Golem V2 Biorelevant Dissolution Device: Tapping the Potential in Prolonged Release Matrix Tablets

Dynamic biorelevant dissolution devices are becoming an important part of pharmaceutical research and development. Golem v2 represents such instrument. The aim of the study was to examine its potential for standard hydrophilic, lipophilic and dual matrices evaluation. The effect of agitation rate was observed. The obtained profiles were assessed by difference and similarity factors, compared to USP II profiles. Selected kinetic and release mechanism models were employed. Hydrophilic matrices differed in modified release excipient hydroxypropylmethylcellulose (10 to 30%) and apart the lowest 10% concentration the profiles were found similar to standard dissolution. Lipophilic matrices differed in tablet hardness, which was shown a major factor resulting in different profiles. Their Golem v2 profiles were also not similar with corresponding USP II dissolution profiles, hinting at possible discriminatory differences and intriguing options in erosion-based dosage forms. Similar behaviour was observed in dual matrix tablets. The different agitation rates yielded similar profiles. In addition, pressure and force values were measured using elements of own construction. Depending on the volume and agitation rate, the difference pressure ranged from 0.29 ± 0.04 kPa to 1.66 ± 0.03 kPa, suggesting values similar to pressure baseline in vivo.