Diaper balancing skin microbiota

Abstract

The invention relates to a diaper comprising a cream or lotion that preserves the natural balance of the skin and does not disrupt its bacterial ecosystem, and balances the skin microbiota.

Description

[0001] DIAPER BALANCING SKIN MICROBIOTA

[0002] Technical Area

[0003] The invention relates to a diaper comprising a cream or lotion that preserves the natural balance of the skin and does not disrupt its bacterial ecosystem, and balances the skin microbiota.

[0004] Prior Art

[0005] Skin conditions such as diaper rash, irritation, redness, skin rash, which are frequently seen after use in diapers, are called diaper dermatitis, which has been a subject of research for a long time. It is a problem caused by physical, chemical, enzymatic, and microbial factors in the diaper environment. The humid and confined environment increases sensitivity to skin friction, while elevated skin moisture and a rise in skin pH disrupt the barrier function of the stratum corneum. Eventually, the skin becomes highly susceptible to mechanical abrasion and microbial infections, and fecal enzymes attack the skin, compounding the damage. In addition, some intestinal microbial residues can also cause skin infection.

[0006] To enhance the physical and chemical properties within the enclosed environment of currently manufactured diapers, various functional features are incorporated into their design. The leading features include minimal rewet and rapid acquisition time. A diaper capable of quickly absorbing urine and retaining it under pressure without releasing it back prevents the formation of a damp and closed environment, and thereby maintaining dryness of the skin. For this purpose, specially developed super absorbent polymers, specially developed acquisition and distribution layers can be used, as well as super absorbent polymer and cellulosic fiber (fluff) mass ratios or channel or embossed absorbent zone designs are among the applications to keep the skin dry. Diapers comprising a breathable outer surface are configured to reduce the formation of a humid environment by facilitating the removal of water vapor from the skin.

[0007] However, despite the implementation of all these preventive features in diapers, diaper dermatitis still occurs in 20% of clinical paediatric cases in babies under 2 years of age. The nature of microbial colonization is also a very important parameter to preventdiaper dermatitis. However, there is currently no diaper that can provide a solution to diaper dermatitis by maintaining the microbiome balance of the skin.

[0008] During the patent search, no patent or literature was found describing a diaper comprising a cosmetic formulation applied to the topsheet in contact with the baby’s skin, which is the subject of the present disclosure. However, some patent applications in a similar technical field are cited below.

[0009] The patent publication number US2010040673A1 describes a method of impregnating a solution on a tissue / nonwoven type fabric (surface) for products such as wet wipes. It is not related to diapers that balance the skin microbiota and there is no application of cream or lotion.

[0010] The patent publication number US2015209468A1 describes a fiber structure comprising microorganisms and a hygiene product comprising such a material. The use of probiotics as microorganisms is mentioned and microorganisms are included in the structure during the fiber preparation stage. Fiber preparation is done by solution and melt spinning (extrusion) methods. It is not related to a diaper that balances the skin microbiota and there is no cream or lotion application.

[0011] The patent publication number US2019282725A1 relates to hygienic products such as sanitary pads, baby diapers, adult diapers with antibacterial properties. It may also have probiotic elements. Antibacterial properties are provided by the use of probiotic elements. These elements are applied to the product during the production of hygienic products by means of a solution. It is not related to a diaper that balances the skin microbiota and there is no cream or lotion application.

[0012] Objectives of the Invention

[0013] The main objective of the present invention is to develop a diaper comprising a cream or lotion that preserves the natural balance of the skin and does not disrupt its bacterial ecosystem, and balances the skin microbiota.

[0014] Within the scope of the present invention, a cream has been developed to minimize the sensitivity of the skin to physical and chemical external influences by preserving the microbiome balance of the skin in order to ensure the skin comfort of the baby and toprevent symptoms such as itching, redness, skin rash, diaper rash, irritation, etc. caused by diapers. The developed cream has been applied to the topsheet of the diaper, which is in contact with the baby’s skin, whereby it has been strived to support not only the physical barrier of the baby’s skin but also its microbiological barrier, namely, the skin microbiota.

