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 the 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 power of the denture, and 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, a denture adhesive can improve the wearing feeling of the denture. A denture adhesive is beneficial, for example, in situations where the denture no longer fits 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] To function effectively, a denture adhesive composition must meet many (sometimes competing) criteria: it must exhibit high adhesiveness upon contact with saliva so that the denture is held in place as soon as it is inserted into the mouth, have sufficient bonding strength to withstand the masticatory stresses that act to dislodge the denture, provide a seal to prevent food debris from getting under the denture, and further, the organoleptic properties (e.g., taste and consistency) of the denture adhesive composition must be acceptable to the user, and the composition must not be overly cumbersome or sticky to apply.

[0005] Denture adhesives are generally sold as creams, liners or strips, liquids, gels or powders, and examples including commercially available denture adhesives such as Poligrip flavor free denture adhesive (tooth stabilizer) cream (manufactured by GlaxoSmithKline), Poligrip Cushion and Comfort denture adhesive (tooth stabilizer) cream (manufactured by GlaxoSmithKline), and Fixodent PLUS Best Hold Premium tooth stabilizer cream (manufactured by P&G) are known in the art.

[0006] WO 1992 / 22280 (Richardson Vicks) discloses a denture stabilizing composition comprising a mixed partial salt of a lower alkyl vinyl ether-maleic acid copolymer.

[0007] WO 2013 / 054236 (Procter & Gamble) discloses a denture adhesive comprising a mixture of a partial salt of a copolymer of methyl vinyl ether-maleic acid, sodium carboxymethylcellulose, and a cohesion builder component in an amount of from about 0.001 wt% to about 10 wt% 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 carboxymethyl cellulose, and bioactive glass.

[0009] International Publication No. 2018 / 175826 (Lubrizol) discloses a composition comprising a combination of (a) a crosslinked poly(acrylic) acid polymer, (b) a carboxymethyl cellulose (CMC) component, and / or (c) an adherence promoting component. The crosslinked poly(acrylic) acid polymer may be a carbomer homopolymer, carbomer copolymer, carbomer interpolymer, polycarbophil, or a mixture thereof.

Summary of the Invention

Problems to be Solved by the Invention

[0010] Although extensive efforts have been made over the years in the development of denture adhesive compositions, there is still a need for further denture adhesives that provide an improved user experience.

Means for Solving the Problems

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

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

[0013] In particular, the denture adhesive composition contains (a) about 15 to about 30% by weight (% w / w) of carboxymethyl cellulose, (b) about 6 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.

[0014] The denture adhesive composition of the present invention may further contain (d) an oil component and / or (e) a petrolatum component. In particular, the denture adhesive composition of the present invention may contain 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 denture adhesive composition of the present invention after preparation is at least 500,000 centipoises (cP). Specifically, the viscosity of the denture adhesive composition of the present invention after preparation is 2,500,000 cP or less, more specifically 2,000,000 cP or less. Specifically, the viscosity of the denture adhesive composition of the present invention after preparation is 500,000 to 2,500,000 centipoises (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 centipoises (cP), and / or (ii) a pH of 4.0 to 10, more specifically a pH of 5.0 to 8.0. Specifically, the viscosity is measured at 25°C ± 1°C. More specifically, the viscosity is measured with a Brookfield RVT viscometer, TE spindle, 2.5 RPM, 25°C ± 1°C.

[0017] Specifically, the viscosity of carboxymethyl cellulose is about 1,000 to about 2,800 centipoise (cP) (measured in a 1% solution at 25°C). More specifically, carboxymethyl cellulose consists of at least 80% fine particles that pass through a 200 U.S. mesh sieve. In corresponding SI units, carboxymethyl cellulose consists of at least 80% fine particles that pass through a 74 μm mesh sieve. Preferably, carboxymethyl cellulose is sodium carboxymethyl cellulose.

[0018] Specifically, the denture adhesive composition of the present invention contains about 5 to about 10% by weight (% w / w) of a crosslinked polyacrylic acid homopolymer, particularly about 6 to about 9% by weight (% w / w) of a crosslinked polyacrylic acid homopolymer.

