The Drive to Simplify Auto-Injectors: Benefits of Two-Step Injectors
Ilan Shopen | 09.11.2020
In the drive to simplify auto-injectors (AI) and reduce costs while meeting stringent regulatory standards, E3D (Elcam Drug Delivery Devices), a subsidiary of Elcam Medical, has developed Flexi-Q-CAI for treating existing conditions and Flexi-Q-EAI for treating emergencies.
The key feature of both these auto-injectors is their simplicity, as both auto-injectors require only two steps. First, the cover is removed. Then, the device is simply pressed on the skin to activate it. The fully automatic injection process eliminates having to use a button to activate the auto-injector, which makes it easier to use, reduces needle phobia (since the needle is hidden throughout the process), prevents needlestick injuries, and improves patience compliance. It’s also expected to reduce skin reactions, since the injection starts only after full needle penetration. For added safety, an optional observation window shows the entire syringe fill volume and injection progress.
Compatible with subcutaneous and intramuscular injections, the Flexi-Q family of products is intended for flexible drug delivery volumes: 0.1 – 1.0 ml for the 1 ml version or 0.1 – 2.25 ml for the 2.25ml pre-filled syringes (PFS). Its proprietary damping mechanism prevents impact on the glass syringe, allowing for the use of extremely strong injection springs for high-viscosity drugs and for fast injections required for emergency drugs.
Two-Step Injectors for Two Key Applications
The fully disposable auto-injectors are intended for two distinct purposes:
- Flexi-Q EAI: emergency injections for acute situations
- Flexi-Q CAI: pre-planned injections for chronic conditions
While the design of both auto-injectors is similar, the Flexi-Q-EAI, because of its use for emergencies or acute situations, undergoes a much tougher regulatory process required by the FDA to ensure reliability. Despite being similar, and while both models undergo the same design verification tests and preconditioning, the acceptance criteria are different and statistical analysis is much stricter. The same is true for the manufacturing process, as the quality control acceptance criteria are different here too. The Flexi-Q-EAI not only conforms to all FDA requirements, it exceeds them.
Fast Track to Market
A key factor in gaining approval for new auto-injector devices lies in its interchangeability. According to FDA requirements, a threshold analysis must be performed that demonstrates the submitted drug product and an already registered drug product are interchangeable. From the user perspective, the Flexi-Q product family is similar to another two-step auto-injector already in the market. Another issue that must be addressed is whether a proposed biosimilar product have a delivery device or container closure system that is different from its reference product. The FDA states that some design differences may be acceptable and that a pre-filled syringe and autoinjector device “are considered the same dosage form.” This makes the move from a three-step to two-step device straightforward, since there are no regulatory obstacles to overcome.
Available in flexible customization options, the Flexi-Q product family represents an affordable and effective autoinjector solution for biologic, biosimilar and small molecule liquid form drugs.