Inhalation

INH0423

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18 April 2023 Inhalation sal Delivery of Biopharmaceuticals. pp.461-481. Springer. doi:10.1007/978-1-4614-9524-6_21. 24. Hastedt JE, Bäckman P, Clark AR, et al. Scope and relevance of a pulmonary biopharmaceutical classification system AAPS/FDA/USP Workshop March 16-17, 2015, Baltimore, MD, US. AAPS Open. 2016;2(1). doi:10.1186/s41120-015-0002-x. 25. Inbrija. Patient brochure. Acorda erapeutics. 2021; www.inbrija.com/patient-brochure.pdf. 26. Henriques P, Fortuna A, Doktorovová S. Spray dried powders for nasal delivery: Process and for- mulation considerations. European Journal of Phar- maceutics and Biopharmaceutics. 2022;176:1-20. doi:10.1016/j.ejpb.2022.05.002. 27. Davis SS, Illum L. Absorption enhancers for nasal drug delivery. Clinical Pharmacokinetics. 2003;42(13):1107-1128. doi:10.2165/00003088-200 342130-00003. 28. Giuliani A, Balducci AG, Zironi E, et al. In vivo nose-to-brain delivery of the hydrophilic antiviral ribavirin by microparticle agglomerates. Drug Deliv- ery. 2018;25(1):376-387. doi:10.1080/10717544.2 018.1428242. 29. Moon C, Smyth HDC, Watts AB, Williams RO 3rd. Delivery technologies for orally inhaled products: An update. AAPS PharmSciTech. 2019;20(3):117. doi:10.1208/s12249-019-1314-2. 30. Lechuga-Ballesteros, D. (2019). Particle engi- neering technology for inhalation. In: Hickey AJ. (Ed.) Pharmaceutical Inhalation Aerosol Technology, ird edition. pp. 349-361. CRC Press. Lliralyn M. McEachern, BSc, is an Engineer and omas S. Lund, BSc, is a Senior Engineer in the Catalent Spray Drying Center of Excellence and Alan B. Watts, PhD, is Director of Innovation and Partner- ships for Orally Inhaled Products at Catalent Pharma Solutions, 14 School House Road, Somerset, NJ 08873, US. Corresponding author: Alan B. Watts, PhD, alan. watts@catalent.com, www.catalent.com. 12. Wang H, Connaughton P, Lachacz K, et al. Inhalable microparticle platform based on a novel shell-forming lipid excipient and its feasibility for respirable delivery of biologics. European Journal of Pharmaceutics and Biopharmaceutics. 2022;177:308- 322. doi:10.1016/j.ejpb.2022.07.013. 13. Pilcer G, Amighi K. Formulation strategy and use of excipients in pulmonary drug delivery. Inter- national Journal of Pharmaceutics. 2010;392(1-2):1- 19. doi:10.1016/j.ijpharm.2010.03.017. 14. Alhajj N, O'Reilly NJ, Cathcart H. Leucine as an excipient in spray dried powder for inhala- tion. Drug Discovery Today. 2021;(10):2384-2396. doi:10.1016/j.drudis.2021.04.009. 15. Masnadi MS, Grace JR, Elyasi S, Bi X. Distribution of multi-phase gas–solid flow across identical parallel cyclones: Modeling and experimental study. Separa- tion and Purification Technology. 2010;72(1):48-55. doi:10.1016/j.seppur.2009.12.027. 16. Miller DA, Ellenberger D, Gil, M. (2016). Spray-drying technology. In: Williams III R, Watts A, Miller D. (Eds). Formulating poorly water sol- uble drugs. AAPS Advances in the Pharmaceuti- cal Sciences Series, Vol 22. Springer, Cham. doi. org/10.1007/978-3-319-42609-9_10. 17. Muschelknautz U. Design criteria for multi- cyclones in a limited space. Powder Technology. 2019;357:2-20. doi:10.1016/j.powtec.2019.08.057. 18. Sibum I, Hagedoorn P, de Boer AH, et al. Challenges for pulmonary delivery of high powder doses. Inter- national Journal of Pharmaceutics. 2018;548(1):325- 336. doi:10.1016/j.ijpharm.2018.07.008. 19. Carrigy N, Vehring R. (2019). Engineering sta- ble spray-dried biologic powder for inhalation. In: Pharmaceutical Inhalation Aerosol Technology. pp. 291-326. doi: 10.1201/9780429055201-12. 20. Abdul‐Fattah AM, Kalonia DS, Pikal MJ. e challenge of drying method selection for protein pharmaceuticals: Product quality implications. Jour- nal of Pharmaceutical Sciences. 2007;96(8):1886- 1916. doi:10.1002/jps.20842. 21. Lechuga‐Ballesteros D, Charan C, Stults CLM, et al. Trileucine improves aerosol performance and stability of spray‐dried powders for inhalation. Jour- nal of Pharmaceutical Sciences. 2008;97(1):287- 302. doi:10.1002/jps.21078. 22. Costantino HR, Andya JD, Nguyen PA, et al. Effect of mannitol crystallization on the stability and aerosol performance of a spray-dried pharmaceutical protein, recombinant humanized anti-IgE monoclo- nal antibody. Journal of Pharmaceutical Sciences. 1998;87(11):1406-1411. doi:10.1021/js9800679. 23. Stevenson CL, Bennett DB. (2014). Develop- ment of the Exubera ® insulin pulmonary delivery system. In: das Neves J, Sarmento B. (Eds). Muco-

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