Oral care strip

Abstract

Described herein are oral care strips comprising a hemostatic component comprising chitosan, a pH adjusting component, and cellulose. Methods of making and using the same are also described.

Description

Technical Field

[0001] This invention relates to oral care strips, and more particularly to oral care strips comprising a hemostatic component containing chitosan, a pH-adjusting component, and cellulose, as well as methods for preparing and using the same. Background Technology

[0002] The oral cavity can sometimes suffer injuries, such as mouth ulcers. Previous attempts to develop products to help accelerate the recovery of such injuries required the presence of active agents (such as steroids). Therefore, there is a need for alternative products that can help repair oral injuries, particularly those focused on mucosal repair.

[0003] Some embodiments of the present invention are designed to satisfy these and other objectives. Summary of the Invention

[0004] In some embodiments, the present invention relates to an oral care strip comprising: a hemostatic component comprising chitosan in an amount ranging from about 5% to about 20% by weight based on the total weight of the oral care strip; an acid present in an amount ranging from about 6.0% to about 30.0% by weight based on the total weight of the oral care strip; and cellulose (e.g., hydroxyalkyl cellulose).

[0005] In some embodiments, the present invention relates to an oral care strip comprising: a hemostatic component comprising a chitosan polymer; a pH adjusting component; hydroxyalkyl cellulose; and wherein the blend exhibits a pH in the range of about 3.0 to about 7.0.

[0006] In some embodiments, the present invention relates to a method of manufacturing oral strips, the method comprising: combining a liquid carrier, a hemostatic component comprising a chitosan polymer and a wetting agent to form a first blend, the first blend having a first pH value; subsequently adding an acid component to the first blend to form a second blend; and forming the second blend into a strip; wherein the second blend exhibits a second pH value in the range of about 3.0 to about 7.0.

[0007] The following description of preferred embodiments is merely exemplary in nature and is in no way intended to limit the invention, its application, or its use. Attached Figure Description

[0008] The invention can be more fully understood from the detailed description and accompanying drawings, in which similar elements are labeled in a similar manner, and in the drawings:

[0009] Figure 1 A perspective view of an oral strip according to various aspects of the present invention;

[0010] Figure 2 for Figure 1A cross-sectional view along line II of the oral cavity strip.

[0011] It should be understood that the aspects are not limited to the arrangements and methods shown in the diagram. Detailed Implementation

[0012] As used throughout, "range" is used as a shorthand to describe the individual values ​​within the range and each value. Any value within the range may be chosen as an endpoint of the range. Furthermore, all references cited herein are incorporated herein by reference in their entirety. In the event of any conflict between the definitions in this disclosure and those in the cited references, the definitions in this disclosure shall prevail.

[0013] Unless otherwise stated, all percentages and quantities expressed herein and elsewhere in this specification shall be understood as percentages by weight. The quantities given are based on the effective weight of the material.

[0014] The terms “contains,” “has,” and “includes” are used in their open, non-restrictive sense.

[0015] The compositions and methods of this disclosure may include, consist of, or substantially consist of, the essential elements and limitations of this disclosure as described herein and any additional or optional components, constituent parts or limitations described herein or otherwise useful, or are composed of, the essential elements and limitations of this disclosure as described herein and any additional or optional components, constituent parts or limitations described herein or otherwise useful.

[0016] The description of illustrative embodiments according to the principles of the invention is intended to be understood in conjunction with the accompanying drawings, which are considered an integral part of the entire written description. Any references to orientation or location in the description of embodiments of the invention disclosed herein are intended merely for ease of description and are not intended to limit the scope of the invention in any way.

[0017] Unless otherwise stated, all percentages and quantities expressed herein and elsewhere in this specification shall be understood as percentages by weight. The quantities given are based on the effective weight of the material.

[0018] Furthermore, all numerical values ​​are specified as “about” or “approximately” and take into account experimental errors and variations that would be anticipated by one of ordinary skill in the art. It should be understood that all numerical values ​​and ranges disclosed herein are approximate values ​​and ranges, whether or not the term “about” is used in conjunction with them. It should also be understood that, as used herein, the term “about” in conjunction with a number means a value that can be ±0.01% (inclusive), ±0.1% (inclusive), ±0.5% (inclusive), ±1% (inclusive), ±2% (inclusive), ±3% (inclusive), ±5% (inclusive), ±10% (inclusive), or ±15% (inclusive). It should also be understood that when a numerical range is disclosed herein, any numerical value falling within that range is also specifically disclosed.

[0019] According to this application, the term "substantially free of" is based on a total reference value of less than about 0.1% by weight. According to this application, the term "free of" is based on a total reference value of 0.0% by weight.

[0020] All ranges and values ​​disclosed herein are inclusive and composable. For example, any value or point described herein that falls within the ranges described herein can be used as a minimum or maximum value, thus yielding subranges, etc. Furthermore, all ranges provided are intended to include each specific range within a given range as well as combinations of subranges between given ranges. Thus, the range 1 to 5 specifically includes 1, 2, 3, 4, and 5, and subranges such as 2 to 5, 3 to 5, 2 to 3, 2 to 4, 1 to 4, etc.

[0021] As used herein, the use of compounds containing several isomers or stereoisomers includes all isomers of the compound. When referring to chemical structures and names, the symbols “C,” “H,” and “O” refer to carbon, hydrogen, and oxygen, respectively. The symbols “–,” “=,” and “≡” refer to single, double, and triple bonds, respectively. For readability purposes, chemical functional groups are presented in their adjective form; for each adjective, the word “group” is assumed to be used. For example, the adjective “alkyl” without a noun should be interpreted as “alkyl group.”

[0022] As used herein, the expression “at least one” may be used interchangeably with the expression “one or more”, and thus includes individual components as well as mixtures / combinations.

[0023] As used herein, the term "treatment" (and its grammatical variations) refers to applying the composition of this disclosure to a surface of skin and / or hair. As used herein, the term "treatment" (and its grammatical variations) also refers to bringing skin or hair into contact with the composition of this disclosure.

[0024] As used in this article regarding percentage amounts of ingredients or ingredients, the term "active material" refers to an ingredient or ingredient that is 100% active.

[0025] The terms "mixtures thereof" or "blends thereof" do not require that the mixture contain all of A, B, C, D, E, and F (although it may contain all of A, B, C, D, E, and F). Rather, it indicates a mixture that may contain any two or more of A, B, C, D, E, and F. In other words, it is equivalent to the phrase "a mixture selected from one or more elements of A, B, C, D, E, and F, and any two or more of A, B, C, D, E, and F".

[0026] Similarly, the term "its salt" also refers to "its various salts". Therefore, when this disclosure refers to "elements selected from A, B, C, D, E, F, their salts and mixtures thereof", it can include one or more of A, B, C, D and F, can include one or more of salts of A, B, C, D, E and F, or can include a mixture of any two of salts of A, B, C, D, E, F, salts of A, B, C, D, E and F.

[0027] Salts as referred to throughout this disclosure may include salts having counterions (e.g., alkali metal, alkaline earth metal, or ammonium counterions). However, the list of such counterions is not limiting.

[0028] The use of "includes" when describing a concentration range means that the boundary of the range is included within the defined interval.

[0029] As used herein, the term "weight ratio" or "mass ratio" refers to the proportion of a substance's amount relative to a mixture containing that substance, and is calculated by dividing the weight of the substance contained in the mixture by the weight of the mixture containing that substance. As an example, in a mixture of A, B, and C, a weight ratio of 0.4 for substance A means that the weight of substance A divided by the total weight of substances A, B, and C is 0.4.

[0030] Some of the identified different categories of components may overlap. In cases where overlap is possible and the composition contains two components (or more than two overlapping components), the overlapping compounds do not represent more than one component. For example, a fatty acid can be referred to as both a nonionic surfactant and a fatty compound. If a particular composition contains both a nonionic surfactant and a fatty compound, then a single fatty acid will either be used only as a nonionic surfactant or only as a fatty compound (a single fatty acid may not be used simultaneously as both a nonionic surfactant and a fatty compound).

[0031] As used herein, the term "volatile" means a flash point less than about 100°C. As used herein, the term "non-volatile" means a flash point greater than about 100°C.

[0032] As defined herein, the term "polymer" includes homopolymers and copolymers formed from at least two different types of monomers. The term "polymer" also includes linear and branched polymer structures, and further encompasses crosslinked polymers and copolymers (which may be crosslinked or uncrosslinked), thus including block copolymers, alternating copolymers, random copolymers, etc. Those compounds referred to herein as "oligomers" are polymers with a molecular weight of less than about 1000 Da, preferably less than about 800 Da.

