A 32 Factorial Design Approach for Formulation and Optimization of Azilsartan Medoxomil Nanosuspension for Solubility Enhancement

Abstract: Background: Azilsartan medoxomil (AZL) is an orally active nonpeptide angiotensin II receptor antagonist with less water solubility and oral bioavailability. Objectives: Increase the dissolving rate of AZL. Materials Methods: For formulation we used a probe sonication approach to create nanocrystals. The impacts independent factors such as % polymer concentration (X1) duration (X2 min) on dependent variables particle size (Y1 nm) drug release (DR) were optimised using 32 response surface methodology (Y2). Results: prepared batches examined for size, polydispersity index (PDI), zeta potential, study dissolution study. AZL nanocrystal (PS2 batch) potential was found be 168 ± 10 nm, 0.314 0.02 - 22.72 2.6 mV respectively. batch (PS2) best results chosen subjected additional testing. In vitro all 13 pure in ranges 51.98-81.99% 11.23 %, Conclusion: FTIR analysis indicated that soluplus have no physical interaction. DSC, XRD, SEM investigations revealed crystalline form medication converted amorphous form, resulting improve rate. Thus studies exhibited nanocrystals by method showed significant enhancement Key words: (AZL), Nanocrystal, Sonication, Solubility, Drug release.