ETHOCEL™ Premium Ethylcellulose PolymersSuperior Product, Superior Performance

Pharma & Food Solutions

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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 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.

*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.

ETHOCELTM AttributesManufacturing Benefits of ETHOCELTM Customer Value

Narrow viscosity specificationsReproducible performance Reduced lot to lot variation

Higher yieldsLower risk of failureReduced quality issuesLower process costsHigher production efficiencySatisfying customer requirements (re-producibility, on time)Eliminates re-processing

Uniform and narrow ethoxyl substitutionPredictable performanceReduced lot to lot variationEnhanced solubilization

Low insoluble fiber levelsEnhanced solubilizationAvoids failure of barrier membranes

Stability / impurity levelsLonger shelf lifeReduced drug interaction effects

Competitor AETHOCELTM USP Guideline

Ethy

lcel

lulo

se V

isco

sity

, cP

45

20

10

7

4

100

Competitor AETHOCELTM

Wt,

%

20

30

40

50

60

10

<47 48-49

Ethoxyl Substitution, %

47-48 >49

Ethylcellulose Viscosity* Ethylcellulose Ethoxyl Substitution

• 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

• 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

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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.

ETHOCELTM ETHOCELTMCompetitor A Competitor A

Fiber Levels

A wide range of product offeringsis available for pharmaceutical applications

Fiber Content in Solution Fiber Content in Films

19%

98%

Competitor AETHOCELTM

Ald

ehyd

e G

ener

atio

n, %

40

60

80

100

20

120

Competitor AETHOCELTM

Fib

er c

oun

t, p

pm

400

600

800

1000

1200

200

15 ppm

1202 ppm

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.

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

ETHOCELTM viscosity performance on day 365 is same as day 1

Lot to lot, ETHOCELTM is manufactured with very low fiber levels

ETHOCELTM can be used with formulations sensitive to impurity levels

Enhanced solubilization due to low fiber content

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).

Competitor AETHOCELTM

Vis

cosi

ty R

eten

tion,

%

92

94

96

98

90

100

Viscosity Retention at 1 year Aldehyde Levels at 1 year

®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.

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