[0033] All publications and patent applications referenced in this specification are incorporated herein by reference and are for any and all purposes as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. In the event of any inconsistency between this disclosure and any publication or patent application incorporated herein by reference, this disclosure shall prevail.

[0034] Any member of the list of species used to exemplify or define a genus may be distinct from, overlap with, be a subset of, be equivalent to, be nearly identical to, or be identical to any other member of the list of species. Furthermore, unless explicitly stated otherwise, for example when describing the Markush group, the list of species defining or exemplifying a genus is open-ended, and it is assumed that other species defining or exemplifying that genus may exist that are as good as or better than any other species listed.

[0035] All components and elements affirmatively set forth in this disclosure may be negatively excluded from the claims. In other words, the personal care compositions of this disclosure may contain no or substantially no components and elements affirmatively recited throughout this disclosure. In some cases, the personal care compositions of this disclosure may contain substantially no non-incidental amounts of the ingredients or compounds described herein. A non-incidental amount of an ingredient or compound is the amount of that ingredient or compound added alone to the personal care composition. For example, a personal care composition may contain substantially no non-incidental amounts of an ingredient or compound, although such an ingredient or compound may be present as part of raw materials included as a blend of two or more compounds.

[0036] Some of the identified different categories of components may overlap. In cases where overlap is possible and a personal care composition contains two components (or more than two overlapping components), the overlapping compounds do not represent more than one component. For example, caprylyl glycol can be referred to as both a wetting agent and a preservative. If a particular personal care composition contains both a wetting agent and a preservative, caprylyl glycol will be used only as either a wetting agent or a preservative, not both.

[0037] As used herein, the terms “composition” and “formulation” are used interchangeably in the product information.

[0038] This invention is not limited to specific hydrogel materials or manufacturing processes, and therefore can be varied. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. It must be noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly specifies otherwise. Thus, for example, reference to “hydrophilic polymer” includes not only a single hydrophilic polymer but also a combination or mixture of two or more different hydrophilic polymers, and reference to “plasticizer” includes a combination or mixture of two or more different plasticizers as well as a single plasticizer, and so on.

[0039] The definition of “natural” polymers refers to naturally occurring macromolecules that can be classified into the following groups: polysaccharides (e.g., cellulose, amylose, dextran, chitin, chitosan, and glycosaminoglycans), proteins (e.g., silk, collagen, gelatin, fibrinogen, elastin, keratin, actin, and myosin), and polynucleotides (DNA, RNA).

[0040] The term "crosslinked" in this article refers to a composition containing intramolecular and / or intermolecular crosslinks (whether arising from covalent or non-covalent bonding). "Non-covalent" bonding includes both hydrogen bonding and electrostatic (ionic) bonding.

[0041] A "phase" is traditionally defined as the homogeneous portion of a heterogeneous system. Specifically, "phase separation" is the transformation from a homogeneous system to a heterogeneous system. Typically, phase separation is accompanied by the formation of interphase boundaries between phases of different compositions. Typical examples of phase separation include sol-gel transitions, precipitation in solution, or the spontaneous formation of multilayer (laminated) structures.

[0042] The terms “active agent,” “pharmacologically active agent,” and “drug” are used interchangeably herein to refer to a chemical substance or compound that induces a desired pharmacological or physiological effect, including agents that are therapeutically, preventively, or cosmeceutical effective, as well as pharmaceutically acceptable, pharmacologically active derivatives and analogs of those active agents specifically mentioned herein, including but not limited to salts, esters, amides, prodrugs, active metabolites, inclusion compounds, and analogs. When the terms “active agent,” “pharmacologically active agent,” and “drug” are used, they should be understood to include both the active agent itself and pharmaceutically acceptable pharmacologically active salts, esters, amides, prodrugs, active metabolites, inclusion compounds, and analogs.

[0043] The term "effective amount" or "cosmeceutical effective amount" refers to a non-toxic but sufficient amount of a cosmeceutical active agent that provides the desired cosmetic effect. The term "effective amount" or "therapeutic effective amount" refers to a non-toxic but sufficient amount of a drug or pharmacological active agent to provide the desired therapeutic effect. The amount considered "effective" varies from subject to subject, depending on individual age and general condition, the specific active agent or agent, etc. Therefore, it is not always possible to specify an exact "effective amount." However, in any individual case, the appropriate "effective" amount can be determined by those skilled in the art using routine experiments. Furthermore, the exact "effective" amount of the active agent incorporated into the compositions or dosage forms of this invention is not important, as long as the concentration is sufficient to allow for convenient administration of the formulation to deliver an amount of active agent within the therapeutically effective range.

[0044] The term "surface" as used in "oral surface" or "body surface" is intended to include body surfaces such as skin, nails, and mucous membranes (e.g., oral mucosa, sublingual, cheek, vagina, rectum, urethra) as well as surfaces inside and around the oral cavity (e.g., teeth, lips, gums, mucous membranes) and surfaces of various skin wounds.

[0045] This invention relates to oral strips. Oral strips can be soluble strips, as discussed in more detail herein.

[0046] Oral strips may contain strip compositions.

[0047] Now refer to Figure 1 and Figure 2 The oral cavity strip 10 may include a first exposed main surface 11 opposite to the second exposed main surface 12. The oral cavity strip 10 may include a side exposed surface 13 extending between the first exposed main surface and the second exposed main surface. The side exposed surface 13 may form the periphery of the oral cavity strip 10.

[0048] The oral strip 10 may have a strip thickness t1 measured based on the distance from the first exposed main surface 11 to the second exposed main surface 12. The strip thickness t1 may range from about 50 micrometers to about 300 micrometers, including all thicknesses and subranges therein.

[0049] In some embodiments, the strip thickness t1 can range from about 50 micrometers to about 290 micrometers, about 50 micrometers to about 280 micrometers, about 50 micrometers to about 270 micrometers, about 50 micrometers to about 260 micrometers, about 50 micrometers to about 250 micrometers, about 50 micrometers to about 240 micrometers, about 50 micrometers to about 230 micrometers, about 50 micrometers to about 220 micrometers, about 50 micrometers to about 210 micrometers, about 50 micrometers to about 200 micrometers, about 50 micrometers to about 190 micrometers, about 5 The range is from 0 micrometers to 180 micrometers, from about 50 micrometers to about 170 micrometers, from about 50 micrometers to about 160 micrometers, from about 50 micrometers to about 150 micrometers, from about 50 micrometers to about 140 micrometers, from about 50 micrometers to about 130 micrometers, from about 50 micrometers to about 125 micrometers, from about 50 micrometers to about 120 micrometers, from about 50 micrometers to about 115 micrometers, from about 50 micrometers to about 110 micrometers, from about 50 micrometers to about 105 micrometers, from about 50 micrometers to about 100 micrometers, including any subranges therein.

[0050] In some embodiments, the strip thickness t1 can range from about 60 micrometers to about 290 micrometers, about 60 micrometers to about 280 micrometers, about 60 micrometers to about 270 micrometers, about 60 micrometers to about 260 micrometers, about 60 micrometers to about 250 micrometers, about 60 micrometers to about 240 micrometers, about 60 micrometers to about 230 micrometers, about 60 micrometers to about 220 micrometers, about 60 micrometers to about 210 micrometers, about 60 micrometers to about 200 micrometers, about 60 micrometers to about 190 micrometers, about 6 The range is from 0 micrometers to 180 micrometers, from about 60 micrometers to about 170 micrometers, from about 60 micrometers to about 160 micrometers, from about 60 micrometers to about 150 micrometers, from about 60 micrometers to about 140 micrometers, from about 60 micrometers to about 130 micrometers, from about 60 micrometers to about 125 micrometers, from about 60 micrometers to about 120 micrometers, from about 60 micrometers to about 115 micrometers, from about 60 micrometers to about 110 micrometers, from about 60 micrometers to about 105 micrometers, from about 60 micrometers to about 100 micrometers, including any subranges therein.

[0051] In some embodiments, the strip thickness t1 can range from about 70 micrometers to about 290 micrometers, about 70 micrometers to about 280 micrometers, about 70 micrometers to about 270 micrometers, about 70 micrometers to about 260 micrometers, about 70 micrometers to about 250 micrometers, about 70 micrometers to about 240 micrometers, about 70 micrometers to about 230 micrometers, about 70 micrometers to about 220 micrometers, about 70 micrometers to about 210 micrometers, about 70 micrometers to about 200 micrometers, about 70 micrometers to about 190 micrometers, about 7 The range is from 0 micrometers to 180 micrometers, from about 70 micrometers to 170 micrometers, from about 70 micrometers to 160 micrometers, from about 70 micrometers to 150 micrometers, from about 70 micrometers to 140 micrometers, from about 70 micrometers to 130 micrometers, from about 70 micrometers to 125 micrometers, from about 70 micrometers to 120 micrometers, from about 70 micrometers to 115 micrometers, from about 70 micrometers to 110 micrometers, from about 70 micrometers to 105 micrometers, from about 70 micrometers to 100 micrometers, including any subranges therein.

