Design and Development of Prolong-acting Intelligent Nano-depot (PaIND) for Improving Patient Adherence

Medication adherence is a major limitation in the current era. The purpose of the current research was to develop a Prolong-acting intelligent nano-depot (PaIND) for patients diagnosed with hypercholesterolemia, utilizing Rosuvastatin (RSV), to reduce the need for frequent medication administration. PaIND were formulated with poly(lactic-co-glycolic acid 75:25) (PLGA) as the biodegradable polymer, Dimethyl sulfoxide (DMSO) as the solvent, sesame oil as the oil, Span 80 and Tween 80 as the surfactant and co-surfactant, respectively. PaIND was developed systematically by application of quality by design (QbD). A risk assessment approach and Taguchi design were used to screen for significant materials (CMAs) and process attributes (CPPs). PaIND was optimized by applying central composite design (CCD). PaIND was designed and evaluated for prolonged controlled RSV release, gelling time, nano-sized particles, stability, sterility, and other parameters. The chosen excipients showed controlled delivery over a prolonged period, with no signs of burst release. Higher delta values and S/N ratios in the Taguchi design indicate a significant influence of the amount of PLGA, span 80, and tween 80 on the quality of PaIND. Quadratic effect was observed for each CMA on chosen CQAs in CCD. The optimum PaIND showed 86.99% RSV release in 30 days, a 173 nm size, and a 3.6 s gelling time-physical properties aligned with prolonged drug release. Lower PDI and viscosity, negative zeta potential, high transmittance and entrapment efficiency, improved stability and sterility, better use of PaIND. PaIND was successfully designed and developed, integrating recent regulatory compliance requirements. The newer system is highly patient-friendly and ready for commercial use following successful preclinical trials.