Denture adhesive

Abstract

The present invention relates to a denture adhesive composition. This composition contains (a) carboxymethyl cellulose, (b) a crosslinked polyacrylic acid homopolymer, and (c) an alkyl vinyl ether-maleic acid copolymer or a salt thereof. The advantage of this composition is that it can exhibit an immediate, strong, and long-lasting holding power.

Description

Technical Field

[0001] Field of Invention The present invention relates to a denture adhesive composition. This composition contains (a) carboxymethyl cellulose, (b) a crosslinked polyacrylic acid homopolymer, and (c) an alkyl vinyl ether-maleic acid copolymer or a salt thereof. Advantageously, this composition exhibits an immediate, strong, and long-lasting hold.

[0002] Background of the Invention A complete denture or partial denture is a form of dental appliance intended to be worn in the mouth as a substitute that functions as a replacement for some or all of the teeth normally present in the oral cavity. When using a denture, it is common to use an adhesive to attach the dental appliance to the surfaces of the oral cavity such as the palate and gum ridge. Such a denture adhesive fixes or temporarily fixes the denture in the mouth, improves the holding force of the denture, and at the same time is removable so that the wearer of the denture can remove the denture for cleaning and maintenance. It is also recommended to remove the denture at the end of the day. Even when the denture fits properly, the denture adhesive can improve the wearing feeling of the denture. The denture adhesive is beneficial, for example, in situations where the denture does not fit perfectly due to natural shrinkage or changes in the gums and oral mucosa over time.

[0003] A denture adhesive composition (also known as a fixative composition) fills the gap between the denture and the gums or tissues. Before wearing the denture in the oral cavity, the denture adhesive is applied to the surface of the denture plate and brought into uniform contact with the gums and oral tissues.

[0004] Denture adhesive compositions must meet many (sometimes competing) criteria to function effectively: they must exhibit high tackiness upon contact with saliva so that dentures are held in place as soon as they are placed in the mouth; they must have sufficient bonding strength to withstand the chewing stress that would otherwise dislodge the dentures; and they must provide a seal to prevent food particles from getting trapped under the dentures. Furthermore, the organoleptic properties (e.g., mouthfeel and consistency) of the denture adhesive composition must be acceptable to the user, and the composition must not be excessively difficult to apply or too sticky.

[0005] Denture adhesives are generally sold as creams, liners or strips, liquids, gels or powders, and examples of commercially available denture adhesives known in this field include Polygrip Flavor Free Denture Adhesive Cream (GlaxoSmithKline), Polygrip Cushion and Comfort Denture Adhesive Cream (GlaxoSmithKline), and Fixodent PLUS Best Hold Premium Denture Adhesive Cream (P&G).

[0006] International Publication No. 1992 / 22280 (Richardson-Vicks Ltd.) discloses a denture stabilizing composition comprising a mixed partial salt of a lower alkyl vinyl ether-maleic acid copolymer.

[0007] International Publication No. 2013 / 054236 (Procter & Gamble) discloses a denture adhesive comprising a mixture of a partial salt of a methyl vinyl ether-maleic acid copolymer, sodium carboxymethylcellulose, and a cohesion builder component in an amount of about 0.001% to about 10% by weight of the denture adhesive composition.

[0008] International Publication No. 2016 / 091738 (Glaxo Group Ltd) discloses a denture adhesive composition comprising a mixed partial salt of a lower alkyl vinyl ether-maleic acid copolymer, sodium carboxymethylcellulose, and bioactive glass.

[0009] International Publication No. 2018 / 175826 (Lubrizol) discloses a composition comprising a combination of (a) a crosslinked poly(acrylic) polymer, (b) a carboxymethylcellulose (CMC) component, and / or (c) an adhesion promoting component. The crosslinked poly(acrylic) polymer may be a carbomer homopolymer, a carbomer copolymer, a carbomer interpolymer, polycarbophil, or a mixture thereof. [Overview of the project] [Problems that the invention aims to solve]

[0010] Despite years of considerable effort in developing denture adhesive compositions, there is still a need for further denture adhesives that deliver an improved user experience. [Means for solving the problem]

[0011] The inventors have developed a composition having desirable adhesive properties, particularly for use in dental appliances such as dentures.

[0012] In a first embodiment, a denture adhesive composition is provided comprising (a) carboxymethylcellulose, (b) crosslinked polyacrylic acid homopolymer, and (c) alkyl vinyl ether-maleic acid copolymer or a salt thereof.

[0013] In particular, the denture adhesive composition comprises (a) about 15 to about 30% by weight (%w / w) of carboxymethylcellulose, (b) about 6 to about 15% by weight (%w / w) of crosslinked polyacrylic acid homopolymer, and (c) about 15 to about 34% by weight (%w / w) of alkyl vinyl ether-maleic acid copolymer or a salt thereof.

[0014] The denture adhesive composition of the present invention may further comprise (d) an oil component and / or (e) a petrolatum component. In particular, the denture adhesive composition of the present invention may comprise about 17 to about 56% by weight (%w / w) of an oil component, a petrolatum component, or a combination thereof.

[0015] In some embodiments, the denture adhesive composition of the present invention may contain about 17 to about 56% by weight (%w / w) of an oil component. In some embodiments, the denture adhesive composition of the present invention may contain about 17 to about 56% by weight (%w / w) of a petrolatum component. In particular, the denture adhesive composition of the present invention may contain about 17 to about 26% by weight (%w / w) of an oil component and about 20 to about 30% by weight (%w / w) of a petrolatum component.

[0016] Specifically, the viscosity of the prepared denture adhesive composition of the present invention is at least 500,000 centipoise (cP). Specifically, the viscosity of the prepared denture adhesive composition of the present invention is 2,500,000 cP or less, more specifically 2,000,000 cP or less. Specifically, the viscosity of the prepared denture adhesive composition of the present invention is 500,000 to 2,500,000 centipoise (cP), more specifically 500,000 to 2,000,000 cP. Specifically, the pH of the composition is 4.0 to 10, more specifically 5.0 to 8.0. More specifically, the denture adhesive composition of the present invention has (i) a viscosity of 500,000 to 2,000,000 centipoise (cP), and / or (ii) a pH of 4.0 to 10, more specifically 5.0 to 8.0. In detail, viscosity is measured at 25°C ± 1°C. More specifically, viscosity is measured using a Brookfield RVT viscometer, TE spindle, 2.5 RPM, at 25°C ± 1°C.

[0017] Specifically, the viscosity of carboxymethylcellulose is approximately 1000 to 2800 centipoise (cP) (measured in a 1% solution at 25°C). More specifically, the carboxymethylcellulose consists of fine particles, at least 80% of which pass through a 200 U.S. mesh sieve. Expressed in corresponding SI units, the carboxymethylcellulose consists of fine particles, at least 80% of which pass through a 74 μm mesh sieve. Preferably, the carboxymethylcellulose is sodium carboxymethylcellulose.

[0018] Specifically, the denture adhesive composition of the present invention contains about 5 to about 10% by weight (%w / w) of cross-linked polyacrylic acid homopolymer, and in particular about 6 to about 9% by weight (%w / w) of cross-linked polyacrylic acid homopolymer.

[0019] Specifically, the cross-linked polyacrylic acid homopolymer is an allyl pentaerythritol cross-linked homopolymer. More specifically, the cross-linked polyacrylic acid homopolymer is a carbomer homopolymer of type A or type B. Even more specifically, the cross-linked polyacrylic acid homopolymer is selected from the group consisting of carbomer 971P NF, carbomer 974P NF, and combinations thereof. Even more specifically, the cross-linked polyacrylic acid homopolymer is selected from the group consisting of Carbopol 971P NF, Carbopol 974P NF, and combinations thereof. Preferably, the cross-linked polyacrylic acid homopolymer is carbomer 971P NF, particularly Carbopol 971P NF.

