Skin film composition containing three types of lipids

Abstract

The stoma skin film composition comprises a water-insoluble pressure-sensitive adhesive component, a hydrophilic component, and at least three different types of lipids, including ceramide, cholesterol, and fatty acids. This skin film composition is configured to provide a skin film with adhesive properties suitable for stoma applications, ensuring secure attachment of a stoma pouch to the user's periostomy skin while minimizing irritation and damage to the periostomy skin.

Description

[Technical Field]

[0001] This disclosure relates to a skin barrier composition, and more specifically, to a skin barrier composition for ostomy appliances that contains lipids. [Background technology]

[0002] Stoma appliances, such as stoma pouches, are used by patients with stomas created by surgical procedures (e.g., colostomy and ileostomy) to collect stoma waste (fecal matter and / or urine). Stoma appliances are typically attached to the skin around the user's stoma via a stoma wafer or stoma faceplate that includes a skin capsule. The skin capsule is designed to absorb moisture and fluids from the periostomy skin, promoting the health of the periostomy skin, while also ensuring secure attachment and support of the stoma appliance, such as a stoma pouch.

[0003] The skin around the stoma of a user is constantly at risk of irritation and damage due to the continuous and long-term use of stoma appliances. Therefore, it is desirable that the skin film be constructed to have sufficient adhesive strength to support the stoma pouch, but at the same time, not to be so aggressive as to damage or irritate the skin during use and removal. Skin films containing ceramides, such as the skin film available from the applicant of this application under the trade name CeraPlus®, have been developed to promote the health of the skin around the stoma.

[0004] This disclosure provides an improved skin film composition comprising a lipid compound that can further reduce the risk of irritation and damage to the periostomy skin and promote the health of the periostomy skin. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] Stoma skin film compositions comprising at least three different types of lipids are provided according to various embodiments. These skin film compositions are configured to provide a skin film with adhesive properties suitable for stoma applications, enabling secure attachment of a stoma pouch to the user's periostomy skin while minimizing irritation and damage to the periostomy skin. [Means for solving the problem]

[0006] In one embodiment, the stoma skin film composition may contain a water-insoluble pressure-sensitive adhesive component, a hydrophilic component, and at least three different types of lipids, including ceramide, cholesterol, and fatty acids. The at least three different types of lipids may be provided as a triple lipid formulation containing ceramide, cholesterol, and fatty acids.

[0007] In one embodiment, the stoma skin film composition, when tested according to ISO 12505-1, has a fluid absorption capacity of approximately 0.4 g / cm³ over 24 hours. 2 ~Approx. 2.0g / cm 2 The stoma skin film composition may be configured to produce a skin film with a peak tack of approximately 1.5 Newtons (N) to approximately 4.5 N when tested according to the Avery Adhesive Test Method (AAT) disclosed in Chuang et al., Avery Adhesive Test Yields More Performance Data than Traditional Probe, Adhesive Age, Sept 1997, and a 180-degree peel adhesion strength of approximately 3 N / m to approximately 6 N / m when tested according to ISO 12505-2. For example, a stoma skin film composition may have a fluid absorption capacity of approximately 0.5 g / cm³ over 24 hours when tested according to ISO 12505-1. 2 ~Approx. 1.5g / cm 2The material may be configured to produce a skin film with a maximum tack force of approximately 2N to 4N when tested according to the Avery Adhesion Test (AAT), and a 180-degree peel adhesion strength of approximately 3.5N / m to 5.5N / m when tested according to ISO 12505-2.

[0008] In some embodiments, the stoma skin film composition may contain about 0.15% to about 2.5% by weight of a trilipid compound. For example, the stoma skin film composition may contain about 0.2% to about 1.8% by weight of a trilipid compound. In some embodiments, the ceramide may be a synthetic pseudoceramide. The fatty acid may be palmitic acid, linoleic acid, stearic acid, or a mixture thereof.

