EP4072534A1 - Produits oraux à combinaisons de principes actifs - Google Patents

Produits oraux à combinaisons de principes actifs

Info

Publication number
EP4072534A1
EP4072534A1 EP20825241.1A EP20825241A EP4072534A1 EP 4072534 A1 EP4072534 A1 EP 4072534A1 EP 20825241 A EP20825241 A EP 20825241A EP 4072534 A1 EP4072534 A1 EP 4072534A1
Authority
EP
European Patent Office
Prior art keywords
composition
weight
amount
total weight
present
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20825241.1A
Other languages
German (de)
English (en)
Inventor
Ross Jay Oden
Matthew Evan Lampe
Kristen Ann Spielbauer
Michael Andrew Zawadzki
Anthony Richard Gerardi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Nicoventures Trading Ltd
Original Assignee
Nicoventures Trading Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US16/706,974 external-priority patent/US20210169129A1/en
Application filed by Nicoventures Trading Ltd filed Critical Nicoventures Trading Ltd
Priority claimed from PCT/IB2020/061472 external-priority patent/WO2021116854A1/fr
Publication of EP4072534A1 publication Critical patent/EP4072534A1/fr
Pending legal-status Critical Current

Links

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
    • A61K9/0058—Chewing gums
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7135—Compounds containing heavy metals
    • A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides 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
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin

Definitions

  • compositions intended for human use are configured for oral use and deliver substances such as flavors and/or active ingredients during use.
  • Such products may include tobacco or a product derived from tobacco, or may be tobacco-free alternatives.
  • Tobacco may be enjoyed in a so-called "smokeless” form.
  • smokeless tobacco products are employed by inserting some form of processed tobacco or tobacco-containing formulation into the mouth of the user.
  • Conventional formats for such smokeless tobacco products include moist snuff, snus, and chewing tobacco, which are typically formed almost entirely of particulate, granular, or shredded tobacco, and which are either portioned by the user or presented to the user in individual portions, such as in single-use pouches or sachets.
  • Other traditional forms of smokeless products include compressed or agglomerated forms, such as plugs, tablets, or pellets.
  • Alternative product formats such as tobacco-containing gums and mixtures of tobacco with other plant materials, are also known.
  • Smokeless tobacco product configurations that combine tobacco material with various binders and fillers have been proposed more recently, with example product formats including lozenges, pastilles, gels, extruded forms, and the like. See, for example, the types of products described in US Patent App. Pub. Nos.
  • compositions configured for oral use, the compositions comprising at least one active ingredient and one or more fillers.
  • the compositions may be in chewable form, tablet form, or in the form of a melt.
  • the disclosure provides a composition in chewable form, configured for oral use, the composition comprising: at least one active ingredient selected from the group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12 (or other B vitamins), vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, and combinations thereof; one or more sugar alcohols in an amount by weight of at least 50%, based on the total weight of the composition; pectin; and an organic acid, a gelation agent, or both, wherein the composition is a homogenous mixture.
  • the one or more sugar alcohols is a combination of isomalt and maltitol.
  • the composition comprises isomalt in an amount of from about 10 to about 25% by weight, based on the total weight of the composition; maltitol in an amount of from about 50 to about 75% by weight, based on the total weight of the composition; and pectin in an amount of from about 1 to about 3% by weight, based on the total weight of the composition.
  • the organic acid is citric acid.
  • the gelation agent is a calcium salt.
  • the calcium salt is calcium diphosphate.
  • the at least one active ingredient comprises caffeine.
  • the at least one active ingredient comprises theanine.
  • the at least one active ingredient comprises taurine.
  • the at least one active ingredient comprises GABA.
  • the at least one active ingredient comprises tryptophan.
  • the at least one active ingredient comprises vitamin B6, vitamin B12, or both., such as vitamins B6 and B12 in a total amount by weight from about 0.008% to about 0.07%.
  • the at least one active ingredient comprises vitamin C.
  • the at least one active ingredient comprises ginseng.
  • the at least one active ingredient comprises lemon balm extract.
  • the at least one active ingredient comprises a combination of caffeine, theanine, and optionally ginseng.
