Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's NMIMS, V.L. Mehta Road, Vile Parle (W), Mumbai 400056, India.
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's NMIMS, V.L. Mehta Road, Vile Parle (W), Mumbai 400056, India.
Carbohydr Polym. 2022 Feb 15;278:118999. doi: 10.1016/j.carbpol.2021.118999. Epub 2021 Dec 9.
Chitosan is a modified natural carbohydrate polymer derived from chitin that occurs in many natural sources. It has a diverse range of applications in medical and pharmaceutical sciences. Its primary and permitted use is biomaterial in medical devices. Chitosan and its derivatives also find utility in pharmaceuticals as an excipient, drug carrier, or therapeutic agent. The USFDA has approved chitosan usage as a biomaterial but not for pharmaceutical use, primarily because of the concerns over its source, purity, and immunogenicity. A large number of clinical studies are underway on chitosan-based materials/ products because of their diverse applications. Herein, we analyze clinical studies to understand their clinical usage portfolio. Our analysis shows that >100 clinical studies are underway to investigate the safety/efficacy of chitosan or its biomaterials/ nanoparticles, comprising ~95% interventional and ~ 5% observational studies. The regulatory considerations that limit the use of chitosan in pharmaceuticals are also deliberated. TEASER: Clinical Trials of Chitosan.
壳聚糖是一种从甲壳素衍生而来的天然碳水化合物聚合物，存在于许多天然来源中。它在医学和药物科学中有广泛的应用。其主要和允许的用途是医疗器械中的生物材料。壳聚糖及其衍生物在药物中也可用作赋形剂、药物载体或治疗剂。美国 FDA 已批准壳聚糖作为生物材料使用，但不批准用于制药，主要是因为担心其来源、纯度和免疫原性。由于其广泛的应用，大量的临床研究正在进行中。在此，我们分析临床研究以了解其临床应用组合。我们的分析表明，正在进行超过 100 项临床研究，以调查壳聚糖或其生物材料/纳米颗粒的安全性/功效，其中包括约 95%的介入性研究和~5%的观察性研究。还讨论了限制壳聚糖在制药中使用的监管考虑因素。概要：壳聚糖的临床试验。
