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Transdermal Adhesives Considerations for Generic Product Development Tim Peterson
October 28, 2015
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3M’s “Stick to Skin” Portfolio
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Transdermal Adhesive Basics
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Transdermal System Designs
Basic Approaches
Reservoir Multilaminate
Drug-in-Adhesive
Backing Drug Membrane Adhesive Liner/Skin
Three of the most utilized transdermal patch designs.
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Key Aspects of Adhesive Performance in Transdermal Systems Secure the
system to the skin
Provide a drug and excipient
reservoir
Facilitate drug release from the system
Biocompatible with skin
Contribute to the stability of
the system
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What is a PSA and how does it work? PSA = Pressure Sensitive Adhesive
• Adheres to a surface using only light pressure
• Removable - no chemical bond between adhesive and substrate
For good adhesion:
• An adhesive must first “wet out” the substrate. The degree of wetting depends on the difference in surface energy between the adhesive and substrate
• High energy surface (metal, glass) = greatest wetting
• Low energy surface (polypropylene, teflon, skin)= more difficult wetting
• The adhesive must have the proper rheology to allow the wetting to occur rapidly (~1 sec)
Mechanisms for adhesion:
• Mechanical adhesion occurs when the adhesive flows into the texture of the substrate.
• Specific adhesive/substrate interactions include electrostatic forces, van der Waals forces and acid-base interactions
6
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Mo
du
lus
Temperature or Time
Glassy
Transition
Rubbery
Flow
Dahlquist tack criterion
<3x106 dyne/cm2
Adhesive Rheology • Pressure Sensitive
Adhesives are viscoelastic
materials
• Dynamic Mechanical
Analysis enables
characterization
• Dahlquist criteria describes
behavior needed for
pressure sensitive materials
• To obtain good quick tack,
the elastic modulus must
be below ~0.3 MPa,
independent of the nature
of the adhesive the
substrate, or the applied
pressure.
--crosslink,
higher Mw
--less flow
--better shear
peel apply
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Adhesives Currently Used in TDD
Adhesive Polymers:
• Acrylate
• Silicone
• Polyisobutylene
• Synthetic Rubber (e.g. Kraton)
Product Design Category Adhesive Category
Transdermal Reservoir
Systemw/ Adh
Overlay DIA Multilaminate PIB Acrylate Silicone
AndrodermR
(testosterone)
BuTransR
(buprenorphine)
Catapres-TTSR
(clonidine)
ClimaraR
(estradiol)
Climara ProR
(estradiol / levonorgestrel)
CombipatchR
(estradiol / norethindrone
DaytranaR
(methylphenidate)
DuragesicR
(fentanyl)
EmsamR
(selegiline)
ExelonR
(rivastigmine)
FlectorR
(diclofenac epolamine)
LidodermR
(lidocaine)
MinitranTM
(nitroglycerin)
NeuproR
(rotigotine)
Nicoderm CQR
(nicotine)
Ortho EvraR
(ethinyl estradiol / norelgestromin)
OxytrolR
(oxybutynin)
NitroDurR
(nitroglycerin)
QutenzaR
(capsaicin)
SancusoR
(granisetron)
Transderm-NitroR
(nitroglycerin)
Transderm ScopR
(scopolamine)
Vivelle DotR
(estradiol)
Matrix
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Polyacrylate PSAs
Polymers designed to be PSAs
Workhorse monomers
acrylic acid acrylamide
(AA) (ACM)
OOH ONH2
-affords tackiness
-low Tg
-reinforcing capability
-polar, interact with substrates
OO OO
2-ethyl hexyl butyl n-vinyl pyrrolidone
(2-EHA) (BA) (NVP)
NO
Advantages
--very diverse chemistry, can adjust
adhesive properties and solubility
characteristics
--excipient/drug tolerant
--biocompatible
--Single polymer with no need to tackify
--good processability
Disadvantages
--high solubility
--can be cross-linked, but not advisable
with drug present