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

[0020] Specifically, the alkyl vinyl ether-maleic acid copolymer or a salt thereof is poly(methyl vinyl ether / maleic acid) salt. More specifically, the alkyl vinyl ether-maleic acid copolymer or a salt thereof is a sodium-calcium mixed partial salt of poly(methyl vinyl ether / maleic acid).

[0021] In one embodiment, the denture adhesive composition (a) 26 to 30% w / w of sodium carboxymethyl cellulose; (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 perfume, 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 a denture adhesive composition according to the first aspect. In particular, this method may include the steps of applying the composition according to the first aspect to the dental appliance, the oral cavity, or both, and attaching the dental appliance to the surface of the oral cavity (such as the palate or gingiva).

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0025] Detailed Description of the Invention The inventors have found an improved denture adhesive composition that addresses many concerns regarding currently available denture adhesives. This composition provides immediate retention, helps to make the denture feel natural and comfortable in the mouth, and avoids the concerns of conventional denture adhesives that often take time to develop good retention after first application. Furthermore, this denture adhesive formulation provides a strong and long-lasting retention force. The material adheres to the gums, provides adhesive properties, creates a cushioning effect between the gingiva and the denture, and increases overall comfort. Also, the denture adhesive formulation can reduce the problems associated with "oozing" that can occur when the adhesive leaks out of the mouth between the gingival line and the denture.

[0026] The denture adhesive composition of the present invention contains (a) carboxymethyl cellulose, (b) a crosslinked polyacrylic acid homopolymer, and (c) an 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 upper and lower types), orthodontic retainers and appliances, protective mouthguards, night guards for preventing 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 upper and lower dentures and combinations thereof, including orthodontic bridges, artificial teeth, denture bases, etc.

[0028] The terms "denture adhesive composition" and "denture adhesive" are terms used in the art and refer to a composition for use with dentures to enhance retention, stability, and function.

[0029] To avoid ambiguity, when referring to "weight %" (% w / w), it means with respect to the total weight of the composition, and the amount of each component is selected such that the total of the components in the composition is 100 weight %.

[0030] Carboxymethyl cellulose The denture adhesive composition of the present invention contains carboxymethyl cellulose (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, it can be 25%, 26%, 27%, 28%, 29% or 30% by weight of CMC. Preferably, the CMC is a food or pharmaceutical grade CMC.

[0031] Specifically, until it is used in the composition of the present invention, the CMC is in powder form, more specifically in fine powder form, and more specifically at least 99.9% of the particles pass through a 60 U.S. mesh sieve, and more specifically at least 90% of the particles pass through an 80 U.S. mesh sieve, and 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, and even more specifically it is provided in a fine powder form such that 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 micrometer (μm), which is an SI term. Therefore, the CMC is provided in a fine powder form such that at least 99.9% of the particles pass through a 250 μm mesh sieve, and more specifically at least 90% of the particles pass through a 177 μm mesh sieve, and 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 the CMC is about 800 to about 3000 centipoises (cP), preferably about 1000 to about 2800 cP (measured in a 1% solution at 25°C).

[0034] Specifically, the degree of substitution (DS) of CMC is from about 0.65 to about 0.95, such as from about 0.65 to about 0.85, preferably about 0.7.

[0035] Preferably, CMC is sodium carboxymethyl cellulose. Specifically, it is sodium carboxymethyl cellulose with a sodium content of 6.5% - 9.5% (such as 7.0% - about 9.2%, etc.), more specifically about 7.0% - about 8.9%.

[0036] Preferably, CMC is sodium carboxymethyl cellulose with an average molecular weight of about 725,000.

[0037] Examples of commercially available CMC 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 (such as WALOCEL CRT 15000PPA(S) sodium, etc.). In certain embodiments, the sodium carboxymethyl cellulose is CMC sodium 7H3SXF, 7H3SF, 7H3SXF PH, 7H3SF PH, WALOCEL CRT 15000, WALOCEL CRT 15000PPA(S) sodium or equivalents thereof.

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

[0039] Crosslinked polyacrylic acid homopolymer The denture adhesive composition of the present invention contains a crosslinked polyacrylic acid homopolymer generally called by the general term "carbomer". Carbomer is a high molecular polymer of acrylic acid crosslinked with either allyl sucrose containing 56% - 68% carboxylic acid (-COOH) groups and 0.75% - 2% crosslinking agent or allyl ether of pentaerythritol. When in contact with water, carbomer easily absorbs water and hydrates and swells.

