The administration of high-dose biologics presents unique challenges and opportunities for the devel opment of drug-delivery systems. With the advent of innovative reusable drug-delivery devices, the landscape of patient adherence and comfort is evolving significantly. These advanced devices are designed to handle higher concentrations and viscosities of therapeutic drugs, allowing for new routes of administration that can be managed by patients themselves at home.
In this Q&A, Bjarne Sørensen, director of front-end innovation for Phillips Medisize, explores how these technological advancements are transforming the administration of biologics, while also focusing on patient adherence, cost savings, and overall improvements in healthcare delivery.
MDB: How are innovative reusable drug-delivery device solutions contributing to enhanced patient adherence and comfort in the administration of high-dose biologics?
Bjarne Sørensen: New possibilities within formulations and suspensions, implementing significantly higher concentrations of therapeutic drug load, open new routes of administration for biologics. When developing high-dose formulations, it is important to consider the required flexibility from the possible device solutions and determine the restrictions they impose on formulation development.
The new possibility of reusable electromechanical devices can enable the patient to self-administer injections with challenging parameters such as high viscosity or higher injection volumes, without any compromises on usability. The possible addition of a connected system can add potential adherence support options to the complete system.
MDB: Can you discuss the potential cost savings that high-dose formulations in biologics and their associated delivery de vices bring to the healthcare industry, particularly in terms of reduced administration frequency and resource utilization?
Sørensen: The possibility of moving IV treatments from hospitals or infusion clinics to home subcutaneous (SC) administration by the patients will not only provide a substantial cost saving for health care systems and payers, but very importantly also potentially im prove the quality of life for patients. The potential of increasing the time between doses is an added benefit impacting cost of care.
MDB: How do high-dose formulations in biologics help in reducing the frequency of administration, and what benefits does this bring to patients and healthcare providers?
Sørensen: New high-dose formulation technologies can, be yond the transition from IV to subcutaneous, also be a potential opportunity for long-acting formulations. These technologies can potentially extend the time between doses, and then additionally reduce the negative impact on the patients. This opportunity will naturally increase the previously mentioned benefits for all the involved.
MDB: What new routes of administration for biologics are being explored with the advent of high-dose formulations, and how might these routes improve patient outcomes and experiences?
Sørensen: The most essential improvement is the possible shift from IV to subcutaneous administration, which will improve the quality of life for the patients and likely also improve the patient’s adherence to the therapy. It is a very significant improvement for the patient if it is possible to self-inject a subcutaneous injection at home instead of having to visit a hospital or infusion clinic for lengthy IV administration. The risk of an adverse event is typically also reduced with a subcutaneous injection versus an IV infusion.
MDB: What specific design features of reusable drug-delivery devices for high-dose biologics have been shown to significantly improve patient comfort and adherence to treatment protocols?
Sørensen: New possibilities include a reusable electronic injection device that can have a completely controlled plunger movement with the ability of very high plunger forces and can also offer the flexibility to handle different primary packaging systems and injection volumes. These are design features that can offer a unique possibility for the pharmaceutical formulation department to select the optimum formulation parameters and still have a device option that can handle the administration diligently due to the superior performance envelope. From the patient perspective, the experience will be very similar to the typical two-step autoinjector experience and convey a very controlled and convincing experience for the patient in a home setting.
Summary
Innovative reusable drug-delivery devices are transforming the administration of high-dose biologics by enabling self-administration of challenging drug formulations. These devices support high viscosity and larger injection volumes, enhancing patient comfort and adherence. The shift from IV treatments in clinical settings to subcutaneous injections at home offers significant cost savings and improves patient quality of life.
High-dose formulations can reduce the frequency of administration, providing long-acting therapeutic benefits and further reducing healthcare costs. New routes of administration, primarily SC injections, improve patient outcomes and adherence by minimizing the need for hospital visits and reducing the risk of adverse events. The design features of these devices such as controlled plunger movement significantly enhance the patient experience, making self-administration more manageable and reliable.
This article was written by Sherrie Trigg, Editor and Director of Medical Content,