  • the caffeine is present in an amount of from about 1 to about 4% by weight, based on the total weight of the composition; the theanine is present in an amount of from about 1 to about 4% by weight, based on the total weight of the composition; and the ginseng, when present, is in an amount of from about 0.1 to about 0.6% by weight, based on the total weight of the composition.
  • the composition further comprises citicoline or sunflower lecithin.
  • the at least one active ingredient comprises a combination of theanine, gamma-amino butyric acid (GABA), and optionally lemon balm extract.
  • GABA gamma-amino butyric acid
  • theanine is present in an amount of from about 1 to about 3% by weight, based on the total weight of the composition
  • the GABA is present in an amount of from about 1.5 to about 4% by weight, based on the total weight of the composition
  • the lemon balm extract when present, is in an amount from about 0.25 to about 2% by weight, based on the total weight of the composition.
  • the at least one active ingredient comprises a combination of caffeine, taurine, and vitamin C.
  • the caffeine is present in an amount of from about 1 to about 4% by weight, based on the total weight of the composition
  • the taurine is present in an amount of from about 1 to about 4% by weight, based on the total weight of the composition
  • the vitamin C is present in an amount of from about 1 to about 3% by weight, based on the total weight of the composition.
  • the composition further comprises trisodium citrate.
  • the composition further comprises vitamin B6, vitamin B12, or both.
  • the at least one active ingredient comprises a combination of caffeine, taurine, and vitamin B6, vitamin B12, or both.
  • the composition further comprises at least one additional component selected from water, sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids, and combinations thereof.
  • the composition further comprises magnesium, such as magnesium in an amount by weight from about 0.1% to about 2%, or from about 0.2 to about 1%, based on elemental magnesium.
  • the magnesium is in the form of a magnesium salt.
  • the magnesium salt is magnesium gluconate.
  • the composition is free of nicotine.
  • the composition is free of tobacco.
  • a composition in tablet form configured for oral use, the composition comprising at least one active ingredient selected from the group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12 (or other B vitamins), vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, and combinations thereof; a glucose-polysaccharide blend; and a sugar alcohol; wherein the tablet form comprises the composition as a homogenous mixture.
  • the glucose-polysaccharide blend is present in an amount of from about 35 to about 55% by weight, based on the total weight of the composition; and the sugar alcohol is present in an amount of from about 30 to about 45% by weight, based on the total weight of the composition.
  • the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or a combination thereof. In one embodiment, the sugar alcohol is isomalt.
  • the at least one active ingredient comprises caffeine.
  • the at least one active ingredient comprises theanine.
  • the at least one active ingredient comprises taurine.
  • the at least one active ingredient comprises tryptophan.
  • the at least one active ingredient comprises GABA.
  • the at least one active ingredient comprises vitamin B6, vitamin B12, or both, such as vitamins B6 and B12 in a total amount by weight from about 0.008% to about 0.07%.
  • the at least one active ingredient comprises vitamin C.
  • the at least one active ingredient comprises ginseng.
  • the at least one active ingredient comprises lemon balm extract.
  • the at least one active ingredient comprises a combination of caffeine, theanine, and optionally ginseng.
  • the caffeine is present in an amount of from about 3 to about 5% by weight, based on the total weight of the composition; the theanine is present in an amount of from about 3 to about 5% by weight, based on the total weight of the composition; and the ginseng, when present, is in an amount from about 0.4 to about 0.6% by weight, based on the total weight of the composition.
  • the composition further comprises citicoline or sunflower lecithin.
  • the at least one active ingredient comprises a combination of caffeine and vitamin B6, vitamin B12, or both. In one embodiment, the at least one active ingredient comprises a combination of caffeine and taurine. In one embodiment, the at least one active ingredient comprises a combination of caffeine, taurine, and vitamin B6, vitamin B12, or both.
  • the at least one active ingredient comprises a combination of theanine, gamma-amino butyric acid (GABA), and optionally lemon balm extract.
