AN ADHESIVE BODY DRESSING AND A METHOD FOR MANUFACTURING AN

ADHESIVE BODY DRESSING

FIELD OF THE INVENTION

The present invention relates to an adhesive body dressing and more particularly to an adhesive body dressing according to the preamble of claim 1. The present invention also relates to a method for manufacturing an adhesive body dressing and more particularly to a method according to preamble of claim 14.

BACKGROUND OF THE INVENTION

Hydrocolloid adhesive dressings are generally known for many different uses as polymer dressings. These hydrocolloid adhesive dressings are used as body or skin dressings for improving or preventing any skin related medical or esthetical concerns such as wounds, blisters, acne, corns, cracked skin, burns, pressure ulcers, scarring or stretch marks, dressings for dermal ulcers, burns and other exudative wounds.

The hydrocolloid adhesive dressings are used for certain time depending on the purpose of use. After use, the hydrocolloid adhesive dressings are removed from the body and skin and discarded. The hydrocolloid material in the hydrocolloid adhesive dressing absorbs moisture from the skin or body creating advantageous healing conditions for a wound or advantageous treatment conditions for skin. At the same time the hydrocolloid adhesive composition is susceptibility to breakdown and detachment from the skin upon swelling due to absorbed moisture. This together with external wearing limit the use time of the hydrocolloid adhesive dressing.

Due to the relative short-term use of the hydrocolloid adhesive dressings as wound dressings and dressings for blisters or the like, they are often removed and discarded in acute situations. Thus, the hydrocolloid adhesive dressings may often end nature and landfills where they may remain causing longterm waste problems.

One of the problems associated with the prior art is that many materials and compositions which are typically used in adhesive body dressings causes allergic reactions to a skin.

Furthermore, hydrocolloid adhesive dressings may be used for a week and thus, the bond between a hydrocolloid adhesive layer and a backing layer must carry stresses over a long time. Typically, durability of a hydrocolloid adhesive dressing is improved with a hot melt glue layer between an hydrocolloid adhesive layer and the backing layer. The hot melt glue layer is used to improve durability of a hydrocolloid dressing but hot melt glues typically comprise harmful compounds.

Furthermore, a backing layer of a hydrocolloid adhesive dressing is usually made of non-renewable material.

BRIEF DESCRIPTION OF THE INVENTION

An object of the present invention is to provide an adhesive body dressing and the method for manufacturing an adhesive body dressing so as to solve or at least alleviate the prior art problems.

The objects of the invention are achieved by an adhesive dressing which is characterized by what is stated in independent claim 1. The objects of the invention are further achieved by a method which is characterized by what is stated in independent claim 14.

The preferred embodiments of the invention are disclosed in the dependent claims.

The invention is based on the idea of providing an adhesive body dressing comprising a backing layer and a hydrocolloid adhesive layer. The backing layer is a film layer or a foam layer comprising a first side and a second side. The backing layer and the hydrocolloid adhesive layer being made of biodegradable material. The hydrocolloid adhesive layer is provided directly on the first side of backing layer. The hydrocolloid adhesive layer comprises a hydrocolloid adhesive material layer made of a hydrocolloid adhesive composition comprising a thickening component and an absorbent component. The thickening component of the hydrocolloid adhesive composition is derived from a polysaccharide comprising source.

Durability of the adhesive body dressing is enhanced by providing the hydrocolloid adhesive layer directly on the first side of backing layer when the thickening component of the hydrocolloid adhesive composition is derived from a polysaccharide comprising source. The hydrocolloid adhesive composition comprising the thickening component derived from a polysaccharide comprising source reduces irritation of a skin when the adhesive body dressing is used.

In some embodiments, the hydrocolloid adhesive material layer comprises fibers of the hydrocolloid adhesive composition. In some embodiments, the hydrocolloid adhesive material layer comprises fibers of the hydrocolloid adhesive composition, and the fibers of the hydrocolloid adhesive composition are laminated to the backing layer.

In some embodiments, the hydrocolloid adhesive material layer comprises fibers of the hydrocolloid adhesive composition, and the fibers of the hydrocolloid adhesive composition are arranged to form a net, and the fibers of the hydrocolloid adhesive composition are laminated to the backing layer.

In some embodiments, the hydrocolloid adhesive layer comprises a uniform hydrocolloid adhesive material layer.

In the context of this application term "biodegradable" means that material or substance can be completely converted into water, CO2, and biomass through the action of microorganisms such as fungi and bacteria. This property is not dependent on the origin of the raw materials, but only on the chemical composition of the polymers. Further, biodegradability of polymers is appropriately described by test and assessment methods in international standards. Industrial composting is today a well-established disposal process for organic waste materials. One test of biodegradability is the controlled composting test according to ISO 14855.

Additionally, ISO 17088:2021, the European standard EN 13432:2000 and the American standard ASTM D 6400 define basic requirements for packaging and packaging materials to be considered as biodegradable and compostable in industrial composting facilities.

In the context of this application biodegradable polymer material and term biodegradable mean a polymer based material which fulfils requirements for a biodegradable and compostable polymer material according to one or more of the following standards: ISO 17088:2012, ISO 14855-1:2012, ISO 14855-2:2018, ISO 16929:2021, ISO 20200:2015, EN 13432:2000, ASTM D5338, ASTM D6400, and OECD Guidelines for the Testing of Chemicals — Guideline 208: Terrestrial Plants, Growth T est.

EN 13432:2000 is a harmonised European standard linked to the European Directive on Packaging and Packaging Waste (94/62/EC). ... Biodegradable product producers use this standard and certification schemes developed upon this standard to show that their products are compostable.

In one embodiment, the backing layer B and the hydrocolloid adhesive layer H being made of biodegradable material fulfilling criteria of compostable material according to EN 13432:2000. In one embodiment, the backing layer B and the hydrocolloid adhesive layer H being made of compostable material according to EN 13432:2000.

In one embodiment, the biodegradable material being compostable material according to EN 13432:2000.

In one embodiment, the adhesive body dressing being made of compostable material according to EN 13432:2000.

