There is much interest in predicting the properties of pharmaceutical dosage forms from the properties of the raw materials they contain. Achieving this with reasonable accuracy would aid the faster development and manufacture of dosage forms. A variety of approaches to prediction or correlation of properties are reviewed. These approaches have variable accuracy, with no single technique yet able to provide an accurate prediction of the overall properties of the dosage form. However, there have been some successes in predicting trends within a formulation series based on the physicochemical and mechanical properties of raw materials, predicting process scale-up through mechanical characterisation of materials and predicting product characteristics by process monitoring. Advances in information technology have increased predictive capability and accuracy by facilitating the analysis of complex multivariate data, mapping formulation characteristics and capturing past knowledge and experience.
目前对从药物剂型所含原材料的性质预测药物剂型性质的兴趣很大。以合理的准确性实现这一点将有助于更快地开发和制造药物剂型。回顾了各种预测或相关性的方法。这些方法的准确性各不相同,目前还没有一种技术能够准确预测药物剂型的整体性质。然而,基于原材料的理化和机械性质预测配方系列内趋势、通过材料的机械特性预测工艺放大以及通过工艺监控预测产品特性等方面已经取得了一些成功。信息技术的进步通过促进对复杂多变量数据的分析、映射配方特性以及捕获过去的知识和经验,提高了预测能力和准确性。