The recent discovery that bioadhesive microspheres may open a whole new range of therapeutic agents to oral delivery is indeed exciting. The bringing of such useful products to commercial reality can be significantly accelerated if concerns such as product purity and sterility can be mitigated. We believe that supercritical fluid processing has much to offer in this regard. We plan to evaluate a novel, cost effective process to formulate hydrophobic microspheres for the controlled release of therapeutic agents. We will replace organic solvents such as methylene chloride used in the conventional formation of polymeric microspheres with easily separated, non-toxic supercritical fluids. Therefore, the number of processing steps, processing time and manufacturing cost will be greatly reduced. In addition, adverse effects of exposing the bioactive compounds to potentially harmful organic solvents will be eliminated. The supercritical fluid process is very amenable to scale up. In addition to improving product quality, the elimination of organic solvents provides benefit to the global environment.
At a commercial scale, benefits of the proposed process may include environmental advantages due to a reduction in the use of organic solvents, improved product quality with less residual solvent contamination, improved product purity, improved sterility and formulation properties and improved process economics.
