Avoiding Needle Injuries
PharmaJet, a spring-powered, needle-free device, offers several advantages over traditional needle syringes, according to Cathy Callender, founder of PharmaJet. “The major problem with needles, of course, is the potential for ‘sharps’ injury and blood/tissue contamination.
“We did a survey across the U.S. and it costs an average of $0.25 to throw away a needle. Our technology does not have to go into a sharp box.” Furthermore, the injector part of the device can be disinfected and cleaned using standard medical cleaning solutions. The injector is made of polypropylene, which is less expensive than the polycarbonate used by most needle-free manufacturers.
There are four components to PharmaJet—the syringe and filling adaptor are disposable; the two injectors (designed for different tissue densities) are reusable. The Light injector is for lighter tissue density (older patients, infants), and the Heavy injector is for adults and children.
Both injectors can deliver either IM or subcutaneous injections. Pinching the tissue allows for subcutaneous delivery; placing the device flat against the skin allows for IM delivery.
The device received FDA clearance about a year ago for delivery of 0.5 mL of any injectable. “We can use any vaccine, and it doesn’t have to be re-formulated. Some other devices require re-formulation, which can be expensive and time-consuming,” explained Callender. Currently, the device is being sold for use with influenza seasonal vaccine and the H1N1 vaccine.
The company has two new products in development: a 0.1 mL device for delivery in the upper 2 mm layer of skin to generate the best immune system reaction, and a variable volume device with the ability to deliver between 0.1 mL and 1.0 mL.
Some of the challenges in delivering new biotech drugs revolve around the fact that many are proteins, which are sensitive to silicone, metal particles like tungsten, and often viscous. In addition, many require refrigeration and/or freezing, which increases storage and packaging costs.
“The big trend now is moving from re-usable devices to disposable devices. Disposables are easier to use and provide better compliance,” explained Joel Cotten, European product manager at BD Medical Pharmaceutical Systems. He added that needle-free devices have not replaced needles because they lack a standardized primary container and tend to be expensive. Also, since needles are already very thin, there is no benefit to needle-free devices regarding pain.
Many factors influence the success of new delivery devices, understanding patients’ needs is a critical factor. “It’s important to understand the difference between new patients and expert patients. An aging patient with a chronic condition prefers a device with a hidden needle. Yet, an expert patient isn’t afraid of needles and wants a very thin needle that can be checked before injection,” Cotton said.
BD is developing several new devices compatible with biotech drugs. The BD PhysioJect™, which delivers between 0.2 mL and 1.0 mL, is a disposable auto-injector developed for chronic disease. The BD MicroInfuser™ will automatically deliver viscous drugs, with volumes between 1.0 mL up to 5 or 6 mL, Cotton said. The third product is pen injectors using cartridges with larger gauge needles.