Assisted syringes with needle safety features, as well as three variations of auto-injector all utlising exactly the same new power source.

Assisted syringes with needle safety features, as well as three variations of auto-injector all utlising exactly the same new power source.

Although the UK-based medical device company is well-known for producing millions of medical devices each year, Bespak has more often been recognized for its work with respiratory devices than with injectable devices. Now, however, that perception has changed significantly.

With increasing numbers of highly viscous and/or high volume injectables coming to market, the need for delivery solutions has resulted in significant attention being focused on a unique powerpack named VapourSoft and its related Syrina auto-injector platform – both developed by Bespak.

In recent years, the company has expanded its range of products and offered services. In 2009, Bespak acquired a UK device company called The Medical House that was producing spring-based auto-injectors as well as needle-free injection systems. Not long afterwards, with two devices on the market, the company gained even more experience in the demanding injectables market. The company invested further by hiring a team of device experts in the Cambridge (UK) area, establishing Bespak Innovations.

During  a relatively short period of time, the team grew in size and developed new intellectual property (IP) in the areas of injectable drug delivery, ophthalmic drug delivery, nasal drug delivery and more. One development programme that has garnered a lot of interest was the development of a new power source that could help to overcome the known issues that spring-based auto-injectors were having with injectables. Based on proven valve technology, a small novel container of liquefied gas was developed as the basis for a powerpack. The propellant, when released, provided sufficient energy in the form of a pressurized vapour to power drug delivery and other functions.

The dampened nature of this new delivery mechanism prevents unnecessary impact on the primary container, which is ideal for either glass PFS or cartridge – helping to minimize further any chance of glass breakage. This system is also flexible in that it can offer a complete spectrum of variation to adapt to the needs of the drug, therapeutic area or the patient itself. For example, by simply altering the propellant within a single container format, injection time could be customized for even the most viscous injectables. And by being able to provide such an effective delivery performance with the use of the same footprint, the efficiency of the space utilized allows for the design of compact devices.

A Flexible Solution
For the first time, changes in delivery volume and viscosity can be accommodated with minimal physical changes to the device and without having a significant impact on device development programme timelines. High viscosities and high delivery volumes can be handled with relative ease. For example, 2 mL of a 200 cPs formulation can be delivered within about 10 seconds. A variety of primary containers can be used with the VapourSoft power pack. Containers with a wider diameter offer no additional challenges and, as such, 1 mL standard, 1 mL long and 2.25 mL syringes can be used without any significant impact on performance. Furthermore, the nature of the drive mechanism ensures that the primary container is completely emptied once the device has been activated.

Biopharma companies face fierce competition in most key therapeutic areas. One way to differentiate is with a device. Auto-injectors and bolus pump-based systems are being looked at to determine which device is best suited to patient needs, can safely and effectively deliver the drug and has the highest likelihood of contributing to compliance. However, at the same time, some of the devices currently offered or already on the market are not well positioned to address the needs of the next wave of biologics and injectables.

Although spring-based auto-injectors continue to have a clear and important role to play in the current market, new technologies will need to be looked at to overcome known issues. Being able to offer consistent delivery performance across the Syrina range gives researchers and biopharmaceutical companies the ability to use Syrina with VapourSoft at a very early stage of development. Several variations of the devices are available for clinical trials and a range of industrial designs are being considered for the body of the auto-injectors to best suit patient needs. Now, biopharmaceutical companies will have the opportunity to use a true platform approach in that the Syrina auto-injector with VapourSoft can accommodate various primary containers, as well as high viscosity and high volume injections.