AFFINISOL™ HPMC HME Drug Solubilization Technology Awarded Bronze at the 2015 Edison Awards
During the Edison 2015 Awards ceremony in New York held last Thrursday, The Dow Chemical Company (NYSE: DOW) was presented with a Bronze Edison Award for the drug solubilization 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 program within the Edison Universe organization, the Edison Awards have recognized some of the most innovative products and companies in the world such as Kimberly-Clark Corporation, Henkel, and Procter & Gamble, and are among the most prestigious accolades honoring excellence and innovation in the development, marketing and launch of new products and services.
The Edison judging committee recognized AFFINISOL™ HPMC HME for its ability to enhance the solubilization and inhibit the recrystallization of Active Pharmaceutical Ingredients (APIs) in hot melt extrusion (HME) formulations.
“Our new AFFINISOL™ HPMC HME offering for drug solubilization 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 favor 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 solubilization performance requirements of APIs for pharmaceutical applications including hot melt extrusion 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 hot melt extrusion formulations has been successful but limited due to the narrow temperature range between thermal softening and discoloration, high melt viscosity and the need to use plasticizers 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 which maintains the crystallization inhibiting properties of traditional HPMC, but can be extruded over a wide temperature range and without the use of plasticizers 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 solubilization 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. And 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. By making new and better drugs available, we can contribute more people living better and healthier lifes.” For more information regarding Dow’s innovations in science and sustainability, visit dow.com.
About Dow Pharma Food Solutions
Dow Pharma & Food Solutions designs differentiated solutions that enable pharmaceutical delivery & nutritional benefits to customers around the world. A business of Dow Consumer Care portfolio, Dow Pharma & Food Solutions offers a single interface to all Dow technologies and expertise focused on solutions serving the pharmaceutical and food manufacturing markets. We provide functional excipients, active pharmaceutical ingredients (APIs) and highly functional food ingredients to help consumers live healthier, more convenient and enjoyable lives. Dow Pharma & Food Solutions employs 1,200 people across nine sites and 15 manufacturing plants, with six cGMP's, serving customers in around 160 countries. Additional details can be found at www.dowpharmaandfood.com.
Dow (NYSE: DOW) combines the power of science and technology to passionately innovate what is essential to human progress. The Company is driving innovations that extract value from the intersection of chemical, physical and biological sciences to help address many of the world's most challenging problems such as the need for clean water, clean energy generation and conservation, and increasing agricultural productivity. Dow's integrated, market driven, industry-leading portfolio of specialty chemical, advanced materials, agrosciences and plastics businesses delivers a broad range of technology-based products and solutions to customers in approximately 180 countries and in high-growth sectors such as packaging, electronics, water, coatings and agriculture. In 2014, Dow had annual sales of more than $58 billion and employed approximately 53,000 people worldwide. The Company's more than 6,000 product families are manufactured at 201 sites in 35 countries across the globe. References to "Dow" or the "Company" mean The Dow Chemical Company and its consolidated subsidiaries unless otherwise expressly noted. More information about Dow can be found at www.dow.com.