Layered adhesive construction with adhesive layers having different hydrocolloid composition

ES 2 349 572 T3

- 2 LAYERED ADHESIVE CONSTRUCTION WITH ADHESIVE LAYERS HAVING DIFFERENT HYDROCOLOID COMPOSITION Description

FIELD OF THE INVENTION

The present invention relates to an adhesive construction comprising at least two layers of hydrocolloid adhesives having a different composition. These adhesive constructions are useful for gluing medical devices, such as ostomy bags, to the skin of patients.

In particular, the invention relates to an adhesive construction with two adhesive layers, in which the hydrocolloids of the first adhesive layer provide a higher initial moisture absorption capacity and a higher moisture absorption rate than the hydrocolloids of the second layer. adhesive, said second layer further comprises, hydrocolloids that provide improved cohesion upon absorption of moisture by the adhesive compared to hydrocolloids in the first adhesive layer. The first hydrocolloid adhesive layer, which provides high moisture absorption capacity and a high absorption rate, is used as a skin contact surface, while the second hydrocolloid adhesive layer provides moisture absorption as well as improves cohesion. , is placed at least partially away from the skin.

BACKGROUND OF THE INVENTION

Ostomy devices of the so-called one-piece and two-piece types are typically provided with an adhesive front face to adhesively secure the pouches to the wearer's peristomal skin and the hydrocolloid-containing adhesives that absorb moisture without damaging the skin have been used as adhesives for these front faces.

ES 2 349 572 T3

An initial type of skin-friendly adhesive is described in U.S. Patent No. 3,339,546 and consists of a mixture of water-soluble and water-swellable hydrocolloids, such as polyvinyl alcohol, pectin, gelatin, and / or carboxymethylcellulose and a water-insoluble elastic binder, such as polyisobutylene. When the hydrocolloids absorb moisture, this composition swells and begins to lose its integrity. To resist dissolution / disintegration, new hydrocolloid adhesive formulations were suggested, including physically cross-linked elastomers, such as styrene-olefin-styrene block copolymers and a fixative, see US Patent No._>^or 4,867,748. In US Patent No._>^or 6,451,883 describes hydrocolloid adhesives composed of a polymer mixture formed by copolymers of polybutene (in particular, polyisobutylene) and a styrene block copolymer (in particular, SIS) and a mixture of hydrocolloids, in particular, a mixture of gelatin , pectin and carboxymethylcellulose. According to this patent, an adhesive can be prepared that does not contain any fixative or oil by selecting an appropriate mixture of polybutenes and styrene block copolymer.

The adhesive construction according to the invention comprises at least two hydrocolloid adhesive layers, an adhesive layer with hydrocolloids providing high moisture absorption capacity and rapid initial moisture absorption as the skin contact layer, and a second layer Hydrocolloid adhesive that provides better cohesion than the first adhesive layer.

Adhesive constructions comprising hydrocolloid adhesive layers are well known in the art:

in the document

EP

1527789A1 describes a construction comprising a film and at least two

ES 2 349 572 T3

- 4 hydrocolloid adhesive layers with different composition.

The primary object of the adhesive construction described herein is to provide a multi-layered adhesive medical pouch having the properties of a tacky, pressure sensitive, skin-friendly adhesive for use close to the skin and a flexible, comfortable, and forgiving adhesive. moisture resistant that resists degradation after sterilization and is able to create a seal around the stoma in a controlled manner, for use away from the skin.

The adhesive for use adjacent to the skin is described as an adhesive comprising polyisobutylene and water-soluble or water-swellable hydrocolloids.

The adhesive for use away from the skin is described as an adhesive comprising polyisobutylenes or mixtures of one or more polyisobutylenes and butyl rubber, one or more radial or block-type styrene copolymer, mineral oil, one or more soluble hydrocolloid gums. in water and a fixative.

It is disclosed that a disadvantage of the known skin-friendly adhesives used adjacent to the skin is that they tend to be somewhat stiffer when they are too thick. Therefore, it is preferred that the adhesive layer adjacent to the skin is thinner than the more flexible, comfortable and moisture tolerant adhesive used away from the skin.

