新通用眼科制剂Latanost®和Latacom®的体外毒性评价。

Q3 Medicine

Journal of Current Glaucoma Practice Pub Date : 2021-09-01 DOI:10.5005/jp-journals-10078-1319

Jessica Sze Chia Ng, Yi Xin Tan, Nor Amalina Ahmad Alwi, Kar Ming Yee, Ahmad Hazri Abdul Rashid, Ka-Liong Tan, Chuei Wuei Leong

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引用次数: 0

摘要

目的和目的:利用三维重建人角膜样上皮(RhCE)组织构建物作为体外模型，评价两种新型眼科通用制剂Latanost®(latanoprost)和Latacom®(latanoprost和timolol)的安全性。材料与方法:采用RhCE法分别对Latanost®(LTN)和Latacom®(LTC)及其相应的创新产品Xalatan®(XLT)和Xalacom®(XLC)进行体外刺激试验。根据经合组织关于化学品测试的第492号指导方针，通过在体外RhCE组织上局部暴露配方来评估眼科配方。MTT法测定细胞活力。结果:LTN和XLT的平均细胞存活率分别为70.5%和75.7%，LTC和XLC的平均细胞存活率分别为95.3和85.7%。两种新的通用制剂(LTN和LTC)没有使RhCE组织的细胞活力降低到≤60%。因此，两者都可以被认为是非刺激性的。结论:两种新开发的仿制药均为非眼部刺激物。临床意义:本研究为用于长期青光眼治疗的新型通用抗青光眼眼液的安全性评价提供了依据。配方的目的是保持眼睛刺激到最低水平。本文引用方式:Ng JSC, Tan YX, Alwi NAA等。新通用眼科制剂Latanost®和Latacom®的体外毒性评价。中华实用青光眼杂志;2011;15(3):139-143。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

In Vitro Toxicity Evaluation of New Generic Latanost® and Latacom® as an Ophthalmic Formulation.

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In Vitro Toxicity Evaluation of New Generic Latanost^® and Latacom^® as an Ophthalmic Formulation.

Aim and objective: To evaluate the safety of two new generic ophthalmic formulations, Latanost^® (latanoprost) and Latacom^® (latanoprost and timolol) by utilizing the three-dimensional reconstructed human cornea-like epithelium (RhCE) tissue constructs as an in vitro model in the assessment of ocular irritation.

Materials and methods: In vitro irritation test was conducted on Latanost^® (LTN) and Latacom^® (LTC) and their corresponding innovators, Xalatan^® (XLT) and Xalacom^® (XLC), respectively, by using RhCE. According to the OECD guidelines No. 492 on the testing of chemicals, the ophthalmic formulations were assessed via topical exposure of the formulations on in vitro RhCE tissue. Cell viability was measured by MTT assay.

Results: The mean cell viability percentage of LTN and XLT was 70.5 and 75.7%, respectively, whereas, for LTC and XLC, the percentage viability was 95.3 and 85.7%, respectively. The two new generic formulations (LTN and LTC) did not reduce the cell viability of the RhCE tissue to ≤60%. Thus, both can be considered as nonirritant.

Conclusion: Both newly developed generics are nonocular irritants.

Clinical significance: This study informs the safety assessment of new generic antiglaucoma ophthalmic solutions applicable for long-term glaucoma treatment. The formulations aim to keep eye irritation to a minimum level.

How to cite this article: Ng JSC, Tan YX, Alwi NAA, et al. In Vitro Toxicity Evaluation of New Generic Latanost^® and Latacom^® as an Ophthalmic Formulation. J Curr Glaucoma Pract 2021;15(3):139-143.

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来源期刊

Journal of Current Glaucoma Practice Medicine-Ophthalmology

CiteScore

1.00

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0.00%

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