An in vitro haemolysis test as an alternative to the draize test for ocular irritation

1994 ◽  
Vol 4 (1) ◽  
pp. 49-54
Author(s):  
B. K. Singleton ◽  
S. E. Libretto ◽  
P. R. Sibley ◽  
C. V. J. Mifsud ◽  
C. M. Andrews
Keyword(s):  
Ocular Irritation ◽  
Draize Test ◽  
Haemolysis Test

Ocular Irritation: Present Cell Culture Models and Perspectives

1992 ◽  
Vol 20 (3) ◽  
pp. 471-475
Author(s):  
Raymonde Guillot
Keyword(s):  
Cell Culture ◽  
In Vitro Tests ◽  
Cellular Viability ◽  
Metabolic Capacity ◽  
Cytotoxic Potential ◽  
Ocular Irritation ◽  
Draize Test ◽  
Culture Models ◽  
Cell Culture Models

Various cell culture models have been proposed as partial or total replacements for in vitro ocular irritation tests. The cytotoxic potential of substances can be evaluated according to various parameters for measuring cellular viability and metabolic capacity. Cell cultures have their limitations, but they also have advantages which justify the inclusion of some such models in a battery of in vitro tests that could replace the Draize test.

Application of the EYTEX™ System to the Evaluation of Cosmetic Products and their Ingredients

1992 ◽  
Vol 20 (1) ◽  
pp. 146-163
Author(s):  
Francis H. Kruszewski ◽  
Laura H. Hearn ◽  
Kyle T. Smith ◽  
Janice J. Teal ◽  
Virginia C. Gordon ◽  
...  
Keyword(s):  
Double Blind ◽  
Eye Irritation ◽  
Ocular Irritation ◽  
Rabbit Eye ◽  
Wide Range ◽  
High Concentrations ◽  
Alkaline Membrane ◽  
Positive Agreement

465 cosmetic product formulations and raw ingredients were evaluated with the EYTEX™ system to determine the potential of this in vitro alternative for identifying eye irritation potential. The EYTEX™ system is a non-animal, biochemical procedure developed by Ropak Laboratories, Irvine, CA, that was designed to approximate the Draize rabbit eye irritation assay for the evaluation of ocular irritation. Avon Products Inc. provided all the test samples, which included over 30 different product types and represented a wide range of eye irritancy. All the EYTEX™ protocols available at the time of this study were used. Samples were evaluated double-blind with both the membrane partition assay (MPA) and the rapid membrane assay (RMA). When appropriate, the standard assay (STD) and the alkaline membrane assay (AMA) were used, as well as specific, documented protocol modifications. EYTEX™ results were correlated with rabbit eye irritation data which was obtained from the historical records of Avon Products Inc. A positive agreement of EYTEX™ results with the in vivo assay was demonstrated by an overall concordance of 80%. The assay error was 20%, of which 18% was due to an overestimation of sample irritancy (false positives) and 2% was attributed to underestimation (false negatives). Overestimation error in this study was due in part to the inability of the protocols to accurately classify test samples with very low irritation potential. Underestimation of sample irritancy was generally associated with ethoxylated materials and high concentrations of specific types of surfactants. 100% sensitivity and 85% predictability were described by the data, indicating the efficiency of EYTEX™ in identifying known irritants. A specificity rate of 39% showed the EYTEX™ assay to be weak in discerning non-irritants. However, the EYTEX™ protocols used in this study were not designed to identify non-irritants. A compatibility rate of 99% proved the effectiveness of the EYTEX™ assay in accommodating a diversity of product types. The EYTEX™ system protocols, when used appropriately, can provide a conservative means of assessing the irritant potential of most cosmetic formulations and their ingredients.

The Use of an Opacitometer to Compare the In Vitro Cornea Opacifying Effects of Timolol With and Without Benzalkonium Chloride

1991 ◽  
Vol 19 (2) ◽  
pp. 263-270
Author(s):  
Haruyoshi Igarashi ◽  
Yasunaga Katsuta ◽  
Yoshiharu Nakazato ◽  
Tohru Kawasaki
Keyword(s):  
Benzalkonium Chloride ◽  
Additive Effects ◽  
Timolol Maleate ◽  
Epithelial Surface ◽  
Endothelial Surface ◽  
Draize Test ◽  
Corneal Opacities

We have evaluated a new in vitro opacitometer method as an alternative to the in vivo Draize test for ocular irritancy. Several concentrations of timolol maleate (timolol) with or without 0.005% benzalkonium chloride were applied to porcine isolated corneas which were either intact or with the epithelium, endothelium, or both epithelium and endothelium removed. Corneal opacities were measured using an opacitometer. In general, timolol with benzalkonium chloride caused a greater degree of opacity to develop in the cornea than did timolol alone. At the lower concentrations of timolol, the increased opacity probably represented additive effects of the two compounds. However, at the highest concentration of timolol (5 x 10 2M), there was an enhanced opacification in the presence of benzalkonium chloride, which may have been due to an increase in penetration, particularly through the epithelium. Timolol caused a greater degree of opacity to develop in the isolated intact porcine corneas when the drug was applied to the endothelial surface, than when applied to the epithelial surface or to both the epithelial and endothelial surfaces. However, timolol with benzalkonium chloride caused a greater degree of opacity in the intact cornea, when the drug was applied to both surfaces than when it was applied only to the epithelial or the endothelial surface.