[0015] To achieve the aforementioned objectives and to support both the physical barrier of the baby's skin and its microbiological barrier, namely, the skin microbiota, the diaper comprises:

[0016] - a lotion comprising a microbiome balancing active ingredient of a prebiotic origin or probiotic origin or synbiotic origin or postbiotic origin or an origin composed of combinations thereof, applied to the diaper in liquid form without heating, or

[0017] - a cream comprising a microbiome balancing active ingredient of a prebiotic origin or probiotic origin or synbiotic origin or postbiotic origin or an origin composed of combinations thereof, applied to the diaper in solid or semi-solid form by heating and resistant to repeated thermal processing.

[0018] Detailed Description of the Invention

[0019] Within the scope of the invention, as a first step, a cream has been developed to be applied to the diaper to come into contact with the baby’s skin. The primary task of the diaper is to absorb the liquid and retain it in the absorbent layer. For this reason, the cream consists solely of the oil phase to prevent the cream to be applied to the diaper from being absorbed by the diaper and to prevent possible microbiological growths that may occur due to cream after production.

[0020] The topsheet of the diaper has the task of transferring the liquid away from the baby's skin to the absorbent layer. For this reason, it is expected to have a porous structure. In order for the cream developed within the scope of the invention to adhere to the topsheet, it must solidify shortly after application.

[0021] For this purpose, a diaper cream with the following composition, which also has the aforementioned properties, has been developed and applied to the diaper’s topsheet, which comes into contact with the baby’s skin, during diaper production.The diaper comprises

[0022] - a lotion comprising a microbiome balancing active ingredient of a prebiotic origin or probiotic origin or synbiotic origin or postbiotic origin or an origin composed of combinations thereof, applied to the diaper in liquid form without heating; or

[0023] - a cream comprising a microbiome balancing active ingredient of a prebiotic origin or probiotic origin or synbiotic origin or postbiotic origin or an origin composed of combinations thereof, applied to the diaper in solid or semi-solid form by heating and resistant to repeated thermal processing,

[0024] in order to support both the physical barrier of the baby's skin and its microbiological barrier, namely, the skin microbiota.

[0025] The diaper cream comprises ester groups, hydrogenated vegetable oils, fatty alcohols, waxes, emulsifiers, probiotics, prebiotics, postbiotics, synbiotics, vegetable oils, extracts, vitamins and essences. These components provide cosmetic functions such as supporting the skin barrier, moisturizing the skin, softening the skin and supporting the microbiome balance of the skin, while in terms of formulation and application to the skin, they have functions such as melting at skin temperature, adjusting viscosity and textural properties, and providing adhesion and diffusion to the surface to be applied.

[0026] Within the scope of the invention, a diaper comprising a microbiome balancing active ingredient or comprising cream or lotion comprising a microbiome balancing active ingredient that preserves the natural balance of the skin and does not disrupt its bacterial ecosystem, has been developed in order to support both the physical barrier of the baby's skin and its microbiological barrier, namely, the skin microbiota.

[0027] The composition in the form of a cream or lotion comprising a microbiome balancing active ingredient is applied to the topsheet, which is the layer in contact with the baby’s skin, either entirely or partially, so as to correspond to one or both of the anterior or posterior genital regions. The aforementioned cream or lotion has a structure that can adhere to the fibrous and porous topsheet of the diaper, and the cream has a structure that can solidify shortly after being applied to the topsheet.The cream is solid at room temperature, begins to melt gradually starting from body temperature and becomes completely liquid starting from 60°C and its density is between 0.50 g / cm3-1 g / cm3between 60°C-80°C and its viscosity is between 200-10 cP.

[0028] The diaper comprises a cream that is applied by melting, has a stable structure between -40°C-90°C and can be repeatedly heated and cooled, and the application tank temperature for said cream is between 55°C-90°C; the hose temperature is between 60°C-85°C; and the gun temperature is between 60°C-85°C.

