Department of Applied Science and Technology, Politecnico di Torino, 24 corso Duca degli Abruzzi, Torino 10129, Italy.
Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, 460 Ottergemsesteenweg, Ghent, Belgium.
Eur J Pharm Biopharm. 2018 Jul;128:210-219. doi: 10.1016/j.ejpb.2018.04.002. Epub 2018 Apr 4.
The stochastic nature of nucleation makes it difficult to control batch homogeneity in conventional freezing, and this lack of control is in contrast with the current emphasis on Quality by Design. Among the techniques which have been developed to overcome this problem, Vacuum Induced Surface Freezing is probably the most promising for application in manufacturing, because it does not require additional equipment and can be scaled-up more easily than other proposed approaches. In this work, we summarize the impact of Vacuum Induced Surface Freezing on product morphology, and the efficiency of the subsequent drying steps as well. We will show that this controlled freezing approach is extremely beneficial for both the efficiency of the freeze-drying process, and the quality and homogeneity of the final product. The hope is that this work could contribute to the commercial implementation of controlled nucleation technology, overcoming the final resistance to its widespread use. It is our opinion that this would be a substantial improvement, beneficial for both the pharmaceutical industry and the end users.
成核的随机性使得在传统冷冻中难以控制批量的均一性，而这种缺乏控制与当前强调的设计质量形成了鲜明对比。为了克服这个问题，已经开发了许多技术，其中真空诱导表面冻结技术在制造中应用最有前途，因为它不需要额外的设备，而且比其他提出的方法更容易扩展。在这项工作中，我们总结了真空诱导表面冻结对产品形态的影响，以及后续干燥步骤的效率。我们将表明，这种受控冷冻方法对冷冻干燥过程的效率以及最终产品的质量和均一性都非常有益。希望这项工作能够为控制成核技术的商业实施做出贡献，克服其广泛应用的最后阻力。我们认为，这将是一个实质性的改进，对制药行业和最终用户都有益。
