Post on 16-Sep-2019
ETHOCEL™ Premium Ethylcellulose PolymersSuperior Product, Superior Performance
Pharma & Food Solutions
pg 2
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
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