[0040] Specifically, the composition contains about 4% to about 15% by weight of a crosslinked polyacrylic acid homopolymer, particularly about 5% to about 10% by weight or more, or more specifically about 6% to about 9% by weight of a crosslinked polyacrylic acid homopolymer. For example, it is 4%, 5%, 6%, 7%, 8%, or 9% by weight of a crosslinked 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 carbomer homopolymer type A or type B. In some embodiments, the crosslinked polyacrylic acid homopolymer is carbomer homopolymer type A. In some embodiments, the crosslinked polyacrylic acid homopolymer is carbomer homopolymer type B.

[0042] In particular, the crosslinked polyacrylic acid homopolymer is of food grade and / or pharmaceutical grade and is provided in a free-flowing powder form, more specifically a free-flowing fine powder form, until used in the composition 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 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 in the pharmaceutical grade form (for oral or mucosal contact) of Carbomer 971 and is called Carbomer 971P. In particular, the Carbomer is Carbomer 971P NF, where "NF" indicates that the Carbomer meets the limitations cited in the current editions of the USP / NF "Carbomer Homopolymer Type A" and Ph.Eur. "Carbomer" monographs.

[0044] In one embodiment, Carbomer 971 has a viscosity of 4000 - 11,000 cP (especially about 7200 cP) (Brookfield RVT at 25°C, 20 rpm, neutralized at pH 7.3 - 7.8, 0.5 wt% mucin, spindle #5 (<10,000 cP) or spindle #6( > 10,000 cP)), a carboxylic acid content of 56.0% - 68.0% (especially about 59.6%), an acrylic acid content (ppm) < 1000 (especially less than 100 ppm, for example about 80 ppm), and an ethyl acetate content < 0.50% (for example about 0.41%).

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

[0046] Alkyl vinyl ether - maleic acid copolymer The denture adhesive composition of the present invention contains an alkyl vinyl ether-maleic acid (AVE / MA) copolymer or a salt thereof (for example, a mixed salt, a partial salt or a mixed partial salt). As used herein, 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 adhesiveness 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 a cationic salt selected from calcium and sodium or a combination thereof. Preferably, the at least one cationic salt is a combination of calcium cation and sodium cation.

[0049] The metal cation may be present on the alkyl vinyl ether-maleic acid copolymer in an amount such that the metal cation is about 10.0% to about 20.0%, for example about 12.0% to about 16.0%, for example about 12.0%, about 12.5%, about 13.0%, about 13.5%, about 14.0%, about 14.5%, about 15.0% or about 15.5%.

[0050] Specifically, the alkyl vinyl ether-maleic acid copolymer contains, or consists essentially 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 consists essentially 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 certain embodiments, the molecular weight is from about 1,000,000 to about 3,000,000.

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

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

[0054] Examples of 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 (copolymer of methyl vinyl ether / maleic anhydride), and GANTREZ MS forms such as GANTREZ MS-955 (sodium / calcium mixed salt of methyl vinyl ether and maleic acid copolymer).

[0055] Other components 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 about 10 centistokes (cSt, mm 2 / s) to a maximum of about 240 cSt at 40°C, more particularly about 10 cSt to about 100 cSt at 40°C, and even more particularly about 10 cSt to about 90 cSt at 40°C. The kinematic viscosity can be measured at 40°C using a calibrated glass capillary viscometer as defined 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 composition of the present invention include, without limitation, light mineral oil, medium mineral oil, and vegetable oils (such as 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 oil, medium oil, and combinations thereof.

[0059] Mineral oil can be characterized from the perspective of its kinematic viscosity. The kinematic viscosity of light oil is generally about 34 cSt or less at 40°C. The kinematic viscosity of medium oil and heavy oil is generally about 35 cSt to about 240 cSt at 40°C.

[0060] In certain embodiments, the oil component is medium oil. In certain embodiments, the oil is medium oil, more particularly, medium oil having a kinematic viscosity at 40°C of about 35 cSt to about 90 cSt, and even more particularly, medium oil having a kinematic viscosity at 40°C of about 63 cSt to about 80 cSt. Suitable medium oils include PIONIER 2071P or equivalents thereof.