  • GABA gamma-amino butyric acid
  • theanine is present in an amount of from about 3 to about 5% by weight, based on the total weight of the composition
  • the GABA is present in an amount of from about 4 to about 6% by weight, based on the total weight of the composition
  • the lemon balm extract when present is in an amount from about 3 to about 4% by weight, based on the total weight of the composition.
  • the at least one active ingredient comprises theanine and tryptophan. In one embodiment, the at least one active ingredient comprises theanine and vitamin B6, B12, or a combination thereof. In one embodiment, the at least one active ingredient comprises theanine, tryptophan, and vitamin B6, B12, or a combination thereof.
  • the at least one active ingredient comprises caffeine and taurine. In one embodiment, the at least one active ingredient comprises a combination of caffeine, taurine, and vitamin C. In one embodiment, the caffeine is present in an amount of from about 3 to about 5% by weight, based on the total weight of the composition; the taurine is present in an amount of from about 4 to about 6% by weight, based on the total weight of the composition; and the vitamin C is present in an amount of from about 4 to about 6% by weight, based on the total weight of the composition. In one embodiment, the composition further comprises trisodium citrate.
  • the composition further comprises at least one additional component selected from sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids, and combinations thereof.
  • the composition further comprises magnesium, such as magnesium in an amount by weight from about 0.1% to about 2%, or from about 0.2 to about 1%, based on elemental magnesium.
  • the magnesium is in the form of a magnesium salt.
  • the magnesium salt is magnesium gluconate.
  • the composition is free of nicotine.
  • the composition is free of tobacco.
  • composition in meltable form configured for oral use, the composition comprising: at least one active ingredient selected from the group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12 (or other B vitamins), vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, and combinations thereof; a sugar alcohol; and a lipid; wherein the meltable form comprises the composition as a homogenous mixture.
  • the sugar alcohol is present in an amount of from about 35 to about 55% by weight, based on the total weight of the composition; and the lipid in an amount of from about 35 to about 50% by weight, based on the total weight of the composition.
  • the lipid has a melting point of about 29°C or above.
  • the lipid has a melting point from about 36°C to about 45°C.
  • the lipid is an oil selected from the group consisting of palm oil, palm kernel oil, soybean oil, sunflower oil, coconut oil, cottonseed oil, and combinations thereof, wherein the oil may be hydrogenated, partially hydrogenated, or non-hydrogenated.
  • the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or a combination thereof. In one embodiment, the sugar alcohol is isomalt.
  • the at least one active ingredient comprises caffeine. In one embodiment, the at least one active ingredient comprises theanine.
  • the at least one active ingredient comprises taurine.
  • the at least one active ingredient comprises GABA.
  • the at least one active ingredient comprises tryptophan.
  • the at least one active ingredient comprises vitamin B6, vitamin B12, or both, such as vitamins B6 and B12 in a total amount by weight from about 0.008% to about 0.07%.
  • the at least one active ingredient comprises vitamin C.
  • the at least one active ingredient comprises ginseng.
  • the at least one active ingredient comprises lemon balm extract.
  • the at least one active ingredient comprises a combination of caffeine, theanine, and optionally, ginseng.
  • the caffeine is present in an amount of from about 2 to about 6% by weight, based on the total weight of the composition; theanine is present in an amount of from about 2 to about 4% by weight, based on the total weight of the composition; and the ginseng when present is in an amount from about 0.3 to about 0.5% by weight, based on the total weight of the composition.
  • composition further comprises citicoline or sunflower lecithin.
  • At least a portion of the caffeine is present in encapsulated form.
  • the at least one active ingredient comprises a combination of theanine, gamma-amino butyric acid (GABA), and optionally lemon balm extract.
  • the theanine is present in an amount of from about 2 to about 4% by weight, based on the total weight of the composition;
  • the GABA is present in an amount of from about 3.5 to about 4.5% by weight, based on the total weight of the composition;
  • the lemon balm extract when present is in an amount of from about 1.5 to about 2.5% by weight, based on the total weight of the composition.
  • the at least one active ingredient comprises theanine and tryptophan. In one embodiment, the at least one active ingredient comprises theanine and vitamin B6, B12, or a combination thereof. In one embodiment, the at least one active ingredient comprises theanine, tryptophan, and vitamin B6, B12, or a combination thereof.
