Title : Integrating QbD for the solubility amelioration of ivacaftor loaded solid lipid nanoparticles in-vitro & in-vivo
Abstract:
The present investigation is focused on the application of the Quality by Design (QbD) approach for the development and optimization of SLN formulation of Ivacaftor (IVF). IVF SLN was formulated with the help of homogenization and ultrasonication methods by incorporating Labrasol as liquid lipid, Cetyl palmitate as solid lipid and Polysorbate 20 as the surfactant. The independent variables such as the amount of Lipid (X1) and amount of surfactant (X2) were studied for their effect on dependent variables namely entrapment efficiency and particle size. The final formulation of IVF-SLN showed a narrow range in size distribution (PDI-0.276 ± 0.014) with a particle size of 102.3 ± 2.34 nm and entrapment efficiency of 78.32 ± 2.36. IVF incorporation into the imperfect crystal lattice was confirmed with the help of a DSC study. In-vitro and In-vivo diffusion showed enhanced profiles for the optimized formulation of IVF-SLN.
Audience Take Away Notes:
- This methodology emphasizes understanding the process and product variables to ensure a high-quality final product
- This knowledge can be used to create more effective and optimized drug formulations in their projects
- This methodology can make the designer’s job more efficient by reducing trial-and-error experimentation, leading to more consistent and predictable results
