Multilayer film for ostomy skin adhesive wafer appliance

Abstract

A multilayer film for an ostomy skin adhesive barrier appliance for adhering to a skin-friendly adhesive and to an ostomy pouch or ostomy pouch intermediate member, includes a first outer polymer layer formed from a polymer compatible with a material of the skin-friendly adhesive and a second outer polymer layer opposite the first outer polymer layer compatible with a material of the ostomy pouch or the ostomy pouch intermediate member. The first outer polymer layer material and the second outer polymer layer material are compatible with one another, and the multilayer film has a tensile strength of at least about 5000 psi in a machine direction and at least about 5000 psi in a transverse direction, and a modulus of elasticity of less than about 15,000 psi in the machine direction and the transverse direction.

Description

MULTILAYER FILM FOR OSTOMY SKIN ADHESIVE WAFER APPLIANCE BACKGROUND

[0001] The following description relates to ostomy appliances, and more particularly, to a multilayer film for an ostomy skin adhesive wafer or barrier appliance.

[0002] Ostomy pouches for collecting bodily waste are used by individuals who have had surgery such as a colostomy, ileostomy, or urostomy. An ostomy pouch may be secured to a user via an ostomy barrier appliance that seals around the stoma and is attached to the peristomal skin surface and protects the peristomal surface from exposure to stomal effluent. The attachment to the user is via a skin-friendly adhesive.

[0003] There are two principal types of pouch systems, one-piece and two-piece pouch systems. In both types of systems, one side of the barrier appliance is attached or mounted to the user and the opposite side of the barrier appliance is directly or indirectly attached to the pouch. In a one-piece pouch system, the opposite side of the barrier appliance is attached directly (or indirectly via an intermediate member) to the pouch, and the barrier appliance and pouch cannot be separated from one another. In a two-piece pouch system the opposite side of the barrier appliance includes a flange that mates with a flange on the ostomy pouch. In such two-piece systems, the flanges can be separated from one another to separate the pouch from the barrier appliance.

[0004] The seals between the barrier appliance and the user and between the barrier appliance and the pouch (whether direct or indirect) is of extreme importance to prevent the leakage of effluent from the pouch system. The skin-friendly adhesive material and the pouch material may not, however, be compatible such that the seals have a sufficiently high integrity. For example, a skin-friendly adhesive such as hydrocolloid mixture may not be compatible with a hot melt adhesive or may not be amenable to direct heat sealing with the pouch material, or other portion or device of the pouch system, such as a convex insert.

[0005] Accordingly, there is a need for a multilayer film for a barrier appliance that can be sealed to a skin-friendly material portion of the barrier and to the pouch or other portion or member of an ostomy pouch system. More desirably, such a barrier appliance seals to both the skin-friendly adhesive and the pouch or other portion of the system with sufficientlyhigh integrity to prevent leakage of stomal effluent. More desirably still, such a seal is provided by a film that can seal to both the skin-friendly adhesive and the pouch portion of the system. BRIEF SUMMARY

[0006] A multilayer film for an ostomy barrier appliance accordingly to the present disclosure can be sealed to a skin-friendly adhesive material portion of the barrier and to the pouch portion of an ostomy pouch system. Such a film allows the barrier appliance to be sealed to both the skin-friendly adhesive and the pouch or other portion or member of the system with sufficiently high integrity to prevent leakage of stomal effluent.

[0007] In one aspect, a multilayer film for an ostomy skin adhesive barrier appliance for adhering to a skin-friendly adhesive and to an ostomy pouch or ostomy pouch intermediate member, includes a first outer polymer layer formed from a polymer compatible with a material of the skin-friendly adhesive and a second outer polymer layer opposite the first outer polymer layer compatible with a material of the ostomy pouch or the ostomy pouch intermediate member.

[0008] The first outer polymer layer material and the second outer polymer layer material are compatible with one another, and the multilayer film has a tensile strength of at least about 5000 psi in a machine direction and at least about 5000 psi in a transverse direction, and a modulus of elasticity less than 15,000 psi in the machine and transverse directions when measured in accordance with standard ASTM D882 Standard Test Method for Tensile Properties of Thin Plastic Sheeting.

