Inhalation

INH0423

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42 April 2023 Inhalation comparing nasal wicks with nasal washes for sampling cytokine lev- els as markers of inflammation after nasal administration of novel and reference formulations. Feedback from workshop delegates A survey of workshop registrants obtained 51 responses (a 33% re- sponse rate). Most respondents (58%) worked in the pharma- ceutical industry, with academia, research students and medicines regulators also represented (Fig- ure 1a). Geographically, most respondents resided in the United Kingdom or Continental Europe, with 23% offering a wider global perspective (Figure 1b). ere was interest in the full range of topics covered, with scores in the 79-94% range for positive inter- est, i.e., "moderately interesting" to "'most interesting" categories, with respondents having a slight preference for biopharmaceutics (in silico) modeling, in vitro exper- imental methods and nonclinical studies compared to clinical and regulatory aspects (Figure 1c). ere was general enthusiasm for further events on nasal biopharma- ceutics, with similar proportions of respondents (approximately two-thirds) indicating they would attend an in-person workshop, online conference or webinar. Free text responses to the question "Was there anything you felt we missed or would like to see next time?" were coded and broadly fell into seven categories (Figure 1d). "Regulatory" was most popu- lar with interest in US versus EU requirements, bioequivalence, reg- ulatory-industry interaction and development of critical quality at- tributes. Interest in "formulation" included excipients, liquids versus powders and formulations tailored for regional deposition or molecu- lar drug class. "Case studies" were requested from key opinion lead- ers or nasal product development companies based on optimization for local or systemic delivery or new molecules/products. Interest in "analytical methods" included nasal casts, dissolution methods, spray characterization and emitted dose. ere was interest in how to target "nose to brain" delivery and in vitro/in vivo correlation for this route, "devices" with an em- phasis on innovation, device/ formulation matching and device switching, and "vaccines" includ- ing mucosal biology. Next steps e content of the workshop is being supplemented by refer- ence to the literature and will be published shortly as a detailed review article titled, "Nasal bio- pharmaceutics: Fit for current and future drug delivery needs?" In addition, the focus group is using the feedback above to plan follow-up events and will an- nounce details soon. References 1. United States Food and Drug Administration. Nasal Spray and Inhalation Solution, Sus- pension, and Spray Drug Products—Chemistry, Manu- facturing, and Controls Docu- mentation. 2002. https://www. fda.gov/regulatory-information/ search-fda-guidance-documents/ n a s a l - s p r a y - a n d - i n h a l a t i o n - solution- suspension-and-spray- d r u g - p r o d u c t s - c h e m i s t r y - manufacturing-and. 2. European Medicines Agency. Guideline on the Pharmaceutical Quality of Inhalation and Nasal Products. 2006. https://www.ema. europa.eu/en/ documents/scien tific-guideline/guideline-pharma ceutical-quality-inhalation-nasal- products_en.pdf. 3. Kiaee M., Wachtel H., Noga M.L., Martin A.R. and Finlay W.H., An Idealized Geometry at Mimics Average Nasal Spray Deposition In Adults: A Compu- tational Study. Comput Biol Med, 2019. 107: p. 206-217. 4. Chen J.Z., Finlay W.H. and Martin A., In Vitro Regional Deposition of Nasal Sprays in an Idealized Nasal Inlet: Comparison with In Vivo Gamma Scintigra- phy. Pharm Res, 2022. 39(11): p. 3021-3028. For more information, please con- tact the corresponding authors: Lucy Goodacre, lucy.goodacre@kcl. ac.uk and Ben Forbes, ben.forbes@ kcl.ac.uk. ADVERTISER INDEX A Astech Projects 7 C Catalent Cover 2 Copley Scientific 3 D DDL 43 I Intertek 5 M MKON 29 MSP 17 P Proveris 9, 37 Q Qualicaps 27 R RDD 1

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