Shenyang Pharmaceutical University, School of Pharmacy, China.
Expert Opin Drug Deliv. 2012 Oct;9(10):1209-23. doi: 10.1517/17425247.2012.717926. Epub 2012 Aug 28.
Currently marketed microsphere products are manufactured with the use of organic solvents which have a negative impact on the environment and stability of biological molecules. With recent advances in fabrication technologies, solvent free methods have demonstrated potential for the preparation of microspheres.
New technical advances recently achieved in solvent based microsphere manufacturing processes have allowed for major improvement in product quality and properties. Novel solvent free fabrication methods combined with newly functionalized biodegradable polymers have been explored for their application in the preparation of microspheres containing biological molecules.
Novel fabrication methods for microspheres have been recently reported but technical challenges and development risks remain high for scale up from bench to industrial commercialization. While the applications of microspheres for delivery of proteins, genes and vaccines have shown promise for clinical use, the approval of newly functionalized polymers as carriers may still face scrutiny on safety and biocompatibility, which can be key factors in securing the regulatory approval of the product.
目前市售的微球产品是使用有机溶剂制造的，这对环境和生物分子的稳定性有负面影响。随着制造技术的最新进展，无溶剂方法已经显示出制备微球的潜力。
溶剂型微球制造工艺中最近取得的新技术进步，使得产品质量和性能得到了极大的提高。新型无溶剂制造方法与新功能化的可生物降解聚合物相结合，已被探索用于制备含有生物分子的微球。
最近已经报道了用于制备微球的新方法，但从实验室到工业商业化的规模扩大仍然存在技术挑战和开发风险。虽然微球在蛋白质、基因和疫苗的递送上的应用已经显示出临床应用的前景，但新功能化聚合物作为载体的批准可能仍然面临安全性和生物相容性的审查，这可能是确保产品监管批准的关键因素。
