Exploring silica nanocarriers SBA-15, SBA-16, COK-12, KIT-6 to enhance Dacomitinib solubility using Quality by Design approach

Dacomitinib is a promising targeted first line drug for lung chemotherapy with high survival rate over other drugs, found with solubility issues limiting its therapeutic efficacy. Silica nanocarriers sought to resolve it. Solubility enhancement performed by applying Quality by Design Principle. Drug and nanocarriers (SBA-15, SBA-16, KIT-6 & COK-12) nanocomplex prepared by dry loading and its formulations characterized using spectroscopy, N2 adsorption, thermogravimetric, microscopic and Invitro studies. The nanomaterial characterizations revealed good compatibility by FTIR studies. XRD showed change in drug crystalline peaks by nanocarrier and its nanocomplexes resulted in solubility improvement by 0.51 mg/ml. Nanocarrier morphology changed due to co-grinding effect, evident with SEM, DTA and TGA studies revealed nanocarrier thermostability effect on drug with 37% drug mass retained at 500°C temperature compared to pure drug with ˂ 10%. N2 adsorption isotherms revealed the drug loading in porous nanocarriers observed by decrease in porosity. Invitro-dissolution studies conducted in 6.8 pH phosphate buffer showed 45% drug release at the end of 72 hrs coinciding Quality by Design. Dacomitinib Solubility can be enhanced with Silica nanocarriers amongst them, SBA-15 proved to be best fulfilling the current objective of study.