Prevalidation of a human cornea construct as an alternative to animal corneas for in vitro drug absorption studies

Journal of Pharmaceutical Sciences
Matthias HahneStephan Reichl

Abstract

The use of ophthalmic drugs has increased consistently over the past few decades. Currently, most research is conducted using in vivo and ex vivo animal experiments; however, they have many disadvantages, including ethical concerns, high costs, the questionable extension of animal results to humans, and poor standardization. Although several cell culture-based cornea models have been developed, none have been validated and accepted for general use. In this study, a standardized, three-dimensional model of the human cornea (Hemicornea, HC) based on immortalized human corneal cells and cultivated in serum-free conditions was developed for drug absorption studies and prevalidated using compounds with a wide range of molecular characteristics (sodium fluorescein, rhodamine B, fluorescein isothiocyanate-labeled dextran, aciclovir, bimatoprost, dexamethasone, and timolol maleate). The HC model was independently cultured in three different laboratories, and the intralaboratory and interlaboratory reproducibility was analyzed and compared with the rabbit cornea. This analysis showed that the HC has a barrier in the same range as excised animal corneas, although with a higher reproducibility and lower variability. Because of the demonst...Continue Reading

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Citations

May 20, 2014·PloS One·Cameron K PostnikoffMaud B Gorbet
Jul 6, 2014·Journal of Controlled Release : Official Journal of the Controlled Release Society·Kati-Sisko VellonenArto Urtti
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May 24, 2016·Journal of Pharmaceutical Sciences·Christian Kölln, Stephan Reichl
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Dec 19, 2020·Pharmaceutics·Laura García-Posadas, Yolanda Diebold
Jun 13, 2021·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Andjelka RačićDanina Krajišnik

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