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3036671 
Journal Article 
The MTT assay as tool to evaluate and compare excipient toxicity in vitro on respiratory epithelial cells 
Scherliess, R 
2011 
Yes 
International Journal of Pharmaceutics
ISSN: 0378-5173
EISSN: 1873-3476 
411 
1-2 
98-105 
English 
21453764 
WOS:000291507400013 
There are not many excipients already approved in drug products for the use in the respiratory tract. In this study, a rapid in vitro screening procedure to assess and compare acute toxicity of soluble excipient substances on respiratory epithelial cells utilising the Calu-3 cell line is presented. The test substances are either dissolved in HBSS+HEPES buffer or are directly applied to the cellular surface. After 4h incubation, the substances are removed and the cell viability is assessed using an MTT assay. The tested excipients include polysorbate 20 and 80, lactose and povidone 30 as well as glycerol and propylene glycol as examples of excipients already being used in formulations for application in the respiratory tract. These substances are sorted according to their toxic effect and new excipients not yet used in the respiratory tract like HPMC can be classified in this scheme. With this, besides information from systemic toxicity tests, a first valuation of the acute toxic effect of the substance on respiratory epithelial cells is gained. This can aid in the choice of new excipients being necessary for modern respiratory formulations comprising new active compounds as biomolecules or new delivery strategies such as sustained or prolonged delivery. 
Acute toxicity; Calu-3; Choice of excipients; Drug products for the respiratory tract; In vitro toxicity method; MTT-assay; Respiratory epithelium