QbD Approach: Tablet Compression Process Optimization Using Design of Experiments

摘要

Present study describes an approach to predict tablet properties by multivariate method. In this study, a quality by design approach has been applied to optimize tablet compression process. The effect of four process parameters on tablet compression process on two compression machines were characterized. Turret speed (two levels), Pre Compression force (two levels), Main compression force (two levels), and Feeder speed (two levels) represent the four parameters studied. Compression machine geometry and powder loading method were treated as constant parameters. Design of experiment (DOE) was used to assess the impact of each parameter on critical tablet properties like hardness, thickness, friability and disintegration time. 24 full factorial design were applied in this study. Minor change in main Compression Force impacts tablet properties significantly. Tablet Properties are not significantly affected by Turret Speed, Pre compression force and feeder speed given the range studied. Process parameters were reproducible having minimal impact on tablet properties in case the machine geometry is same.