[0061] In certain embodiments, the oil component is light oil. In certain embodiments, the oil is light oil, more particularly, light oil having a kinematic velocity at 40°C of about 10 cSt to about 34 cSt, and even more particularly, medium oil having a kinematic velocity at 40°C of about 10 cSt to about 20 cSt, and even more particularly still, medium oil having a kinematic velocity at 40°C of about 14 cSt to about 17 cSt. Suitable light oils include BLANDOL white mineral oil or equivalents thereof.

[0062] For use in the present invention, medium oil (as defined above) is preferred.

[0063] The term "petrolatum" is a term in the art used 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), which is used to determine the penetration of petrolatum as an empirical measure of consistency. Petrolatum can have a cone penetration consistency value (mm / 10, 25 °C) of from about 10 to about 500, particularly from about 25 to about 300, more specifically from about 50 to about 250. Preferably, the petrolatum has a cone penetration consistency value of from about 100 to about 200, more preferably from about 130 to about 195 (mm / 10, 25 °C).

[0064] In particular, the denture adhesive composition of the present invention may contain from about 10 to about 56% by weight (% w / w) of an oil component and / or a petrolatum component, more particularly from 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 from 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 from 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. 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 (such as 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 (such as 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 an even more preferred embodiment, the denture adhesive composition of the present invention contains about 18% by weight (% w / w) of a medium oil component and about 25% by weight (% w / w) of a petrolatum component.

[0067] Sensory components The denture adhesive composition can contain at least one sensory component. The "sensory component" refers to a component that can be used to impart flavor, fragrance, color and / or sensation (such as a cooling sensation, a warming sensation or a tingling sensation, etc.) to the composition. Generally, except for imparting desirable organoleptic properties to the composition for the consumer, the sensory component is not an active ingredient, in other words, it does not play an active role in adhesion, retention time or cushioning property. In particular, the sensory component is at least one flavorant, perfume and / or colorant. The sensory components are known in the art and can be natural or artificial (synthetic).

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

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

[0070] The denture adhesive composition includes the use of sweeteners well-known in the art. The sweeteners can be selected from a wide range of materials including water-soluble ones, water-soluble artificial sweeteners, and dipeptide-based sweeteners (including mixtures thereof). Representative sweeteners include (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., sodium saccharin salt or calcium saccharin salt), cyclamate salts, acesulfame-K, sucralose, and the free acid form of saccharin; (c) dipeptide-based sweeteners such as L-aspartyl-L-phenylalanine methyl ester; and (d) natural sweeteners such as stevia, but are not limited thereto. In one embodiment, the denture adhesive composition includes from about 0.001 wt% to about 5.0 wt% of a sweetener.

[0071] Colorants useful in the present invention include pigments and dyes suitable for food, pharmaceutical, and cosmetic applications. These colorants are known as FD&C (Food, Drug, and Cosmetic) and D&C (Drug and Cosmetic) dyes and lakes. Exemplary ones include D&C Red No. 30 Aluminum Lake Paste, D&C Red No. 7 Calcium Lake Paste, Erythrosine Lake Paste, Indigo dye known as FD&C Blue No. 2 (which is the disodium salt of 5,5'-indigotindisulfonic acid); FD&C Green No. 1 (which contains a triphenylmethylene dye and is the monosodium salt of 4-[4-N-ethyl-p-sulfobenzylamino)diphenylmethylene]-[l-(N-ethyl-N-P-sulfobenzyl)-2,5-cyclohexadienimine]), but are not limited thereto. In some embodiments, the colorant is FD&C Red No. 3. In some embodiments, the denture adhesive composition includes from about 0 wt% to about 0.2 wt% of a colorant.

[0072] In a preferred embodiment, the denture adhesive composition does not include a flavoring agent, a fragrance, and / or a colorant.

[0073] Consumers can 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, for example, on a non-adhesive self-supporting layer that can be peeled off to enable application of the adhesive.

[0074] To facilitate dispensing, when measured after the composition is prepared, 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. To avoid doubt, the viscosity may be measured within 2 months from the preparation of the composition, more specifically within 1 month from the preparation of the composition. For example, when measured within 1 month from the preparation of the composition, the viscosity is 1,000,000 to 2,000,000 cP. Specifically, the viscosity is measured at 25°C ± 1°C. More specifically, the viscosity is measured with 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 (for example, 5.0 to 8.0), preferably about 5.0 to about 7.5 (for example, about 5.2 to about 7.1).

