Investigation of the effects of materials and dry granulation process on the mirabegron tablet by integrated QbD approach with multivariate analysis

Abstract

The purpose of this study was to evaluate the relationship among numerous variables to enhance the understanding of the effects of materials and process parameters on drug product quality. The study consisted of two stages: the first stage involved experimental designing to optimize formulation and process parameters, and the second stage involved assessing the relationship between intermediate quality attributes (IQAs) and critical quality attributes (CQAs) by multivariate analysis (MVA). Initial risk assessment was conducted to select critical material attributes (CMAs) and critical process parameters (CPPs), which have a high effect on CQAs and IQAs. The correlation between IQAs and CQAs was confirmed via Pearson correlation analysis and principal component analysis. The robustness of the correlation was verified using a wide range of variables. Therefore, the study suggests that risk in the development of drug products can be reduced via an integrated quality by design (QbD) approach employing MVA.