Fonte Pedro, Andrade José Carlos, Seabra Vítor, Sarmento Bruno
Department of Pharmaceutical Sciences, CICS, Health Sciences Research Center, Instituto Superior de Ciências da Saúde, Gandra, Portugal.
Methods Mol Biol. 2012;899:471-87. doi: 10.1007/978-1-61779-921-1_28.
Therapeutic proteins represent a significant part of the new pharmaceuticals coming on the market every year and are now widely spread in therapy to treat or relief symptoms related to many metabolic and oncologic diseases. The parenteral route remains as a primary strategy for protein administration essentially due to its specific physicochemical properties. However, the research on alternative nonparenteral delivery routes continues. The high molecular weight (MW), hydrophilicity, and charged nature of therapeutically valued proteins render transport through membranes very difficult. In this regard, chitosan arises as a promising candidate for the development of protein-containing drug formulations, due to its exceptional biological properties. Chitosan-based delivery systems have been proposed as valid approaches to provide protective conditions to proteins from denaturation and loss of activity, during preparation and delivery, as well as during long-term storage of the prepared formulation. In this chapter, one production method of a chitosan-based nanoparticle formulation is presented, as well as several characterization techniques to assess both nanoparticles and proteins characteristics and stability.
治疗性蛋白质占每年上市的新型药物的很大一部分，目前广泛应用于治疗或缓解与许多代谢和肿瘤疾病相关的症状。由于其特殊的物理化学性质，肠胃外给药途径仍然是蛋白质给药的主要策略。然而，对替代性非肠胃外给药途径的研究仍在继续。具有治疗价值的蛋白质的高分子量、亲水性和带电性质使得其通过细胞膜的运输非常困难。在这方面，壳聚糖因其特殊的生物学性质，成为开发含蛋白质药物制剂的有前景的候选材料。基于壳聚糖的递送系统已被提议作为有效的方法，在制备、递送以及所制备制剂的长期储存过程中，为蛋白质提供保护条件，防止其变性和活性丧失。在本章中，介绍了一种基于壳聚糖的纳米颗粒制剂的生产方法，以及几种用于评估纳米颗粒和蛋白质特性及稳定性的表征技术。
