The relationship between the delivery system design and the end-user perhaps is the most important factor in a drug product’s success. A drug is not effective if it’s not administered properly, or the patient does not adhere to the appropriate regimen. Systems that support or improve patient compliance can provide a competitive advantage to their companion drug products, particularly in a crowded market.
Growth in injectable therapies has resulted in an increasing number of new biologic drug products. Treatment regimens for these products can be complex, and often fall directly to the patient or a caregiver rather than a trained clinician. As the trend toward self-injection grows, auto-injection systems and devices are evolving to suit patient needs for subcutaneous delivery.
Many new and desirable treatment regimens may require larger doses, which would require multiple injections by the patient. Biologic drug products often are of a higher viscosity and may require a high-volume dose that cannot be easily delivered using traditional methods. Delivery devices such as auto-injectors often are the best choice for self-administration. However, current systems based on glass primary containers have had problems with issues such as breakage, incomplete injection and poor product quality due to glass delamination. In addition, many are limited with regard to dose size, which can detract from the patient experience by either requiring more frequent injections or intravenous administration due to the high volume of drug needed.
A successful integrated system must consider not only the needs of the end-user and how the patient interacts with the delivery system, but also how the drug product interacts with its primary containment system. A drug product must provide effective treatment in an appropriate form that enables effective delivery with an optimum delivery rate and frequency. Additionally, the drug must be held in a container that maintains effectiveness, safety and optimum quality over a period of time. Finally, the drug should be compatible with the containment system and designed to enhance the drug delivery experience for the patient or caregiver.
As the trend toward self-care continues, and patients take an even greater role in decisions regarding their treatment, easy-to-use delivery systems will be essential. Increasingly, the market is evolving toward the use of sophisticated, patient-friendly delivery systems with increased capabilities for use in the home environment that deliver more than 1mL in a single injection, including electronic patch injection systems. These technologies deliver biologics and other high-viscosity drugs at larger volume doses over a longer period of time with minimal patient discomfort or inconvenience.
There is a strong correlation between drug product administration and patient adherence, so manufacturers must shift from a product-centric focus to a patient-centric focus when designing an effective drug delivery system. To build an effective delivery system, manufacturers must focus on the relationship between the delivery system design and the patient, and develop a deeper understanding of the emotional and physical needs of the intended user.
Human factors testing allows manufacturers to support delivery system development from a range of critical perspectives. From a regulatory standpoint, such testing accounts for important human factors inputs that the FDA expects to see as part of the development process for any delivery system. These same inputs also ensure that risks from user-based errors are properly identified and go hand-in-hand with technical risk definition in order to provide stronger guidance for the development team to mitigate these risks throughout the development cycle.
The process by which a testing team engages users should also yield valuable information regarding a user’s physical and emotional needs, desires and the lifestyle challenges faced in managing the disease. Understanding how to analyze and effectively use this information serves as a strong foundation for guiding the design process to develop delivery systems that are not only intuitive and easy to use, but also encourage experiences that enable positive emotional connections between the user and delivery system.
Addressing all of these factors is the cornerstone to enabling a delivery system to achieve the goals of encouraging adherence and fostering brand loyalty between patient and pharmaceutical manufacturer while mitigating both product and development risks. Drug manufacturers should seek partners who can apply proprietary technologies, manufacturing excellence, and market and patient understanding to ensure that a partnership works seamlessly to help mitigate risk, encourage patient adherence and enhance the value of a product.
Graham Reynolds joined West in 1980 as a polymer technologist, and throughout his 32-year career with West has held a range of positions with increasing responsibility. In his current role as vice president, Marketing and Innovation, Reynolds works within the Delivery Systems business segment where he leads initiatives and develops strategies for future growth, including the acquisition and development of new technologies that enhance the West portfolio. His activities include working to understand market and customer needs, with a focus on integrated drug delivery systems for injectable products, including prefillable syringes, self-injection systems, and various safety and administration systems.