Dow’s New Excipient Is Designed for Hot-Melt Extrusion

At CPhI Worldwide 2015, The Dow Chemical Company announced the global commercial availability of AFFINISOL HPMC HME, a new generation of cellulosic polymer for drug solubilization. The polymer is designed for use by pharmaceutical companies looking to enhance the solubilization and inhibit the recrystallization of APIs in hot-melt extrusion (HME) formulations. The product’s ability to overcome solubilization of poorly soluble APIs addresses one of the main challenges facing the pharmaceutical industry today and may help pharmaceutical companies to enhance the commercial viability of pipeline APIs.

“AFFINISOL HPMC HME is a cellulosic polymer that incorporates the crystallization-inhibiting properties of hypromellose (HPMC), a sustainable plant-based polymer, but which can also be extruded over a wide temperature range and without the use of plasticizers,” said Christophe Massip, global marketing director for Dow Pharma & Food Solutions, in a press release. “We are very excited that it is now available for commercial sampling, encouraged by the initial feedback from our customers and by our receipt of the Bronze 2015 Edison Award for innovation in the Science/Medical/Dental category earlier this year.”

Trends in drug characteristics increasingly favor greater degrees of lipophilicity, higher molecular weight, greater physical form complexity, and significantly lower aqueous solubility. Consequently, an estimated 70% of new chemical entities in drug-development pipelines have poor water solubility. Low aqueous solubility severely limits the percentage of a total drug dose that reaches a patient’s bloodstream and, therefore, also limits the clinical and commercial viability of the drug product. As a consequence, many APIs that could potentially help cure diseases and improve consumers’ lives never even enter the market. Addressing this challenge, the AFFINISOL family of excipients is distinctly tailored to address the solubilization performance requirements of APIs for pharmaceutical applications, including HME formulations.