The Living Dermal Equivalent as an In Vitro Model for Predicting Ocular Irritation

1992 ◽  
Vol 11 (1) ◽  
pp. 47-68 ◽  
Author(s):  
Roger J. Gay ◽  
Mark Swiderek ◽  
Douglas Nelson ◽  
Thomas J. Stephens
Keyword(s):  
In Vitro Model ◽  
Dermal Equivalent ◽  
Ocular Irritation ◽  
Vitro Model

scholarly journals Emulsion of Chloramphenicol: an Overwhelming Approach for Ocular Delivery

Folia Medica ◽  
2017 ◽  
Vol 59 (1) ◽  
pp. 23-30 ◽  
Author(s):  
Kalpesh C. Ashara ◽  
Ketan V. Shah
Keyword(s):  
Ternary Phase Diagram ◽  
Ex Vivo ◽  
Sterility Testing ◽  
Ocular Irritation ◽  
Peg 400 ◽  
Significant Difference ◽  
Oil Mixtures ◽  
Student’S T ◽  
The Impact

Abstract Background: Ophthalmic formulations of chloramphenicol have poor bioavailability of chloramphenicol in the ocular cavity. Aim: The present study aimed at exploring the impact of different oil mixtures in the form of emulsion on the permeability of chloramphenicol after ocular application. Materials and methods: Selection of oil mixture and ratio of the components was made by an equilibrium solubility method. An emulsifier was chosen according to its emulsification properties. A constrained simplex centroid design was used for the assessment of the emulsion development. Emulsions were evaluated for physicochemical properties; zone of inhibition, in-vitro diffusion and ex-vivo local accumulation of chloramphenicol. Validation of the design using check-point batch and reduced polynomial equations were also developed. Optimization of the emulsion was developed by software Design® expert 6.0.8. Assessment of the osmolarity, ocular irritation, sterility testing and isotonicity of optimized batch were also made. Results: Parker Neem®, olive and peppermint oils were selected as an oil phase in the ratio 63.64:20.2:16.16. PEG-400 was selected as an emulsifier according to a pseudo-ternary phase diagram. Constrained simplex-centroid design was applied in the range of 25-39% water, 55-69% PEG-400, 5-19% optimized oil mixture, and 1% chloramphenicol. Unpaired Student’s t-test showed for in-vitro and ex-vivo studies that there was a significant difference between the optimized batch of emulsion and Chloramphenicol eye caps (a commercial product) according to both were equally safe. Conclusion: The optimized batch of an emulsion of chloramphenicol was found to be as safe as and more effective than Chloramphenicol eye caps.

Ophthalmic Delivery of Riboflavin Loaded Nanoparticulate Suspension in Keratoconus: A Preclinical Study in Rabbit Model

2021 ◽  
Vol 17 (9) ◽  
pp. 1866-1873
Author(s):  
Ling Zhang ◽  
Chunlai Fang ◽  
Qiong Wu
Keyword(s):  
Spherical Surface ◽  
Rabbit Model ◽  
Preclinical Study ◽  
Solvent Evaporation Method ◽  
Experimental Animals ◽  
Ophthalmic Administration ◽  
Draize Test ◽  
Ophthalmic Delivery ◽  
Probe Sonication

The present investigation undertakes the formulation of nanoparticulate suspension of Riboflavin to treat keratoconus disease by applying it to the infected mice corneas. The nanoparticles of Riboflavin were prepared using single solvent evaporation method and later formulated as suspension using continuous probe sonication method. Then, both riboflavin nanoparticles and suspension were evaluated for various parameters. The nanoparticles showed smooth and spherical surface with in vitro drug release up to 77.89%. The drug content was found to be 97.23%–98.89%. The suspension was found to be visually clear with pH ranging from 6 to 7. The drug entrapment was found to be from 76.37% to 97.34%. Since there was no hemolytic activity, this formulation was suitable for ophthalmic administration. The Draize test confirmed the non-irritant, non-itchy nature of formulation. The prepared formulations, such as nanoparticulate gel and suspension, were found to be significantly efficacious in experimental animals.

An in vitro method for estimating ocular irritation

1990 ◽  
Vol 4 (4-5) ◽  
pp. 332-335 ◽  
Author(s):  
R.J. Soto ◽  
V.C. Gordon
Keyword(s):  
In Vitro Method ◽  
Ocular Irritation
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