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

Orally disintegrating tablets (ODTs) improve patient compliance, but they present challenges in terms of masking the bitter taste of active pharmaceutical ingredients such as dexketoprofen trometamol (DEX). The study aimed to develop palatable DEX ODTs by granulating drug with Kollicoat MAE 30DP® to create a physical barrier. Using a quality by design (QbD) approach, an initial risk assessment identified Prosolv® ODT G2, Emdex®, and Magnasweet® MM100 and tablet compression pressure as critical variables. A Box-Behnken design was employed to prepare 26 formulations, systematically evaluating the impact of these variables across low and high polymer concentrations. The results showed that although high concentrations of Kollicoat MAE 30DP initially delayed the dissolution rate, this barrier effect did not affect the final extent of drug release. Disintegration was predominantly governed by compression pressure, which altered tablet porosity, whereas PROSOLV® ODT G2 significantly influenced the overall dissolution profile. By optimizing the superdisintegrant-to-binder ratio, high-polymer formulations successfully overcame the initial retardation, consistently exceeding an 85% cumulative release at 30 minutes.