The effect of different granulation amounts of kollicoat MAE 30DP® on ODT CQAs using risk assessment

In this study, Dexketoprofen trometamol granulated with Kollicoat MAE 30DP to evaluate tableting properties was developed as an orally disintegrating formulation via using a quality by design approach. FMEA was used to identify the critical material properties and critical process parameters, as a result of which Prosolv® ODT G2, Emdex®, and Magnasweet® MM100 were determined as critical materials, and tablet compression pressure as a critical process parameter. Tablet properties of 54 prepared formulations were analyzed using the Box-Behnken design to evaluate the amount of polymer which can affect the tablet properties in the granulation process. In conclusion, it was observed that the low amount of Kollicoat MAE 30DP in the formulation had a low effect on the dissolution rate, especially at late-stage time points of the dissolution time horizon. However, the high amount of Kollicoat MAE 30DP had undesirable effects. Based on data, it can be concluded that it is critical to determine the content ratio of the Kollicoat MAE 30DP in the orally disintegrating tablet formulation of Dexketoprofen trometamol since it affects not only the bitter taste masking, but also tablet properties such as friability, breaking strength, disintegration time, and dissolution ratio.