[0020] Specifically, alkyl vinyl ether-maleic acid copolymer or its salts are poly(methyl vinyl ether / maleic acid) salts. More specifically, alkyl vinyl ether-maleic acid copolymer or its salts are poly(methyl vinyl ether / maleic acid) sodium-calcium mixed partial salts.

[0021] In one embodiment, the denture adhesive composition is (a) 26-30% w / w sodium carboxymethylcellulose; (b) 6 to 10% w / w of a crosslinked polyacrylic acid homopolymer; (c) 16 to 26% w / w of a sodium-calcium mixed partial salt of poly(methyl vinyl ether / maleic acid); (d) 17 to 22% w / w of an oil component; (e) 23% to 29% of petrolatum; and optionally (f) at least one fragrance, coloring agent, preservative, surfactant or a mixture thereof comprising or consisting essentially of these, wherein the composition has a viscosity of 1,000,000 to 2,000,000 centipoises (cP) and a pH of 5.0 to 7.5.

[0022] Specifically, the denture adhesive composition does not contain polyethylene glycol, sodium alginate and / or zinc. Preferably, the denture adhesive composition of the present invention does not contain polyethylene glycol, sodium alginate and zinc.

[0023] In a second aspect, there is provided a denture adhesive composition according to the first aspect for use in a method of adhering a dental appliance to a surface, particularly a surface within the oral cavity. Also provided is a method of adhering a dental appliance to a surface (particularly a surface within the oral cavity) using the denture adhesive composition according to the first aspect. In particular, this method may include the steps of applying the composition of the first aspect to the dental appliance, the oral cavity, or both, and attaching the dental appliance to a surface of the oral cavity (such as the palate or gingiva).

Brief Description of the Drawings

[0024] [Figure 1] Shows the adhesion profiles of Formulations 1 to 6 compared to a control formulation (a polygrip-free denture adhesive cream). [Figure 2] Shows the adhesion profiles of Formulations 7 to 14 compared to a control formulation (a polygrip-free denture adhesive cream). [Figure 3] Shows the adhesion profiles of Formulations 16, 17 and 20 compared to a control formulation (a polygrip-free denture adhesive cream). [Figure 4] The effect of varying the ratio of mineral oil to petrolatum on the adhesion profiles of formulations 22, 23, and 24 is shown. [Figure 5] The adhesive layer thicknesses of formulations 22, 23, and 24 before and during compression are shown. Each formulation maintained a greater layer thickness than the control (Figure 5(a)). [Figure 5(a)] The layer thickness of the control adhesive before and during compression is shown. [Figure 6] Incisal bite force (BF) until the maxillary denture becomes dislodged, measured at baseline and at 0.5, 1, 3, 6, 9, and 12 hours after denture insertion, with and without denture adhesive (black circles). Note that the error bars are slightly offset to the left of the black square symbols and to the right of the black circle symbols, respectively, to aid visualization and clearer distinction. [Modes for carrying out the invention]

[0025] Detailed description of the invention The inventors have discovered an improved denture adhesive composition that addresses many of the concerns associated with currently available denture adhesives. This composition provides immediate retention, helps make dentures feel natural and comfortable in the mouth, and avoids the concern of conventional denture adhesives, which often take time to achieve good retention after initial application. Furthermore, this denture adhesive formulation provides strong and long-lasting retention. In addition to adhering to the gums and providing adhesive properties, the material creates a cushioning effect between the gums and the denture, increasing overall comfort. The denture adhesive formulation can also mitigate the problem associated with "oozing," which can occur when the adhesive leaks into the oral cavity from between the gingival margin and the denture.

[0026] The denture adhesive composition of the present invention comprises (a) carboxymethylcellulose, (b) crosslinked polyacrylic acid homopolymer, and (c) alkyl vinyl ether-maleic acid copolymer or a salt thereof, and the pH of the composition is 5.0 to 8.0, particularly 5.0 to 7.5.

[0027] As used herein, the term “dental appliance” refers to dentures or partial dentures, artificial teeth, removable orthodontic bridges and denture bases (both maxillary and mandibular types), orthodontic retainers and appliances, protective mouthguards, night guards to prevent bruxism and / or temporomandibular joint (TMJ) disorders, etc. The term “denture” is used to refer to a subset of dental appliances, including dentures or partial dentures, such as maxillary and mandibular dentures and combinations thereof, including orthodontic bridges, artificial teeth, and denture bases.

[0028] The terms "denture adhesive composition" and "denture adhesive" are terms used in this field and refer to compositions used with dentures to enhance retention, stability, and function.

[0029] To avoid ambiguity, when we say "by weight %" (%w / w), it means relative to the total weight of the composition, and the amount of each component is selected so that the sum of the components in the composition equals 100% by weight.

[0030] Carboxymethylcellulose The denture adhesive composition of the present invention contains carboxymethylcellulose (CMC), which is a cellulose derivative. Specifically, the composition contains about 15% to about 30% by weight of CMC, particularly about 20% to about 30% by weight, and more specifically about 26% to about 30% by weight of CMC. For example, 25%, 26%, 27%, 28%, 29%, or 30% by weight of CMC. Preferably, the CMC is food-grade or pharmaceutical-grade CMC.

[0031] More specifically, CMC is provided in powder form, more specifically in fine powder form, until used in the compositions of the present invention, such that at least 99.9% of the particles pass through a 60 U.S. mesh sieve, more specifically at least 90% of the particles pass through an 80 U.S. mesh sieve, even more specifically at least 80% of the particles pass through a 100 U.S. mesh sieve, and even more specifically at least 80% of the particles pass through a 200 U.S. mesh sieve.

[0032] A 60 U.S. mesh sieve corresponds to a sieve with an opening of 250 microns. An 80 U.S. mesh sieve corresponds to a sieve with an opening of 177 microns. A 100 U.S. mesh sieve corresponds to a sieve with an opening of 149 microns. A 200 U.S. mesh sieve corresponds to a sieve with an opening of 74 microns. The term micron can be used interchangeably with the SI term micrometer (μm). Therefore, CMC is provided in a fine powder form such that at least 99.9% of the particles pass through a 250 μm mesh sieve, more specifically at least 90% of the particles pass through a 177 μm mesh sieve, even more specifically at least 80% of the particles pass through a 149 μm mesh sieve, and even more specifically at least 80% of the particles pass through a 74 μm mesh sieve.

[0033] Specifically, the viscosity of CMC is approximately 800 to 3000 centipoise (cP), preferably approximately 1000 to 2800 cP (measured in a 1% solution at 25°C).

[0034] Specifically, the degree of substitution (DS) of CMC is approximately 0.65 to approximately 0.95, for example, approximately 0.65 to approximately 0.85, preferably approximately 0.7.

[0035] Preferably, the CMC is sodium carboxymethylcellulose. Specifically, it is sodium carboxymethylcellulose with a sodium content of 6.5% to 9.5% (for example, 7.0% to about 9.2%), more specifically, about 7.0% to about 8.9%.

[0036] Preferably, the CMC is sodium carboxymethylcellulose having an average molecular weight of about 725,000.

