Improvement of the Bovine Corneal Opacity and Permeability (BCOP) assay as an in vitro alternative to the Draize rabbit eye irritation test

Verstraelen, Sandra; Jacobs, An; Wever, Bart De; Vanparys, Philippe

doi:10.1016/j.tiv.2013.02.018

Cited by 31 publications

(17 citation statements)

References 19 publications

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“…The scoring system of bovine cornea is based on assessing the disruption that a test substance can make to the epithelium barrier and consequently, corneal opacity and permeability induced. Corneal opacity which is determined by measuring the amount of light transmitted through the cornea, and corneal permeability is determined by measuring the amount of fluorescein dye that penetrates to the corneal stroma (Verstraelen et al, 2013). The sum score was calculated and the mean scores for each of the 3 exposed eyes were used to interpret the corneal irritation potential of the tested formulations.…”

Section: Bovine Corneal Opacity and Permeability (Bcop) Testmentioning

confidence: 99%

Poloxamer-based thermoresponsive ketorolac tromethamine in situ gel preparations: Design, characterisation, toxicity and transcorneal permeation studies

Fathalla

Vangala

Longman

et al. 2017

European Journal of Pharmaceutics and Biopharmaceutics

139

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, Poloxamer-based thermoresponsive ketorolac tromethamine in situ gel preparations: Design, characterisation, toxicity and transcorneal permeation studies, European Journal of Pharmaceutics and Biopharmaceutics (2017), doi: http://dx.doi.org/10. 1016/j.ejpb.2017.01.008 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. AbstractThis study was aimed at preparing, characterising and evaluating in situ gel formulations based on a blend of two hydrophilic polymers i.e. poloxamer 407 (P407) and poloxamer 188 (P188) for a sustained ocular delivery of ketorolac tromethamine (KT). Drug-polymer interaction studies were performed using DSC and FT-IR. The gelation temperature (T sol-gel ), gelation time, rheological behaviour, mucoadhesive characteristics of these gels, transcorneal permeation and ocular irritation as well as toxicity was investigated. DSC and FT-IR studies revealed that there may be electrostatic interactions between the drug and the polymers used.P188 modified the T sol/gel of P407 bringing it close to eye temperature (35 o C) compared with the formulation containing P407 alone. Moreover, gels that comprised P407 and P188 exhibited a pseudoplastic behaviour at different concentrations. Furthermore, mucoadhesion study using mucin discs showed that in situ gel formulations have good mucoadhesive characteristics upon increasing the concentration of P407. When comparing formulations PP11 and PP12, the work of adhesion decreased significantly (P < 0.001) from 377.9 ± 7.79 mN.mm to 272.3 ± 6.11 mN.mm. In vitro release and ex vivo permeation experiments indicated that the in situ gels were able to prolong and control KT release as only 48% of the KT released within 12 h. In addition, the HET-CAM and BCOP tests confirmed the nonirritancy of KT loaded in situ gels, and HET-CAM test demonstrated the ability of ocular protection against strongly irritant substances. MTT assay on primary corneal epithelial cells revealed that in situ gel formulations loaded with KT showed reasonable and acceptable percent cell viability compared with control samples.

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Section: Bovine Corneal Opacity and Permeability (Bcop) Testmentioning

confidence: 99%

Poloxamer-based thermoresponsive ketorolac tromethamine in situ gel preparations: Design, characterisation, toxicity and transcorneal permeation studies

Fathalla

Vangala

Longman

et al. 2017

European Journal of Pharmaceutics and Biopharmaceutics

139

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“…Each chamber has its own dosing hole which allows both the epithelium and endothelium to be treated independently. Currently, opacity is measured using an OP-KIT opacitometer, which provides a centerweighted reading of light transmission by measuring the changes in voltage when the transmission of white light alters as it passes through the cornea (Verstraelen et al, 2013). However, opacity readings can be underestimated as opaque areas tend to develop in spots in a non-homogeneous manner around the corneal periphery (Verstraelen et al, 2013).…”

Section: Ex Vivo Testsmentioning

confidence: 99%

“…(2010) developed a prototype laser light based opacitometer (PLLBOA), which has been further improved via the introduction of a camera with a speckle noise reducer, and an optimization of treatment conditions to more closely mimic the in vivo scenario (Jamur and Oliver, 2010;Verstraelen et al, 2013). A minimum of three eyes are used per test.…”

Section: Ex Vivo Testsmentioning

confidence: 99%

An overview of current techniques for ocular toxicity testing

2015

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Given the hazardous nature of many materials and substances, ocular toxicity testing is required to evaluate the dangers associated with these substances after their exposure to the eye. Historically, animal tests such as the Draize test were exclusively used to determine the level of ocular toxicity by applying a test substance to a live rabbit's eye and evaluating the biological response. In recent years, legislation in many developed countries has been introduced to try to reduce animal testing and promote alternative techniques. These techniques include ex vivo tests on deceased animal tissue, computational models that use algorithms to apply existing data to new chemicals and in vitro assays based on two dimensional (2D) and three dimensional (3D) cell culture models. Here we provide a comprehensive overview of the latest advances in ocular toxicity testing techniques, and discuss the regulatory framework used to evaluate their suitability.

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“…One group of test systems is based on isolated animal eyes, e.g. the Bovine Corneal Opacity and Permeation (BCOP) test and the Isolated Chicken Eye (ICE) test (Gautheron et al, 1992;Prinsen and Koeter, 1993;Barile, 2010;Verstraelen et al, 2013). A second group takes advantage of the reactions evoked by chemicals in incubated hen eggs (Eskes et al, 2005) or invertebrates (Adriaens et al, 2005(Adriaens et al, , 2008.…”

Section: Introductionmentioning

confidence: 99%

Development of an in vitro ocular test system for the prediction of all three GHS categories

Bartok

Gabel

Zorn-Kruppa

et al. 2015

Toxicology in Vitro

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Improvement of the Bovine Corneal Opacity and Permeability (BCOP) assay as an in vitro alternative to the Draize rabbit eye irritation test

Cited by 31 publications

References 19 publications

Poloxamer-based thermoresponsive ketorolac tromethamine in situ gel preparations: Design, characterisation, toxicity and transcorneal permeation studies

Poloxamer-based thermoresponsive ketorolac tromethamine in situ gel preparations: Design, characterisation, toxicity and transcorneal permeation studies

An overview of current techniques for ocular toxicity testing

Development of an in vitro ocular test system for the prediction of all three GHS categories

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