[0009] The first outer layer and the second outer layer can be formed from polymers or copolymers of polyester elastomer, ethylene vinyl acetate copolymers, anhydride modified ethylene vinyl acetate, acid modified ethylene vinyl acetate, acrylate modified ethylene vinyl acetate, acid modified ethylene acrylate, ethylene acrylic acid copolymers, ethylene methyl acrylic acid copolymers, ethylene methyl acrylate, anhydride grafted ethylene acrylate, anhydride grafted methyl acrylate, anhydride modified low density polyethylene, anhydride modified linear low density polyethylene, propylene based elastomers, olefin block copolymers, olefin thermoplastic elastomers, thermoplastic olefin, thermoplastic elastomers, thermoplastic polyester elastomers and blends or compounds thereof.

[0010] In embodiments, the first outer layer is formed from a thermoplastic elastomer, such as a thermoplastic polyester elastomer. In embodiments, the second outer layer can be formed from an ethylene acid copolymer. In embodiments, the first and second outer layers are adjacent one another.

[0011] Such a film can have an elongation of at least about 500 percent in the machine direction and at least about 500 percent in the transverse direction. A film can have a tensile strength of at least about 5,000 psi in the machine direction and at least about 5,000 psi in the transverse direction, and a modulus of elasticity of less than about 15,000 psi in the machine and transverse directions. And, a film, when adhered at the first outer layer to a skin friendly adhesive and adhered at the second outer layer to the pouch or other portion or member of the pouch system by a hot melt adhesive, has a 180opeak load of at least about 59.9 Newtons, a 180opeel force of at least about 55.8 Newtons, a 90opeak load of at least about 23.0 Newtons and a 90opeel force of at least about 62.7 Newtons.

[0012] In an aspect a multilayer film for an ostomy skin adhesive barrier appliance for adhering to a skin-friendly adhesive and to an ostomy pouch or ostomy pouch intermediate member, includes a first outer polymer layer formed from a polymer compatible with a material of the skin-friendly adhesive, a second outer polymer layer opposite the first outer polymer layer compatible with a material of the ostomy pouch or the ostomy pouch intermediate member and one or more intermediate layers disposed between the first and second outer layers.

[0013] In such a film, the first outer polymer layer material and an adjacent one of the one or more intermediate layers are compatible with one another, and the second outer polymer layer and an adjacent one of the one or more intermediate layers are compatible with one another. The intermediate layers are compatible with adjacent ones of the intermediate layers. Such films can have a tensile strength of at least about 5000 psi in a machine direction and at least about 5000 psi in a transverse direction, and a modulus of elasticity of less than about 15,000 psi in the machine and transverse directions. when measured in accordance with standard ASTM D882 Standard Test Method for Tensile Properties of Thin Plastic Sheeting.

[0014] In embodiments, the one or more intermediate layers is one layer, and wherein the first outer polymer layer material and the intermediate layer are compatible with oneanother, and wherein the second outer polymer layer and the intermediate layer are compatible with one another.

[0015] In embodiments, the first outer layer and the second outer layer can be formed from polymers or copolymers of polyester elastomer, ethylene vinyl acetate copolymers, anhydride modified ethylene vinyl acetate, acid modified ethylene vinyl acetate, acrylate modified ethylene vinyl acetate, acid modified ethylene acrylate, ethylene acrylic acid copolymers, ethylene methyl acrylic acid copolymers, ethylene methyl acrylate, anhydride grafted ethylene acrylate, anhydride grafted methyl acrylate, anhydride modified low density polyethylene, anhydride modified liner low density polyethylene, propylene based elastomers, olefin block copolymers, olefin thermoplastic elastomers, thermoplastic olefin, thermoplastic elastomers, thermoplastic polyester elastomers and blends or compounds thereof.

[0016] The first outer layer can be formed from a thermoplastic elastomer, such as a thermoplastic polyester elastomer. The second outer layer can be formed from an ethylene acid copolymer. Such films can have an elongation of at least about 500 percent in themachine direction and at least about 500 percent in the transverse direction. Films can have a tensile strength of at least about 5,000 psi in the machine direction and at least about 5,000 psi in the transverse direction, an a modulus of elasticity of less than about 15,000 psi in the machine and transverse directions.