[0037] Examples of commercially available CMCs useful in the compositions of the present invention include 7H products available from Aqualon, such as 7H3SXF and 7H3SF, and products available from DuPont, such as WALOCEL CRT 2000, WALOCEL CRT 10000, or WALOCEL CRT 15000 (e.g., WALOCEL CRT 15000PPA(S) sodium). In some embodiments, the sodium CMC is sodium CMC 7H3SXF, 7H3SF, 7H3SXF PH, 7H3SF PH, WALOCEL CRT 15000, WALOCEL CRT 15000PPA(S) sodium, or equivalents.

[0038] In one embodiment, sodium carboxymethylcellulose is a food or pharmaceutical grade CMC having a viscosity of about 1000 to about 2800 cP (measured in a 1% solution at 25°C), a degree of substitution of about 0.65 to about 0.95, a sodium content of 6.5% to 9.5%, and an average molecular weight of about 725,000.

[0039] Cross-linked polyacrylic acid homopolymer The denture adhesive composition of the present invention contains a crosslinked polyacrylic acid homopolymer, commonly referred to as "carbomer." Carbomer is a high-molecular-weight polymer of acrylic acid crosslinked with either allyl ether of allyl curethrose or pentaerythritol, containing 56% to 68% carboxylic acid (-COOH) groups and 0.75% to 2% crosslinking agent. Upon contact with water, carbomer readily absorbs water, hydrates, and swells.

[0040] Specifically, the composition contains about 4% to about 15% by weight of cross-linked polyacrylic acid homopolymer, particularly about 5% to about 10% or more by weight, or more specifically about 6% to about 9% by weight of cross-linked polyacrylic acid homopolymer. For example, 4% by weight, 5% by weight, 6% by weight, 7% by weight, 8% by weight, or 9% by weight of cross-linked polyacrylic acid homopolymer.

[0041] In particular, the crosslinked polyacrylic acid homopolymer is an allyl pentaerythritol crosslinked homopolymer. More specifically, the crosslinked polyacrylic acid homopolymer is an allyl pentaerythritol crosslinked homopolymer polymerized in ethyl acetate. The crosslinked polyacrylic acid homopolymer may be a carbomer homopolymer of type A or type B. In some embodiments, the crosslinked polyacrylic acid homopolymer is a carbomer homopolymer of type A. In some embodiments, the crosslinked polyacrylic acid homopolymer is a carbomer homopolymer of type B.

[0042] In particular, the cross-linked polyacrylic acid homopolymer is food-grade and / or pharmaceutical-grade and is provided in a fluid powder form, more specifically in a free-flowing fine powder form, until used in the compositions of the present invention.

[0043] In one embodiment, the CAS number of the crosslinked polyacrylic acid homopolymer is 9003-01-4. Specifically, the chemical formula of the carbomer is C3H4O2. Preferably, the crosslinked polyacrylic acid homopolymer is selected from the group consisting of carbomer 971, carbomer 974, and combinations thereof. More preferably, the crosslinked polyacrylic acid homopolymer is carbomer 971 or carbomer 974. In a preferred embodiment, the crosslinked polyacrylic acid homopolymer is carbomer 971. More specifically, the carbomer is a pharmaceutical-grade form (for oral or mucosal contact) of carbomer 971, referred to as carbomer 971P. In particular, the carbomer is carbomer 971P NF, where "NF" indicates that the carbomer satisfies the limitations cited in the current edition of the USP / NF "Carbomer Homopolymer Type A" and the Ph.Eur. "Carbomer" monograph.

[0044] In one embodiment, carbomer 971 has a viscosity of 4,000 to 11,000 cP (especially about 7,200 cP) (neutralized to 25°C Brookfield RVT, 20 rpm, pH 7.3 to 7.8, 0.5 wt% viscous, spindle #5 (<10,000 cP) or spindle #6 ( > The pH is 10,000 cP), the carboxylic acid content is 56.0% to 68.0% (especially around 59.6%), the acrylic acid content (ppm) is <1000 (especially less than 100 ppm, e.g., around 80 ppm), and the ethyl acetate content is <0.50% (e.g., around 0.41%).

[0045] Preferred commercial forms of carbomer 971 or carbomer 974 are available from Lubrizol, for example, as CARBOPOL 971P NF and CARBOPOL 974P NF, or from Corel Pharma, for example, as ACRYPOL 971 and ACRYPOL 974. In a specific embodiment, the crosslinked polyacrylic acid homopolymer is CARBOPOL 971P NF.

[0046] Alkyl vinyl ether-maleate copolymer The denture adhesive composition of the present invention comprises an alkyl vinyl ether-maleic acid (AVE / MA) copolymer or a salt thereof (e.g., a mixed salt, a partial salt, or a mixed partial salt). In this specification, the term "mixed salt" refers to a salt in which at least two different cations are mixed with each other or with other salts on the same polymer. The term "partial salt" refers to a salt of a polymer in which less than 100% of the acidic groups have reacted.

[0047] Specifically, the denture adhesive composition contains a partial salt of an alkyl vinyl ether-maleic acid copolymer. More specifically, the denture adhesive composition contains a mixed partial salt of an alkyl vinyl ether-maleic acid copolymer.

[0048] The alkyl vinyl ether-maleic acid copolymer contains at least one cationic salt selected from the group consisting of strontium, zinc, iron, magnesium, calcium, and sodium. Preferably, the alkyl vinyl ether-maleic acid copolymer contains at least one cationic salt selected from the group consisting of calcium and sodium. Therefore, in some embodiments, the AVE / MA copolymer contains cationic salts selected from calcium and sodium or a combination thereof. Preferably, the at least one cationic salt is a combination of a calcium cation and a sodium cation.

[0049] Metal cations may be present on the alkyl vinyl ether-maleic acid copolymer in amounts of approximately 10.0% to approximately 20.0%, for example, approximately 12.0% to approximately 16.0%, for example, approximately 12.0%, approximately 12.5%, approximately 13.0%, approximately 13.5%, approximately 14.0%, approximately 14.5%, approximately 15.0%, or approximately 15.5%.

[0050] Specifically, the alkyl vinyl ether-maleic acid copolymer contains, or essentially consists of, about 1.0% to about 15.0% calcium cations and about 0.5% to about 5.0% sodium cations. More specifically, the alkyl vinyl ether-maleic acid copolymer contains, or essentially consists of, about 9.0% to about 15.0% calcium cations and about 1.0% to about 3.0% sodium cations. Preferably, the alkyl vinyl ether-maleic acid copolymer does not contain zinc cations.

[0051] Preferably, the molecular weight of the alkyl vinyl ether-maleic acid copolymer is at least 900,000 daltons. In some embodiments, the molecular weight is about 1,000,000 to about 3,000,000.

[0052] Specifically, the denture adhesive composition contains about 15 to about 34% by weight of alkyl vinyl ether-maleic acid copolymer or a salt thereof. More specifically, the denture adhesive composition contains about 15 to about 26% by weight of alkyl vinyl ether-maleic acid copolymer or a salt thereof. Even more specifically, the denture adhesive composition contains about 15 to about 22% by weight of alkyl vinyl ether-maleic acid copolymer or a salt thereof. Even more specifically, the denture adhesive composition contains about 16% to about 20% by weight of alkyl vinyl ether-maleic acid copolymer or a salt thereof (e.g., about 16%, about 17%, about 18%, about 19%, or about 20%).

[0053] Preferably, the alkyl vinyl ether-maleic acid copolymer or its salt is a poly(methyl vinyl ether / maleic acid) salt. More preferably, the alkyl vinyl ether-maleic acid copolymer or its salt is a poly(methyl vinyl ether / maleic acid) sodium-calcium mixed partial salt.

