Blog Article: Handheld Devices for Viscous Drugs a Defined Market
Purpose-designed Devices are Competing with Legacy Technologies to Create New Options for Drug Developers According to Greystone Research Associates
As the number of biological drugs continues to increase as a percentage of all approved therapeutics, the need for devices that can administer them has created a significant opportunity and challenge for device designers. Because biologicals often possess viscosities well-above the range traditionally considered the upper limit for handheld injections, drug developers and their device partners have been working to create new ways to deliver high viscosity medicines. In the process they are extending the design envelope for injectable devices as they target a range of viscosities that extend from 20 to over 1000 cp.
The five categories of handheld injection devices that can reliably administer high viscosity drugs include legacy devices, modified designs, non-glass injectors, needle-free injectors and novel devices based upon pressurized gas and mechanical assist designs. As a group this current crop of devices increases the addressable range of viscous drug delivery capabilities in a wide range of use cases.
Injection devices designed to deliver high viscosity drugs employ a number of methods for moving the drug from the primary container, through the cannula or needle, and into the patient. Most of the devices utilize a piston or piston-type method to deliver the drug, although liquified, pressurized gas and mechanically assisted devices have been introduced.
Because the current class of biologicals has been developed for long-term self-administration, they represent the first group of injectables that have been designed with the end user in mind. These drugs are the first beyond insulin and vaccines to limit packaging in vials in favor of prefilled syringes and specialty injection devices. The price points for recombinant protein drugs allow developers to view the higher cost of customized branded delivery devices as an investment in patient compliance and satisfaction.
As the trend toward self-administration continues, the need for careful consideration of primary container design and interaction with biologics, devices, and the patient become more critical. Regulatory scrutiny in this space is likely to continue to increase, requiring a more proactive approach on the part of pharmaceutical/biologic companies to address these questions.
Because a significant number of injectable drugs are being formulated or re-formulated for self-administration, it has become essential for drug developers and their injection device design partners to understand user preferences and to define usability features as they pertain to specific treatment groups. The critical nature of this requirement is further underscored by the design trend in specialty prefilled devices to incorporate a unique look-and-feel to devices in order to achieve product differentiation in the direct-to-consumer marketplace.
Information for this article was taken from the following market report:
Handheld Devices for High Viscosity Injectables (September 2023)