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Advantages
--low surface energy
--non-interactive with drug
--biocompatible
--MVTR is great
--low solubility
SiSiSiSiO O O O
Silicone
Polydimethylsiloxane, PDMS
Dimethicone
“Tackify” with “silicate resin” to make a PSA
O Si
CH3
CH3
CH3
silica
OS
iC
H3
CH
3
CH
3
OSi
CH3
CH3
CH3
OSi
CH3
CH3
CH3
OS
i
CH
3 CH
3
CH
3
OSiC
H 3
CH 3
CH 3
Disadvantages
--cost
--material compatibility
--low solubility
Silicone PSAs
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Adhesion to Skin
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Factors Affecting Good Skin Adhesion Key Characteristics of Skin
Human
Skin
Breathing, Sensitive Surface
Cell Renewal
Cycle
Elastic Surface
Low Surface Energy
Rough Texture
Stratum corneum - 14 days
Epidermis - 50 days
Reversible Stretch up to
50%
25 dynes/cm (Skin)
31 dynes/cm (Polypropylene)
>700 dynes/cm (Stainless)
Hair & Growth
Pores
Skin Wrinkles
Dead Skin Cells
Sweat
Salt
Lotions & Powders
Allergies
MVTR - Masceration
Mechanical Trauma
Contaminated Surface
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Epidermal cells on surface of adhesive following removal from skin
a) “Gentle” PSA tape, b) “Aggressive” PSA tape
Skin / Adhesive Peel Interface
a) b)
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Design Considerations
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Design Consideration #1: Choose an Adhesive with Optimal Solubility for the API
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• API solubility is highly
dependent on adhesive
selection
• There is no universal
best choice – depends
on the API
physicochemical
properties
API #1
API #2
API #3
API #4
API #5
API #6
Solubility of API in various TDD Adhesive Materials
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Fentanyl solubility in IOA/HEA adhesives
0
2
4
6
8
10
12
14
16
0 0.1 0.2 0.3 0.4 0.5
Percent HEA in Soft Segment
Fen
tanyl
Solu
blit
y, %
w/w
Choice of Acrylate Co-monomer Can Influence Solubility
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Assessment of Drug Solubility in Adhesive Matrices Crystal Growth Method
Growth
Absorption
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Optimal Solubility Choose an adhesive with solubility for the drug and excipients such that:
• Adhesive matrix has adequate solubility to keep drug and excipient in a
solvated state (unless the design calls for a drug suspension)
• Adhesive matrix has adequate solubility to maintain delivery for the
desired wear period
• Adhesive matrix does not have excess solubility, otherwise:
• Diffusional driving force is diminished (because the drug has lower
thermodynamic activity)
• High residual drug may remain in the patch at the end of the wear
period
The ability to screen multiple adhesives or modulate drug solubility within the
adhesive is important.
Crystallized API in Adhesive Matrix -
Avoid This!
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Design Consideration #2: Choose an adhesive that has good mechanical properties (adhesion) even when loaded with drug and excipient
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Effect of Excipient and Drug Loading
• Excipients (and drugs) alter the physical
properties of adhesives
• Higher loadings lead to larger effects
• Some adhesive polymers are more
tolerant of drug/excipient than others
H-bonding
polymer
Add excipient
Weakened
polymer to polymer
interaction
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Mo
du
lus
Temperature or Time apply peel
Add excipients
Mo
du
lus
Temperature or Time apply peel
--Excipients are like plasticizers
--To accept higher excipient levels, the base adhesive may need to be stiff (high modulus)
Not a PSA…. above Dalhquist criterion Excipient loading creates PSA
Excipients – What is Happening to the Rheology?
