The goal of this program is the development of a novel membrane-based two-phase flow system for the separation of enantiomers in a racemic mixture. This system is based on the use of chiral fine particles, which selectively adsorb one of two enantiomers from an organic solution containing the racemic mixture. Preliminary experimental results support the proposed approach. The process promises to offer substantial advantages over competing enantiomer-separation processes, including kinetic resolution, diasteromeric derivatization, and chiral chromatography. These advantages include: 1) high selectivity, 2) low cost, 3) suitability for use on a preoperative (e.g., 1- to 100-gram) scale, and 4) wide applicability for many chiral compounds. In Phase I, the feasibility of the process for the separation of enantiomers of propranolol, an important cardiovascular drug, from a racemic mixture will be demonstrated. In Phase II, the approach will be evaluated and characterized for the separation of a wide spectrum of pharmacologically relevant chiral compounds and the process will be optimized for a selected compound. Based on the commercial promise of this concept, it is expected to proceed directly to commercialization of the process in Phase III.
