Long-acting systems, such as combination products and implantable systems, are an increasingly popular approach for long-term drug delivery, offering the potential for targeted drug release, lower dosage requirements, and increased patient compliance. A well-designed drug-eluting system can positively impact bioavailability, stability, and pharmacokinetics of an active pharmaceutical ingredient (API) while also offering potential intellectual property and life-cycle management opportunities.
Common examples of drug device combination products include:
- Antiretroviral-loaded intravaginal rings
- Drug-eluting pace maker leads
- Hormonal subcutaneous implants
- Drug-coated balloon catheters
The demand for these types of products is constantly growing. However, combining a drug product and medical device creates additional development and regulatory complexity, which is why choosing the right partner is critical. LLS Health makes it easy to navigate this complex path with our extensive knowledge of drug-eluting systems and variety of service offerings, including:
- Pathway™ TPU - LLS Health offers biocompatible, biostable thermoplastic polyurethanes (TPUs) for implantable drug delivery and drug device combination products. Our Pathway polymers possess unique qualities beneficial to drug eluting systems, including customizable mechanical properties and compatibility with a wide-range of APIs. Pathway TPUs have established Drug Master Files (DMFs) and are manufactured under IPEC-PQG good manufacturing practice guidelines, which is commonly FDA-required when working with a pharmaceutical or incorporating one into a medical device.
- Development and manufacturing of drug device combination products - Our CDMO Division specializes in complex drug products, including drug-eluting systems. We offer an integrated suite of services that can support a client’s combination product or implantable system from early development all the way through to commercialization. As a CDMO, we work with virtually all commercially available polymers, including biodurable and biodegradable options.