A Novel Method to Optimize Drug Delivery for Parenteral Products Involving New Therapies and Unmet Needs.

Abstract

Healthcare trends continue to move from hospital to home and many targeted therapies and precision medicines are now being designed to be self-administered by patients or delivered in a home setting. In the case of long acting injectables and bio-therapeutics, the importance of optimal drug/biologic-device combination in terms of user needs becomes critical for successful clinical outcomes. The risk especially increases for novel therapies due to unknowns and uncertainties surrounding new formulation flow behavior, delivery methods, new injection sites and therapeutic optimization. Other risk factors include patient tolerability and acceptability. The success of the clinical outcome is now dependent on the optimal delivery in these situations for a consistent pharmacokinetics (PK) response. In addition, the complexity of formulations and challenging delivery needs have brought to light some of the limitations of existing legacy device technology, which may not be suited for these novel applications. The formulation itself may not be an exact fit to deliver with existing standard device technologies and may need to be designed to deliver the specific formulation appropriately. Formulations may have to be optimized both for delivery and for the therapeutic outcome creating many iterative development cycles. Rapid development of the therapies requires simultaneous development of drug and device and thus the importance of early-stage characterization. We present a novel integrated approach that includes drug delivery optimization via an autoinjector simulator in pre-clinical and clinical studies to assess the PK performance and potential to establish path to device early on and reduce time to the clinic.