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Design Consideration #3: Choose an adhesive that is compatible with other components of the system
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Adhesive Compatibility with Other System Components
Adhesive Compatibility
Compatible with Drug and
Excipients
Compatible with Release
Liner
Compatible with Backing
film
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Adhesive Compatibility with Other System Components
Adhesive Compatibility
Compatible with Drug and
Excipients
Compatible with Release
Liner
Compatible with Backing
film
• Ensure low residuals • Monomers • Initiators • Solvents
• Avoid strong intermolecular interactions with drug
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Adhesive Compatibility with Other System Components
Adhesive Compatibility
Compatible with Drug and
Excipients
Compatible with Release
Liner
Compatible with Backing
film
• Ensure release liner peel force remains within an acceptable range throughout the shelf life
• Normal for release liner peel force to build over time
• Acceptable upper limit is ~60 g/cm*
• Wokovich, A. M., Shen, M., Doub, W. H., Machado, S. G. and Buhse, L. F. (2010), “Release liner removal method for transdermal drug delivery systems (TDDS).” • J. Pharm. Sci., 99: 3177–3187. doi: 10.1002/jps.22067
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Adhesive Compatibility with Other System Components
Adhesive Compatibility
Compatible with Drug and
Excipients
Compatible with Release
Liner
Compatible with Backing
film
• Ensure adequate adhesion to backing to prevent delamination
• Low surface energy substrates )like PE) are more difficult
• May require surface treatment (e.g. corona) to obtain an adequate bond
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Regulatory Considerations
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Adhesives for Generic TDD Products
• For generic TDD products (in the U.S.), all components (including adhesive) should have a
history of use in previously approved products using the same route of administration and
dosage form.
• Necessitates the use of adhesives that have been used in previously approved TDD products.
• FDA’s Inactive Ingredient Database (IID) provides information on which adhesives have been
used in previously approved products
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Adhesives listed in the FDA’s Inactive Ingredient Database Ingredient_Name Route Dosage_Form
CAS_Number
UNII Potency_A
mount PotencyUni
t ACRYLATES COPOLYMER TRANSDERMAL FILM, CONTROLLED RELEASE N/A 382.22 MG
ACRYLATES COPOLYMER TRANSDERMAL PATCH, CONTROLLED RELEASE N/A 677.68 MG
ACRYLIC ACID-ISOOCTYL ACRYLATE COPOLYMER TRANSDERMAL FILM, CONTROLLED RELEASE 9017689 Pending 56.4 MG
ACRYLIC ADHESIVE 788 TRANSDERMAL FILM N/A 10.17 MG
ACRYLIC ADHESIVE 788 TRANSDERMAL FILM, CONTROLLED RELEASE N/A 20.08 MG
ACRYLIC ADHESIVE 788 TRANSDERMAL PATCH N/A
ADHESIVE TAPE TRANSDERMAL FILM, CONTROLLED RELEASE N/A
