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Clinical translation of long-acting drug delivery formulations
Nature Reviews Materials ( IF 83.5 ) Pub Date : 2022-01-24 , DOI: 10.1038/s41578-021-00405-w
Wei Li 1, 2 , Mark R. Prausnitz 1 , Jie Tang 3, 4 , Steven P. Schwendeman 3 , Dennis Lee 5 , Thomas R. Tice 6
Affiliation  

Most pharmaceuticals are given using short-acting formulations that require frequent administration, which can negatively affect patient compliance and increase failure risks associated with inconsistent use. By contrast, long-acting release formulations can achieve sustained release of drugs for weeks, months or years. In this Review, we discuss long-acting drug delivery formulations that release drugs for at least 1 month and that have received approval from the US Food and Drug Administration (FDA), with an emphasis on materials used in their formulation. We highlight different slow-release mechanisms, including dissolution-based, biodegradation-based (preformed and in situ-formed), non-degradable implantable and hydrogel-based formulations, and investigate the clinical applications of long-acting drug delivery formulations, including long-acting contraceptives, extended sex hormone suppression, opioid and alcohol addiction treatments and localized drug delivery to the eye. Finally, we summarize release mechanisms, delivery duration, pharmaceutical forms, administration routes, indications, manufacturers and inactive ingredients of 63 FDA-approved long-acting drug products. We conclude by looking at the future challenges and opportunities for long-acting drug delivery formulations.



中文翻译:

长效给药制剂的临床转化

大多数药物使用需要频繁给药的短效制剂,这会对患者的依从性产生负面影响,并增加与使用不一致相关的失败风险。相比之下,长效释放制剂可以实现药物持续数周、数月或数年的持续释放。在这篇综述中,我们讨论了释放药物至少 1 个月并已获得美国食品和药物管理局 (FDA) 批准的长效给药制剂,重点是其制剂中使用的材料。我们重点介绍了不同的缓释机制,包括基于溶解、基于生物降解(预制和原位形成)、不可降解的可植入和基于水凝胶的制剂,并研究长效给药制剂的临床应用,包括长效避孕药、延长性激素抑制、阿片类药物和酒精成瘾治疗以及向眼睛局部给药。最后,我们总结了 63 种 FDA 批准的长效药物产品的释放机制、给药时间、药物形式、给药途径、适应症、制造商和非活性成分。最后,我们着眼于长效给药制剂的未来挑战和机遇。

更新日期:2022-01-24
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