In one embodiment, the thickening component of the hydrocolloid adhesive composition being a structural acidic heteropolysaccharide or a thickening component of the hydrocolloid adhesive composition being a cellulose derivate.

Cellulose is suitable source for the thickening component as cellulose has no taste, is odorless, is hydrophilic and cellulose is widely produced.

In an alternative embodiment, the thickening component of the hydrocolloid adhesive composition being pectic polysaccharides or the thickening component of the hydrocolloid adhesive composition carboxymethyl cellulose or the thickening component is derived from carboxymethyl cellulose.

In another alternative embodiment, the thickening component of the hydrocolloid adhesive composition being carboxymethyl cellulose or the thickening component of the hydrocolloid adhesive composition is derived from carboxymethyl cellulose.

In a yet another alternative embodiment, the thickening component of the hydrocolloid adhesive composition is derived from natural cellulose.

Cellulose allows for less toxic products than non-water-soluble binders.

In a yet another alternative embodiment, the thickening component of the hydrocolloid adhesive composition being a salt of carboxymethyl cellulose.

In a yet another alternative embodiment, the thickening component of the hydrocolloid adhesive composition being sodium carboxymethyl cellulose.

Water solubility of sodium carboxymethyl cellulose allows for less toxic and costly products than with non-water-soluble binders.

In one embodiment, the absorbent component of the hydrocolloid adhesive composition being polymer.

In alternative embodiment, the absorbent component of the hydrocolloid adhesive composition being polyolefin.

In another alternative embodiment, the absorbent component of the hydrocolloid adhesive composition being mucoadhesive polymer; or

In a yet another alternative embodiment, the absorbent component of the hydrocolloid adhesive composition being polyacrylic acid.

Polyacrylic acid (PAA) is a polymer with the formula (CH -CHCO HJn. Polyacrylic acid is a polyolefin polymer. Polyacrylic acid is a super-adsorbent suitable biocompatible matrices for medical applications such as gels. Crosslinked hydrogels of PAA and the thickening component may be used as a glue.

In one embodiment, the hydrocolloid adhesive composition comprising 10 - 80 wt% a thickening component and 20 - 90 wt% an absorbent component, based on the total weight of the composition.

In an alternative embodiment, the hydrocolloid adhesive composition comprising 10 - 80 wt% a thickening component and 20 - 90 wt% an absorbent component, based on the total weight of the composition and with the proviso that components of the hydrocolloid adhesive composition taken together adds up to 100 wt%.

Crosslinked hydrogels of absorbent component and the thickening component may be used as a glue.

In an another alternative embodiment, the hydrocolloid adhesive composition comprising 10 - 50 wt% a thickening component obtained from a compound comprising polysaccharides, 20 - 50 wt% absorbent component, and 20 wt% - 35 wt% water component, based on the total weight of the composition.

Crosslinked hydrogels of absorbent component and the thickening component may be used as a glue

In a yet another alternative embodiment, the hydrocolloid adhesive composition comprising 10 - 50 wt% a thickening component obtained from a compound comprising polysaccharides, 20 - 50 wt% absorbent component, and 20 wt% - 35 wt% water component, based on the total weight of the composition, and with the proviso that components of the hydrocolloid adhesive composition taken together adds up to 100 wt%.

Crosslinked hydrogels of absorbent component and the thickening component may be used as a glue and the water component provides for less toxic products.

The water component being purified water.

In a yet another alternative embodiment, the hydrocolloid adhesive composition comprising 10 - 50 wt% a thickening component obtained from a compound comprising polysaccharides, 20 - 50 wt% absorbent component, and 27 wt% - 32 wt% water component, based on the total weight of the composition, and with the proviso that components of the hydrocolloid adhesive composition taken together adds up to 100 wt%.

Crosslinked hydrogels of absorbent component and the thickening component may be used as a glue and the water component provides for less toxic products.

The water component being purified water.

In one embodiment, the hydrocolloid adhesive composition further comprising 1 wt% - 5 wt% glyserin component, based on the total weight of the composition.

In alternative embodiment, the hydrocolloid adhesive composition further comprising 1 wt% - 5 wt% glyserin component, based on the total weight of the composition and with the proviso that components of the hydrocolloid adhesive composition taken together adds up to 100 wt%.

In another alternative embodiment, the hydrocolloid adhesive composition further comprising 2 wt% - 4 wt% glyserin component, based on the total weight of the composition and with the proviso that components of the hydrocolloid adhesive composition taken together adds up to 100 wt%.

Glyserin having antimicrobial and antiviral properties

In one embodiment, the hydrocolloid adhesive composition further comprising 0,1 wt% - 0,5 wt% carbamide component, based on the total weight of the composition.

In an alternative embodiment, the hydrocolloid adhesive composition further comprising 0,1 wt% - 0,25 wt% carbamide component, based on the total weight of the composition and with the proviso that components of the hydrocolloid adhesive composition taken together adds up to 100 wt%.

Carbamide promotes rehydration of the skin.

In one embodiment, the hydrocolloid adhesive composition further comprising 0,1 wt% - 0,15 wt% aluminium glycinate component, based on the total weight of the composition.

In an alternative embodiment, the hydrocolloid adhesive composition further comprising 0,05 wt% - 0,15 wt% aluminium glycinate component, based on the total weight of the composition and with the proviso that components of the hydrocolloid adhesive composition taken together adds up to 100 wt%.

Aluminium glycinate neutralizes acidity.

In one embodiment, the hydrocolloid adhesive composition further comprising 0,1 wt% - 0,3 wt% dipotassium glycyrrhizate component, based on the total weight of the composition. In an alternative embodiment, the hydrocolloid adhesive composition further comprising 0,1 wt% - 0,3 wt% dipotassium glycyrrhizate component, based on the total weight of the composition and with the proviso that components of the hydrocolloid adhesive composition taken together adds up to 100 wt%.

Dipotassium glycyrrhizate accelerate the skin healing process.

