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Open AccessArticle

Ex-Vivo and In-Vivo Assessment of Cyclamen europaeum Extract After Nasal Administration

1
Biopharmaceutical and Pharmacokinetics Unit, Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy and Food Science, University of Barcelona, Joan XXIII Avenue s/n, 08028 Barcelona, Spain
2
Pharmacy and Pharmaceutical Technology Department, Faculty of Pharmacy, Campus of Cartuja Street s/n, University of Granada, 18071 Granada, Spain
3
Physiology Section, Department of Biochemistry and Physiology, Faculty of Pharmacy and Food Science, University of Barcelona, Joan XXIII Avenue s/n, 08028 Barcelona, Spain
4
Scientific Technological Centers, University of Barcelona, Baldiri i Reixac 10-12, 08028 Barcelona, Spain
*
Author to whom correspondence should be addressed.
Pharmaceutics 2019, 11(9), 426; https://doi.org/10.3390/pharmaceutics11090426
Received: 8 June 2019 / Revised: 22 July 2019 / Accepted: 13 August 2019 / Published: 21 August 2019
(This article belongs to the Special Issue Intranasal Drug Delivery Systems)
Rhinosinusitis is a prevalent disorder with a severe impact on the health-related quality of life. Saponins of Cyclamen europaeum exert a clinically proven curative effect on rhinosinusitis symptoms when instilled into the nasal cavity, however, more extensive preclinical assessment is required to better characterize the efficacy of this botanical extract. This work evaluates the potential use of a natural freeze-dried extract of C. europaeum given as topical nasal administration. Permeation experiment on porcine nasal mucosa was performed with Franz diffusion cells. Experiments in rabbits were performed to test for any toxicological, hematological, biochemical or histological evidence of systemic action. No theoretical levels of saponins were found in the receptor chamber of Franz diffusion cells. Hematological data did not show significant differences between control and experimental animals (p > 0.05). Histological studies also showed that enhanced secretory activity in response to intranasal administration was not accompanied by any visible signs of injury. An examination of the brain, lungs, liver, kidneys, spleen, and gastrointestinal organs did not reveal any abnormality. The absence of mucosal permeation of saponins and negligible probability of C. europaeum saponins absorption in the course of a therapeutic application was demonstrated. View Full-Text
Keywords: Cyclamen europaeum; nasal dosage form; nasal drug delivery; permeability; rhinosinusitis Cyclamen europaeum; nasal dosage form; nasal drug delivery; permeability; rhinosinusitis
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Fernández-Campos, F.; Clares, B.; Rodríguez-Lagunas, M.J.; Jauregui, O.; Casals, I.; Calpena, A.C. Ex-Vivo and In-Vivo Assessment of Cyclamen europaeum Extract After Nasal Administration. Pharmaceutics 2019, 11, 426.

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