  • the at least one active ingredient comprises a combination of caffeine, taurine, and vitamin C.
  • the caffeine is present in an amount of from about 2 to about 6% by weight, based on the total weight of the composition;
  • the taurine is present in an amount of from about 3.5 to about 4.5% by weight, based on the total weight of the composition;
  • the vitamin C is present in an amount of from about 3.5 to about 4.5% by weight, based on the total weight of the composition.
  • at least a portion of the caffeine is present in encapsulated form.
  • the composition further comprises sodium citrate.
  • the composition further comprises at least one additional component selected from sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids, and combinations thereof.
  • the composition further comprises magnesium, such as magnesium in an amount by weight from about 0.1% to about 2%, or from about 0.2 to about 1%, based on elemental magnesium.
  • the magnesium is in the form of a magnesium salt.
  • the magnesium salt is magnesium gluconate.
  • the composition is free of nicotine.
  • the composition is free of tobacco.
  • a composition in chewable, tablet, or melting form as disclosed herein wherein the at least one active ingredient is a combination of: a) caffeine in an amount of from about 1.5 to about 5% by weight, based on the total weight of the composition; taurine in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition; vitamin C in an amount of from about 2 to about 6% by weight, based on the total weight of the composition; and sodium citrate in an amount of from about 1 to about 3% by weight, based on the total weight of the composition; b) theanine in an amount of from about 1 to about 5% by weight, based on the total weight of the composition;
  • GABA in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition
  • lemon balm extract in an amount of from about 1 to about 4% by weight, based on the total weight of the composition
  • caffeine in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition
  • theanine in an amount of from about 1.5 to about 5% by weight, based on the total weight of the composition
  • ginseng in an amount of from about 0.2 to about 0.6% by weight, based on the total weight of the composition
  • optionally, citicoline or sunflower lecithin in an amount of from about 0.3 to about 1.5% by weight, based on the total weight of the composition.
  • the disclosure includes, without limitations, the following embodiments.
  • Embodiment 1 A composition in chewable form, configured for oral use, the composition comprising: at least one active ingredient selected from the group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, and combinations thereof; one or more sugar alcohols in an amount by weight of at least 50%, based on the total weight of the composition; pectin; and an organic acid, a gelation agent, or both, wherein the composition is a homogenous mixture.
  • active ingredient selected from the group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, and combinations thereof
  • one or more sugar alcohols in an amount by weight of at least 50%, based on the total weight of the composition
  • pectin and an organic acid, a gelation agent, or both, wherein the composition is
  • Embodiment 2 The composition of embodiment 1, wherein the one or more sugar alcohols is a combination of isomalt and maltitol.
  • Embodiment 3 The composition of embodiment 1 or 2, comprising isomalt in an amount of from about 10 to about 25% by weight, based on the total weight of the composition; maltitol in an amount of from about 50 to about 75% by weight, based on the total weight of the composition; and pectin in an amount of from about 1 to about 3% by weight, based on the total weight of the composition.
  • Embodiment 4 The composition of any one of embodiments 1 to 3, wherein the organic acid is citric acid.
  • Embodiment 5 The composition of any one of embodiments 1 to 4, wherein the at least one active ingredient comprises a combination of caffeine, theanine, and optionally ginseng.
  • Embodiment 6 The composition of any one of embodiments 1 to 5, wherein: the caffeine is present in an amount of from about 1 to about 4% by weight, based on the total weight of the composition; theanine is present in an amount of from about 1 to about 4% by weight, based on the total weight of the composition; and the ginseng is present in an amount of from about 0.1 to about 0.6% by weight, based on the total weight of the composition.
  • Embodiment 7 The composition of any one of embodiments 1 to 6, further comprising citicoline or sunflower lecithin.
  • Embodiment 8 The composition of any one of embodiments 1 to 4, wherein the at least one active ingredient comprises a combination of theanine, gamma-amino butyric acid (GABA), and optionally lemon balm extract.