[0054] Suitable commercially available alkyl vinyl ether-maleic acid copolymers are sold under the trade name GANTREZ (ISP Investments LLC), available from Thermo Fisher or Ashland. These include GANTREZ AN (anhydride) forms such as GANTREZ AN169 (methyl vinyl ether / maleic anhydride copolymer) and GANTREZ MS forms such as GANTREZ MS-955 (sodium / calcium mixed salt of methyl vinyl ether and maleic anhydride copolymer).

[0055] Other ingredients The denture adhesive composition of the present invention may further contain (d) an oil component and / or (e) a petrolatum component.

[0056] The kinematic viscosity of the oil useful in the composition of the present invention is approximately 10 centistokes (cSt, mm) at 40°C. 2 The kinematic viscosity may be approximately 240 cSt at a maximum of 40°C, more specifically about 10 cSt to 100 cSt at 40°C, and even more specifically about 10 cSt to 90 cSt at 40°C. The kinematic viscosity can be measured at 40°C using a calibrated glass capillary viscometer, as specified in ASTM Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids D445 (DOI:10.1520 / D0445-21E01).

[0057] Examples of oils suitable for use in the compositions of the present invention include, but are not limited to, light mineral oil, medium mineral oil, and vegetable oils (e.g., olive oil, oleic acid, sesame oil, safflower oil, corn oil, soybean oil, cottonseed oil, castor oil, palm oil, and coconut oil).

[0058] Preferably, the oil component is selected from the group consisting of light oils, medium oils, and combinations thereof.

[0059] Mineral oils can be characterized in terms of their kinematic viscosity. The kinematic viscosity of light oils is generally about 34 cSt or less at 40°C. The kinematic viscosity of medium and heavy oils is generally about 35 cSt to about 240 cSt at 40°C.

[0060] In one embodiment, the oil component is a medium-grade oil. In another embodiment, the oil is a medium-grade oil, more specifically, a medium-grade oil having a kinematic viscosity at 40°C of about 35 cSt to about 90 cSt, and even more specifically, a medium-grade oil having a kinematic viscosity at 40°C of about 63 cSt to about 80 cSt. A preferred medium-grade oil is PIONIER 2071P or an equivalent thereto.

[0061] In one embodiment, the oil component is a light oil. In another embodiment, the oil is a light oil, more specifically a light oil having a dynamic velocity of about 10 cSt to about 34 cSt at 40°C, more specifically a medium oil having a dynamic velocity of about 10 cSt to about 20 cSt at 40°C, and more specifically a medium oil having a dynamic velocity of about 14 cSt to about 17 cSt at 40°C. A suitable light oil is BLANDOL white mineral oil or an equivalent thereto.

[0062] For use in this invention, medium-grade oil (as defined above) is preferred.

[0063] The term "petrolatum" is a term used in the art to refer to a semi-solid mixture of hydrocarbons. The viscosity of petrolatum can be determined using the ASTM Standard Test Method for Cone Penetration of Petrolatum (D937-07) for determining the penetration of petrolatum as an empirical measure of consistency. Petrolatum may have a cone penetration consistency value (mm / 10, 25°C) of about 10 to about 500, particularly about 25 to about 300, and more specifically about 50 to about 250. Preferably, petrolatum has a cone penetration consistency value of about 100 to about 200, more preferably about 130 to about 195 (mm / 10, 25°C).

[0064] In particular, the denture adhesive composition of the present invention may contain about 10 to about 56% by weight (%w / w) of an oil component and / or a petrolatum component, and more particularly about 17 to about 56% by weight (%w / w) of an oil component and / or a petrolatum component.

[0065] In some embodiments, the denture adhesive composition of the present invention may contain about 17 to about 56% by weight (%w / w) of an oil component. In some embodiments, the denture adhesive composition of the present invention may contain about 17 to about 56% by weight (%w / w) of a petrolatum component.

[0066] Specifically, the denture adhesive composition of the present invention may contain about 17 to about 26% by weight (%w / w) of an oil component and about 20 to about 30% by weight (%w / w) of a petrolatum component. More specifically, the denture adhesive composition of the present invention may contain about 18 to about 22% by weight (%w / w) of an oil component and about 20 to about 27% by weight (%w / w) of a petrolatum component. Even more specifically, the denture adhesive composition of the present invention may contain about 18 to about 22% by weight (%w / w) of an oil component and about 23 to about 27% by weight (%w / w) of a petrolatum component. More specifically, the denture adhesive composition of the present invention may contain about 18% to about 22% by weight (%w / w) of an oil component (e.g., about 18%, about 19%, about 20%, about 21%, or about 22%) and about 23% to about 27% by weight (%w / w) of a petrolatum component (e.g., about 23%, about 24%, about 25%, about 26%, or about 27%). In a preferred embodiment, the denture adhesive composition of the present invention contains about 18% by weight (%w / w) of an oil component and about 25% by weight (%w / w) of a petrolatum component. In a more preferred embodiment, the denture adhesive composition of the present invention contains about 18% by weight (%w / w) of a medium-grain oil component and about 25% by weight (%w / w) of a petrolatum component.

[0067] Sensory components Denture adhesive compositions may contain at least one sensory component. A "sensory component" refers to an ingredient that may be used to impart flavor, aroma, color, and / or sensation (such as cold, warm, or tingling) to the composition. Generally, sensory components are not active ingredients, in other words, they do not play an active role in adhesive strength, retention time, or cushioning, except to impart desirable organoleptic properties to the composition. In particular, sensory components are at least one flavor, fragrance, and / or colorant. Sensory components may be known in the art and may be natural or artificial (synthetic).

[0068] The composition of the present invention may contain about 0.01% to about 5% by weight of sensory components, particularly about 0.01% to about 2% by weight of sensory components.

[0069] The composition of the present invention may contain flavorings well known in the art of denture adhesives. These flavorings include, but are not limited to, synthetic flavoring oils and / or oils derived from plants, leaves, flowers, fruits, etc., and combinations thereof. Representative flavoring oils include spearmint oil, cinnamon oil, wintergreen oil (methyl salicylate), and peppermint oil. Citrus oils such as lemon, orange, grape, lime, and grapefruit, and artificial, natural, or synthetic fruit flavorings such as apple, strawberry, cherry, and pineapple fruit essences are also useful. The flavorings may be liquid, spray-dried, encapsulated, adsorbed onto a carrier, or mixtures thereof. In one embodiment, the flavoring is peppermint oil. The amount of flavoring used varies depending on factors such as the type of flavoring, the adhesive composition, and the desired strength. In one embodiment, the denture adhesive composition contains about 0.01% to about 3.0% by weight of flavoring. In another embodiment, the denture adhesive composition contains about 0.01% to about 2.0% by weight of flavoring. In yet another embodiment, the denture adhesive composition contains about 0.05% to 2.0% by weight of flavoring.

[0070] Denture adhesive compositions also include the use of sweeteners well known in the art. Sweeteners can be selected from a wide range of materials, including water-soluble sweeteners, water-soluble artificial sweeteners, and dipeptide sweeteners (including mixtures thereof). Typical sweeteners include, but are not limited to, (a) sugar alcohols such as sorbitol, xylitol, mannitol, maltitol, hydrolyzed hydrogenated starch, and mixtures thereof; (b) water-soluble artificial sweeteners such as soluble saccharin salts (i.e., saccharin sodium salt or saccharin calcium salt), cyclamate salts, acesulfame-K, sucralose, and free acid forms of saccharin; (c) dipeptide sweeteners such as L-aspartyl-L-phenylalanine methyl ester; and (d) natural sweeteners such as stevia. In one embodiment, the denture adhesive composition contains about 0.001% to about 5.0% by weight of sweetener.

