Drug/Device Combination Products (DDCPs) are unique in that they involve components normally regulated under separate FDA centers, and are subsequently classified based on their "primary mode of action" (PMOA). Regardless of whether your combination product’s PMOA is as a medical device or a pharmaceutical product, Lubrizol is the leading solutions provider for DDCPs. We supply both pharmaceutical-grade polymers (excipients) and contract development and manufacturing services for a wide variety of combination products. Common examples of drug/device combination products include:
- Drug-eluting pace maker leads
- Antiretroviral-loaded intravaginal rings
- Drug-coated balloon catheters
- Hormonal subcutaneous implants
The demand for these types of products is constantly growing, as the global combination products segment is forecasted to hit $115 billion by 2019. However, the developmental and regulatory complexity of combining a drug and medical device into a singular product still intimidates many, which is why choosing the right product partner is critical. Lubrizol makes it easy to navigate this complex path with our extensive drug-eluting system knowledge and variety of service offerings, including:
- Pathway™ TPU: Lubrizol offers biocompatible, biostable thermoplastic polyurethanes (TPUs) for implantable drug delivery and drug-eluting devices. Our Pathway™ TPU possess many unique qualities beneficial to DDCPs, including adaptable mechanical properties and flexible chemistry, which allows for the product’s compatibility with a wide-range of active pharmaceutical ingredients (drugs). Pathway™ also has established Drug Master Files (DMFs) and is manufactured under IPEC-PQG good manufacturing practice guidelines, which is commonly FDA-required when incorporating a drug into a medical device.
- Development and Manufacturing of DDCPs: Particle Sciences, a Lubrizol company, is a leading Contract Development and Manufacturing Organization (CDMO) specializing in complex drug products, including DDCPs. We offer an integrated suite of services that can support a client’s DDCP from early development all the way through to commercialization. Particle Sciences works with virtually all commercially available polymers, but also has direct access to all of Lubrizol’s extensive polymer resources. This can be leveraged to customize Pathway TPU for expedited development of a client’s drug-eluting device.