  • GABA gamma-amino butyric acid
  • Embodiment 9 The composition of any one of embodiments 1 to 8, wherein: the theanine is present in an amount of from about 1 to about 3% by weight, based on the total weight of the composition; the GABA is present in an amount of from about 1.5 to about 4% by weight, based on the total weight of the composition; and the lemon balm extract when present is in an amount of from about 0.25 to about 2% by weight, based on the total weight of the composition.
  • Embodiment 10 The composition of any one of embodiments 1 to 4, wherein the at least one active ingredient comprises: theanine; theanine and tryptophan; or theanine and one or more of vitamins B6 and B12; and optionally tryptophan.
  • Embodiment 11 The composition of any one of embodiments 1 to 4, comprising theanine and one or both of vitamins B6 and vitamin B12.
  • Embodiment 12 The composition of any one of embodiments 1 to 4, wherein the at least one active ingredient comprises a combination of caffeine, taurine, and vitamin C.
  • Embodiment 13 The composition of any one of embodiments 1 to 12, wherein: the caffeine is present in an amount of from about 1 to about 4% by weight, based on the total weight of the composition; the taurine is present in an amount of from about 1 to about 4% by weight, based on the total weight of the composition; and the vitamin C is present in an amount of from about 1 to about 3% by weight, based on the total weight of the composition.
  • Embodiment 14 The composition of any one of embodiments 1 to 13, further comprising trisodium citrate.
  • Embodiment 15 The composition of any one of embodiments 1 to 14, further comprising at least one additional component selected from water, sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids, and combinations thereof.
  • Embodiment 16 The composition of any one of embodiments 1 to 15, wherein the composition is free of nicotine.
  • Embodiment 17 The composition of any one of embodiments 1 to 16, wherein the composition is free of tobacco.
  • Embodiment 18 A composition in tablet form configured for oral use, the composition comprising: at least one active ingredient selected from the group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, and combinations thereof; a glucose-polysaccharide blend; and a sugar alcohol; wherein the tablet form comprises the composition as a homogenous mixture.
  • Embodiment 19 The composition of embodiment 18, wherein: the glucose-polysaccharide blend is present in an amount of from about 35 to about 55% by weight, based on the total weight of the composition; and the sugar alcohol is present in an amount of from about 30 to about 45% by weight, based on the total weight of the composition.
  • Embodiment 20 The composition of embodiment 18 or 19, wherein the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or a combination thereof.
  • Embodiment 21 The composition of any one of embodiments 18 to 20, wherein the sugar alcohol is isomalt.
  • Embodiment 22 The composition of any one of embodiments 18 to 21, wherein the at least one active ingredient comprises a combination of caffeine, theanine, and optionally ginseng.
  • Embodiment 23 The composition of any one of embodiments 18 to 22, wherein: the caffeine is present in an amount of from about 3 to about 5% by weight, based on the total weight of the composition; theanine is present in an amount of from about 3 to about 5% by weight, based on the total weight of the composition; and the ginseng is present in an amount of from about 0.4 to about 0.6% by weight, based on the total weight of the composition.
  • Embodiment 24 The composition of any one of embodiments 18 to 23, further comprising citicoline or sunflower lecithin
  • Embodiment 25 The composition of any one of embodiments 18 to 21, wherein the at least one active ingredient comprises a combination of theanine, gamma-amino butyric acid (GABA), and optionally lemon balm extract.
  • GABA gamma-amino butyric acid
  • Embodiment 26 The composition of any one of embodiments 18 to 25, wherein: the theanine is present in an amount of from about 3 to about 5% by weight, based on the total weight of the composition; the GABA is present in an amount of from about 4 to about 6% by weight, based on the total weight of the composition; and the lemon balm extract is present in an amount of from about 3 to about 4% by weight, based on the total weight of the composition.
  • Embodiment 27 The composition of any one of embodiments 18 to 21, wherein the at least one active ingredient comprises a combination of caffeine, taurine, and vitamin C.
  • Embodiment 28 The composition of embodiment 27, wherein: the caffeine is present in an amount of from about 3 to about 5% by weight, based on the total weight of the composition; the taurine is present in an amount of from about 4 to about 6% by weight, based on the total weight of the composition; and the vitamin C is present in an amount of from about 4 to about 6% by weight, based on the total weight of the composition.
