Implementation of central composite face-centered design (CCFD) for the development and optimization of nanosponge formulations of amygdalin for the treatment of colon cancer via In vitro assessment

Colon cancer is the third most common cancer and has killed nearly 0.9 million people. The incidence and mortality rate of colorectal cancer increased day by day. Amygdalin act as an anticancer, anti-inflammatory, anti-atherosclerosis, anti-asthmatic, and immunosuppression. The goal of our research is to develop amygdalin-loaded nanosponges to sustainably deliver the drug to the colon region. Ultrasonication-assisted solvent evaporation method was employed to formulate AMY-loaded nanosponges using different concentrations of ERS-100 and PVA. Central composite face-centred design (CCFD) was implemented for statistical analysis and optimization and subsequent characterization, including DLS, ATR-FTIR, DSC, XRD, SEM, in vitro drug release, and MTT assay. The optimized formulation had a particle size of 154.4±11.46, a %EE of 72.96±1.06%, a %CDR_24h of 83.191±0.93%, zeta potential of -5.045±2.45, and PDI value of 0.783±0.245. SEM analysis confirmed the porous and spherical nature of the nanosponges. ATR-FTIR, DSC, and XRD showed the polymer compatibility, entrapment of the drug in ERS-100 core, non-crystalline structure of amygdalin in nanosponges. Cytotoxicity study showed that pure amygdalin significantly decreased the cell viability of HT-29 colon cancer cell line. This study proved that AMY-loaded NS may be an effective delivery system for the effective treatment of colon cancer.