FORMULATION DEVELOPMENT OF CARVEDILOL ORAL SELF-NANOEMULSION CONCENTRATE BY FULL FACTORIAL DESIGN

Poor solubility of new chemical entities often leads to low bioavailability. Addressing this, selfnanoemulsifying systems for drugs like carvedilol, a cardiovascular drug, offer promising solutions. This study used a 3² factorial design to optimize a carvedilol nanoemulsion for cardiovascular disease. CCTriglyceride, Kolliphor®, and PEG 400 were identified as optimal excipients to maximize solubility. Differential Scanning Calorimetry confirmed no drug-excipient interactions. A pseudo-ternary phase diagram guided the development of a stable system, with formulation F10 achieving 95 % drug release within 30 min and minimal precipitation (1.2 %). In vitro dissolution studies showed 70 % - 90 % release within 20 min. Zeta potential analysis confirmed stability (particle size: 38.3 nm; charge: -2.059 mV). Pharmacokinetic studies in Wistar rats showed Cmax of 602.0 ng mL-1 and Tmax of 0.8 h. One-month stability tests indicated consistent appearance and drug release, with slight precipitation. This optimized nanoemulsion enhances carvedilol's bioavailability and stability, offering significant pharmaceutical potential.