Gaps In Traditional Reconstitution Process Filled By Water-For-Injection Syringe

By Mike Schaefers, Vice President of Marketing for Europe, West Pharmaceutical Services, and Thomas Otto, Managing Director, Vetter

Since the 1930s, pharmaceutical manufacturers have leveraged a method called “lyophilization” to reconstitute freeze-dried drugs from which water has been removed into liquid form. The recent rise in biopharmaceutical drugs has sparked renewed interest in lyophilization as a way to bring injectable biologics and other drugs to market more quickly.

While many drug products are later available as a liquid, some drugs are not stable in other forms or within an aqueous solution and, thus, require lyophilization for their entire life cycle. Lyophilization offers several advantages that may appeal to pharmaceutical manufacturers. For example, in lyophilized form a drug’s shelf-life may be extended while maintaining potency. Also, lyophilized drugs may withstand broader temperature ranges and prove easier to ship and store – particularly where cold storage chains are less reliable.

By nature of their freeze-dried form, lyophilized drug products require an additional preparation step prior to administration. This process, called reconstitution, entails mixing the freeze-dried drug with a liquid to create an injectable solution.