In one embodiment, the hydrocolloid adhesive composition comprises 35 wt% - 45 wt% absorbent component, the absorbent component being polyacrylic acid, 20 wt% - 30 wt% thickening component, the thickening component of the hydrocolloid adhesive composition being sodium carboxymethyl cellulose, 25 wt% - 35 wt% water component, and 2 wt% - 4 wt% glycerin, based on the total weight of the composition.

This composition forms a strong structure with the backing layer, sticks on a skin and accelerates the skin healing process .

In an alternative embodiment, the hydrocolloid adhesive composition comprises 35 wt% - 45 wt% absorbent component, the absorbent component being polyacrylic acid, 20 wt% - 30 wt% thickening component, the thickening component of the hydrocolloid adhesive composition being sodium carboxymethyl cellulose, 25 wt% - 35 wt% water component, and 2 wt% - 4 wt% glycerin, based on the total weight of the composition and with the proviso that components of the hydrocolloid adhesive composition taken together adds up to 100 wt%.

This composition forms a strong structure with the backing layer, sticks on a skin and accelerates the skin healing process.

In one embodiment, the hydrocolloid adhesive composition comprises:

- 35 wt% - 45 wt% absorbent component, the absorbent component being polyacrylic acid,

- 20 wt% - 30 wt% thickening component, the thickening component of the hydrocolloid adhesive layer being sodium carboxymethyl cellulose,

- 25 wt% - 35 wt% water component,

- 2 wt% - 4 wt% glycerin component,

- 0,1 wt% - 0,5 wt% carbamide component,

- 0,05 wt% - 0,15 wt% aluminium glycinate component, and

- 0,1 wt% - 0,3 wt% dipotassium glycyrrhizate component, based on the total weight of the composition and with the proviso that components of the hydrocolloid adhesive composition taken together adds up to 100 wt%. This composition forms a strong structure with the backing layer, sticks on a skin and accelerates the skin healing process.

In one embodiment, the backing layer having a backing layer thickness in a direction between the first side and the second side, and the backing layer thickness being between 10 gm and 50 gm.

In an alternative embodiment, the backing layer having a backing layer thickness in a direction between the first side and the second side, and the backing layer thickness being between 20 gm and 40 gm.

The relatively small thickness of the backing layer provides necessary surface layer for the hydrocolloid adhesive layer without making the adhesive body dressing unnecessary thick.

In one embodiment, the backing layer is made of biodegradable material or compostable material comprising polymers obtained from renewable biomass sources.

In an alternative embodiment, the backing layer is made of biodegradable material or compostable material comprising polyester.

In an another alternative embodiment, the backing layer is made of biodegradable material or compostable material comprising polyester obtained from renewable biomass sources.

In a yet another alternative embodiment, the backing layer is made of biodegradable material or compostable material comprising aliphatic polyester.

In a yet another alternative embodiment, the backing layer is made of compostable material comprising aliphatic polyester.

In a yet another alternative embodiment, the backing layer is made of compostable material comprising polylactic acid.

In a yet another alternative embodiment, the backing layer is made of polylactic acid.

In a yet another alternative embodiment, the backing layer is made of compostable material comprising polylactic acid 50 - 100 wt%, based on the total weight of the composition.

Polylactic acid, also known as polyflactic acid) or polylactide (abbreviation PLA) is a thermoplastic polyester. PLA is aliphatic polyester. PLA has become a popular material due to it being economically produced from renewable resources. PLA is compostable.

In one embodiment, the hydrocolloid adhesive layer having a first side and a second side, the hydrocolloid adhesive layer having a hydrocolloid adhesive layer thickness in a direction between the first side and the second side, and the hydrocolloid adhesive layer thickness being more than 0,05 mm or more than 0,1 mm.

In an alternative embodiment, the hydrocolloid adhesive layer thickness being between 0,1 mm and 10 mm.

In another alternative embodiment, and the hydrocolloid adhesive layer thickness being between 0,2 mm and 5 mm.

In a yet another alternative embodiment, the hydrocolloid adhesive layer thickness being between 0,2 mm and 0,5 mm.

In a yet another alternative embodiment, the hydrocolloid adhesive layer thickness being between 0,05 mm and 0,2 mm.

The thickness of the hydrocolloid adhesive layer is provided with a material thickness such that adequate material volume is achieved for adsorption of body fluids during use of the adhesive body dressing.

In one embodiment, a hydrocolloid adhesive layer having a first side and a second side, the second side of the hydrocolloid adhesive layer is provided in contact with the first side of the baking layer, the adhesive body dressing comprises a first removable covering layer provided on the first side of hydrocolloid adhesive layer, and the first removable covering layer is made of biodegradable material or compostable material.

Thus, the adhesive surface of the adhesive body dressing which is to be placed against the skin of the user may be kept clean without deterioration before use. Furthermore, an adhesive body dressing which is fully biodegradable or compostable is achieved.

In an alternative embodiment, a hydrocolloid adhesive layer having a first side and a second side, the second side of the hydrocolloid adhesive layer is provided in contact with the first side of the baking layer, the adhesive body dressing comprises a second removable covering layer provided on the second side of the baking layer, and the second removable covering layer is made of biodegradable material or compostable material.

The second removable covering layer is used to protect the backing layer before the adhesive body dressing is placed on a skin. In some embodiments the second removable covering layer increases durability of the adhesive body dressing is used before it is placed on a skin

In another alternative embodiment, a hydrocolloid adhesive layer having a first side and a second side, the second side of the hydrocolloid adhesive layer is provided in contact with the first side of the baking layer, the adhesive body dressing comprises a first removable covering layer provided on the first side of hydrocolloid adhesive layer, and the first removable covering layer is made of biodegradable material or compostable material, the adhesive body dressing comprises a second removable covering layer provided on the second side of the baking layer, and the second removable covering layer is made of biodegradable material or compostable material.

In one embodiment, the hydrocolloid adhesive layer is made of fully absorbing material. In other words, the hydrocolloid adhesive layer does not deliver any therapeutically active ingredients on a skin.

In the context of this application, a therapeutically active ingredient means any natural or synthetic substance which may heal or relief symptoms caused by an injury or a decease or a discomfort, which may act as a vaccine, which may be used for change any property of a skin, or which may affect an appearance of a skin.

