Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
  • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
  • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
  • A61K31/465—Nicotine; Derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
  • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
  • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
  • A61K47/38—Cellulose; Derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
  • A61K8/0216—Solid or semisolid forms
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
  • A61K8/34—Alcohols
  • A61K8/345—Alcohols containing more than one hydroxy group
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/60—Sugars; Derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/20—Pills, tablets, discs, rods
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/20—Pills, tablets, discs, rods
  • A61K9/2004—Excipients; Inactive ingredients
  • A61K9/2013—Organic compounds, e.g. phospholipids, fats
  • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
  • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P25/00—Drugs for disorders of the nervous system
  • A61P25/26—Psychostimulants, e.g. nicotine, cocaine
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
  • A61P31/04—Antibacterial agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Definitions

• Oral cleansing can be difficult or inconvenient at times, depending on the nature of the cleansing and the situation in which the cleansing must occur.
• Brushing, flossing, cleaning your tongue and gargling using a variety of devices and compositions well-suited for the privacy of one's home are common oral care practices.
• the devices and compositions used in oral cleansing practices are less convenient to use away from home, where bathroom facilities might be scarce, unavailable or unsanitary.
• portable flossers can clean teeth on the go, but they are not discreet as well as not enjoyable to use, therefore consumers do not use them compliantly.
• a mouthspray Like a mouthwash, a mouthspray can provide the consumer with a quick burst of strong breath-freshening action, which might be overwhelming in an extended-consumption product like gum or lozenges.
• mouthspray s are obtrusive. Spraying a mouthspray typically generates a noise, which undesirably draws the attention of the public to the consumer.
• mouthsprays are typically packaged in relatively expensive and complex metal canisters, which can clog in use and are not environmentally friendly.
• misdirecting the spray not only wastes the product, but can result in irritated eyes, a sticky face and/or stained clothing.
• the tablets of the present invention are chewable, dissolvable tablets.
• chewable, dissolvable tablets include tablets that can be bitten and chewed by a user and tend to dissolve over time, as opposed to, for example, gums and/or relatively harder solid formats (e.g. lozenges and/or hard candies) which tend to be more difficult to bite (hard solid formats) and/or contain portions that do not dissolve over time for its normal use (gums).
• the tablets of the present invention may be prepared via any of a variety of tableting methods known in the art.
• Conventional methods of tablet production include direct compression ("dry blending"), dry granulation followed by compression, wet granulation followed by drying and compression, application of energy to a blend of materials to be tableted, including applying heat, microwave, infrared, and other energies, combinations of two or more thereof, and the like.
• dry blending dry granulation followed by compression
• wet granulation followed by drying and compression application of energy to a blend of materials to be tableted, including applying heat, microwave, infrared, and other energies, combinations of two or more thereof, and the like.
• the tablets comprise one or more sugar alcohols selected from the group consisting of sorbitol, lactitol, xylitol, mannitol, maltitol, isomalt, and combinations two or more thereof.
• the carbohydrates for use in the present invention may be direct compressible (DC) or non-directly compressible (non-DC).
• DC and non-DC are readily understood by one of skill in the art.
• Suppliers of sugar alcohols provide clear guidance to the user as for the ability for use in relation to compression of tablets.
• a non-DC particle in this connection is referred to as a particle which is not expressly recommended by the supplier for compression.
• An example of a non-DC grade of erythritol is Zerose erythritol 16952F supplied by Cargill whereas an example of a direct compressible (DC) grade of erythritol includes ZeroseTM DC 16966 also supplied by Cargill.
• the tablets comprise both DC and non-DC carbohydrates.
• the tablets comprise non-DC erythritol in combination with one or more DC sugar alcohols.
• the amount of non-DC erythritol particles is relatively high. It is particularly high when considering that the erythritol in a conventional sense is not regarded attractive for compression, but the mouthfeel and salivation perceived by the user in such methods is improved when compared to low amounts or the same amounts of DC erythritol.
• the tablets of the present invention comprise a total amount of all carbohydrates in amount of at least 40% by weight of the tablet, including from about 40 to about 99%), from about 60 to 99%, from about 75 to about 95%, from about 80 to about 90%) by weight of the tablets.
• the carbohydrates comprise one or more sugar alcohols
• the tablet comprises a total amount of sugar alcohols of at least 40%) by weight of the tablet, including from about 40 to about 99%, from about 60 to 99%), from about 75 to about 95%, from about 80 to about 90% by weight of the tablets.
• the tablets comprise at least 20% of each of two or more carbohydrates, including at least 20% of xylitol and at least 20% of one or more other sugar alcohols.
