Research Project
3499148
Chiral drugs, when administered in enathiomerically pure form, offer significant clinical advantages over their racemic counterparts. However, available methods for chiral resolution of racemic compounds, such as diasteriomeric derivatization and chiral chromatography, have drawbacks, including high cost, difficulty with scale-up and lack of applicability for many chiral compounds. This project is directed toward demonstrating the feasibility of an economical, large-scale chromatographic process for the chiral resolution of a broad range of racemic compounds. The main focus of this program will be the development of a single, representative chromatographic medium suitable for use in the process. This novel medium will be packed into a highly efficient column and used to resolve three pharmacologically relevant drugs on a laboratory scale. This Phase I program has three objectives: 1) to demonstrate that the process is technical feasible, 2) to demonstrate that the process can resolve three racemic drugs to enantiomeric purity suitable for pharmaceutical use, and 3) to demonstrate that the process promises to be economical. Success in Phase I would lead to Phase II proposal focusing on expanding the technology to a wide range of chiral compounds, developing strategies for optimization, identifying scale-up issues, validating the process on a larger scale, and completing a detailed economic analysis.
