Lubrizol Introduces New Pharmaceutical Excipient
The Lubrizol LifeScience Polymers (LSP) business announces the introduction of a new pharmaceutical-grade excipient, Pathway. As pharmaceutical companies face the challenge of the patent cliff, the development of new routes of administration for existing drug products is an important potential strategy they can use to help maintain the success of their product franchises. Pathway excipients help drug manufacturers achieve their goals of developing these novel, controlled-release drug products.
LSP’s medical-grade thermoplastic polyurethane (TPU) has been used for decades in both short- and long-term devices, such as ventricular assist devices, vascular prostheses, tissue adhesives, skin wound dressings, as well as insulators for cardiac pacing leads and pacemaker headers designed to last many years. With the implementation of the Good Manufacturing Practices (GMP) quality system at Lubrizol’s facility in Wilmington, MA, earlier this year, this is the first time the company can offer pharmaceutical-grade TPU polymers in addition to medical-grade ones.
“It is not often that someone can say they are introducing a new excipient into the drug development market,” said Joey Glassco, Lubrizol LifeScience Polymers Global Market Manager. “Now our clients can have all of the benefits that TPU has to offer, the assurance of working with a company like Lubrizol and the GMP quality they seek.” Most clients express an interest in using Pathway excipients for controlled-release drug delivery systems, however, conscientious device manufacturers are also showing interest as their concerns about increased regulatory scrutiny mount.
TPU is very versatile compared to traditional materials used in drug delivery applications. It can be designed at various shore hardness while simultaneously varying the water uptake characteristics. Lubrizol can also tailor the polymer to meet a manufacturer’s drug delivery requirements: zero-order, Fickian diffusion driven or hybrid release profiles, as well as to improve the miscibility of a wide variety of drugs.
Pathway excipients come with the support Lubrizol LifeScience Polymers healthcare customers have come to expect, including the company’s commitment to quality, regulatory compliance, and supply chain reliability. The US FDA drug master files and support for drug regulatory submissions are available for select products manufactured under this process. “When it comes to Lubrizol’s TPUs, another major difference we provide is the experience level of our people in the pharmaceutical arena,” explained Glassco. “We bring decades of manufacturing, quality and regulatory experience, including our 35-year history as a leading excipient manufacturer.”
Lubrizol’s LifeScience Polymers team is focused on linking science to life by developing innovative polymer solutions and providing world-class support services to the healthcare industry. For more information, visit www.lubrizol.com/lifesciencepolymers.
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