The current study aims to develop orodispersible lyophilisates (ODLs), containing olmesartan medoxomil (OLM), by applying a quality by design approach to ensure product robustness. A thorough risk assessment study was done, where the effects of each of the types of matrix former and superdisintegrant were assessed on the drug content, friability %, cumulative drug released within 15 minutes (Q15%), disintegration time, and wetting time. This was followed by a D-optimal design, for the optimization of the ODL. The optimization study focused on studying the effects of the solubilizer concentration (X1 ) and solubilizer type (X2 ) on the disintegration time (Y1 ) and Q15% (Y2 ). A design space was created with an optimized formula, OLM-ODL, which was prepared and tested to indicate the validity of the design. The optimized formula showed fast drug release with a short disintegration time. Further characterization tests were done on OLM-ODL, as morphological examination, which showed a highly porous nature. Infrared spectroscopy showed no incompatibility. The extent of OLM absorption from the optimized ODL compared to oral OLM suspension from a pharmacokinetic study. The ODL showed an enhancement of the relative bioavailability of the optimized formula of about 345%. Thus, ODLs were successfully developed using a quality by design approach with noticeably improved biopharmaceutical performance.
Key words: Olmesartan medoxomil, Soluplus, Oro-dispersible lyophilisates, Ishikawa diagram, Quality target product profile.
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