[0029] In order to preserve and support the skin’s microbiome balance, the cream or lotion comprises 0.1%-20% of plant-based fermented probiotics, yeast / fungal probiotics, bacterial probiotics, or animal-derived probiotics.

[0030] To preserve and support the microbiome balance of the skin, the cream or lotion comprises 0.1%-20% of prebiotics such as plant-based polypeptides, phytosterols, amino acid derivatives, oligosaccharides such as a-glucan, monosaccharides such as glucose, fructose, galactose, polysaccharides such as inulin.

[0031] In order to preserve and support the skin’s microbiome balance and barrier, the cream or lotion comprises 0.1%-20% of postbiotics such as lactic acid, [3-glucans, acetic acid, ceramides, polyphenols and phenolic compounds, antimicrobial peptides, and oligosaccharides.

[0032] In order to preserve and support the skin’s microbiome balance and barrier, the cream or lotion comprises 0.1 %-20% of synbiotics in which probiotics and prebiotics are used together.

[0033] In order to preserve and support the skin’s microbiome balance and barrier, the cream or lotion comprises 0.1%-20% of any two or three of prebiotics, probiotics, and synbiotics together.

[0034] In order to preserve and support the skin’s physical barrier, the cream or lotion comprises 0.01 %-5% of vegetable oils, extracts, and vitamins.

[0035] The cosmetic composition in the form of a cream or lotion comprising a microbiome balancing active ingredient has an odor control system. The cosmetic composition inthe form of a cream or lotion comprising a microbiome balancing active ingredient comprises ingredients such as essences, perfumes and the like that mask unpleasant odors. The composition in the form of a cream or lotion comprising a microbiome balancing active ingredient is free from allergens. The composition in the form of a cream or lotion comprising a microbiome balancing active ingredient comprises agents such as cyclodextrins, zeolites, and the like, that neutralize and break down unpleasant odors.

[0036] The composition in the form of a cream or lotion comprising a microbiome balancing active ingredient comprises indicators such as optical whitener, UV agent.

[0037] The composition in the form of a cream or lotion comprising a microbiome balancing active ingredient also comprises an antifoaming agent.

[0038] In one embodiment of the invention, the microbiome balancing active ingredient is added directly or as a solution, to the sheets (layers), which directly or indirectly come into contact with the baby's skin, during the spinfinish stage of the production process of the diaper.

[0039] In one embodiment of the invention, the microbiome balancing active ingredient is added to the sheets (layers), which directly or indirectly come into contact with the baby's skin, during the production process of the diaper.

[0040] The diaper of the present disclosure includes a packaging that comprises a microbiome balancing active ingredient. The microbiome balancing active ingredient is incorporated into the packaging during the diaper production process. Alternatively, the microbiome balancing active ingredient may be directly incorporated into the packaging during the packaging production process.

[0041] As previously stated, the invention relates to the development of a diaper aimed at preserving the skin microbiome balance in the diaper area. During the study, the effect of the developed cream on the skin’s microbiome flora was primarily evaluated. The human microbiome varies from person to person and is highly individualized; however, each area harbors a characteristic composition of bacteria, viruses, and fungi. In babies, the skin barrier is not fully matured immediately after birth. The skin is thin and permeable, which means it is more sensitive to external factors. Due to thispermeability, each region of the baby’s skin becomes similarly colonized by microorganisms from the environment. However, the environmental contact of baby skin is limited and the conditions of care are similar. Therefore, the microflora of a baby's skin is considered similar in all regions. A test has been designed to study the effect of products on the main organisms typical for baby’s skin. The test examined the effect of the product on the growth behavior of microorganisms. Specified organisms are brought into direct and indirect contact with the product and their growth is observed. The desired result is that the growth or number of different organisms is not affected by the product, while maintaining the diversity of a specific microbiome.

