SheffCoat - Kerry

www.SheffieldBioScience.com

Aqueous BasedCoating SystemsCustomized Immediate Release and Enteric Film Coating Systems

SheffCoat™

SheffCoatTM | 2

A Name You Know Can TrustFor 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 | 3

SheffCoat™ : The Standard of ComparisonBuilding 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 ExpertiseSheffCoat™ 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 SupportOur 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 AssuranceKerry 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 handling systems.

Various blenders with liquid addition and high sheer mixing.

Accurate scale-up and multiple batch sizes.

SheffCoatTM | 4

New Product FormulationWhen 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

• Previously Coated Tablets

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

• Pantone Number

• PDR or On-Line References

SheffCoatTM | 5

1001* 1011

1032

1041 1061 1091

1005*

1006*

1015

1024*

1033

1044 1054* 1064 1074

1085

1094

1103*

1124

1002* 1012

1021* 1051*

1062

1071 1081

1092

1101* 1121

1016

1025* 1065 1075

1084 1104*

1125

1003* 1013

1022*

1031

1042 1052* 1072

1083

1122

1026*

1034

1035

1036 1046

1045 1055*

1056* 1066 1076 1086

1095

1096

1105*

1106* 1126

1004* 1014

1023* 1043 1053* 1063 1073

1082

1093

1102*

1123

SheffCoat™ Standard Color CollectionColored 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.

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.

*contains Iron Oxide

SheffCoatTM | 6

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.

Industry standard – strong smoothcoating with good adhesion

Increased processing efficiency,adhesion, and moisture protection

Ability to use a wider range of coating temperatures and a

smoother appearance

SheffCoat™ MPHPMC + PVA

Cost Reduction

SheffCoat™ PlusCSheffCoat™ L (Lactose)

HPMC + lactose

SheffCoat™ D (polyDextrose)HPMC + Polydextrose

SheffCoat™ S (Starch)HPMC + starch

SheffCoat™HPMC base

SheffCoat™ HSHPMC + HPC

Increased film strength and adhesion

SheffCoat™ PVAPVA base

Additional moisture protection

SheffCoat™ PVA+PVA + lecithin

SheffCoat™ VLVLow viscosity HPMC

Increased processing efficiency, elasticity and better adhesion

Increase processing efficiency and decreased coating time (heat and moisture exposure)

SheffCoat ™HP (High Pigment)SheffCoat System™ + additional pigment

SheffCoat™ ProLow viscosity HPMC

SheffCoatTM | 7

SheffCoat™ Optimization Matrix

Po

lym

er

Mo

istu

re S

ensi

tive

AP

I - a

que

ous

co

atin

g

Moi

stur

e Se

nsit

ive

API

- al

coho

l or

solv

ent

coat

ing

Tem

per

atur

e Se

nsit

ive

AP

I

AP

I sen

siti

ve t

o p

last

iciz

er in

tera

ctio

n

Wax

y o

r p

oo

r ad

hesi

on

core

s

Soft

tab

lets

(he

rbal

fo

rmul

atio

ns)

Low

Vis

cosi

ty/

hig

h so

lids

solu

tio

n

Imp

rove

d L

og

o D

efin

itio

n

Cle

aner

lab

el

Pro

p 6

5 R

estr

icti

ons

Tita

nium

dio

xid

e fr

ee

Nat

ural

Pig

men

ts

Tast

e o

r O

do

r M

aski

ng

Glo

ssy

Fini

sh

Glo

ss t

op

coat

Pre

coat

fo

r fr

iab

le c

ore

s

Pre

coat

fo

r en

teri

c co

atin

g

Aq

ueo

us E

nter

ic C

oat

ing

Alc

oho

l or

Solv

ent

Bas

ed C

oat

ing

SheffCoat™ HPMC X X X X X X X X

SheffCoat™ Pro HPMC X X X X X

SheffCoat™ PVA PVA X X X X X X X X

SheffCoat™ PVA+ PVA X

SheffCoat™ HS HPMC+ HPC X X X X X X

SheffCoat™ L HPMC+ Lactose X X

SheffCoat™ D HPMC+Polydextrose X X

SheffCoat™ S HPMC+Starch

SheffCoat™ MP HPMC+PVA X X X X

Sheff HP™ (High Pigment)

HPMCand/or PVA X

SheffCoat™ ENT Methacrylate copolymer X

SheffCoat™ EC HPMC+Ethylcellulose X X X

SheffCoatTM | 8

Placebo’s were coated to 3% weight gain. PEG was used as the plasticizer.

She Coat Viscosities - PVA based

0

200

400

600

800

1000

1200

1400

10 12 14 16 18 20 22 24% solids

Visc

osit

y, c

ps She Coat™

She Coat™ PVA

She Coat™ MP

She Coat™ PVA+

0

200

400

600

800

1000

1200

1400

1600

10 12 14 16 18 20 22 24

Visc

osity

, cps

% solids

SheffCoat Viscosities

SheffCoat

SheffCoat PVA

SheffCoat D

SheffCoat HP

SheffCoat Pro

SheffCoat MP

SheffCoat PVA+

SheffCoat HS

0

2

4

6

8

10

12

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

kg/m

m

Free Film Strength

0

1

2

3

4

5

6

7

8

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

mm

/mm

Free Film Elasticity

0

0.02

0.04

0.06

0.08

0.1

0.12

0.14

0.16

SheffCoat SheffCoat HS SheffCoat MP SheffCoat PVA SheffCoat PVA+

cc/m

m3/

day

Free Film Moisture Transmission

SheffCoatTM | 9

The Original SheffCoat™

Film Performance

SheffCoat™ film coating system provide exact matches to competitive products with comparable formula and functionality

without comprimising important film attributes.

