Abstract:
The aim of the current work is to utilize quality by design (QbD) approach to develop and optimize nanovesicular carriers of a hydrophobic drug. Rosuvastatin calcium was used as a model drug, which suffers poor bioavailability. Several tools were used in the risk assessment study as Ishikawa diagrams. The critical process parameters (CPP) were found to be the particle size, polydispersity index, zeta potential and entrapment efficiency. Factorial design was used in risk analysis, which was complemented with artificial neural network (ANN); to assure its accuracy. A design space was established, with an optimized nanostructured lipid carrier formula containing 3.2% total lipid content, 0.139% surfactant and 0.1197 mg % drug. The optimized formula showed a sustained drug release up to 72 hours. It successfully lowered each of the total cholesterol, low density lipoprotein and triglycerides and elevated the high-density lipoprotein levels, as compared to the standard drug. Thus, the concurrent use of the factorial design with ANN using QbD approach permitted the exploration of the experimental regions for a successful nanovesicular carrier formulation, and could be used as a reference for many nanostructured drug delivery studies during their pharmaceutical development and product manufacturing.