The layered adhesive construction according to the invention differs from the construction described in EP 1527789A1 in that the characteristic of the hydrocolloids is different in the two layers and in that the continuous phase (see below) is identical, or essentially identical in the two layers. two layers.

Similar adhesive constructions with two layers of hydrocolloid adhesives with different composition are described in EP 686381B2. According to

In ES 2 349 572 T3 this patent, the adhesive layer that secures the adhesive construction to the skin is composed of a skin-friendly hydrocolloid containing adhesive that has a resistance to dissolution and / or disintegration relatively when it enters with the fluids of the stoma, while that adhesive placed away from the adhesive material deform under the one in contact the other skin layer is composed of relatively white sealant, easy and extrudable that is more resistant to dissolution or disintegration by stoma liquids than the adhesive material in contact with the skin. From the drawings it is clear that the adhesive layer adjacent to the skin is thinner than the layer positioned away from the skin.

Again the laminated adhesive construction according to the invention differs from the construction described in the EP document, the characteristics of the hydrocolloids are different in the two layers and in that the continuous phase is identical, or essentially identical, in the adhesive.

the two layers

<td>In the</td><td>document</td><td>EP 413250A1</td><td>I know</td>

<td>building</td><td colspan="2">adhesive for use,</td><td>by</td>

<td>part of a</td><td>device</td><td>ostomy,</td><td>that</td>

<td colspan="2">reinforcing layer and two</td><td colspan="2">adhesive layers</td>

describes comprises hydrocolloids.

According to this document example, both adhesive layers are in contact with the skin, the adhesive layer in contact with the skin in the central part of the device being more than twice as thick as the adhesive layer in contact with the skin in the peripheral portion of the building.

It is indicated that the continuous phase of the two adhesive layers can be the same or different.

Two different compositions are mentioned for the adhesive layers, where the polymeric or continuous phase is different and the hydrocolloid mixture is identical, but it is presented in different amounts.

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- 6 In US Patent No. 4,538,603 an adhesive construction is also described that comprises two adhesive layers, which are of different composition and where the adhesive layer intended for contact with the skin is thicker than the adhesive layer placed away from the skin. The adhesive layer positioned away from the skin is relatively thin and is adhered to a foam layer that carries a film on the outer surface of the adhesive layer. The adhesive construction described herein is constructed to be useful in covering exudative wounds or ulcers. The relatively thin skin-contacting layer is disclosed to be comprised of ingredients that allow the adhesive construction to remain in place on the skin for several days. Water dispersible hydrocolloids, water-swellable cohesive reinforcing agents, and hydratable polymers distributed throughout the adhesive layer hydrate over time. Eventually, the adhesive layer is hydrated such that the construction can be removed without tearing or macerating the skin surrounding the wound. The relatively thick adhesive layer that is placed on the skin comprises a thermoplastic elastomer, such as a low molecular weight polyisobutylene, and hydrocolloids, water-swellable cohesive reinforcing agents, and hydratable polymers, while the relatively thin adhesive layer was placed away from the skin. Skin and sticking to the foam layer can also comprise plasticizers and fixatives.

Again, the two hydrocolloid adhesive layers have a different continuous phase.

In WO 94/15562 adhesive constructions composed of two adhesives are described, where one adhesive constitutes a layer in the form of an area within the other adhesive layer. It is described as the

ES 2 349 572 T3 additional material unit constituting the area may be of a less cohesive material than the adhesive material constituting the remainder of the construction.

It is also described how the difference in the cohesiveness of the two adhesives used is achieved by using different continuous phases for the two adhesives, while the hydrocolloid mixture remains the same in the two layers.

The layered laminated adhesive construction according to the invention differs from known laminated constructions in that the discontinuous phase (or hydrocolloids) is different in the two layers, in that the continuous phase of the adhesive is identical, or essentially identical, for the two layers of hydrocolloid adhesive and / or in which the adhesive layer in contact with the skin is thinner than the adhesive layer interposed between the backing layer and the adhesive layer in contact with the skin.

