SheffCoat™

Aqueous Based
Coating Systems
Customized Immediate Release and
Enteric Film Coating Systems

www.SheffieldBioScience.com
A Name You Know Can Trust
For more than 75 years, we have earned our reputation for reliability and excellence in serving the biotech, pharmaceutical
and nutrition markets by delivering unsurpassed product value, enhanced opportunities for supply chain consolidation,
and new technology innovation. We bring together our superior products with new innovative solutions and market-driving
alternatives to help our customer succeed in today’s challenging global marketplace.

As part of the Kerry Group, a $6 Billion leader, we can provide you the global technical service, regulatory and application
support whether this is in the development process, or trouble-shooting commercial production challenges.

We make it our business to exceed our customers’ expectations every day. We collaborate directly with formulators in the
development of new drugs and delivery systems. We understand the requirements and regulations needed to succeed.

SheffCoat™ Benefits
• Pre-blended, ready-to-use dry clear or colored coatings that optimize performance and efficiency
• Complete line of cost effective aqueous coating systems
• Based on industry standard polymers, pigments, and plasticizers that meet all regulatory requirements
• Applied with standard film coating processes and equipment
• R&D application labs for custom & collaborative formulation development
• Match or exceed performance of current coating system
• Precise color matching of existing coating system and assurance of batch to batch color consistency

SheffCoatTM |2
SheffCoat™ : The Standard of Comparison
Building on 75 years of innovation, commitment and reliability as a world class excipient supplier, Kerry has created a
one step, ready-to-use system to match your existing coating and color, while offering a full spectrum of best-in-class,
cost effective solutions.

SheffCoat™ film coating systems are based on industry standard, regulatory accepted polymers, pigments and
plasticizers that are applied with standard film coating processes and equipment. With our extensive knowledge and
experience we can match or exceed the functionality of any competitive coating system as well as custom match or
create any desired color. We provide formulation, technical, regulatory and quality support through every step of your
development, scale-up and production process.

Manufacturing Expertise
SheffCoat™ coating systems are manufactured in Norwich, NY which is a CFR 210-11 Registered Drug Establishment,
and Vadodara, India. We are committed to exceeding the cGMP expectations of our pharmaceutical customer base with
our extensive quality assurance programs. Each batch is produced in accordance within approved specifications and are
GMP/GLP compliant with IPEC guidelines as well as regional requirements globally.

Our individual and isolated manufacturing suites have separate air handling systems. We have various blenders allowing
for accurate scale-up and enabling batch sizes up to 1,000 kg.

Global Technical Support

Our core technical expertise and extensive knowledge in industrial pharmaceutical tablet coating enables us to support
our customers in optimizing SheffCoat™ performance and efficiency. We are available to assist customers with on-site
coating trials and problem solve with production issues.

Regulatory and Quality Assurance

Kerry has a dedicated regulatory group to ensure product compliance to global regulatory requirements. Our regulatory
team provides full customer support to customers in every step of the process including regional regulatory agency
compliance, vendor forms, and audits to complete formulation changes.

Changing to SheffCoat™ assures seamless changes from your current formulations’ quality and performance while
improving your cost competiveness, and flexibility.

*Drug Master Files are available.

Individual and Isolated suites have separate air Various blenders with liquid addition and high Accurate scale-up and multiple batch sizes.
handling systems. sheer mixing.

SheffCoatTM |3
New Product Formulation
When you need something unique, Kerry has the technical and applications expertise and is ready to work with your
R&D team to create a unique solution.

Our state of the art pilot plants and application labs in the US, Brazil, Turkey, and India are fully equipped to perform
tablet functionality testing to ensure our products conform to the highest standards. Our application experts will
collaborate with you to develop a customized formulation that will optimize performance and efficiency while using
ingredients that meet all regulatory and consumer requirements.

Kerry’s application technicians can provide solutions to solve coating issues such as:

• Soft or friable cores

• Uneven or inconsistent cores
• Heat sensitive APIs
• Moisture sensitive APIs
• Process efficiency requirements

Color match sources can include, but are not limited to:
• Existing Formulations
• Pantone Number
• Previously Coated Tablets
• PDR or On-Line References

R&D/Application Support
• Custom collaborative coating development capabilities
• Color matching of existing coating system
• Pilot scale coating trials
• Extensive knowledge in scale-up into manufacturing
• Complete tablet functionality testing capabilities

• Capabilities to match or exceed performance of current coating system

SheffCoatTM |4
SheffCoat™ Standard Color Collection
Colored tablet coatings provide brand recognition and dose discrimination functions, as well as mask the tablet core.
Kerry has coatings to meet label requirements, regulatory requirements and stability needs for all regions. We offer a
portfolio of off-the-shelf colors that can also be customized to create a distinctive color.

