Composition for peristomal sealing - Patent application

Abstract

A cellulose composition for peristomal sealing, an ostomy appliance or accessory for an ostomy appliance comprising the composition, and a method for peristomal sealing, the composition comprising a continuous phase and a discontinuous phase, the continuous phase comprising a cellulosic material and a plasticizer, and the discontinuous phase comprising an absorbent material, the cellulosic material being soluble in the plasticizer, the composition comprising 15-40% by weight of the cellulosic material, 10-30% by weight of the plasticizer, and 40-70% by weight of the absorbent material.

Description

[Technical field]

[0001] The present invention relates to compositions for sealing the peristomal area, as well as ostomy appliances containing such compositions and methods of using such compositions. [Background technology]

[0002] In connection with the treatment of gastrointestinal disorders, part or all of the colon, ileum or urethra must be surgically removed or temporarily bypassed. A temporary or permanent abdominal stoma is created in the patient through which bodily fluids or waste are drained and collected in a collection bag. The bag is usually sealed to the skin using an adhesive wafer or plate with an inlet opening to accommodate the stoma. Individual adhesive rings and / or adhesive pastes may be used as attachments to fill the area between the stoma and the adhesive wafer. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0003] Hereinafter, whenever reference is made to the proximal side or proximal portion of the appliance, it means the side that faces the skin when the ostomy appliance is worn by a user. Similarly, whenever reference is made to the distal side or distal portion of the appliance, it means the side that faces away from the skin when the ostomy appliance is worn by a user. In other words, the proximal side is the side closest to the user when the appliance is worn by a user, and the distal side is the opposite side - the side furthest away from the user when in use.

[0004] An embodiment provides a cellulose composition for peristomal sealing, comprising 20-40% by weight of a cellulose derivative material, 10-30% by weight of a plasticizer, and 40-70% by weight of an absorbent material. As shown in the examples, compositions of this type achieve desirable swelling properties and can adequately and rapidly seal the peristomal area.

[0005] The composition is a cellulosic composition, meaning that one or more cellulosic materials make up a significant portion of the composition.

[0006] The composition is a peristomal sealing composition, which means that it is suitable for application to or near the skin of a person around the stoma to form a seal between the stoma and the composition, the purpose of this sealing action being to prevent leakage of stoma output onto the skin of the person.

[0007] The cellulosic material of the composition can be said to form a matrix into which other components are incorporated. In other words, the composition includes a matrix, sometimes referred to as a continuous phase, and some separate components within the matrix, which may be referred to as a discontinuous or separate phase. An embodiment provides a cellulosic composition including a continuous phase and a discontinuous phase, the continuous phase including a cellulosic material and a plasticizer, and the discontinuous phase including an absorbent material. In an embodiment, the continuous phase is hydrophilic. In an embodiment, the cellulosic material is soluble in the plasticizer. For example, the cellulosic derivative hydroxypropyl cellulose (HPC), which may be a component of the continuous phase, is soluble in polyethylene glycol (PEG200), an average molecular weight of 200 Daltons, which is a plasticizer. In an embodiment, the absorbent material is not soluble in the plasticizer. For example, carboxymethyl cellulose (CMC), which is an absorbent material and a possible component of the discontinuous phase, is not soluble in PEG200.

[0008] In the context of the present invention, solubility refers to the ability of one component of the composition to be dissolved by another component of the composition. For example, if a cellulosic material is soluble in a plasticizer, this means that the plasticizer in the composition can dissolve the cellulosic material in the composition. Conversely, if something is not soluble, this means that one component of the composition cannot be dissolved by another component of the composition. For example, if an absorbent material is not soluble in a plasticizer, this means that the plasticizer in the composition cannot dissolve the absorbent material. The inventors recognize that solubility is a relative term: only a certain amount of material can be dissolved in a given amount of solvent. In the context of the present invention, solubility is seen in the context of the composition itself. The cellulosic material of the composition being soluble in a plasticizer means that any amount of the cellulosic material can be dissolved in any amount of the plasticizer. It simply means that the cellulosic material in the composition can be dissolved by the plasticizer in the composition.

[0009] An embodiment provides a cellulose composition for peristomal sealing comprising a continuous phase and a discontinuous phase, wherein the continuous phase comprises a cellulosic material and a plasticizer, and the discontinuous phase comprises an absorbent material, and the cellulosic material is soluble in the plasticizer, and the cellulose composition comprises 20-40% by weight of the cellulosic material, 10-30% by weight of the plasticizer, and 40-70% by weight of the absorbent material.