[0042] The analysis was performed according to the MyMicrobiome Laboratory Standard and was planned according to the neonatal microbiota, as the microbiota after the neonatal period is very difficult to determine and shows a lot of variability. The baby skin microbiota can be represented as follows:

[0043] S. epidermidis (10,000 cfu / ml)

[0044] S. mitis (1 ,000,000 cfu / ml)

[0045] P. acnes (1 ,000,000 cfu / ml)

[0046] C. tuberculostearicum (100,000 cfu / ml)

[0047] L. crispatus (500,000 cfu / ml)

[0048] Before examining the effect of the cream on microorganisms on baby's skin, there are some criteria that must be met in order for the test results to be evaluated positively. Limit values for the relevant criteria are given in Table 1.

[0049] Table 1. Limit Values Required for Successful Test Result

[0050] Limit Values

[0051] Children under 3 years

[0052] of age, products

[0053] specially designed for

[0054] Organism Type Other Products

[0055] the skin around the

[0056] eyes or mucous

[0057] membranes

[0058]

[0059] Total number of mesophilic,

[0060] aerobic microorganisms

[0061] < 1 x 102 cfu / g or mla< 1 x 102 cfu / g or ml (bacteria, yeasts, mouldsb(TAMC and TYMC))

[0062] Not detectable in 1g or Not detectable in 1g or Escherichia coli

[0063] 1 ml. 1 ml.

[0064] Not detectable in 1g or Not detectable in 1g or Pseudomonas aeruginosa

[0065] 1 ml. 1 ml.

[0066] Not detectable in 1g or Not detectable in 1g or Staphylococcus aureus

[0067] 1 ml. 1 ml.

[0068] Not detectable in 1g or Not detectable in 1g or Candida albicans

[0069] 1 ml. 1 ml.

[0070]

[0071] *a >200 cfu / g or ml, b >200! D cfu / g or ml

[0072] The results of the limit test that the cream mentioned in the invention should meet are given in Table 2. When the results are evaluated, it is seen that the cream meets the limit values.

[0073] Table 2. Limit Test Results for Cream

[0074] Parameter Result

[0075] TAMC [cfu / 0.1 ml] < 1.0E+01

[0076] TYMC (incl. Candida albicans) [in 0.1 ml] negative

[0077] Escherichia coli [in 0.1 ml] negative

[0078] Pseudomonas aeruginosa [in 0.1 ml] negative

[0079] Staphylococcus aureus [in 0.1 ml] negative

[0080]

[0081] In the continuation of the test, bacteria selected for baby skin microbiota were studied. Initially, the cream was brought into direct contact with the microorganisms, and its effect on the growth of microorganisms was analyzed by comparing it with the control group. The results are presented in Table 3. Table 4 shows the results of the change of microorganisms after indirect contact with the product. Compared to the control group, the results where the % change was up to 10% were scored as 1 , the results between 10%-20% were scored as 2, and the changes seen at 20% and above were scored as 3. According to the results, the product with a score in the range of 1 to 2 was evaluated as a product that helps to keep the skin microbiota in balance, while the product with a score in the range of 2.1 to 3 was evaluated as a product that cannot preserve thebalance of the skin microbiota. When Table 3 and Table 4 are evaluated together, it is determined that the cream supports the baby skin microbiota according to both contact types when the average evaluation results over all microorganisms subjected to the test are analyzed.

[0082] Table 3. Effect of Direct Contact with Cream on the Growth of Microorganisms Change Microorganism Compared

[0083] cfu / ml Score

[0084] to Control

[0085] Group (%)

[0086] control 1029.3

[0087] C. tuberculostearicum -0.3 1

[0088] product 1032

[0089] control 53.3

[0090] L. crispatus -14.4 1

[0091] product 61

[0092] control 332

[0093] P. acnes 36.7 3

[0094] product 210

[0095] control 450.7

[0096] S. epidermidis 3.7 1

[0097] product 434

[0098] control 1133.7

[0099] S. mitis -0.8 1

[0100] product 1142.3

[0101] Average Score 1.4

[0102]

[0103] Table 4. Effect of Direct Contact with Cream on the Growth of Microorganisms Change

[0104] Compared Microorganism cfu / ml Score

[0105] to Control

[0106] Group (%)

