Toyama University Graduate School of Medicine and Pharmaceutical Sciences
Yoshinori Onuki, Visiting Professor, School of Medicine and Pharmaceutical Sciences, University of Toyama
In recent drug development, the concept of Quality by Design (QbD) is emphasized.The purpose of QbD is to clarify the causal relationship between design factors (components, manufacturing process conditions, etc.) and characteristics that make up a drug product, and to design an optimal drug product manufacturing method based on scientific evidence.It is strongly recommended to use the experimental design method for the practice of QbD.In this study, a definitive screening design (DSD) installed in JMP was used to examine the formulation of mini-tablets, which have recently attracted attention as pediatric products.DSD is a new experimental design for screening that has attracted attention in recent years because it can evaluate the effects of interactions and squared terms with fewer experiments than the conventional experimental design.In the experiment, model preparations were prepared under various conditions based on DSD, and the causal relationship between design factors and characteristics was evaluated.As a result of the experiment, it was possible to identify design factors that affect the formulation characteristics, and many useful findings were obtained in designing the mini-tablet formulation.From the above, DSD is considered to be extremely useful in the formulation design of mini-tablet preparations.