[0052] In some embodiments, the strip thickness t1 can range from about 80 micrometers to about 290 micrometers, about 80 micrometers to about 280 micrometers, about 80 micrometers to about 270 micrometers, about 80 micrometers to about 260 micrometers, about 80 micrometers to about 250 micrometers, about 80 micrometers to about 240 micrometers, about 80 micrometers to about 230 micrometers, about 80 micrometers to about 220 micrometers, about 80 micrometers to about 210 micrometers, about 80 micrometers to about 200 micrometers, about 80 micrometers to about 190 micrometers, about 8 The range is from 0 micrometers to 180 micrometers, from about 80 micrometers to about 170 micrometers, from about 80 micrometers to about 160 micrometers, from about 80 micrometers to about 150 micrometers, from about 80 micrometers to about 140 micrometers, from about 80 micrometers to about 130 micrometers, from about 80 micrometers to about 125 micrometers, from about 80 micrometers to about 120 micrometers, from about 80 micrometers to about 115 micrometers, from about 80 micrometers to about 110 micrometers, from about 80 micrometers to about 105 micrometers, from about 80 micrometers to about 100 micrometers, including any subranges therein.

[0053] In some embodiments, the strip thickness t1 can range from about 90 micrometers to about 290 micrometers, about 90 micrometers to about 280 micrometers, about 90 micrometers to about 270 micrometers, about 90 micrometers to about 260 micrometers, about 90 micrometers to about 250 micrometers, about 90 micrometers to about 240 micrometers, about 90 micrometers to about 230 micrometers, about 90 micrometers to about 220 micrometers, about 90 micrometers to about 210 micrometers, about 90 micrometers to about 200 micrometers, about 90 micrometers to about 190 micrometers, about 90 The range is approximately 180 micrometers, approximately 90 micrometers to approximately 170 micrometers, approximately 90 micrometers to approximately 160 micrometers, approximately 90 micrometers to approximately 150 micrometers, approximately 90 micrometers to approximately 140 micrometers, approximately 90 micrometers to approximately 130 micrometers, approximately 90 micrometers to approximately 125 micrometers, approximately 90 micrometers to approximately 120 micrometers, approximately 90 micrometers to approximately 115 micrometers, approximately 90 micrometers to approximately 110 micrometers, approximately 90 micrometers to approximately 105 micrometers, and approximately 90 micrometers to approximately 100 micrometers, including all thicknesses and subranges therein.

[0054] The exposed side surface 13 of the oral strip 10 may include a first side surface 13a opposite to the second side surface 13b, and a third side surface 13c opposite to the fourth side surface 13d. The first side surface 13a and the second side surface 13b may intersect with the third side surface 13c and the fourth side surface 13d. In some embodiments, the first side surface 13a may be parallel to the second side surface 13b. In some embodiments, the third side surface 13c may be parallel to the fourth side surface 13d. In some embodiments, the first side surface 13a may be orthogonal to the third side surface 13c and the fourth side surface 13d. In some embodiments, the second side surface 13b may be orthogonal to the third side surface 13c and the fourth side surface 13d.

[0055] In other embodiments (not shown), the side surface 13 may be a curved surface forming a closed loop around the periphery of the oral cavity strip 10. In one non-limiting example, the side surface 13 may be formed with a circular periphery shape. In one non-limiting example, the side surface 13 may be formed with an oval periphery shape. In one non-limiting example, the side surface 13 may be formed with an elliptical periphery shape. In one non-limiting example, the side surface 13 may be formed with a polygonal periphery shape having 3, 4, 5, 6, 7, 8, 9, 10 sides, etc. In one non-limiting example, the side surface 13 may be formed with a non-geometric periphery shape having 3, 4, 5, 6, 7, 8, 9, 10 sides, etc.

[0056] The oral cavity strip 10 may have a strip width W as measured from the first side surface 13a to the second side surface 13b. S The oral cavity strip 10 may have a strip length L as measured from the third side surface 13c to the fourth side surface 13d. S .

[0057] In one non-limiting embodiment, the strip width W S The range can be from about 2 mm to about 76 mm, including all widths and sub-ranges therein. In one non-limiting embodiment, the strip width W S The range can be from about 10 mm to about 64 mm, including all widths and sub-ranges therein. In one non-limiting embodiment, the strip width W S The range can be from about 20mm to about 51mm, including all widths and subranges in between.

[0058] In one non-limiting embodiment, the strip length L S The range can be from about 2 mm to about 76 mm, including all widths and sub-ranges therein. In one non-limiting embodiment, the strip length L S The range can be from about 10 mm to about 64 mm, including all widths and sub-ranges therein. In one non-limiting embodiment, the strip length L S The range can be from about 20mm to about 51mm, including all widths and subranges in between.

[0059] The oral strip 10 may include a body 100, which includes an upper surface 101 opposite to the lower surface 102 and a side surface extending between the upper surface 101 and the lower surface 102. The body 100 may be formed of a strip composition. As further discussed herein, the various components constituting the body 100 may be uniformly distributed throughout the entire volume of the body 100.

[0060] In some embodiments, the upper surface 101 of the body 100 may form the first exposed main surface 11 of the oral cavity strip 10. In other words, the first exposed main surface 11 of the oral cavity strip 10 may include the upper surface 101 of the body 100. In some embodiments, the lower surface 102 of the body 100 may form the second exposed main surface 11 of the oral cavity strip 10. In other words, the second exposed main surface 11 of the oral cavity strip 10 may include the lower surface 102 of the body 100. In some embodiments, the side surface 103 of the body 100 may form the side exposed surface 13 of the oral cavity strip 10. In other words, the side exposed surface 13 of the oral cavity strip 10 may include the side surface 103 of the body 100.

[0061] The body may have a body thickness as measured between the upper surface 101 and the lower surface 102 of the body 100, the body thickness being substantially equal to the strip thickness t. S The body may have a body length as measured between the side surfaces 103 of the body 100, the body length being substantially equal to the strip length L. S The body may have a body width as measured between the side surfaces 103 of the body 100, the body width being substantially equal to the strip width W.S .

[0062] Oral strips are formed from strip compositions. In oral strips, the strip composition can be in a dry state. The term "dry state" can refer to a strip composition that is substantially free of a liquid carrier (e.g., liquid water). During the manufacture of oral strips, the strip composition can also be in a wet state. A wet state can be a blend of components that also contain a liquid carrier (e.g., liquid water). The relative amounts of the components of the strip composition will be provided herein based on both dry and wet states.

[0063] In a dry state, the strip composition can be formed as a solid, semi-solid, or gel-like body 100 and oral strip 10. In some embodiments, the dry strip composition can be formed as a solid body 100 and oral strip 10. In some embodiments, the dry strip composition can be formed as a semi-solid body 100 and oral strip 10. In some embodiments, the dry strip composition can be formed as a gel-like body 100 and oral strip 10. The term semi-solid can refer to a composition that is not entirely solid because it can flow under applied pressure but also exhibits the ability to maintain its shape and support its own weight.

[0064] The strip composition may contain a hemostatic component. The term "hemostatic component" refers to a component that can treat, reduce, stop, or prevent bleeding. Blends may form up to 100% by weight of the oral strip composition. In other words, the oral strip composition may consist of blends. The strip composition may form up to 100% by weight of the oral strip. In other words, the oral strip may consist of the strip composition. In other embodiments, the oral strip may contain one or more components other than the strip composition. In a non-limiting example, the oral strip may include a printed layer applied to the strip composition.

[0065] The strip composition may also contain an acid component. The strip composition may also contain a wetting agent. The strip composition may also contain a cellulose component. The strip composition may also contain an alkali component.

[0066] Hemostatic components may include natural polymers. Natural polymers may include chitosan polymers (also referred to as "chitosan"). The presence of chitosan in oral strips can impart anti-hemorrhagic properties to the applied tissue surface and can also be used to deliver active ingredients, as further discussed herein.

[0067] Based on the total weight of the dry strip composition, the hemostatic component may be present in an amount ranging from about 5.0 wt% to about 25.0 wt%, including all wt% and all sub-ranges therebetween. In some embodiments, based on the total weight of the dry strip composition, the hemostatic component may be present in an amount ranging from about 10.0 wt% to about 18.0 wt%, including all wt% and all sub-ranges therebetween.

