Evaluation of disintegrants functionality for orodispersible mini tablets

<p><b>Objective:</b> This work evaluates the functionalities of different superdisintegrants (SD) for manufacturing orodispersible mini tablets (ODMT) by direct compression.</p> <p><b>Methods:</b> Twenty-three formulations varying in SD type, concentration, and lubricant were used to manufacture ODMT. The ODMT were then characterized for the following properties: friability, porosity, tensile strength, <i>in vivo</i> and <i>in vitro</i> disintegration time (DT).</p> <p><b>Results:</b> The results show that the presence, type, and concentration of SD did not influence friability, porosity, or tablet tensile strength. With regards to <i>in vivo</i> DT, only cross-linked poly (vinyl pyrrolidone) improved DT in all the tested formulations. Results also showed that when using microcrystalline cellulose (MCC) above 20% in the formulation, DT is longer. Cross-linked carboxymethyl cellulose accelerates DT when the MCC content is less than 20%. As for cross-linked carboxymethyl starch and calcium alginate showed no improvement on DT. Results for <i>in vitro</i> DT were all shorter than <i>in vivo</i> results and there was no correlation with the <i>in vivo</i> evaluation.</p> <p><b>Conclusions:</b> This study shows that there is a need to develop better <i>in vitro</i> testing that precisely simulates <i>in vivo</i> conditions and that are adapted to ODMT. This standardization of the test methods for ODMTs must be accompanied by an improvement in the comprehension of SD mechanisms.