Need to precisely match an existing color? We understand the importance and we get it right. Visual and spectrophotometric
color match specifications are part of every product.

The below are standard collection colors. Contact us for customized colors per your requirements.

1001* 1011 1021* 1031 1041 1051* 1061 1071 1081 1091 1101* 1121

1002* 1012 1022* 1032 1042 1052* 1062 1072 1082 1092 1102* 1122

1003* 1013 1023* 1033 1043 1053* 1063 1073 1083 1093 1103* 1123

1004* 1014 1024* 1034 1044 1054* 1064 1074 1084 1094 1104* 1124

1005* 1015 1025* 1035 1045 1055* 1065 1075 1085 1095 1105* 1125

1006* 1016 1026* 1036 1046 1056* 1066 1076 1086 1096 1106* 1126

*contains Iron Oxide

Packaging and Samples

All of our samples are shipped with coated placebos and
a sufficient quantity of coating powder formulations so you
can evaluate the color prior to performing any coating trials.

SheffCoat™ is packaged in a 25kg poly lined, tamper

evident boxes. Customized packaging and batch sizes
available upon request.

Standard sample is 0.5 kg, but larger samples are available

upon request.

SheffCoatTM |5
SheffCoat™ Immediate Release Offerings: Coatings Overview
SheffCoat™ Immediate Release film coatings allows the customer to select from numerous plasticizers and a wide range
of colorants to customize a film coating that is compatible with your API and regional regulatory requirements. We offer
a variety of different viscosities and film strengths to exactly match your existing film coating or customize a film coating
that will provide superior film performance and adhesion while providing excellent logo definition without compromising
disintegration time or other important tablet properties.

SheffCoat™ Pro
SheffCoat™ VLV SheffCoat™ SheffCoat™ PVA
Low
Low viscosity HPMC
viscosity HPMC HPMC base PVA base

Increased processing efficiency, Industry standard – strong smooth Increased processing efficiency,
elasticity and better adhesion coating with good adhesion adhesion, and moisture protection

SheffCoat™ MP SheffCoat™ PVA+

HPMC + PVA PVA + lecithin
Ability to use a wider range of
coating temperatures and a Additional moisture protection
smoother appearance

SheffCoat™ HS SheffCoat ™HP (High Pigment)

SheffCoat™ PlusC
HPMC + HPC SheffCoat System™ + additional pigment
SheffCoat™ L (Lactose)
Increased film strength Increase processing efficiency and decreased
HPMC + lactose and adhesion coating time (heat and moisture exposure)

SheffCoat™ D (polyDextrose)
HPMC + Polydextrose
SheffCoat™ S (Starch)
HPMC + starch

Cost Reduction

SheffCoatTM |6
 PVA+

Pigment)
SheffCoat™
SheffCoat™

SheffCoat™ L

SheffCoat™ S
SheffCoat™ D
SheffCoat™ HS

SheffCoat™ EC
SheffCoat™ MP
SheffCoat™ Pro

SheffCoat™ PVA

Sheff HP™ (High

SheffCoat™ ENT
Polymer

PVA
PVA

HPC

HPMC
HPMC
HPMC

Lactose

HPMC+
HPMC+
HPMC+
HPMC+

copolymer
and/or PVA
HPMC+PVA
Polydextrose

Methacrylate

Ethylcellulose
HPMC+Starch
X
X
X
Moisture Sensitive API - aqueous coating

X
Moisture Sensitive API - alcohol or solvent coating

X
X
Temperature Sensitive API

API sensitive to plasticizer interaction

X
X
X X
SheffCoat™ Optimization Matrix

Waxy or poor adhesion cores

X
Soft tablets (herbal formulations)

X
Low Viscosity/ high solids solution

X
X
X X X
Improved Logo Definition

X X X
Cleaner label

X
X
Prop 65 Restrictions

Titanium dioxide free

X X X X X

X
Natural Pigments

X
X X X

Taste or Odor Masking

X
Glossy Finish
X X

Gloss topcoat
X

Precoat for friable cores

X

Precoat for enteric coating

X
Aqueous Enteric Coating

X
Alcohol or Solvent Based Coating

SheffCoatTM
|7
 SheffCoat Viscosities
1600
1400
SheffCoat
1200
SheffCoat PVA
Viscosity, cps

1000
SheffCoat D
800
SheffCoat HP
600
SheffCoat Pro
400
SheffCoat MP
200
SheffCoat PVA+
0
10 12 14 16 18 20 22 24 SheffCoat HS

