Development of a lyophilized liposomal dosage form indolocarbazole derivative — LHS-1208

Abstract

Aim. The aim of this work was to create a lyophilized liposomal dosage form of native hydrophobic antitumor compound from the group of indolocarbazole derivatives — LHS-1208. Materials and methods. Quantitative determination of the drug content was carried out on a Cary 100 spectrophotometer using a standard sample at λ = 320 ± 2 nm. The analysis of the average diameter of liposomes was carried out by the method of correlation spectroscopy of light scattering using devices Nicomp-380 nanosizer and Zetasizer Nano ZS zetasizer, using the latter, the zeta potential of the liposomal dispersion was also measured. To measure the pH of the solution, a HANNA pH 211 pH meter was used. The dynamic viscosity was measured on a Vibro Viscometer SV-10 viscometer. Lyophilization was carried out in an Edwards Minifast DO.2 freeze-drying chamber. Results. Experimental models of compositions of lyophilized liposomal dosage form LHS-1208 with various molar ratios of components were obtained and analyzed. TLC analysis using several solvent systems can be used to detect and identify LHS-1208 in a liposomal dosage form. According to the results of the study, a spectrophotometric method was developed for the quantitative determination of the LHS-1208 content in the composition of a liposomal dosage form. Based on the studies carried out, quality indicators were selected for standardization of lyophilized liposomal dosage form LHS-1208 and subsequent development of the draft regulatory documentation. Conclusion. As a result of the complex pharmaceutical research, the optimum composition of the components was determined, and the technology for production of liposomal dosage form LHS-1208 was developed.