The adhesive construction according to the invention comprises at least two adhesive layers, a first adhesive layer with hydrocolloids that provides a high initial moisture absorption capacity and a rapid absorption of moisture towards the adhesive of the layer in contact with the skin and a second adhesive layer comprising hydrocolloids that provide good moisture absorption capacity and improved cohesion after absorption compared to the first adhesive layer. The second adhesive layer is positioned, at least in part, behind the first adhesive layer and away from the skin and is preferably thicker than the first adhesive layer. The second thicker layer of adhesive provides, together with its absorption capacity, an efficient method of transporting the first adhesive layer and even moisture from the second adhesive layer, where disintegration and formation of disintegrated adhesive clumps between the skin is decreased. and the

ES 2 349 572 T3 first layer of adhesive.

Due to the absorbency of the second adhesive layer, it will begin to swell once moisture begins to be absorbed from the first adhesive layer or possibly other sources. This is a particular advantage when the adhesive construction of the invention has a hole to receive a stoma and is used as a front face for the ostomy bag, since the second adhesive layer can swell and act to provide a seal in a situation where the that the first adhesive layer has partially disintegrated in the area around the stoma.

By selecting the same continuous phase for the two adhesive layers, the layers are completely compatible with each other and the migration of the components from one layer to the other is avoided.

SUMMARY OF THE INVENTION

Therefore, the present invention relates to a laminated adhesive construction comprising a reinforcing layer and a first and second hydrocolloid adhesive layer, where the first and second hydrocolloid adhesive layer have different composition and the second hydrocolloid adhesive layer is at the same time. less partially interposed between the first layer of hydrocolloid adhesive and the backing layer, the first and second adhesive layer consisting of a continuous phase and a discontinuous phase, where:

a) the discontinuous phase of the first adhesive layer comprises a hydrocolloid that provides a high moisture absorption capacity and a higher initial rate of moisture absorption for the adhesive than the hydrocolloids in the discontinuous phase of the second adhesive layer and

b) the discontinuous phase of the second adhesive layer comprises hydrocolloids that provide cohesion

ES 2 349 572 T3 _ 9 _ higher after moisture absorption than the hydrocolloids of the discontinuous phase of the first adhesive layer.

DETAILED DESCRIPTION OF THE INVENTION

As used herein, discontinuous phase means the hydrocolloids or mixture of hydrocolloids and any other particulate solids in the adhesive phases, such as fillers (native starch), colors, etc.

As used herein "continuous phase" means the entire adhesive composition except for the discontinuous phase defined above.

As used herein a higher cohesion upon moisture absorption relative to two hydrocolloid adhesives means a lower degree of disintegration / dissolution of the adhesive when the adhesives are exposed to water under the same conditions.

The difference in cohesion of the adhesives can be evaluated by coating samples of adhesives of identical dimensions with saline solution (0.9%) at a temperature of 37 ° C for a period of time (recommended for 18 hours) and then evaluating, visually the cohesiveness and touching and manipulating the samples to assess whether and to what degree disintegration or dissolution has occurred.

Absorption capacity ”is the amount of water absorbed when the adhesive has become saturated with water. Absorption capacity can be measured by placing samples of identical dimensions (eg. g., a 25 x 25 mm sample with a thickness of 1 mm) on a glass plate and covering the samples with saline solution (0.9%) at 37 ° C ± 2 ° C and wetting the sample (after surface of the sample has dried) after 5 min, 10 min, 20 min, 30 min, 60 min and 120 min, or until there is no further weight gain, then calculating the capacity absorption as the weight of water absorbed per unit weight of the

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- 10 adhesive, or per unit area of ​​the adhesive, when the adhesive is saturated with water.

As used herein, "initial absorption rate" is the absorption rate at 5 minutes. The initial absorption rate can be measured by placing samples of identical dimensions (eg. g., a 25 x 25 mm sample with a thickness of 1 mm) on a glass plate and covering the samples with saline solution (0.9%) at 37 ° C ± 2 ° C for 5 minutes and weighing the samples after drying the surface of the same and then calculating the increase in weight per unit weight of the adhesive and per unit area of ​​the adhesive, and calculating the absorption rate in the first 5 minutes by dividing by 5.

