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Greystone Research Associates: Self Injection Systems Adapting to Address the Dosing Challenges of Evolving Therapeutics

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AMHERST, N.H., Nov. 28, 2017 /PRNewswire/ — In response to new and emerging drug classes, evolving formulations and patient safety initiatives, the injectable drug segment has seen a marked increase in the level of drug/device integration and feature expansion, according to Greystone Research Associates. Some of these advances are aimed at improving the patient experience while others are required to support the commercialization of formulations that could not be delivered via legacy injection devices. By incorporating new and/or enhanced capabilities, these devices are adapting to the evolving injectable drug landscape. We are forecasting rapid uptake of these adaptive devices as the trend toward therapeutic biological drugs continues to outpace small molecule drugs.

As the administration of injectables continues to move away from practitioner offices and healthcare facilities and into patient homes, adaptive self injection will increasingly require devices and methods that are ergonomically correct and intuitive to use. Adaptive device development is occurring on several parallel levels, each addressing one or more self-injection requirements.

Devices that support adaptive dosing and administration reflect the need for therapeutic doses that are determined by analyte measurement. Conditions such as anticoagulation therapy, diabetes and reproductive medicine require devices that allow the patient to set a specific dose to match the measured therapeutic need at a given point in time.

To enhance patient acceptance, developers have created devices that support injection device customization. Customizable injection parameters include variable injection rates and selectable needle insertion speed and depth.

For self-administration of injectable drugs, patient safety continues to be an important consideration. Numerous devices designed for patient use now incorporate ease of use and patient feedback features, such as audial patient prompts and guidance, push-on-skin injection activation, and injection event confirmation.

As the number of biological drugs increases, the number of lyophilized drugs and the need to reconstitute them also grows. Device developers have addressed this need by designing one-piece enclosed point-of-care reconstitution systems that allow drugs in the powder state to be reconstituted prior to administration, typically by twisting and shaking the device.

Monoclonal antibodies (mAbs) represent the single largest class of drugs currently under development. These powerful therapeutic substances have been in use for more than a decade, treating formerly refractory conditions particularly in the area of autoimmunity. mAbs along with other protein-derived drugs often have viscosities that are many time higher than the practical limit for delivery via piston-type syringes and injectors. By engineering injection devices that can deliver non-customary

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