[0010] The composition is water-swellable, which means that the composition swells in the presence of water. Water swelling is an increase in volume as a result of water being absorbed by the composition. Water swelling can occur by the cellulosic matrix itself absorbing water and / or by the absorbent material absorbing water. Swelling requires an increase in the volume of the composition, which is different from, for example, sponges or other porous materials that absorb water by incorporating it into existing holes or pores, without this uptake of water increasing the volume of the material. The swelling of the composition, and the resulting increase in volume, leads to a sealing action. The composition expands in volume and can fill gaps, for example to provide a peristomal seal. Swelling is also a result of the absorbent material, possibly the cellulosic material, absorbing liquid. The inventors have found that the disclosed mixture of cellulosic matrix, plasticizer and absorbent material provides the right balance of rapid swelling and sufficient adhesion.

[0011] In embodiments, the composition is moldable, meaning that it can be permanently deformed by the application of pressure. The moldability of the composition can be adjusted, for example, by increasing the amount of the continuous phase, thereby making it softer and more moldable. On the other hand, increasing the amount of the discontinuous phase generally makes the composition harder and less moldable.

[0012] The inventors of the present invention have found that it is difficult to obtain a good and effective seal around the stoma. On the one hand, the seal must be quite snug to prevent leakage. On the other hand, the stoma is usually very vulnerable and cannot withstand high pressure against it or friction with fabric. The stoma easily becomes irritated and further secretions from the stoma may occur. Furthermore, it is important to establish a seal around the stoma as soon as possible after applying the composition to the skin. If the seal is established too late, there will be time for the effluent and secretions from the stoma to leak onto the human skin before the seal is established. This means that the skin and anything attached to the skin, such as an ostomy adhesive wafer, will already be compromised from the very beginning by the effluent or secretions on the skin. This also means that the risk of damage to the skin and the possibility of failure of the attachment of other appliances to the skin increases dramatically.

[0013] When using ostomy products, such as ostomy pouches attached to adhesive base plates, there is often a gap between the product and the stoma. This gap can expose the skin to waste from the stoma. This waste contains surface active bile salts and proteolytic enzymes, which can damage the skin. The adhesive part of the stoma product usually contains various absorbing and gelling compounds, which when exposed to moisture in waste, will start to swell and reduce the gap over time. However, this process is very slow and may not close the gap fast enough to prevent skin damage.

[0014] With all this in mind, the inventors have devised the compositions of the present invention to provide a rapid peristomal sealing action while at the same time being gentle enough not to damage or irritate the stoma.

[0015] The composition comprises a matrix, which is the backbone of the composition. The matrix is ​​typically sufficiently tacky to maintain sufficient structural integrity of the composition and to prevent it from disintegrating or dissolving when exposed to liquid for a short period of time, such as 2-12 hours. The matrix comprises a cellulosic material.

[0016] The composition further comprises a plasticizer which acts to plasticize or soften the composition and impart desired rheological properties to it.

[0017] The composition further comprises an absorbent material, which is capable of absorbing liquids, such as water.

[0018] In an embodiment, the composition is a non-adhesive composition. Non-adhesive means that the composition is not able to maintain adequate adhesion to a surface such as human skin as it is. In an embodiment, non-adhesive means that the composition exhibits a peel force of less than 1 N / 25 as measured by the peel force test method described herein. Such a peel force of less than 1 N / 25 means that the composition can be very easily removed from, for example, human skin without damage. To ensure that the non-adhesive composition remains in place, it can be incorporated into, for example, a multi-component product that can maintain adhesion by itself. Alternatively, other adhesive components can be used to secure the composition to the skin, such as an adhesive on the base plate of an ostomy appliance.

[0019] In an embodiment, the cellulosic material is selected from the group consisting of hydroxypropyl cellulose, methylhydroxypropyl cellulose, ethyl cellulose and methylhydroxyethyl cellulose.