[0018] In embodiments, when the film is adhered at the first outer layer to a skin friendly adhesive and adhered at the second outer layer to the pouch or other portion or member of the pouch system by a hot melt adhesive, has a 180opeak load of at least about 59.9 Newtons, a 180opeel force of at least about 55.8 Newtons, a 90opeak load of at least about 23.0 Newtons and a 90opeel force of at least about 62.7 Newtons.

[0019] The foregoing general description and the following detailed description are examples only and are not restrictive of the present disclosure. Other aspects, objectives and advantages will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The benefits and advantages of the present embodiments will become more readily apparent to those of ordinary skill in the relevant art after reviewing the following detailed description and accompanying drawings, wherein:

[0021] FIG.1 is a schematic cross-sectional illustration of a barrier appliance for an ostomy pouch system, showing a convex insert a skin-friendly adhesive and a multi-layer film according to embodiments of the present disclosure between the skin-friendly adhesive and the convex insert;

[0022] FIG.2 is a cross-sectional illustration of an embodiment of the multi-layer film;

[0023] FIG.3 is a cross-sectional illustration of another embodiment of the multi- layer film; and

[0024] FIG.4 is a cross-sectional illustration of still another embodiment of the multi-layer film. DETAILED DESCRIPTION

[0025] While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described presently preferred embodiments with the understanding that the present disclosure is to be considered an exemplification and is not intended to limit the disclosure to the specific embodiments illustrated.

[0026] Referring now to the figures, and in particular to FIG.1, there is shown an example of an ostomy barrier appliance 10 (“barrier”). The barrier 10 is one part of an ostomy pouch system which includes an ostomy pouch (not shown). The barrier 10 includes a user- facing side 12 and a pouch attachment side 14 which will be referred to as the pouch side. The illustrated barrier 10 is shown with a convex insert 16. An opening 18 through the barrier 10 and the convex 16 insert is configured to receive a stoma. The barrier 10 mounts and seals the pouch system to the user and to the ostomy pouch, such that there is no leakage of stomal effluent from the system.

[0027] The barrier 10 includes, generally, a skin-friendly adhesive 20 to securethe barrier 10 to the user and a film 22 that allows for attachment of the barrier 10 to a pouch or an intermediate member that attaches the barrier to the pouch or, for example, the convex insert 16, which intermediate member is adhered to the film 22 by a hot melt adhesive shown schematically at 24. Other intermediate members will be recognized by those skilled in the art.

[0028] In many systems, the skin-friendly adhesive 20 is incompatible with the pouch material or the intermediate member 24 material and as such direct attachment or mounting of the skin-friendly adhesive 20 to the pouch or the intermediate member 24 is difficult or may not have the integrity desired. For example, It may be difficult to adherer the convex insert 16 directly to the skin friendly adhesive 20.

[0029] Referring to FIG.2, there is shown an embodiment of a film 22 for mounting to the skin-friendly adhesive 20 (herein the “adhesive”) and for mounting to the pouch or intermediate member 24. The film 22 is a multilayer film and includes a first outer layer 26 that is compatible with (and sealable to) the adhesive 20 and a second outer layer 28 that is compatible with (and sealable to) a material of the pouch or intermediate member 24 and / or a method of sealing to the pouch or intermediate member 24. The first outer layer or adhesive sealing layer 26 is formed from a polymer that is compatible with the adhesive 20. The second outer layer or pouch sealing layer 28 is formed from a polymer that is compatible with the pouch or intermediate member 24. The first and second outer layers 26, 28 are also compatible with each other. For purposes of the present disclosure it is to be understood that reference to a pouch sealing layer 28 is that layer that seals to the pouch or to the intermediate member 24.

[0030] The polymers for the first and second outer layers 26, 28 are selected from a group of polymers having some same or similar functional groups allowing the first and second outer layers 26, 28 to bond to each other and create strong chemical bonds. The polymers also have others of some functional groups in their respective molecular structures which allows the polymers to bond to dissimilar polymers. That is, the polymers of the first and second outer layers 26, 28 also have some same or similar functional groups that allow them to bond to their respective skin friendly adhesive 20 or pouch material or intermediate member 24.

