WILMINGTON, Mass.—Lubrizol Corp.'s LifeScience Polymers division recently revamped its manufacturing practices and quality systems at its Wilmington facility with the implementation of the International Pharmaceutical Excipients Council's Good Manufacturing Practice.
The process took about a year to complete and was finalized at the end of April. The upgrade allowed the firm to produce Pathway, a line of pharmaceutical-grade thermoplastic urethane excipients. Lubrizol unveiled the line at the Controlled Release Society's annual meeting held July 13-16.
The company would not disclose the investment details related to the upgrade, but the process also included the availability of a U.S. Food and Drug Administration drug master file for specific Pathway grades.
Pathway has the versatility to be used to manufacture devices to deliver both hydrophobic drugs that are not compatible with water and hydrophilic drugs. Lubrizol said its hydrophilic line is formulated to absorb water from 20 percent to 1,000 percent while maintaining many of its mechanical properties.
“There is definitely a market trend toward combination type products meant for drug delivery,” said Joey Glassco, global market manager for Lubrizol's LifeScience Polymers division. “There is a trend in the market toward novel drug delivery systems, and TPU is obviously well positioned.”
The firm said the polymer can be hot-melt extruded or solvent cast into shapes, such as rods, tubes, films and other matrix-type designs. Pathway is non-biodegradable, which gives it two advantages, according to Glassco, and it has near immediate reversibility and near-zero order release.
“The more versatile the polymer can be, the more creative designers can get to get to the end result,” he said.
Pathway can be used in a number of applications, ranging from controlled release drug products, to drug reservoirs, drug matrices, rate controlling membranes, drug eluting medical implants, monitoring devices, drug eluting catheters and combination products.
“As the FDA regulations increase, device manufacturers are also trying to differentiate themselves,” Glassco said. “We've seen folks that are using our product in sensor type devices as well.”
Lubrizol's LifeScience Polymers is one of five divisions and, according to Glassco, was formed two years ago.