[0071] The colorants useful in this invention include pigments and dyes suitable for food, pharmaceutical, and cosmetic applications. These colorants are known as FD&C (Food, Pharmaceutical, and Cosmetic) and D&C (Pharmaceutical and Cosmetic) dyes and lakes. Exemplary examples include, but are not limited to, D&C Red 30 aluminum lake paste, D&C Red 7 calcium lake paste, erythrosine lake paste, the indigo dye known as FD&C Blue 2 (which is the disodium salt of 5,5-indigotin disulfonic acid); and FD&C Green 1 (which contains the triphenylmethylene dye, the monosodium salt of 4-[4-N-ethyl-p-sulfobenzylamino)diphenylmethylene]-[l-(N-ethyl-NP-sulfobenzyl)-2,5-cyclohexadieneimine]). In some embodiments, the colorant is FD&C Red 3. In some embodiments, the denture adhesive composition contains about 0% to about 0.2% by weight of the colorant.

[0072] In preferred embodiments, the denture adhesive composition does not contain flavorings, fragrances, and / or colorings.

[0073] Consumers may dispense the denture adhesive composition of the present invention from a multi-dose package, pump, or tube. Alternatively, the denture adhesive composition of the present invention may be pre-dispensed in a single-dose package onto, for example, a non-adhesive self-supporting layer that can be peeled off to allow for application of the adhesive.

[0074] To facilitate dispensing, the denture adhesive composition of the present invention may have a viscosity of 500,000 to 2,500,000 centipoise (cP), more specifically 1,000,000 to 2,000,000 cP, when measured after the composition has been prepared. To avoid doubt, the viscosity may be measured within two months of the preparation of the composition, more specifically within one month of the preparation of the composition, for example, a viscosity of 1,000,000 to 2,000,000 cP when measured within one month of the preparation of the composition. Specifically, the viscosity is measured at 25°C ± 1°C. More specifically, the viscosity is measured using a Brookfield RVT viscometer, TE spindle, 2.5 RPM, at 25°C ± 1°C.

[0075] The pH of the composition of the present invention is preferably 4.0 to 10.0 (e.g., 5.0 to 8.0), and preferably about 5.0 to about 7.5 (e.g., about 5.2 to about 7.1).

[0076] Typically, the compositions of the present invention are stable at 25°C for at least 3 months, particularly at 25°C for at least 6 months, more specifically at 25°C for at least 12 months, even more specifically at 25°C for at least 24 months, and even more specifically at 25°C for 36 months. As used herein, the term “stable” refers to the ability of a composition to maintain certain physical or chemical properties, such as adhesion, for a certain period after manufacture at a specific storage temperature. The stability of the compositions of the present invention can be evaluated using standard methods known in the art.

[0077] Specifically, the proportion of (a) carboxymethylcellulose, (b) crosslinked polyacrylic acid homopolymer, and (c) alkyl vinyl ether-maleic acid copolymer or a salt thereof in the denture adhesive composition is 54% w / w (i.e., (a) + (b) + (c) = 54% w / w).

[0078] In particular, the denture adhesive composition does not contain polyethylene glycol, sodium alginate, and / or zinc. Preferably, the denture adhesive composition of the present invention does not contain polyethylene glycol, sodium alginate, and zinc. In particular, the denture adhesive composition of the present invention does not contain SiO2.

[0079] The present invention provides a denture adhesive composition for use in a method of adhering dental appliances to a surface (particularly the surface inside the oral cavity). The present invention also provides a method for adhering dental appliances to a surface (particularly the surface inside the oral cavity) using the denture adhesive composition of the present invention.

[0080] In particular, this method may include the steps of applying the composition of the first embodiment to a dental appliance, the oral cavity, or both, and attaching the dental appliance to the surface of the oral cavity, such as the palate or gums.

[0081] General Matters The term “contains” includes “encompassing,” and for example, a composition “contains” X may contain additional elements (e.g., X + Y). In some embodiments, the term “contains” may mean not only the indicated activator (e.g., the described compound), but also other activators, and carriers, excipients, emollients, adhesives, etc., that are generally known and recognized as safe (GRAS) in the consumer health industry. When the transitional expression “essentially consists of” is used, it should be interpreted that the claims should encompass the specific materials or processes described in the claims and those that do not substantially affect the basic and novel features of the invention described in the claims. See In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis added); also see MPEP Section 211.03. Accordingly, the term “essentially consists of” as used in the claims of the present invention is not intended to be interpreted as equivalent to “contains.” The term "consists of" and its variations mean including and being limited to (for example, the specific components or processes described). In certain fields, the term "contains an active ingredient consisting of" may be used instead of "essentially consisting of". The term "about" with respect to a numerical value x is optional and means that the value may include some variation around the stated value (e.g., x±10%, x±5%, x±4%, x±3%, x±2%, or x±1%) to allow for routine experimental variation, measurement variability, or to include small deviations that can achieve substantially the same results as the stated value. The word "substantially" does not exclude "completely". For example, a composition that "substantially does not contain" Y may not contain Y at all. Where necessary, "substantially" may be omitted from the definitions of the present invention. All percentages and ratios used herein are relative to the total weight of the composition unless otherwise specified.

[0082] All documents or patent applications cited herein are incorporated herein by reference.

[0083] Embodiments of the Invention The following sections describe specific embodiments of the present invention.

[0084] Embodiment 1 (a) 26-30% w / w sodium carboxymethylcellulose; (b) 6-9% w / w crosslinked polyacrylic acid homopolymer; (c) 16-20% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) 17-22% w / w oil content; (e) 23% to 29% petrolatum; and optionally (f) at least one fragrance, colorant, preservative, surfactant or mixture thereof A denture adhesive composition containing, or essentially consisting of, these.

[0085] Embodiment 2 (a) 26-30% w / w sodium carboxymethylcellulose; (b) 6-9% w / w crosslinked polyacrylic acid homopolymer; (c) 16-20% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) 17-22% w / w oil content; (e) 23% to 29% petrolatum; and optionally (f) at least one fragrance, colorant, preservative, surfactant, or mixture thereof; A denture adhesive composition comprising, or essentially consisting thereof, A denture adhesive composition having a viscosity of 1,000,000 to 2,000,000 centipoise (cP, measured at 25°C ± 1°C) and a pH of 5.0 to 7.5.

[0086] Embodiment 3 (a) 26-30% w / w sodium carboxymethylcellulose; (b) 6-9% w / w crosslinked polyacrylic acid homopolymer; (c) 16-20% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) 18-22% w / w oil components; and (e) 23%~27% petrolatum, A denture adhesive composition containing, or essentially consisting of, these.

[0087] Embodiment 4 (a) 26-30% w / w sodium carboxymethylcellulose; (b) 6-9% w / w crosslinked polyacrylic acid homopolymer; (c) 16-20% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) 18-22% w / w oil content; (e) 23% to 27% petrolatum; A denture adhesive composition comprising, or essentially consisting thereof, A denture adhesive composition having a viscosity of 1,000,000 to 2,000,000 centipoise (measured at 25°C ± 1°C) and a pH of 5.0 to 7.5.

[0088] Embodiment 5 (a) 26-30% w / w sodium carboxymethylcellulose; (b) Approximately 8% w / w cross-linked polyacrylic acid homopolymer; (c) Approximately 18% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) 17-22% w / w oil content; (e) 23% to 29% petrolatum; A denture adhesive composition comprising, or essentially consisting thereof, A denture adhesive composition having a viscosity of 1,000,000 to 2,000,000 centipoise (measured at 25°C ± 1°C) and a pH of 5.0 to 7.5.

