Development of nanoparticles formulations with model protein active substance for biological drugs investigation of physical and chemical properties

Developing Model Protein Active Substances and Nanoparticles Formulations for Biotechnological Drugs and Investigation of Chemical Properties The main purpose of this study is to prepare combined model protein-containing nanoparticle formulations, to evaluate and obtain model protein-loaded nanoparticle systems with emulsification – solvent evaporation methods in terms of various parameters. The formulation was developed with the method selected from many nanoparticle production methods. Mixing speed, polymer/model protein ratio and model protein/model protein ratio parameters were selected among the parameters affecting the physical and chemical properties of the formulations produced using PLGA polymer, which is a biodegradable polymer. On these selected parameters, box behnken factorial design, five center points and 17 analysis formulations were obtained. The 17 formulations obtained were evaluated in terms of particle size, polydispersity index and zeta potential, and the final two formulations that gave the smallest particle size and remained in the range of 0.1-0.25 pdI were selected. The selected final two formulations were repeatedly obtained and evaluated in terms of relevant parameters. The final two formulations determined as a result of the evaluation showed consistency in terms of particle size and pdI values. Release studies of the final two formulations were performed and BCA and SDS-PAGE analyzes were performed. At the end of the analysis, it was observed that the release ended after the first two hours and was not at a sufficient concentration for the band to be seen. As a result, two model protein-loaded nanoparticle formulations were developed and evaluated in terms of various physical and chemical properties. Thus, it formed a basis for more comprehensive studies and in-vivo evaluations. Keywords: Biotechnology, Nanoparticle, Emulsification – Solvent Evaporation, Polylactic co glycolic acid, Model protein.