Healthcare Solutions

Review of silicone adhesives in healthcare applications

Jerry Schalau II, Anne-Lise Girboux, Xavier Thomas

Abstract wear discreetly and securely for a couple of weeks, as well

as easily change or reposition when required. Again, silicone
This review report provides foundational knowledge of the
technology is well-positioned to provide suitable adhesive
use, success and challenges of medical silicone adhesives
solutions by building on its recognized suitability in well-
in healthcare applications. Specifically, the authors discuss
established medical applications and extending its performance
chemistry, characterization and demonstrated applications
to answer the new challenges rising from the development of
of pressure sensitive adhesive (PSA) and soft skin adhesive
advanced e-health systems.
(SSA) technologies. The authors report factors that should
be considered when determining an appropriate adhesive
The term “silicone” normally refers to a chemical structure based
for healthcare applications and discuss recently developed
on the siloxane unit as shown in Figure 1, with the substituent R
adhesives and considerations for future adhesive
being mainly an alkyl group or another siloxane sequence. The
developments.
substitution also can be designed to be a reactive functionality
(e.g., H, OH, vinyl, alkoxy, etc.) or to deliver specific properties,
such as surfactant with polyether chain or anchorage with
Structure/properties of silicones
glycidyl or amine group.
First commercialized in 1942 for use as insulating dielectric
grease in aircraft ignition systems, silicone-based materials Figure 1. Typical The most commercially available
experienced very rapid development in all segments of the dimethyl siloxane unit; molecular sequence is the
industry1 thanks to their unique physical properties – R1, R2 are alkyl groups polydimethylsiloxane structure,
as masterfully explained by Dr. M.J. Owen in “Why Silicones commonly adopted for economic reasons –
Behave Funny,” successively published in 1981 and 20042,3. R1
and because it delivers the optimal
The health industry quickly understood the potential of this interfacial properties, which are the
technology, and it is not surprising that the history of silicones Si
O raison d’être of silicones. Regarding their
as biomaterials finds its origin with chlorosilane to coat n uses as adhesives, the dimethylsiloxane
blood-containing devices to delay clotting4 or with the use of
R 2
architecture is directly responsible for
silicone elastomer for duct repair in biliary surgery5 in 1946. the bulk viscoelasticity and the surface activity that are the key
physical parameters allowing a material to both adhere to a
Since then, silicones have been used in various applications substrate and be removed from it. Associated with the confirmed
for life improvement and health restoration; they now benefit biocompatibility, silicone technology allows for designing
from more than 70 years of safety and efficacy in medical and different types of pressure sensitive adhesives to answer the
pharmaceutical applications, making them a common choice demanding needs of medical applications for temporarily
when designing advanced medical and drug systems. This is attaching and securing therapeutic devices to the body.
particularly true when the device is to be attached to the human
body for a few hours to several days, requiring reliable yet Pressure sensitive adhesives (PSAs) differ from structural
comfortable adhesion to skin. In wound care and transdermal adhesives in that the adhesive-substrate interface does not resist
drug delivery systems, medical silicone skin adhesives have separation when the adhesive is peeled off. In other words, PSAs
demonstrated their efficacy in providing both atraumatic are intended to show adhesive failure – especially when skin
adhesion and optimal drug diffusion. The emerging trends is the substrate – whereas this would be considered a major
toward remote patient monitoring to anticipate health issues flaw for cement and glue. Silicone material can be designed
and allow return-to-home care with confidence and prevent and formulated to be pressure sensitive adhesives (e.g., sticking
rehospitalization have positively fueled the demands for plaster, adhesive bandage) and/or structural adhesives (e.g.,
wearable and connected medical devices that patients can sealant, surgical glue).6
 Silicone pressure sensitive adhesives (PSAs) The two most important factors in determining the performance
characteristics of silicone PSAs are the resin-to-polymer ratio and
Silicone PSAs are viscoelastic compounds based on the resin-
the degree of crosslinking7. A certain amount of resin is required
in-polymer concept. Unlike organic PSAs, they do not need
to tackify the polymer so that it exhibits PSA qualities. Above the
additives such as antioxidants, stabilizers, plasticizers, catalysts or
minimum level, increased resin content results in a more tightly
other potentially extractable substances. They are produced by
crosslinked silicone network and more cohesive strength (or
condensing silanol end-blocked polymer with a silicate resin in
shear strength). More fluid leads to higher tackiness, softness and
the presence of ammonia, as shown in Figure 2. The polymer
adhesion to skin as the PSA flows and more readily conforms to
is a medium-viscosity to low-viscosity silanol end-blocked
the skin surface.
polydimethylsiloxane. The resin is a three-dimensional silicate
network. Ammonia initiates the crosslinking reaction, resulting in
In each family (standard or amine-compatible), silicone PSAs
a reinforced siloxane network with improved cohesive strength.
are proposed with three different ratios of resin-to-polymer,
respectively:
Figure 2. Silicone PSA schematic
• Low tack and high cohesion
• Balanced tack/cohesion
• High tack

