Michael Earl, director, Pharmaceutical Services at Owen Mumford, explains how Owen Mumford’s Covid-compliant study design and careful planning allowed them to finalise their product design and present this innovative product to the market. The platform disposable auto-injector, Aidaptus, is designed to address the priorities of both patients and pharmaceutical manufacturers.
Key highlights:
- OM's Aidaptus introduces a consistent injection process for users. The injection process has two phases, where needle insertion and dose delivery are controlled by two separate springs.
- The Aidaptus’ design keeps the needle hidden before, during and after use; this feature can help to make injection less intimidating and may encourage treatment adherence as a result.
- Aidaptus’ design aims to provide pharma manufacturers the option to modify drug volumes and viscosities, without needing to change their selected delivery device.
Facilitating the injection process
The aim of platform devices is to accommodate a broad range of possible drug delivery options, and allow use with a variety of formulations from the clinical trial phase through the product lifecycle. This minimises the level of validation testing and regulatory requirements when selecting a device for each drug and formulation. However, this means that during device development, the needs of multiple potential patient groups must be considered – as the final therapy area is not yet determined – and any identified risk factors related to use of the product need to be addressed. These considerations need to cover the whole injection process, from use to disposal.
The Aidaptus disposable auto-injector introduces a consistent injection process for users. The injection process has two phases, where needle insertion and dose delivery are controlled by two separate springs. The needle is automatically activated with pressure on the injection site, followed by delivery of the drug. This two-step delivery makes it less likely that patients will experience drug wastage or ‘wet injections’ before completing their injection. They can also check dose progression and that they’ve administered the full dose with the help of the bright yellow plunger rod clearly visible in the viewing window, and audible clicks at the start and end of dose delivery. The window also allows users to clearly inspect the drug before injection, and check drug clarity and colour.
Injecting medication can cause anxiety for many patients, and some may suffer from needle phobia. Aidaptus’ design keeps the needle hidden before, during and after use; this feature can help to make injection less intimidating and may encourage treatment adherence as a result. To protect patients from needlestick injury, the safety shroud locks in place once injection is complete, so that the needle is not exposed to the user before disposal into a sharps container.
Creating a versatile product
Timescales from drug development to clinical trials and final regulatory approval have shortened in recent years. This places some pressure on drug delivery devices, as they should ideally be able to accommodate modifications to the drug during the formulation, development and life-cycle management process – without significantly impacting the final product timelines.
Aidaptus’ design aims to provide pharma manufacturers the option to modify drug volumes and viscosities, without needing to change their selected delivery device. The self-adjusting plunger with its patented design adapts to a range of syringe fill volumes without any changes to the device and with no change in parts. The auto-injector is also compatible with either a 1mL or 2.25mL prefilled syringe, with a minimal number of change parts and without affecting the product’s small, discreet size (162mm x 18mm). For further flexibility, both vented and vacuum filling are possible, allowing for a choice of contract filling partners.
As the market for drug delivery devices develops, Aidaptus’ over wrap can be tailored to integrate additions or Near Field Communication (NFC) to enable connectivity. With this level of versatility, drug developers can focus on optimising their products for patients, with minimal concern about selecting a device that is both suitable for the drug formulation and user-friendly.
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