Professor MIT Mechanical Engineering, United States
Introduction:: Concentrated subcutaneous biotherapeutic formulations have the potential to offer convenient treatments for several clinically challenging conditions, but their delivery is often complicated by their high viscosities. Methods for injecting highly viscous and concentrated drug formulations typically require either chemical additives which require validation and reformulation, or are significantly mechanically complex.
Materials and Methods:: Here, we introduce a universal injector which leverages core annular flow to enable simple, low-cost, and fast manual injections for even the most concentrated formulations without the need for reformulation. A low-viscosity lubricant decreases the injection force, and the drug buffer can be used as this lubricant. We demonstrate with a variety of protein quality assays that the drug formulations are not tangibly impacted by the injection process.
Results, Conclusions, and Discussions:: The injector enables viscosity agnostic manual injection of formulations as viscous as 1200cP while being comparable in cost to a disposable syringe and being entirely injection moldable. Low injection forces (~10N) and compatibility are demonstrated with clinically relevant viscous mAb formulations supplied by Janssen (Johnson and Johnson). Applications of the new technology and devices are discussed for both drug products that are already on the market and for new drug development.