In an alternative embodiment, the hydrocolloid adhesive layer comprises a therapeutically active ingredient.

In another alternative embodiment, the hydrocolloid adhesive layer comprises microneedles.

In a yet another alternative embodiment, the hydrocolloid adhesive layer comprises microneedles comprising the therapeutically active ingredient so that the microneedles are arranged to dissolve and deliver gradually the therapeutically active ingredient through a skin.

In one embodiment, the hydrocolloid adhesive layer comprises a therapeutically active ingredient and the hydrocolloid adhesive layer thickness being between 0,05 mm and 0,2 mm or between 0,05 mm and 0,5 mm.

In one embodiment, the therapeutically active ingredient being niacinamide or tranexamic acid or ferulic acid or salicylic acid or aloe vera leaf extract or retinol or totarol or beta Glucan or hyaluronic acid or sodium hyaluronate or melaleuca alternifolia (tea tree) leaf oil or butylene glycol or propanediol, 1,2-Hexanediol or madecassoside or dipotassium glycyrrhizate, or caprylyl glycol or ethoxydiglycol or ethylhexylglycerin any combination thereof.

In one embodiment, the microneedles having a microneedle height, and the microneedle height being between 0,05 mm and 2 mm.

In one embodiment, the microneedles comprising a microneedle base and a microneedle tip, the microneedle base is provided on the first side of the hydrocolloid adhesive layer, the microneedles protruding from the microneedle base in a direction away from the backing layer, the microneedle base having a microneedle base width, and the microneedle height being between 2 and 4 times the microneedle base width.

In one embodiment, the hydrocolloid adhesive layer comprises 2 - 1000 pcs. microneedles / cm2 or 50 - 500 pcs. microneedles / cm2.

In embodiment, the microneedles comprise polyvinyl alcohol (PVA).

The present invention also relates to a method for manufacturing an adhesive body dressing having a hydrocolloid adhesive layer and a backing layer. The method comprises forming a backing layer of a biodegradable material and providing an the hydrocolloid adhesive layer directly on the backing layer. The hydrocolloid adhesive layer comprising a hydrocolloid adhesive material layer being made of an hydrocolloid adhesive composition, the hydrocolloid adhesive composition being made of biodegradable material, and the hydrocolloid adhesive composition comprising a thickening component derived from a polysaccharide comprising source and an absorbent component.

In one embodiment, the adhesive body dressing being any above disclosed embodiment of the adhesive body dressing.

An advantage of the invention is that the adhesive body dressing is provided fully biodegradable. Thus, the adhesive body dressing degrades in nature diminishing waste problem and providing environmentally friendly the adhesive body dressing. Furthermore, materials of the backing layer and the hydrocolloid adhesive layer according to the invention improves durability of the adhesive body dressing without an additional glue layer between the hydrocolloid adhesive layer and the backing layer. Furthermore, materials of the adhesive body dressing according to the invention are well adapted with users of the adhesive body dressing.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is described in detail by means of specific embodiments with reference to the enclosed drawings, in which

Figure 1 shows schematically general structure of one embodiment of an adhesive body dressing according to the present invention;

Figure 2 shows schematically an upper view of an adhesive body dressing; Figure 3 shows schematically a bottom view of an adhesive body dressing;

Figures 4 - 12 show schematically general structure of different embodiments of an adhesive body dressing according to the present invention; and Figure 13 shows schematically a further embodiment of an adhesive body dressing according to the present inventiomand

Figure 14 shows schematically general structure of one embodiment of an adhesive body dressing according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Figure 1 shows schematically a general structure of one embodiment of an adhesive body dressing 10. The adhesive body dressing 10 comprises a backing layer B comprising a backing material layer 20. The backing layer B being on top surface of the adhesive body dressing 10. The adhesive body dressing further comprises a hydrocolloid adhesive layer H comprising a hydrocolloid adhesive material layer 30. The hydrocolloid adhesive layer being on bottom surface of the adhesive body dressing 10. The backing layer B is made of biodegradable material and the hydrocolloid adhesive layer H is made of biodegradable material.

In the context of this application hydrocolloid adhesive layer comprises one or more layers of the hydrocolloid adhesive material. Hydrocolloid material or hydrocolloid adhesive material or hydrocolloid dressing material refers to a flexible sheet which contains material that forms a gel in the presence of water. Hydrocolloid dressing material may be adhered to the skin without the use of adhesives or separate taping, as the hydrocolloid adhesive material or hydrocolloid dressing material is self-adhesive or comprises self-adhesive properties.

In contact with a fluid (e.g., a wound exudate, pus, oil, blood, etc.), the hydrocolloid material of the hydrocolloid adhesive layer H absorbs water and swell, forming a gel which is held within the structure of the adhesive matrix. The gel which is formed as a result of the absorption of fluid is not mobile and free running but held within the structure of the adhesive matrix. Suitably, a hydrocolloid dressing is waterproof.

In one embodiment, the hydrocolloid adhesive layer H is made of compostable material. The backing layer B and the hydrocolloid adhesive layer H are superposed. The backing layer B comprises a first side Bl and a second side B2. The hydrocolloid adhesive layer H is provided directly on the first side Bl of backing layer B. Thus, the backing layer B and the hydrocolloid adhesive layer H are superposed in the structure of the adhesive body dressing 10. A first side Hl of the hydrocolloid adhesive layer H is arranged to be placed against the skin of the user.

In other words, the hydrocolloid adhesive layer H protruding from the backing layer B.

In one embodiment, the hydrocolloid adhesive layer H is provided directly on the backing material layer 20.

The backing layer B is a film layer or a foam layer.

In the context of this application the film layer is a continuous form of material and the foam layer is a layer formed by trapping pockets of gas in a liquid or solid.

In a preferred embodiment, the film layer and the foam layer being homogeneous material.

In one embodiment, the backing layer B is made of compostable material.

In one embodiment, the backing material layer 20 of the backing layer B is made of biobased aliphatic biobased polyesters. Biobased aliphatic biobased polyesters are biodegradable polymers. Most synthetic polyesters are not biodegradable. Aliphatic biobased polyesters having an open-chain structure.

