Pharma & Food Solutions
METHOCEL™ DC2 Premium Excipients
Saving the Industry Time and Money to Focus on
Life-saving Innovations
METHOCEL™ DC2 Premium Excipients
Formulate with Cost Efficiency in Mind
METHOCEL™ DC2 Premium Excipients help you enjoy
the benefits of dry powder processing techniques while
maintaining consistent modified release performance. They
offer the performance reliability expected from the proven
family of METHOCEL™ CR excipients.
METHOCEL™ DC2 polymers are designed to offer:
• Considerably improved flow properties, providing
excellent processability in the industry-preferred
methods of roller compaction and direct compression;
• Greater reproducibility in tablet properties, such as
weight uniformity, hardness and content uniformity;
• Shortened development time and lower manufacturing
costs (up to 60%) through the elimination of the wet
granulation process;
• Convenience and Reliability, with low regulatory hurdles
to use, as they are pure pharmacopeial HPMC;
• Better formulation option for heat- and moisturesensitive APIs.
2
METHOCEL™ DC2 Advantages:
• Science-based, designed morphology, enabling
the switch from batch wet granulation techniques
to continuous dry processing techniques, like roller
compaction and direct compression
• Pure pharmacopeial HPMC, no additives • Demonstrated benefits using multiple model API Formulations
• Reliably supplied from Midland, Michigan, United States,
with alternative production in Bomlitz, Germany
METHOCEL™ DC2 Premium Excipients
Considerably Improved Flow Properties
The powder bulk flow of METHOCEL™ DC2 is greatly
improved over that of METHOCEL™ CR.
Differences in morphology drive the improved flow and
processability.
METHOCEL™ DC2 has:
• Less fines;
• More spherical morphology.
Powder Bulk Flow Rate of METHOCEL™ DC2
Powder Bulk Flow Rate (g/s)
100
80
60
40
20
It should be noted that METHOCEL™ DC2 is chemically identical
to METHOCEL™ CR. Thus, METHOCEL™ DC2 meets all HPMC
pharmacopeial requirements.
0
METHOCEL™ DC 2
METHOCEL™ CR
Morphology Grade Within Chemistry / MW Grade
Data is based on results from internal studies.
Funnel Flow Test
Screen shots of a time lapse video over 14 seconds show the difference in powder
flow through a glass funnel between METHOCEL™ DC2 and METHOCEL™ CR.
0 sec
4 sec
8 sec
14 sec
Internal Test from DOW R&D, Midland, MI (2014)
3
METHOCEL™ DC2 Premium Excipients
Excellent Processability in Dry Powder Techniques,
Such As Direct Compression and Roller Compaction
Streamline Manufacturing and Gain Efficiencies:
In the example table displayed below, a comparison between a wet granulation and direct compression
process illustrates the potential for significant time and cost savings for tablet manufacturers.
High Shear Wet Granulation
Direct Compression
Cost / hour
Hours
Hours
Equipment Preparation
$150
3
1
Material Dispensing
$120
3
3
Excipient Blend
$160
1
1
Lubrication Blend
$160
0.5
0.5
High Shear Granulation
$240
1
0
Drying the Granulation
$240
1
0
Granulation Sizing
$120
1
0
Clean up Costs
$120
5
1
15.5
6.5
Total Hours
~61%*
Savings
* Actual Results will vary based on formulation, manufacturing process and labor costs.
Direct Compression
Measuring
raw
materials
Screening
Blending
Add
additives
and mix
Compress
granules
into tablets
Dedust
and bulk
package
Add
additives
and mix
Compress
granules
into tablets
Dedust
and bulk
package
Add
additives
and mix
Compress
granules
into tablets
Dedust
and bulk
package
Dry Granulation
Measuring
raw
materials
Screening
Blending
Pre-
compression/
compaction
Dry-
screening
Wet Granulation
Measuring
raw
materials
Screening
Blending
Source: Chemical Engineering, November 2003
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Wetting
(granulation)
Wet-
screening
Drying
Dryscreening
While METHOCEL™ CR is an excellent option in wet granulation, METHOCEL™ DC2 enables both direct compression and roller compaction.
METHOCEL™ DC2 Premium Excipients
Greater Reproducibility
In Tablet Properties
Consistency
The figures below illustrate that METHOCEL™ DC2 facilitates higher reproducibility
in weight and content uniformity when used for direct compression.
