Focus on Patient Needs for Effective Drug Delivery
Today, patients with chronic conditions are increasingly administering their own medications, and recent trends point to a prevalence toward injectables, reports Graham Reynolds, VP Marketing & Innovation, West Pharmaceutical Services Inc. “We are now seeing the emergence of alternative systems such as patch injectors and more sophisticated pen systems. In other therapeutic areas, such as autoimmune diseases and hemophilia, a patient or caregiver is responsible for the effective administration of a drug, which may require preparation prior to administering and delivery through a subcutaneous or IV route. The opportunity to combine a drug with a delivery device presents added convenience to the patient and differentiation for the drug company.”
VP Marketing & Innovation
West Pharmaceutical Services Inc.
Reynolds will be speaking about emerging trends in drug delivery and injectables at the upcoming Pharmapack North America conference on May 23 in Philadelphia.
Reynolds reports that “understanding the needs of the patient is critical, not only to ensure an effective delivery, but also to encourage adherence to a treatment regimen.” In addition, “a thorough understanding of all aspects of the drug delivery system, including the interfaces between the drug, the container, the administration/delivery system and the interface with the patient, is critical in ensuring successful drug delivery.”
Drug delivery devices may also be considered combination products, given their drug or biological component and a functional delivery device. But what consideration takes priority: product stability or device function?
“It is difficult to say which of the key elements of an integrated delivery system takes priority,” Reynolds says. “A drug must remain effective over time, so long-term stability is key. However, if the drug remains stable, but the device fails to deliver a full dose effectively, or the patient chooses not to take the medication in accordance with the appropriate regimen, the net result is a failure of the overall system.” Patient safety is clearly a priority, because failure to get that drug into the patient effectively can also be a safety or compliance concern, he adds.
Human factors must be considered alongside safety and effectiveness data, Reynolds explains. “A company like West, which offers a full solution from early phase concept development to the patient, may be engaged earlier in the process. Such a partner should help guide the pharmaceutical customer through the development process, including providing regulatory support. The level of support necessary may vary depending upon the relative knowledge of each partner.”
Of course, drug stability remains a key factor, as is selection of containment materials, Reynolds reports. “Many customers are aware of the concerns and issues related to glass containers, and are actively pursuing alternative polymeric materials, such as a cyclic olefin polymer. It is important to understand the ultimate means of administration and the required dose volume/frequency at an early stage in order to determine the most appropriate pathway. For example, if the effective dose volume is 3mL per treatment, should the solution be three injections of 1mL or one injection of 3mL? The decision may be based on the drug itself, the patient population, user preference and/or available technologies.”
When asked whether combination products are experiencing heightened regulatory scrutiny, Reynolds acknowledges that it has, which he believes has increased following recent recalls where the drug container, delivery device, or combination of the two, has created a safety concern. “FDA is continuously reviewing and updating guidance; however, it is clear that earlier evaluation of the system is beneficial in meeting requirements,” he explains. “The method of delivery may have an impact on the overall effectiveness of the drug, so it has to be evaluated early in the development process.”