Polyester is a category of polymers that contain the ester functional group in every repeat unit of their main chain. Biobased aliphatic biobased polyesters have excellent biodegradability and biocompatibility. Starch-based bioplastics are often blended with biodegradable polyesters to produce starch/polylactic acid, starch/polycaprolactone or polybutylene adipate-co- terephthalate produced by blends. These blends are also compostable.

In one embodiment, the backing layer B is made of compostable material comprising polylactic acid. Polylactic acid, also known as polyflactic acid) or polylactide (abbreviation PLA) is a thermoplastic polyester with backbone formula or [-C(CH3)HC(=O)O-] n, formally obtained by condensation of lactic acid C(CH3)(OH)HCOOH with loss of water (hence its name). It can also be prepared by ring-opening polymerization of lactide [-C(CH3)HC(=O)O-]2, the cyclic dimer of the basic repeating unit.

The backing layer B having a backing layer thickness BT in a direction between the first side Bl and the second side B2, and

In one embodiment, the backing layer thickness BT being between 10 gm and 50 gm.

In an alternative embodiment, the backing layer thickness BT being between 20 gm and 40 gm.

The hydrocolloid adhesive material layer 30 of the hydrocolloid adhesive layer H comprises the hydrocolloid adhesive composition comprising 10 - 80 wt% the thickening component obtained from a compound comprising polysaccharides and 20 - 90 wt% the absorbent component, based on the total weight of the composition.

A thickening component is a substance which increases the viscosity of the composition.

Natural saccharides are generally composed of simple carbohydrates called monosaccharides with general formula (CH OJn where n is three or more. Examples of monosaccharides are glucose, fructose, and glyceraldehyde. Polysaccharides, meanwhile, have a general formula of CxfH OJy where x is usually a large number between 200 and 2500. When the repeating units in the polymer backbone are six-carbon monosaccharides, as is often the case, the general formula simplifies to (CeHioOsJn, where typically 40 < n < 3000.

Cellulose is an example of structural polysaccharides. Cellulose is an organic compound with the formula (CeHioOsJn, a polysaccharide consisting of a linear chain of several hundred to many thousands of P(l->4) linked D-glucose units.

Cellulose is an important structural component of the primary cell wall of green plants. Cellulose for industrial use is mainly obtained from wood pulp and cotton.

Carboxymethyl cellulose (CMC) or cellulose gum is a cellulose derivative with carboxymethyl groups (-CH2-COOH) bound to some of the hydroxyl groups of the glucopyranose monomers that make up the cellulose backbone. It is often used as its sodium salt, sodium carboxymethyl cellulose.

In the context of this application, the thickening component obtained from a compound comprising from polysaccharides being a chemical derived from an element with the formula (CeHioOsJn.

In the context of this application, the thickening component of the hydrocolloid adhesive layer H derived from a polysaccharide comprising source means that the thickening component is produced from a compound comprising polysaccharides such as cellulose.

In other words, the thickening component derived from a polysaccharide comprising source maybe a cellulose derivate with carboxymethyl groups or sodium carboxymethyl cellulose (CsHisNaOs).

It should be noted that in the context of this application derived and derivative means that there may be one or more process steps to obtain the final formula from the source.

It should be noted that in the context of this application a polysaccharide comprising source means that the source comprises a compound comprising polysaccharide as one element. In other words, the polysaccharide comprising source may comprise compounds comprising polysaccharide and other elements.

In one embodiment, the polysaccharide comprising source being cellulose.

The absorbent component of the hydrocolloid adhesive composition having an ability to absorb and retain water and swell to many times to its original volume.

In one embodiment, the absorbent component of the hydrocolloid adhesive composition being polymer.

In an alternative embodiment, the absorbent component of the hydrocolloid adhesive composition being polyolefin.

In another alternative embodiment, the absorbent component of the hydrocolloid adhesive composition being mucoadhesive polymer.

In a yet another alternative embodiment, the absorbent component of the hydrocolloid adhesive composition being polyacrylic acid.

Polyacrylic acid (PAA) is a polymer with the formula (CH -CHCChHjn. It is a derivative of acrylic acid (CH2=CHCO2H). Polyacrylic acid is a polyolefin. It can be viewed as polyethylene with carboxylic acid (CO2H) substituents on alternating carbons. PAA is produced by free radical polymerization. Initiators include potassium persulfate and azobisisobutyronitrile (A1BN). A1BN is an organic compound with the formula [(CH3)2C(CN)]2N2.

In one embodiment, the hydrocolloid adhesive composition comprising 10 - 50 wt% the thickening component obtained from a compound comprising polysaccharides, 20 - 50 wt% the absorbent component, and 20 wt% - 35 wt% water, based on the total weight of the composition, based on the total weight of the composition. In an alternative embodiment, the hydrocolloid adhesive composition comprising 10 - 50 wt% the thickening component obtained from a compound comprising polysaccharides, 20 - 50 wt% the absorbent component, and 27 wt% - 32 wt% water, based on the total weight of the composition, based on the total weight of the composition.

In one embodiment, the hydrocolloid adhesive composition comprising 1 wt% - 5 wt% glyserin, based on the total weight of the composition.

In an alternative embodiment, the hydrocolloid adhesive composition comprising 2 wt% - 4 wt% glyserin, based on the total weight of the composition.

Glycerol also called glycerine in British English and glycerin in American English is a simple polyol compound. Glycerol is generally obtained from plant and animal sources where it occurs in triglycerides, esters of glycerol with long-chain carboxylic acids . The hydrolysis, saponification, or transesterification of these triglycerides produces glycerol as well as the fatty acid derivative. Glyserol having a chemical formula C3H3O3.

In one embodiment, the hydrocolloid adhesive composition comprising 0,1 wt% - 0,5 wt% carbamide, based on the total weight of the composition.

In an alternative embodiment, the hydrocolloid adhesive composition comprising 0,1 wt% - 0,25 wt% carbamide, based on the total weight of the composition.

