Application of Quality by Design Approach to Develop Novel Optimized Self-emulsifying Drug Delivery System of Ezetimibe for Treatment of Poorly Water-soluble Antilipidemic Drug to Enhance its Bioavailability by Using D-optimal Mixture Design
Mukesh S. Patel, Alpesh D. Patel, Mayur Patel · Acta Scientific Pharmaceutical Sciences · 2021
The purpose of the research aimed to develop and optimize a novel dosage form of the self-emulsifying drug delivery systems of the Ezetimibe using quality by design (QbD) to enhancing its solubility.We performed solubility and emulsification tests to select a suitable initial risk assessment facilitated the selection of Capmul PG-8 (oil), Kolliphor RH40 (surfactant), Transcutol P (co-surfactant) as Critical Material Attributes (CQA) for the formulation of SEDDS.A d-optimal mixture design use to optimize the concentration of components used in the SEDDS formulation to achieve excellent physicochemical characteristics.Sixteen distinct formulations were prepared and assessed to check the model fit.It earmarked the patient-centric quality target product profile and CQAs.QbD resulted in a powerful and economical technique for improving the bioavailability of the medication, as confirmed by the portrayal investigations of the optimized batch.It saw a great arrangement among anticipated and exploratory qualities for mean droplet size, drug content, emulsification time, and percentage of medication delivered in 20 minutes.Optimized SEDDS formulation showed a smaller droplet size of 56.25 nm, PDI 0.230, and zeta potential -13.6 mV.To sum up, we successfully used QbD oriented development of novel Ezetimibe-loaded SEDDS formulation using the d-optimal mixture design to improve the oral absorption of poorly watersoluble drugs.