[0107] control 986.7

[0108] C. tuberculostearicum 1.6 1

[0109] product 970.7

[0110] control 62

[0111] L. crispatus 8.1 1

[0112] product 57

[0113]

[0114] control 207.7

[0115] P. acnes -5.6 1

[0116] product 219.3

[0117] control 478.7

[0118] S. epiderm idis 3.5 1

[0119] product 462

[0120] control 1125

[0121] S. mitis -1.0 1

[0122] product 1136.7

[0123] Average Score 1

[0124]

[0125] In Table 5, the results of the 4-hour use simulation of the diaper with the cream that keeps the skin microbiota in balance, the results of which are given in Tables 3 and 4, are shared. Looking at the total evaluation, it was observed that the diaper applied with cream, which ensures an average score of 2, helped preserve the skin microbiome balance.

[0126] Table 5. The Effect of Direct Contact with Cream-Applied Diapers on the Growth of _ Microorganisms _

[0127] Change

[0128] Compared Microorganism cfu / ml Score

[0129] to Control

[0130] Group (%)

[0131] control 886.7

[0132] C. tuberculostearicum 24.8 2

[0133] product 666.7

[0134] control 1070

[0135] L. crispatus -18.4 1

[0136] product 1266.7

[0137] control 1698.3

[0138] P. acnes -24.5 1

[0139] product 2115

[0140] control 7691.7

[0141] S. epiderm idis 83.4 3

[0142] product 1278.3

[0143] control 22633.3

[0144] S. mitis 79.3 3

[0145] product 4688.3

[0146]

[0147] Average Score: 2

[0148]

[0149] Thanks to the application of the cream on the topsheet of the diaper that comes into contact with the baby’s skin, the cream applied to touch the baby’s skin during use minimizes potential issues such as diaper rash, redness, and irritation by supporting the skin’s physical barrier.

[0150] The cream applied to the diaper supports the baby's skin microflora. The cream used in the diaper preserves the microbiome balance of the skin and thus supports the microbiome barrier of the skin.

[0151] The cream-applied diaper supports the baby’s skin microbiota. The cream-applied diaper preserves the microbiome balance of the skin, thereby supporting its microbiome barrier.

Claims

CLAIMS1. A diaper that preserves the natural balance of the skin and does not disrupt its bacterial ecosystem, characterized in that said diaper comprises- a lotion comprising a microbiome balancing active ingredient of a prebiotic origin or probiotic origin or synbiotic origin or postbiotic origin or an origin composed of combinations thereof, applied to the diaper in liquid form without heating; or- a cream comprising a microbiome balancing active ingredient of a prebiotic origin or probiotic origin or synbiotic origin or postbiotic origin or an origin composed of combinations thereof, applied to the diaper in solid or semi-solid form by heating and resistant to repeated thermal processing,in order to support both the physical barrier of the baby's skin and its microbiological barrier, namely, the skin microbiota.

2. The diaper according to claim 1, characterized in that the composition in the form of a cream or lotion comprising the microbiome balancing active ingredient are applied to the topsheet, which is the layer in contact with the baby’s skin, either entirely or partially, so as to correspond to one or both of the anterior or posterior genital regions3. The diaper according to claim 1 , characterized in that the cream or lotion has a property that can adhere to the fibrous and porous topsheet of the diaper, and the cream has a structure that can solidify shortly after being applied to the topsheet.

4. The diaper according to claim 1 , characterized in that the cream is solid at room temperature, begins to melt gradually starting from body temperature and becomes completely liquid starting from 60°C and its density is between 0.50 g / cm3-1 g / cm3between 60°C-80°C and its viscosity is between 200-10 cP.

5. The diaper according to claim 1, characterized in that it comprises a cream that is applied by melting, has a stable structure between -40°C-90°C and can be repeatedly heated and cooled, and the application tank temperature for the cream is between 55°C-90°C; the hose temperature is between 60°C-85°C; and the gun temperature is between 60°C-85°C.