[0009] The water-insoluble pressure-sensitive adhesive components may include polyisobutylene (PIB), hydrogenated styrene-butadiene rubber (HSBR), styrene-isoprene-styrene block copolymer (SIS), styrene-butadiene-styrene block copolymer (SBS), styrene-ethylene / propylene-styrene block copolymer (SEPS), styrene-ethylene / butylene-styrene block copolymer (SEBS), styrene-ethylene / ethylene / propylene-styrene block copolymer (SEEPS), styrene-ethylene / butylene-olefin crystalline block copolymer (SEBC), mineral oil, tackifiers, or mixtures thereof. Hydrophilic components may include gum arabic, tragacanth gum, galactan, guar gum, carob gum, karaya gum, carrageenan, pectin, agar, starch, xanthan gum, dextrin, dextran, succinoglucan, pullulan, casein, albumin, gelatin, methylcellulose, ethylcellulose, methylhydroxypropylcellulose, hydroxyethylcellulose, sodium cellulose sulfate, hydroxypropylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, sodium alginate, propylene glycol alginate, polyvinyl alcohol, polyvinyl methyl ether, polyvinylpyrrolidone, carboxyvinyl polymer, sodium polyacrylate, polyacrylamide, polyethyleneimine, sucrose, or mixtures thereof.

[0010] In one embodiment, the stoma skin film composition may contain about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component comprising HSBR, PIB, mineral oil, and a tackifier; about 30% to about 60% by weight of a hydrophilic component comprising carboxymethylcellulose (CMC) and pectin; and about 1.8% by weight of a trilipid formulation containing ceramide PC104, cholesterol, and linoleic acid in a ratio of 1:3:1.

[0011] In another embodiment, the stoma skin film composition may comprise about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component comprising HSBR, PIB, mineral oil, and a tackifier; about 30% to about 60% by weight of a hydrophilic component comprising CMC and pectin; and about 1.8% by weight of a trilipid formulation containing ceramide PC104, cholesterol, and stearic acid in a ratio of 4:2:1.

[0012] In yet another embodiment, the stoma skin film composition may comprise about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component comprising HSBR, PIB, mineral oil, and a tackifier; about 30% to about 60% by weight of a hydrophilic component comprising CMC and pectin; and about 0.6% by weight of a trilipid formulation containing ceramide PC104, cholesterol, and palmitic acid in a ratio of 4:2:1.

[0013] In one embodiment, the stoma skin film composition may contain about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component comprising HSBR, PIB, mineral oil, and a tackifier; about 30% to about 60% by weight of a hydrophilic component comprising CMC and pectin; and about 1.8% by weight of a trilipid formulation containing ceramide PC104, cholesterol, and palmitic acid in a ratio of 3:1:1.

[0014] In another embodiment, the stoma skin film composition may comprise about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component comprising HSBR, PIB, mineral oil, and a tackifier; about 30% to about 60% by weight of a hydrophilic component comprising CMC and pectin; and about 0.6% by weight of a trilipid formulation containing ceramide PC104, cholesterol, and linoleic acid in a ratio of 3:1:1.

[0015] In yet another embodiment, the stoma skin film composition may comprise about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component comprising HSBR, PIB, mineral oil, and a tackifier; about 30% to about 60% by weight of a hydrophilic component comprising CMC and pectin; and about 0.6% by weight of a trilipid formulation containing ceramide PC104, cholesterol, and stearic acid in a ratio of 1:3:1.

[0016] In some embodiments, the stoma skin film composition may also contain glycerol. For example, the stoma skin film composition may contain about 2% to about 12% by weight of glycerol.

[0017] In one embodiment, the stoma skin film composition may contain about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component comprising HSBR, PIB, mineral oil, and a tackifier; about 20% to about 55% by weight of a hydrophilic component comprising CMC and pectin; about 5% to about 10% by weight of glycerol; and about 1.8% by weight of a trilipid compound containing ceramide PC104, cholesterol, and palmitic acid in a ratio of 3:1:1.

[0018] In one embodiment, the stoma skin film composition may comprise about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component comprising HSBR, PIB, mineral oil, and hydrogenated hydrocarbon tackifier resin; about 20% to about 55% by weight of a hydrophilic component comprising CMC and pectin; about 5% to about 10% by weight of glycerol; and about 0.15% to about 2% by weight of a trilipid compound comprising ceramide PC104, cholesterol, and palmitic acid. In such embodiments, the stoma skin film composition may also comprise about 0.01% to about 1.2% by weight of ceramide PC104, about 0.03% to about 0.5% by weight of cholesterol, and about 0.15% to about 1.2% by weight of palmitic acid, where ceramide PC104, cholesterol, and palmitic acid are present in a ratio of 1:3:20, 1:1:10, or 1:3:100.

[0019] In one embodiment, the stoma skin film composition may include a water-insoluble pressure-sensitive adhesive component of about 40% to about 70% by weight, including HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifying resin, a hydrophilic component of about 20% to about 55% by weight, including CMC and pectin, and about 5% to about 10% by weight of glycerol, about 0.01% to about 0.03% by weight of ceramide PC104, about 0.02% to about 0.04% by weight of cholesterol, and about 0.1% to about 0.3% by weight of palmitic acid.