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER TRANSDERMAL FILM, CONTROLLED RELEASE 24938167 905HNO1SIH
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER TRANSDERMAL PATCH 24938167 905HNO1SIH
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER TRANSDERMAL PATCH, ELECTRICALLY CONTROLLED 24938167 905HNO1SIH 10 MG
DURO-TAK 280-2516 TRANSDERMAL FILM, CONTROLLED RELEASE N/A
DURO-TAK 387-2516 TRANSDERMAL FILM, CONTROLLED RELEASE N/A 37.4 MG
DURO-TAK 80-1196 TRANSDERMAL FILM, CONTROLLED RELEASE N/A 172 MG
DURO-TAK 87-2070 TRANSDERMAL FILM, CONTROLLED RELEASE N/A
DURO-TAK 87-2194 TRANSDERMAL FILM, CONTROLLED RELEASE N/A 208.28 MG
DURO-TAK 87-2287 TRANSDERMAL FILM N/A 537.7 MG
DURO-TAK 87-2287 TRANSDERMAL FILM, CONTROLLED RELEASE N/A 121.1 MG
DURO-TAK 87-2296 TRANSDERMAL PATCH, CONTROLLED RELEASE N/A 43 MG
DURO-TAK 87-2888 TRANSDERMAL PATCH N/A 175.9 MG
DURO-TAK 87-2888 TRANSDERMAL PATCH, CONTROLLED RELEASE N/A 175.9 MG
DURO-TAK 87-2979 TRANSDERMAL FILM, CONTROLLED RELEASE N/A
GELVA 737 TRANSDERMAL FILM, CONTROLLED RELEASE Pending
POLYISOBUTYLENE TRANSDERMAL FILM 9003274 N/A 16.83 MG
POLYISOBUTYLENE TRANSDERMAL FILM, CONTROLLED RELEASE 9003274 N/A 119 MG
POLYISOBUTYLENE TRANSDERMAL PATCH, CONTROLLED RELEASE 9003274 N/A 10.5 MG
POLYISOBUTYLENE (1100000 MW) TRANSDERMAL FILM, CONTROLLED RELEASE 9003274 FLT10CH37X 69 MG
POLYISOBUTYLENE (1100000 MW) TRANSDERMAL PATCH 9003274 FLT10CH37X 22.65 MG
POLYISOBUTYLENE (2300 MW) TRANSDERMAL FILM, CONTROLLED RELEASE 9003274 DSQ2V1DD1K 121.68 MG
POLYISOBUTYLENE (35000 MW) TRANSDERMAL FILM, CONTROLLED RELEASE 9003274 98553S1MHQ 86 MG
POLYISOBUTYLENE (55000 MW) TRANSDERMAL FILM 9003274 TQ77WR8A02 238.44 MG
POLYISOBUTYLENE (55000 MW) TRANSDERMAL PATCH 9003274 TQ77WR8A02 28.32 MG
POLYISOBUTYLENE (800000 MW) TRANSDERMAL FILM 9003274 Y132ZOQ9H7 159 MG
POLYISOBUTYLENE LOW MOLECULAR WEIGHT TRANSDERMAL PATCH, CONTROLLED RELEASE 9003274 N/A 8.13 MG
POLYISOBUTYLENE MEDIUM MOLECULAR WEIGHT TRANSDERMAL PATCH, CONTROLLED RELEASE 9003274 N/A 1.63 MG
POLYISOBUTYLENE/POLYBUTENE ADHESIVE TRANSDERMAL FILM, CONTROLLED RELEASE N/A 221.25 MG
SILICONE TRANSDERMAL FILM, CONTROLLED RELEASE 63394025 N/A 353.51 MG
SILICONE TRANSDERMAL PATCH 63394025 N/A
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Adhesives listed in the FDA’s Inactive Ingredient Database Ingredient_Name Route Dosage_Form
CAS_Number
UNII Potency_A
mount PotencyUni
t ACRYLATES COPOLYMER TRANSDERMAL FILM, CONTROLLED RELEASE N/A 382.22 MG
ACRYLATES COPOLYMER TRANSDERMAL PATCH, CONTROLLED RELEASE N/A 677.68 MG
ACRYLIC ACID-ISOOCTYL ACRYLATE COPOLYMER TRANSDERMAL FILM, CONTROLLED RELEASE 9017689 Pending 56.4 MG
ACRYLIC ADHESIVE 788 TRANSDERMAL FILM N/A 10.17 MG
ACRYLIC ADHESIVE 788 TRANSDERMAL FILM, CONTROLLED RELEASE N/A 20.08 MG
ACRYLIC ADHESIVE 788 TRANSDERMAL PATCH N/A
ADHESIVE TAPE TRANSDERMAL FILM, CONTROLLED RELEASE N/A
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER TRANSDERMAL FILM, CONTROLLED RELEASE 24938167 905HNO1SIH