As used herein a front layer for an ostomy bag means a flat adhesive construction useful for bonding a bag to the peristomal skin of a patient and for protecting the skin surrounding the stoma.

The hydrocolloids in the adhesive layers can be of a single hydrocolloid type and a mixture of hydrocolloids.

Ideally, the hydrocolloids (or the mixture of hydrocolloids) in the first and second layers of the adhesives are different.

The continuous phases of the first and second adhesive layers are conveniently identical or essentially identical.

As used herein essentially identical means that other components may be present in lesser amounts in one continuous phase compared to the other continuous phase (less than 0.5% deviation per component from one continuous phase to another) and / or there is a smaller deviation in the composition of the two continuous phases, so that each constituent of one phase is present within ± 0.5% in the other phase.

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- 11 According to a preferred embodiment of the invention, the first hydrocolloid adhesive layer comprises hydrocolloids, which are capable of absorbing a large amount of moisture at a high initial absorption rate, that is, a hydrocolloid such as carboxymethylcellulose (in particular sodium carboxymethylcellulose ) or another hydrocolloid that provides similar absorption capacity and high initial absorption rate to the adhesive. A disadvantage of this adhesive composition is that the adhesive has a tendency to disintegrate upon absorption of moisture, especially if moisture is not efficiently transported through and away from the adhesive layer.

The second layer of the adhesive construction of the invention comprises a hydrocolloid that provides high cohesion to the adhesive upon absorption of moisture, such as guar gum or other hydrocolloids that provide similar good absorption and cohesion upon adsorption of the adhesive. Preferably, the second layer of adhesive is thicker than the first layer, thereby increasing the absorption capacity of the adhesive layer.

The combination of the two layers where the first adhesive layer, which is in contact with the moisture of the skin, presents a high and rapid initial absorption of moisture with a layer of hydrocolloid adhesive that is capable of absorbing large amounts of moisture while preserving its integrity (high cohesion), providing an adhesive construction where moisture is effectively absorbed by the first adhesive layer and carried through the first adhesive layer and into the second adhesive layer. This means that the sticky part of the first adhesive layer is preserved and therefore disintegration decreases.

It is necessary that the first adhesive layer is not particularly thick and is preferably thinner than

ES 2 349 572 T3 the second adhesive layer.

The hydrocolloids used in the layers of the adhesive construction of the invention can be selected from natural, synthetic and semi-synthetic hydrocolloids. Hydrocolloids useful for adhesives are well known in the art. Suitable water-soluble and water-swellable hydrocolloids include carboxymethylcellulose (eg sodium carboxymethylcellulose), pectin, gelatin, guar gum, locust bean gum, karaya gum, and the like.

According to one embodiment of the invention, the discontinuous phase of the first adhesive layer comprises 4050% w / w, preferably 45% w / w (based on the weight of the discontinuous phase) of sodium carboxymethylcellulose or of a hydrocolloid that provides a absorption capacity and initial absorption rate similar to the adhesive, and the discontinuous phase of the second adhesive layer comprises 35-45% w / w, preferably 40% w / w (based on the weight of the discontinuous phase) of guar gum or a hydrocolloid that provides absorbency and cohesion upon absorption of moisture similar to the adhesive.

Preferably, the discontinuous phase of the first adhesive layer comprises between 40 and 50% w / w, preferably 45% w / w of carboxymethylcellulose (conveniently sodium carboxymethylcellulose) and the discontinuous phase of the second adhesive layer comprises between 35 and 45% w / w, preferably 40% w / w guar gum and 15-25% w / w, preferably 20% w / w carboxymethylcellulose (eg sodium carboxymethylcellulose).

The hydrocolloids of the first adhesive layer in any of the above embodiments are conveniently a mixture of pectin, gelatin, and carboxymethylcellulose (preferably

ES 2 349 572 T3 sodium carboxymethyl cellulose) and the hydrocolloids in the second adhesive layer are conveniently a mixture of guar gum, gelatin and carboxymethyl cellulose (eg sodium carboxymethyl cellulose).

