There has been a long-standing interest among the medical community to develop needle-free devices for delivering drugs through the skin. Indeed, workable solutions are nothing new, but it seems the technology has recently taken a major step forward, opening the possibility of its widespread use.
Greater awareness of the importance of infection control, especially in the USA and Europe, has led to a greater need for single-use devices. Previously, this meant modified traditional syringes, but now there is a needle-free alternative.
'Needle-free technologies were first created at the beginning of the last century, and multi-use devices were used for vaccinations in the army and in the third world,' explains Bruno Besse, director of medical affairs for Crossject SA. 'Now, we have developed small, single use devices. Big, expensive devices have now been miniaturised.'
Crossject designs and develops drug delivery solutions for the pharmaceutical industry. Its single-use, needle-free technology relies on its unique gas generator technology, which uses energetic materials similar to an airbag to produce a pressure customised to the chosen drug and the required depth of delivery through the skin.
For the patient, this technology offers many advantages, of which the most significant is the absence of a needle. Needlephobia, according to the American Psychiatric Association, affects around 10% of the population. Beyond those people, there are also many who may not qualify as phobic, but who might avoid vaccination or be less compliant with self-injection therapies due to a strong aversion to needles.
'Needlephobia is not uncommon, and there are others who just don't feel comfortable with needles,' says Besse. 'Self-injection can be hard, so our device has been designed by ergonomists to not resemble a syringe with a needle.
'There is a lot of interest from the point of view of patient care and the use of self-injection for more than just diabetes. So, there is more focus on a small device that is simple to use for self-therapy.'
For health workers and hospitals, the Crossject solution has additional benefits. For instance, it features a detachable nozzle, which allows the drug-filled glass cylinder to be removed. These glass vials can be quickly and easily filled using standard technology.
BETTER LONG-TERM VALUE
Tests on this latest evolution of needle-free technology show it to be at least as effective as traditional syringes in terms of volume of drug delivered. Furthermore, it exhibited improved diffusion and more reliable depth of penetration.
As well as improving safety and protecting against infection, needle-free devices for single-use could also offer cost benefits in the long-term. More reliable penetration, for example, could mean more efficient use of drugs.
'Overall, cost would be the same or maybe lower. To inject the same volume of drug, you don't need to fill the device as much - you can save around 8% in volume of vaccines. With expensive drugs, this can be important. Then you have to discount the human cost of people not complying with self-injection therapy,' explains Besse.
Developers like Crossject are already looking to produce smaller devices, which might enable intradermal injection. Though this is normally time-consuming to perform, and there are few drugs designed for this method of delivery, it could be the preferred mechanism for delivery administering gene-vaccines or bio-tech drugs. It is also a method that requires around 20% of the volume of the drug compared to IM or subcutaneous injection and so promises further cost efficiencies.
Despite the test results, doubts nevertheless linger among some leading pharmacists. 'There is a lot of interest, but people are sceptical because of the failure of one of our competitors a few years ago,' notes Besse. 'But, they also see that the delivery technology, which is not a medical device, but has a patent that could cover the drug, like a pre-filled pen. This can prolong the lifecycle of an existing drug, as well as providing a differentiator in the market for new drugs.' There is little doubt that the technology is ready, but it needs the mindset of the industry to accept it.