Carbamide, also known as urea, is an organic compound with chemical formula COfNH J .

In one embodiment, the hydrocolloid adhesive composition comprising 0,1 wt% - 0,15 wt% aluminium glycinate, based on the total weight of the composition.

In an alternative embodiment, the hydrocolloid adhesive composition comprising 0,05 wt% - 0,15 wt% aluminium glycinate, based on the total weight of the composition.

Aluminium glycinate having a formula of C2H8AINO5.

In one embodiment, the hydrocolloid adhesive composition comprising 0,1 wt% - 0,3 wt% dipotassium glycyrrhizate, based on the total weight of the composition.

Dipotassium glycyrrhizate having a formula of C42H60K2O16.

In one embodiment hydrocolloid adhesive composition comprises:

- 35 wt% - 45 wt% the absorbent component, the absorbent component being polyacrylic acid,

- 20 wt% - 30 wt% the thickening component, the thickening component of the hydrocolloid adhesive layer being sodium carboxymethyl cellulose,

- 25 wt% - 35 wt% water, and

- 2 wt% - 4 wt% glycerin, based on the total weight of the composition.

In an alternative embodiment, the hydrocolloid adhesive composition comprises:

35 wt% - 45 wt% the absorbent component, the absorbent component being polyacrylic acid,

- 20 wt% - 30 wt% the thickening component, the thickening component of the hydrocolloid adhesive layer H being sodium carboxymethyl cellulose,

- 25 wt% - 35 wt% water,

- 2 wt% - 4 wt% glycerin,

- 0,1 wt% - 0,5 wt% carbamide,

- 0,05 wt% - 0,15 wt% aluminium glycinate, and

- 0,1 wt% - 0,3 wt% dipotassium glycyrrhizate based on the total weight of the composition.

In other words, the water component consists of water or purified water, the glycerin component consist of glycerin, the carbamide component consists of carbamide, the aluminium glycinate component consists of aluminium glycinate, and the dipotassium glycyrrhizate component consists of dipotassium glycyrrhizate.

In one embodiment, the hydrocolloid adhesive layer H having a first side Hl and a second side H2, the hydrocolloid adhesive layer H having a hydrocolloid adhesive layer thickness HT in a direction between the first side Hl and the second side H2, and the hydrocolloid adhesive layer thickness HT being more than 0,1 mm.

In an alternative embodiment, the hydrocolloid adhesive layer thickness HT being between 0,1 mm and 10 mm.

In another alternative embodiment, and the hydrocolloid adhesive layer thickness HT being between 0,2 mm and 5 mm.

In a yet another alternative embodiment, the hydrocolloid adhesive layer thickness HT being between 0,2 mm and 0,5 mm. It should be noted, that the size and shape of the adhesive body dressing 10 of the present invention may vary and the present invention is not restricted to any particular shape or size.

Figure 2 shows schematically a top view, figure 3 shows schematically a bottom view and figure 4 shows schematically general structure of one embodiment of an adhesive body dressing according to the present invention. The adhesive body dressing 10 comprises a backing material layer 20 on top surface of the adhesive body dressing 10. The adhesive body dressing further comprises a hydrocolloid adhesive material layer 30 on bottom surface of the adhesive body dressing 10.

It should be noted, that the size and shape of the adhesive body dressing 10 of the present invention may vary and the present invention is not restricted to any particular shape or size.

In this embodiment, the backing material layer 20 is larger than the hydrocolloid adhesive material layer 30. Thus, the surface area of the backing material layer 20 is larger than the surface area of the hydrocolloid adhesive material layer 30, as shown in figure 3. Accordingly, the hydrocolloid adhesive material layer 30 is provided at peripheral distance BO from the peripheral edges of the backing material layer 20. The backing material layer 20 extends beyond the hydrocolloid adhesive material layer 30 or the peripheral edges of the hydrocolloid adhesive material layer 30 such that the peripheral area BO is provided. This enables the hydrocolloid adhesive material layer 30 to be protected and not to be exposed during use of the adhesive body dressing. The hydrocolloid adhesive material layer 30 remains covered between the backing material layer 20 and the skin of the user and against the skin of the user.

The backing material layer 20 may comprises any above disclosed material of the backing layer B and the hydrocolloid adhesive material layer 30 may comprises any above disclosed composition of the hydrocolloid adhesive H.

Figure 5 shows one embodiment in which the backing layer B comprises the surface backing material layer 20 and an intermediate backing material layer 40. The intermediate backing material layer 40 is provided between the surface backing material layer 20 and the hydrocolloid adhesive layer H.

The intermediate backing material layer 40 is arranged against the bottom surface 22 of the surface backing material layer 20 and the upper surface of the hydrocolloid adhesive layer H. The upper surface of the hydrocolloid adhesive layer H being on the second side H2 of the hydrocolloid adhesive layer H. In some embodiments, the intermediate backing material layer 40 is an intermediate elastomer layer.

In some embodiments, the intermediate backing material layer 40 comprises or is made of biodegradable biopolyesters.

The intermediate backing material layer 40 comprises an intermediate top surface 44 and an intermediate bottom surface 42, as shown in figure 9. The intermediate top surface 44 of the intermediate backing material layer 40 is arranged towards or against the surface backing material layer 20 and/or the bottom surface 22 thereof. The intermediate bottom surface 42 of the intermediate backing material layer 40 is arranged towards or against the hydrocolloid adhesive layer H.

The surface backing material layer 20 or the intermediate backing material layer 40 may be adhesive or self-adhesive for bonding the surface backing material layer 20 and the intermediate backing material layer 40 together.

The intermediate bottom surface 42 of the intermediate backing material layer 40 is arranged towards or against the hydrocolloid adhesive layer H, as shown in figure 9. The intermediate bottom surface 42 of the intermediate backing material layer 40 or the intermediate backing material layer 40 may be adhesive or self-adhesive for attaching to the hydrocolloid adhesive layer H and/or to the skin at the peripheral area A.

Figure 6 shows schematically general structure of different embodiments of an adhesive body dressing according to the present invention.

