NEW YORK — Lubrizol Corp. introduced a medical-grade thermoplastic polyurethane with flame-retardant properties and a new pharmaceutical excipient for implantable controlled-release drug delivery June 10 at the Medical Design & Manufacturing East conference and trade show in New York.
The flame retardant TPU will be part of the Wickliffe, Ohio-based company’s Tecothane line and offered in five different grades, all designed to meet the exacting requirements of health care applications — including ISO 10993-5 test cytotoxicity requirements and sterilization needs — while still enhancing patient comfort, said Robert Miller business development director for Lubrizol LifeScience Polymers.
The new TPU, available in matte, can be processed with injection molding or extrusion and is already getting good reviews from processors, Miller said, “particularly on the feeling — it’s not tacky. No PVC could do this.”
At the three-day event in New York, Lubrizol also introduced medical device makers to Pathway, a new pharmaceutical-grade excipient aimed at TPU products for implantable controlled drug release devices. Implementing Good Manufacturing Practices (GMP), a pharma standard, at the company’s Wlimington, Mass., facility earlier this year opened the door for the first pharma-grade TPU in addition to Lubrizol’s medical-grade lines, said Joey Glassco, global market manager with Lubrizol LifeScience Polymers.
Drug loading into TPU devices can be achieved with blending and them melt-processing thermally stable drugs and then injection molding or extruding or by dissolving the polymer in compatible solvents — offering more processing versatility than silicone or ethyl vinyl acetate (EVA) competitors, Glassco said. The result is devices ideal for subcutaneous drug delivery systems, such as one that offers 30 to 90 day continuous opiate delivery for helping relive the pain of cancer patients in third-world countries or a variety of vaginal rings delivering birth control or other medications including tenofovir, an anti-microbial proven effective in combating HIV.