[0020] In embodiments, the plasticizer is selected from the group consisting of di-, tri-, and tetraethylene glycols, polyethylene glycols, dipropylene glycols, tripropylene glycols, polypropylene glycols, glycerol, glyceryl glucoside, diglycerin, triglycerin, polyglycerin, ethoxylated glycerol, ethoxylated methyl glycoside, monoacetin, diacetin, triacetin, aliphatic diols, triols, and polyols, xylitol, erythritol, sorbitol, mannitol, inositol, dibutyl tartrate, diethyl tartrate, choline, urea, hydroxyethyl urea, PPG-10 methyl glucose ether, aliphatic esters of di- and tricarboxylic acids, aliphatic esters of fatty acids. In embodiments, the plasticizer is selected from liquid rosin derivatives, aromatic olefin oligomers, vegetable and animal oils and derivatives, polar oils such as esters, ethers and glycols, polypropylene oxides such as α-butoxy-polyoxypropylene, mineral oils, citrate oils, paraffin oils, phthalates, adipates (such as DOA), and liquid or solid resins.

[0021] In an embodiment, the absorbent material is selected from the group consisting of hydrocolloids, starches, water-soluble salts, mono-, di- and oligosaccharides, sugar alcohols, polypeptides, organic acids, inorganic acids, amino acids, amines, urea, superabsorbent particles such as polyacrylic acid, glycols such as polyethylene glycol, fumed silica and bentones. In an embodiment, the absorbent material is selected from the group consisting of carboxymethylcellulose, methylcellulose, hydroxypropylmethylcellulose, potato starch, corn starch, modified starch, hydroxyethyl starch, hydroxypropyl distarch phosphate, pectin, guar gum, locust bean gum, tara gum, agar, alginates, sodium alginate, calcium alginate, carrageenan, gellan gum, xanthan gum, gelatin, cellulose derivatives, salts of carboxymethylcellulose, sodium carboxymethylcellulose, methylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, sodium starch glycolate and polyvinyl alcohol. In an embodiment, the absorbent material is hydroxyethylcellulose having a weight average molecular weight in the range of 500,000 to 2,000,000 g / mol, such as 750,000 to 1,500,000 g / mol, such as 800,000 to 1,200,000 g / mol, such as 1,000,000 g / mol. In an embodiment, the absorbent material is Natrosol 250HX hydroxyethylcellulose available from Ashland.

[0022] In an embodiment, the cellulosic material and the absorbent material are different materials.

[0023] In embodiments, the composition comprises 15-40, 15-25, 15-20, 20-30, 30-40, 20-25, 25-30, 30-35, or 35-40 wt.% of the cellulosic material.

[0024] In embodiments, the composition comprises 15-30, 20-30, 25-30, 15-25, or 15-20 weight percent of the plasticizer.

[0025] In embodiments, the composition comprises 40-60, 40-50, 50-60, 60-70, 50-55, 50-65, 55-60, 60-65, or 65-70% by weight of absorbent material.

[0026] In an embodiment, the composition comprises or consists essentially of 15-25% by weight cellulosic material, 15-25% by weight plasticizer, and 50-65% by weight absorbent material.

[0027] In an embodiment, the composition further comprises an antioxidant, such as butylated hydroxytoluene.When ether is used in the composition, the antioxidant may be particularly useful.In an embodiment, the composition comprises an antioxidant in an amount of less than 5% by weight, such as less than 2% by weight, such as less than 1% by weight, such as 0.5% by weight.

[0028] In an embodiment, the composition further comprises one or more filler materials, such as calcium carbonate, magnesium oxide, magnesium hydroxide, aluminum hydroxide, fumed silica, and lignin. The filler materials may include non-reinforcing fillers, such as talc, calcium carbonate, wood flour, or precipitated or fumed silica. More specifically, examples of such fillers include: calcium carbonate (dry ground grades of calcium carbonate, wet ground grades of calcium carbonate, beneficiated grades of calcium carbonate, precipitated grades of calcium carbonate, surface treated grades of calcium carbonate, etc.); kaolin and other clay-based minerals; talc (dry ground talc, calcined talc, etc.); silica, such as quartz and natural silica (crystalline silica, fused silica, microcrystalline silica, microcrystalline novaculite, diatomaceous silica, perlite, etc.) or synthetic. Silica (fumed silica, precipitated silica, etc.); mica (ground grades of mica, white grades of mica, surface modified grades of mica, metal coated mica grades, etc.); metal oxides and other compounds (titanium dioxide, alumina trihydrate, wollastonite, barium sulfate, antimony oxide, magnesium oxide, magnesium hydroxide, calcium sulfate, anhydrous calcium sulfate, calcium sulfate dihydrate, feldspar and nepheline syenite, etc.); microspheres, solid microspheres, hollow microspheres (coated hollow microsphere fillers, metalite aluminium microspheres, polymer encapsulated gas microspheres, etc.); synthetic silicates (aluminum silicate, mullite, sillimanite, kyanite, andalusite, synthetic alkali metal aluminosilicates, calcium silicate, magnesium silicate, zirconium silicate, etc.). Optional fillers include, for example, calcium carbonate, magnesium oxide, hydrophobic fumed silica, or lignin. Suitable hydrophobic fumed silicas include, for example, AEROSIL® R812 (BET specific surface area 230-290 g / cm 2 ), AEROSIL® R974 (BET specific surface area 150-190 g / cm 2 ) or AEROSIL® 200 (BET specific surface area 200±25g / cm 2 ) are mentioned.

