BD UltraSafe Plus 2.25 mL passive needle guard

BD (Becton, Dickinson and Company) has announced the BD UltraSafe Plus 2.25 mL passive needle guard for use by pharmaceutical companies in drug-device combination products. When combined with a glass prefillable syringe, the system enables the subcutaneous delivery of biologic solutions of different fill volumes up to 2 mL and viscosities up to 30 cP.

The needle guard is designed to meet the needs of healthcare providers, patients and caregivers in performing manual injections of biologic solutions. The design complements biopharmaceutical companies’ combination product strategies, enabling patient-controlled injection for complex, high-viscosity drugs.

Biologic therapies are often self-administered by patients or caregivers and require delivery systems that provide ease of use and safety benefits for use in non-clinical settings. However, the viscosity and injection volume of biologics have shown a tendency to increase over the last years (>1 mL, >10 cP) beyond the capabilities of many commercialised injectable drug delivery systems. Biologic formulations with high volumes and viscosities often require stronger forces to inject, which can create challenges from a user’s perspective.

The needle guard was designed to provide confidence and ease of use to patients and improve their self-injection experience, and to serve the expanding biologic drug delivery design space. The patient-centric solution was evaluated in a human factors validation study in which usability was demonstrated and the majority of participants expressed confidence that the activated safety mechanism would protect them from needlestick injuries, the company says. The technology is compatible with the BD Neopak 2.25 mL glass prefillable syringe.