Silva Ana C, Amaral Maria H, Lobo Jose M S, Lopes Carla M
Laboratory of Pharmaceutical Technology/Centre of Research in Pharmaceutical Sciences, Faculty of Pharmacy, University of Porto, Rua Jorge Viterbo Ferreira, 228, P-4050-313 Porto Portugal.
Curr Pharm Biotechnol. 2015;16(4):291-302. doi: 10.2174/1389201015666141229103709.
Biopharmaceuticals comprise therapeutic protein-based, nucleic acids and cell-based products. According to their therapeutic success, the clinical use of these products has been growing. Therefore, the development of efficient biopharmaceuticals delivery systems, which overcome their limitations for administration, remains an excellent prospect for pharmaceutical technologists. In this area, lipid nanoparticles have been increasingly recognized as one of the most promising delivery systems, due to their exclusive advantages. However, no clinical biopharmaceutical lipid nanoparticle-based products are yet available. This fact could be explained by the lack or failure of in vivo studies, regarding stability and toxicological concerns, and also by the complex regulatory issues that must be accomplished. The present review article focuses on the different classes of biopharmaceuticals, their characteristics and limitations for administration. A state of the art regarding the use of lipid nanoparticles to improve biopharmaceuticals delivery is presented and a critical prospect of the future directions that should be addressed by pharmaceutical technologists is also discussed.
生物制药包括基于治疗性蛋白质、核酸和细胞的产品。鉴于其治疗成效，这些产品的临床应用一直在增加。因此，开发高效的生物制药递送系统以克服其给药方面的局限性，对药物技术专家来说仍是一个绝佳的前景。在这一领域，脂质纳米颗粒因其独特优势，越来越被认为是最有前途的递送系统之一。然而，目前尚无基于脂质纳米颗粒的临床生物制药产品。这一事实可以通过体内研究在稳定性和毒理学方面的不足或失败来解释，也可以通过必须完成的复杂监管问题来解释。本综述文章重点关注不同类别的生物制药、它们的特性以及给药方面的局限性。介绍了使用脂质纳米颗粒改善生物制药递送的现状，并讨论了药物技术专家应解决的未来方向的关键前景展望。
