Abstract：
Advancements in recombinant DNA technology have made proteins and peptides available for diagnostic and therapeutic applications, but their effectiveness when taken orally leads to poor patient compliance, requiring clinical administration. Among the alternative routes, transmucosal delivery has the advantage of being noninvasive and bypassing hepato-gastrointestinal clearance. Various mucosal routes-buccal, nasal, pulmonary, rectal, and vaginal-have been explored for delivering these macromolecules. Nanofibers, due to their unique properties like high surface-area-to-volume ratio, mechanical strength, and improved encapsulation efficiency, serve as promising carriers for proteins and peptides. These nanofibers can be tailored for quick dissolution, controlled release, enhanced encapsulation, targeted delivery, and improved bioavailability, offering superior pharmaceutical and pharmacokinetic performance compared to conventional methods. This leads to reduced dosages, fewer side effects, and enhanced patient compliance. Hence, nanofibers hold tremendous potential for protein/peptide delivery, especially through mucosal routes. This review focuses on the therapeutic application of proteins and peptides, challenges faced in their conventional delivery, techniques for fabricating different types of nanofibers and, various nanofiber-based dosage forms, and factors influencing nanofiber generation. Insights pertaining to the precise selection of materials used for fabricating nanofibers and regulatory aspects have been covered. Case studies wherein the use of specific protein/peptide-loaded nanofibers and delivered via oral/vaginal/nasal mucosa for diagnostic/therapeutic use and related preclinical and clinical studies conducted have been included in this review.
摘要：
重组DNA技术的进步使蛋白质和肽可用于诊断和治疗应用。但是口服时它们的有效性会导致患者依从性差，需要临床管理。在替代路线中，经粘膜给药具有非侵入性和绕过肝-胃肠道清除的优点。各种粘膜途径-口腔，鼻部,肺,直肠,和阴道-已经被探索用于递送这些大分子。纳米纤维，由于它们独特的特性，如高表面积与体积比，机械强度,提高了封装效率，作为蛋白质和肽的有前途的载体。这些纳米纤维可以定制快速溶解，控释,增强封装，有针对性的交付，和提高生物利用度，与常规方法相比，提供优越的药物和药代动力学性能。这导致剂量减少，副作用少,增强患者依从性。因此，纳米纤维具有巨大的蛋白质/肽输送潜力，尤其是通过粘膜途径。本文综述了蛋白质和肽的治疗应用,在常规交付中面临的挑战，制造不同类型纳米纤维的技术，各种基于纳米纤维的剂型，以及影响纳米纤维生成的因素。已经涵盖了有关用于制造纳米纤维的材料的精确选择和监管方面的见解。本综述包括使用特定蛋白质/肽负载的纳米纤维并通过口腔/阴道/鼻粘膜递送用于诊断/治疗用途的案例研究以及相关的临床前和临床研究。
