Determination of critical parameters of production technology for Lesfal
Keywords:liposomes, technology, critical parameters of production
Currently some success has been achieved when using liposomes in development of new drugs with various actions. Scientists have demonstrated the use of phospholipids as the raw material for production of liposomes. Supercritical fluids are used for producing multilayer, large and small monolayer liposomes. The size and behaviour of liposomes are determined primarily by the presence of a closed membrane wall. As a result, liposomes remain undamaged under various unfavourable conditions, and their membrane is capable to self-regenerate after its structural damages. A positive factor is that flexibility and fluidity of the bilayer give liposomes a high ductility. An important task in development of the liposomal drug technology is to determine the critical parameters that affect obtaining of stable, well characterized liposomal dispersions in large quantities. Critical parameters of the production technology of Lesfal liposomal drug for injection have been determined. It has been found that the most critical step is to obtain a lipid film. The main factors affecting formation of impurities in the process of producing liposomes of Lesfal drug for injection are time; temperature and the vacuum level. The critical parameters for these factors such as time (45 min), temperature (43°C), the vacuum level (not less than 14 gPa) have been determined. They are the optimal values for producing a lipid film for Lesfal liposomes.
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