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Inhalation August 2024 17 Looking ahead, future research efforts should focus on establishing a quantitative in vitro/in vivo rela- tionship between dissolution data and systemic phar- macokinetic profiles. is would facilitate a deeper understanding of how dissolution behavior correlates with drug absorption in vivo. References 1. Patton, J.S., et al., Inhaling medicines: Delivering drugs to the body through the lungs. Nature Reviews Drug Discovery, 2007. 6 (1): p. 67-74. 2. Salama, R.O., et al., Preparation and character- isation of controlled release co-spray dried drug- polymer microparticles for inhalation 2: Evaluation of in vitro release profiling methodologies for con- trolled release respiratory aerosols. European Journal of Pharmaceutics and Biopharmaceutics, 2008. 70 (1): p. 145-152. 3. Radivojev, S., et al., Searching for physiologically relevant in vitro dissolution techniques for orally inhaled drugs. International Journal of Pharmaceu- tics, 2019. 556: p. 45-56. 4. Kumar, A., et al., A biocompatible synthetic lung fluid based on human respiratory tract lining fluid composition. Pharmaceutical Research, 2017. 34 (12): p. 2454-2465. 5. Ong, H.X., et al, Do in-vitro dissolution rates dif- fer between beclomethasone dipropionate particles generated from solution-based pMDIs formulated with HFA134a, HFA152a and HFO-1234ze(E) propellants? Drug Delivery to the Lungs, 2023. 34; p. 96-100. 6. Lewis, D., et al, Case studies on reformulation of BDP MDIs using low GWP propellants HFO1234ze and HFA152a. Respiratory Drug Delivery, 2024. 7. Grainger, C.I., et al., Critical characteristics for corticosteroid solution metered dose inhaler bio- equivalence. Molecular Pharmaceutics, 2012. 9 (3): p. 563-569. 8. Hassoun, M., et al., Use of PBPK modeling to evalu- ate the performance of DissolvIt, a biorelevant dissolu- tion assay for orally inhaled drug products. Molecular Pharmaceutics, 2019. 16 (3): p. 1245-1254. 9. Son, Y.-J., et al., Optimization of an in vitro disso- lution test method for inhalation formulations. Dis- solution Technologies, 2010. 17 (2): p. 6-13. 10. Davies, N.M., et al., A novel method for assess- ing dissolution of aerosol inhaler products. Interna- tional Journal of Pharmaceutics, 2003. 255 (1-2): p. 175-187. 11. Patton, J.S., et al., e lungs as a portal of entry for systemic drug delivery. Proceedings of the Ameri- can oracic Society, 2004. 1 (4): p. 338-344. 12. Sakagami, M., et al., In vivo-relevant Transwell dish-based dissolution testing for orally inhaled cor-

