Lyophilization, a process of freeze-drying injectable drugs, is now required for a significant number of drugs, whether to protect biological activity, extend shelf life, or increase dosing precision. And with lyophilization comes reconstitution, the process of mixing the lyophilized drug with a diluent prior to administration to create an injectable.
Traditional reconstitution requires a number of components: 2 vials (1 of the lyophilized drug and 1 of a diluent such as water for injection), a disposable syringe, and 2 needles. It also requires experience and training and carries the risk of a needle stick injury to the person administering the drug. And if the diluent is not measured precisely, the patient may be at risk of an underdose or overdose during administration.
WFI syringes add value to your injectable
WFI ready-to-use syringes eliminate multiple components and processes used in traditional reconstitution, thereby reducing many of the risks and opening up new opportunities for your product. These self-contained systems are simpler and safer for patients to use – they minimize handling, decrease the potential for dosing errors, maintain a stable pH value, and even help protect against tampering.
WFI syringes expand your competitive edge
Taking advantage of Vetter’s WFI services can help your product stand apart from the competition.
Faster time-to-market – stability data and registration documents (for several countries) are readily available to streamline registration
All-in-one simplicity – prefilled format increases end-user safety and convenience
Custom flexibility – kits can be designed to meet specific patient or clinical needs
Distinctive quality – Vetter process technology and premium packaging enable high-quality aseptic products
Vetter will work directly with your team to determine the ideal filling volumes for your WFI syringe as well as the process for a streamlined launch.