Silicone PSAs are available in different processing solvents,

mainly ethyl acetate or heptane. The solvent is selected
according to the final patch formulation strategy, (e.g., selecting
a solvent in which all formulation components may be
homogenized during the coating step). Solventless varieties of
silicone PSAs also are available and may be processed using
standard hot-melt coating equipment.

Characterization of PSAs
PSA characterization is critical to product development and
quality control. Physical performance property testing –
sometimes referred to as “tape tests” and “peel tests” – often is
Standard silicone PSAs contain a certain level of silanol conducted. Common properties assessed by tape testing include
functionality that can favorably participate in the compatibilization adhesion, shear strength, tackiness and the force required to
of drugs and excipients. However, these reactive hydroxyl groups remove the release liner from the adhesive. This type of testing
could further react with amine-containing drugs, thus impacting is not limited to healthcare applications, and many of the tests
adhesive performance and potentially drug release rates. For this for healthcare adhesives were derived from similar tests for the
reason, a second family of adhesives is produced by further broader adhesive market. Tape testing typically is performed by
reacting the adhesive with a trimethylsilyl endcapping agent. casting or coating the adhesive onto a substrate in a specified
This family is referred to as amine-compatible and exhibits thickness – essentially creating a tape – and then measuring
enhanced chemical stability, especially in the presence of properties of the created tape. Silicone PSA testing typically
amine-functional drugs. Silicone PSAs produced by this process is conducted on relatively thin adhesive layers, commonly
have been shown to have many key features that make them between 2 to 5 mil (approximately 51 to 127 micron). Adhesive
suitable for applications bonding to skin. peel tests are well-described in the literature and are common
to most adhesives; they typically occur at 90° or 180°, and the
A subfamily of standard PSAs referred as “standard reduced force to remove the adhesive from a substrate (e.g., stainless
silanol” (SRS) was developed to offer a lower level of silanol steel in many cases) is measured. The advantages of tape
groups. These PSAs still are classified as standard PSAs from a testing methodology include ease of setup, reproducibility and
regulatory point of view. The reduced residual silanol level in SRS a straightforward interpretation of data. Unfortunately, these
BIO-PSAs is achieved by using a less-reactive resin for the silanol tests often have a high degree of variability, resulting in wide
condensation reaction. The use of a less-reactive resin leads to specification limits and poor correlation between users, and
“softer” adhesives with: thus limited prediction of the adhesive’s performance in real-
• Less silanol condensation life applications. Tape test results may be influenced heavily
• Lower complex viscosity (i.e., eta star ( η*)) by adhesive coating thickness, the substrate onto which the
• Lower viscosity adhesive is coated and the substrate against which the PSA’s
adhesion is measured. To minimize these influences, there must
The adhesive performance of silicone PSAs is based on the be accurate control of sample preparation, including adhesive
viscoelastic behavior as demonstrated by their rheological thickness, standardization of tape materials (e.g., backing and
profiles, ensuring a good balance of wetting and spreadability release liner) and test parameters. Despite these drawbacks,
(viscous component) brought by the silanol polydimethylsiloxane tape testing is nearly ubiquitous amongst adhesive
and cohesiveness (elastic component) brought by the resin. manufacturers and users.

