Title : Showcasing the Quality by Design Framework on Nano Drug Delivery Systems
Abstract:
The Quality by Design (QbD) approach empowers the researchers to minimize the number of experimental trials, errors and time during process of formulation development. It helps to identify the significant, influential factors such as critical material attributes, critical formulation variables, and critical process parameters, which may significantly impact the Quality of the products. Nano Drug Delivery System (NDDS) are a selective class of nanomaterials that exploits the nano sized properties to enhance the oral bioavailability of poorly water-soluble drugs, increases drug loading capacity, increase in surface area for optimum interaction at the target binding site, facilitates enhanced permeation and retention (EPR) in cancer cells, reduces enzymatic degradation of the drug, cross blood brain barrier(BBB), accesses the micro circulation in pulmonary system and tight junctions of the endothelial cells. Well, precised and reproducible results might be obtained to achieve the required therapeutic goals of the formulation using the systematic approach called Quality by Design. The systematic QbD-based development of optimized NDDS of poorly water-soluble drugs, providing a fast, efficient, and cost-effective approach to the formulation with enhanced bioavailability potentials. Moreover, functionalization of such NDDS with antibodies and peptide linkers specific to target site enhances their target site concentrations to achieve the therapeutic benefit. The preliminary preformulation studies and the risk assessment enabled the proper identification and selection of independent variables to further optimize the dependent variables. Identification of such key variables and optimization of the same using the QBD or DoE approach is critical towards consistency in developing nano drug delivery systems.
