sheffcoat - kerry
TRANSCRIPT
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
Competitor SheffCoat
minutes
Film Elasticity
0
0.2
0.4
0.6
0.8
1
1.2
1.4
Competitor SheffCoat
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™HPMC base
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
SheffCoat™HPMC base
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
SheffCoat™HPMC base
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
SheffCoat™HPMC base
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.
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MC/Coating/082015