Pharma & Food SolutionsETHOCEL™ Premium Ethylcellulose Polymers Superior Product, Superior Performance ETHOCEL™ Comparative Information | 03-2014 ETHOCELTM attributes play critical roles in final product performance of barrier membrane dosage forms. By consistently manufacturing quality ethylcellulose our customers will extract more benefits from ETHOCELTM and experience improved performance in a variety of dosage forms. ETHOCELTM Attributes Manufacturing Benefits of ETHOCELTM Customer Value Narrow viscosity specifications Reproducible performance Reduced lot to lot variation Uniform and narrow ethoxyl substitution Predictable performance Reduced lot to lot variation Enhanced solubilization Low insoluble fiber levels Enhanced solubilization Avoids failure of barrier membranes Stability / impurity levels Longer shelf life Reduced drug interaction effects Higher yields Lower risk of failure Reduced quality issues Lower process costs Higher production efficiency Satisfying customer requirements (reproducibility, on time) Eliminates re-processing ETHOCELTM viscosity and ethoxyl substitution are the attributes which impart modified release to the final dosage form. Tight control and narrow distributions of these attributes make ETHOCELTM the leading excipients for modified release. Ethylcellulose Viscosity* Ethylcellulose Ethoxyl Substitution 60 50 7 Wt, % Ethylcellulose Viscosity, cP 4 10 40 30 20 20 45 10 100 <47 ETHOCELTM Competitor A USP Guideline • Narrow viscosity can assure reproducible performance even for difficult dosage forms • Customer benefit includes working with dosage forms where small changes in viscosity might result in major performance change 47-48 >49 ETHOCELTM Competitor A • Ethylcellulose manufactured in the targeted 48.0 – 49.5% ethoxyl substitution range will result in predictable performance, reduced lot to lot variation, and enhanced solubilization *Roger TL and Wallick D, Drug Dev Ind Pharm 2012; 38(12): 129-157. The properties shown on each graph are typical but not to be construed as specifications. Each graph is based on results from internal studies from February - April 2013. pg 2 48-49 Ethoxyl Substitution, % ETHOCEL™ Comparative Information | 03-2014 ETHOCELTM is manufactured to contain very low insoluble fiber levels. Avoiding these insoluble fibers will greatly improve efficiency and performance at the processing level. Fiber Levels Fiber Content in Solution 1202 ppm 1200 Fiber count, ppm Fiber Content in Films 1000 800 600 15 ppm 400 200 ETHOCELTM Competitor A ETHOCELTM Lot to lot, ETHOCELTM is manufactured with very low fiber levels Competitor A Enhanced solubilization due to low fiber content ETHOCELTM Competitor A Defect free films will avoid the most common failure of barrier ETHOCELTM is manufactured to retain superior shelf life by keeping impurity formations to a minimum. This assures our customer a clean product that performs the same from the day it is purchased to the day it is ultimately used (per product specifications). Viscosity Retention at 1 year Aldehyde Levels at 1 year 120 Aldehyde Generation, % Viscosity Retention, % 100 98 96 94 92 90 98% 100 80 60 40 19% 20 ETHOCELTM Competitor A ETHOCELTM Competitor A ETHOCELTM viscosity performance on day 365 is same as day 1 ETHOCELTM can be used with formulations sensitive to impurity levels A wide range of product offeringsis available for pharmaceutical applications Application ETHOCELTM Polymer Controlled Release Coating ETHOCELTM Standard 7, 10, 20 Premium Micro-encapsulation ETHOCELTM Standard 45 or 100 Premium Tablet Coating ETHOCELTM Standard 7, 10, 20 Premium Binder/Direct Compression ETHOCELTM Standard 7 FP, 10 FP, 20 FP Premium Hot Melt Extrusion ETHOCELTM Standard 10 Premium The properties shown on each graph are typical but not to be construed as specifications. Each graph is based on results from internal studies from February - April 2013. pg 3 North America Europe, Middle East, Africa Pacific Latin America +1 800 447 4369 +31 11 567 2626 +60 3 7965 5392 +55 11 5184 8722 www.dowpharmaandfood.com ®TMTrademark of The Dow Chemical Company (“Dow”) or an affiliated company of Dow • Form No. 198-02297 - 03/14 EST Dow requests that customers considering use of Dow products in medical applications notify Dow so that appropriate assessments may be conducted. Dow has a Corporate Medical Application Policy in place that guides the use of Dow products in potential new pharmaceutical and medical device uses. Dow reviews all new applications/uses according to this Medical Application Policy to determine if the use is appropriate for Dow materials. Dow does not endorse or claim suitability of its products for specific medical applications. It is the responsibility of the medical device or pharmaceutical manufacturer to determine that the Dow product is safe, lawful, and technically suitable for the intended use. DOW MAKES NO WARRANTIES, EXPRESS OR IMPLIED, CONCERNING THE SUITABILITY OF ANY DOW PRODUCT FOR USE IN MEDICAL APPLICATIONS. NOTICE: No freedom from infringement of any patent owned by Dow or others is to be inferred. Because use conditions and applicable laws may differ from one location to another and may change with time, Customer is responsible for determining whether products and the information in this document are appropriate for Customer’s use and for ensuring that Customer’s workplace and disposal practices are in compliance with applicable laws and other government enactments. The product shown in this literature may not be available for sale and/or available in all geographies where Dow is represented. The claims made may not have been approved for use in all countries. Dow assumes no obligation or liability for the information in this document. References to “Dow” or the “Company” mean the Dow legal entity selling the products to Customer unless otherwise expressly noted. NO WARRANTIES ARE GIVEN; ALL IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ARE EXPRESSLY EXCLUDED.