LLS Health has been a leading supplier of medical and pharmaceutical grade polymers for more than 50 years. Our Pathway
™ TPU excipients build upon this expertise, offering controlled drug release and compatibility with a wide range of active pharmaceutical ingredients (APIs). Pathway TPU is an ideal option for implantable drug delivery systems and
drug/device combination products. Whether you are developing a 505(b)(2) product or creating a novel
drug device combination product for a new chemical entity, Pathway polymers serve as a highly customizable, reliable option for controlled drug delivery. Unique advantages of Pathway polymers include:
- Versatile chemistry – Increased flexibility in chemical structure compared to other biocompatible, non-bioabsorbable polymers, such as silicone or ethyl vinyl acetate (EVA), offering better control of drug elution and compatibility with a wider variety of APIs
- Customizable mechanical properties – Choose from a variety of Shore durometers, from 72A to 60D
- Tunable drug release – Ability to deliver zero-order, Fickian-diffusion-driven, or hybrid drug release profiles
- Flexible supply – Availability in small to large batch sizes, including lab or pilot scale to support early development and GMP material for clinical trials and commercial production
- A history of use – Lubrizol’s TPU polymers have been used in FDA-approved implantable systems for decades due to their biocompatibility, chemical resistance, and customizable mechanical properties
Additionally, our 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 an API or incorporating one into a medical device. Our most requested TPUs for these purposes include:
- Pathway Hydrophobic polymers – Aliphatic polyether TPU available in a variety of durometers
- Pathway Low Melt Hydophobic polymers - Aliphatic polyether TPU formulated for applications utilizing thermally labile APIs
- Pathway Hydrophilic polymers – Aliphatic polyether TPU formulated to absorb water from 5% to more than 150% by weight of the dry resin while maintaining many of its mechanical properties
LLS Health’s TPUs have a long history of
in vivo safety, stability, and biocompatibility and, as a result, have been used for decades in biomedical applications such as implantable devices. Our TPU has been studied for the delivery of a variety of APIs in multiple diseases states, including HIV, mental health, pain, respiratory and hormone regulation. See additional references supporting
TPU usage in drug delivery.