[0068] Based on the total weight of the wet strip composition, the hemostatic component may be present in an amount ranging from about 1.0 wt% to about 8.0 wt%, including all wt% and all sub-ranges therebetween. In some embodiments, based on the total weight of the wet strip composition, the hemostatic component may be present in an amount ranging from about 1.0 wt% to about 6.0 wt%, including all wt% and all sub-ranges therebetween. In some embodiments, based on the total weight of the wet strip composition, the hemostatic component may be present in an amount of about 2 wt%.

[0069] The presence of chitosan in oral strips can confer anti-hemorrhagic properties to the applied tissue surface and can also be used to deliver active ingredients, as further discussed in this paper.

[0070] As described, the wet strip composition may contain a liquid carrier. The liquid carrier may include water. The water may be deionized water. Based on the total weight of the wet strip composition, the liquid carrier may be present in an amount ranging from about 80.0% by weight to about 95.0% by weight, including all weight percent and all subranges therebetween. In some embodiments, based on the total weight of the wet strip composition, the liquid carrier may be present in an amount ranging from about 84.0% by weight to about 92.0% by weight, including all weight percent and all subranges therebetween.

[0071] The acid component may be an organic acid. The acid component may be selected from one or more of the following: citric acid, tartaric acid, fumaric acid, malic acid, maleic acid, gluconic acid, succinic acid, salicylic acid, adipic acid, and sulfamic acid, and combinations thereof. In some embodiments, the acid component includes citric acid.

[0072] Based on the total weight of the dry strip composition, the acid component may be present in an amount ranging from about 6.0 wt% to about 30.0 wt%, including all wt% and all subranges therebetween. In some embodiments, based on the total weight of the dry strip composition, the acid component may be present in an amount ranging from about 8.0 wt% to about 28.0 wt%, including all wt% and all subranges therebetween.

[0073] The acid component can be distributed throughout the entire body 100 of the oral strip 10 in a dry state.

[0074] Based on the total weight of the wet strip composition, the acid component may be present in an amount ranging from about 0.2 wt% to about 3.0 wt%, including all wt% and all subranges therebetween. In some embodiments, based on the total weight of the wet strip composition, the acid component may be present in an amount ranging from about 1.0 wt% to about 2.5 wt%, including all wt% and all subranges therebetween. In some embodiments, based on the total weight of the wet strip composition, the acid component may be present in an amount of about 2.5 wt%.

[0075] The humectant may be selected from one or more orally acceptable humectants. Non-limiting examples of humectants may include polyols such as glycerol, propylene glycol, sorbitol, xylitol, diglycerol, propylene glycol, butylene glycol, pentanediol, propanediol, 1,2-hexanediol, sorbitol, dextrose; glucose; D-ribose; low molecular weight polyethylene glycol (PEG); and combinations thereof.

[0076] Based on the total weight of the dry strip composition, the wetting agent may be present in an amount ranging from about 0.0 wt% to about 35.0 wt%, including all wt% and all sub-ranges therein. Based on the total weight of the dry strip composition, the wetting agent may be present in an amount ranging from about 5.0 wt% to about 35.0 wt%, including all wt% and all sub-ranges therein. In some embodiments, based on the total weight of the dry strip composition, the wetting agent component may be present in an amount ranging from about 10.0 wt% to about 35.0 wt%, including all wt% and all sub-ranges therein. In some embodiments, based on the total weight of the dry strip composition, the wetting agent component may be present in an amount ranging from about 15.0 wt% to about 35 wt%.

[0077] The wetting agent can be distributed throughout the entire body 100 of the oral strip 10 of the strip composition in a dry state.

[0078] Based on the total weight of the wet strip composition, the wetting agent may be present in an amount ranging from about 0.0 wt% to about 4.0 wt%, including all wt% and all sub-ranges therebetween. Based on the total weight of the wet strip composition, the wetting agent may be present in an amount ranging from about 1.0 wt% to about 4.0 wt%, including all wt% and all sub-ranges therebetween. In some embodiments, based on the total weight of the wet strip composition, the wetting agent component may be present in an amount ranging from about 2.0 wt% to about 4.0 wt%, including all wt% and all sub-ranges therebetween. In some embodiments, based on the total weight of the wet strip composition, the wetting agent component may be present in an amount of about 2.0 wt%.

[0079] The blend may also contain one or more emulsifiers. The emulsifier may be selected from one or more of the following sorbitol esters: sorbitol monolaurate, sorbitol monopalmitate, sorbitol monostearate, sorbitol tristearate, sorbitol monooleate, sorbitol trioleate, sorbitol isostearate, polyoxyethylene (20) sorbitol monolaurate, polyoxyethylene (20) sorbitol monopalmitate, polyoxyethylene (20) sorbitol monostearate, polyoxyethylene (20) sorbitol monooleate, polyoxyethylene (20) sorbitol monooleate, polyoxyethylene (4) sorbitol monolaurate, polyoxyethylene (4) sorbitol monostearate, polyoxyethylene (5) sorbitol monooleate, and combinations thereof.

[0080] Based on the total weight of the dry blend, the emulsifier may be present in an amount ranging from about 0.0 wt% to about 30.0 wt%, including all wt% and all sub-ranges therein. Based on the total weight of the dry blend, the emulsifier may be present in an amount ranging from about 15.0 wt% to about 30.0 wt%, including all wt% and all sub-ranges therein.

[0081] The emulsifier component can be distributed throughout the entire body 100 of the oral strip 10 in a dry state.

[0082] Based on the total weight of the wet strip composition, the emulsifier may be present in an amount ranging from about 0.0 wt% to about 4.0 wt%, including all wt% and all subranges therein. Based on the total weight of the wet strip composition, the emulsifier may be present in an amount ranging from about 1.0 wt% to about 4.0 wt%, including all wt% and all subranges therein. In some embodiments, based on the total weight of the wet strip composition, the emulsifier component may be present in an amount ranging from about 2.0 wt% to about 4.0 wt%, including all wt% and all subranges therein.

[0083] The blend may also contain one or more other natural polymers, such as additional polysaccharides that may include cellulose ethers or esters (e.g., methylcellulose, carboxymethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxymethylpropylcellulose, cellulose acetate, cellulose nitrate, nitrocellulose).

[0084] This invention may also include cellulose-based associative polymers, also known as "cellulose components." According to this invention, the term "cellulose-based compound" refers to any polysaccharide compound having a linear sequence of dehydrated glucose pyranose residues (AGU) linked together via β(1,4) bonds in its structure. The repeating unit is a cellobiose dimer. The AGU is in a chair conformation and carries three hydroxyl functional groups: two secondary alcohols (at positions 2 and 3) and one primary alcohol (at position 6). The resulting polymer is bonded together via hydrogen-type intermolecular bonds, thereby providing cellulose with a fibrous structure (approximately 1500 molecules per cellulose).

[0085] The degree of polymerization varies greatly depending on the source of cellulose; its value can range from hundreds to tens of thousands.

[0086] The hydroxyl groups of cellulose can react partially or completely with various chemical reagents to produce cellulose derivatives with inherent properties. Cellulose derivatives can be anionic, cationic, amphoteric, or nonionic. Among these derivatives, cellulose ethers, cellulose esters, and cellulose ester ethers are distinct.

[0087] In nonionic cellulose ethers, alkyl cellulose, such as methyl cellulose and ethyl cellulose; hydroxyalkyl cellulose, such as hydroxymethyl cellulose, hydroxyethyl cellulose and hydroxypropyl cellulose; and mixed hydroxyalkylalkyl cellulose, such as hydroxypropyl methyl cellulose, hydroxyethyl methyl cellulose, hydroxyethyl ethyl cellulose and hydroxybutyl methyl cellulose.

[0088] Based on the total weight of the dry strip composition, the cellulose component may be present in an amount ranging from about 10.0 wt% to about 40.0 wt%, including all wt% and all sub-ranges therebetween. In some embodiments, based on the total weight of the dry strip composition, the cellulose component may be present in an amount ranging from about 15.0 wt% to about 40.0 wt%, including all wt% and all sub-ranges therebetween. In some embodiments, based on the total weight of the dry strip composition, the cellulose component may be present in an amount ranging from about 15.0 wt% to about 38.0 wt%, including all wt% and all sub-ranges therebetween.

[0089] The cellulose component can be distributed throughout the entire body 100 of the oral strip 10 of the strip composition in a dry state.

[0090] Based on the total weight of the wet strip composition, the cellulose component may be present in an amount ranging from about 1.0 wt% to about 8.0 wt%, including all wt% and all subranges therebetween. In some embodiments, based on the total weight of the wet strip composition, the cellulose component may be present in an amount ranging from about 3.5 wt% to about 7.5 wt%, including all wt% and all subranges therebetween. In some embodiments, based on the total weight of the wet strip composition, the cellulose component may be present in an amount of about 4.0 wt%.

