Merck, a leading science and technology company, has 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% or more, while other excipients may be limited to 10-15% in HME. Drug load is a measure of the amount of API by weight that can be combined with the excipient.
“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, Life Science.
“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) by the US Food and Drug Administration and complies with US Pharmacopeia, European Pharmacopeia and Japanese Pharmacopeia for excipient monographs.
Parteck MXP excipient is an expansion of Merck’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 programme.
Using this programme, 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.
