Case Study VI: Chemical stabilization of an IV formulation.
A client was interested in a new use of a well known compound for the reversal of anesthesia subsequent to dental procedures. The compound was relatively unstable in aqueous solution, and had been previously formulated as a lyophilized powder for reconstitution. The new use required a stable liquid for injection. IriSys initiated a multivariate formulation screening process that included buffer species, buffer concentration, pH, antioxidants, organic co-solvents, inert atmosphere for filling, and packaging configuration evaluation. The analytical methods required to quantify and monitor the apperance of low concentration degradation products were developed and validated. The formula and manufacturing process that resulted from this study provided sufficient stability to allow commercialization of the new product.