[0076] Typically, the composition of the present invention is 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 still more specifically at 25°C for 36 months. As used herein, the term "stable" refers to the ability of the composition to maintain certain physical or chemical properties, such as adhesiveness, at a specific storage temperature for a certain period after manufacture. The stability of the composition of the present invention can be evaluated using standard methods known in the art.

[0077] Specifically, the compounding ratios of (a) carboxymethyl cellulose, (b) crosslinked polyacrylic acid homopolymer, and (c) alkyl vinyl ether-maleic acid copolymer or a salt thereof in the denture adhesive composition are 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] There is provided a denture adhesive composition of the present invention for use in a method of adhering a dental appliance to a surface (particularly a surface in the oral cavity). Also provided is a method of adhering a dental appliance to a surface (particularly a surface in the oral cavity) using the denture adhesive composition of the present invention.

[0080] In particular, the 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 the gingiva.

[0081] General matters The term "comprising" includes "including"; for example, a composition "comprising" X may further include additional elements (e.g., X + Y). In some embodiments, the term "comprising" means that it includes not only the indicated active agent (e.g., the described compound), but also other active agents, and carriers, excipients, emollients, adhesives, etc. that are known in the consumer health industry and generally recognized as safe (GRAS). When the transitional phrase "consisting essentially of" is used, it is meant that the claim should be construed to cover those things that do not materially affect the basic and novel characteristics of the particular materials or steps recited in the claim and of the invention described in the claim. See In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original); see also MPEP § 211.03. Accordingly, the term "consisting essentially of" as used in the claims of the present invention is not intended to be construed as equivalent to "comprising". The term "consisting of" and its variations mean including (e.g., the specific components or steps recited) and limited to these. In certain fields, the term "comprising an active ingredient consisting essentially of" may be used instead of "consisting essentially of". The term "about" with respect to a numerical value x is optional and means that the numerical value may have some variation around the recited numerical value (e.g., like x ± 10%, x ± 5%, x ± 4%, x ± 3%, x ± 2% or x ± 1%) to allow for normal experimental variations, measurement variations, or to include minor deviations that can achieve substantially the same result as the recited numerical value. The word "substantially" does not exclude "completely". For example, a composition "substantially free of" Y may possibly be completely free of Y. If necessary, "substantially" may be omitted from the definitions of the present invention. All percentages and ratios used herein are by weight of the total composition, unless otherwise specified.

[0082] All documents or patent applications cited within this patent specification are hereby incorporated by reference into this specification.

[0083] Embodiments of the Invention In the following sections, specific embodiments of the present invention will be described.

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

[0085] Embodiment 2 (a) 26 - 30% w / w sodium carboxymethyl cellulose; (b) 6 - 9% w / w crosslinked polyacrylic acid homopolymer; (c) 16 - 20% w / w sodium - calcium mixed partial salt of poly(methyl vinyl ether / maleic acid); (d) 17 - 22% w / w oil component; (e) 23% - 29% petrolatum; and optionally (f) at least one flavoring agent, coloring agent, preservative, surfactant or a mixture thereof; A denture adhesive composition comprising or consisting essentially of these, wherein the viscosity of the composition is 1,000,000 - 2,000,000 centipoises (cP, measured at 25°C ± 1°C), and the pH of the composition is 5.0 - 7.5.

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

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

[0088] Embodiment 5 (a) 26 - 30% w / w sodium carboxymethyl cellulose; (b) Approximately 8% w / w crosslinked polyacrylic acid homopolymer; (c) Approximately 18% w / w sodium - calcium mixed partial salt of poly(methyl vinyl ether / maleic acid); (d) 17 - 22% w / w oil component; (e) 23% - 29% petrolatum; A denture adhesive composition comprising or consisting essentially of these, A denture adhesive composition wherein the viscosity of the composition is 1,000,000 to 2,000,000 centipoises (measured at 25°C ± 1°C) and the pH of the composition is 5.0 to 7.5.