[0020] In another embodiment, the stoma skin film composition may include a water-insoluble pressure-sensitive adhesive component of about 40% to about 70% by weight, including HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifying resin, a hydrophilic component of about 20% to about 55% by weight, including CMC and pectin, and about 5% to about 10% by weight of glycerol, about 0.05% to about 0.15% by weight of ceramide PC104, about 0.05% to about 0.15% by weight of cholesterol, and about 0.5% to about 1.5% by weight of palmitic acid.

[0021] In yet another embodiment, the stoma skin film composition may include a water-insoluble pressure-sensitive adhesive component of about 40% to about 70% by weight, including HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifying resin, a hydrophilic component of about 20% to about 55% by weight, including CMC and pectin, and about 5% to about 10% by weight of glycerol, about 0.01% to about 0.03% by weight of ceramide PC104, about 0.02% to about 0.04% by weight of cholesterol, and about 0.5% to about 1.5% by weight of palmitic acid.

[0022] Other aspects, objects, and advantages will become more apparent from the following detailed description when considered in conjunction with the accompanying drawings.

[0023] The benefits and advantages of this embodiment will become more readily apparent to those skilled in the art upon examination of the following detailed description and the accompanying drawings.

Brief Description of the Drawings

[0024] [Figure 1] Figure 1 is a graph of transepidermal water loss (TEWL) measurements of the test skin after repeated application and removal of skin film samples formed from skin film compositions according to various embodiments.

[0025] [Figure 2] Figure 2 is a graph showing the results of tests on the maximum tack force of skin film samples formed from skin film compositions according to various embodiments.

[0026] [Figure 3] Figure 3 is a graph showing the results of fluid absorption tests for skin film samples formed from skin film compositions according to various embodiments.

[0027] [Figure 4] Figure 4 illustrates the location of the TEWL test site on the user.

[0028] [Figure 5] Figure 5 is a graph of TEWL measurements obtained from the user test site shown in Figure 4 for skin film samples formed from skin film compositions according to various embodiments. [Modes for carrying out the invention]

[0029] While various forms of embodiment are possible in this disclosure, the drawings show a currently preferred embodiment, which is described below. However, this disclosure should be considered illustrative and is not intended to limit the disclosure to the specific embodiments described herein.

[0030] In one embodiment, the skin film composition may comprise a water-insoluble pressure-sensitive adhesive component, a hydrophilic component, and at least three different types of lipids, including ceramide, cholesterol, and fatty acids. The skin film composition has a fluid absorption capacity of approximately 0.4 g / cm³ over 24 hours when tested according to ISO 12505-1. 2 ~Approx. 2.0g / cm 2 Preferably about 0.5 g / cm³2 ~Approx. 1.5g / cm 2 The material may be configured to produce a skin film in which the maximum tack force is approximately 1.5 Newtons (N) to approximately 4.5 N, preferably approximately 2 N to approximately 4 N, when tested according to the Avery Adhesive Test Method (AAT) disclosed in Chuang et al., Avery Adhesive Test Yields More Performance Data than Traditional Probe, Adhesive Age, Sept 1997, and the 180-degree peel adhesion strength is approximately 3 N / m to approximately 6 N / m, preferably approximately 3.5 N / m to approximately 5.5 N / m, when tested according to ISO 12505-2.

[0031] Suitable polymers for water-insoluble pressure-sensitive adhesive components include, but are not limited to, polyisobutylene (PIB), hydrogenated styrene-butadiene rubber (HSBR), styrene-isoprene-styrene block copolymer (SIS), styrene-butadiene-styrene block copolymer (SBS), styrene-ethylene / propylene-styrene block copolymer (SEPS), styrene-ethylene / butylene-styrene block copolymer (SEBS), styrene-ethylene / ethylene / propylene-styrene block copolymer (SEEPS), and styrene-ethylene / butylene-olefin crystalline block copolymer (SEBC).

[0032] Examples of materials suitable for hydrophilic components include, but are not limited to, gum arabic, tragacanth gum, galactan, guar gum, carob gum, karaya gum, carrageenan, pectin, agar, starch, xanthan gum, dextrin, dextran, succinoglucan, pullulan, casein, albumin, gelatin, methylcellulose, ethylcellulose, methylhydroxypropylcellulose, hydroxyethylcellulose, sodium cellulose sulfate, hydroxypropylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, sodium alginate, propylene glycol alginate, polyvinyl alcohol, polyvinyl methyl ether, polyvinyl pyrrolidone, carboxyvinyl polymer, sodium polyacrylate, polyacrylamide, and polyethyleneimine.

