Challenges and recent advances in erythropoietin stability.

IF 2.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Bahgat Fayed, Shanshan Luo, Alaa Eldeen B Yassin
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引用次数: 0

Abstract

Erythropoietin (EPO) is a pivotal hormone that regulates red blood cell production, predominantly synthesized by the kidneys and also produced by the liver. Since the introduction of recombinant human EPO (rh-EPO) in 1989 through recombinant DNA technology, the therapeutic landscape for anemia has been improved. rh-EPO's market expansion has been substantial, with its application extending across various conditions such as chronic kidney disease, cancer-related anemia, and other disorders. Despite its success, significant concerns remain regarding the stability of EPO, which is critical for preserving its biological activity and ensuring therapeutic efficacy under diverse environmental conditions. Instability issues, including degradation and loss of biological activity, challenge both drug development and treatment outcomes. Factors contributing to EPO instability include temperature fluctuations, light exposure, and interactions with other substances. To overcome these challenges, pharmaceutical research has focused on developing innovative strategies such as stabilizing agents, advanced formulation techniques, and optimized storage conditions. This review article explores the multifaceted aspects of EPO stability, examining the impact of instability on clinical efficacy and drug development. It also provides a comprehensive review of current stabilization strategies, including the use of excipients, lyophilization, and novel delivery systems.

红细胞生成素稳定性方面的挑战和最新进展。
促红细胞生成素(EPO)是一种调节红细胞生成的重要激素,主要由肾脏合成,也可由肝脏产生。自 1989 年通过 DNA 重组技术推出重组人 EPO(rh-EPO)以来,贫血症的治疗前景得到了改善。rh-EPO 的市场扩张非常迅速,其应用范围已扩展到慢性肾病、癌症相关贫血症和其他疾病等多种疾病。尽管取得了成功,但人们对 EPO 的稳定性仍有很大的担忧,因为在不同的环境条件下,EPO 的稳定性对于保持其生物活性和确保疗效至关重要。包括降解和生物活性丧失在内的不稳定性问题对药物开发和治疗效果都提出了挑战。导致 EPO 不稳定的因素包括温度波动、光照以及与其他物质的相互作用。为了克服这些挑战,制药研究一直致力于开发创新策略,如稳定剂、先进的制剂技术和优化的储存条件。这篇综述文章探讨了 EPO 稳定性的多个方面,研究了不稳定性对临床疗效和药物开发的影响。文章还全面回顾了当前的稳定策略,包括辅料的使用、冻干和新型给药系统。
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
5.90
自引率
2.90%
发文量
82
审稿时长
1 months
期刊介绍: Pharmaceutical Development & Technology publishes research on the design, development, manufacture, and evaluation of conventional and novel drug delivery systems, emphasizing practical solutions and applications to theoretical and research-based problems. The journal aims to publish significant, innovative and original research to advance the frontiers of pharmaceutical development and technology. Through original articles, reviews (where prior discussion with the EIC is encouraged), short reports, book reviews and technical notes, Pharmaceutical Development & Technology covers aspects such as: -Preformulation and pharmaceutical formulation studies -Pharmaceutical materials selection and characterization -Pharmaceutical process development, engineering, scale-up and industrialisation, and process validation -QbD in the form a risk assessment and DoE driven approaches -Design of dosage forms and drug delivery systems -Emerging pharmaceutical formulation and drug delivery technologies with a focus on personalised therapies -Drug delivery systems research and quality improvement -Pharmaceutical regulatory affairs This journal will not consider for publication manuscripts focusing purely on clinical evaluations, botanicals, or animal models.
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