[0031] Stated another way, the first outer layer 26 has some functional groups that allow it be bond with, for example, the skin friendly adhesive 20 and other functional groups that allow it to bond with the second outer layer 28. The second outer layer 28 has some functionalgroups that allow it to bond with the pouch material or intermediate member 24 and other functional groups that allow it to bond with the first outer layer 26.

[0032] FIG.3 illustrates another embodiment of a multilayer film 122 for an ostomy appliance barrier 10. This embodiment includes a first outer layer or adhesive sealing layer 126 that is formed from a polymer that is compatible with the adhesive 20 and a second outer layer or pouch sealing layer 128 that is formed from a polymer that is compatible with the pouch or intermediate member 24. An intermediate layer 130 is positioned between the first and second outer layers 126, 128. The intermediate layer 130 is compatible with both the first outer layer 126 and the second outer layer 128. The intermediate layer 130 can be used where, for example, the first and second outer layers 126, 128 bond well to their respective skin friendly adhesive 20 and pouch material or intermediate 24, but do not bond well to each other. In such situations, the intermediate layer 130 can be formulated such that it provides an intermediate bonding material for the first and second outer layers 126, 128.

[0033] FIG.4 illustrates still another embodiment of a multilayer film 222 for an ostomy appliance barrier 10. This embodiment includes a first outer layer or adhesive sealing layer 226 that is formed from a polymer that is compatible with the adhesive 20 and a second outer layer or pouch sealing layer 228 that is formed from a polymer that is compatible with the pouch or intermediate member 24. A plurality of intermediate layers 230a, 230b, 230c are positioned between the first and second outer layers 226, 228. This configuration may be used where a single intermediate layer is not sufficiently compatible with the first and second outer layers 226, 228, but multiple intermediate layers provide successively increasing and sufficient bonding to one another and ultimately to the first and second outer layers 226, 228.

[0034] In embodiments, the polymers of the first and second outer layers 226, 228 are formed from a group of polymers or copolymers of polyester elastomer, ethylene vinyl acetate copolymers, ethylene acid copolymers, ethylene acrylic acid copolymers, ethylene methyl acrylic acid copolymers, ethylene methyl acrylate, anhydride grafted ethylene acrylate, anhydride grafted methyl acrylate, modified liner low density polyethylene, propylene based elastomers, olefin block copolymers, olefin thermoplastic elastomers, thermoplastic polyester elastomers, thermoplastic olefin, and / or their blends or compounds.

[0035] Some suitable polymers for the first outer layer 26, 126, 226 includethermoplastic polyester elastomers (TPEs), such as the HYTREL®, such as HYTREL® 4056 commercially available from E.I. du Pont de Nemours and Company. Some suitable polymers for the second outer layer 28, 128, 228, include ethylene acid copolymer resins, such as NUCREL™, such as NUCREL™ 925, NUCREL™ 3990, NUCREL™ 0910HS, and NUCREL™ 30901, commercially available from Dow Chemical Company. Other suitable polymers for the first and second outer layers, as well as any intermediate layers 130, 230 if used, will be recognized by those skilled in the art.

[0036] In those embodiments that include one or more intermediate layers 130, 230, the polymers between the first outer layer 126, 226 and its nearest intermediate layer 130, 230a are formed from a group of polymers having the same or similar functional groups allowing them to create strong chemical bonds. Similarly, the polymers between the second outer layer 128, 228 and its nearest intermediate layer 130, 230c are formed from a group of polymers having the same or similar functional groups allowing them to create a strong chemical bond. The polymers of and between adjacent intermediate layers 230, when more than one intermediate layer 230 is used, are formed from a group of polymers having the same or similar functional groups allowing them to create strong chemical bonds. The polymers of the two outer layers 26, 126, 226, 28, 128, 228 have dissimilar functional groups in their molecular structures which allows the two sides of the film (i.e., the first and second outer layers) to bond to two dissimilar polymers (e.g., the skin friendly adhesive 20 and the pouch or intermediate member 24 material).