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER TRANSDERMAL PATCH 24938167 905HNO1SIH
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER TRANSDERMAL PATCH, ELECTRICALLY CONTROLLED 24938167 905HNO1SIH 10 MG
DURO-TAK 280-2516 TRANSDERMAL FILM, CONTROLLED RELEASE N/A
DURO-TAK 387-2516 TRANSDERMAL FILM, CONTROLLED RELEASE N/A 37.4 MG
DURO-TAK 80-1196 TRANSDERMAL FILM, CONTROLLED RELEASE N/A 172 MG
DURO-TAK 87-2070 TRANSDERMAL FILM, CONTROLLED RELEASE N/A
DURO-TAK 87-2194 TRANSDERMAL FILM, CONTROLLED RELEASE N/A 208.28 MG
DURO-TAK 87-2287 TRANSDERMAL FILM N/A 537.7 MG
DURO-TAK 87-2287 TRANSDERMAL FILM, CONTROLLED RELEASE N/A 121.1 MG
DURO-TAK 87-2296 TRANSDERMAL PATCH, CONTROLLED RELEASE N/A 43 MG
DURO-TAK 87-2888 TRANSDERMAL PATCH N/A 175.9 MG
DURO-TAK 87-2888 TRANSDERMAL PATCH, CONTROLLED RELEASE N/A 175.9 MG
DURO-TAK 87-2979 TRANSDERMAL FILM, CONTROLLED RELEASE N/A
GELVA 737 TRANSDERMAL FILM, CONTROLLED RELEASE Pending
POLYISOBUTYLENE TRANSDERMAL FILM 9003274 N/A 16.83 MG
POLYISOBUTYLENE TRANSDERMAL FILM, CONTROLLED RELEASE 9003274 N/A 119 MG
POLYISOBUTYLENE TRANSDERMAL PATCH, CONTROLLED RELEASE 9003274 N/A 10.5 MG
POLYISOBUTYLENE (1100000 MW) TRANSDERMAL FILM, CONTROLLED RELEASE 9003274 FLT10CH37X 69 MG
POLYISOBUTYLENE (1100000 MW) TRANSDERMAL PATCH 9003274 FLT10CH37X 22.65 MG
POLYISOBUTYLENE (2300 MW) TRANSDERMAL FILM, CONTROLLED RELEASE 9003274 DSQ2V1DD1K 121.68 MG
POLYISOBUTYLENE (35000 MW) TRANSDERMAL FILM, CONTROLLED RELEASE 9003274 98553S1MHQ 86 MG
POLYISOBUTYLENE (55000 MW) TRANSDERMAL FILM 9003274 TQ77WR8A02 238.44 MG
POLYISOBUTYLENE (55000 MW) TRANSDERMAL PATCH 9003274 TQ77WR8A02 28.32 MG
POLYISOBUTYLENE (800000 MW) TRANSDERMAL FILM 9003274 Y132ZOQ9H7 159 MG
POLYISOBUTYLENE LOW MOLECULAR WEIGHT TRANSDERMAL PATCH, CONTROLLED RELEASE 9003274 N/A 8.13 MG
POLYISOBUTYLENE MEDIUM MOLECULAR WEIGHT TRANSDERMAL PATCH, CONTROLLED RELEASE 9003274 N/A 1.63 MG
POLYISOBUTYLENE/POLYBUTENE ADHESIVE TRANSDERMAL FILM, CONTROLLED RELEASE N/A 221.25 MG
SILICONE TRANSDERMAL FILM, CONTROLLED RELEASE 63394025 N/A 353.51 MG
SILICONE TRANSDERMAL PATCH 63394025 N/A
From the 8/15/2015 Update of the IID
37 entries that pertain to adhesives (after filtering on transdermal or topical patches)
Some entries are duplicative (~20 unique entries)
Some entries are not very descriptive of the adhesive polymer
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Relevant Regulatory Documents and Adhesive Tests • USP <3> Topical and Transdermal Drug Products – Product Quality Tests
• Peel Adhesion
• Release Liner Peel Test
• Tack - Probe or Rolling Ball (ASTM D3121)
• FDA Guidance on Residual Drug in Transdermal and Related Drug Delivery Systems
• EMA/CHMP/QWP/608924/2014 “Guideline on Quality of Transdermal Patches”
• Peel Adhesion, Liner Release, Tack, Cold Flow
• Ph. Eur. Monograph 1011 Transdermal Patches
• EMA Guideline on the Pharmacokinetic and clinical evaluation of modified-release dosage
forms.