[0033] In certain embodiments, at least three different types of lipids include synthetic pseudo-ceramides such as ceramide PC104 (C 39 H 78 N2O5), cholesterol (C 27 H 46 O), and at least one fatty acid, such as palmitic acid (C 16 H 32 O2), linoleic acid (C 18 H 32 O2), and stearic acid (C 18 H 36 O2). The at least three different types of lipids can be prepared as a trilipid formulation in an amount of about 0.15 weight percent (wt.%) to about 2.5 weight percent, preferably about 0.2 weight percent to about 1.8 weight percent, comprising ceramide, cholesterol, and fatty acid. In some embodiments, the trilipid formulation can contain ceramide, cholesterol, and fatty acid in a ratio of about 1-5:1-5:1-100. For example, the trilipid formulation can contain ceramide, cholesterol, and fatty acid in a ratio of 3:1:1 or 1:3:1 or 4:2:1 or 1:3:20 or 1:1:10 or 1:3:100.

[0034] Skin film samples formed from skin film compositions containing trilipid formulations according to various embodiments of this disclosure were prepared and tested for fluid absorption capacity, pH, maximum tack force, 180-degree peel adhesion strength, storage modulus, and erosion resistance. Each skin film composition was formulated using the same or similar base hydrophilic colloidal adhesive formulation containing a water-insoluble pressure-sensitive adhesive component and a hydrophilic component, with the amount of the water-insoluble pressure-sensitive adhesive component adjusted according to the varying amounts of trilipid formulations.

[0035] The TL1 skin film sample was formed from a skin film composition comprising 54.06% by weight of a water-insoluble pressure-sensitive adhesive component containing hydrogenated styrene-butadiene rubber (HSBR), polyisobutylene (PIB), mineral oil, and hydrogenated hydrocarbon tackifier; 44.14% by weight of a hydrophilic component containing carboxymethylcellulose (CMC), pectin, and sucrose; and 1.8% by weight of a trilipid compound containing ceramide PC104, cholesterol, and linoleic acid in a ratio of 1:3:1.

[0036] The TL2 skin film sample was formed from a skin film composition comprising 54.06% by weight of a water-insoluble pressure-sensitive adhesive component containing HSBR, PIB, mineral oil, and hydrogenated hydrocarbon tackifier resin; 44.14% by weight of a hydrophilic component containing CMC, pectin, and sucrose; and 1.8% by weight of a trilipid compound containing ceramide PC104, cholesterol, and stearic acid in a ratio of 4:2:1.

[0037] The TL3 skin film sample was formed from a skin film composition comprising 55.26% by weight of a water-insoluble pressure-sensitive adhesive component containing HSBR, PIB, mineral oil, and hydrogenated hydrocarbon tackifier resin; 44.14% by weight of a hydrophilic component containing CMC, pectin, and sucrose; and 0.6% by weight of a trilipid compound containing ceramide PC104, cholesterol, and palmitic acid in a ratio of 4:2:1.

[0038] The TL4 skin film sample was formed from a skin film composition comprising 54.06% by weight of a water-insoluble pressure-sensitive adhesive component containing HSBR, PIB, mineral oil, and hydrogenated hydrocarbon tackifier resin; 44.14% by weight of a hydrophilic component containing CMC, pectin, and sucrose; and 1.8% by weight of a trilipid compound containing ceramide PC104, cholesterol, and palmitic acid in a ratio of 3:1:1.

[0039] The TL5 skin film sample was formed from a skin film composition comprising 55.26% by weight of a water-insoluble pressure-sensitive adhesive component containing HSBR, PIB, mineral oil, and hydrogenated hydrocarbon tackifier resin; 44.14% by weight of a hydrophilic component containing CMC, pectin, and sucrose; and 0.6% by weight of a trilipid compound containing ceramide PC104, cholesterol, and linoleic acid in a ratio of 3:1:1.

[0040] The TL6 skin film sample was formed from a skin film composition comprising 55.26% by weight of a water-insoluble pressure-sensitive adhesive component containing HSBR, PIB, mineral oil, and hydrogenated hydrocarbon tackifier resin; 44.14% by weight of a hydrophilic component containing CMC, pectin, and sucrose; and 0.6% by weight of a trilipid compound containing ceramide PC104, cholesterol, and stearic acid in a ratio of 1:3:1.

