As new biological therapies are developed, further advancing the treatment of chronic conditions, drug delivery devices must also keep up the pace of innovation. With limited suitable delivery devices, new biologics that are more viscous and need high volume doses may have to be administered intravenously. However, with immense pressure on healthcare services, subcutaneous administration is a more favourable route, allowing patients to administer their own treatment outside of the healthcare setting. For pharmaceutical businesses, enabling subcutaneous administration of their drugs may provide a competitive advantage, whether to hold on to original biologic market share or to capture an emerging biosimilar opportunity.
 
Typically, standard prefilled syringes and related safety devices have been designed for 1mL fill volumes and a viscosity that is under 10cP. Recognising that these existing devices would not be suitable for the fill volumes of some of the new biologics entering the market, Owen Mumford Pharmaceutical Services has developed an adapted version of the established UniSafe® safety device for 1mL prefilled syringes. With a capacity of up to 2.25 mL, the innovative design of this new iteration retains all the simplicity of the original device.
 

• MANUFACTURING SIMPLICITY

UniSafe 2.25 is spring-free, eliminating the complex process of adding a spring to the device under high tension. The product is comprised of only five components, which can be easily assembled with a prefilled syringe. It is compatible with standard small round flange and cropped flange prefilled syringes, allowing for a wide choice of suppliers. Syringes with 29G or 27G needles, or even 25G needles, should help to limit pain during injection, and for more viscous biologics, thin-wall needles are designed to aid the flow of the drug.

• WASTAGE PREVENTION

Internal springs typically used in safety devices for prefilled syringes can cause the device to accidentally activate during transit, and may result in costly drugs or biologics leaking before reaching the end user. The springless design of UniSafe 2.25 not only prevents accidental activation and leakage but also gives patients clearer visibility of the syringe contents before administration. This helps the patient to check for drug clarity before injection, and ensure that the dosage has been fully delivered after injection – a critical feature given the small dosage volumes of some biologics. The integrated syringe plunger is designed to resist easy removal therefore preventing the drug from inadvertently escaping, as well as ensuring tamper evidence and preventing possible repeat use.

• EASE OF USE

Like the 1mL device, UniSafe 2.25 can be used intuitively in exactly the same way as a conventional syringe. The large comfortable plunger head and smooth, integrated finger flange facilitates injection, helping to control the amount of pressure needed and the length of time it takes to inject. This is especially important for patients who may have impaired strength or dexterity.

• PASSIVE SAFETY

The product’s safety mechanism is automatic, so patients do not need any additional manipulation of the device to protect themselves during injection. When the plunger is fully depressed, the device’s safety mechanism is automatically deployed, and the needle retracts into a safety shroud. Since the needle is no longer exposed after injection, patients or users are immediately protected from the risk of needlestick injury. You can see exactly how this works in the video below.