[0037] In all of the embodiments, the multilayer film 22, 122, 222 has a tensile strength of about 3000 to about 12000 psi, preferably about 5000 to about 9000 psi (Table 1), elongation above about 3000 percent preferably above about 500 percent (Table 2), and modulus ranges from about 4000 to about 16000 psi, preferably about 5000 to about 14000 psi (Table 3). Testing was in accordance with ASTM D882 Standard Test Method for Tensile Properties of Thin Plastic Sheeting.

[0038] These films 22, 122, 222 are strong, stretchable, and very flexible so as to meet ostomy skin adhesive wafer flexibility requirements. The balance of these properties is achieved by optimizing the layer ratio, and in some cases blend ratios of the individual layers, and thicknesses.

[0039] The peel force between the outside of the second outer layer 28, 128, 228and the hotmelt adhesive is above 30 Newton / in, preferably above 40 Newton / in, tested using an internal test method, TM-07087.

[0040] Table 1 below shows the results of tensile strength testing in pounds per square inch (psi) for films formed from various materials. The materials are shown in the left- hand column. The tensile strength in psi in the machine direction (MD) and the transverse direction (TD), along with the standard deviation (StDev) for each are shown. Tensile Strength, psi MD StDev TD StDev Hytrel monolayer 8168 844 8043 560 Hytrel / Nucrel925 4939 946 6132 540 Hytrel / Nucrel3990 5452 786 7166 1381 Hytrel / Nucrel 0910HS 5143 363 6499 513 Hytrel / Nucrel 30901 5162 976 6573 622 EMAC 2250 2088 53 1826 45 TPU 55519045930789EBA 5300 442 4919 308 EVA 8%VA / BOPP 1757 387 1739 582 Table 1 – Tensile Strength Testing of Various Multilayer Films

[0041] Table 2 below shows the results of elongation testing in percent (%) for the films formed from the materials listed in Table 1. Elongation is also shown in the machine direction (MD) and the transverse direction (TD) along with the standard deviation for each of the materials’ measurements. Elongation, % MD StDev TD StDev Hytrel monolayer 765 35 796 9 Hytrel / Nucrel925 521 117 721 26 Hytrel / Nucrel3990 560 71 740 17 Hytrel / Nucrel 0910HS 607 44 789 3 Hytrel / Nucrel 30901 503 136 764 25 EMAC 2250 628 20 745 22 TPU 296 28 337 42 EBA 822 58 796 55 EVA 8%VA / BOPP 260 67 454 148 Table 2 – Elongation Testing of Various Multilayer Films

[0042] Table 3 below shows the results of the results of modulus of elasticitytesting in psi for the films formed from the materials listed in Table 1. The modulus is likewise shown in the machine direction (MD) and the transverse direction (TD) along with the standard deviation for each of the materials’ measurements. Modulus, psi MD StDev TD StDev Hytrel monolayer 9115 981 9291 606 Hytrel / Nucrel925 13304 845 14415 741 Hytrel / Nucrel3990 13588 3041 11466 1384 Hytrel / Nucrel 0910HS 11701 1393 10845 535 Hytrel / Nucrel 30901 14820 1969 11726 981 EMAC 2250 4839 63 4933 56 TPU 5629 966 5943 1110 EBA 12369 449 13051 527 EVA 8%VA / BOPP 12975 958 17066 4906 Table 3 – Modulus Testing of Various Multilayer Films

