title: Characterization of new eye drops with choline salicylate and assessment of their irritancy by in vitro short time exposure tests.
abstract: The aim of our study was to examine the irritation potential of new eye drops containing 2% choline salicylate (CS) as an active pharmaceutical ingredient (API) and various polymers increasing eye drop viscosity (hydroxyethylcellulose, hydroxypropyl methylcellulose, methylcellulose, polyvinyl alcohol, polyvinylpyrrolidone). The standard method for assessing the potential of irritating substances has been the Draize rabbit eye test. However the European Centre for Validation of Alternative Methods and the Coordinating Committee for Validation of Alternative Methods recommend, short time exposure (STE) in vitro tests as an alternative method for assessing eye irritation. The eye irritation potential was determined using cytotoxicity test methods for rabbit corneal cell line (SIRC) after 5 min exposure. The viability of cells was determined using two cytotoxicity assays: MTT and Neutral Red Uptake. According to the irritation rankings for the short time exposure test, all tested eye drops are classified as non-irritating (cell viability >70%).
authors.affiliation: Department of Pharmaceutical Technology, Poznan University of Medical Sciences, 6 Grunwaldzka Street, 60-780 Poznan, Poland.
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Wroblewska
authors.affiliation: Department of Toxicology, Poznan University of Medical Sciences, 30 Dojazd Street, 60-631 Poznan, Poland.
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Kucinska
authors.affiliation: Department of Toxicology, Poznan University of Medical Sciences, 30 Dojazd Street, 60-631 Poznan, Poland.
authors.forename: Marek
authors.initials: M
authors.lastname: Murias
authors.affiliation: Department of Pharmaceutical Technology, Poznan University of Medical Sciences, 6 Grunwaldzka Street, 60-780 Poznan, Poland.
authors.forename: Janina
authors.initials: J
authors.lastname: Lulek
keywords: Choline salicylate; Eye drops; MTT; Neutral Red Uptake; Short time exposure (STE) in vitro tests