Intraocular delivery considerations of ocular biologic products and key preclinical determinations.

IF 5 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Patrick Hughes, Hongwen M Rivers, Vladimir Bantseev, Chun-Wan Yen, Hanns-Christian Mahler, Swati Gupta
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引用次数: 1

Abstract

Introduction: Ophthalmic diseases of the retina are a significant cause of vision loss globally. Despite much progress, there remains an unmet need for durable, long-acting treatment options. While biologic therapies show great promise, they present many challenges, including complexities in biochemical properties, mechanism of action, manufacturing considerations, preclinical evaluation, and delivery mechanism; these are confounded by the unique anatomy and physiology of the eye itself.

Areas covered: This review describes the current development status of intravitreally administered drugs for the treatment of ophthalmic disease, outlines the range of approaches that can be considered for sustained drug delivery to the eye, and discusses key preclinical considerations for the evaluation of ocular biologics.

Expert opinion: The required frequency of dosing in the eye results in a great burden on both patients and the health care system, with direct intraocular administration remaining the most reliable and predictable route. Sustained and controlled ophthalmic drug delivery systems will go a long way in reducing this burden. Sustained delivery can directly dose target tissues, improving bioavailability and reducing off-target systemic effects. Maintaining stability and activity of compounds can prevent aggregation and enable extended duration of release, while sustaining dosage and preventing residual polymer after drug depletion.

眼部生物制品眼内递送的考虑和关键的临床前决定。
导读:视网膜眼部疾病是全球视力丧失的重要原因。尽管取得了很大进展,但对持久、长效治疗方案的需求仍未得到满足。虽然生物疗法显示出巨大的前景,但它们也面临许多挑战,包括生物化学特性、作用机制、制造考虑、临床前评估和给药机制的复杂性;这些都被眼睛本身独特的解剖学和生理学搞糊涂了。涵盖领域:本综述描述了目前用于治疗眼部疾病的玻璃体内给药药物的发展现状,概述了可考虑持续给药到眼睛的方法范围,并讨论了眼部生物制剂评估的关键临床前考虑因素。专家意见:所需的眼部给药频率对患者和卫生保健系统造成了巨大负担,直接眼内给药仍然是最可靠和可预测的途径。持续和受控的眼科药物输送系统将大大有助于减轻这一负担。持续给药可以直接给药靶组织,提高生物利用度,减少脱靶全身效应。维持化合物的稳定性和活性可以防止聚集并延长释放时间,同时维持剂量并防止药物耗尽后残留聚合物。
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
CiteScore
11.10
自引率
3.00%
发文量
104
审稿时长
3 months
期刊介绍: Expert Opinion on Drug Delivery (ISSN 1742-5247 [print], 1744-7593 [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles covering all aspects of drug delivery research, from initial concept to potential therapeutic application and final relevance in clinical use. Each article is structured to incorporate the author’s own expert opinion on the scope for future development.
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