Solubisation technology scoops Bronze Edison Award

During the Edison 2015 Awards ceremony in New York, The Dow Chemical Company was presented with a Bronze Edison Award for the drug solubilisation technology AFFINISOL HPMC HME in the Science/Medical/Dental category. The award is the second win for the Dow Consumer Care portfolio of businesses, which also received a Gold 2015 Edison award for its POLYOX Water-Soluble Polymers technology in the Protection & Safety category.

A programme within the Edison Universe organisation, the Edison Awards have recognised some of the most innovative products and companies in the world such as Kimberly-Clark Corporation, Henkel and Procter & Gamble, and they are among the most prestigious accolades honouring excellence and innovation in the development, marketing and launch of new products and services.

The Edison judging committee recognised AFFINISOL HPMC HME for its ability to enhance the solubilisation and inhibit the recrystallisation of active pharmaceutical ingredients (APIs) in hot melt extrusion (HME) formulations.

“Our new AFFINISOL HPMC HME offering for drug solubilisation reflects deep technology development capabilities in Dow Pharma and Food Solutions,” said Sarah Eckersley, Global R&D director for Dow Pharma & Food Solutions. “We accessed our strengths in polymer design, structure property understanding of polymer/drug active interactions and polymer processing to yield a distinctly advantaged product that aids in drug delivery. We are very proud of the talent and creativity of our scientists.”

Trends in drug characteristics increasingly favour greater degrees of lipophilicity, higher molecular weight, greater physical form complexity and significantly lower aqueous solubility.  Consequently, up to 90% of new chemical entities in drug development pipelines have poor water solubility. Low aqueous solubility severely limits the compound’s oral bioavailability, the percentage of the total drug dose that reaches the patient’s bloodstream, and therefore also limits the commercial viability of a new product. As a consequence, many APIs that could potentially help cure diseases and improve consumers’ lives never even enter the market. 

To address this challenge, Dow Pharma & Food Solutions scientists developed the AFFINISOL family of excipients distinctly tailored to enable extrusion and address the solubilisation performance requirements of APIs for pharmaceutical applications including HME formulations.

The versatile and sustainable plant-based polymer Hypromellose (HPMC) has a long history of safe and effective use as an excipient and controlled-delivery component in oral medications. However, application of HPMC into HME formulations has been successful but limited owing to the narrow temperature range between thermal softening and discolouration, high melt viscosity and the need to use plasticisers to broaden the processing range, which can be detrimental to the final product.

In response to these issues, Dow designed AFFINISOL HPMC HME, a new generation of cellulosic polymer that maintains the crystallisation inhibiting properties of traditional HPMC, but that can be extruded over a wide temperature range and without the use of plasticisers, which simplifies formulation requirements, helps improve physical stability, and may reduce formulation toxicity. Thanks to its lower glass transition temperature (Tg) and a greater processing window, AFFINISOL HPMC HME also provides drug formulators with new capabilities to formulate amorphous solid dispersions and controlled release profiles via extrusion processes.

“The current trends in drug characteristics mean that solubilisation of poorly soluble APIs is one of the main challenges facing the pharmaceutical industry today,” said Marc van Gerwen, global business director for Dow Pharma & Food Solutions.

Ralf Brinkmann, global business president Consumer Care, added: “The Edison Award recognition is very important to us, as it shows our technologies and innovations, like AFFINISOL HPMC HME, can enable the pharmaceutical industry to overcome challenges and formulate new APIs, ultimately leading to new medicines and treatments for consumers around the world.”