Evaluation of Dissolution Profiles of a Newly Developed Solid Oral Immediate-Release Formula Containing Alpha-Lipoic Acid

Alpha-lipoic acid (ALA, thioctic acid), a naturally-occurring essential dithiol compound, has become common ingredient in many pharmaceutical and food supplement products (FSP), used oxidative stress-dependent pathologies; oral bioavailability of ALA is limited by pharmacokinetic particularities that reduce its therapeutic efficacy-reduced solubility, lack gastric stability hepatic degradation, doubled formulation hinders. The objectives were to develop solid 600 mg FSP obtain an optimal profile compared reference listed drug (RLD) with similarity factor f2 50. A comparative dissolution study was performed; HPLC method for quantification. After planning combinatory simulations (formulation stage), two prototype formulas (#1 #2) manufactured further optimized adjusting physical characteristics the excipients quantities (#3 #4) order achieve Quality Target Product Profile. misshapen ALA’s vitro release observed #3 Formula (f2 = 31.6); obtained #4 58.5). simple quantitative formula not enough assure good bioavailability; needs multiple compounding modulations under physicochemical compatibility algorithms, profiles testing back-ups. It ensure comparable RLD, allowing compound reach target level optimum claimed antioxidant activity at cellular level, even formulations.