(759e) The Effect of Blend Shearing and Compression On Dissolution Dynamics for Immediate Release Tablets

Knowledge of the effect of processing parameters and formulation variations in drug release kinetics is key for assessing the risks involved in manufacturing tablets. This is the core of Quality by Design principle, the vehicle for how drugs are developed and commercially manufactured nowadays.

We study tablets compacted from blends of Micro-Cellulose and Lactose at different ratios, lubricant agent Magnesium Stearate and Acetaminophen as active ingredient. Blends are pre-processed at diverse shearing conditions and then compacted at different pressures. We investigate the effect of formulation, shearing of the blend and compaction force variations on the dissolution profiles obtained experimentally using the USP-II apparatus. We discuss the results in view of tablet characterization experiments (including SEM/EDS, X Ray Micro Computerized Tomography, Mercury Porosimetry) as well as independent dissolution experiments in which we monitor liquid penetration dynamics and tablet deformation.