Posted by The surge in neurological disorders necessitates innovative strategies for delivering active pharmaceutical ingredients to the brain. The non-invasive intranasal route has emerged as a promising approach to optimize drug delivery to the central nervous system by circumventing the blood–brain barrier. While the intranasal approach offers numerous advantages, the lack of a standardized protocol for drug testing poses challenges to both in vitro and in vivo studies, limiting the accurate interpretation of nasal drug delivery and pharmacokinetic data. This review [1] explores the in vitro experimental assays employed by the pharmaceutical industry to test intranasal formulation. The focus lies on understanding the diverse techniques used to characterize the intranasal delivery of drugs targeting the brain. Parameters such as drug release, droplet size measurement, plume geometry, deposition in the nasal cavity, aerodynamic performance and mucoadhesiveness are scrutinized for their role in evaluating the performance of nasal drug products. The review further discusses the methodology for in vivo characterization in detail, which is essential in evaluating and refining drug efficacy through the nose-to-brain pathway. Animal models are indispensable for pre-clinical drug testing, offering valuable insights into absorption efficacy and potential variables affecting formulation safety.
The following CD-related examples are mentioned
- Chitosan/cyclodextrin/tripolyphosphate nanoparticles with insulin (5 IU/kg) (65–75 µL into each nostril of male New Zealand albino rabbits) resulted in 35 % decrease in blood glucose levels at 1 h post-nasal administration [2]
- Spray-freeze dried particles with insulin, sodium taurocholate or β-cyclodextrin (male Sprague Dawley albino rats) resulted in increased bioavailability (4.4–7 %) and reduced blood glucose level after administration [3]
References>
C. Y. J. Wong, A. Baldelli, O. Tietz, J.van der Hoven, J. Suman, H.X. Ong, D. Traini (2024) An overview of in vitro and in vivo techniques for characterization of intranasal protein and peptide formulations for brain targeting. International Journal of Pharmaceutics 654, 123922.
https://doi.org/10.1016/j.ijpharm.2024.123922.
Serim, T.M.; Kožák, J.; Rautenberg, A.; Özdemir, A.N.; Pellequer, Y.; Lamprecht, A. (2021) Spray Freeze Dried Lyospheres® for Nasal Administration of Insulin. Pharmaceutics 13, 852. https://doi.org/10.3390/pharmaceutics13060852
D. Teijeiro-Osorio, C. Remuñán-López, M.J. Alonso (2009) New generation of hybrid poly/oligosaccharide nanoparticles as carriers for the nasal delivery of macromolecules. Biomacromol., 10, 243-249. https://doi.org/10.1021/bm800975j