ABSTRACT
With the advent of biotechnology medicines, freeze-drying formulation and process development have embarked on new heights of importance in the parenteral industry. Roughly 40% of commercial biopharmaceutical products are freeze-dried; this percentage likely will keep increasing with time. Freeze-drying and lyophilization mean the same thing. Freeze-drying perhaps is more accurate because the process involves both freezing of a solution and then removing the solvent from that solution that involves drying procedures. Lyophilization means to “love the dry state,” but the title does not emphasize the cooling/freezing segment. Freezedrying involves:
1. Compounding, filtering, and filling drug formulations as solutions into vials historically although now more syringes are being used as primary container for lyophilized products. Most of the discussion in this chapter will focus on the vial being the primary package.