The hydrocolloids in the discontinuous phase of the first adhesive layer, suitably comprise a mixture of:

40-50% w / w, preferably 45% w / w carboxymethylcellulose (e.g. carboxymethylcellulose 15-25% w / w, preferably 20% w / w pectin and 30-40% w / w, preferably 33-35% w / w based on the weight of the discontinuous phase.

The hydrocolloids in the discontinuous phase of the second adhesive layer, suitably comprise a mixture of:

the

35-45% w / w, preferably 40% w / w guar gum, 15-25% w / w, preferably 20% w / w carboxymethylcellulose (eg, carboxymethylcellulose 35-45% w / w, preferably 40% w / w gelatin based on the weight of the discontinuous phase.

the

The first adhesive layer conveniently comprises

45-55% by weight of the discontinuous phase, preferably the% of the discontinuous phase.

The second adhesive layer also conveniently comprises 45-55% by weight of the discontinuous phase, preferably the%

of the discontinuous phase.

The polymer matrix composition of the first and second adhesive layer is preferably identical or essentially identical.

The continuous phase of the two adhesive layers can be

ES 2 349 572 T3

- 14 any known polymer composition that provides a pressure sensitive adhesive suitable for sticking to the skin.

Preferably, the continuous phase consists of a blend of a styrene block copolymer with a viscous liquid polyolefin, such as polyisobutylene. The need for oil that softens the styrene blocks and the fixative that improves the adhesive properties of the continuous phase can be avoided by selecting the appropriate mixture of styrene block copolymer in relation to the amount of viscous liquid polymer, see US Pat. .US. No. 6,451,883.

According to another embodiment of the invention, the aforementioned continuous phase can contain up to 15% w / w of a fixing resin, oil, etc.

According to a preferred embodiment of the invention, the continuous phase comprises 15-25% w / w, preferably about 20% w / w of styrene block copolymer, such as Kraton D1107, Kraton D-1161 NU or block copolymers of similar styrene and 7585% w / w, preferably 80% w / w viscous liquid polyisobutylene, such as Oppanol B 12 SFN.

These compositions are described in US 6,451,883.

In one embodiment of the invention, the second adhesive layer extends beyond the perimeter of the first adhesive layer and may contact the skin beyond the area where the first adhesive layer contacts the skin. According to this embodiment of the invention, the first adhesive layer can be thinner than the second adhesive layer and the first adhesive layer can be embedded in the second adhesive layer. This embodiment of the invention is illustrated in Fig. 1, showing the reinforcing layer (1), the second adhesive layer (2) and the first adhesive layer (3).

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- 15 As used in this embedded document means that one layer is embedded in the other layer so that only one of the surfaces of the embedded layer is not covered by the other layer. These adhesive constructions can be prepared as described in WO 00/18554.

In another embodiment of the invention, the second adhesive layer is glued on top of the first adhesive layer and the second adhesive layer extends beyond the perimeter of the first adhesive layer and can come into contact with the skin beyond the area where the first adhesive layer adhesive layer comes into contact with the skin. This is illustrated in Fig. 2, which shows the reinforcing layer (1), the second adhesive layer (2) and the first adhesive layer (3). Conveniently, the first adhesive layer is thinner than the second adhesive layer.

The first and second adhesive layers may have the same area and shape, and be aligned one on top of the other. Again, preferably the first adhesive layer is thinner than the second adhesive layer, see Fig. 3 which shows the reinforcing layer (1), the second adhesive layer (2) and the first adhesive layer (3). These adhesive constructions are prepared by preparing the layers separately and laminating the second adhesive layer between the backing layer and the first adhesive layer.

Conveniently, the thickness of the first adhesive layer is conveniently 0.1-0.4 mm, preferably 0.25-0.35 mm or, more preferably 0.3 mm, and the thickness of the second adhesive layer between the layer of reinforcement and the first adhesive layer is suitably between 0.5-1 mm, preferably 0.5-0.9 mm, more preferred 0.5-0.8 mm, or more preferred 0.5-0 , 7 mm.

