Johansen P, Merkle H P, Gander B
Institute of Pharmaceutical Sciences, ETH Zurich, Zurich, Switzerland.
Eur J Pharm Biopharm. 2000 Nov;50(3):413-7. doi: 10.1016/s0939-6411(00)00123-5.
Research and development of therapeutics and vaccines based on biodegradable polymers are intensive and one of the most promising fields in controlled drug delivery. However, new applications necessitate successful technology transfer and industrial scale-ups. In an endeavour to produce clinical samples of a single-administration tetanus vaccine based on poly(lactide-co-glycolide) microspheres, we report on technological parameters that are of importance in the up-scaling of the spray-drying process. The results show that an up-scaling of the encapsulation of protein vaccines or drug by spray-drying is feasible, but that additives, the type of polymer solvent, the polymer concentration, the w/o ratio and the product collection method influence process and product quality.
基于可生物降解聚合物的治疗药物和疫苗的研发工作正在大力开展，并且是控释药物递送领域中最具前景的领域之一。然而，新的应用需要成功的技术转移和工业规模扩大。为了生产基于聚（丙交酯-共-乙交酯）微球的单剂量破伤风疫苗的临床样品，我们报告了在喷雾干燥过程放大中重要的技术参数。结果表明，通过喷雾干燥扩大蛋白质疫苗或药物的包封规模是可行的，但是添加剂、聚合物溶剂的类型、聚合物浓度、水包油比和产物收集方法会影响工艺和产品质量。