2
A distinction between peel adhesion and the tack of an adhesive Rheology is a technique to characterize viscoelastic properties
should be made; peel adhesion is representative of the bonding of polymers and also may predict wear performance of PSAs.
strength of an adhesive, whereas tack is representative of the As shown in Figure 4, a generalized rheological curve can be
ability to quickly stick to a substrate. Analytically, the distinction correlated to common tape properties8,9,10,11.
between peel adhesion and tack measurements is the time
allowed for the adhesive to bond with the substrate. When Figure 4. Schematic representation of the link between
measuring tack, the measurement is taken almost immediately rheological profile and PSA wear performance
after the adhesive contacts the test substrate, whereas peel
adhesion is measured after the adhesive is left in contact with
the substrate for a longer period. A longer dwell time between
application and testing allows the adhesive to wet out on the Peel
surface and the adhesion to build.

G’, Pa
Tack
Application
Due to the influence of substrates on adhesion and tack, the on skin
shear test may have more direct relevance to skin contact Creep under
adhesive applications than peel adhesion and tack tests. Typically, load

the static shear test is the measurement of the time for the 0.01 0.1 1.0 10 100
adhesive to detach from a surface (e.g., stainless steel) under Frequency, rad/s
a constant weight and is indicative of the cohesive strength of
an adhesive. Shear tests of fully formulated adhesive matrices
may be conducted to evaluate how additives (e.g., drugs and For viscoelastic materials, such as silicone PSAs, the frequency
other materials used to solubilize and enhance drug permeation) sweep curves are sensitive to structural differences (e.g., crosslink
impact the shear strength of a transdermal drug formulation. By density) and formulation changes (e.g., resin-to-polymer ratio).
way of example, as shown in Figure 3, the addition of different This sensitivity provides a means to identify, characterize and
levels of propylene glycol does not have a statistical impact on predict adhesive wear performance.
the static shear of a low-resin-content silicone PSA. However, a
significant decrease of the static shear was observed with the The storage modulus (G’) is an indicator of how elastic the
addition of isopropyl myristate, demonstrating how different adhesive is and how much energy is stored during deformation.
materials can impact the cohesiveness of the adhesive matrix. The loss modulus (G”) is an indicator of viscous component of the
PSA and how much energy is lost as heat. The complex viscosity
Figure 3. Impact of the addition of different levels of isopropyl
( η*) is an indicator of the adhesive bulk viscosity and can be
myristate (IPM), propylene glycol on the static shear of a low-
related to cold flow of the adhesive. Bonding of an adhesive
resin-content silicone PSA
system is dependent on the wetting behavior of the adhesive
10 when it encounters skin and occurs at a low deformation rate.
Rheologically, the storage modulus (G’) values at low frequency
8 are used for predicting wetting and creep (cold flow) resistance.
Optimum wetting occurs when the adhesive modulus is low.
Shear time, hr

Subsequently, debonding of a transdermal system occurs at high

4
deformation rates. Rheologically, the storage modulus (G’) and
loss modulus (G”) at high frequency may be related to the peel
2
adhesion and tack (i.e., quick stick) properties of an adhesive.
0
For bonding, the viscous contribution should be higher than the
Pure IPM IPM IPM Propylene Propylene Propylene elastic contribution to the PSA’s viscoelastic profile. In rheological
glycol glycol glycol
% excipient 0 1.6 3.4 8.2 1.6 4.0 8.0
terms, it means that at low frequencies, G’ should be less than
G” – and the opposite for the debonding step, represented at high
frequencies, where G‘ should be greater than or equal to G”.
Tape properties may predict how quickly a system bonds to a Based on those interpretations, the rheological traces in Figure 5
substrate and how much force is needed to remove it. However, suggest that the increase of resin content should lead to a
those tests do not measure the wear performance of the system. reduction of adhesive cold flow (i.e., an increase of the complex
To better understand and predict the wear performance of viscosity with resin content) and an increase of the adhesion
adhesive systems, rheology often is used to understand the level (i.e., an increase of both G’ and G” with resin content).
adhesive bulk viscoelastic behavior. Rheological characterization
allows the analyst to overcome the inherent uncertainty linked to
peel, tack and shear tests by minimizing the influence of
sample preparation and substrate variability on adhesive
characterization results.