[0043] Table 4 below shows the results of peel force testing for the various films that were adhered to the pouch or intermediate member by different adhesives. The first and second columns show the film and the adhesive, respectively. The second through eighth columns show the average forces (AVG), in Newtons, for 180opeak load and peel force, and 90opeak load and peel force, and the standard deviations for each of the peak load and peel force measurements. Film-Adhesive 180° peak load, Newtons 180° peel force, Newtons 90° peak load, Newtons 90° peel force, Newtons Film Adhesive AVG StDev AVG StDev AVG StDev AVG StDev Hytrel TPE Hotmelt 70.6 9.3 36.0 5.6 71.3 11.1 48.3 25.1 Nucrel30907 / Hytrel Olefin Hotmelt 59.9 4.0 55.8 3.0 23.0 13.7 62.7 1.0 Nucrel3990 / Hytrel Olefin Hotmelt 74.5 5.8 67.2 68.4 64.9 1.9 33.0 94.1 Nucrel0910HS / Hytrel Olefin Hotmelt 67.9 9.4 61.4 7.5 61.4 8.2 38.8 18.5 Nucrel925 / Hytrel Olefin Hotmelt 62.9 6.1 59.1 79.4 62.0 2.5 36.4 65.9 Evatane24-03 Olefin Hotmelt 36.1 1.3 33.9 19.7 10.2 1.1 5.1 11.8 Lotryl29MA03T Olefin Hotmelt 2.1 2.1 0.2 0.1 1.1 0.2 0.4 0.1 Lotader4503 Olefin Hotmelt 12.0 6.4 1.4 0.4 8.9 2.3 3.1 1.2 Table 4 – Peak and Peel Force Measurements for Various Multilayer Films and Adhesives

[0044] In each of the embodiments, that is the two-layer direct contact embodiment of FIG.2, as well as the multilayer embodiments (first and second outer layers withintermediate layers of FIGS.3 and 4), the polymer layers, that is, the polymeric layers are provided by known film fabrication processes. A suitable process is coextrusion for producing permanent layer adhesion from the various selected polymers. Other processes such as coating, extrusion-coating, and lamination processes may be used, but due care must be taken to prevent layer separation.

[0045] It will be appreciated that the present multilayer film for a barrier appliance overcomes the disadvantages of some prior sealing arrangements in that it can be sealed to a skin-friendly material portion of the barrier and to the pouch or other portion or member of an ostomy pouch system. Such a barrier appliance seals to both the skin-friendly adhesive and the pouch or other portion of the system with sufficiently high integrity to prevent leakage of stomal effluent. Further, such a seal is provided by a film that can seal to both the skin-friendly adhesive and the pouch portion of the system.

[0046] All patents referred to herein, are hereby incorporated herein in their entirety, by reference, whether or not specifically indicated as such within the text of this disclosure.

[0047] In the present disclosure, the words “a” or “an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular.

[0048] From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present disclosure. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.

Claims

CLAIMS What is claimed is:

1. A multilayer film for an ostomy skin adhesive barrier appliance for adhering to a skin-friendly adhesive and to an ostomy pouch or ostomy pouch intermediate member, comprising: a first outer polymer layer formed from a polymer compatible with a material of the skin- friendly adhesive; and a second outer polymer layer opposite the first outer polymer layer compatible with a material of the ostomy pouch or the ostomy pouch intermediate member, wherein the first outer polymer layer material and the second outer polymer layer material are compatible with one another, and wherein the multilayer film has a tensile strength of at least about 5000 psi in a machine direction and at least about 5000 psi in a transverse direction, and a modulus of elasticity of less than about 15,000 psi in the machine direction and the transverse direction when measured in accordance with standard ASTM D882 Standard Test Method for Tensile Properties of Thin Plastic Sheeting.

2. The multilayer film of claim 1, wherein first outer layer and the second outer layer are formed from polymers or copolymers of polyester elastomer, ethylene vinyl acetate copolymers, anhydride modified ethylene vinyl acetate, acid modified ethylene vinyl acetate, acrylate modified ethylene vinyl acetate, acid modified ethylene acrylate, ethylene acrylic acid copolymers, ethylene methyl acrylic acid copolymers, ethylene methyl acrylate, anhydride grafted ethylene acrylate, anhydride grafted methyl acrylate, anhydride modified low density polyethylene, anhydride modified liner low density polyethylene, propylene based elastomers, olefin block copolymers, olefin thermoplastic elastomers, thermoplastic olefin, thermoplastic elastomers, thermoplastic polyester elastomers and blends or compounds thereof.

3. The multilayer film of claim 2, wherein the first outer layer is formed from a thermoplastic elastomer.

4. The multilayer film of claim 3, wherein the first outer layer is formed from a thermoplastic polyester elastomer.

5. e mu t ayer m of any one of claims 1-4, wherein the second outer layer is formed from an ethylene acid copolymer.