[0041] Skin film samples were tested for maximum tack force by the AAT method, 180-degree peel adhesion strength ("peel adhesion strength") according to ISO 12505-2, fluid absorption capacity according to ISO 12505-1, storage modulus (G') according to ASTM D-4092-07, erosion resistance measured based on weight loss, and pH level according to ISO 12505-1 Skin films for stoma aids - Test methods - Part 1: Size, surface pH, and water absorption. C+ and C- samples were also tested as control samples. C+ is a sample of CerapPlus® skin film containing 0.3 wt% ceramide 2, which is available from the applicant of this application. C- is a film sample that does not contain any lipids. The test results are summarized in Table 1. [Table 1]

[0042] The transepidermal water loss (TEWL) of TL1 samples containing linoleic acid and TL4 samples containing palmitic acid was further tested using the TM300, a standard TEWL probe from Courage Khazaka. The effects of repeated application and removal of skin film on the skin were investigated by repeatedly applying and removing TL1, TL4, C+, and C- film samples, and measuring the TEWL of the ex vivo test skin after each application and removal ("stripping"). Flextend® skin film, available from the applicant of this application, was used to prepare the C- sample (lipid-free skin film). Abdominal skin derived from abdominoplasty was used as the ex vivo test skin. Lower TEWL values ​​(i.e., lower water loss) may indicate less skin irritation and therefore more desirable for the skin film. Figure 1 is a graph of TEWL measurements for ex vivo test skin no. 1 after repeated application and removal of skin film. As shown in Figure 1, the TL1 and TL4 samples exhibit lower TEWL compared to the C+ and C- (Flextend®) samples.

[0043] In some embodiments, the skin film composition may also contain glycerol (propane-1,2,3-triol) in addition to lipids to further enhance the moisturizing properties of the skin and the fluid absorption properties of the skin film. The skin film composition may contain about 2% to about 12% by weight, preferably about 4% to about 8% by weight of glycerol.

[0044] The TL4G skin film sample was formed from a skin film composition containing 54.06% by weight of a water-insoluble pressure-sensitive adhesive component including HSBR, PIB, mineral oil, and hydrogenated hydrocarbon tackifier resin; 37.47% by weight of a hydrophilic component including CMC and pectin; 6.67% by weight of glycerol (also referred to herein as "glycerin"); and 1.8% by weight of a trilipid compound containing ceramide PC104, cholesterol, and palmitic acid in a 3:1:1 ratio (1.08% by weight of ceramide PC104, 0.36% by weight of cholesterol, and 0.36% by weight of palmitic acid). Figure 2 is a graph of the maximum tack force test results for the TL1, TL4, TL4G, and C+ samples. Figure 3 is a graph of the fluid absorption test results for the TL1, TL4, TL4G, and C+ samples. These test results and further research and development have shown that skin film compositions containing trilipids and glycerol can provide skin films with adhesive properties and improved fluid absorption properties suitable for stoma skin films, without adversely affecting their erosion resistance.

[0045] User trials were conducted on TL4G skin film samples ("delta film samples") and TL1 skin film samples ("theta film samples"). Thirty-two users participated in these trials. Each user was provided with three delta film samples and three theta film samples for use and evaluation. One user withdrew after evaluating the theta film samples, so the delta film samples were evaluated by 31 users. Users were asked to evaluate and score each film sample based on the following questions. • Overall Acceptability: To what extent was the use of the coated sample acceptable overall? (Rating scale: 1-5 - Very high to very low acceptance) • Ease of application: How easy was it to apply the coated sample? (Rating scale: 1-5 - extremely easy to extremely difficult) • Swelling: To what extent did the coated sample swell after peeling? (Rating scale: 1-4 - no swelling to significant swelling) * To calculate the average score, the rating scale from 1 to 4 was converted to 1 to 5. • Stability / Adhesion: How stably the coating sample adhered to the skin during application. Rating scale: 1-5 (Extremely stable to extremely unstable) • Ease of removal: How easy was it to remove the coated sample? (Rating scale: 1-5 - extremely easy to extremely difficult) • Erosion: After use and removal of the coated sample, to what extent was the sample eroded? (Rating scale: 1-4 - No erosion to severe erosion) * To calculate the average score, the rating scale from 1 to 4 was converted to 1 to 5.