% solids

1400
She Coat Viscosities - PVA based
1200

1000
She Coat™
Viscosity, cps

800
She Coat™ PVA

600
She Coat™ MP

400
She Coat™ PVA+

200

0
10 12 14 16 18 20 22 24
% solids

Free Film Strength

12

10

8
kg/mm

0
SheffCoat SheffCoat HP SheffCoat HS SheffCoat D SheffCoat MP SheffCoat Pro SheffCoat PVA SheffCoat
PVA+

Free Film Elasticity

8
7
6
5
mm/mm

4
3
2
1
0
SheffCoat SheffCoat HP SheffCoat HS SheffCoat D SheffCoat MP SheffCoat Pro SheffCoat PVA SheffCoat
PVA+

Free Film Moisture Transmission

0.16
0.14
0.12
cc/mm3/day

0.1
0.08
0.06
0.04
0.02
0
SheffCoat SheffCoat HS SheffCoat MP SheffCoat PVA SheffCoat PVA+
Placebo’s were coated to 3% weight gain.
PEG was used as the plasticizer.

SheffCoatTM |8
The Original SheffCoat™

• The most basic film coating; widely used across the

pharmaceutical industry for decades

• Numerous plasticizers available; plasticizers chosen

to be compatible with API and regional regulatory
requirements, or label requirements
SheffCoat™
TM

• Wide range of colors available; chosen to be

HPMC base compatible with API and regional regulatory
requirements, or customers preferences

• Different viscosities and molecular weights available

• SheffCoat™ is equivalent in performance and

appearance to other HPMC coatings on the market

Film Performance
SheffCoat™ film coating system provide exact matches to competitive products with comparable formula and functionality
without comprimising important film attributes.

Film Performance Film Elasticity

250
1.4

200 1.2

1
150
g/0.001" mm/0.001" 0.8

100 0.6

0.4
50
0.2

0 0
Competitor SheffCoat Competitor SheffCoat

Coated Tablet Disintegration Time

12

10

minutes 6

0
Competitor SheffCoat

SheffCoatTM |9
SheffCoat™ PVA

• Applied with 20% solids spray suspensions for

improved efficiency over HPMC

• Superior film coating to HPMC

SheffCoat™ PVA • Ideal “slip” for bottle packaging equipment
PVA base and blister pack machines

• No change in tablet dissolution and compared

to HPMC

• Excellent adhesion properties

SheffCoat™ PVA+
• SheffCoat™ PVA+ provides the same benefits
PVA + lecithin of a traditional PVA coating but contains
lecithin for additional moisture protection.

Film Performance

Viscosity of Aqueous Dispersions Moisture transmission

1500 (cc/mm3/day)
0.09
1300
0.08
1100
0.07
900
0.06
cps
700 HPMC Coating 0.05
500 0.04
™
SheffCoat PVA
300 0.03
100 Competitive 0.02
-100 PVA 0.01
1 2 3
0
% solids in dispersion HPMC/HPC ™
SheffCoat PVA Competitive PVA

SheffCoatTM | 10
SheffCoat™ Pro
HPMC Based Coating Platform
SheffCoat™ Pro is a low viscosity HPMC film coating that provides increased processing efficiency, elasticity and
adhesion over traditional HPMC systems. It can be sprayed at a significantly lower temperature than PVA and
HPMC allowing for increased energy savings and making it ideal for heat sensitive APIs. SheffCoat™ Pro is an
ideal high efficiency coating when PVA based coatings cannot be used due to regulatory requirements, process
temperature, or plasticizer considerations.

• Applied at 25% solids (up to twice as fast as traditional

HPMC systems)

• Utilizes VLV – a low viscosity HPMC without the brittle

characteristics of E3.

SheffCoat
SheffCoat™VLV™
Pro • Adhesive and elastic coating with good appearance
Low Dow VLV
viscosity HPMC and excellent logo definition

• Considered a trouble shooting coating

• Sprayable at lower temperatures allowing for increased
energy savings and ideal for heat sensitive APIs

SheffCoatTM | 11
SheffCoat™ HS
HPMC Based Coating Platform with Increased Film Elasticity
and Adhesion
Some tablets have softer cores and may need a very durable coating with increased adhesion in order
to ensure the tablet core does not erode during the coating process. There are also certain APIs that are
extremely sensitive to moisture. The addition of HPC provides improved film characteristics to overcome
these issues.

• HPC adds film elasticity and adhesion

SheffCoat™ • HPC may also increase viscosity at higher
HPMC base usage rates, slightly lowering solids content
of spray suspension

increase film elasticity

increase adhesion to core

SheffCoat™ HS (High Strength)

HPMC + HPC (Hydroxypropyl cellulose)

SheffCoatTM | 12
SheffCoat™ PlusC Systems
HPMC Based Coating Platform with Improved Processing Efficiency
and Less Cost
The need for higher than 15% solids spray suspension is desired when faster processing times are needed
because the tablets cannot have prolonged exposure to heat and moisture.The addition of a carbohydrate
provides the increased processing efficiency without using PVA.

