Hydrogel-based hybrid membrane enhances in vitro ophthalmic drug evaluation in the OphthalMimic device

IF 4.2 3区 生物学 Q1 BIOCHEMICAL RESEARCH METHODS
Geisa N. Barbalho, Manuel A. Falcão, Venâncio A. Amaral, Jonad L. Contarato, Guilherme M. Gelfuso, Marcilio Cunha-Filho, Tais Gratieri
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Abstract

Envisaging to improve the evaluation of ophthalmic drug products while minimizing the need for animal testing, our group developed the OphthalMimic device, a 3D-printed device that incorporates an artificial lacrimal flow, a cul-de-sac area, a moving eyelid, and a surface that interacts effectively with ophthalmic formulations, thereby providing a close representation of human ocular conditions. An important application of such a device would be its use as a platform for dissolution/release tests that closely mimic in vivo conditions. However, the surface that artificially simulates the cornea should have a higher resistance (10 min) than the previously described polymeric films (5 min). For this key assay upgrade, we describe the process of obtaining and thoroughly characterizing a hydrogel-based hybrid membrane to be used as a platform base to simulate the cornea artificially. Also, the OphthalMimic device suffered design improvements to fit the new membrane and incorporate the moving eyelid. The results confirmed the successful synthesis of the hydrogel components. The membrane’s water content (86.25 ± 0.35 %) closely mirrored the human cornea (72 to 85 %). Furthermore, morphological analysis supported the membrane’s comparability to the natural cornea. Finally, the performance of different formulations was analysed, demonstrating that the device could differentiate their drainage profile through the viscosity of PLX 14 (79 ± 5 %), PLX 16 (72 ± 4 %), and PLX 20 (57 ± 14 %), and mucoadhesion of PLXCS0.5 (69 ± 1 %), PLX16CS1.0 (65 ± 3 %), PLX16CS1.25 (67 ± 3 %), and the solution (97 ± 8 %). In conclusion, using the hydrogel-based hybrid membrane in the OphthalMimic device represents a significant advancement in the field of ophthalmic drug evaluation, providing a valuable platform for dissolution/release tests. Such a platform aligns with the ethical mandate to reduce animal testing and promises to accelerate the development of safer and more effective ophthalmic drugs.

基于水凝胶的混合膜增强了 OphthalMimic 设备中的体外眼科药物评估。
为了改进眼科药物产品的评估,同时最大限度地减少动物试验的需要,我们的研究小组开发了 OphthalMimic 设备,这是一种三维打印设备,包含人工泪道流、内眦区、活动眼睑和可与眼科制剂有效互动的表面,从而提供了人体眼部条件的近似代表。这种装置的一个重要应用是将其用作溶解/释放测试平台,以近似模拟体内条件。然而,人工模拟角膜的表面应该比之前描述的聚合物薄膜(5 分钟)具有更高的电阻(10 分钟)。为了实现这一关键测定的升级,我们介绍了获取水凝胶混合膜并对其进行全面鉴定的过程,该膜将用作人工模拟角膜的平台基底。此外,OphthalMimic 设备在设计上也进行了改进,以适应新膜并结合活动眼睑。结果证实了水凝胶成分的成功合成。膜的含水量(86.25 ± 0.35 %)与人类角膜(72 至 85 %)非常接近。此外,形态分析也证明了膜与天然角膜的可比性。最后,对不同配方的性能进行了分析,结果表明该装置可以通过 PLX 14(79 ± 5 %)、PLX 16(72 ± 4 %)和 PLX 20(57 ± 14 %)的粘度以及 PLXCS0.5(69 ± 1 %)、PLX16CS1.0(65 ± 3 %)、PLX16CS1.25(67 ± 3 %)和溶液(97 ± 8 %)的粘附性来区分它们的引流曲线。总之,在 OphthalMimic 设备中使用基于水凝胶的混合膜是眼科药物评估领域的一大进步,为溶解/释放测试提供了一个宝贵的平台。这种平台符合减少动物试验的伦理要求,有望加速开发更安全、更有效的眼科药物。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Methods
Methods 生物-生化研究方法
CiteScore
9.80
自引率
2.10%
发文量
222
审稿时长
11.3 weeks
期刊介绍: Methods focuses on rapidly developing techniques in the experimental biological and medical sciences. Each topical issue, organized by a guest editor who is an expert in the area covered, consists solely of invited quality articles by specialist authors, many of them reviews. Issues are devoted to specific technical approaches with emphasis on clear detailed descriptions of protocols that allow them to be reproduced easily. The background information provided enables researchers to understand the principles underlying the methods; other helpful sections include comparisons of alternative methods giving the advantages and disadvantages of particular methods, guidance on avoiding potential pitfalls, and suggestions for troubleshooting.
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