[0089] Embodiment 6 (a) Approximately 28% w / w of sodium carboxymethyl cellulose; (b) Approximately 6% w / w of a crosslinked polyacrylic acid homopolymer; (c) Approximately 20% 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; A denture adhesive composition comprising, consisting of, or essentially consisting of these, wherein the viscosity of the composition is 1,000,000 to 2,000,000 centipoises (measured at 25°C ± 1°C) and the pH of the composition is 5.0 to 7.5.

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

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

[0092] Embodiment 9 (a) Approximately 28% w / w of sodium carboxymethyl cellulose; (b) Approximately 8% w / w of a cross - linked polyacrylic acid homopolymer; (c) Approximately 18% w / w of sodium - calcium mixed partial salt of poly(methyl vinyl ether / maleic acid); (d) 17 - 22% w / w of an oil component; (e) 23% - 29% of petrolatum; A denture adhesive composition comprising, consisting essentially of, or consisting of these, wherein the viscosity of the composition is 1,000,000 - 2,000,000 centipoises (measured at 25°C ± 1°C) and the pH of the composition is 5.0 - 7.5.

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

[0094] Embodiment 11 (a) Approximately 28% w / w of sodium carboxymethyl cellulose; (b) Approximately 8% w / w of crosslinked polyacrylic acid homopolymer; (c) Approximately 18% w / w of sodium-calcium mixed partial salt of poly(methyl vinyl ether / maleic acid); (d) Approximately 21% w / w of an oil component; (e) Approximately 25% of petrolatum; A denture adhesive composition comprising or consisting essentially of these, wherein the viscosity of the composition is 1,000,000 - 2,000,000 centipoises (measured at 25°C ± 1°C) and the pH of the composition is 5.0 - 7.5.

[0095] Embodiment 12 (a) Approximately 28% w / w of sodium carboxymethyl cellulose; (b) Approximately 8% w / w of crosslinked polyacrylic acid homopolymer; (c) Approximately 18% w / w of sodium-calcium mixed partial salt of poly(methyl vinyl ether / maleic acid); (d) Approximately 17% w / w of an oil component; (e) Approximately 29% of petrolatum; and optionally, (f) At least one flavoring agent, coloring agent, preservative, surfactant or a mixture thereof A denture adhesive composition comprising, consisting of, or consisting essentially of these, wherein the viscosity of the composition is 1,000,000 - 2,000,000 centipoises (measured at 25°C ± 1°C) and the pH of the composition is 5.0 - 7.5.

[0096] Embodiment 13 (a) Approximately 28% w / w of sodium carboxymethyl cellulose; (b) Approximately 6% w / w of crosslinked polyacrylic acid homopolymer; (c) Approximately 20% w / w of sodium-calcium mixed partial salt of poly(methyl vinyl ether / maleic acid); (d) An oil component of about 17% w / w; (e) About 29% petrolatum; and optionally, (f) At least one fragrance, coloring agent, preservative, surfactant or a mixture thereof; A denture adhesive composition comprising, consisting of, or essentially consisting of these, 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. A denture adhesive composition.

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

[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 2 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 17: The denture adhesive composition according to Embodiments 14 to 16, wherein the viscosity of carboxymethyl cellulose (measured in a 1% solution at 25°C) is about 1000 to about 2800 centipoise (cP).

[0101] Embodiment 18 : The denture adhesive composition according to Embodiment 17, wherein at least 80% of the carboxymethyl cellulose consists of fine particles passing through a 200 U.S. mesh sieve (corresponding to a 74 μm mesh sieve).

[0102] Embodiment 19 : The denture adhesive composition according to Embodiment 17 or 18, wherein the crosslinked polyacrylic acid homopolymer is an allylpentaerythritol crosslinked homopolymer.

[0103] Embodiment 20 : The denture adhesive composition according to Embodiment 19, wherein the crosslinked polyacrylic acid homopolymer is Carbomer homopolymer 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 : The 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) About 28% w / w of sodium carboxymethyl cellulose; (b) Approximately 8% w / w crosslinked polyacrylic acid homopolymer; (c) Approximately 18% w / w sodium-calcium mixed partial salt of poly(methyl vinyl ether / maleic acid); (d) Approximately 21% w / w oil component; (e) Approximately 25% petrolatum; and optionally, (f) At least one fragrance, coloring agent, preservative, surfactant or a mixture thereof; The denture adhesive composition according to Embodiment 23, comprising, consisting of, or essentially consisting of these.