  • Embodiment 29 The composition of embodiment 28, further comprising trisodium citrate.
  • Embodiment 30 The composition of any one of embodiments 18 to 21, wherein the at least one active ingredient comprises: theanine; theanine and tryptophan; or theanine and one or more of vitamins B6 and B12; and optionally tryptophan.
  • Embodiment 31 The composition of any one of embodiments 18 to 21, comprising theanine and one or both of vitamins B6 and vitamin B12.
  • Embodiment 32 The composition of any one of embodiments 18 to 31, further comprising at least one additional component selected from sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids, and combinations thereof.
  • Embodiment 33 The composition of any one of embodiments 18 to 32, wherein the composition is free of nicotine.
  • Embodiment 34 The composition of any one of embodiments 18 to 33, wherein the composition is free of tobacco.
  • Embodiment 35 A composition in meltable form, configured for oral use, the composition comprising: at least one active ingredient selected from the group consisting of caffeine, taurine, GABA, tryptophan, theanine, vitamin B6, vitamin B12, vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, and combinations thereof; a sugar alcohol; and a lipid; wherein the meltable form comprises the composition as a homogenous mixture.
  • Embodiment 36 The composition of embodiment 35, wherein: the sugar alcohol is present in an amount of from about 35 to about 55% by weight, based on the total weight of the composition; and the lipid in an amount of from about 35 to about 50% by weight, based on the total weight of the composition.
  • Embodiment 37 The composition of embodiment 35 or 36, wherein the lipid has a melting point of about 29°C or above.
  • Embodiment 38 The composition of any one of embodiments 35 to 37, wherein the lipid has a melting point from about 36°C to about 45°C.
  • Embodiment 39 The composition of any one of embodiments 35 to 38, wherein the lipid is an oil selected from the group consisting of palm oil, palm kernel oil, soybean oil, sunflower oil, cottonseed oil, coconut oil, and combinations thereof, wherein the oil may be hydrogenated, partially hydrogenated, or non-hydrogenated.
  • the lipid is an oil selected from the group consisting of palm oil, palm kernel oil, soybean oil, sunflower oil, cottonseed oil, coconut oil, and combinations thereof, wherein the oil may be hydrogenated, partially hydrogenated, or non-hydrogenated.
  • Embodiment 40 The composition of any one of embodiments 35 to 38, wherein the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or a combination thereof.
  • Embodiment 41 The composition of any one of embodiments 35 to 40, wherein the sugar alcohol is isomalt.
  • Embodiment 42 The composition of any one of embodiments 35 to 41, wherein the at least one active ingredient comprises a combination of caffeine, theanine, and optionally, ginseng.
  • Embodiment 43 The composition of embodiment 42, wherein: the caffeine is present in an amount of from about 2 to about 6% by weight, based on the total weight of the composition; theanine is present in an amount of from about 2 to about 4% by weight, based on the total weight of the composition; and the ginseng, when present, is in an amount from about 0.3 to about 0.5% by weight, based on the total weight of the composition.
  • Embodiment 44 The composition of embodiment 43, further comprising citicoline or sunflower lecithin.
  • Embodiment 45 The composition of embodiment 42, wherein at least a portion of the caffeine is present in encapsulated form.
  • Embodiment 46 The composition of any one of embodiments 35 to 41, wherein the at least one active ingredient comprises a combination of theanine, gamma-amino butyric acid (GABA), and optionally lemon balm extract.
  • GABA gamma-amino butyric acid
  • Embodiment 47 The composition of embodiment 46, wherein: the theanine is present in an amount of from about 2 to about 4% by weight, based on the total weight of the composition; the GABA is present in an amount of from about 3.5 to about 4.5% by weight, based on the total weight of the composition; and the lemon balm extract when present is in an amount from about 1.5 to about 2.5% by weight, based on the total weight of the composition.
  • Embodiment 48 The composition of any one of embodiments 35 to 41, wherein the at least one active ingredient comprises a combination of caffeine, taurine, and vitamin C.
