Traditional methods of subcutaneous drug delivery include autoinjectors and infusion pumps. These delivery regimens allow for small-volume delivery of low-viscosity drugs, with a high value put on minimizing delivery time - getting the drug into the injection site as quickly as possible. Patient experience has traditionally been secondary to overall drug efficacy and safety.  The introduction of biotherapeutics, which require higher concentrations of active pharmaceutical ingredient to meet efficacy requirements, has not only challenged the previously established limits of volume, viscosity, and flowrate, but the devices used to deliver them. The trend for subcutaneous administration is moving to large-volume injections of high-viscosity drugs. But there are many questions that are not well understood. What is it like to inject 5, 10, 15 milliliters (mL) and greater volumes of a high-viscosity biotherapeutic into subcutaneous tissue at high flowrates? More importantly, can the patient continue to tolerate this approach?  Many peer-reviewed studies have focused on administration volumes of up to 3 mL, flowrates of up to 10 mL per minute, and viscosities of up to 50 centipoise. These studies have been singularly focused on one or two of the abovementioned performance attributes due to limitations with the devices used for delivery. Data is needed on patient tolerability with the combination of large volumes, various flow rates, and higher viscosities associated with subcutaneous infusion.  Devices need to adapt to this new class of drugs. The best design will incorporate a unique set of device attributes and requirements, as well as anticipate key drug and patient variables to produce a safe and efficacious delivery, while maximizing a positive patient experience.

Patient tolerability with high-viscosity, large-volume subcutaneous infusions: Need for something different

2019 Fall National Meeting

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