12.02.16
MilliporeSigma has introduced Parteck MXP, a polyvinyl alcohol-based excipient designed to enhance solubility of a wide range of active pharmaceutical ingredients (APIs) 10 with poor bioavailability.
Parteck MXP excipient maintains stability at temperatures above 200 degrees Celsius, making it suited for hot melt extrusion (HME), a process used by drug manufacturers to enhance the solubility and bioavailability of APIs. According to the company, the new excipient can achieve drug loads of 30% or more, while other excipients may be limited to 10-15% in HME.
"More than 90% 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 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.
Parteck MXP excipient uses simple chemistry, potentially streamlining regulatory processes, according to the company. The polymer used in Parteck MXP is generally recognized as safe (GRAS) by the U.S. FDA and complies with U.S. Pharmacopeia, European Pharmacopeia and Japanese Pharmacopeia for excipient monographs.
Parteck MXP excipient will also be incorporated into the company's Emprove program, where customers have instant, online access to regulatory and technical information about the excipient, more than 400 other chemicals, filters and single-use components to help facilitate risk assessment and qualification processes.
Parteck MXP excipient maintains stability at temperatures above 200 degrees Celsius, making it suited for hot melt extrusion (HME), a process used by drug manufacturers to enhance the solubility and bioavailability of APIs. According to the company, the new excipient can achieve drug loads of 30% or more, while other excipients may be limited to 10-15% in HME.
"More than 90% 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 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.
Parteck MXP excipient uses simple chemistry, potentially streamlining regulatory processes, according to the company. The polymer used in Parteck MXP is generally recognized as safe (GRAS) by the U.S. FDA and complies with U.S. Pharmacopeia, European Pharmacopeia and Japanese Pharmacopeia for excipient monographs.
Parteck MXP excipient will also be incorporated into the company's Emprove program, where customers have instant, online access to regulatory and technical information about the excipient, more than 400 other chemicals, filters and single-use components to help facilitate risk assessment and qualification processes.