[0108] Embodiment 25 : (a) Approximately 28% w / w sodium carboxymethyl cellulose; (b) Approximately 6% w / w crosslinked polyacrylic acid homopolymer; (c) Approximately 20% w / w sodium-calcium mixed partial salt of poly(methyl vinyl ether / maleic acid); (d) Approximately 21% w / w oil component; (e) Approximately 25% petrolatum; and optionally (f) At least one fragrance, coloring agent, preservative, surfactant or a mixture thereof, The denture adhesive composition according to Embodiment 23, comprising, consisting of, or essentially consisting of these.

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

[0110] Embodiment 27 : The 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 shown. These examples are for illustrative purposes only and should not be construed as limiting the scope of the present invention in any way.

Example

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

Table 1

[0113] Briefly, the petrolatum component was melted, the mineral oil component was added, and then beeswax dissolved with stirring was added. Next, carbomer, sodium carboxymethyl cellulose, sodium-calcium mixed partial salt of poly(methyl vinyl ether / maleic acid), and Cab-o-sil M5 were added in powder form with stirring. The composition was cooled and flavor components (Frescolat, spearmint oil, peppermint oil) were added. After further mixing, the formulation was degassed.

[0114] To compare the adhesion profiles of denture adhesives, a BioPuls Bath and an Instron Texture Analyzer (5943) equipped with a 500 N load cell were used (Instron, UK). A fixed amount of adhesive was placed on the test surface of the texture analyzer and compressed to a uniform thickness of 1 mm across the entire test surface, and the compression / extension cycle was repeated several times. After the compression / extension cycle, the crosshead was rapidly separated 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] The retention profiles of none of the formulations were sufficiently improved to match that of the control formulation (a sodium-calcium mixed partial salt-containing, Carbopol-free, Poligrip-free denture adhesive cream) (Figure 1). Adding sodium-calcium mixed partial salts of poly(methyl vinyl ether / maleic acid) at 14% w / w or less to the formulations was not sufficient to improve the adhesion profile.

[0116] [Example 2: Effect of Carbomer on Viscosity] Eight additional formulations were prepared using commercially available ingredients. These formulations were based on a commercially available Carbopol-free denture adhesive cream (containing calcium / sodium PVM / MA copolymer, petrolatum, cellulose gum, and liquid paraffin) and incorporated Carbomer components. [Table 2]

[0117] The formulations were 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 with stirring. Next, Carbomer, sodium carboxymethyl cellulose, and sodium-calcium mixed partial salts of poly(methyl vinyl ether / maleic acid) were added in powder form with stirring. The composition was cooled and degassed.

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

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

[0120] Formulations containing more than 18% w / w of carbomer have viscosities that are not suitable for general use because they are difficult to formulate and / or difficult for consumers to extrude from dispensers such as tubes. Therefore, it was determined that commercially desirable formulations should contain less than 18% w / w of carbomer.

[0121] [Example 3: Denture Adhesive Composition II] Seven additional formulations were prepared using commercially available components. These formulations are based on a commercially available poly - grip - free denture adhesive cream (containing calcium / sodium PVM / MA copolymer, petrolatum, cellulose gum and liquid paraffin), and were formulated with carbomer, less AVE / MA and various amounts of CMC while maintaining an acceptable viscosity profile.

Table 3

[0122] The formulations were prepared as described above.

[0123] To compare the adhesion profiles of denture adhesives, a BioPuls Bath and an Instron Texture Analyzer (5943) equipped with a 500 N load cell were used (Instron, UK). A defined amount of adhesive was placed on the test surface of the texture analyzer and compressed so that the entire test surface had a uniform thickness of 1 mm, and the compression / extension cycle was repeated several times. After the compression / extension cycle, the crosshead was rapidly separated at a speed of 6 lbf / min, and the maximum tensile force was recorded. This was repeated at least 20 times for each sample.

[0124] The results of the formulations containing 4% Carbopol showed sub-optimal performance compared to the control. However, some formulations showed retention performance comparable to or improved over existing commercial formulations (Figure 2).

