Concentration Method for Thermally Labile Pharmaceutical

DESCRIPTION (provided by applicant): Freeze-drying is commonly employed to concentrate temperature-sensitive pharmaceuticals. Freeze-drying is expensive and causes product degradation. Osmotic distillation (OD) is a candidate for gentler and lower-cost concentration but has not been commercially developed because microporous membranes fail due to wet-out. In Phase I, Compact Membrane Systems (CMS) used novel membranes to concentrate a model enzyme without wetting-out or causing activity loss as compared to control. Working with an industrial pharmaceutical company, we used OD to concentrate an antibiotic prior to super critical fluid extraction (SCFE). The OD-SCFE method recovered 27% more antibiotic than the traditional chemical extraction method. We have gained support from an industrial pharmaceutical company and two major membrane companies. These relationships enhance CMS's ability to complete Phase II and commercialize this technology. In Phase II, we will collaborate with our pharmaceutical partner to develop a process using OD for initial dewatering and SCFE for final concentration. Our Phase II focus will be: a) Further developing membrane/module for OD of pharmaceutical products b) Working with our pharmaceutical partner to build and test prototype system c) Obtaining key basic data and performing economic analysis d) Performing long-term stability testing of OD process and biopharmaceutical product.