Orodispersible films containing ball milled aripiprazole-poloxamer®407 solid dispersions.

This research aimed at developing ODFs containing an antipsychotic drug - aripiprazole (ARP). ARP, as a BCS II class molecule, requires enhancing its water solubility prior to formulating. Therefore, a solid dispersion of ARP - Poloxamer® 407 was prepared by ball milling, then incorporated into the films. It was found that co-processing led to an over 100-fold increase in drug solubility in comparison with pure drug. Moreover, ODFs with solid dispersion showed faster drug release (>95% below 15 min) and disintegration (<30 s), compared with raw ARP films. These results are believed to be due to the solubilization effect of poloxamer and enhanced wettability of the film. Films containing solid dispersions were found to possess smoother film surfaces and favorable mechanical properties - flexibility and strength. The ODF formulations, prepared by a casting method, were based on three different polymers (Kollicoat® IR, Kollicoat® Protect or PVA). It was found that not only the form of the incorporated drug, but also the type of film-forming polymer had an impact on the analyzed parameters. The use of PVA was beneficial in the film formulation with aripiprazole in comparison to other tested film-forming polymers.