3
 Figure 5. Typical frequency sweeps of silicone PSAs at two common Figure 6. Chang viscoelastic window concept adapted for
resin contents (high, 8 mm parallel plates, 0.35% strain; low, 25 mm low-resin-content silicone PSA with differing amounts of IPM
plates, 0.5%); all samples tested at 30°C and 1.5 mm gap versus neat adhesive

High resin content Low resin content BIO-PSA – pure BIO-PSA + 0.8% IPM BIO-PSA + 1.7% IPM
109 1010
BIO-PSA + 3.3% IPM Dahlquist’s criteria
G', dyne/cm2; G'', dyne/cm2

108 109
107

107 108

Eta*, P
106

106 107
105

G’, Pa
105 106
104

104 105
10-2 10-1 100 101 102 103
Frequency, rad/s
102
102 103 104 105 106 107
In 1969, Carl Dahlquist defined a specific elastic modulus point
G”, Pa
below which a material will have quick tack regardless of other
parameters. In the early 1990s, E.P. Chang developed a theory
to interpret rheological data of PSAs and establish criteria for
PSA classification when used in conjunction with the Dahlquist Soft skin adhesives (SSAs)
criteria. This theory is now well-known and used as the “Chang Silicone tacky gel technology was introduced to the wound care
viscoelastic window.” As shown in Figure 6, a G’ versus G” graph market and named “soft skin adhesives” (SSAs) by Dow Corning
is divided into 4 quadrants with a central axis. The location of Corporation in the 1990s. Similar materials are offered today
the analyzed PSA within this graph allows a straightforward under a variety of brand names from many silicone suppliers.
extrapolation from rheological properties to real-world adhesion In a segment historically dominated by acrylic adhesives, the
performance. For example, the upper-right quadrant corresponds tacky gel technology concept disrupted the industry by securing
to high modulus and high dissipation. Therefore, materials in this wound dressings while providing gentle adhesion upon removal.
quadrant with characteristic high G’ modulus compensated by Due to their reliable adhesiveness while being easier to remove
the high G” are anticipated to be adhesive materials with high and causing less pain upon removal than many other adhesive
adhesion but low tack and high shear resistance. Conversely, technologies, SSAs have become the material of choice in many
the lower-left quadrant corresponds to low modulus and low advanced wound care and scar therapy applications.
dissipation. For these materials, peel values usually are low
because of the comparatively low debonding cohesive strength The elastomeric structure of SSAs is obtained by crosslinking a
and low dissipation. network of polydimethylsiloxane (PDMS). The reaction is based
on an addition reaction (hydrosilylation) between vinyl-functional
The lowermost edge of the window, which is linked to bonding PDMS (polymer) and hydrogen-functional siloxanes (crosslinker)
of the adhesive, is far below Dahlquist’s criteria, so the adhesive as shown in Figure 7. The cure reaction is catalyzed by a platinum
can be expected to have reasonable tack. Changes in the Chang complex, which can occur at room temperature or be accelerated
viscoelastic window of a low-resin-content (high-tack) silicone at elevated temperature (80°C to 145°C) without the formation
PSA can be observed as isopropyl myristate (IPM) – a commonly of reaction by-products. As crosslinked, thermoset materials,
used permeation enhancer that can plasticize or soften the SSAs have a low susceptibility to cold flow and plasticizing
adhesive – is added. As illustrated in Figure 6, the Chang effects. SSAs are supplied as two-part systems with the catalyst
viscoelastic window moves from the upper-right quadrant for in one part and the crosslinker in the other. The materials
the neat adhesive to the lower-left quadrant as more IPM is characteristically are transparent before and after curing into a
added and the adhesive softens. There is a significant shift in solid matrix6,12.
the position of the upper-right corner as IPM content increases.
This shift is linked to debonding (peel) efficiency, suggesting that
an increase in IPM content decreases peel efficiency. Adhesives
with poor peel efficiency may remove less cleanly from surfaces
to which they have bonded. Finally, the window size increase
indicates a decrease of PSA shear strength that likely is due
to better solvent compatibility in the PSA. These data support
known observed changes in adhesive properties as plasticizing
agents like IPM are added and support the further use of
rheological measurements to characterize changes in PSA
wear properties.

