Quality by Design (QbD) Approach for Optimization and Development of Nano Drug Delivery Systems

To clearly understand the formulation of high quality pharmaceutical products, FDA generalized quality by design (QbD) in the field of pharmacy, which is based on the thorough understanding of how materials and process parameters affect the quality profile of final products. Quality by design is a risk management and science-based approach promoted by the United States food and drug administration to enhance pharmaceutical development throughout a product’s life cycle. The application of QbD in formulation and process design of nano drug delivery systems is based on a good understanding of the sources of variability and the manufacture process. In this paper, the basic knowledge of QbD, objectives and elements of QbD are briefly reviewed. Tools for QbD implementation in pharmaceutics field, including risk assessment, design of experiment, and process analytical technology (PAT), are introduced briefly. Moreover, the actual applications of QbD in formulation of various nanocarriers are summarized and presented. Keywords: Quality by design, design of experiments, nanocarriers, risk management Cite this Article Daisy Arora, Bharat Khurana, Narang RK et al. Quality by Design (QbD) Approach for Optimization and Development of Nano Drug Delivery Systems. Trends in Drug Delivery . 2016; 3(3): 23–32p.