Pilot-Scale Technology for Obtaining a Substance of Lipid-Stabilized Nanoparticles Containing a Complex of Biologically Active Substances Isolated from Gland Secretion of Musk Deer with Specified Stability Parameters

Abstract

In the course of improving the pilot-scale technology for manufacturing a liposomal substance of biologically active substances (BAS) isolated from the gland secretion of musk deer, the authors established operations and modes to ensure the production of liposomes with the specified stability parameters (shape, hydrodynamic diameter, charge, and polydispersity index) in full compliance with GMP requirements and the maximum inclusion of BAS from deer musk into liposomes with the preservation of the initial biological activity of its most important components. The established modes provide for a two-fold reduction in the technological cycle duration with the substance yield of more than 90%. The improved technology ensures the production of at least 80% of liposomes with the main liposome fraction in experimental samples in the range of 200+50 nm and 250+100 nm for the final substance (before lyophilization) and after its recovery (rehydration), respectively, which is considered optimal for transmucosal drug administration. The polydispersity index was less than 0.3, and the zeta (Z)-potential was less than -35 mV. The quality indicators characterizing the dispersity of the resulting liposomal substance were studied by conventional analytical methods (dynamic light scattering, electron microscopy). On the basis of the obtained results, a draft specification for a liposomal substance (powder) containing a complex of BAS isolated from deer musk was finalized.