The study was performed using 50 biological molecules commonly used in Mesotherapy products, including Growth Factors and Mimetic Peptides.
To carry out the study, advanced instrumental techniques were used such as High Performance Liquid Chromatography (HPLC) and Mass Spectrometry (MS).
The products were filled and lyophilized using Current Lyo Aseptic Filling Practices and, once reconstituted, analysed taking, as standards, the newly synthesized biological substances. Previously, the identity and, therefore, the correct biological sequence of these patterns were identified.
99% of the biological principles obtained using this procedure maintained their molecular configurations intact as demonstrated by the mass spectrums of the products.
The first 6 hours of the solution (obtained after rebuilding the products) Monitoring showed a very high stability from t0 to t6 hours.
The pharmaceutical freeze-drying technique combined with the Aseptic Filling / Packaging technique using Current Lyo Aseptic Filling Practices avoids degradation of the active substances which may lead to the appearance of unwanted related substances and impurities. In the case of Growth Factors and Mimetic Peptides, the molecular structure is degraded and becomes totally inactive for the intended aesthetic purpose. The degradation of the chains also gives rise to other molecules that can present undesired effects.
This technique is a method used in the pharmaceutical industry for the preservation of active principles and it is essential to apply it in the field of Mesotherapy for those products that incorporate easily degradable substances. Therefore, if Mesotherapy wants to be a good alternative in the aesthetic field, it should provide products with a large basis of pharmaceutical development and manufacturing that take into account such important aspects as patient safety and treatment effectiveness. The products must be manufactured in pharmaceutical facilities subject to good manufacturing standards (GMP), suitable for filling sterile products, carrying out stability studies in accordance with international harmonization standards (ICH) and following-up the real degradation of active principles. The market of Mesotherapy should provide health specialists security in the application of products and effectiveness in treatments. If the market adapts to the changes related to pharmaceutical manufacturing and development, the products obtained with this technique will always guarantee safety and effectiveness.