The hydrocolloid adhesive layer H may comprise one or more hydrocolloid adhesive material layers which are made of or comprise same or different hydrocolloid materials.

The one or more hydrocolloid adhesive material layers are preferably made of or comprise any embodiment of above disclosed a hydrocolloid adhesive composition.

In the embodiment of figures 4 and 10, the hydrocolloid adhesive layer H comprise only one hydrocolloid adhesive material layer 30.

The hydrocolloid adhesive material layer 30 comprises a hydrocolloid top surface 34 and a hydrocolloid bottom surface 32, as shown in figure 10. The hydrocolloid bottom surface 32 of the hydrocolloid adhesive material layer 30 forms bottom surface of the adhesive body dressing 10 and an active surface of the adhesive body dressing 10 which is to be placed against the skin of the user.

The hydrocolloid adhesive material layer 30 and the hydrocolloid bottom surface 32 thereof is usually self-adhesive for attachment to skin of the user. Alternatively, the hydrocolloid bottom surface 32 of the hydrocolloid adhesive material layer 30 may be provided with additional adhesive layer (not shown). The additional adhesive layer is preferably made of biodegradable or compostable adhesive material.

The hydrocolloid top surface 34 of the hydrocolloid adhesive material layer 30 is arranged towards or against the backing material layer B, or the surface backing material layer 20 and/or the bottom surface 22 thereof, or the intermediate backing material layer 40 and/or the intermediate bottom surface 42 thereof.

The hydrocolloid adhesive material layer 30 may be adhesive or self- adhesive for attaching the hydrocolloid adhesive material layer 30 and the backing layer B together.

Figures 6, 7 and 11 show an alternative embodiment in which the hydrocolloid adhesive layer H comprises a first hydrocolloid adhesive material layer 50 and a second hydrocolloid adhesive material layer 60. The first hydrocolloid adhesive material layer 50 is provided between the backing layer B and the second hydrocolloid adhesive material layer 60.

The first hydrocolloid adhesive material layer 50 and the second hydrocolloid adhesive material layer 60 are preferably made of or comprise biodegradable or compostable polymer materials.

The first hydrocolloid adhesive material layer 50 comprises a first hydrocolloid top surface 54 and a first hydrocolloid bottom surface 52, as shown in figure 11. The second hydrocolloid adhesive material layer 60 comprises a second hydrocolloid top surface 64 and a second hydrocolloid bottom surface 62.

The first hydrocolloid top surface 54 forms the hydrocolloid top surface 34 and the second hydrocolloid bottom surface 62 forms the bottom surface of the active surface of the adhesive body dressing 10 to be placed against skin of the user.

The first hydrocolloid bottom surface 52 and the second hydrocolloid top surface 64 are arranged towards or against each other.

It should be noted that the hydrocolloid adhesive layer H may comprise one or more hydrocolloid adhesive material layers 30, 50, 60 made of same or different material or hydrocolloid materials or comprises same or different hydrocolloid substances.

Similarly, the backing layer may comprise one or more backing material layers 20, 40 made of or comprising same or different biodegradable polymer materials.

Figure 12 shows an embodiment of the adhesive body dressing 10 in which a first removable covering layer CF provided on a first side H2 of the hydrocolloid adhesive layer H or on the bottom or active bottom surface of the adhesive body dressing 10. The first covering layer CF may be a conventional release liner which is used to protect the exposed active surface of the hydrocolloid adhesive layer H, and optionally the exposed portion of the backing layer B, the peripheral area A. The first covering layer CF is removed just before applying the adhesive body dressing 10 to skin of the user.

A second removable covering layer CS is provided the top surface of the backing layer B or the top surface 24 of the backing material layer 20 or the second side B2 of the backing layer B for preventing wrinkling, curling or deteriorating of the edges of backing layer B. The second covering layer CS may support the exposed periphery of backing layer B during application of the adhesive body dressing 10 to skin of the user. Once the adhesive body dressing 10 is in place on the skin, the second covering layer is removed.

The first and/or second removable covering layers CF, CS may also comprise or made of biodegradable polymer material. The biodegradable polymer material of the first and/or second removable covering layers CF, CS may be made of or comprise one of the biodegradable polymer materials mentioned above in connection with the backing layer B.

Alternatively, the first and/or second removable covering layer may be made of biodegradable paper-based material or some biodegradable material.

Figure 13 shows a schematic cross sectional view of the adhesive body dressing 10. The hydrocolloid adhesive layer H has a larger thickness in the central portion of the adhesive body dressing 10 than in the peripheral portions of the hydrocolloid adhesive layer H. Thus, the thickness of the hydrocolloid adhesive layer H decreases from the central portion of the adhesive body dressing 10 towards the edges of the adhesive body dressing 10 or towards the peripheral areas A. This may provide the structure of the adhesive body dressing 10 more resistant to wear and enhance the attachment of the adhesive body dressing 10 skin during use.

Figure 14 shows schematically general structure of one embodiment of an adhesive body dressing according to the present invention.

In this embodiment, the hydrocolloid adhesive layer H comprises microneedles 50. In one embodiment, the hydrocolloid adhesive layer H comprises microneedles 50 comprising the therapeutically active ingredient so that the microneedles 50 are arranged to dissolve and deliver gradually the therapeutically active ingredient through a skin.

In one embodiment, the hydrocolloid adhesive layer H comprises a therapeutically active ingredient and the hydrocolloid adhesive layer thickness HT being between 0,05 mm and 0,2 mm or between 0,05 mm and 0,5 mm.

In one embodiment, the therapeutically active ingredient being niacinamide or tranexamic acid or ferulic acid or salicylic acid or aloe vera leaf extract or retinol or totarol or beta Glucan or hyaluronic acid or sodium hyaluronate or melaleuca alternifolia (tea tree) leaf oil or butylene glycol or propanediol, 1,2-Hexanediol or madecassoside or dipotassium glycyrrhizate, or caprylyl glycol or ethoxydiglycol or ethylhexylglycerin any combination thereof.

In one embodiment, the microneedles 50 having a microneedle height NH, and the microneedle height NH being between 0,05 mm and 2 mm.

