Quality by Design approach for nanosystem based topical drug delivery

Abstract

The skin is increasingly being acknowledged as a chief drug administration route. Its natural barrier stratum corneum (SC) usually obstructs this route's effectiveness; hence, different strategies have been investigated to improve percutaneous drug transport. The design of Nano delivery systems, striving to solve skin delivery issues, is essentially explored, thanks to their prospect of revolutionizing dermal therapies, reducing side effects and enhancing therapeutic effectiveness. Optimization of the nanosystem and the process of manufacturing the nanosystem is complicated, typically involving a vast number of variables. Thus, Quality by design (QbD), the science and riskoriented approach, provides comprehensive knowledge, rendering drug products of exceptional quality without large-scale regulatory obligation. This review gives an idea of the QbD development strategy, containing preliminary and systematic risk assessments, with CMAs (critical material attributes) and CPPs (critical process parameter) recognition for distinct nanosystems presumably utilized for dermal therapies.

Keywords

• topical formulations
• quality-by-design
• nano-delivery systems
• risk assessments