[0029] In an embodiment, the composition is in the form of a ring. The ring shape is particularly useful for providing a complete seal around the stoma. The composition may alternatively be in the form of a half ring, in which case the user may apply one or two half rings according to need and preference.

[0030] In an embodiment, the ring has an outer diameter of 40-100 mm, such as 50-80 mm, for example 50-60 mm, and has a central hole with a diameter of 5-30 mm, for example 10-20 mm.

[0031] In an embodiment, the ring has a thickness of 0.2 to 3 mm, such as 0.3 to 2 mm, for example 0.5 to 1.5 mm.

[0032] In embodiments, the composition has a swelling of at least 0.75 mm, 1 mm, 1.25 mm, or 1.5 mm after 30 minutes, as measured according to the Swelling Rate Test described herein. This swelling rate is preferred because it provides a fairly rapid seal around the stoma, minimizing the risk of leakage of waste onto the skin of the user. In embodiments, the swelling may be at least 2 mm after 1 hour.

[0033] In an embodiment, the composition comprises 15-25% by weight of cellulosic material, 15-25% by weight of plasticizer, and 45-70% by weight of absorbent material.

[0034] In an embodiment, the composition consists essentially of 15-25% by weight cellulosic material, 15-25% by weight plasticizer, and 45-70% by weight absorbent material.

[0035] In an embodiment, the composition comprises 15-25% by weight of cellulosic material, 15-25% by weight of plasticizer, and 45-70% by weight of absorbent material.

[0036] In an embodiment, the cellulosic material is hydroxypropyl cellulose. In an embodiment, the absorbent material comprises carboxymethyl cellulose and polyacrylic acid. In an embodiment, the plasticizer comprises polyethylene glycol of molecular weight 200 Daltons.

[0037] Provided is an ostomy appliance comprising an adhesive for attaching the appliance to the skin of a user, a release liner on a proximal surface of the adhesive, a backing layer on a distal surface of the adhesive, a hole for accommodating a stoma, and a collection bag attached to the backing layer, further comprising a composition as described herein. In an embodiment, the composition is disposed on the distal surface of the backing layer. In an embodiment, the composition is disposed between the adhesive and the backing layer.

[0038] An accessory for an ostomy appliance is provided, comprising an adhesive for attaching the accessory to the peristomal skin of a user, an aperture for accommodating a stoma, and a composition as described herein disposed on a distal surface of the adhesive. In an embodiment, the accessory further comprises a release liner on the proximal surface of the adhesive. In an embodiment, the accessory further comprises a backing layer on the distal surface of the composition.

[0039] Provided is a method of sealing the peristomal area, comprising the steps of providing a composition described herein; applying the composition to the peristomal area; and allowing the composition to swell, thereby sealing the peristomal area.

