Modern pharmaceutical technology still seeks new excipients and investigates the further use in already known ones. An example is magnesium aluminometasilicate Neusilin^® US2 (NEU), a commonly used inert filler with unique properties that are usable in various pharmaceutical fields of interest. We aimed to explore its application in hypromellose matrix systems (HPMC content 10–30%) compared to the traditionally used microcrystalline cellulose (MCC) PH 102. The properties of powder mixtures and directly compressed tablets containing individual fillers NEU or MCC, or their blend with ratios of 1.5:1, 1:1, and 0.5:1 were investigated. Besides the routine pharmaceutical testing, we have enriched the matrices’ evaluation with a biorelevant dynamic dissolution study and advanced statistical analysis. Under the USP apparatus 2 dissolution test, NEU, individually, did not provide advantages compared to MCC. The primary limitations were the burst effect increase followed by faster drug release at the 10–20% HPMC concentrations. However, the biorelevant dynamic dissolution study did not confirm these findings and showed similarities in dissolution profiles. It indicates the limitations of pharmacopoeial methods in matrix tablet development. Surprisingly, the NEU/MCC blend matrices at the same HPMC concentration showed technologically advantageous properties. Besides improved flowability, tablet hardness, and a positive impact on the in vitro drug dissolution profile toward zero-order kinetics, the USP 2 dissolution data of the samples N75M50 and N50M50 showed a similarity to those obtained from the dynamic biorelevant apparatus with multi-compartment structure. This finding demonstrates the more predictable in vivo behaviour of the developed matrix systems in human organisms.

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.