[0046] The test results are summarized in Table 2. [Table 2]

[0047] The delta-coated samples scored better than the theta-coated samples in overall acceptability, swelling, stability / adhesion, ease of removal, and erosion. The ease of application was the same for both the delta-coated and theta-coated samples.

[0048] Further embodiments of skin film compositions containing glycerin and palmitic acid were prepared and tested. Skin film sample of mixture number 8 was formed from a skin film composition comprising 54.66% by weight of a water-insoluble pressure-sensitive adhesive component containing HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifier, 37.47% by weight of a hydrophilic component containing CMC and pectin, 6.67% by weight of glycerol, and 1.2% by weight of a trilipid formulation containing ceramide PC104, cholesterol, and palmitic acid in a ratio of 1:1:10 (0.1% by weight of ceramide PC104, 0.1% by weight of cholesterol, and 1.0% of palmitic acid). The skin film sample of mixture number 10 was formed from a skin film composition comprising 54.82% by weight of a water-insoluble pressure-sensitive adhesive component containing HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifier; 37.47% by weight of a hydrophilic component containing CMC and pectin; 6.67% by weight of glycerol; and 1.04% by weight of a trilipid compound containing ceramide PC104, cholesterol, and palmitic acid in a ratio of 1:3:100 (0.01% by weight of ceramide PC104, 0.03% by weight of cholesterol, and 1.00% of palmitic acid). The skin film sample of mixture number 17 was formed from a skin film composition comprising 55.62% by weight of a water-insoluble pressure-sensitive adhesive component containing HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifier; 37.47% by weight of a hydrophilic component containing CMC and pectin; 6.67% by weight of glycerol; and 0.24% by weight of a trilipid compound containing ceramide PC104, cholesterol, and palmitic acid in a ratio of 1:3:20 (0.01% by weight of ceramide PC104, 0.03% by weight of cholesterol, and 0.20% of palmitic acid).

[0049] Coating samples of mixture number 8, mixture number 10, and mixture number 17 were tested for fluid absorption capacity according to ISO 12505-1, maximum tack force by AAT method, 180-degree peel adhesion strength ("peel adhesion strength") according to ISO 12505-2, corrosion resistance measured based on weight loss, and elastic modulus according to ASTM D4092-07 (Standard Terminology for Plastics - Dynamic Mechanical Properties). The test results are shown in Table 3. [Table 3]

[0050] User tests were conducted to measure TEWL for the Delta coating sample, the coating sample of mixture number 8, the coating sample of mixture number 10, the coating sample of mixture number 17, the C+ coating sample, the C- coating sample, and the C+3XPC104 coating sample. The C+3XPC104 coating sample was formed from a skin coating composition containing 55.21% by weight of a water-insoluble pressure-sensitive adhesive component including HSBR, PIB, mineral oil, and hydrogenated hydrocarbon tackifier, 43.88% by weight of a hydrophilic component including CMC, pectin, and sucrose, and 0.91% by weight of ceramide PC104. Figure 4 shows the placement of each coating sample on the user's body for TEWL measurement, including application and removal. As a control, the TEWL of the same user was measured without coating application / removal.

[0051] Figure 5 is a graph of TEWL measurements after seven repetitions of coating application and removal. The C+ coated sample was tested at user sites 1 and 10. The Delta coated sample was tested at user site 2. The coated sample with mixture number 8 was tested at user sites 4 and 11. The coated sample with mixture number 10 was tested at user site 5. The coated sample with mixture number 17 was tested at user site 7. The C+3XPC104 coated sample was tested at user site 8. The C- coated sample was tested at user sites 3 and 9. At user site 6, TEWL was measured without coating application / removal as a control. As shown in Figure 5, the film samples of Delta, mixture number 8, mixture number 10, and mixture number 17, formed from a skin film composition containing a trilipid formulation including glycerin and palmitic acid, showed lower TEWL values ​​(less water loss) than the film samples of C+, C-, and C+3XPC104.

[0052] All patents referenced herein, whether specifically indicated as such within the text of this disclosure or not, are incorporated herein by reference in their entirety.

[0053] In this disclosure, the words "a" or "an" should be interpreted as including both singular and plural forms. Conversely, references to multiple items should, where appropriate, include the singular form.

[0054] From the above, you will notice that numerous modifications and variations can be realized without departing from the true essence and scope of the novel concepts of this disclosure. It should be understood that the specific embodiments illustrated are not intended to be limiting, nor should they be presumed to be so. This disclosure intends to encompass all such modifications included in the claims by the appended claims.