4
Figure 7. A proposed schematic for the hydrosilylation reaction reliable adhesiveness and cohesiveness, gentle adhesion to
fragile and compromised skin, no skin-stripping, and pain-free
Vinyl- and hydrogen-
functional groups device removal6,12.
Polydimethylsiloxane
R
H3C Si CH3 Substrate selection is important when designing an adhesive

y
H O device based on SSA, as the nature of the substrate can have
CH3 CH3 C H H Si CH3 a significant impact on the coating and cure conditions during
R Si O Si C
the manufacturing phase. Anchorage of the adhesive to the

x
CH3 CH3 H O
n H3C Si CH3 substrate, cohesiveness of the adhesive after cure and the
ultimate wear behavior of the device when applied to the body
R
Catalyst all can be impacted by substrate selection.
R
H3C Si CH3 SSAs typically are processed by mixing the two parts and coating
y

CH3 CH3 H H O the mixture directly onto the final substrate (e.g., backing film),
R Si O Si C C Si CH3 with the understanding that this film must be impermeable
CH3 CH3 H H
enough to prevent the uncured liquid SSA from wicking through.
x

n O
H3C Si CH3 The typical coat weight for SSA can vary widely depending on the
desired final properties, but it often ranges between 150 g/m² and
R
250 g/m². The curing phase typically is completed at an elevated
R = Continuation of polymer chain/network
temperature that is adjusted to the temperature sensitivity of
the substrate. After cooling, the adhesive surface is protected by
SSAs are based on a polydimethylsiloxane network that supports
a release liner that is peeled off when the end-user applies the
the critical adhesive attributes required for securing the device in
adhesive to skin. The choice of release liner is a critical factor,
place and removing it without leaving residue or damaging the
as it can affect the device stability and make it unusable if the
skin. Unlike silicone PSAs – which build adhesiveness on a
protective film cannot be removed easily from the adhesive
viscous phase bodied with a silicate resin – SSAs are based on
prior to use. Traditional silicone release liners that are used
silicone elastomer technology modified to deliver the relevant
ubiquitously with acrylic adhesives cannot be used with SSA, as
viscoelastic profile. They also differ from analogous silicone
the silicone release liner chemistry is similar enough to SSA that
elastomers (e.g., liquid silicone rubber [LSR] technology) by the
they are highly likely to interact and experience an irreversible
absence of reinforcing silica filler. As a result, SSAs have a similar
lockup effect upon storage. However, uncoated polyethylene
texture and feel to other gels; however, SSAs are not typical
films – especially low-density polyethylene (LDPE) grade – can
polymeric gels because they are not based on an insoluble
provide an acceptably low and reasonably consistent release
polymer network swollen with fluids. The viscoelastic behavior of
force from the SSA13,12.
SSA also differs from silicone PSA: Despite their low consistency
and a high degree of compressibility, SSAs show resilience and
quick recovery under cyclic deformation.
Relevant markets & uses
The adhesive property of SSAs is based on the capacity of the Transdermal drug delivery systems (TDDS) are suitable
elastomer surface to quickly wet the skin and conform to skin alternatives to oral dosage forms to overcome the very low
irregularities without the additional compression step required bioavailability encountered with some molecules, such as
for a PSA. Thanks to the low intensity of the viscous component rotigotine. The adhesive is a critical component of a TDDS –
of the SSA rheological profile, the adhesive does not flow both as reservoir matrix and delivery vector of the drug. A
significantly, and very little dissipation of the energy occurs judicious selection of the appropriate adhesive is an important
when deformation pressure is applied to the SSA. As a result, consideration for the development of a new TDDS for optimizing
SSA debonding happens at low peel force – without skin-stripping skin penetration and wear properties. The adhesive must be
and painful skin-pulling when the adhesive device is removed. compatible with the drug and the other excipients, as well as
Being elastomeric by nature, SSAs experience very limited flow, with the variability of patient skin. Finally, it is critical that the
and they consequently have little ability to pick up materials adhesive provides acceptable release of the drug and favors its
from the surface of the skin. Therefore – unlike silicone PSAs partitioning into the skin.
– the adhesive surface of SSAs remains relatively clean upon
removal from the skin, which allows for removal and easy Silicone PSAs have been used in TDDS for more than 40 years.
reapplication of the dressing or device to the skin and makes They were introduced in this use in 1981 in a nitroglycerine
repositioning possible. reservoir patch for the treatment of angina pectoris. Since then,
many patch products using silicone PSAs – either as the primary
The SSA technology has been used extensively in scar treatment adhesive system or in combination with acrylic adhesives in
and advanced wound management, demonstrating safety and multilayer designs – have gained approval. Multiple designs
efficacy recognized by wound care professionals. SSAs may be are reported in the literature and are available commercially,
recommended for use in designing medical adhesive devices, including reservoir, matrix and drug-in-adhesive systems.
tapes, bandages, drapes and wound dressings. They have been Examples of active pharmaceutical ingredients (APIs) used in
noted for many benefits, including high tack for quick bonding commercial TDDS are fentanyl for pain management, estradiol
to skin, permeability to moisture and gases (e.g., CO2, O2), for hormone replacement therapy, and rotigotine or rivastigmine
for CNS diseases12.
5
 During the last 30-plus years, multiple fentanyl patches have To tackle new market trends in terms of adhesives for advanced
been formulated with silicone PSAs. The first fentanyl patch medical systems such as wearable devices and topical drug
was introduced to the U.S. market in 1991. In general, fentanyl delivery patches, new SSA technology has been adapted and
patches containing silicone PSAs have the highest drug customized to allow more effective processability and to achieve
depletion and lowest residual drug content after the 72-hour higher adhesion and longer wear times of final products22,23,24,25.
wear period compared to patches containing polyisobutylene These advancements have been accomplished through the use
(PIB) or acrylic PSAs. of various silicone polymer chain lengths (i.e., molecular weight),
differing functionalities and reinforcement of the open three-
A rotigotine transdermal system called NEUPRO® was developed dimensional structure. While it is unknown exactly which needs
and approved for idiopathic Parkinson’s disease and restless or applications will materialize, silicone adhesives have a proven
legs syndrome in the U.S. and European Union. This transdermal history of alterations to meet market challenges and increasingly
delivery system consists of a thin, silicone-based, matrix-type demanding needs, and applications requiring increased electrical
patch with a 24-hour wear period14. conductivity and hydrophilicity may be on the horizon. §

