Reducing Injection Steps
BD is expanding its autoinjector offerings to give patients and combination product manufacturers more options for patient convenience and cost savings. The company’s Physioject autoinjector has been a popular choice for nearly two decades—BD reports that it has sold 50 million Physioject autoinjectors since 2010. To further ease self-injection, BD has developed Intevia, a platform device that combines an autoinjector and a prefillable syringe in one integrated system. The system is also designed for use with a range of viscosities without additional customization. The system is designed to effectively and safely inject a variety of drugs of different viscosities up to 35 centapoise and different fill volumes up to 1mL.
“We worked on the form factor and broadened the range of drug viscosities,” Lionel Maritan, BD’s associate director for R&D, told MD+DI in describing Intevia. “Our goal is to offer a more flexible platform.” The design of BD Intevia 1 mL enables the pharmaceutical industry to adopt it for a variety of drugs without customizing the system components, he added.
Intevia will be launched October 22 at the PDA’s 2019 Universe of Pre-Filled Syringes and Injection Devices conference in Gothenburg, Sweden.
The main difference between Physioject and Intevia is the reduction in the number of steps users must follow for injection. “With Physioject, users must remove the cap, apply the device to the skin, and then push a button to deliver the drug,” Maritan said. “With Intevia, users just apply [it] to skin to trigger administration.” Users receive both visual and audible feedback that the correct dose has been delivered.
Physioject has had a solid design with few reported concerns over the years, Maritan said. Still, the company sought to see whether a next-generation design could further please patients and meet growing demand for home administration.
During development, BD conducted human factors formative studies with both patients and clinicians, observing them as they used autoinjectors. “Some users preferred to minimize the number of steps—less control, more automatic,” he said. “Some prefer to keep control.”
Intevia was also developed to manage a broad range of viscosities with one platform, Maritan said. “It can be a nightmare, a complex challenge to manage a number of different supplier options,” he said. “The 1-ml version can handle the entire range of 25 to 35 centapoise, and a 2.25 ml is currently under development and planned for launch in one to two years.”
In addition to developing the autoinjector system in house, BD also developed the glass syringes to ensure they work together seamlessly.
BD provides necessary documentation to ease registration for a combination product, Maritan said. “Product manufacturers won’t have to redo verification and validation activities,” he explained. BD’s lab is available for studying the reaction of the glass or plastic container to the drug as well as evaluating all materials according to ISO 10993. And the company continues to study Intevia in clinical trials. “It is a way for us to ensure that we’ve set the right needle penetration. We offer a choice of lengths that are prevalidated and preverified.
“Our ultimate goal is to provide a solution—not just a device,” said Maritan.