[0040] item 1. A cellulose composition for peristomal sealing comprising: - 20-40% by weight of cellulose derivative materials; - 10 to 30% by weight of plasticizer; and - 40-70% by weight of absorbent material; 1. A cellulose composition comprising: 2. The composition of item 1, wherein the composition is water-swellable. 3. The composition of item 1 or 2, wherein the composition is non-adhesive. 4. The composition of any one of items 1 to 3, wherein the cellulose derivative material is selected from the group consisting of hydroxypropyl cellulose, methylhydroxypropyl cellulose, ethyl cellulose and methylhydroxyethyl cellulose. 5. The composition of any one of items 1 to 4, wherein the absorbent material is selected from the group consisting of hydrocolloids, starches, water soluble salts, mono-, di- and oligosaccharides, sugar alcohols, polypeptides, organic acids, inorganic acids, amino acids, amines, urea, superabsorbent particles, glycols, fumed silica, and bentones. 6. The composition of any one of items 1 to 5, wherein the composition is in the shape of a ring. 7. The composition of any one of items 1-6, wherein the composition has a swelling of at least 1.5 mm after 30 minutes when measured according to the Swelling Test method described herein. 8. The composition of any one of items 1 to 7, comprising 15 to 25% by weight of a cellulosic material, 15 to 25% by weight of a plasticizer, and 45 to 70% by weight of an absorbent material. 9. The composition of any one of items 1 to 8, consisting essentially of 15 to 25% by weight of a cellulosic material, 15 to 25% by weight of a plasticizer, and 45 to 70% by weight of an absorbent material. 10. An ostomy appliance comprising an adhesive for attaching the appliance to the skin of a user, a release liner on a proximal side of the adhesive, a backing layer on a distal side of the adhesive, a hole for accommodating a stoma, and a collection bag attached to the backing layer, further comprising the composition of any one of items 1-9. 11. The ostomy appliance of item 10, wherein the composition is disposed on the distal surface of the backing layer or between the adhesive and the backing layer. 12. An accessory for an ostomy appliance comprising an adhesive for attaching the accessory to the peristomal skin of a user, a hole for accommodating a stoma, and a composition according to any one of items 1 to 9 disposed on the distal surface of the adhesive. 13. The accessory of item 12, further comprising a release liner on the adjacent surface of the adhesive. 14. The accessory of item 12 or 13, further comprising a backing layer on a distal surface of the composition. 15. A method for sealing a stoma, comprising: - providing a composition according to any one of items 1 to 9; - applying the composition around the stoma; and allowing the composition to swell, thereby forming a peristomal seal.

[0041] Test Method Peel Force Test Method To carry out the peel test, a rectangular sample with a size of 25 mm x 100 mm was provided. The sample was pressed firmly onto a thoroughly cleaned Teflon plate. Then, a 25 x 300 mm rectangular sample of the auxiliary tape was pressed firmly onto a thoroughly cleaned Teflon plate. 2 The strip was placed on the sample and the entire sample was placed under a pressure roller to ensure that the bond between the tape and the sample being tested was firmly secured. After conditioning for 30 minutes at 23°C, the sample was mounted in a tensile tester and a 90° peel test was performed at a speed of 304mm / min. Results are given in N / 25mm.

[0042] Swelling Rate Test Method The swelling rate was tested by hot pressing the composition to be tested between sheets of release liner (siliconized paper) at a thickness of 1 mm for 30 seconds at 90° C. From this, rings (outer diameter 57 mm, hole diameter 27 mm) were cut.

[0043] A hard plastic (polyoxymethylene, "POM") disk (17 mm diameter, 3 mm thick) was attached to the center of a glass Petri dish with double-sided adhesive tape. A ring of the swellable composition was placed on the glass Petri dish centered on the POM disk, leaving a 5 mm gap between the POM and the ring of the swellable composition.

[0044] When isotonic saline was added to the sample to initiate swelling, the process is inherently a low contrast event. To increase contrast, crossed polarizing filters were used: a sheet of polarizing film was attached to a light table. The sample was placed on top of this film. A camera (Canon EOS 1200D) was positioned to view the sample from above. Another polarizing filter was placed on the camera lens. The filter was then adjusted to transmit the least amount of light (this occurs when the two filters are oriented at 90 degrees to each other). An initial photograph of the sample was taken, saline was added to cover the ring, and subsequent photographs were taken at predefined time points, such as 1-24 hours. ImageJ was used to measure the gap between the ring and the POM disk at the 12-3-6-9 o'clock position, both at the initial time point (t0) and at later time points. The average change in the size of the gap was calculated and reported in mm at different time points.