[0089] Embodiment 6 (a) Approximately 28% w / w sodium carboxymethylcellulose; (b) Approximately 6% w / w crosslinked polyacrylic acid homopolymer; (c) Approximately 20% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) 17-22% w / w oil content; (e) 23% to 29% petrolatum; A denture adhesive composition comprising, consisting of, or essentially consisting of, A denture adhesive composition having a viscosity of 1,000,000 to 2,000,000 centipoise (measured at 25°C ± 1°C) and a pH of 5.0 to 7.5.

[0090] Embodiment 7 (a) Approximately 28% w / w sodium carboxymethylcellulose; (b) Approximately 6% w / w crosslinked polyacrylic acid homopolymer; (c) Approximately 20% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) Approximately 17% w / w oil content; (e) Approximately 29% petrolatum; A denture adhesive composition comprising, consisting of, or essentially consisting of, A denture adhesive composition having a viscosity of 1,000,000 to 2,000,000 centipoise (measured at 25°C ± 1°C) and a pH of 5.0 to 7.5.

[0091] Embodiment 8 (a) Approximately 28% w / w sodium carboxymethylcellulose; (b) Approximately 6% w / w crosslinked polyacrylic acid homopolymer; (c) Approximately 20% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) Approximately 21% w / w oil content; (e) Approximately 25% petrolatum; A denture adhesive composition containing, or essentially consisting of, these.

[0092] Embodiment 9 (a) Approximately 28% w / w sodium carboxymethylcellulose; (b) Approximately 8% w / w cross-linked polyacrylic acid homopolymer; (c) Approximately 18% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) 17-22% w / w oil content; (e) 23% to 29% petrolatum; A denture adhesive composition containing, essentially consisting of, or comprising the following: A denture adhesive composition having a viscosity of 1,000,000 to 2,000,000 centipoise (measured at 25°C ± 1°C) and a pH of 5.0 to 7.5.

[0093] Embodiment 10 (a) Approximately 28% w / w sodium carboxymethylcellulose; (b) Approximately 8% w / w cross-linked polyacrylic acid homopolymer; (c) Approximately 18% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) Approximately 17% w / w oil content; (e) Approximately 29% petrolatum; A denture adhesive composition comprising, consisting of, or essentially consisting of, A denture adhesive composition having a viscosity of 1,000,000 to 2,000,000 centipoise (measured at 25°C ± 1°C) and a pH of 5.0 to 7.5.

[0094] Embodiment 11 (a) Approximately 28% w / w sodium carboxymethylcellulose; (b) Approximately 8% w / w cross-linked polyacrylic acid homopolymer; (c) Approximately 18% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) Approximately 21% w / w oil content; (e) Approximately 25% petrolatum; A denture adhesive composition comprising, or essentially consisting thereof, A denture adhesive composition having a viscosity of 1,000,000 to 2,000,000 centipoise (measured at 25°C ± 1°C) and a pH of 5.0 to 7.5.

[0095] Embodiment 12 (a) Approximately 28% w / w sodium carboxymethylcellulose; (b) Approximately 8% w / w cross-linked polyacrylic acid homopolymer; (c) Approximately 18% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) Approximately 17% w / w oil content; (e) about 29% petrolatum; and optionally, (f) at least one fragrance, colorant, preservative, surfactant, or mixture thereof A denture adhesive composition comprising, consisting of, or essentially consisting of, A denture adhesive composition having a viscosity of 1,000,000 to 2,000,000 centipoise (measured at 25°C ± 1°C) and a pH of 5.0 to 7.5.

[0096] Embodiment 13 (a) Approximately 28% w / w sodium carboxymethylcellulose; (b) Approximately 6% w / w crosslinked polyacrylic acid homopolymer; (c) Approximately 20% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) Approximately 17% w / w oil content; (e) about 29% petrolatum; and optionally, (f) at least one fragrance, colorant, preservative, surfactant, or mixture thereof; A denture adhesive composition comprising, consisting of, or essentially consisting of, A denture adhesive composition having a viscosity of 1,000,000 to 2,000,000 centipoise (measured at 25°C ± 1°C) and a pH of 5.0 to 7.5.

[0097] Embodiment 14 (a) 26-30% w / w sodium carboxymethylcellulose; (b) 6-9% w / w crosslinked polyacrylic acid homopolymer; (c) 16-20% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) 17-23% w / w oil content; (e) 23% to 29% petrolatum; and optionally, (f) at least one fragrance, colorant, preservative, surfactant, or mixture thereof; A denture adhesive composition containing, consisting of, or essentially consisting of.

[0098] Embodiment 15 The denture adhesive composition according to Embodiment 14, wherein the pH of the composition is 4.0 to 10, particularly 5.0 to 8.0.

[0099] Embodiment 16 The denture adhesive composition according to Embodiment 14 or 15, wherein the viscosity of the composition measured within two months after preparation (measured at 25°C ± 1°C) is 500,000 to 2,500,000 centipoise (cP), particularly 500,000 to 2,000,000 centipoise (cP).

[0100] Embodiment 17Denture adhesive compositions according to embodiments 14 to 16, wherein the viscosity of carboxymethylcellulose (measured in a 1% solution at 25°C) is approximately 1000 to approximately 2800 centipoise (cP).

[0101] Embodiment 18 The denture adhesive composition according to Embodiment 17, wherein the carboxymethylcellulose consists of fine particles, at least 80% of which pass through a 200 U.S. mesh sieve (equivalent to a 74 μm mesh sieve).

[0102] Embodiment 19 The denture adhesive composition according to Embodiment 17 or 18, wherein the cross-linked polyacrylic acid homopolymer is an allyl pentaerythritol cross-linked homopolymer.

[0103] Embodiment 20 The denture adhesive composition according to Embodiment 19, wherein the crosslinked polyacrylic acid homopolymer is a carbomer homopolymer of type A or type B.

[0104] Embodiment 21 The denture adhesive composition according to Embodiment 20, wherein the crosslinked polyacrylic acid homopolymer is carbomer 971P NF and / or carbomer 974P NF, particularly Carbopol 971P NF and / or Carbopol 974P NF.

[0105] Embodiment 22 A denture adhesive composition according to any one of Embodiments 18 to 21, wherein the alkyl vinyl ether-maleic acid copolymer or a salt thereof is a poly(methyl vinyl ether / maleic acid) salt.

[0106] Embodiment 23 The denture adhesive composition according to Embodiment 22, wherein the alkyl vinyl ether-maleic acid copolymer or a salt thereof is a poly(methyl vinyl ether / maleic acid) sodium-calcium mixed partial salt.

[0107] Embodiment 24 (a) Approximately 28% w / w sodium carboxymethylcellulose; (b) Approximately 8% w / w cross-linked polyacrylic acid homopolymer; (c) Approximately 18% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) Approximately 21% w / w oil content; (e) about 25% petrolatum; and optionally, (f) at least one fragrance, colorant, preservative, surfactant, or mixture thereof; A denture adhesive composition according to Embodiment 23, comprising, or essentially comprising the elements.

[0108] Embodiment 25 : (a) Approximately 28% w / w sodium carboxymethylcellulose; (b) Approximately 6% w / w crosslinked polyacrylic acid homopolymer; (c) Approximately 20% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) Approximately 21% w / w oil content; (e) about 25% petrolatum; and optionally (f) at least one fragrance, colorant, preservative, surfactant or mixture thereof A denture adhesive composition of Embodiment 23, comprising, or essentially comprising, the following.