The adhesive construction according to the invention may have beveled perimeters, where both adhesive layers are beveled, or in the case where the second

ES 2 349 572 T3 adhesive layer extends beyond the edges

- 16 peripherals of the first adhesive layer, only the second adhesive layer is beveled.

This is illustrated in

Fig. 1. As indicated, the second adhesive layer can be made thinner than the first adhesive layer at the beveled peripheral portion.

The surface of the adhesive layer (eg, the second adhesive layer) adhered to the backing layer is suitably completely covered by the backing layer.

The reinforcing layer may be a thin polymeric film, a film having multiple polymeric layers, a non-woven structure, or an optionally closed cell or open cell foam layer having its outer surface covered by a film.

Suitable materials for thin polymeric films include polyolefins, such as polyethylene, polypropylene, acrylic acids and ethylene, vinyl and ethylene acetates, polyvinylchlorides, polyether sulfones, polyether ketones, polyurethanes, etc. Polymeric films are conveniently impermeable to liquid water and can have varying degrees of permeability to water vapor. Nonwoven structures include those made from polyester fibers, polypropylene fibers, nylon fibers, mixed / composite olefin fibers, or cellulose.

The thickness of the reinforcing layer can vary depending on the material of which it is composed. The thickness of the backing layer is conveniently 30-100 pm, preferably 40-70 pm.

The backing layer can also be a foam layer as described in US 4,538,603.

The reinforcing layer can be a weldable material so that other parts or devices can be welded

ES 2 349 572 T3 on the reinforcing layer.

The types of release liner well known in the art can be applied to the adhesive surface of the adhesive construction according to the invention. These release liner papers are well known in the art.

The adhesive construction according to the invention may contain additional adhesive layers, additional film layers or other layers.

According to a further embodiment of the invention, the laminated adhesive construction has a pattern of indentations in the form of grooves on the surface that provides the reinforcing layer.

These grooves enhance the flexibility of the adhesive construction and are formed in the adhesive layers closest to the backing layer (eg, the second adhesive layer), leaving the backing layer and skin-contacting adhesive layer intact. . The depth of the grooves is preferably less than the thickness of the adhesive layers close to the backing layer, e.g. eg, the second adhesive layer.

According to one embodiment, the indentations extend radially from the center of the laminated adhesive construction towards the periphery of the laminated adhesive construction.

Optionally, the adhesive construction also has curvilinear indentations that pass through the radial indentations.

The use of indentations to improve the flexibility of an adhesive construction has been described in WO 04/087004.

EXPERIMENTAL PROCEDURE

Materials:

<td>Oppanol B 12 SFN,</td><td>polyisobutylene</td><td>from BASF,</td><td>P.M:</td>

<td> 60.000-80.000</td><td></td><td></td><td></td>

<td>Kraton D-1161 NU,</td><td>copolymer in</td><td>SIS block</td><td>of</td>

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- 18 KRATON Polymers

Akucell AF 2881, Sodium Carboxymethyl Cellulose from AKZO

Gelatin UF 220 from PB Gelatins Guar Gum FG-200 from Nordisk Gelatine

Pectin Pomosin LM 12 CG-Z / 200 from Copenhagen Pectin Bayferrox, Fe₂OR₃ available from Bayer.

EXAMPLE 1

Composition of the second adhesive layer:

<td>Component</td><td>Amount in grams</td>

<td>Oppanol B 12 SFN</td><td> 40</td>

<td>Kraton D-1161 NU</td><td> 10</td>

<td>Akucell AF 2881</td><td> 10</td>

<td>Gelatin UF 220</td><td> 20</td>

<td>Guar Gum FG-200</td><td> 20</td>

EXAMPLE 2

Composition of the first adhesive layer:

<td>Component</td><td>Amount in grams</td>

<td>Oppanol B 12 SFN</td><td> 40</td>

<td>Kraton D-1161 NU</td><td> 10</td>

<td>Pectin Pomosin LM 12 CG-Z / 200</td><td> 10</td>

<td>Akucell AF 2881</td><td> 22,5</td>

<td>Gelatin PB 220</td><td> 17,47</td>

<td>Bayferrox</td><td> 0,03</td>

EXAMPLE 3

Hydrocolloid adhesives can be prepared by heating the components in a Z-mixer according to procedures well known in the art and the layered adhesive construction can be prepared as described herein.

