Ocular tolerance of absorption enhancers in ophthalmic preparations

Furrer, Pascal; Mayer, Joachim M.; Plazonnet, Bernard; Gurny, Robert

doi:10.1208/ps040102

Cited by 46 publications

(28 citation statements)

References 19 publications

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“…Previous studies with Tween 20 have also noted a similar response in increasing very dilute concentrations: doubling the concentration from 0.5% to 1% had little effect on the corneal surface epithelium (27). This response was also reflected in the experiment with no significant damage seen in the lens tissue between 0% and 1% Tween 20 treatments.…”

supporting

confidence: 75%

The Effects of Tween 20 onin vitroBovine Lenses

Lagrou¹,

Lalonde²,

Moran³

et al. 2005

Cutaneous and Ocular Toxicology

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The optical properties of the cultured bovine lens were analyzed after exposure to various concentrations of Tween 20, a nonionic surfactant, to find a nonirritating concentration for commercial products. Bovine lenses were extracted and placed into a culture chamber for 24 hours at 37 C with 4-5% CO 2 . The lenses were placed into three treatment (1%, n ¼ 10; 10%, n ¼ 9; and 100%, n ¼ 10 Tween 20) and one control group (n ¼ 7) for 15 minutes. For 8 days following treatment, the lens optics were analyzed periodically for back vertex distance (focal length) and back vertex distance variability (sharpness of focus) using a laser-scanning device. For both the control and the 1% Tween 20 condition, no significant change was seen from the beginning of the experiment (p > 0.05). The 10% Tween 20 solution induced significant loss of sharp focus (0.62 AE 0.1 mm SEM) 4 hours after exposure, increasing to BVD ¼ 1.69 AE 0.3 mm SEM by the end of experimentation (p < 0.05). At full strength (100%), Tween 20 began to cause damage after 4 hours (BVD ¼ 0.50 AE 0.06 mm SEM), and this change increased to BVD ¼ 4.46 AE 0.59 mm SEM after 8 days following treatment (p < 0.05). Therefore, a dose-dependant increase in back vertex distance (BVD) variability was detected. This research suggests that using 1% Tween 20 in commercial solutions should not produce ocular irritation, whereas concentrations above 10% will cause significant irritation. As well, the bovine lens assay, paired with the automated lens scanner, provided a sensitive approach to measure mild ocular irritation.

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supporting

confidence: 75%

The Effects of Tween 20 onin vitroBovine Lenses

Lagrou¹,

Lalonde²,

Moran³

et al. 2005

Cutaneous and Ocular Toxicology

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“…Good ocular tolerability and no signs of ocular damage of the rabbit corneas have been reported after application of 0.5% (w/v) CH solution onto rabbit eyes. 81 A possible reason is the inclusion of CH molecules in the bilayer membrane of the prepared niosomes, which is likely to reduce the direct contact of CH molecules with ocular surface.…”

Section: Resultsmentioning

confidence: 99%

Design and Evaluation of Controlled-Release Niosomes and Discomes for Naltrexone Hydrochloride Ocular Delivery

Abdelkader

Ismail

Kamal

et al. 2011

Journal of Pharmaceutical Sciences

157

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“…5,6 Unfortunately, excipients enhancing transcorneal transport have a significant potential to induce ocular toxicity, likely because they affect the integrity of interepithelial tight junctions and/or epithelial membrane function. [7][8][9][10] In particular, the most effective penetration enhancer identified for scFv, 5,6 sodium caprate, is toxic to the cornea 11 and is not approved for topical use by the FDA.…”

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confidence: 99%