• compositions of the present invention comprise essential oils.
• Essential oils are volatile aromatic oils which may be synthetic or may be derived from plants by distillation, expression or extraction, and which usually carry the odor or flavor of the plant from which they are obtained.
• Useful essential oils may provide antiseptic activity. Some of these essential oils also act as flavoring agents.
• Menthol (CH3C6H9(C3H7)OH), also known as hexahydrothymol) is also only slightly soluble in alcohol, and is fairly volatile. Menthol, in addition to any antiseptic properties, provides a cooling, tingling sensation.
• Suitable antimicrobial agents include Halogenated Diphenyl Ethers, 2',4,4'- trichloro-2-hydroxy-diphenyl ether (Triclosan), 2,2'-dihydroxy-5,5'-dibromo-diphenyl ether, Halogenated Salicylanilides, 4'5-dibromosalicylanilide, 3,4',5-trichlorosalcylanilide, 3,4',5- tribromosalicylanilide, 2,3,3 ',5-tetrachlorosalicylanilide, 3,3 ',5-tetrachlorosalicylanilide, 3,5, dibromo-3 '-trifluorom ethyl salicylanilide, 5-n-octanoyl-3 '-trifluoromethyl salicylanilide, 3,5- dibromo-4'-trifluorom ethyl salicylanilide, 3, 5 -dibromo-3 '
• cyclic sesquiterpene alcohols such as farnesol
• N'-alkyl-L-arginine alkyl ester e.g., Lauroyl Arginine Ethyl Ester
• salts such as described in U.S. Pat. No. 5,874,068 to Engelman et al., herein incorporated by reference in its entirety
• Amino acid derivative compounds as described in U.S. Patent Publication No. 20160145203 to Gambogi, et al., herein
• the tablets for use in the present invention may comprise any of a variety of additional ingredients suitable for use in the tablets including, for example, sweeteners, lubricants, fillers, adsorbents, disintegrants, glidants, superdisintegrants, flavor and aroma agents, antioxidants, preservatives, texture enhancers, coloring agents, and the like, and mixtures of two or more thereof.
• the tablets may comprise any suitable total amounts of additional sweeteners including from 0.001 to about 8% by weight, including from about 0.02 to about 8%, from about 0.1 to about 3%, from about 0.1 to about 1%, and from about 0.1 to about 0.5% by weight of the tablet.
• the tablets may also include lubricant materials in certain embodiments.
• Suitable lubricants include, but are not limited to, long chain fatty acids and their salts, such as magnesium stearate and stearic acid, talc, glycerides waxes, and mixtures thereof.
• Such materials may be present in any suitable amount including from about 0.01 to about 5%, including from about 0.1 to about 5%, from about 0.5 to about 3%, including from about 0.5 to about 2% by weight of the tablet.
• flavors and aromatics include, but are not limited to, essential oils including distillations, solvent extractions, or cold expressions of chopped flowers, leaves, peel or pulped whole fruit containing mixtures of alcohols, esters, aldehydes and lactones; essences including either diluted solutions of essential oils, or mixtures of synthetic chemicals blended to match the natural flavor of the fruit (e.g., strawberry, raspberry and black currant); artificial and natural flavors of brews and liquors, e.g., cognac, whisky, rum, gin, sherry, port, and wine; tobacco, coffee, tea, cocoa, and mint; fruit juices including expelled juice from washed, scrubbed fruits such as lemon, orange, and lime; spear mint, pepper mint, wintergreen, cinnamon, cacoe/cocoa, vanilla, liquorice, menthol, eucalyptus, aniseeds nuts (e.g., peanuts, coconuts, hazelnuts, chestnuts, walnuts, colanuts), almonds, raisins; and
• texture enhancers include, but are not limited to, pectin, polyethylene oxide, and carrageenan, and mixtures thereof. In one embodiment, texture enhancers are used at levels of from about 0.1% to about 10% percent by weight.
• the tablets may be made by mixing its ingredients and heating them until they melt into a syrup, then exposing the mixture to pressurized carbon dioxide gas (about 600 pounds per square inch, or psi) and allowing it to cool. The process causes tiny high-pressure bubbles to be trapped inside the candy. When the tablet is placed in the mouth and comes into contact with saliva, the tablet breaks and dissolves, releasing the carbon dioxide from the bubbles, resulting in a popping and sizzling sound and leaving a slight tingling sensation.
• pressurized carbon dioxide gas about 600 pounds per square inch, or psi
• the tablets of the present invention are not gums and are substantially free of gum bases as used conventionally to manufacture gums, as opposed to chewable, dissolvable tablets.