SheffCoat™ replace some HPMC with less viscous material,

HPMC base to enable faster coating with higher solids

increase sprayability to 18-20%

carbohydrates are widely used /widely approved
excellent logo definition

SheffCoat™ L (Lactose)
HPMC + lactose

SheffCoat™ D (polyDextose) • Creates adequate film and is low cost

alternative to HPMC
HPMC + Polydextrose
• Excellent logo definition

SheffCoat™ S (Starch)
HPMC + Starch

SheffCoatTM | 13
SheffCoat™ MP
HPMC Based Coating Platform with Improved Processing
Efficiency and Film
It is possible to increase processing efficiency of a basic HPMC formulation while maintaining film strength and
adhesion.Instead of replacing HPMC with a carbohydrate, a high performing film forming polymer such as PVA is used
in combination.

SheffCoat™
HPMC base
Provides the benefits of HPMC while
providing higher solid and better elas-
ticity
increase processing efficiency
increase moisture protection • Ability to coat at lower temperatures
than PVA
• PVA allows for higher solids in spray
suspension – faster processing times
SheffCoat MP (Mixed Polymer) • PVA provides increased elasticity
over HPMC
HPMC + PVA

SheffCoat™ High Pigment Systems

HPMC Based Coating Platform with Increase Pigment Loading
Increasing the levels of pigment in the formulation provides greater efficiency while maintaining the the film performance.

SheffCoat™
HPMC base

decrease in material used • An increase in pigment load

less coating time translates to theoretical 1/3
less exposure to heat and moisture decrease in coating weight gain and
processing time to achieve same
visual effect
SheffCoat™
SheffCoat™ HP Systems)
HP (High Pigment • Suitable for most tablet cores

HPMC Elasticity and adhesion is maintained

Polymer++additional pigment •
additional pigment

SheffCoatTM | 14
SheffCoat™ Enteric Film Coatings
SheffCoat™ ENT is a functional delayed release or enteric film coating that releases the API at a specific pH and/or
area of the digestive tract.

• Complete ready-to-spray powder formulations

• Consistent and reproducible delayed release
performance
SheffCoat™ ENT • Targeted drug delivery for applications
including tablets, granules, and beads
Methylmethacrylate Copolymers
• pH Dependent Release
• Solubilizes at pH 5.5
• Variety of plasticizers available

Film Performance

% tablets passing modified USP test

Release of ASA from enterically coated 105.0

120
cores 100.0
95.0
100 90.0
80 85.0
% Dis Acid Phase 80.0
60 Buffer Phase
0-120 minutes 75.0
40 120-21- minutes
70.0
20 65.0
0 60.0
0 50 100 150 200 4 5 6 7 8 9 10
Time in Minutes % weight gain of SheffCoat ENT

SheffCoatTM | 15
 Americas
3400 Millington Road
Beloit, WI USA
Tel: 608-363-1200

Asia Pacific
8 Biomedical Grove
#02-01/04 Neuros
Singapore 138665
Tel: +65-6715-3400
Fax: +65-6464-2004

4th Floor, Building No. 92

1122 Qin Zhou Bei Road
Caohejing Hi-Tech Park
Shanghai 200233
Peoples Republic of China
China
Tel: +86-21-54265333
Fax: +86-21-54265350

Europe, MIddle East and Africa

Millennium Business Park,
Osberstown, Naas,
Co. Kildare, Ireland
Tel: +353(0)45911563
Tel: +353(0)45911616
Tel: +353(-)45911564

India
Unit 114-115-116, 1st Floor Midas Building
Sahar Plaza, J B Nagar,
Andheri Kurla Road, Mumbai,
Maharashtra, 400059
India
Tel: +91-22-40015700

Latin America
Av. Mercedes Benz
460 - Distrito Industrial
Sheffield and SheffCoat™ are trademarks of Kerry Group. Cep - 13054-750
Campinas, Sao Paulo
Please note that the information herein is believed to be accurate and Brazil
complete. However, no warranty or guarantee whatsoever is made or is to Tel: +55-19-3765-5000
be implied with respect to such information or with respect to any other
Fax: +55-19-3765-5108
product, method, performance or apparatus referred herein. Nothing
herein shall be construed as a recommendation to use, manufacture, sell
or act in violation of any intellectual property rights or legal requirements. Visit us at www.SheffieldBioScience.com
Sheffield Bio-Science is a trademark of Kerry Group.

MC-SheffCoat-8/2012
MC/Coating/082015