• 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

• Wide range of colors available; chosen to be

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

TMSheffCoat™HPMC base

Film Performance

0

50

100

150

200

250

Competitor SheffCoat

g/0.001"

Coated Tablet Disintegration Time

0

2

4

6

8

10

12


minutes

Film Elasticity

0

0.2

0.4

0.6

0.8

1

1.2

1.4


mm/0.001"

SheffCoatTM | 10

SheffCoat™ PVA

Film Performance

SheffCoat™ PVAPVA base

Moisture transmission(cc/mm3/day)

0

0.01

0.02

0.03

0.04

0.05

0.06

0.07

0.08

0.09

HPMC/HPC SheffCoat PVA Competitive PVA

Viscosity of Aqueous Dispersions

-100

100

300

500

700

900

1100

1300

1500

1 2 3

% solids in dispersion

cpsHPMC Coating

SheffCoat PVA

CompetitivePVA

• Applied with 20% solids spray suspensions for improved efficiency over HPMC

• Superior film coating to HPMC

• Ideal “slip” for bottle packaging equipment and blister pack machines

• No change in tablet dissolution and compared to HPMC

• Excellent adhesion properties

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

SheffCoat™ PVA+PVA + lecithin

™

™

SheffCoatTM | 11

SheffCoat™ Pro

HPMC Based Coating PlatformSheffCoat™ 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.

• Adhesive and elastic coating with good appearance and excellent logo definition

• Considered a trouble shooting coating

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

SheffCoat VLV™Dow VLV

SheffCoat™ ProLow viscosity HPMC

SheffCoatTM | 12

SheffCoat™ HS (High Strength)HPMC + HPC (Hydroxypropyl cellulose)


SheffCoat™ HS

HPMC Based Coating Platform with Increased Film Elasticity and AdhesionSome 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

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

increase film elasticity

increase adhesion to core

SheffCoatTM | 13

SheffCoat™ PlusC Systems

HPMC Based Coating Platform with Improved Processing Efficiency and Less CostThe 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™ L (Lactose)HPMC + lactose

SheffCoat™ D (polyDextose)HPMC + Polydextrose

SheffCoat™ S (Starch)HPMC + Starch


increase sprayability to 18-20%

carbohydrates are widely used /widely approved

excellent logo definition

replace some HPMC with less viscous material,

to enable faster coating with higher solids

• Creates adequate film and is low cost alternative to HPMC

• Excellent logo definition

SheffCoatTM | 14

SheffCoat™ HPHPMC + additional pigment


decrease in material used

less coating time

less exposure to heat and moisture

• An increase in pigment load translates to theoretical 1/3 decrease in coating weight gain and processing time to achieve same visual effect

• Suitable for most tablet cores

• Elasticity and adhesion is maintainedPolymer + additional pigment

SheffCoat™ HP (High Pigment Systems)

SheffCoat™ MP

HPMC Based Coating Platform with Improved Processing Efficiency and FilmIt 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.

Provides the benefits of HPMC while providing higher solid and better elas-ticity

• Ability to coat at lower temperatures than PVA

• PVA allows for higher solids in spray suspension – faster processing times

• PVA provides increased elasticity over HPMC

SheffCoat MP (Mixed Polymer)HPMC + PVA


increase processing efficiency

increase moisture protection

SheffCoat™ High Pigment Systems HPMC Based Coating Platform with Increase Pigment LoadingIncreasing the levels of pigment in the formulation provides greater efficiency while maintaining the the film performance.

SheffCoatTM | 15

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.

SheffCoat™ ENTMethylmethacrylate Copolymers

• Complete ready-to-spray powder formulations

• Consistent and reproducible delayed release performance

• Targeted drug delivery for applications including tablets, granules, and beads

• pH Dependent Release

• Solubilizes at pH 5.5

• Variety of plasticizers available

Release of ASA from enterically coated cores

0

20

40

60

80

100

120

0 50 100 150 200

Time in Minutes

% Dis Acid Phase0-120 minutes Buffer Phase

120-21- minutes

% tablets passing modified USP test

60.0

65.0

70.0

75.0

80.0

85.0

90.0

95.0

100.0

105.0

4 5 6 7 8 9 10

% weight gain of SheffCoat ENT

Film Performance

MC-SheffCoat-8/2012

Sheffield and SheffCoat™ are trademarks of Kerry Group.

Please note that the information herein is believed to be accurate and complete. However, no warranty or guarantee whatsoever is made or is to be implied with respect to such information or with respect to any other 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. Sheffield Bio-Science is a trademark of Kerry Group.

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

Cep - 13054-750

Campinas, Sao Paulo

Brazil

Tel: +55-19-3765-5000

Fax: +55-19-3765-5108

Visit us at www.SheffieldBioScience.com

MC/Coating/082015

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SheffCoat - Kerry