Unilife Develops Multiple-Chamber Prefilled Syringes

Unilife Corporation recently announced the development and patenting of the Unifill EZMix multiple-chamber ready-to-fill (prefilled) syringes. Unifill EZMix syringes have been developed in direct response to the unmet needs of pharmaceutical companies seeking an innovative and convenient delivery system for the reconstitution and administration of lyophilized drugs and vaccines. Unifill EZmix syringes feature two or more primary drug containers within a single glass barrel to store a combination of liquid stable or lyophilized drugs along with up to 1 mL of diluent for reconstitution.

In addition to being the world’s first and only dual or multi-chamber prefilled syringes with automatic (passive) safety features fully integrated within the glass barrel, the Unifill EZMix syringe offers minimal steps of use for healthcare workers and patients alike. The end-user simply advances the plunger to mix the lyophilized powder with the diluent, before swirling the device to complete reconstitution. An audible, tactile click signals the injection of the full dose and the activation of a passive safety system that allows operators to control the speed of needle retraction directly from the body into the barrel.

The Unifill EZMix syringe will be available with either a fixed (staked) needle for drugs indicated for subcutaneous injections, or with attachable needles of up to 1.5 inches in length.

“Unifill EZMix syringes are designed to address the unmet needs of pharmaceutical and biotechnology companies active within the large, fast-growing market for lyophilized drugs and vaccines,” said Unilife CEO, Alan Shortall. “Nearly a third of all novel drugs approved by the FDA in the past 3 years were lyophilized either because a drug’s large molecular composition made it unsuitable for liquid stable form or a pharmaceutical company wanted to fast-track the time to market.”

“With the development pipelines of many pharmaceutical companies teeming with complex biologics that must be reconstituted at the point of delivery, we expect the market for lyophilized drugs and vaccines to experience double-digit growth for the foreseeable future,” added Mr. Shortall. “In addition, there are dozens of approved drugs requiring reconstitution that are approaching patent expiration and coming under increased pressure from brand-name, biosimilar or generic competition. Pharmaceutical companies recognize that innovative, convenient devices can help enhance therapy compliance, improve patient care, and generate powerful brand differentiation within competitive therapeutic classes therefore enabling them to increase market share and revenue. However, until now, there has never been a fully integrated delivery system that combines convenient drug reconstitution, intuitive use by the operator, and optimal protection from needlestick injuries. Our Unifill EZMix syringes bring these distinct market needs together in one elegant and highly effective drug delivery system.”

Unilife Corporation is a US-based developer, manufacturer, and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in 2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines. Unilife has developed a broad, differentiated proprietary portfolio of its own injectable drug delivery products, including the Unifill and Unitract product lines of safety syringes with automatic, operator-controlled needle retraction. Unifill represents the world’s first prefilled syringe technology integrating safety within the primary drug container. The products are ideally positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and enhance patient care.