STUDY OF PHARMACO-TECHNOLOGICAL PARAMETERS OF MODIFIED LIPOIC ACID
Abstract
The paper presents the results of a comprehensive pharmaco-technological assessment of a new substance “Tiotsin”, a zinc coordination compound based on modified α-lipoic acid. Organoleptic properties, solubility and hygroscopicity were evaluated along with particle morphology (microscopy), particle-size distribution (sieve analysis), residual moisture, flowability, angle of repose, bulk and tapped density. In addition, the Carr’s compressibility index and the Hausner ratio were calculated. The substance was found to be slightly hygroscopic (0.8%) and characterized by low residual moisture (1.27%). Microscopic examination revealed predominantly amorphous-granular isometric particles and pronounced polydispersity, which may affect powder handling during solid dosage form development. Based on flowability parameters (angle of repose 31.5±2.3°, Carr’s index 9.4%, Hausner ratio 1.16), “Tiotsin” can be classified as a powder with good flow properties; however, the broad particle-size distribution supports the need for excipients and/or granulation to ensure robust manufacturing of solid dosage forms.