In one embodiment, the microneedles 50 comprising a microneedle base 51 and a microneedle tip 52, the microneedle base 51 is provided on the first side Hl of the hydrocolloid adhesive layer H, the microneedles 50 protruding from the microneedle base 51 in a direction away from the backing layer B, the microneedle base 51 having a microneedle base width NW, and the microneedle height NH being between 2 and 4 times the microneedle base width NW.

In one embodiment, the hydrocolloid adhesive layer H comprises microneedles 50 2 pcs - 1000 pcs I cm2 or 50 pcs - 500 pcs / cm2.

The present invention further provides a method for manufacturing an adhesive body dressing 10 having a hydrocolloid adhesive layer H and a backing layer B, the method comprises:

- forming a backing layer B of a biodegradable material; and

- providing an hydrocolloid adhesive layer H directly on the backing layer B, the hydrocolloid adhesive layer H being made of biodegradable material and the hydrocolloid adhesive layer H comprises 10 - 80 wt% a thickening component obtained from a compound comprising polysaccharides and 20 - 90 wt% absorbent component, based on the total weight of the composition.

In one embodiment, the backing layer B being any above disclosed embodiment of the hydrocolloid adhesive layer H.

In one embodiment, the hydrocolloid adhesive layer H being any above disclosed embodiment of the hydrocolloid adhesive layer H.

In one embodiment, the adhesive body dressing 10 being any above disclosed embodiment of the adhesive body dressing 10.

Example 1 (comparative example)

An adhesive body dressing is produced on the laboratory. The hydrocolloid adhesive layer is produced as follows: 40 wt% polyacrylic acid; 26,5 wt% gelatin; 30 wt% purified water; 3 wt% glycerin; 0,15 wt% carbamide; 0,1 wt% aluminium glycinate, and 0,2 wt% dipotassium glycyrrhizate is stirred and hydrocolloid adhesive is obtained. A typical commercially available compostable film is supplied for a backing layer. The compostable film is made of material comprising polymers obtained from renewable biomass sources. The polymers comprise polylactic acid.

Finally, the hydrocolloid adhesive layer is used to cover the backing layer to provide an adhesive body dressing. The hydrocolloid adhesive layer has thickness of 0,3 mm.

The adhesive body dressing was worn by six volunteer test subj ects for the purpose of determining its characteristics with duration of adhesion and general convenience. The adhesive body dressing was worn between 24 and 48 hours by the test subjects.

After a test adhesive body dressing was removed from a test subject, the results were evaluated on the basis of a multiple-choice questionnaire.

All test adhesive body dressing was remained on the skin until a test subject decided to detach a test adhesive body dressing. One of the test subjects reported a slight irritation on a skin.

Gelatin is a collection of peptides and proteins produced by partial hydrolysis of collagen extracted from the skin, bones, and connective tissues of animals such as domesticated cattle, chicken, pigs, and fish. During hydrolysis, some of the bonds between and within component proteins are broken. Its chemical composition is, in many aspects, closely similar to that of its parent collagen. Gelatin is non-carbohydrate (polysaccharide) thickening component.

Example 2 in accordance with the invention An adhesive body dressing of the invention is produced on the laboratory. The hydrocolloid adhesive layer is produced as follows: 40 wt% polyacrylic acid; 26,5 wt% sodium carboxymethyl cellulose; 30 wt% purified water; 3 wt% glycerin; 0,15 wt% carbamide; 0,1 wt% aluminium glycinate, and 0,2 wt% dipotassium glycyrrhizate is stirred and a hydrocolloid adhesive is obtained. A typical commercially available compostable film is supplied for a backing layer. The compostable film is made of material comprising polymers obtained from renewable biomass sources. The polymers comprise polylactic acid. Finally, the hydrocolloid adhesive layer is used to cover the backing layer to provide an adhesive body dressing . The hydrocolloid adhesive layer has thickness of 0,3 mm.

The adhesive body dressing was worn by the six volunteer test subjects for the purpose of determining its characteristics with duration of adhesion and general convenience. The adhesive body dressing was worn between 24 and 48 hours by the test subjects.

After a test adhesive body dressing was removed from a test subject, the results were evaluated on the basis of a multiple-choice questionnaire.

All test adhesive body dressing was remained on the skin until a test subject decided to detach a test adhesive body dressing.

None of the subjects reported any kind of irritation on a skin. Therefore, theinventors surprisingly found out that an adhesive body dressing having a hydrocolloid adhesive layer comprising a thickening component obtained from a compound comprising polysaccharides is more user friendly than an adhesive body dressing having a hydrocolloid adhesive layer comprising a thickening component comprising gelatin.

Example 3

Adhesive body dressings are produced on the laboratory. The hydrocolloid adhesive layer is same as in example 2.

Films having thickness 35 gm and 20 gm are supplied for a backing layer. The films are typical commercially available compostable films. The compostable films are made of material comprising polymers obtained from renewable biomass sources. The polymers comprise polylactic acid.

Two adhesive body dressings are produced providing the hydrocolloid adhesive layer directly on the backing layer. Two adhesive body dressings are produced such that an adhesive layer made of a hot melt glue is provided on the backing layer and the hydrocolloid adhesive layer is provided on the adhesive layer.

The hot melt glue is made of compostable materials and it comprises 18 wt% waxes, 64 wt% resins and 18 wt% polymers, based on the total weight of the composition.

A strength between the layers of the adhesive body dressings was tested and results are shown in table 1.

Table 1 strength between the layers of the adhesive body dressings

The inventors surprisingly found out that an adhesive body dressings comprising a thickening component derived from a polysaccharide comprising source in hydrocolloid adhesive layer and a backing layer made of biodegradable or compostable material is more durable when a hydrocolloid adhesive layer is directly provided on a backing layer compared to a similar adhesive body dressings comprising a hot melt glue between a hydrocolloid adhesive layer and a backing later.

The invention has been described above with reference to the examples and to the examples shown in the figures. However, the invention is in no way restricted to the above examples but may vary within the scope of the claims.