Recently, Puri at al. reported the development of a TDDS for

tenofovir alafenamide – a potent drug of tenofovir – for
human immunodeficiency virus (HIV) prophylaxis and HIV
and hepatitis B virus treatment. The silicone-based patch
showed the highest permeation compared to PIB-based and
acrylates-based patches15.

New SSA technologies have been developed that can achieve

higher adhesion, longer wear times and improved drug
compatibility to address emerging medical market trends,
including wearable devices and topical drug delivery patches6.
The use of SSA technology to formulate drug delivery matrices
enables drug delivery system designs that address the need for
secure and gentle fixation to fragile, sensitive or compromised
skin conditions common in dermatology, wound care, pediatrics
and gerontology. Several studies were conducted to evaluate
the compatibility of various drugs and their release from SSA
matrices. A variety of APIs have been studied, including those
indicated for pain relief and local anesthesia, antibiotics, and
dermatological actives13. Wound care products that utilize silicone
tacky gels as the skin contact adhesive and are loaded with
chlorhexidine gluconate and other antimicrobial agents have
been investigated and commercialized16,17. This may signal further
interest in the utilization of SSA in even more advanced active-
loaded therapies in addition to the traditional wound therapies
where it historically has been used.

New silicone adhesive developments

Performance-enhancing advancements have been realized
for both PSAs and tacky gels, enabling their utility in more-
demanding applications. Hybrid PSAs that combine silicone
and organic functionalities promise expansion in healthcare
applications, enhancing drug solubility and enabling treatment
options for drugs and indications not available with previous
adhesive chemistries. One of the most advanced systems
has been silicone-acrylic PSA technology, either as blend
or copolymer18,19,20,21. Unlike simple blends, the copolymer-
based adhesives are capable of much finer domain sizes and
demonstrate superior phase stability during formulation and
in cast films. Other hybrid adhesive developments promise
increased hydrophilicity, allowing straightforward incorporation
of hydrophilic drugs and improved wearability on moist skin, with
similar adhesion to traditional PSA while utilizing less-specialized
release liners.

6
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For further information
Please contact Anne-Lise Girboux: [email protected]

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Form No. 06-1048-01-AGP0422 #16798