Implantable drug eluting systems (also referred to as implantable devices) offer several unique advantages over conventional oral or other parenteral drug delivery methods. These advantages include localized, site-specific drug delivery, lower dosage requirements than alternative routes of administration, and improved patient compliance, which is one of the greatest challenges in healthcare.
While implantable drug delivery systems are appealing, they are also uniquely challenging to develop and may not follow traditional design, formulation, or production pathways. In some cases, a drug is added to an existing medical device to improve performance. In other cases, an implantable system is developed to provide extended release or controlled release of a drug. Implantable drug delivery systems are also lifecycle management tools, offering intellectual property protection for new chemical entities and enabling 505(b)(2) filings.
Whatever the goal, LLS Health has extensive experience with implantable devices, offering both Pathway™
thermoplastic polyurethane (TPUs) excipients as well as contract development and manufacturing (CDMO)
services. We have experience developing a range of products, including intravaginal rings, subcutaneous implants, ophthalmic implants, drug-eluting coatings, API-loaded polymers, and other novel combination products
LLS Health offers specialty pharmaceutical excipients ideal for use in implantable drug eluting devices. Our pharmaceutical-grade Pathway TPUs offer multiple advantages for implantable dosage forms, including:
- Biostability and biocompatibility – Lubrizol’s TPU polymers have been used in FDA-approved implantable systems for decades due to their biocompatibility, chemical resistance, and customizable mechanical properties
- Customizable chemistry – Pathway TPUs come in a range of Shore durometers (72A to 60D) and chemistries (hydrophobic and hydrophilic), offering control of drug elution and compatibility with a broad range of APIs
- Flexible supply – Pathway polymers are available in small to large batch sizes, including lab or pilot scale to support early development and GMP material for clinical trials and commercial production
Lubrizol Life Science also has preferred relationships with the world’s leading polymer suppliers, giving us access to a reliable and varied supply of biodurable and biodegradable materials.
Our polymer excipients are manufactured under GMPs in ISO:9001 certified facilities, have established DMFs, and come with supporting biocompatibility and safety data.
All LLS Health products and services are supported by a knowledgeable Technical Solutions
staff and technical centers around the world dedicated to aiding our clients.
Our CDMO Division
is a leading developer of biodegradable and biodurable implantable devices and vaginal rings. We have led the way in vaginal ring design for over 20 years, developing and co-patenting a contraceptive device now marketed in Europe. Our team is also well-versed in subcutaneous implants, ophthalmic implants, films, and intermediates such as dexamethasone-loaded silicone. Our team will find the right material and device design for your application, ensuring the success of your product and creating a seamless path to commercialization.