METHOCEL™ CR Control Chart: Tablet Weight
215
215
210
210
Tablet weight (mg)
Tablet weight (mg)
METHOCEL™ DC2 Control Chart: Tablet Weight
205
200
195
190
205
200
195
190
5
10
15
20
25
5
30
10
UCL = 213.31
Avg = 209.43
LCL = 205.55
15
20
25
30
Tablet Collection
Time (min)
Tablet Collection
Time (min)
UCL = 207
Avg = 198.73
LCL = 190.46
CpK: 3.397
Sigma Level: 10
CpK: 1.594
Sigma Level: 4σ
Results from internal studies carried out in 2013 using a gliclazide model formulation.
Uniformity
API content uniformity remained consistent with METHOCEL™ DC2, but showed signs of
API segregation over the duration of the direct compression trial with METHOCEL™ CR.
METHOCEL™ CR Run Chart: API Content per Tablet
120
120
115
115
Assayed API Content
per Tablet (%)
Assayed API Content
per Tablet (%)
METHOCEL™ DC2 Run Chart: API Content per Tablet
110
105
100
95
90
110
105
100
95
90
5
10
15
20
Tablet Collection Time (min)
UCL = 109.09
Avg = 99.61
LCL = 90.13
25
30
5
10
15
20
25
30
Tablet Collection Time (min)
UCL = 116.77
Avg = 104.69
LCL = 92.61
5
METHOCEL™ DC2 Premium Excipients
Metformin HCl Formulation
Roller Compaction
The following charts show the results from an internal study of a metformin HCl formulation, produced
using dry granulation/roller compaction. When using dry powder processing techniques, like Roller
Compaction, formulators can achieve more reproducible tablet properties with METHOCEL™ DC2.
Tablet Weight
The tablets produced with METHOCEL™ DC2 showed less tablet-to-tablet weight variation. Both grades
exhibited similar modified release performance, matching the control (commercially available tablet).
METHOCEL™ CR
1050
1050
1000
1000
950
950
Weight (mg)
Weight (mg)
METHOCEL™ DC2
900
850
900
850
800
800
750
750
700
700
1
3
6
9
12
1
15
3
6
12
9
Time (min)
Time (min)
UCL = 1025.50
Avg = 995.28
LCL = 965.05
UCL = 943.98
Avg = 840.58
LCL = 737.19
15
Metformin Release Profiles
Tablet Assays – Roller Compacted Material
METHOCEL™ DC2 and CR grades deliver the expected
modified release performance.
An assay of the tablets shows greater API content uniformity
when using METHOCEL™ DC2.
• Assays measured on individual tablets
• % API based on expected content per tablet
115
% Expected API in Tablet
100
90
% Drug Release
80
70
60
50
40
METHOCEL™ DC2
30
20
METHOCEL™ CR
Control – Commercial Generic Tablet
10
0
0
0
5
10
15
Time (h)
6
20
25
110
105
100
95
0
3
6
9 12 15
DC2
0
3
6
9 12 15
CR
Production Time (min) / Grade
Internal Studies conducted by DP&FS R&D, Midland, Michigan, USA (2013)
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CONTROLLED RELEASE ALLIANCE
Our Direct Compression Portfolio
Three direct compression grades are currently available: METHOCEL™ K100LV Premium DC2,
METHOCEL™ K4M Premium DC2 and METHOCEL™ K100M Premium DC2. These polymers have been
developed to optimize dry powder processability while maintaining the same viscosities, degrees
of methyl and hydroxypropyl substitution, and other important properties as the corresponding
Controlled Release (CR) grades. The DC2 grades are chemically identical to original METHOCEL™
Premium products. The DC2 grades meet US Pharmacopoeia, European Pharmacopoeia and
Japanese Pharmacopoeia monograph.
Colorcon/Dow Controlled Release Alliance Support
• Dow polymer chemistry expertise and manufacturing capability
•Colorcon dedicated team provides formulation expertise
• Starter formulations available through Colorcon HyperStart formulation service
•Colorcon local technical support for trials, scale-up and troubleshooting
•Colorcon global supply and logistics
North America
Europe, Middle East, Africa
Pacific
Latin America
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+31 11 567 2626
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