CONCENTRATION METHOD FOR THERMALLY LABILE PHARMACEUTICAL

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Concentration of aqueous process streams is common in pharmaceutical industry. When product activity is sensitive to temperatures above room temperature, processes such as freeze drying are employed. Osmotic Distillation (OD) is candidate for lower cost method for concentration of higher quality product, but has not been developed for the application because of potential failure due to penetration of microporous membrane structure by solution to be concentrated. Suitability of new porous/nonporous membrane will be demonstrated for use in OD of pharmaceutical products. The nonporous nature will avoid the failure mode described above. The membrane is based on novel polymer which has high water permeability required. High chemical and thermal resistance of this polymer allows common sterilization methods to be used. Preliminary OD testing has shown system to work well. Objectives of Phase I include producing suitable modules of nonporous and porous membranes, investigating relative efficiency of each in concentrating a model solution, demonstrating their relative tendencies to "wet out", or fail due to fouling of membrane by process streams, and determination of conformational changes to surface and effect on macromolecule stability. Strong industry interest allows actual Phase I pilot testing. PROPOSED COMMERCIAL APPLICATION: Development of this process will have an immediate impact on the agility of Pharmaceutical Companies to concentrate products without losing activity of such, and the ability to do so at a lower cost. Other applications that may benefit include the concentration of fruit and vegetable juices and removal of volatile components from liquids, for example the dealcoholization of wine.