USE OF SULFOALKYL ETHER CYCLODEXTRIN AS A PRESERVATIVE

摘要

A method of preserving formulations is provided. The method includes the ste p of including a derivatized cyclodextrin in a formulation capable of sustaini ng microbial growth. One embodiment of the formulation employs a sulfoalkyl eth er cyclodextrin as a preservative and optionally as a solubilizing and complexi ng agent. A suitable cyclodextrin is the CAPTISOL" brand cyclodextrin (sulfobut yl ether R-cyclodextrin). Whether or not the formulation includes a conventiona l preservative, the formulation will remain preserved for at least a minimum predetermined period. Specific embodiments of the invention include a carrie r, a derivatized cyclodextrin and optionally one or more active agents, one or more water activity-reducing agents, and/or one or more complexation-enhanci ng agents. The derivatized cyclodextrin reduces the water activity of the formulation. A liquid formulation can be lyophilized or otherwise dried to yield a solid formulation that is optionally reconstitutable.