[0109] Embodiment 26 A denture adhesive composition according to Embodiment 24 or 25, wherein the viscosity of the composition is 1,000,000 to 2,000,000 centipoise (measured at 25°C ± 1°C) and the pH of the composition is 5.0 to 7.5.

[0110] Embodiment 27 A denture adhesive composition according to any one of Embodiments 1 to 26, wherein the composition does not contain polyethylene glycol, sodium alginate, and zinc.

[0111] To better understand the present invention, the following examples are provided. These examples are for illustrative purposes only and should not be construed as limiting the scope of the present invention in any way. [Examples]

[0112] [Example 1: Denture Adhesive Composition I] Six formulations were prepared using commercially available ingredients. The formulations are based on the commercially available product POLIGRIP Cushion and Comfort denture adhesive cream (containing cellulose gum, liquid paraffin (Paraffinum liquidum), petrolatum, carbomer, silica, Cera Alba, aroma, and limonene), with the addition of a poly(methyl vinyl ether / maleate) sodium-calcium mixed salt component to enhance retention. [Table 1]

[0113] In short, the petrolatum component was melted, the mineral oil component was added, and then melted beeswax was added while stirring. Next, carbomer, sodium carboxymethylcellulose, poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt, and Cab-o-sil M5 were added in powder form while stirring. The composition was cooled, and flavoring components (Frescolat, spearmint oil, peppermint oil) were added. After further mixing, the mixture was degassed.

[0114] To compare the adhesive profiles of denture adhesives, an Instron Texture Analyzer (5943) equipped with a BioPuls Bath and a 500N load cell was used (Instron, UK). A fixed amount of adhesive was placed on the test surface of the Texture Analyzer, and the entire test surface was compressed to a uniform thickness of 1 mm. The compression / stretch cycle was repeated many times. After the compression / stretch cycle, the crosshead was rapidly released at a rate of 6 lbf / min, and the maximum tensile force was recorded. This was repeated at least 20 times for each sample.

[0115] None of the formulations sufficiently improved the retention profile to a degree comparable to the control formulation (Poligrip additive-free denture adhesive cream containing a sodium-calcium mixed partial salt but without Carbopol) (Figure 1). Adding less than 14% w / w of poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt to the formulations was not sufficient to improve the adhesion profile.

[0116] [Example 2: Effect of carbomer on viscosity] Eight more formulations were prepared using commercially available ingredients. These formulations are based on the commercially available Poligrip Additive-Free Denture Adhesive Cream (containing calcium / sodium PVM / MA copolymer, petrolatum, cellulose gum, and liquid paraffin), with the addition of carbomer. [Table 2]

[0117] The formulation was prepared according to a process similar to that described in International Patent Application Publication No. WO16091738. Briefly, the petrolatum component was melted, and the mineral oil component was added while stirring. Next, carbomer, sodium carboxymethylcellulose, and poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt were added in powder form while stirring. The composition was cooled and degassed.

[0118] The initial viscosity of each compound was measured using a stress-controlled rheometer (CarriMed CSL500) in a dynamic cone-plate configuration at 37°C with a constant strain mode of 10 rad / s angular velocity. Five separate specimens were measured for each compound.

[0119] The viscosity of formulations containing at least 18% w / w carbomer was extremely high (>4,000,000 cPs). Formulations 13 and 14, containing 36% w / w and 54% w / w carbomer respectively, were too viscous to be properly formulated or tested.

[0120] Formulations containing more than 18% w / w carbomer have a viscosity unsuitable for general use because they are difficult to formulate and / or difficult for consumers to squeeze out from dispensers such as tubes. Therefore, commercially desirable formulations should contain less than 18% w / w carbomer.

[0121] [Example 3: Denture Adhesive Composition II] Seven additional formulations were prepared using commercially available ingredients. These formulations are based on the commercially available Polygrip additive-free denture adhesive cream (containing calcium / sodium PVM / MA copolymer, petrolatum, cellulose gum, and liquid paraffin), and incorporate carbomer, lower amounts of AVE / MA, and varying amounts of CMC while maintaining an acceptable viscosity profile. [Table 3]

[0122] The formulation was prepared as described above.

[0123] To compare the adhesive profiles of denture adhesives, an Instron Texture Analyzer (5943) equipped with a BioPuls Bath and a 500N load cell was used (Instron, UK). A fixed amount of adhesive was placed on the test surface of the Texture Analyzer, and the entire test surface was compressed to a uniform thickness of 1 mm. The compression / stretch cycle was repeated many times. After the compression / stretch cycle, the crosshead was rapidly released at a rate of 6 lbf / min, and the maximum tensile force was recorded. This was repeated at least 20 times for each sample.

[0124] The results for formulations containing 4% Carbopol showed sub-optimal performance compared to the control. However, some formulations showed retention performance comparable to or better than existing commercially available formulations (Figure 2).

[0125] The formulation containing 8% Carbopol and 18% poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt showed the highest biopuls peak, while the formulation containing 6% Carbopol and 20% poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt showed performance similar to commercially available formulations. All of these formulations showed high adhesion work scores over 10–20 cycles (Figure 3).

[0126] [Example 4: Mineral oil and petrolatum] Based on positive in-vitro data regarding retention and viscosity, formulations 16 (6% Carbopol / 20% AVE / MA / 28% CMC) and 17 (8% Carbopol / 18% AVE / MA / 28% CMC) were selected and further studied.

[0127] We investigated the effects of varying the amounts of petrolatum and mineral oil on tackiness and viscosity. [Table 4]

[0128] Reducing the proportion of petrolatum and increasing the proportion of mineral oil significantly decreased viscosity. However, after the initial decrease in viscosity, further increasing the proportion of mineral oil beyond 21% w / w had little effect.

[0129] Changing the ratio of mineral oil to petrolatum did not affect the adhesion profiles of formulations 22, 23, and 24 (Figure 4).

[0130] The thickness of the adhesive layer was also measured (Figure 5). Each formulation maintained a greater layer thickness than the control (Figure 5(a)), suggesting a possible improved cushioning effect.

[0131] The purpose of the above description is to illustrate some embodiments of the present invention without implying limitation. It will be apparent to those skilled in the art that various modifications and variations can be made to the apparatus or procedures of the present invention without departing from the scope or spirit of the invention.

[0132] [Example 5: Clinical Trial] A study was conducted to evaluate the maximum maxillary occlusal force in a group of 42 maxillary complete denture wearers. This study compared the maximum incisal bite force (the force required for maxillary denture dislodgement) after 12 hours, with and without experimental denture adhesive formulation 25. Formulation 25 was applied to the denture as a continuous, long strip. [Table 5]

[0133] The incisal occlusal force (BF) until the maxillary denture became dislodged was measured at baseline and at 0.5, 1, 3, 6, 9, and 12 hours after denture insertion (Figure 6).

