Tamai Usuda, 1st year master's student, Department of Pharmaceutical Sciences, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama Yoshinori Onuki, Visiting Professor, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
In recent years, the concept of Quality by Design (QbD) has been emphasized in pharmaceutical development. In QbD, the causal relationship between the design factors (ingredients, manufacturing process conditions, etc.) that make up the formulation and the characteristics is clarified, and the optimal formulation manufacturing method is designed based on scientific evidence. In addition, the use of experimental design is strongly recommended for the practice of QbD. In this study, we used the definitive screening design (DSD) installed in JMP to examine the formulation of minitablet formulations, which have been attracting attention in recent years as pediatric formulations. 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 conventional experimental designs. In the experiment, model formulations were prepared under various conditions based on DSD, and the causal relationship between the design factors and characteristics was evaluated. As a result of the experiment, we were able to identify the design factors that affect the formulation characteristics, and many useful insights were obtained for designing minitablet formulations. From the above, it is believed that DSD is also extremely useful in the formulation design of minitablet formulations.
