Application Of Computer Aided DOE In Research And Development Of C-0301 Liposome

Background: The traditional approach to drug research and development includes molecular design, formulation screen, process optimization and quality criteria establishment, as well as pilot trial scale-up, flow control and large scale manufacture under GMP in the later stage. The whole theme involved continues optimization of tremendous correlated factors under their different levels. Also process to acquire the best combination is time consuming and labor consuming. Computer aided DOE technology has been applied to the whole process of drug development process. DOE technology could help researchers control drug developmental cycle and resource investment, thereby producing enormous economic and social returns.Integrating comprehensive statistical theory and computer data process capability, DOE can efficiently retrieve optimized condition. Since exploited from 1958 by Fisher, DOE has been used extensively in agriculture and engineering. Also applications of DOE are steadily increasing in the field of pharmaceuticals over the past decades, especially in nanopharma field in which highly precise and optimized process parameters are required. A large of raw data need to be analyzed and processed in DOE by computer software, and thereby researchers obtain optimal parameters. Because of its simplicity and flexibility, Design Expert, a DOE software, could be widely accepted by experimenters, even without in-depth knowledge of statistics. The traditional one-factor-at-a-time approach is time consuming. Moreover, the interactions among various factors may be ignored, which made attainment of a correct optimum condition not possible. DOE also could determinate multiple factors and their interaction effects simultaneously which decrease the development cycle, save the resource and improve the production quality.C-0301 has various physiological activities, such as vasodilatation, reduction of blood pressure, inhibition of platelet aggregation, and inhibition of arteriosclerosis. However its chemical instability and fast degradation after passage through the lung ask more challenge for offering better formulation for clinical application. Liposomes have been applied in drug delivery system. In this study, we hope via liposome encapsulation and delivery,...