Long-Acting Drug Delivery: Injections, Implants, and Combination Products
Combination products and drug delivery devices aid in patient compliance and a movement toward point-of-care at home. In this article, Nick DiFranco, Market Manager – Long-Acting Drug Delivery and Combination Products, discusses trends in the market for long-acting injectables, long-acting implantables, and next-generation combination products. Portions of this article appeared in Pharmaceutical Focus: A Look at Combination Products, published by Medical Product Outsourcing.
What is the current state of drug delivery/combination products? How do the medical device and pharmaceutical industries interact?
As chronic conditions continue to dominate the global healthcare industry (Figure 1), drug delivery systems are playing a critical role in modernizing the administration of pharmaceuticals. Solving chronic care requires collaboration between device engineers, pharmaceutical formulators, and contract development and manufacturing organizations (CDMOs) who each provide specialized skills in highly competitive fields.
No one function exists in a bubble when it comes to developing long-acting drug products. For example, a pharmaceutical scientist developing an intravaginal ring may work closely with their polymer supplier to understand API-polymer interactions and optimize their manufacturing process. And medical device designers developing the next generation of injector devices may rely on the skills of pharmaceutical CDMOs to ensure a formulation is compatible with their device or provide expertise in pharmaceutical quality systems.
What are the latest trends in drug delivery/combination products that you are seeing in the industry?
Innovation in drug delivery is being driven by a singular goal: to improve patient compliance (Figure 1). There are two approaches to this challenge that are garnering the most attention and funding. The first are wearable injector devices, which enable patients to administer large volume biologics at home, saving frequent trips to the doctor’s office and differentiating products in the rapidly growing large molecule space. The second are long-acting injectables and implantables, which not only enable delivery of an active for weeks or months at a time, but also enable lifecycle management and alternative regulatory pathways such as 505(b)(2)s. These dosage forms require complex pharmaceutical formulation expertise as well as the proper delivery device to be successful.
What are OEMs asking for the most when it comes to drug delivery/combination products?
In development, OEMs are seeking service providers who can truly act as an extension of their R&D groups, providing unbiased access to new technologies that overcome challenges such as poor water solubility and bioavailability of actives or stabilization of drugs for injector devices or long-acting dosage forms.
From a manufacturing perspective, OEMs are seeking partners who can offer flexible, sterile fill-finish operations to support their client projects or their own clinical evaluations. Companies who are developing the next generation of combination products need access to the facilities and expertise of pharmaceutical manufacturers, especially those with experience in small-batch clinical and commercial manufacturing, like we offer at Lubrizol. These partnerships with pharmaceutical contract development and manufacturing organizations (CDMOs) enable OEMs to offer a complete solution to their customers, from device design and supply through filling, testing, and packaging of a complete drug product.