6. The diaper according to claim 1, characterized in that the cream or lotion comprises the components such as ester groups, hydrogenated vegetable oils, fatty alcohols, waxes, emulsifiers, probiotics, prebiotics, postbiotics, synbiotics, vegetable oils, extracts, vitamins and essences, all of which have cosmetic functions such as supporting the skin barrier, moisturizing the skin, softening the skin and supporting the microbiome balance of the skin, melting at skin temperature, adjusting viscosity and textural properties, and providing adhesion and diffusion to the surface to be applied.

7. The diaper according to claim 1, characterized in that the cream or lotion comprises 0.1%-20% plant-derived fermented probiotics, yeast / fungal probiotics, bacterial probiotics or animal probiotics to preserve and support the microbiome balance of the skin.

8. The diaper according to claim 1, characterized in that the cream or lotion comprises 0.1%-20% of prebiotics such as plant-derived polypeptides, phytosterols, amino acid derivatives, oligosaccharides such as a-glucan, monosaccharides such as glucose, fructose, galactose, polysaccharides such as inulin to preserve and support the microbiome balance of the skin.

9. The diaper according to claim 1, characterized in that the cream or lotion comprises 0.1%-20% of postbiotics such as lactic acid, [3-glucans, acetic acid, ceramides, polyphenols and phenolic compounds, antimicrobial peptides, and oligosaccharides in order to preserve and support the microbiome balance and barrier of the skin.

10. The diaper according to claim 1, characterized in that the cream or lotion comprises 0.1%-20% of synbiotics in which probiotics and prebiotics are used together, in order to preserve and support the microbiome balance and barrier of the skin.

11. The diaper according to claim 1, characterized in that the cream or lotion comprises 0.1%-20% of any two or three of prebiotics, probiotics, and synbiotics together, in order to preserve and support the microbiome balance and barrier of the skin.

12. The diaper according to claim 1, characterized in that the cream or lotion comprises 0.01 %-5% of vegetable oils, extracts, and vitamins in order to preserve and support the physical barrier of the skin.

13. The diaper according to claim 1, characterized in that the cream or lotion comprising a microbiome balancing active ingredient is applied to the topsheet, which is the layer in contact with the baby’s skin, either entirely or partially, so as to correspond to one or both of the anterior or posterior genital regions.

14. The diaper according to claim 1, characterized in that the cream or lotion comprising a microbiome balancing active ingredient has an odor control system feature.

15. The diaper according to claim 14, characterized in that the cream or lotion comprising a microbiome balancing active ingredient comprises ingredients such as essences, perfumes, and the like, for masking unpleasant odor.

16. The diaper according to claim 15, characterized in that the cream or lotion comprising a microbiome balancing active ingredient is free from allergens.

17. The diaper according to claim 16, characterized in that the cream or lotion comprising a microbiome balancing active ingredient comprises agents such as cyclodextrins, zeolites, and the like, which neutralize and break down unpleasant odors.

18. The diaper according to claim 1, characterized in that the cream or lotion comprising a microbiome balancing active ingredient comprises indicators such as optical whitener, UV agent.

19. The diaper according to claim 1, characterized in that the cream or lotion comprising a microbiome balancing active ingredient comprises an antifoaming agent20. The diaper according to claim 1 , characterized in that the microbiome balancing active ingredient is added directly or as a solution, to the sheets (layers), which directly or indirectly come into contact with the baby's skin, during the spinfinish stage of the production process of the diaper.

21. The diaper according to claim 1 , characterized in that the microbiome balancing active ingredient is added to the sheets (layers), which directly or indirectly come into contact with the baby's skin, during the production process of the diaper.

22. The diaper according to claim 1 , characterized in that the microbiome balancing active ingredient is present in the packaging.

23. The diaper according to claim 22, characterized in that the microbiome balancing active ingredient is directly incorporated into the packaging during the diaper production process.

24. The diaper according to claim 23, characterized in that the microbiome balancing active ingredient is directly incorporated into the packaging during packaging production.

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