[0091] The blend composition may also contain a base. The base can be any edible or pharmacologically acceptable pH-raising alkaline agent or an alkaline agent that can be used to raise the pH of the blend. Exemplary pH-raising agents include hydroxides, edible bicarbonates, edible carbonates, basic amino acids, buffers, and mixtures thereof. Suitable hydroxides for raising the pH of the acidic active ingredient may include sodium hydroxide, calcium hydroxide, magnesium hydroxide, potassium hydroxide, and mixtures thereof. Suitable edible carbonates may include alkali metal carbonates, such as calcium carbonate, sodium carbonate, and potassium carbonate. Exemplary edible bicarbonates may include alkali metal bicarbonates, such as sodium bicarbonate and potassium bicarbonate. Exemplary basic amino acids include lysine and arginine. Exemplary buffers may include sodium phosphate buffers, potassium phosphate buffers; sodium citrate buffers, and potassium citrate buffers. In one non-limiting embodiment, the base may include sodium hydroxide.

[0092] Based on the total weight of the dry strip composition, the alkali may be present in an amount ranging from about 0.0 wt% to about 6.0 wt%, including all wt% and all sub-ranges therebetween. Based on the total weight of the dry strip composition, the alkali may be present in an amount ranging from about 2.0 wt% to about 6.0 wt%, including all wt% and all sub-ranges therebetween. In some embodiments, based on the total weight of the dry strip composition, the alkali may be present in an amount ranging from about 3.0 wt% to about 5.0 wt%, including all wt% and all sub-ranges therebetween.

[0093] The alkali can be distributed throughout the entire body 100 of the oral strip 10 in the dry state of the strip composition.

[0094] Based on the total weight of the wet strip composition, the alkali may be present in an amount ranging from about 0.0 wt% to about 0.45 wt%, including all wt% and all sub-ranges therebetween. Based on the total weight of the wet strip composition, the alkali may be present in an amount ranging from about 0.1 wt% to about 0.45 wt%, including all wt% and all sub-ranges therebetween. In some embodiments, based on the total weight of the wet strip composition, the alkali may be present in an amount ranging from about 0.25 wt% to about 0.45 wt%, including all wt% and all sub-ranges therebetween. In some embodiments, based on the total weight of the wet strip composition, the cellulose component may be present in an amount of about 1.8 wt%.

[0095] In some embodiments, the composition may also contain one or more water-soluble fillers. Suitable examples of water-soluble fillers include, but are not limited to, substances comprising: natural gums, such as sodium alginate, carrageenan, xanthan gum, gum arabic, gum arabic, guar gum, amylopectin, agar, chitin, pectin, iris gum, zeaxanthin, barley gliadin, wheat gliadin, locust bean gum, astragalus gum, and other polysaccharides; starches, such as maltodextrin, amylose, high amylose, corn starch, potato starch, rice starch, cassava starch, pea starch, sweet potato starch, barley starch, wheat starch, glutinous corn starch, modified starches (e.g., hydroxypropylated high amylose), dextrin, fructan, elsinan, and gluten; and proteins, such as collagen, whey protein isolate, casein, milk protein, soy protein, and gelatin. The composition may also contain dispersible or expandable fillers, such as modified starch, alginate, and one or more of divalent or polyvalent ionic salts of alginate.

[0096] The filler can be distributed throughout the entire body 100 of the oral strip 10 in a dry state.

[0097] In some embodiments, the strip composition may also contain one or more colorants. The colorant may be a pigment or dye (including metallic and pearlescent pigments) and may be introduced into the strip as a solid or as a masterbatch (e.g., dye-containing granular polyethylene). In various embodiments, the strip contains a formulation colorant that imparts color to the strip. In various embodiments, film fragments contrasting with the carrier may be present and may be white, black, or have any color visible or contrasting with the other components of the strip composition. Any colorant known in the art is suitable for use in the compositions of the present invention. Formulation colorants among those available herein include non-toxic, water-soluble dyes or pigments, such as, for example, metal oxide "lakes". In some embodiments, the colorant is approved by a regulatory agency for use in food or pharmaceuticals, such as FD&C or D&C pigments and dyes approved by the FDA for use in the United States.

[0098] The colorant can be distributed throughout the entire body 100 of the oral strip 10 of the strip composition in a dry state.

[0099] In some embodiments, the strip composition may also contain a flavoring agent. For example, in some oral care embodiments, the flavoring agent can be rapidly released when the strip dissolves during use, delivering a fresh breath or desired taste or sweetness to the mouth. Available flavoring agents include, but are not limited to, synthetic flavor oils or flavoring aromatics; oleoresins and extracts derived from plants, leaves, flowers, fruits, etc.; and combinations thereof. Representative flavor oils include spearmint oil, cinnamon oil, peppermint oil, clove oil, laurel oil, thyme oil, cedarwood oil, nutmeg oil, sage oil, and bitter almond oil. Flavoring agents can be used alone or in combination. Commonly used flavorings include peppermint (e.g., peppermint), artificial vanilla, cinnamon oil, and various fruit flavorings.

[0100] In some embodiments, the composition may contain a sweetener. The sweeteners available herein include natural and synthetic sweeteners. In one embodiment, the sweetener is a water-soluble sweetener such as a monosaccharide, disaccharide, or polysaccharide. Examples of water-soluble sweeteners include xylose, ribose, glucose (dextrose), mannose, lactose, fructose (levose), sucrose (sugar), maltose, soluble saccharin salts (i.e., sodium or calcium saccharin), cyclohexylsulfamic acid salts, dipeptide-based sweeteners such as L-aspartic acid-derived sweeteners such as L-aspartyl-L-phenylalanine methyl ester (aspartame).

[0101] Flavoring agents and / or sweeteners may be distributed throughout the body 100 of the oral strip 10 of the strip composition in a dry state.

[0102] In some embodiments, the composition may also contain one or more active agents (also called therapeutic agents). In a non-limiting example, the therapeutic agent may be used to prevent or treat physiological disorders, conditions, or systemic diseases. Such disorders or conditions include those of the oral cavity. The specific therapeutic active ingredient is preferably determined based on the desired utility of the composition.

[0103] Surfactants may include antimicrobial agents and preservatives, such as triclosan; parabens such as methylparaben, potassium methylparaben, potassium butylparaben, potassium phenylparaben, and sodium isobutylparaben; and hexadecylpyridine chloride. Domiphen bromide; quaternary ammonium salts; zinc compounds; octonidine; EDTA; essential oils such as thymol, methyl salicylate, eucalyptol, and menthol.

[0104] Active agents may include nonsteroidal anti-inflammatory drugs, such as aspirin, acetaminophen, ibuprofen, ketoprofen, diflunisal, fenofofen calcium, naproxen, tometetin sodium, indomethacin, etc.

[0105] Active agents may include antitussives such as benzonatate, dextromethorphan disulfate, menthol, dextromethorphan hydrobromide, and chlorpheniramine hydrochloride.

[0106] Active agents may include decongestants, such as pseudoephedrine hydrochloride, norepinephrine, phenylpropanolamine, pseudoephedrine sulfate, etc.

[0107] Active agents may include antihistamines, such as brompheniramine maleate, chlorpheniramine maleate, carbisamine maleate, chlormastine fumarate, dextromethorphan maleate, diphenhydramine hydrochloride, diphenhydramine hydrochloride, atazatidine maleate, diphenhydramine citrate, doxylamine succinate, promethazine hydrochloride, mepipramine maleate, tripipramine citrate, triprolidine hydrochloride, arvastin, loratadine, brompheniramine, dextromethorphan, etc.

[0108] Active agents may include expectorants, such as guaiacol glycerol ether, ipecac, potassium iodide, hydrated terpenes, etc.

[0109] Active agents can include common non-selective CNS stimulants, such as caffeine, nicotine, strychnine, tetrandrine, pentylenetetrazol, etc.

[0110] Active agents can include analgesics and antipyretics, such as salicylates, phenylbutazone, indomethacin, phenacetin, etc.

[0111] The surfactant can be distributed throughout the entire body 100 of the oral strip 10 in a dry state.

[0112] The blend may also contain one or more components suitable for such oral care applications. Such additional components may include one or more of additional plasticizers, cooling agents, surfactants, stabilizers, emulsifiers, thickeners, binders, and film-forming agents.

[0113] Other reagents may be distributed throughout the entire body 100 of the oral strip 10 in the dry state of the strip composition.

