Selected physicochemical properties of Lyophilized hydrogel with liposomal fraction of calcium dobesilate

Abstract

Lyophilization is the process of drying and improving the stability of various pharmaceutical preparations. In this work we evaluated the properties of 11 hydrophilic gels calcium dobesilate with liposomes based on soybean lecithin, subjected to the freeze-drying procedure. Liposomes were produced by using method thin lipid film. Lyophilization was carried out under conditions of temperature equal (-30 °C) and pressure 0.37 mbar. We evaluated the preparations with dynamic light scattering (DLS) method, optical microscopy and Fourier-transform infrared spectroscopy (FTIR). In this work we presented the average results for the particle diameter in the sample and PDI (polydispersity index) value for the samples that produced the results. When testing using the DLSmethod on aMalvern Zetaseizer, results for 7 samples were not obtained. Two of next four samples were characterized by an increased size of the liposome particle resulting from a lower concentration of ethanol compared to the rest of them. Three samples under the microscope did not show any differences. It was possible only to see single crystals probably of undissolved calcium dobesilate. Some clusters were observed in the 4 samples, and when they appeared they were very small. The aggregates and irregular liposomes present in the rest of the samples may have been formed due to the destabilizing activity of ethanol towards lipid membranes. In the FTIR spectrum forMC, the peak was observed at the wavenumber of ca. 2900 cm-1 and of about 1050 cm-1. In case of pure calcium dobesilate we observed low pick at the wavenumber of about 3400 cm-1. The spectrum has a low peak at the wavenumber of 1450 cm-1 and intense peaks ranging from approx. 1000 cm-1 to approx. 1200 cm-1. Decay of the lecithin peak in formulations with liposomes at 1725 cm-1 wavelength may indicate the occurrence of the hydrolysis reaction in the system. Probably there was a hydrolysis of the ester bond connecting the rest of the phosphoric acid and the choline with the glycerol residue.