SHL Medical discusses the evolution of drug formulations and how it’s supporting cartridge-based subcutaneous drug delivery in redefining the field of patient self-injection.
Key highlights:
- The growth of autoinjectors is down to their ease of use, they can be designed into two- or three-step self-injection devices that do not expose the user to the needle.
- A mechanism called Needle Isolation Technology (NIT) has been developed to address the challenges associated with cartridge-based injection systems.
- Treatments in the oncology area have also been exploring the subcutaneous route through enzyme-assisted drug formulations, further opening the possibility for cartridge-based autoinjector combination product development.
In the past decade, notable advancements in formulation science facilitating better delivery of subcutaneous injections have resulted in several defining moments within the space of parenteral drug delivery. For example, a second-generation GLP-1 receptor agonist suspension drug was approved in 2017 in a cartridge-based autoinjector to offer its patients a more convenient injection experience. And in 2020, the industry saw the regulatory approval of a 2.0 mL autoinjector format of a breakthrough biologic therapy for atopic disorders, a first in the self-injection space.
The constant evolution of drug formulations across various disease areas has opened a wider avenue for subcutaneous drug delivery and fortified the merits of drug delivery devices like autoinjectors. One reason behind the growth of autoinjectors is their ease of use. Autoinjectors are conventionally developed around the pre-filled syringe, which with their staked needles, can be designed into two- or three-step self-injection devices that do not expose the user to the needle. In comparison, cartridge-based injectors traditionally required the user to manually attach the needle to the device before injection, resulting in an extra step for the user and also posing a risk of contamination and needle stick injuries.
Another reason lies in the expanded scope of container choices built for self-injection technologies. Syringe-based systems, which have traditionally been limited to 1.0 mL, have seen successful expansion into 2.0 mL dosing volumes. Meanwhile, cartridges can go up to 3.0 mL, and at the same time, we see that larger-volume cartridges holding 5.0 mL are well-adapted for complex formulations. This expanded scope of container choices built upon self-injection technologies enables pharmaceutical companies to further explore cartridge-based autoinjectors for the next generation of drug formulations under development.
An innovative mechanism called Needle Isolation Technology (NIT) has been developed to address the challenges associated with cartridge-based injection systems. Based on a pre-installed needle hidden inside the device, the technology eliminates the need for users to manually attach the needle. With NIT, users simply untwist the cap to introduce the needle prior to injection, opening up the fluid path and allowing the injector to automatically prime.
Because NIT makes it possible for the cartridge to behave like a traditional pre-filled syringe with a staked needle, it means that the device can be built into an integrated autoinjector with complete needle covering and shielding - before and after injection. Such a cartridge-based technology also allows for increased delivered dose volume and accommodation of lyophilised or suspension formulations.
More recently, treatments in the oncology area have also been exploring the subcutaneous route through enzyme-assisted drug formulations, further opening the possibility for cartridge-based autoinjector combination product development. Finally, the technology supports complete control of cannula gauge and length to enable target injection time and depth.
As we enter a post-pandemic healthcare landscape, advancements in parenteral drug delivery will not waiver. With an evolving industry understanding of autoinjector devices, their usability, and the continued rise of novel drug formulations – cartridge-based subcutaneous drug delivery will continue to redefine the field of patient self-injection.