[0114] The strip composition of the present invention for forming oral strip compositions is suitable for forming dissolving strips. Dissolving strips are suitable for the treatment of oral herpes, and particularly for use in oral mucosal repair medical devices. The oral strip can be softened by the user's saliva and become a soft, gel-like sheet that adheres to the gums or oral mucosa. When the oral strip can adhere to the soft tissues in the oral cavity, it can continuously release active ingredients that accelerate the oral healing process. In particular, the oral strip can act as a physical barrier to protect affected tissues in the mouth, reducing irritation and pain.

[0115] Such oral strips can provide an effective way to treat oral injuries, while being offered in a form that is easy to store, carry, and use in a portable manner. In particular, the presence of a hemostatic polymer (i.e., chitosan) plays a multifunctional role in the blend formulation. Chitosan can provide therapeutic benefits including anti-bleeding, antibacterial, wound-healing, pain relief, and improved penetration. Chitosan can also provide the function of imparting strip integrity and its sponge-like structure to the forming agent, which is useful for active loadings (i.e., when the blend also contains an active agent).

[0116] Oral strips formed from strip compositions may be capable of disintegrating during use. In other embodiments, the strip composition may be capable of not disintegrating during use. In some embodiments, when the strip composition disintegrates during use, it may release an active agent. As referred to herein, "disintegration" means the physical breakdown of the strip or fragment material, resulting in a strip or strip of reduced size compared to the original strip. Such breakdown can occur by mechanical, thermal, chemical, or physicochemical means. Disintegration may be caused, for example, by shearing, dissolution, abrasion, or exposure to elevated temperatures during use.

[0117] The present invention also includes a method for manufacturing oral strips. The method may include a first step of forming a first blend of a liquid carrier, a hemostatic component, and a wetting agent. The first blend may be agitated at a first temperature for a first time period. The first time period may be a non-zero time, and the first temperature may be room temperature or an elevated temperature above room temperature. The first blend may exhibit a first pH value. The first pH value ranges from about 7.0 to about 9.0—inclusive of all pH values ​​and subranges therein.

[0118] Following a first time period in which the first blend is thoroughly mixed, a subsequent step may occur in which an acidic component may be added to the first blend to form a second blend. The second blend may exhibit a second pH value in the range of about 3.0 to about 7.0, including all pH values ​​and subranges therebetween. The second blend may be agitated at a second temperature for a second time period. The second time period may be a non-zero time and the second temperature may be room temperature or a temperature elevated above room temperature. The second temperature may be the same as the first temperature. The second blend may also contain a cellulose component. The second blend may also contain an alkali.

[0119] The second blend can form an oral strip composition, which can be processed into a final strip. In some embodiments, the oral strip composition can be cast to form a strip.

[0120] In other embodiments, the present invention provides an oral care strip comprising: a hemostatic component comprising chitosan in an amount ranging from about 5% to about 20% by weight, based on the total weight of the oral care strip; an acid present in an amount ranging from about 6.0% to about 30.0% by weight, based on the total weight of the oral care strip; and cellulose (e.g., hydroxyalkyl cellulose). In some embodiments, chitosan is present in amounts of about 6% to about 19% by weight, optionally about 7% to about 18% by weight, or about 8% to about 17% by weight, or about 9% to about 16% by weight, or about 10% to about 15% by weight, or about 11% to about 14% by weight, or about 11.25% to about 13.75% by weight, or about 11.5% to about 13.5% by weight, or about 11.75% to about 13.25% by weight, or about 12% to about 13% by weight, or about 11%, about 12%, about 13%, about 14%, or about 15% by weight, based on the total weight of the oral care strip.

[0121] In some embodiments, the acid is selected from: citric acid; lactic acid; acetic acid; fumaric acid; malic acid; tartaric acid; phosphoric acid; and combinations of two or more thereof. In some embodiments, the acid is present in amounts based on the total weight of the oral care strip: about 7.5% by weight to about 30% by weight, optionally about 11% by weight to about 29% by weight, about 12% by weight to about 28% by weight, about 13% by weight to about 27% by weight, about 14% by weight to about 26% by weight, about 15% by weight to about 25% by weight, about 16% by weight to about 24% by weight, about 17% by weight to about 23% by weight, about 18% by weight to about 22% by weight, about 19% by weight to about 23% by weight, about 18% by weight to about 22% by weight, and about 19% by weight to about 23% by weight. Approximately 21% by weight, or approximately 8% by weight, approximately 9% by weight, approximately 10% by weight, approximately 11% by weight, approximately 12% by weight, approximately 13% by weight, approximately 14% by weight, approximately 15% by weight, approximately 16% by weight, approximately 17% by weight, approximately 18% by weight, approximately 19% by weight, approximately 20% by weight, approximately 21% by weight, approximately 22% by weight, approximately 23% by weight, approximately 24% by weight, approximately 25% by weight, approximately 26% by weight, approximately 27% by weight, approximately 28% by weight, approximately 29% by weight, or approximately 30% by weight.

[0122] In some implementations, the oral care strips are essentially water-free. In other implementations, the oral care strips are dried to the point where no detectable water residue remains.

[0123] Other embodiments of the invention provide oral care strips that further comprise a wetting agent. In these embodiments, the wetting agent is selected from: glycerin, diglycerin, betaine, glycol, propylene glycol, butylene glycol, pentanediol, propanediol, 1,2-hexanediol, sorbitol, dextrose; and combinations of two or more thereof. In some embodiments, the wetting agent is present in amounts based on the total weight of the oral care strip: about 15% by weight to about 35% by weight, optionally about 16% by weight to about 34% by weight, or 17% by weight to about 33% by weight, or 18% by weight to about 32% by weight, or 19% by weight to about 31% by weight, or 20% by weight to about 30% by weight, or about 21% by weight to about 29% by weight, or about 22% by weight to about 28% by weight, or about 23% by weight to about 27% by weight, or about 24% by weight to about 26% by weight, or about 25% by weight.

[0124] In some embodiments, the present invention provides an oral care strip, wherein the cellulose is selected from: hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxyethylpropyl cellulose, hydroxybutyl methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, and combinations of two or more thereof. In other embodiments, based on the total weight of the oral care strip, cellulose is present in the following amounts: about 25% to about 70% by weight, optionally about 26% to about 69% by weight, or about 27% to about 68% by weight, or about 28% to about 67% by weight, or about 29% to about 66% by weight, or about 30% to about 65% by weight, or about 31% to about 65% by weight, or about 32% to about 65% by weight, or about 33% to about 65% by weight, or about 34% to about 65% by weight, or about 35% to about 64% by weight, or about 35% to about 63% by weight, or about 35% to about 62% by weight, or about 35% to about 61% by weight, or about 35% to about 60% by weight, or about 35% by weight, about 40% by weight, about 45% by weight, about 50% by weight, about 55% by weight, or about 60% by weight.

[0125] In some embodiments, based on the total weight of the oral care strip, the oral care strip also contains alkali in the following amounts: about 1.0 wt% to about 8.0 wt%, optionally about 1.5 wt% to about 7.5 wt%, or about 2.0 wt% to about 7.0 wt%, or about 2.5 wt% to about 6.5 wt%, or about 3.0 wt% to about 6.0 wt%, or about 4.0 wt% to about 5.0 wt%, or about 0.5 wt%, or about 1 wt%, or about 1.5 wt%, or about 2 wt%, or about 2.5 wt%, about 3 wt%, or about 3.5 wt%, or about 4 wt%, or about 4.5 wt%, or about 5 wt%. In some embodiments, the alkali is selected from: sodium hydroxide, potassium hydroxide, sodium bicarbonate, tripotassium phosphate, dipotassium hydrogen phosphate, potassium bicarbonate, magnesium oxide, and combinations of two or more thereof.

[0126] Some embodiments of the present invention provide an oral care strip comprising: a hemostatic component containing a chitosan polymer; a pH adjusting component; and hydroxyalkyl cellulose. In some embodiments, the pH adjusting component comprises an acid selected from: citric acid, lactic acid, acetic acid, fumaric acid, malic acid, tartaric acid, and combinations of two or more thereof. In some embodiments, the pH adjusting component is present in amounts based on the total weight of the oral care strip: about 5% by weight to about 35% by weight, optionally about 7.5% by weight to about 32.5% by weight, or about 10% by weight to about 30% by weight, or about 11% by weight to about 29% by weight, about 12% by weight to about 28% by weight, about 13% by weight to about 27% by weight, about 14% by weight to about 26% by weight, about 15% by weight to about 25% by weight, about 16% by weight to about 24% by weight, about 17% by weight to about 23% by weight, about 18% by weight to about 22% by weight, about 19% by weight to about 21% by weight, or about 5% by weight. %, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, about 10% by weight, about 11% by weight, about 12% by weight, about 13% by weight, about 14% by weight, about 15% by weight, about 16% by weight, about 17% by weight, about 18% by weight, about 19% by weight, about 20% by weight, about 21% by weight, about 22% by weight, about 23% by weight, about 24% by weight, about 25% by weight, about 26% by weight, about 27% by weight, about 28% by weight, about 29% by weight, or about 30% by weight, or about 31% by weight, or about 32% by weight, or about 33% by weight, or about 34% by weight, or about 35% by weight.

