Design and Evaluation of Repaglinide Nanosuspension for Oral Controlled Drug Delivery System by using 32 Factorial Design

The current work proposed a nanocrystal-based formulation to overcome the solubility issues of repaglinide. Using the lyophilization procedure, REP nanosuspension was successfully transformed towards solid form. To make also preserve REP nanosuspension, polyvinyl alcohol as well as Eudragit S100 were used as protectors. Lyophilization's suitability for enhancing physical stability was assessed by considering important restrictions, such as the shape of solid dispersion, on the characteristics of nanosuspension. The generated nanocrystals' solid-state characteristics were also evaluated. Process factors that were improved increased the polydispersity index, zeta potential, drug content, also average particle size. Selective cryoprotectants (lactic acid) were used to assess the lyophilization procedure as an appropriate solidification approach. With an average particle diameter of 317 ± 3.4 nm, PDI about 0.150, also zeta potential about -10.2 ± 0.85 mV, formulation remained stable throughout three months at 4°C. The generated nanosuspension's discharge profile showed a cumulative release of over 92.23%, compared to 8.02% during the first ten hours with unprocessed medicine. These findings suggest that the new formulation successfully increases Repaglinide's water solubility.