved, particularly in nose-to-brain delivery, and a cycle of continuous improvement to challenge prototype mod- els with data to understand their strengths and limitations. Modeling deposition in the nasal cavity Andrew Martin, University of Alberta (Canada), focused on in silico and experimental modeling