MilliporeSigma Launches Parteck® MXP Excipient for Increased Solubility

• Enhances solubility of active pharmaceutical ingredients with poor bioavailability
• Enables higher amount of API loading with excellent stability

Billerica, Massachusetts, December 2, 2016 — MilliporeSigma, a leading science and technology company, today introduced Parteck® MXP, a polyvinyl alcohol-based excipient that enhances solubility of a wide range of active pharmaceutical ingredients (APIs) with poor bioavailability.

Parteck® MXP excipient maintains stability at temperatures above 200 degrees Celsius, making it well-suited for hot melt extrusion (HME), a process used by drug manufacturers to enhance the solubility and bioavailability of APIs. The new excipient can achieve drug loads of 30 percent or more, while other excipients may be limited to 10-15 percent in HME. Drug load is a measure of the amount of API by weight that can be combined with the excipient.

"More than 90 percent of drugs in the pharmaceutical pipeline have solubility issues that lead to poor bioavailability, a key factor in the success of a drug candidate," said Andrew Bulpin, Head of Process Solutions Strategic Marketing & Innovation, MilliporeSigma. "Parteck® MXP excipient is the latest addition to our comprehensive excipients portfolio and allows our customers to address solubility challenges that otherwise might have prevented promising and potentially life-changing drug candidates from progressing through the pipeline."

The new excipient has been successfully tested on eight commonly used and poorly soluble APIs, including ibuprofen, indomethacin and itraconazole, and can be used in formulations for both immediate and sustained release.

In contrast with more complex excipients, Parteck® MXP excipient uses simple chemistry, potentially streamlining regulatory processes. The polymer used in Parteck® MXP is generally recognized as safe (GRAS)i by the U.S. Food and Drug Administration and complies with U.S. Pharmacopeia, European Pharmacopeia and Japanese Pharmacopeia for excipient monographs.

Parteck® MXP excipient is an expansion of MilliporeSigma’s portfolio of products that enhance bioavailability by improving poor aqueous solubility and controlled release. After rigorous testing, Parteck® MXP excipient will also be incorporated into the company’s Emprove® program. Using this program, customers have instant, online access to regulatory and technical information about the excipient, more than 400 other chemicals, filters and single-use components to facilitate risk assessment and qualification processes.

i http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm153970.htm