Claims

1. Water-insoluble pressure-sensitive adhesive component, Hydrophilic components, and At least three different types of lipids, including ceramides, cholesterol, and fatty acids. A stoma skin barrier composition comprising the above.

2. When tested according to ISO 12505-1, the fluid absorption capacity over 24 hours was approximately 0.4 g / cm³. ２ ~Approx. 2.0g / cm ２ The stoma skin film composition according to claim 1, wherein the composition is configured to provide a skin film having a peak tack of approximately 1.5 Newtons (N) to approximately 4.5 N when tested according to the Avery Adhesion Test (AAT), and a 180-degree peel adhesion strength of approximately 3 N / m to approximately 6 N / m when tested according to ISO 12505-2.

3. When tested according to ISO 12505-1, the fluid absorption capacity over 24 hours was approximately 0.5 g / cm³. ２ ~Approx. 1.5g / cm ２ The stoma skin film composition according to claim 2, wherein the composition is configured to provide a skin film having a maximum tack force of about 2 N to about 4 N when tested according to the Avery Adhesion Test (AAT), and a 180-degree peel adhesion strength of about 3.5 N / m to about 5.5 N / m when tested according to ISO 12505-2.

4. The aforementioned at least three different types of lipids are provided as a trilipid formulation containing ceramide, cholesterol, and fatty acids. The stoma skin film composition comprises about 0.15% to about 2.5% by weight of the trilipid compound. A stoma skin film composition according to any one of claims 1 to 3.

5. The aforementioned at least three different types of lipids are provided as a trilipid formulation containing ceramide, cholesterol, and fatty acids. The stoma skin film composition contains about 0.2% to about 1.8% by weight of the trilipid compound. A stoma skin film composition according to any one of claims 1 to 3.

6. The stoma skin film composition according to any one of claims 1 to 5, wherein the ceramide is a synthetic pseudo-ceramide.

7. The stoma skin film composition according to any one of claims 1 to 6, wherein the fatty acid is palmitic acid, linoleic acid, stearic acid, or a mixture thereof.

8. The stoma skin film composition according to any one of claims 1 to 7, wherein the water-insoluble pressure-sensitive adhesive component comprises polyisobutylene (PIB), hydrogenated styrene-butadiene rubber (HSBR), styrene-isoprene-styrene block copolymer (SIS), styrene-butadiene-styrene block copolymer (SBS), styrene-ethylene / propylene-styrene block copolymer (SEPS), styrene-ethylene / butylene-styrene block copolymer (SEBS), styrene-ethylene / ethylene / propylene-styrene block copolymer (SEEPS), styrene-ethylene / butylene-olefin crystalline block copolymer (SEBC), mineral oil, a tackifier, or a mixture thereof.

9. The stoma skin film composition according to any one of claims 1 to 8, wherein the hydrophilic component comprises gum arabic, tragacanth gum, galactan, guar gum, carob gum, karaya gum, carrageenan, pectin, agar, starch, xanthan gum, dextrin, dextran, succinoglucan, pullulan, casein, albumin, gelatin, methylcellulose, ethylcellulose, methylhydroxypropylcellulose, hydroxyethylcellulose, sodium cellulose sulfate, hydroxypropylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, sodium alginate, propylene glycol alginate, polyvinyl alcohol, polyvinyl methyl ether, polyvinylpyrrolidone, carboxyvinyl polymer, sodium polyacrylate, polyacrylamide, polyethyleneimine, sucrose, or a mixture thereof.

10. The stoma skin film composition according to any one of claims 1 to 3, wherein the stoma skin film composition comprises about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component comprising hydrogenated styrene-butadiene rubber (HSBR), polyisobutylene (PIB), mineral oil, and a hydrogenated hydrocarbon tackifier; about 30% to about 60% by weight of a hydrophilic component comprising carboxymethylcellulose (CMC) and pectin; and about 1.8% by weight of a trilipid formulation containing ceramide PC104, cholesterol, and linoleic acid in a ratio of 1:3:

1.

11. The stoma skin film composition according to any one of claims 1 to 3, wherein the stoma skin film composition comprises about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component comprising HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifier resin; about 30% to about 60% by weight of a hydrophilic component comprising CMC and pectin; and about 1.8% by weight of a trilipid compound containing ceramide PC104, cholesterol, and stearic acid in a ratio of 4:2:

1.