• the tablets of the present invention are not sufficiently heated to form hard candies nor lozenges as such terms and their manufacture is understood in the art and which product forms are intended to dissolve more slowly than chewable, dissolvable tablets.
• the methods of the present invention comprise chewing said tablet to generate a fluid in the oral cavity, preferably chewing said tablet to dissolve, or while dissolving, at least a portion thereof and generate a fluid comprising ingredients from said tablet.
• the tablet may be chewed for any time sufficient to generate fluid in accord with embodiments comprising a chewing step, including, for example, chewing for at least 5 seconds, including at least 10 seconds, at least 15 seconds, at least 20 seconds, or at least 30 seconds. In certain preferred embodiments, the tablet is chewed for about 10 seconds or for at least 10 seconds.
• the fluid is forced around the oral cavity using muscular movements of the cheeks and/or tongue. In certain embodiments, the fluid is forced around the oral cavity with the lips closed. In certain preferred embodiments, the forcing step comprises forcing at least a portion of the fluid generated around the mouth, with lips closed, using muscular movements of the cheeks and tongue.
• the fluid may be forced/moved within the oral cavity for any suitable period of time including at for at least 5 seconds, including at least 10 seconds, at least 15 seconds, at least 20 seconds, or at least 30 seconds. In certain preferred embodiments, the fluid is agitated for about 30 seconds or for at least 30 seconds.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Veterinary Medicine (AREA)
• Chemical & Material Sciences (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Epidemiology (AREA)
• Chemical Kinetics & Catalysis (AREA)
• General Chemical & Material Sciences (AREA)
• Engineering & Computer Science (AREA)
• Organic Chemistry (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Molecular Biology (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Birds (AREA)
• Nutrition Science (AREA)
• Biophysics (AREA)
• Physiology (AREA)
• Zoology (AREA)
• Biochemistry (AREA)
• Oil, Petroleum & Natural Gas (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Emergency Medicine (AREA)
• Communicable Diseases (AREA)
• Psychiatry (AREA)
• Neurosurgery (AREA)
• Biomedical Technology (AREA)
• Neurology (AREA)
• Inorganic Chemistry (AREA)
• Oncology (AREA)
• Medicinal Preparation (AREA)
• Cosmetics (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
• Medicines Containing Plant Substances (AREA)
• Confectionery (AREA)

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• 2017
  • 2017-10-13 JP JP2019526601A patent/JP6840849B2/ja active Active
  • 2017-10-13 AU AU2017360378A patent/AU2017360378A1/en not_active Abandoned
  • 2017-10-13 AU AU2017360584A patent/AU2017360584B2/en active Active
  • 2017-10-13 CN CN201780078391.0A patent/CN110087634A/zh active Pending
  • 2017-10-13 BR BR112019010115A patent/BR112019010115A8/pt active Search and Examination
  • 2017-10-13 EP EP17783711.9A patent/EP3541359B1/en active Active
  • 2017-10-13 MX MX2019005828A patent/MX2019005828A/es unknown
  • 2017-10-13 JP JP2019527172A patent/JP7297666B2/ja active Active
  • 2017-10-13 BR BR112019008138A patent/BR112019008138A2/pt active Search and Examination
  • 2017-10-13 CA CA3044382A patent/CA3044382A1/en active Pending
  • 2017-10-13 MX MX2019005928A patent/MX2019005928A/es unknown
  • 2017-10-13 CN CN201780070970.0A patent/CN109952092B/zh active Active
  • 2017-10-13 EP EP17788088.7A patent/EP3541360A1/en active Pending
  • 2017-10-13 CA CA3040830A patent/CA3040830C/en active Active
  • 2017-10-13 PL PL17783711T patent/PL3541359T3/pl unknown
  • 2017-10-13 KR KR1020197017276A patent/KR102582802B1/ko active IP Right Grant
  • 2017-10-13 RU RU2019117886A patent/RU2736072C1/ru active
  • 2017-10-13 ES ES17783711T patent/ES2860802T3/es active Active
  • 2017-10-13 WO PCT/DK2017/050342 patent/WO2018091050A1/en active Search and Examination
  • 2017-10-13 WO PCT/US2017/056554 patent/WO2018093501A1/en unknown
  • 2017-10-13 DK DK17783711.9T patent/DK3541359T3/da active
  • 2017-10-13 MA MA046822A patent/MA46822A/fr unknown
• 2021
  • 2021-02-10 AU AU2021200826A patent/AU2021200826B2/en active Active
• 2023
  • 2023-08-11 AU AU2023214357A patent/AU2023214357A1/en active Pending

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