Title : QbD based development of resveratrol-loaded mucoadhesive lecithin/chitosan nanoparticles for prolonged ocular drug delivery

Authors : Mithun Saha, Diti Rani Saha, Tahamina Ulhosn, Shazid Md. Sharker, Md. Hasanuzzaman Shohag, Muhammad Saiful Islam, Swapan K. Ray, G.M. Sayedur Rahman, Hasan Mahmud Reza

Abstract : The lower drug retention to the eye's anterior portion is a prime concern in the ocular drug delivery system. To improve the drug retention capacity, we aimed to develop drug–containing nanoparticles using Quality by Design (QbD) approach. The current study describes the development of resveratrol-loaded mucoadhesive lecithin/chitosan nanoparticles (RMLCNs) to be instilled on eyes. The initial risk assessments were carried out using a fishbone diagram followed by final risks assessment using the risk assessment matrix (RAM). A definitive screening design (DSD) study was performed for the CMAs/CPPs (critical material attributes/critical process parameters) on CQAs (critical quality attributes). The identified central composite design (CCD) with a design space showed an optimal desire formulation value of 0.913. The optimized formulation had a particle size of 163.3 nm, PDI (polydispersity index) of 0.254, zeta potential of 46.4 mV, entrapment efficiency of 97.03%, the release of 96.87, and R2 of the zero-order release kinetics of 0.9897, that were within the predictive range at an alpha level of ±0.05 with a bias percentage of ?3.422. Finally, the AUC0-6 and MRT of the optimized formulation were found to be 6.44 and 2.458 times higher than those of resveratrol solution, respectively, demonstrating the adaptation efficiency of QbD to the development of RMLCNs.

Journal : Journal of Drug Delivery Science and Technology Volume : 63 Year : 2021 Issue : 102480
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