• A useful reference:
• “Measuring Adhesive Performance in Transdermal Delivery systems”, P. Minghetti, F. Cilurzo and A. Casiraghi; Am J Drug Deliv 2
(3): 193-206, (2004)
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Quality Tests that pertain to Transdermal Adhesives
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Quality Testing of PSA Raw Materials
• Adhesive polymers used in TDD products are typically provided in solvent
• Typical Raw Material testing includes:
• ID
• % Solids
• Molecular Weight (or a surrogate such as Inherent Viscosity – I.V.)
• Residuals Content
• Initiator
• Monomers
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Peel Adhesion
• Measurement of the force
required to peel an adhesive
system from a test substrate
• Can be quite sensitive to
environmental conditions
• Example test substrates are
stainless steel or HDPE
• Practical experience: There is
no test substrate that mimics
skin.
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• There is no correlation between adhesion to steel and adhesion to skin
• Adhesion to steel is quite often (but not always!) substantially higher than adhesion to skin
• Increasing the adhesion to steel will not necessarily increase the adhesion to skin (sometimes just the opposite)
• Adhesion to steel is useful as a quality test only
• Useful reference: • Fauth C, Wiedersberg S, Neubert RHH, Dittgen M. Adhesive backing
foil interactions affecting the elasticity, adhesion strength of laminates, and how to interpret these properties of branded transdermal patches. Drug Dev Ind Pharm. 2002;28(10):1251-9.
Adhesion to Steel vs Adhesion to Skin
1509 LDPE 1513 PET 9877 PET
Adhesive Type Acrylate Same as #1509 Synthetic Rubber
Adhesion to Steel,
Typical
1450 g/in 1730 g/in 3400 g/n
Initial Adhesion to
Skin, Recorded Range
30-50 g/in 30-50 g/in 30-50 g/in
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Tack
• Measurement of the force required to pull a probe
(usually stainless steel) away from the adhesive
• Intended to quantify the “quick stick” of the
adhesive
• Practical experience – probe tack values have no
correlation with adhesion to skin performance
Probe Tack
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Release from Liner
• Measurement of the force required to peel
the adhesive system from the release liner
• Peel angle is usually 90 or 180 degrees
• Force is usually quite low (1-60 g/cm)
• This force is very representative of what the
patient experiences as they remove the liner
prior to patch application.
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Shear Adhesion
• Intended to be a measurement of the
internal (cohesive) strength of the adhesive
matrix
• Testing can be either static (hanging weight)
or dynamic
• Practical experience – shear testing is not
correlated with in vivo adhesion to skin
performance.
Static Shear
Dynamic Shear
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Cold Flow
• Measurement of the degree of adhesive
migration or detachment at the edge of the
TDD system
• Cold flow (when it occurs) is usually time
dependent
• A variety of test methods can be used:
• Visual
• Gravimetric
• Microscopic distance measurement
• Assay
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Summary
• Adhesive polymers play a crucial role in the performance of
TDD products
• Selection of an appropriate adhesive for TDD systems
requires consideration of it’s impact on many dimensions of
product performance
• Adhesion to skin is a particular challenge, and in vitro quality
tests are not predictive of in vivo performance
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Acknowledgements
Jim Dizio
Keith Dahmen
Kris Godbey
Steven Schull
© 3M 2015. All Rights Reserved. 3M Confidential
Thank you
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