[0045] Erosion Resistance Test Method To test the erosion resistance, the composition was hot pressed to 0.5 mm between two sheets of release liner (siliconized paper). A square sample (25×25 mm) was made and a triangular notch of the material (approximately 10×10×10 mm) was cut from the top of the square with the tip of the triangle pointing towards the center of the square. The notched square was placed on a glass plate. The glass plate was then mounted in an upright position (approximately 10 degrees from vertical) in front of a light table (also in an upright position) that had a polarizing filter (as in the swelling rate test method above). The sample was observed with a camera with a polarizing filter. The filter was adjusted to maximum darkness. A bath with saline was placed under the sample, from which saline was pumped into the notch of the sample at 4 mL / min. Time-lapse photography was started and the time it took for the flowing liquid to etch a clear flow path through the material was used as a measure of erosion resistance. EXAMPLES

[0046] The following compositions were prepared: CMC is carboxymethylcellulose sodium salt, and GR-221 is sodium polyacrylate superabsorbent powder, both of which are absorbent materials. PEG200 is polyethylene glycol with an average molecular weight of 200 Daltons, which is a plasticizer. HPC is hydroxypropyl cellulose. BHT is butylated hydroxytoluene, which is an antioxidant.

[0047] [Table 1]

[0048] Recipes A, B, C, and D were prepared to test HPC grades with different molecular weights, all of which were prepared as described in Example 3 below, with the exception that various grades of HPC components were used, and BHT was added to the matrix mix prepared according to Example 1.

[0049] Recipe E is the exact recipe taken from Example 3 below.

[0050] Recipes F and G were prepared in the same manner as described in Example 3, but with varying contents of different ingredients.

[0051] Example 1: Hydroxypropylcellulose-based matrix 34.5 g of PEG200 was added to a glass beaker. 34.5 g of hydroxypropyl cellulose (Klucel LF PHARM, Ashland) was then added with stirring. The mixture was left to solidify at room temperature for 1 hour, then heated and mixed (Brabender) at 80° C. for 40 minutes at 50 rpm. This resulted in a soft, sticky paste at room temperature.

[0052] Example 2: Ethylcellulose-based matrix 34.5 g of tributyl citrate was added to a glass beaker. Then, 34.5 g of ethyl cellulose (Aqualon EC N4, Ashland) was added with stirring. The mixture was left to solidify at room temperature for 1 hour, then hot mixed (Brabender) at 80° C. for 40 minutes at 50 rpm. This resulted in a soft, sticky paste at room temperature.

[0053] Example 3: Swellable composition with a hydroxypropyl cellulose-based matrix binder 21 g of matrix paste from Example 1, 19.5 g of carboxymethylcellulose (Akucell AF2881, Nouryon) and 19.5 g of sodium polyacrylate (GR-221 superabsorbent powder, Chase Corporation) were added to a Speedmixer cup and mixed at 2000 rpm (3 x 1 min) (Speedmixer DAC150.1FVZ, Hauschild), resulting in a soft paste when hot and solidifying into a hard paste when cooled to room temperature.

[0054] Example 4: Swellable composition with an ethylcellulose-based matrix 21 g of matrix from Example 2, 19.5 g of carboxymethylcellulose (Akucell AF2881, Nouryon) and 19.5 g of sodium polyacrylate (GR-221 superabsorbent powder, Chase Corporation) were added to a Speedmixer cup and mixed at 2000 rpm (3 x 1 min) (Speedmixer DAC150.1FVZ, Hauschild), resulting in a soft paste when hot and solidifying into a hard paste when cooled to room temperature.

[0055] Example 5: Comparison of the swelling rate of a commercially available ostomy sealing ring and the swelling composition "Recipe B" The swelling rate of a commercially available ostomy sealing ring (hydrophobic adhesive matrix with hydrocolloid) was measured as described herein above in the "Swelling Rate Test Method" section. The commercially available product was a hydrophobic adhesive with hydrophilic filler particles. Swelling rate measurements were taken at 0, 1.5, 4, 8, 12 and 16 hours.

[0056] Similarly, the swellable composition according to Recipe B of Table 1 was tested according to the "Swelling Rate Test Method" described herein and measurements were taken at 15, 30, 60 and 120 minutes. As Recipe B showed significantly faster swelling, measurements were taken earlier and at shorter intervals.

[0057] The swelling rates of the commercial ostomy seal and Recipe B are compared in Table 2. All results reported are the average of four individual samples. Results in parentheses are calculations based on curve fits to the measured results.

