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.

In order to preserve and increase the biological effectiveness of biologically active substances isolated from deer musk, we studied technological aspects of obtaining a substance of lipid-stabilized stable nanoparticles from deer musk. The stability of the obtained substance was evaluated. It was found that homogenization under high pressure is an optimal approach to obtaining biologically active substances from deer musk. The modes of preparation of a liposomal form of biologically active substances with predetermined dispersion parameters (average particle diameter 250 ± 100 nm, polydispersity index 0.3 ± 0.1, and zeta potential from -5 to -35 mV) were determined. It was found that the high-pressure homogenizer “Donor-5” makes it possible to obtain liposomal dispersions with standard parameters and the degree of inclusion of musk biologically active substances up to 60%, at the same time as providing minimal oxidation and hydrolysis of phospholipids (oxidation index 0.3). Our studies showed that the use of a domestic phosphatidylcholine is economically justified and allows obtaining liposomal forms of proper quality. The quality indicators of the obtained liposomal substance were characterised by conventional analytical methods (dynamic light scattering, electron microscopy, gel chromatography, chromatography-mass spectrometry, etc.). On the basis of the results obtained, a draft specification was developed for a liposomal substance (powder) containing a complex of biologically active substances isolated from deer musk. The developed technology for obtaining a liposomal form of biologically active substances from deer musk can be scaled up in accordance with GMP requirements.