Inhalation

INH0424

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Inhalation April 2024 15 the Alberta Idealized Nasal Inlet. Respiratory Drug Delivery 2023. 12. Henriques, P. et al. Amorphous Nasal Powder Advanced Performance: In Vitro/Ex Vivo Studies and Correlation with In Vivo Pharmacokinetics. J Pharm Investig 2023, 53: 723-742. 13. Murphy, B.M. et al. Intranasal Powder Adminis- tration of a Spray-Dried Tuberculosis Vaccine Candi- date Characterized Using the Alberta Idealized Nasal Inlet. Respiratory Drug Delivery 2022. 14. Chen, J.Z et al. In Vitro Regional Deposition of Nasal Sprays in an Idealized Nasal Inlet: Comparison with In Vivo Gamma Scintigraphy. Respiratory Drug Delivery 2022. 15. Al-Ghananeem, A.M. et al. Gamma Scintigra- phy for Testing Bioequivalence: A Case Study on Two Cromolyn Sodium Nasal Spray Preparations. Int J Pharm 2008, 357: 70-76. 16. Leach, C.L. et al. Nasal Deposition of HFA- Beclomethasone, Aqueous Fluticasone Propionate and Aqueous Mometasone Furoate in Allergic Rhi- nitis Patients. J Aerosol Med Pulm Drug Deliv 2015, 28: 334-340. 17. Murphy, B.M. et al. Intranasal Delivery of a Synthetic Entamoeba Histolytica Vaccine Contain- ing Adjuvant (LecA+ GLA-3 M-052 Liposomes): In Vitro Characterization. Int J Pharm 2022, Oct 15; 626: 122141. 18. Potts, J.C. et al. Investigations into the Rela- tionship Between Spray Dried Powder Particle Size and Deposition in Nose and Lung Analogues When Actuated from a Nasal Device. Respiratory Drug Delivery 2023. Clair Brooks, PhD, is an Applications Specialist and Matthew Fenn, MBA is Head of Business Develop- ment, Copley Scientific Ltd., Colwick Quays Business Park, Road No. 2, Nottingham, NG4 2JY. UK, Tel.: +44 1159 616229, info@copleyscientific.co.uk, www. copleyscientific.com. experiments and in accelerating product develop- ment in the face of considerable inter-subject vari- ability in the physiology of the nose, even within specific patient populations. e science behind the AINI and the test data and methods summarized here illustrate the potential of the AINI within this context, highlighting its ability to underpin prog- ress, focus in vivo studies and help to bring safer, more effective nasal drug products to market. References 1. Hafner, A. Advances in Development, Character- isation and Application of Nasal Drug Delivery Sys- tems. Pharmaceutics 2022, Aug; 14(8): 1562. 2. Doub, W.H. et al. Laboratory Performance Testing of Aqueous Nasal Inhalation Products for Droplet/ Particle Size Distribution: An Assessment from the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) White Paper. AAPS PharmSciTech 2023, 24: 208. 3. Chen, J.Z. et al. In Vitro Assessment of an Ideal- ized Nose for Nasal Spray Testing: Comparison with Regional Deposition in Realistic Nasal Replicas. Int J Pharm 2020, 582: 119341. 4. Zhang, Y. et al. Experimental Measurement and Numerical Study of Particle Deposition in Highly Idealized Mouth-roat Models. Aerosol Sci Tech 2006, 40: 361-372. 5. Zhang, Y. et al. In Vivo–In Vitro Comparison of Deposition in ree Mouth roat Models with Qvar ® and Turbuhaler ® Inhalers. J Aerosol Med 2007, 20(3): 227-235. 6. Copley, M. et al. Evaluating the Alberta roat: An Innovation to Support the Acquisition of More Clinically Applicable Aerosol Aerodynamic Parti- cle Size Distribution (APSD) Data in Oral Inhaled Product (OIP) Development. Inhalation 2011, 5(4): 12-16. 7. Williams, G. et al. In Vitro Anatomical Models for Nasal Drug Delivery. Pharmaceutics 2022, Jul; 14(7): 1353. 8. Finlay, W.H. et al. Development of an Idealized Nasal Geometry for Estimation of Regional Depo- sition of Nasal Sprays. Respiratory Drug Delivery 2021. 9. US Pharmacopoeia Chapter <601> Aerosols, Nasal Sprays, Metered Dose Inhalers and Dry Powder Inhalers. 10. FDA Guidance for Industry Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Draft Guidance). April 2003. 11. Henriques, P. et al. Benchmarking of Parti- cle Engineering Strategies for Nasal Powder Deliv- ery: Characterization of Nasal Deposition Using

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