12. The stoma skin film composition according to any one of claims 1 to 3, wherein the stoma skin film composition comprises about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component containing HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifier resin; about 30% to about 60% by weight of a hydrophilic component containing CMC and pectin; and about 0.6% by weight of a trilipid compound containing ceramide PC104, cholesterol, and palmitic acid in a ratio of 4:2:

1.

13. The stoma skin film composition according to any one of claims 1 to 3, wherein the stoma skin film composition comprises about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component comprising HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifier resin; about 30% to about 60% by weight of a hydrophilic component comprising CMC and pectin; and about 1.8% by weight of a trilipid compound containing ceramide PC104, cholesterol, and palmitic acid in a ratio of 3:1:

1.

14. The stoma skin film composition according to any one of claims 1 to 3, wherein the stoma skin film composition comprises about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component containing HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifier resin; about 30% to about 60% by weight of a hydrophilic component containing CMC and pectin; and about 0.6% by weight of a trilipid compound containing ceramide PC104, cholesterol, and linoleic acid in a ratio of 3:1:

1.

15. The stoma skin film composition according to any one of claims 1 to 3, wherein the stoma skin film composition comprises about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component containing HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifier; about 30% to about 60% by weight of a hydrophilic component containing CMC and pectin; and about 0.6% by weight of a trilipid compound containing ceramide PC104, cholesterol, and stearic acid in a ratio of 1:3:

1.

16. The stoma skin film composition according to any one of claims 1 to 15, further comprising glycerol.

17. The stoma skin film composition according to claim 16, wherein the stoma skin film composition contains about 2% to about 12% by weight of glycerol.

18. The stoma skin film composition according to claim 17, wherein the stoma skin film composition comprises about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component comprising HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifier; about 20% to about 55% by weight of a hydrophilic component comprising CMC and pectin; about 5% to about 10% by weight of glycerol; and about 1.8% by weight of a trilipid compound containing ceramide PC104, cholesterol, and palmitic acid in a ratio of 3:1:

1.

19. The stoma skin film composition according to any one of claims 1 to 3, wherein the stoma skin film composition comprises about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component containing HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifier; about 20% to about 55% by weight of a hydrophilic component containing CMC and pectin; about 5% to about 10% by weight of glycerol; and about 0.15% to about 2% by weight of a trilipid compound containing ceramide PC104, cholesterol, and palmitic acid.

20. The stoma skin film composition according to claim 19, wherein the stoma skin film composition contains about 0.01% to about 1.2% by weight of ceramide PC104, about 0.03% to about 0.5% by weight of cholesterol, and about 0.15% to about 1.2% by weight of palmitic acid.

21. The stoma film composition according to claim 19 or claim 20, wherein the three-lipid compound comprises ceramide PC104, cholesterol, and palmitic acid in a ratio of 1:3:

20.

22. The stoma film composition according to claim 19 or claim 20, wherein the three-lipid compound comprises ceramide PC104, cholesterol, and palmitic acid in a ratio of 1:1:

10.

23. The stoma film composition according to claim 19 or claim 20, wherein the three-lipid compound comprises ceramide PC104, cholesterol, and palmitic acid in a ratio of 1:3:

100.

24. The stoma skin film composition according to any one of claims 1 to 3, wherein the stoma skin film composition comprises about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component including HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifier; about 20% to about 55% by weight of a hydrophilic component including CMC and pectin; about 5% to about 10% by weight of glycerol; about 0.01% to about 0.03% by weight of ceramide PC104; about 0.02% to about 0.04% by weight of cholesterol; and about 0.1% to about 0.3% by weight of palmitic acid.

25. The stoma skin film composition according to any one of claims 1 to 3, wherein the stoma skin film composition comprises about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component including HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifier; about 20% to about 55% by weight of a hydrophilic component including CMC and pectin; about 5% to about 10% by weight of glycerol; about 0.05% to about 0.15% by weight of ceramide PC104; about 0.05% to about 0.15% by weight of cholesterol; and about 0.5% to about 1.5% by weight of palmitic acid.

26. The stoma skin film composition according to any one of claims 1 to 3, wherein the stoma skin film composition comprises about 40% to about 70% by weight of a water-insoluble pressure-sensitive adhesive component including HSBR, PIB, mineral oil, and a hydrogenated hydrocarbon tackifier; about 20% to about 55% by weight of a hydrophilic component including CMC and pectin; about 5% to about 10% by weight of glycerol; about 0.01% to about 0.03% by weight of ceramide PC104; about 0.02% to about 0.04% by weight of cholesterol; and about 0.5% to about 1.5% by weight of palmitic acid.

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