CriticalSorb™: enabling systemic delivery of macromolecules via the nasal route

Drug Delivery and Translational Research
Andrew L LewisLisbeth Illum

Abstract

Systemic delivery of proteins via the nasal route has to date been limited by their poor absorption across the nasal mucosa, and the less than optimal tolerability of known permeation enhancers. We have recently developed a highly effective nasal delivery system (CriticalSorb™) based on Solutol HS15. Extensive toxicology studies have shown CriticalSorb™ to be very well tolerated, non-toxic and non-irritant. Cell culture and ex vivo-isolated tissue studies have shown it to promote transport of molecules mainly via transcellular but also to some extent, via paracellular routes. Pharmacokinetic/pharmacodynamic studies in rats, rabbits, non-human primates and recently in man have demonstrated significantly enhanced systemic delivery of nasally administered proteins including insulin (~6 kDa) and human growth hormone (~22 kDa), and pharmacodynamics similar to those after subcutaneous injection. CriticalSorb™ therefore opens up the possibility of developing nasal spray formulations for macromolecules such as proteins.

References

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Feb 4, 2012·Journal of Controlled Release : Official Journal of the Controlled Release Society·Lisbeth Illum
Jun 20, 2012·Journal of Controlled Release : Official Journal of the Controlled Release Society·Lisbeth IllumAndrew L Lewis

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Citations

Dec 18, 2013·Biomedical Microdevices·Ludivine BolMyriam Taverna
Feb 19, 2015·Therapeutic Delivery·Andrew L Lewis, Joël Richard
Apr 21, 2017·Drug Development and Industrial Pharmacy·Michele PozzoliFabio Sonvico
Jul 18, 2019·Pharmaceutics·Sam MaherLisbeth Illum
Feb 23, 2021·Advanced Drug Delivery Reviews·Joël BrunnerGerrit Borchard
Jul 28, 2021·Advanced Drug Delivery Reviews·Matilde Durán-LobatoMaría José Alonso

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