Company insight


Aidaptus: a new platform device


Owen Mumford specialises in the design, development and manufacturing of injectable drug delivery systems for the pharmaceutical, biotech and generics industries. The company’s trusted devices are used daily in the delivery of various medications for a multitude of conditions across the globe. Michael Earl, director of pharmaceutical services, introduces the company’s latest innovative offering.


he rise in patient self-administration has further increased the attractiveness of autoinjectors as a drug delivery option. A convenient and effective means of delivering subcutaneous injections, autoinjectors allow patients to administer their own medication outside of healthcare settings and often without the help of a healthcare practitioner. To optimise patient comfort and encourage treatment adherence, manufacturers are continually reviewing measures to strengthen the ergonomic features of their autoinjectors and improve ease of use. This focus on human factors is a key differentiator from a commercial point of view, but also increasingly important to pass regulatory scrutiny.


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Michael Earl, director of pharmaceutical services, Owen Mumford


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The formulation of the drug itself also impacts patient comfort; for instance, high viscosity or high volume can make injection more difficult, longer to administer or even painful. During the development process for injectable drugs, there are typically


formulation and/or dose changes, which may affect the choice of delivery device. Custom devices can therefore be limiting and inherently more expensive, and this has led to greater uptake of platform devices. Platform devices are designed to accommodate a range of possible delivery capabilities and formulations. The platform approach can allow companies to maintain the same base device even if adjustments are made to internal components, eliminating the need to trial, test and validate multiple devices before taking the final combination product to market.


A patient-centric platform autoinjector A pioneer in the development and manufacture of autoinjectors, Owen Mumford Pharmaceutical Services has now launched Aidaptus, a platform disposable autoinjector. To allow maximum flexibility and versatility, the autoinjector is compatible with either a 1ml or 2.25ml prefilled syringe, with a minimal number of change parts, and maintains its discreet size (162mm x 18mm). The device can be used with a range of syringe fill volume options without needing device modifications, thanks to the novel self-adjusting plunger. As a result, at the drug filling stage, both vented and vacuum filling are possible, and this may allow a choice of contract filling partners.


Aidaptus’ versatility means there is scope to further enhance its patient benefits in the future.


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Since platform devices are designed without a specific user group in mind, and


with the aim of being used for a variety of conditions, they must be thoroughly tested among a broad user population to take into account varying physical and cognitive abilities. Aidaptus was tested with a cohort that included healthcare professionals, children and adults, and people with musculoskeletal, neurological, visual and hearing impairments, all with and without injection experience. This new generation product incorporates a number of valuable features to aid injection: ■ Independent two step delivery: using Aidaptus, needle insertion and dose delivery take place as two separate phases, so that drug delivery does not take place until the needle is fully inserted into the skin, helping to prevent drug spillage before injection and making sure patients receive the full dose.


■ Needle safety: to protect patients from injury with minimal effort on their part, the needle is hidden before, during and after use to prevent needle exposure. The autoinjector’s safety shroud locks in place once injection is complete, ensuring that the needle cannot be exposed and present a risk to the user. Patients with needle phobia may find this particularly helpful.


■ Audiovisual notifications: so that patients can clearly tell when injection is complete, there are audible clicks at the start and end of dose delivery, and patients can also visually confirm the end of the dose with the help of the bright yellow plunger rod in the viewing window. The large window allows patients to easily see the drug before administration, and to check drug clarity and colour. ●


www.ompharmaservices.com/ product-portfolio/


Packaging Insight / www.worldpharmaceuticals.net


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