[0134] AOB 0-12Since the data were found not to be statistically normally distributed, an additional post-hoc analysis was performed to support the primary analysis. In the post-hoc analysis, the occlusal force results were expressed as a percentage increase compared to baseline. [Table 6]

[0135] The experimental denture adhesive was generally well-tolerated. The primary analysis showed that the experimental denture adhesive resulted in statistically significantly higher occlusal forces over 12 hours compared to the control group (p<0.05). The post-hoc analysis supported the primary analysis results, demonstrating that the experimental denture adhesive effectively increased denture retention over 12 hours compared to the control group. The present invention includes, for example, the following embodiments. [Section 1] A denture adhesive composition comprising (a) carboxymethylcellulose, (b) crosslinked polyacrylic acid homopolymer, and (c) alkyl vinyl ether-maleic acid copolymer or a salt thereof. [Section 2] The denture adhesive composition according to item 1, comprising (a) about 15 to about 30% by weight (%w / w) of carboxymethylcellulose, (b) about 4 to about 15% by weight (%w / w) of a crosslinked polyacrylic acid homopolymer, and (c) about 15 to about 34% by weight (%w / w) of an alkyl vinyl ether-maleic acid copolymer or a salt thereof. [Section 3] (d) an oil component and / or (e) a petrolatum component, further comprising the denture adhesive composition according to claim 1 or 2. [Section 4] A denture adhesive composition according to claim 1, 2, or 3, wherein the composition has (i) a viscosity of 500,000 to 2,000,000 centipoise (cP measured at 25°C ± 1°C), and / or (ii) a pH of 4.0 to 10, particularly 5.0 to 8.0. [Section 5] A denture adhesive composition according to item 3 or 4, comprising (e) about 17 to about 26% by weight (%w / w) of an oil component, and (e) about 20 to about 30% by weight (%w / w) of petrolatum. [Section 6] The denture adhesive composition according to item 5, wherein carboxymethylcellulose has a viscosity of about 1000 to about 2800 centipoise (cP) (measured in a 1% solution at 25°C). [Section 7] The denture adhesive composition according to item 6, wherein the carboxymethylcellulose comprises fine particles, at least 80% of which pass through a 200 U.S. mesh sieve (equivalent to a 74 μm mesh sieve). [Section 8] A denture adhesive composition according to item 6 or 7, wherein the carboxymethylcellulose is sodium carboxymethylcellulose. [Section 9] A denture adhesive composition according to any one of the above items 1 to 8, comprising approximately 5 to approximately 10% by weight (%w / w) of a cross-linked polyacrylic acid homopolymer, particularly approximately 6 to approximately 9% by weight (%w / w) of a cross-linked polyacrylic acid homopolymer. [Section 10] The denture adhesive composition according to item 8, wherein the cross-linked polyacrylic acid homopolymer is an allyl pentaerythritol cross-linked homopolymer. [Section 11] The denture adhesive composition according to item 10, wherein the crosslinked polyacrylic acid homopolymer is a carbomer homopolymer of type A or type B. [Section 12] The denture adhesive composition according to item 11, wherein the crosslinked polyacrylic acid homopolymer is carbomer 971P NF and / or carbomer 974P NF, in particular Carbopol 971P NF and / or Carbopol 974P NF. [Section 13] A denture adhesive composition according to any one of claims 9 to 12, wherein the alkyl vinyl ether-maleic acid copolymer or a salt thereof is a poly(methyl vinyl ether / maleic acid) salt. [Section 14] The denture adhesive composition according to item 13, wherein the alkyl vinyl ether-maleic acid copolymer or a salt thereof is a poly(methyl vinyl ether / maleic acid) sodium-calcium mixed partial salt. [Section 15] (a) 26-30% w / w sodium carboxymethylcellulose; (b) 6-9% w / w crosslinked polyacrylic acid homopolymer; (c) 16-20% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) 17-23% w / w oil content; (e) 23% to 29% petrolatum; and optionally, (f) at least one fragrance, colorant, preservative, surfactant, or mixture thereof; A denture adhesive composition according to any one of the preceding paragraphs 1 to 14, comprising or essentially consisting of the above. [Section 16] (a) Approximately 28% w / w sodium carboxymethylcellulose; (b) Approximately 8% w / w cross-linked polyacrylic acid homopolymer; (c) Approximately 18% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) Approximately 21% w / w oil content; (e) about 25% petrolatum; and optionally, (f) at least one fragrance, colorant, preservative, surfactant, or mixture thereof; A denture adhesive composition according to item 15, comprising, or essentially comprising, the following: [Section 17] (a) Approximately 28% w / w sodium carboxymethylcellulose; (b) Approximately 6% w / w crosslinked polyacrylic acid homopolymer; (c) Approximately 20% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) Approximately 21% w / w oil content; (e) about 25% petrolatum; and optionally (f) at least one fragrance, colorant, preservative, surfactant, or mixture thereof; A denture adhesive composition according to item 15, comprising, or essentially comprising, the following: [Section 18] A denture adhesive composition according to any one of claims 15 to 17, wherein the composition has a viscosity of 1,000,000 to 2,000,000 centipoise (cP) and a pH of 5.0 to 7.5. [Section 19] A denture adhesive composition according to any one of claims 1 to 16, wherein the composition does not contain polyethylene glycol, sodium alginate, and zinc.

Claims

1. A denture adhesive composition comprising (a) 15 to 30% by weight (%w / w) of carboxymethylcellulose, (b) 5 to 10% by weight (%w / w) of a crosslinked polyacrylic acid homopolymer, and (c) 15 to 34% by weight (%w / w) of an alkyl vinyl ether-maleic acid copolymer or a salt thereof.

2. (d) an oil component and / or (e) a petrolatum component, further comprising the denture adhesive composition according to claim 1.

3. The denture adhesive composition according to claim 1, wherein the composition has a pH of 4.0 to 10.

4. The denture adhesive composition according to claim 2, comprising (d) 17 to 26% by weight (%w / w) of an oil component and (e) 20 to 30% by weight (%w / w) of petrolatum.

5. The denture adhesive composition according to claim 1, wherein the carboxymethylcellulose consists of fine particles, at least 80% of which pass through a 200 U.S. mesh sieve (equivalent to a 74 μm mesh sieve).

6. The denture adhesive composition according to claim 5, wherein the carboxymethylcellulose is sodium carboxymethylcellulose.

7. The denture adhesive composition according to claim 1, comprising 6 to 9% by weight (%w / w) of a crosslinked polyacrylic acid homopolymer.

8. The denture adhesive composition according to claim 6, wherein the crosslinked polyacrylic acid homopolymer is an allyl pentaerythritol crosslinked homopolymer.

9. The denture adhesive composition according to claim 7, wherein the alkyl vinyl ether-maleic acid copolymer or a salt thereof is a poly(methyl vinyl ether / maleic acid) salt.

10. The denture adhesive composition according to claim 9, wherein the alkyl vinyl ether-maleic acid copolymer or a salt thereof is a poly(methyl vinyl ether / maleic acid) sodium-calcium mixed partial salt.

11. (a) 26–30% w / w sodium carboxymethylcellulose; (b) 6-9% w / w crosslinked polyacrylic acid homopolymer; (c) 16-20% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) 17–23% w / w oil content; (e) 23%–29% petrolatum; and optionally, (f) at least one fragrance, colorant, preservative, surfactant, or mixture thereof; A denture adhesive composition according to claim 1, comprising or essentially consisting of the following.

12. (a) 28% w / w sodium carboxymethylcellulose; (b) 8% w / w crosslinked polyacrylic acid homopolymer; (c) 18% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) 21% w / w oil content; (e) 25% petrolatum; and optionally, (f) at least one fragrance, colorant, preservative, surfactant, or mixture thereof; A denture adhesive composition according to claim 11, comprising, consisting of, or essentially consisting of the following.

13. (a) 28% w / w sodium carboxymethylcellulose; (b) 6% w / w crosslinked polyacrylic acid homopolymer; (c) 20% w / w poly(methyl vinyl ether / maleate) sodium-calcium mixed partial salt; (d) 21% w / w oil content; (e) 25% petrolatum; and optionally (f) at least one fragrance, colorant, preservative, surfactant, or mixture thereof; A denture adhesive composition according to claim 11, comprising, consisting of, or essentially consisting of the following.

14. The denture adhesive composition according to claim 1, wherein the composition does not contain polyethylene glycol, sodium alginate, and zinc.

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