6. The multilayer film of any one of claims 1-5, wherein the multilayer film has an elongation of at least about 500 percent in the machine direction and at least about 500 percent in the transverse direction.

7. The multilayer film of any one of claims 1-6, wherein the multilayer film has a tensile strength of at least about 5,000 psi in the machine direction and at least about 5,000 psi in the transverse direction, and a modulus of elasticity of less than 15,000 psi in the machine direction and the transverse direction.

8. The multilayer film of any one of claims 1-7, wherein the film, when adhered at the first outer layer to a skin friendly adhesive and adhered at the second outer layer to an intermediate layer between the second outer layer and the ostomy pouch by a hot melt adhesive, has a 180opeak load of at least about 59.9 Newtons, a 180opeel force of at least about 55.8 Newtons, a 90opeak load of at least about 23.0 Newtons and a 90opeel force of at least about 62.7 Newtons.

9. A multilayer film for an ostomy skin adhesive barrier appliance for adhering to a skin-friendly adhesive and to an ostomy pouch or ostomy pouch intermediate member, comprising: a first outer polymer layer formed from a polymer compatible with a material of the skin- friendly adhesive; a second outer polymer layer opposite the first outer polymer layer compatible with a material of the ostomy pouch or the ostomy pouch intermediate member and one or more intermediate layers disposed between the first and second outer layers,wherein the first outer polymer layer material and an adjacent one of the one or more intermediate layers are compatible with one another, and wherein the second outer polymer layer and an adjacent one of the one or more intermediate layers are compatible with one another, and wherein the multilayer film has a tensile strength of at least about 5000 psi in a machine direction and at least about 5000 psi in a transverse direction, and a modulus of elasticity of less than 15,000 psi in the machine direction and the transverse direction when measured in accordance with standard ASTM D882 Standard Test Method for Tensile Properties of Thin Plastic Sheeting.

10. The multilayer film of claim 9, wherein the one or more intermediate layers is one layer, and wherein the first outer polymer layer material and the intermediate layer are compatible with one another, and wherein the second outer polymer layer and the intermediate layer are compatible with one another.

11. The multilayer film of claim 9, wherein the intermediate layers are compatible with adjacent ones of the intermediate layers.

12. The multilayer film of any one of claims 9-11, wherein first outer layer and the second outer layer are formed from polymers or copolymers of polyester elastomer, ethylene vinyl acetate copolymers, anhydride modified ethylene vinyl acetate, acid modified ethylene vinyl acetate, acrylate modified ethylene vinyl acetate, acid modified ethylene acrylate, ethylene acrylic acid copolymers, ethylene methyl acrylic acid copolymers, ethylene methyl acrylate, anhydride grafted ethylene acrylate, anhydride grafted methyl acrylate, anhydride modified low density polyethylene, anhydride modified liner low density polyethylene, propylene based elastomers, olefin block copolymers, olefin thermoplastic elastomers, thermoplastic olefin, thermoplastic elastomers, thermoplastic polyester elastomers and blends or compounds thereof.

13. The multilayer film of claim 12, wherein the first outer layer is formed from a thermoplastic elastomer.

14. The multilayer film of claim 13, wherein the first outer layer is formed from a thermoplastic polyester elastomer.

5. e mu t ayer m of any one of claims 12-14, wherein the second outer layer is formed from an ethylene acid copolymer.

16. The multilayer film of any one of claims 9-15, wherein the multilayer film has an elongation of at least about 500 percent in the machine direction and at least about 500 percent in the transverse direction.

17. The multilayer film of any one of claims 9-16, wherein the multilayer film has a tensile strength of at least about 5,000 psi in the machine direction and at least about 5,000 psi in the transverse direction, and a modulus of elasticity of less than about 15,000 psi in the machine direction and the transverse direction.

18. The multilayer film of any one of claims 9-17, wherein the film, when adhered at the first outer layer to a skin friendly adhesive and adhered at the second outer layer to an intermediate layer between the second outer layer and the ostomy pouch by a hot melt adhesive, has a 180opeak load of at least about 59.9 Newtons, a 180opeel force of at least about 55.8 Newtons, a 90opeak load of at least about 23.0 Newtons and a 90opeel force of at least about 62.7 Newtons.

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