[0127] In some embodiments, the pH-adjusting component further includes an alkali. In other embodiments, the alkali is present in amounts ranging from about 0.1% by weight to about 7.5% by weight, optionally from about 0.25% by weight to about 7% by weight, or from about 0.5% by weight to about 6.5% by weight, or from about 1% by weight to about 6.25% by weight, or from about 2% by weight to about 6% by weight, or from about 2.5% by weight to about 5.5% by weight, or from about 3% by weight to about 5% by weight, or from about 3.5% by weight to about 4.75% by weight, or from about 4% by weight to about 4.5% by weight, or from about 0.5% by weight, or from about 1% by weight, or from about 1.5% by weight, or from about 2% by weight, or from about 2.5% by weight, or from about 3% by weight, or from about 3.5% by weight, or from about 4% by weight, or from about 4.5% by weight. In other embodiments, the base is selected from sodium hydroxide, potassium hydroxide, sodium bicarbonate, tripotassium phosphate, dipotassium hydrogen phosphate, potassium bicarbonate, magnesium oxide, and combinations of two or more thereof.

[0128] In some embodiments, the hemostatic component further includes a hemostatic agent selected from tranexamic acid, aprotinin, hydrogen peroxide, and combinations of two or more thereof. Still other embodiments provide the hemostatic agent present in amounts within the following ranges based on the total weight of the oral care strip: about 5% to about 35% by weight, optionally about 7.5% to about 32.5% by weight, or about 10% to about 30% by weight, or about 11% to about 29% by weight, about 12% to about 28% by weight, about 13% to about 27% by weight, about 14% to about 26% by weight, about 15% to about 25% by weight, about 16% to about 24% by weight, about 17% to about 23% by weight, about 18% to about 22% by weight, about 19% to about 21% by weight, or about 5% by weight. Approximately 6% by weight, approximately 7% by weight, approximately 8% by weight, approximately 9% by weight, approximately 10% by weight, approximately 11% by weight, approximately 12% by weight, approximately 13% by weight, approximately 14% by weight, approximately 15% by weight, approximately 16% by weight, approximately 17% by weight, approximately 18% by weight, approximately 19% by weight, approximately 20% by weight, approximately 21% by weight, approximately 22% by weight, approximately 23% by weight, approximately 24% by weight, approximately 25% by weight, approximately 26% by weight, approximately 27% by weight, approximately 28% by weight, approximately 29% by weight, or approximately 30% by weight, or approximately 31% by weight, or approximately 32% by weight, or approximately 33% by weight, or approximately 34% by weight, or approximately 35% by weight.

[0129] Some embodiments of the present invention provide a method for preparing oral care strips, the method comprising (a) mixing a liquid carrier, a hemostatic component containing a chitosan polymer, and a wetting agent to form a first blend, the first blend having a first pH value; (b) adding a pH-adjusting component to the first blend to form a second blend; and (c) forming the second blend into strips; wherein the second blend exhibits a second pH value in the range of about 3.0 to about 7.0. In some embodiments, the first pH value ranges from about 7.0 to about 9.0. In some embodiments, the second pH is less than the first pH.

[0130] Other implementation methods provide ways to treat, prevent, suppress, or improve symptoms associated with oral diseases, disorders, or conditions, including applying oral care strips as described herein to a subject in need. In some implementation methods, oral diseases, disorders, or conditions are selected from: oral abrasion; oral ulcers; gingivitis; periodontitis; vitamin deficiencies (e.g., vitamin C or vitamin K); excessive plaque buildup; and dry mouth.

[0131] Example

[0132] Numerous experiments were conducted to evaluate the various formulations and manufacturing methods of the present invention.

[0133] Experiment 1

[0134] A first experiment was conducted to determine the effect of citric acid in the composition of the present invention. The formulations used in the first experiment are shown in Table 1 below.

[0135] HEC-hydroxyethyl cellulose

[0136] HPMC—Hydroxypropyl Methylcellulose

[0137] Table 1

[0138]

[0139] The formulations in Table 1 were cast into strips, and the surface smoothness of the strips was evaluated. The results are shown in Table 2 below.

[0140] Table 2

[0141] Comparative Example 1 Example 1 Example 2 Surface roughness 3.0 1.0 0.0

[0142] Surface roughness can be quantified using numerical values, where 0 represents the lowest roughness level, indicating a very smooth surface, and 4 represents the highest roughness level, indicating a very rough surface. Within this range, the classification is as follows:

[0143] 0: Smooth

[0144] 1: Slightly rough

[0145] 2: Medium roughness

[0146] 3: Relatively rough

[0147] 4: Extremely rough

[0148] As shown in Table 2, the addition of citric acid enhanced chitosan solubility and resulted in a smooth strip surface. In particular, increasing the amount of citric acid led to improved strip smoothness, with the addition of 2.5% by weight of citric acid showing the best results.

[0149] Experiment 2

[0150] A second experiment was conducted to assess the impact of how the stripes were formed. Table 3 illustrates the various experimental schemes.

[0151] Table 3

[0152]

[0153] As shown in Table 3, adding the wetting agent to chitosan as a separate step before adding citric acid produces strips with smoothness, while strips formed by blends formed in a single blending step do not exhibit the aforementioned smoothness.

[0154] Experiment 3

[0155] A third experiment was conducted to evaluate the effect of cellulose in the strip formulation. The formulations used in the third experiment are shown in Table 4 below.

[0156] Table 4

[0157]

[0158] The formulations in Table 4 were cast into strips, and the surface smoothness of the strips was evaluated. The results are shown in Table 5 below.

[0159] Table 5

[0160] Comparative Example 3 Comparative Example 4 Example 4 surface properties Unable to form a strip 4.0 0.0

[0161] As shown in Table 5, the addition of HEC not only contributes to the smoothness of the resulting strips, but also imparts structure to them, as demonstrated in Comparative Example 3, which does not even form strips.

[0162] Experiment 4

[0163] A fourth experiment was conducted to evaluate the effects of various wetting agents in the strip formulation. The formulations used in the third experiment are shown in Table 6 below. Additional components included:

[0164] PEG-40 - Polyethylene Glycol (MW 40)

[0165] Tween 80-polyoxyethylene (80) dehydrated sorbitan monooleate (MW 80)

[0166] Table 6

[0167]

[0168] The formulations in Table 6 were cast into strips, and the surface smoothness, pore dispersibility, and water activity of the strips were evaluated. The results are shown in Table 7 below.

[0169] Table 7

[0170] Example 5 Example 6 Example 7 Example 8 surface properties 0 0 0 0 Pore ​​Dispersion uniform uniform uniform uniform Hole diameter (μm) 1 to 5 5 to 10 10 to 15 10 to 15 Water activity 0.5005 0.5815 0.535 0.5065

[0171] As shown in Table 7, the various wetting agents present formed strips with sufficient surface smoothness and pore dispersibility. Water activity (aw) was assessed using a water activity meter. This measurement was performed to determine the microbial robustness of the strips. The incorporation of various wetting agents can potentially increase water activity levels, which affects the membrane's susceptibility to microbial fouling. If the water activity is below 0.65 or 0.75, it indicates that the substance is resistant to microbial fouling, eliminating the need for additional preservatives.

[0172] Finally, the hemostatic ability of each sample was evaluated. This analysis was performed by adding human whole blood directly to the strip of each respective embodiment of the formulation and incubating for 10 minutes. After incubation, water was added to wash away any unclotted blood from the strip, and the absorbance was read via a spectrophotometer. The blood clotting index (BCI) was calculated using the following formula:

[0173]

[0174] A lower BCI indicates better hemostatic efficacy (i.e., better reduction in bleeding). The performance of each sample is shown in Table 8 below.

[0175] Table 8

[0176] Comparison Example 5 Example 6 Example 7 Example 8 BCI 100 38.65 3.69 6.11 25.84

[0177] As shown in Table 8, the presence of glycerol exhibited the best hemostatic effect in the obtained strips.

Claims

1. An oral care strip, comprising: The hemostatic component, based on the total weight of the oral care strip, comprises chitosan in an amount ranging from about 5% to about 20% by weight; The acid, based on the total weight of the oral care strip, is present in an amount ranging from about 6.0% by weight to about 30.0% by weight; and Cellulose (e.g., hydroxyalkyl cellulose).

