Parteck® MXP: two polymers, unparalleled value – Polyvinyl alcohol for hot melt extrusion

Poor active pharmaceutical ingredient (API) solubility is a critical challenge in drug development. One formulation technique to increase solubility and, consequently, improve bioavailability of drugs is hot melt extrusion (HME). With this technology, the API is dispersed within a polymer matrix to form an amorphous solid dispersion. Hot melt extrusion is a solvent-free process and so also provides unique benefits from a sustainability perspective.

Polyvinyl alcohol (PVA), from a chemical perspective, is ideal for application in HME due to its capabilities in stabilization of amorphous APIs, solubility enhancement, and precipitation inhibition. From a regulatory and safety perspective, PVA has a strong track record in oral solid dosage forms and is Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration.

Our Parteck® MXP range, Parteck® MXP 3-82 and Parteck® MXP 4-88, has been specifically designed with HME performance in mind.

Low melt viscosity, prolongation of supersaturation and the ability to stabilize active APIs over a broad temperature range are important assets of the Parteck® MXP range. Finally, both of our Parteck® MXP products come supported with extensive and market leading Emprove® dossiers of quality information.

Key parameters

With a lower degree of hydrolysis along the PVA chain, Parteck® MXP 3-82 polyvinyl alcohol is especially beneficial in forming strong interactions with hydrophobic drug molecules – in the solid state and in solution.

Due to this, Parteck® MXP 3-82 excipient has very high capabilities as a precipitation inhibitor and can maintain high levels of supersaturation for physiologically relevant timescales.

As a result, Parteck® MXP 3-82 polyvinyl alcohol can provide solubility enhancement for even the most challenging molecules. Furthermore, Parteck® MXP 3-82 is compliant with Ph. Eur.

Parteck® MXP 3-82 dissolution with a
strong precipitation inhibition profile

With a hydrolysis grade of 88%, Parteck® MXP 4-88 polyvinyl alcohol is more hydrophilic, which provides unique benefits for stabilization of certain molecules in the amorphous form.

Furthermore, with a uniquely high thermal application range, Parteck® MXP 4-88 excipient can be utilized for molecules across a broad range of melting temperatures while still providing strong performance, including those classically seen as unsuitable for extrusion due to high melting points.