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Dissolution studies cannot distinguish phenomena occurring inside the dosage forms when studying formulation with similar dissolution profiles-such formulations can behave differently when considering their physical changes. The application of flow-through dissolution apparatus integrated with magnetic resonance imaging (MRI) system for discriminative evaluation of controlled release dosage forms with similar dissolution profiles was presented. Hydrodynamically balanced systems (HBS) containing L: -dopa and various grades hydroxypropyl methylcelluloses were prepared. The dissolution studies of L: -dopa were performed at high field (4.7 T) MR system with MR-compatible flow-through cell. MRI was done with 0.14 x 0.14 x 1-mm spatial resolution and temporal resolution of 10 min to record changes of HBS parameters during dissolution in 0.1 M HCl. Structural and geometrical changes were evaluated using the following parameters: total area of HBS cross-section, its Feret's diameter, perimeter and circularity, area of hydrogel layer, and "dry core" area. While the dissolution profiles of L: -dopa were similar, the image analysis revealed differences in the structural and geometrical changes of the HBS. The mechanism of drug release from polymeric matrices is a result of synergy of several different phenomena occurring during dissolution and may differ between formulations, yet giving similar dissolution profiles. A multivariate analysis was performed to create a model taking into account dissolution data, data from MRI, information about chemical structure, and polymer viscosity. It provided a single model for all the formulations which was confirmed to be competent. The presented method has merit as a potential Process Analytical Technology tool.

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Novel Application of MRI Technique Combined with Flow-Through Cell Dissolution Apparatus as Supportive Discriminatory Test for Evaluation of Controlled Release Formulations