Over their development history, the therapeutic performance and value of DEDs has evolved significantly, and recent innovation has expanded the range of diseases and chronic conditions this technology can effectively treat.
As a therapeutic tool, DEDs offer several advantages over traditional dosage forms, including localized, targeted delivery, lower dosage requirements, and greater patient compliance. Conventional dosage forms such as pills and tablets are often not used as prescribed, which leads to poor patient outcomes and increased healthcare costs. DEDs remove compliance from the equation, which is a tremendous benefit for treatment regimens. In this article, Bruce Frank, Vice President of Operations and Client Services at CDMO Particle Sciences, explores the latest trends in DEDs and what the future holds for these products.
Implantable DEDs are considered combination products, defined in 21 CFR 3.2(e) as therapeutic and diagnostic products comprising “two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity.”
One of the great advantages of combination devices is they can be designed to achieve various sustained drug release rates and profiles. Through careful selection of excipients (materials), device design , and processing methods, DED developers can optimize delivery of their specific drug. For example, some DEDs are designed as reservoir systems wherein a drug-filled core is surrounded with a rate-controlling polymer membrane. These systems can be manipulated to achieve zero-order drug release, meaning the release rate remains steady throughout the lifetime of the device. Other designs such as matrix systems and coatings can introduce varying release profiles depending on how they are designed. This flexibility offers tremendous potential to drug developers looking to enhance the therapeutic value and performance of their medications.
In addition to improved control of drug release, DEDs allow for more efficient drug utilization. When only localized delivery of a drug is desired, placing a DED directly at the site of action can achieve a therapeutic effect without systemic side effects. An example of this is Ozurdex®, an ophthalmic DED that is implanted directly into the eye to reduce local inflammation. In cases where systemic delivery is required, implanted DEDs are often able to achieve the same therapeutic effect as conventional dosage forms with a lower dose of drug. This can minimize common dose-related side effects.
From a regulatory standpoint, DEDs can offer an appealing route to approval through the 505(b)(2) generic pathway. Incorporating a drug into an existing medical device may also have benefits, including extended product lifecycles and differentiation from competition.