[0125] The formulation containing 8% Carbopol and 18% sodium-calcium mixed partial salt of poly(methyl vinyl ether / maleic acid) had the highest biopuls peak, while the formulation containing 6% Carbopol and 20% sodium-calcium mixed partial salt of poly(methyl vinyl ether / maleic acid) showed performance similar to the commercial formulation. All of these formulations showed high adhesion work scores at 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 for further study.

[0127] The amounts of petrolatum and mineral oil were varied to investigate their effects on tackiness and viscosity. [Table 4]

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

[0129] Changing the ratio of mineral oil to petrolatum had no effect on 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 layer thickness greater than the control (Figure 5(a)) and may exhibit an improved cushioning effect.

[0131] The purpose of the above description is to illustrate some embodiments of the present invention without meaning to be limiting. It will be apparent to those skilled in the art that various modifications and variations can be made to the apparatus or procedure 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 upper jaw biting force in a group of complete maxillary denture wearers (42 subjects). In this study, the maximum incisal bite force until the maxillary denture became detached after 12 hours was compared between the experimental denture adhesive formulation 25 and the case without an adhesive. Formulation 25 was applied to the denture as a continuous long strip.

Table 5

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

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

Table 6

[0135] The test denture adhesives were generally well-tolerated. As a result of the primary analysis, it was shown that the test denture adhesives had a statistically significantly greater bite force for more than 12 hours (p<0.05) compared to the case without using the adhesive. The results of the post hoc analysis supported the results of the primary analysis, indicating the effectiveness of the test denture adhesives in enhancing the retention of dentures over 12 hours compared to the case without using the adhesive.

Claims

1. A denture adhesive composition comprising: (a) 15 to 30% by weight (% w / w) of carboxymethyl cellulose; (b) 5 to 10% by weight (% w / w) of cross-linked 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. 10. The denture adhesive composition of claim 1, further comprising (d) an oil component and / or (e) a petrolatum component.

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

4. A denture adhesive composition as described in claim 2, comprising (d) 17 to 26 weight percent (% w / w) of an oil component, and (e) 20 to 30 weight percent (% w / w) of petrolatum.

5. 10. The denture adhesive composition of 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. 6. The denture adhesive composition of claim 5, wherein the carboxymethyl cellulose is sodium carboxymethyl cellulose.

7. The denture adhesive composition of claim 1, comprising 6 to 9 weight percent (% w / w) of cross-linked polyacrylic acid homopolymer.

8. 7. The denture adhesive composition of claim 6, wherein the cross-linked polyacrylic acid homopolymer is an allylpentaerythritol cross-linked homopolymer.

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

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

11. (a) 26-30% w / w sodium carboxymethylcellulose; (b) 6-9% w / w cross-linked polyacrylic acid homopolymer; (c) 16-20% w / w poly(methyl vinyl ether / maleic acid) sodium-calcium mixed partial salt; (d) 17–23% w / w oil content; (e) 23% to 29% petrolatum; and optionally, (f) at least one flavoring, coloring, preservative, surfactant, or mixture thereof; 10. The denture adhesive composition of claim 1, comprising, or consisting essentially of:

12. (a) 28% w / w sodium carboxymethylcellulose; (b) 8% w / w cross-linked polyacrylic acid homopolymer; (c) 18% w / w poly(methyl vinyl ether / maleic acid) sodium-calcium mixed partial salt; (d) 21% w / w oil content; (e) 25% petrolatum; and optionally, (f) at least one flavoring, coloring, preservative, surfactant, or mixture thereof; 12. The denture adhesive composition of claim 11 comprising, consisting of, or consisting essentially of:

13. (a) 28% w / w sodium carboxymethylcellulose; (b) 6% w / w cross-linked polyacrylic acid homopolymer; (c) 20% w / w poly(methyl vinyl ether / maleic acid) sodium-calcium mixed partial salt; (d) 21% w / w oil content; (e) 25% petrolatum; and optionally (f) at least one flavoring, coloring, preservative, surfactant, or mixture thereof; 12. The denture adhesive composition of claim 11 comprising, consisting of, or consisting essentially of:

14. 10. The denture adhesive composition of claim 1, wherein the composition is free of polyethylene glycol, sodium alginate, and zinc.

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