GOLEM V2 BIORELEVANT DISSOLUTION DEVICE: TAPPING THE POTENTIAL IN PROLONGED RELEASE MATRIX TABLETS
| Authors | |
|---|---|
| Year of publication | 2025 |
| Type | Article in Periodical |
| Magazine / Source | Acta Poloniae Pharmaceutica |
| MU Faculty or unit | |
| Citation | |
| web | https://www.ptfarm.pl/download/?file=File%2FActa_Poloniae%2F2024%2F5%2F851.pdf |
| Doi | http://dx.doi.org/10.32383/appdr/199377 |
| Keywords | biorelevant dynamic dissolution; matrix tablets; Golem v2; prolonged release; HPMC; gastric pressure |
| Description | Dynamic biorelevant dissolution devices have become an important part of pharmaceutical research and development. Golem v2 represents such an instrument. The aim of this study was to examine its potential for use in the evaluation of standard hydrophilic, lipophilic, and dual matrices. The effect of the agitation rate was observed. The obtained profiles were assessed based on difference and similarity factors compared with the USP II profiles. Selected kinetic and release mechanism models were used in this study. Hydrophilic matrices differed in modified release excipient hydroxypropylmethylcellulose (10-30%), and apart from the lowest 10% concentration, the profiles were found to be similar to standard dissolution. Lipophilic matrices differed in tablet hardness, which was shown to be a major factor resulting in different profiles. Their Golem v2 profiles were also not similar to the corresponding USP II dissolution profiles, hinting at possible discriminatory differences and intriguing options for erosion-based dosage forms. Similar behavior was observed for the dual-matrix tablets. Different agitation rates yielded similar profiles. Additionally, the pressure and force values were measured using the elements of their 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. |
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