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How to Design a Body-Worn Injector

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How to Design a Body-Worn Injector Expert View HOW TO DESIGN Advising on glass tubing that suits you best A BODY-WORN INJECTOR Glass • 5 plants worldwide with an annual capacity of >90,000 t Tubing • Glass tubing NSV51; the choice of leading pharmaceutical players Body-worn injectors require you to understand your user, your drug and your • Ensured global supply of premium quality technology – and there are numerous pitfalls for the unwary. In this article, Stephen Augustyn, Head of Mechanical Engineering Group at Team Consulting, gives some insights into how to design a successful body-worn injector – or select a device Providing you with the best drug-packaging compatibility that is suitable for your needs. Primary • 13 state-of-the-art plants globally Body-worn injectors are tricky little beasts Packaging – they aim to combine the convenience of “A body-worn injector • Portfolio of pre-fillable syringes, vials, cartridges, ampoules an autoinjector with the precision of an • Different quality levels for fast & efficient container customization infusion pump but aren’t quite either of intended to treat a patient these devices. There is a wealth of devices recovering from surgery and technologies on the market – or about will have a very different Enabling you to differentiate your drug product to reach the market – all vying for your attention. But how can you make sure set of requirements from Accessories for Reconstitution devices you’re choosing the correct product or Kit-packaging • one intended to help a making the right design decisions? • Nasal sprays It really comes down to three key points patient manage a • Hypodermic needles in hard case – understand your user, understand your chronic condition.” drug and understand your technology (Figure 1). If you have secure knowledge of Optimizing your packaging characteristics these three areas, your chance of creating UNDERSTANDING YOUR USER Laboratory – or selecting – the right device increases Services • New glass container development enormously. Team Consulting has spent There are many reasons why you may the last six years designing and identifying wish to use a body-worn injector over Optimization of existing glass pharmaceutical packaging • the right body-worn injectors for clients an autoinjector – you may be delivering and contributing to the new ISO standard more drug than an autoinjector can to help regulate these products. This article comfortably hold, you may wish to spend offers a distillation of some of the key things longer delivering the drug or you may that we have learned. even want to delay, or modulate, the drug There are some excellent products in this delivery. However, the single biggest space but there is no single device that will driver for body-worn injectors has been be the optimum choice in all applications. the requirement to deliver larger drug A body-worn injector intended to treat a payloads. Most autoinjectors on the market patient recovering from surgery will have have a prefilled syringe (PFS) at their a very different set of requirements from heart – a rigid glass or polymer syringe, one intended to help a patient manage a with a sterile needle, storing 1-2.25 mL of chronic condition. drug product. Stephen Augustyn Head of Mechanical Engineering Group T: +44 1799 532 780 E: steve.augustyn Your Optimal Pharmaceutical Packaging @team-consulting.com Team Consulting Ltd BENEFITS OF A VERTICALLY INTEGRATED PARTNER Abbey Barns Duxford Road Saffron Walden Essex CB10 1SX MM-1316 - 10.Jan2020 Figure 1: Understand your user, United Kingdom your drug and your technology. www.team-consulting.com NIPRO PHARMAPACKAGING INTERNATIONAL www.nipro-group.com Copyright © 2020 Frederick Furness Publishing Ltd www.ondrugdelivery.com 61 Expert View If you have a device with an integral needle or cannula, you will have no option but to affix the product directly to the skin – but there is the option of remote delivery. This is the model used by most continuous subcutaneous insulin infusion (CSII) pumps and can be practical for disposable pumps as well. Patients with chronic conditions may present problems when asked to adhere a pump to the same area of the body day after day, so separating the pump from the infusion site may offer a real advantage. USER INTERFACE On-body injectors will often feature electronics as part of the delivery system and this will then come with the temptation to give ever more feedback to the user, add smartphone integration and offer “helpful” advice on use of the product. This is a huge area to explore, and beyond the scope of this article, but every new feature must justify its place on the product and what may seem Figure 2: How the like an incredibly helpful and smart feature injector will attach in the design office may be very confusing to the body is a to patients. It’s worth dedicating significant key consideration. time and effort to investigating and testing products with target users as it will reveal requirements for an adhesive that only challenges you didn’t see coming. Get your “The design of the patch needs to work for 10 minutes whilst a product concepts in front of representative patient is stationary are very different from users as early as possible and let your and careful consideration the adhesive that needs to work on an active decision making be based on evidence. of the removing features user and stay in place for hours. The profile of the patient will also make CO-MORBIDITIES AND is also critical.” a big difference – young children and the COMPLEX TREATMENTS elderly can have very delicate skin, and some conditions or drugs may make the skin It is increasingly the case that users present The principal difference between an more susceptible to damage and irritation. to their healthcare practitioners with autoinjector and an on-body injector is The design of the patch (Figure 2) and complex conditions – e.g. diabetes, high that the patient holds the autoinjector careful consideration of the removing blood pressure and diabetic neuropathy. throughout the delivery sequence whereas, features is also critical – the patch should These are precisely the patients who could with a body-worn injector, the user allow the user to stabilise the skin around most benefit from a body-worn injector and attaches the device, begins the delivery and the patch, get a secure grip on the patch their needs will have to be considered if they removes the device once delivery is complete. and remove it with a gentle peeling action. are your target group. If the device is not This aspect of on-body injectors should 3M has a useful “find my adhesive” facility sold prefilled and the user needs to transfer result in a more comfortable and consistent on its website that can help you identify or reconstitute a drug, how is the patient injection experience for the patient but a suitable material but be prepared to do going to manage this process? it does require a more sophisticated and some testing and evaluation work. The ISO Committee ISO TC84 examined expensive device. the challenges that visually impaired users have with injectors when it created ISO ATTACHING AND REMOVING 11608-7:2016. The design guidance in ISO THE INJECTOR “One of the key questions 11608-7 has many useful recommendations that may assist designers developing new Precisely how the injector will attach to that can impact the design on-body devices. the body should be a key consideration of a body-worn injector for the designer. If the device is a single- is whether the device will UNDERSTANDING YOUR DRUG use disposable product, adhesive would be the obvious choice but even that solution come prefilled or not.” One of the key questions that can impact the requires some deeper consideration. The design of a body-worn injector is whether 62 www.ondrugdelivery.com Copyright © 2020 Frederick Furness Publishing Ltd Expert View the device will come prefilled or not. If the device will be prefilled, there will “The intellectual property landscape around these drive and be a fundamental impact on the design of the primary container, the environmental sensing technologies is extremely crowded and identifying storage of the drug/device combination and freedom to operate can be a significant challenge.” the stability studies undertaken. Storing the injector below room temperature will have an impact on the materials and power sources in your device. Even a few degrees’ Experience from running dozens of there is no reason why a spring can’t be change can make plastic materials more verification studies on different parenteral used on a body-worn injector. Compression brittle and less flexible. This could mean products suggests that ageing products springs are cheap, accurate, reliable and that the critical fluid seal on your device and introducing a live drug for the first easily made to your specification. They are no longer works as it did during your time always have an impact on device also large, need to be stored in a compressed development testing, your injection forces performance. So, start testing with either (highly loaded) form, can’t be controlled become larger or fluid lines don’t flex as the active drug or a highly representative after release and lose power as they expand. they should. placebo as early as you can in the If you have a highly variable injection The effect of temperature on drug development as you don’t want to be force (for example, a high break-free behaviour should also be examined in detail making fundamental discoveries on device force and a low glide force) then springs and testing should reflect real-world use of behaviour when you get to your design may not be ideal. Also, if you need a the product.
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