35th Anniversary Special: Future Innovation in Drug Delivery

What will be the future innovation in drug delivery? To gain a perspective, Pharmaceutical Technology asked leading experts for their views. Participating in the industry roundtable were Anthony Recupero, PhD, senior director, licensing, Aptalis Pharmaceutical Technologies; Linda A. Felton, PhD, chair of the Department of Pharmaceutical Sciences and associate professor of pharmaceutics, the College of Pharmacy at the University of New Mexico, Health Sciences Center, and member of the Steering Committee of the Modified Release Focus Group of the American Association of Pharmaceutical Scientists; and Louise Righton, global divisional marketing manager for 3M Drug Delivery Systems.

PharmTech: Looking ahead over the next five to 10 years, in what areas do you see the opportunity for the greatest innovation in drug delivery? How may factors, such as increased development of specialty medicines for targeted patient populations and personalized medicines, affect approaches in drug delivery or influence specific drug-delivery technology?

Recupero (Aptalis Pharmaceutical Technologies): In the next five to ten years, we see a great opportunity for innovation in drug delivery by designing novel formulations that target particular pharmacokinetic (PK) profiles needed for the corresponding patient populations that are underserved by current drug formulations on the market. Whether these drugs use oral or parenteral formulations, the key focus will be on customized drug release that provides for a novel PK profile that leads to greater efficacy and/or reduced safety risks for specific patient populations within particular therapeutic areas. These patients may be identified by characteristics, such as age, co-morbidities, or a variety of potential of biomarkers that indicate a favorable response to the drug of interest, if dosed under the appropriate conditions. Central nervous system is a general therapeutic area where these strategies are likely to pay off significantly, given the variability in patient responses based on a variety of personal factors.

The customized drug-release profiles required will necessitate the use of multiple types of technologies, including extended-release, sustained- release, and timed-pulsatile release. Much of the innovation will come from developing a better understanding of the patient rather than the identification of new molecules.

From a business perspective, it will be key to have proprietary technologies available with strong patent estates behind them for these applications. This will allow companies to develop a protected pathway to market exclusivity in a manner that can be protected not only by technology and formulation patents, but also by new use patents that are the result of novel clinical findings based on the enablement of the delivery system. This will allow companies and investors to maximize their return on investment and encourage further innovation in drug delivery.

Felton (University of New Mexico:) The next decade will continue to be an exciting time to be a formulation scientist as the industry moves away from incremental innovations and 'me-too' drugs in favor of more significant advances. As we look toward the future of pharmacy, I see many opportunities for improvements in drug delivery and patient safety. With a better understanding of diseases and anatomy and physiology, I expect to see more targeted drug-delivery systems being developed. These systems will include targeting specific sites in the body as well as targeting chemicals to specific cells in the body. A great deal of effort is currently being expended on targeting at the cellular level to improve therapeutic outcomes and reduce systemic toxicities. These new chemical entities, however, are likely to create additional delivery challenges for formulation scientists. Such challenges will likely be resolved using innovative approaches.

Significant research effort is currently focused on identifying new indications for existing drugs. Such repurposing will further contribute to the need for alternative delivery routes as well as targeted drug release. I expect to see improvements in vaccine delivery, including needle-free technologies, delivery by the inhaled route, and enhanced product stability. There are also opportunities for improved therapies in the management of chronic pain, where premature drug release (dose dumping) is minimized. Such systems would also reduce the potential for abuse. Further development and implementation of anticounterfeiting technologies is expected and would also contribute to patient safety, especially as the global marketplace continues to grow.

The aging population will also create opportunities for the development of new and novel drug delivery systems. In addition to improvements in taste-masking technologies and alternative delivery routes, there is a growing need for combination products to reduce total daily doses of medication. While there has been much discussion about personalized medicine, creating combination products unique for individual patients has potential to greatly impact patient adherence to therapeutic regimens, improve disease state management, and enhance quality of life and could be easily implemented in community pharmacies.

Righton (3M Drug Delivery Systems): Consideration of the user's experience and interface with drug-delivery devices is on the rise and will continue to have a significant impact on the success of a product. Throughout the next decade, companies will continue to seek efficient and user-friendly ways to deliver drugs, which build patient preference while still meeting the needs of healthcare providers and regulatory agencies. In this increasingly patient-driven marketplace, companies are observing that the integration of patient-friendly features, such as adding a dose counter to meter-dose inhaler devices, can not only serve as an asset in the regulatory process, but can also build patient preference and loyalty. Furthermore, the increased patient convenience found in needle-free drug delivery devices can offer companies an important life-cycle management tool that can differentiate their product and provide a competitive edge.