This research used Quality by Design (QbD) to formulate and optimize a liposomal preparation containing clindamycin (CLN) and hydrocortisone (HCN) to improve acne topical treatment by maximizing stability, drug delivery, and therapeutic efficacy while minimizing systemic side effects. Thin-film hydration was used to manufacture liposomes with different lecithin-cholesterol ratios, CLN, and HCN. Pre-formulation solubility and FTIR compatibility tests were done. A factorial design modified CQAs such vesicle size, PDI, and zeta potential. Particle size, drug entrapment efficiency, drug release, spreadability, pH, viscosity, and stability under various storage conditions were assessed for the improved formulation. The enhanced liposomal formulation showed greater colloidal stability with a mean particle size of 401.5 ± 23.6 nm, a PDI of 0.33 ± 0.21, and a zeta potential of-54.3 ± 1.3 mV. CLN and HCN had sustained drug release and high entrapment efficiency (91.1% and 87.3%). The formulation had a skin-compatible pH (6.4 ± 0.1) and an acceptable spreadability (141.11 ± 0.49 g·sec). After three months in various storage conditions, stability testing showed negligible pH and viscosity fluctuation. The QbD-optimized liposomal formulation of CLN and HCN is a stable, effective, and patient-friendly acne topical therapy with anti-inflammatory and antibacterial activities, improved skin penetration, and reduced side effects.
BARBAR et al. (Sun,) studied this question.