2. The oral care strip according to claim 1, wherein the acid is selected from: citric acid, lactic acid, acetic acid, fumaric acid, malic acid, tartaric acid, phosphoric acid, and combinations of two or more thereof.

3. The oral care strip according to claim 1 or claim 2, wherein the acid is present in an amount of about 15.0% by weight to about 26.0% by weight based on the total weight of the oral care strip.

4. The oral care strip according to any of the preceding claims, wherein the oral care strip is substantially water-free.

5. The oral care strip according to any of the preceding claims, wherein the oral care strip further comprises a humectant.

6. The oral care strip according to claim 5, wherein the humectant is selected from: glycerin, diglycerin, betaine, glycol, propylene glycol, butylene glycol, pentanediol, propanediol, 1,2-hexanediol, sorbitol, dextrose, and combinations thereof.

7. The oral care strip according to claim 5 or claim 6, wherein the wetting agent is present in an amount of about 15.0% by weight to about 35.0% by weight based on the total weight of the oral care strip.

8. The oral care strip according to any one of claims 5 to 7, wherein the wetting agent is selected from glycerin, propylene glycol, and combinations thereof.

9. The oral care strip according to any of the preceding claims, wherein the cellulose is selected from: hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxyethylpropyl cellulose, hydroxybutyl methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, and combinations of two or more thereof.

10. The oral care strip according to any of the preceding claims, wherein the cellulose is present in an amount of about 15% to about 40% by weight based on the total weight of the oral care strip.

11. The oral care strip according to any of the preceding claims, further comprising an alkali in an amount of about 2.0% to about 6.0% by weight, based on the total weight of the oral care strip.

12. The oral care strip according to claim 11, wherein the alkali is selected from: sodium hydroxide, potassium hydroxide, sodium bicarbonate, tripotassium phosphate, dipotassium hydrogen phosphate, potassium bicarbonate, magnesium oxide, and combinations of two or more thereof.

13. The oral care strip according to any of the preceding claims, wherein the pH of the oral care strip is from about 3.0 to about 7.

0.

14. An oral care strip, comprising: A hemostatic component, wherein the hemostatic component comprises a chitosan polymer; pH adjusting components; Hydroxyalkyl cellulose, and The blends exhibit a pH range of approximately 3.0 to approximately 7.

0.

15. The oral care strip of claim 14, wherein the pH adjusting component comprises an acid selected from the group consisting of citric acid, lactic acid, acetic acid, fumaric acid, malic acid, tartaric acid, and combinations thereof.

16. The oral care strip according to claim 14 or claim 15, wherein the pH adjusting component is present in an amount ranging from about 6.0% by weight to about 26.0% by weight based on the total weight of the oral care strip.

17. The oral care strip of claim 16, wherein the pH adjusting component is present in an amount of about 15.0% by weight to about 26.0% by weight based on the total weight of the oral care strip.

18. The oral care strip according to any one of claims 14 to 17, wherein the oral care strip is substantially water-free.

19. The oral care strip according to any one of claims 14 to 18, further comprising a humectant.

20. The oral care strip of claim 19, wherein the wetting agent is present in an amount of about 15.0% by weight to about 35.0% by weight based on the total weight of the oral care strip.

21. The oral care strip according to claim 19 or claim 20, wherein the humectant is selected from: glycerin, diglycerin, betaine, glycol, propylene glycol, butylene glycol, pentanediol, propanediol, 1,2-hexanediol, sorbitol, dextrose, and combinations thereof.

22. The oral care strip according to any one of claims 19 to 21, wherein the wetting agent comprises glycerin, propylene glycol, or a combination thereof.

23. The oral care strip according to any one of claims 14 to 22, wherein the hydroxyalkyl cellulose is selected from: hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxyethylpropyl cellulose, hydroxybutyl methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, and combinations of two or more thereof.

24. The oral care strip according to any one of claims 14 to 23, wherein the hydroxyalkyl cellulose is present in an amount of about 15.0% by weight to about 40.0% by weight based on the total weight of the oral care strip.

25. The oral care strip according to any one of claims 14 to 24, wherein the pH adjusting component further comprises an alkali in an amount ranging from about 2.0% by weight to about 6.0% by weight, based on the total weight of the oral care strip.

26. The oral care strip according to claim 25, wherein the alkali is selected from: sodium hydroxide, potassium hydroxide, sodium bicarbonate, tripotassium phosphate, dipotassium hydrogen phosphate, potassium bicarbonate, magnesium oxide, and combinations of two or more thereof.

27. The oral care strip according to any one of claims 14 to 26, wherein the hemostatic component further comprises a hemostatic agent selected from tranexamic acid, aprotinin, hydrogen peroxide, and combinations thereof.

28. The oral care strip according to any one of claims 14 to 27, wherein the hemostatic agent is present in an amount ranging from about 5.0% by weight to about 20.0% by weight, based on the total weight of the oral care strip.

29. The oral care strip according to any one of claims 14 to 28, wherein the chitosan polymer is present in an amount ranging from about 5.0% by weight to about 20.0% by weight based on the total weight of the oral care strip.

30. A method for preparing oral care strips, the method comprising: A liquid carrier, a hemostatic component comprising a chitosan polymer, and a wetting agent are mixed to form a first blend, the first blend having a first pH value; Subsequently, a pH-adjusting component was added to the first blend to form a second blend; The second blend is formed into strips; The second blend exhibits a second pH value in the range of about 3.0 to about 7.

0.

31. The method of claim 32, wherein the first pH value ranges from about 7.0 to about 9.

0.

32. The method of claim 30 or claim 31, wherein the pH adjusting component is present in an amount ranging from about 1.0 wt% to about 4.0 wt% based on the total weight of the second blend.

33. The method according to any one of claims 30 to 32, wherein the pH adjusting component comprises an acid selected from citric acid, lactic acid, acetic acid, fumaric acid, malic acid, tartaric acid, phosphoric acid, and combinations of two or more thereof.

34. The method according to any one of claims 30 to 33, wherein the liquid carrier comprises water.

35. The method of claim 34, wherein the water is present in an amount ranging from about 85.0% by weight to 95.0% by weight, based on the total weight of the second blend.

36. The method according to any one of claims 30 to 35, wherein the second pH is less than the first pH.

37. The method according to any one of claims 30 to 36, wherein the wetting agent is present in an amount ranging from about 1.0% by weight to about 4.0% by weight, based on the total weight of the second blend.

38. The method according to any one of claims 30 to 37, wherein the wetting agent is selected from: glycerol, diglycerol, betaine, glycol, propylene glycol, butylene glycol, pentanediol, propanediol, 1,2-hexanediol, sorbitol, dextrose, and combinations of two or more thereof.

39. The method according to any one of claims 30 to 38, wherein the wetting agent comprises propylene glycol, glycerin, or a combination thereof.

40. The method according to any one of claims 30 to 39, wherein the second blend further comprises hydroxyalkyl cellulose.

41. The method of claim 40, wherein the hydroxyalkyl cellulose is selected from: hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxyethylpropyl cellulose, hydroxybutyl methylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose, and combinations of two or more thereof.

42. The method of claim 40 or claim 41, wherein the hydroxyalkyl cellulose is present in an amount ranging from about 1% by weight to about 10% by weight, based on the total weight of the second blend.

43. The method according to any one of claims 30 to 42, wherein the pH adjusting component further comprises an alkali in an amount ranging from about 0.3% by weight to about 2.0% by weight, based on the total weight of the second blend.

44. The method according to claim 43, wherein the base is selected from: sodium hydroxide, potassium hydroxide, sodium bicarbonate, tripotassium phosphate, dipotassium hydrogen phosphate, potassium bicarbonate, magnesium oxide, and combinations of two or more thereof.

45. The method according to any one of claims 30 to 44, wherein the hemostatic component further comprises a hemostatic agent selected from tranexamic acid, aprotinin, hydrogen peroxide, and combinations of two or more thereof.

46. ​​The method according to any one of claims 30 to 45, wherein the hemostatic component is present in an amount ranging from about 1.0% by weight to about 3.0% by weight, based on the total weight of the second blend.

47. A method for treating, preventing, suppressing or improving symptoms related to diseases, disorders or conditions of the oral cavity, comprising applying an oral care strip according to any one of claims 1 to 29 to a person in need of it.

48. The method of claim 47, wherein the oral disease, disorder, or symptom is selected from: oral abrasion, oral ulcers, gingivitis, periodontitis, vitamin deficiency (e.g., vitamin C or vitamin K), excessive plaque buildup, and dry mouth.

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