The growing practice of using lyophilisation to stabilise drugs has enabled entry into markets in far flung places. Mike Schäfers, West Pharmaceutical Services, Inc, and Thomas Otto, Vetter, explain how a further innovation fills a need in simplifying the reconstitution process
Lyophilisation – the process of freeze-drying drugs such as vaccines and other injectables by removing water from the material and sealing the material in a vial – has made it easier and faster for many new drugs to reach the market. Lyophilised products require an additional preparation step prior to administration. This process, known as reconstitution, entails mixing the dry drug with a liquid to create an injectable solution.
Traditional reconstitution requires two vials – one of the lyophilised drug and one of a diluent such as water for injection – a disposable syringe and two needles. It also requires experience and training, and has the potential to put the person administering the drug at risk of an accidental needle-stick injury. Further, the patient may be at risk of an under- or over-dose because the diluent may not be measured precisely.
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