Employing Design of Experiments (DoE) to Evaluate the Robustness of an Automated Content Uniformity Method for the Triple Fixed Dose Combination Tablets

The content uniformity determination of three actives in Triple Fixed Dose Combination (FDC) tablets has been successfully automated using a TPW (Tablet Processing Workstation) bench-top robotic system. To our knowledge, this is the first TPW method developed for a triple fixed dose combo product. The method was implemented to enable in-process CU testing of drug product process justification batches, which represents a significant number of samples for this fast track project. The data will be used for process robustness evaluation and monitoring plan. During method development, a Design of Experiments (DoE) study with a center composite design was performed to optimize the operating ranges of the critical sample extraction parameters as to determine the interactions between these parameters. The parameters studies were diluent composition, homogenizer speed, time and number of pulses. The detail study design and results will be discussed in this presentation.