Quality by Design approach in the development of Solid Lipid Nanoparticles of Linagliptin
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The main objective of this study was to optimize the manufacturing process of solid lipid nanoparticles and to identify the impact of critical process parameters and critical material attributes on critical Quality attributes using Quality by Design approach (QbD).
Material and methods
Design of experiments was used to investigate the effect of critical process parameters on dependant and independent variables. As a result design space was established to understand the relationship between Critical process parameters and critical quality attributes of solid lipid nanoparticles. Screening revealed that independent variables like amount of lipid and surfactant concentration two most important factors which affect the dependent variable like particle size, Entrapment efficiency and in vitro drug release of solid lipid nanoparticles. Nanoparticles were prepared hot homogenization technique using response surface methodology exploiting Design of Expert®11 software.
Desirability functional approach was used for the optimization. Solid lipid nanoparticles desirability value was 0.988 respectively under optimal conditions. Hence there are chances of 0.012 errors.
Falling outside of design space can be considered a change, need to be evaluated for risks that may impact the product quality. Hence all the formulations of SLN's were within the design space there are less errors in the production of solid lipid nanoparticles.
Quality by design, Solid lipid nanoparticles, Design of experiments, Critical Quality attributes, Critical process parameters.