Abstract: A method of making a pharmaceutical composition in a pre-filled syringe including preparing a batch solution by providing a solvent having an initial dissolved oxygen content, sparging the solvent with a first inert gas until the solvent has a reduced dissolved oxygen content that is lower than the initial dissolved oxygen content, and combining the solvent with an active agent and an antioxidant. The solvent is continuously sparged with the first inert gas during combination with the active agent and the antioxidant. The method also includes introducing at least a portion of the batch solution into a syringe while sparging the batch solution with a second inert gas that is the same as or different from the first inert gas. The pharmaceutical composition in the pre-filled syringe has a concentration of total impurities of the active agent of no more than about 5.5% (w/v) after three months of storage in accelerated storage conditions. Also described are pharmaceutical compositions in a pre-filled syringe.

Abstract: A method for providing a sterile pharmaceutical composition in a pre-filled syringe, the method including solubilizing an active agent and a pH adjusting agent in a solvent to provide a pharmaceutical composition, filtering the pharmaceutical composition through a membrane to provide a sterile pharmaceutical composition, and providing the sterile pharmaceutical composition in a pre-filled syringe having a labeled size, wherein the active agent includes sugammadex, the pre-filled syringe has a headspace volume that is less than 7.5% of the labeled size, and the method is free of a heat-based sterilization process. Also provided are sterile pharmaceutical compositions prepared according to the method.