Four clinical studies were conducted using the layered adhesive construction.

EXAMPLE 4

In the DK 151 OS study (approved by the commission

ES 2 349 572 T3

- 19 Freiburger ethics, study code: DK145OS, Feci code: 05/1609) 64 German individuals with an ileostomy tested the layered adhesive construction with a drainage bag compared to a reference product, the Moderma Flex adhesive sheet with space chamber technology ”from Hollister Inc. The study was an open-label, randomized, comparative, multicenter, crossover study. The study showed that the participants experienced less erosion with the laminated adhesive, 77% showed no or little erosion with the laminated adhesive and 55% for the reference. It was also recognized that the immediate adhesion to the skin (tack) was significantly better with the layered adhesive experienced by 83%, while it was 55% for the reference, as well as it was less painful to remove the layered adhesive compared to the reference. .

EXAMPLE 5

In the feasibility study DK 153 OS (approved by the Comité Consultatif de Protection des Personnes dans Ia Recherche Biomedicale de haute Normandie 12/08/2005 sous Ie n ° 2005/031) 59 French individuals with an ileostomy tested the layered adhesive construction with a drainage bag compared to Convatec's Esteem with Invosiclose reference product. The study was an open-label, randomized, cross-group comparison study. The study showed that immediate adhesion to the skin (tack) was better or much better with the layered adhesive in 93% of the participants compared to 66% for the Esteem adhesive. It was also found that adhesion during use was also good or very good in 76% with the layered adhesive, which was significantly better than the 45% experienced for the

ES 2 349 572 T3

- 20 Esteem adhesive. Immediate adhesion and in-use adhesion were linked to initial water absorption rate and water absorption after 120 minutes. The study also showed that the participants experienced significantly less residue left on the skin when the layered adhesive was used. A significantly better sense of security was also experienced with the layered adhesive construction.

EXAMPLE 6

In the feasibility study DK 109 OS (approved by the Regionale Videnskabsetiske Komité 0ST J. no .: 2005-207G) 68 Danish individuals with a colostomy tested the layered adhesive construction with a closed bag. The product was tested against the comparator, Nova 1, with a single layer adhesive from Dansac A / S. The study was a randomized, cross-over comparative study. The study showed that immediate adhesion to the skin (tack) and in-use adhesion were significantly better when using the layered adhesive construction compared to the reference product (immediate adhesion, p &lt;0.0001 and in-use adhesion). p &lt;0.0175). Immediate adhesion and in-use adhesion were linked to initial water absorption rate and water absorption after 120 minutes. The pain when the bag was removed was also found to be significantly less compared to the reference product as well as the overall feeling of security.

EXAMPLE 7

In the DK 145 OS study (approved by the Freiburger Ethics Commission, study code: DK145OS, Feci code: 05/2099) 69 German individuals with a colostomy tested the layered adhesive construction with a closed bag. The product was tested against the comparator

ES 2 349 572 T3

- 21 Moderma Flex from Hollister. The study was a randomized, cross-over comparative study. The study showed that the immediate adhesion to the skin (tack) was significantly better when the layered adhesive construction was used compared to the reference product (p &lt;0.0001).

As mentioned above, the first hydrocolloid adhesive layer providing high moisture absorption capacity and high absorption rate is used as the skin contact surface, while the second hydrocolloid adhesive layer providing moisture absorption As well as improving cohesion, it is placed at least partially away from the skin. That the cohesion is stronger for the layered adhesive after being covered with water with 0.9% NaCl for 18 hours was demonstrated in the test notified to the Danish Institute of Technology, publication number: 1220519-02 fgu / eta. This is shown for each of the Convatec, Dansac A / S, and Hollister adhesives.