[0058] [Table 2]

[0059] The results in Table 2 show that the commercially available ostomy seal product swells rather slowly and therefore takes a long time to close the gap between the adhesive and the POM disc. Even after 4 hours, the ostomy seal had only swelled 1.3 mm. Translated to a use situation where the POM disc mimics a stoma and the gap mimics exposed skin, the skin is exposed to stoma output for a very long time before being sealed by the slowly swelling adhesive. This is in contrast to the swelling composition of Recipe B, which swelled 2.6 mm after only 1 hour. Even after only 15 minutes, the composition of Recipe B swells 1.6 mm, thereby acting very quickly to close the gap between the applied composition and the POM disc.

[0060] Example 6: Erosion resistance The compositions were tested for erosion resistance as described in the Erosion Resistance Test Method herein above. To better understand the effect of different HPC grades, recipes A-D were tested, and to examine the effect of different amounts of HPC in the composition, recipes E-G were tested. The results are shown in Table 3, where erosion resistance is reported as the time it takes for a liquid to carve a flow path through the material. A higher number represents a higher erosion resistance.

[0061] [Table 3]

[0062] The results in Table 3 show that the higher the molecular weight of the HPC material, the higher the erosion resistance. On the other hand, increasing the content of HPC (and plasticizer) in the absorbent decreases the erosion resistance. This information can be used to fine-tune the properties of the composition for commercial use. The test methods used do not directly translate to the expected rate of erosion when the composition is worn, for example, on the skin of an ostomy patient. However, all compounds tested are considered to have an acceptable level of erosion resistance in that they are suitable for use as peristomal sealing compositions.

Claims

1. A cellulose composition for sealing around a stoma, comprising a continuous phase and a discontinuous phase, wherein the continuous phase comprises a cellulose derivative material and a plasticizer, and the discontinuous phase comprises an absorbent material, and the cellulose derivative material is soluble in the plasticizer, and: - 15 to 40% by weight of the cellulose derivative material, - 10 to 30% by weight of the plasticizer, and - The absorbent material: 40 to 70% by weight, A cellulose composition containing [the specified ingredient].

2. The composition according to claim 1, wherein the absorbent material is not soluble in the plasticizer.

3. The composition according to claim 1 or 2, which is water-swellable.

4. The composition according to claim 1 or 2, which is non-adhesive.

5. The composition according to claim 1 or 2, wherein the cellulose derivative material is selected from the group consisting of hydroxypropyl cellulose, methylhydroxypropyl cellulose, ethyl cellulose, and methylhydroxyethyl cellulose.

6. The composition according to claim 1 or 2, wherein the absorbent material is selected from the group consisting of hydrophilic colloids, starch, water-soluble salts, monosaccharides, disaccharides and oligosaccharides, sugar alcohols, polypeptides, organic acids, inorganic acids, amino acids, amines, urea, superabsorbent particles, glycols, fumed silica, and benton.

7. The composition according to claim 1 or 2, which takes the shape of a ring.

8. The composition according to claim 1 or 2, which, when measured according to the swelling rate test method described herein, has a swelling of at least 0.75 mm after 30 minutes.

9. The composition according to claim 1 or 2, comprising 15 to 25% by weight of a cellulose derivative material, 15 to 25% by weight of a plasticizer, and 45 to 70% by weight of an absorbent material.

10. The composition according to claim 1 or 2, comprising essentially 15 to 25% by weight of a cellulose derivative material, 15 to 25% by weight of a plasticizer, and 45 to 70% by weight of an absorbent material.

11. An ostomy appliance comprising an adhesive for attaching the appliance to the user's skin, a release liner on the adjacent surface of the adhesive, a backing layer on the distal surface of the adhesive, a hole for containing a stoma, and a collection bag attached to the backing layer, further comprising the composition according to claim 1 or 2.

12. The ostomy appliance according to claim 11, wherein the composition is disposed on the distal surface of the backing layer, or between the adhesive and the backing layer.

13. An accessory for an ostomy appliance, comprising an adhesive for attaching the accessory to the skin around the user's stoma, a hole for housing the stoma, and the composition according to claim 1 or 2 disposed on the distal surface of the adhesive.

14. The accessory according to claim 13, further comprising a release liner on the adjacent surface of the adhesive.

15. The accessory device according to claim 13, further comprising a backing layer on the distal surface of the composition.

16. A method of sealing the area around a stoma, - A step of providing the composition according to claim 1 or 2; - The step of applying the composition around the stoma; and - A method of swelling the composition so that the area around the stoma is sealed.