The next generation platform disposable auto-injector
A convenient and effective means of delivering subcutaneous injections, auto-injectors have been utilised by healthcare professionals since the 1980s. Today, various factors have led to an increase in their use, including an aging population prone to chronic diseases and the rise in patients being treated outside of acute care facilities to help reduce healthcare costs. In addition, the recent emergence and subsequent increase in biologics and biosimilars has meant that low volume formulations have been developed for administration via the subcutaneous route.
Benefits of auto-injectors for patients
Auto-injectors provide the patient with many benefits, primarily the ability to administer their medication in the privacy of their own home without a healthcare professional present. The convenience of auto-injectors also helps patients take more responsibility for their disease treatment, improving adherence and patient outcomes.
More flexibility with platform devices
Auto-injectors were originally introduced as custom devices commissioned by pharmaceutical companies with specific drugs in mind. Now, the industry has seen a shift towards the advent of platform devices. The platform approach aims to provide an efficient and flexible solution for the pharma industry that also better complements the drug development process and timeline. The base platform is designed with a wide envelope of possible delivery capabilities to suit various formulations. This also reduces the level of testing required across a range of formulations.
Versatility and Flexibility
After the pioneering development of auto-injectors in the mid-’80s, Owen Mumford Pharmaceutical Services has now proudly launched a platform auto-injector that offers next-generation benefits of flexibility and versatility.
Maintaining a small, discreet size of 162mm x 18mm, Aidaptus® is compatible with either a 1mL or 2.25mL prefilled syringe (in the same device), with a minimal number of change parts. Uniquely, the novel plunger with auto-adjust technology also accommodates a range of syringe fill volume options with no change to the device. Both key features offer considerable benefits to the pharmaceutical industry due to device selection and formulation changes that typically occur during the development and lifecycle of injectable drugs.
What’s more, the ability to alter the drug volume while maintaining the same device can have significant advantages during the clinical trial phases of development. This is because modifications to dosages are often required to determine optimum efficacy and dosing frequency for the intended patient population. From a drug filling perspective, the option to use either vented or vacuum filling provides additional flexibility and a choice of contract-filling partners.
Aidaptus® auto-adjust plunger is designed to help prevent container closure integrity (CCI) breaches by limiting the rearward movement of the stopper in the syringe barrel. The auto-adjust plunger and other strategies for CCI mitigation are particularly important in eradicating risks of microbial ingress during transit of the product throughout the supply chain from plant to patient.
To combat the issue of ‘wet injections’ that can occasionally occur with auto-injectors, Aidaptus® has an automatic pressure-activated needle insertion that ensures a consistent user experience. Aidaptus® also has a two-phase needle insertion and dose delivery controlled independently from each other. This means that the delivery of the medication will not take place until the needle is fully inserted into the patient’s skin, helping to prevent drug spillage before injection. In addition, this dual-phase action helps to prevent syringe breakage.
Safety features and ease of use
When designing a device with a needle or sharp, it is crucial to comply with international safety regulations for needlestick prevention. Aidaptus®’ needle is hidden throughout the injection process to minimise risk of injury. Once the injection is complete, the safety shroud locks in place to ensure that the needle cannot be exposed to the user. The needle is also encased in a safety shroud to reassure patients with a needle phobia.
Aidaptus® gives audible and visual notifications for complete clarity during the injection procedure. There are audible clicks at the start and end of dose delivery, as well as a bright yellow plunger in the viewing window to confirm the dose has been distributed. The device window is sufficiently large to allow clear visualisation of the drug before administration. This allows the user to check drug clarity and colour. For a 1mL dose, 80% can be seen through the window before use. There are no internal mechanisms visible through the window for easy, unobstructed viewing to provide user confidence.
What makes Aidaptus® so versatile is the ability to brand and customise the device, thanks to the two base platform options that are available: a clear outer body or opaque solid housing. This allows options for branding and flexibility of the window size. With many innovations available around label technology, such as surface finish and texture to aid grip and handling, integrated Near Field Communication (NFC), and temperature sensor technology, additional patient benefits can be added to the design of Aidaptus® where necessary.