  • Embodiment 49 The composition of embodiment 48, wherein: the caffeine is present in an amount of from about 2 to about 6% by weight, based on the total weight of the composition; the taurine is present in an amount of from about 3.5 to about 4.5% by weight, based on the total weight of the composition; and the vitamin C is present in an amount of from about 3.5 to about 4.5% by weight, based on the total weight of the composition.
  • Embodiment 50 The composition of embodiment 48, wherein at least a portion of the caffeine is present in encapsulated form.
  • Embodiment 51 The composition of embodiment 48, further comprising trisodium citrate.
  • Embodiment 52 The composition of any one of embodiments 35 to 41, wherein the at least one active ingredient comprises: theanine; theanine and tryptophan; or theanine and one or more of vitamins B6 and B12; and optionally tryptophan.
  • Embodiment 52 The composition of any one of embodiments 35 to 41, comprising theanine and one or both of vitamins B6 and vitamin B12.
  • Embodiment 53 The composition of any one of embodiments 35 to 52, further comprising at least one additional component selected from sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids, and combinations thereof.
  • Embodiment 54 The composition of any one of embodiments 35 to 53, wherein the composition is free of nicotine.
  • Embodiment 55 The composition of any one of embodiments 35 to 54, wherein the composition is free of tobacco.
  • Embodiment 56 The composition of any one of embodiments 1, 18, or 35, wherein the at least one active ingredient is a combination of: a) caffeine in an amount of from about 1.5 to about 5% by weight, based on the total weight of the composition; taurine in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition; vitamin C in an amount of from about 2 to about 6% by weight, based on the total weight of the composition; and sodium citrate in an amount of from about 1 to about 3% by weight, based on the total weight of the composition; b) theanine in an amount of from about 1 to about 5% by weight, based on the total weight of the composition;
  • GABA in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition
  • lemon balm extract in an amount of from about 1 to about 4% by weight, based on the total weight of the composition
  • caffeine in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition
  • theanine in an amount of from about 1.5 to about 5% by weight, based on the total weight of the composition
  • ginseng in an amount of from about 0.2 to about 0.6% by weight, based on the total weight of the composition
  • optionally, citicoline or sunflower lecithin in an amount of from about 0.3 to about 1.5% by weight, based on the total weight of the composition.
  • Embodiment 57 The composition of any one of embodiments 1-56, further comprising magnesium, such as magnesium in an amount by weight from about 0.1% to about 2%, or from about 0.2 to about 1%, based on elemental magnesium.
  • the invention includes any combination of two, three, four, or more of the above-noted embodiments as well as combinations of any two, three, four, or more features or elements set forth in this disclosure, regardless of whether such features or elements are expressly combined in a specific embodiment description herein.
  • This disclosure is intended to be read holistically such that any separable features or elements of the disclosed invention, in any of its various aspects and embodiments, should be viewed as intended to be combinable unless the context clearly dictates otherwise.
  • compositions configured for oral use, the compositions comprising at least one active ingredient and one or more fillers.
  • the one or more fillers generally comprise a sugar alcohol or a combination of sugar alcohols.
  • the at least one active ingredient may include one or more botanical materials, stimulants, amino acids, vitamins, antioxidants, nicotine components, cannabinoids, cannabimimetics, terpenes, pharmaceutical agents, or combinations thereof.
  • the compositions may be in chewable form, tablet form, or in the form of a melt.
  • compositions as described herein comprise at least one active ingredient and one or more fillers.
  • the compositions may further comprise binders, organic acids, water, sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids, and combinations thereof.
  • the relative amounts of the various components within the composition may vary, and typically are selected so as to provide the desired sensory and performance characteristics to the oral composition. The example individual components of the composition are described herein below.
  • compositions as described herein comprise one or more fillers.
  • Fillers may fulfill multiple functions, such as enhancing certain organoleptic properties such as texture and mouthfeel, enhancing cohesiveness or compressibility of the product, and the like.
  • the amount of filler can vary, but is typically greater than about 20%, and up to about 75% of the composition by weight, based on the total weight of the composition.
  • a typical range of filler within the composition can be from about 20 to about 75% by total weight of the composition, for example, from about 20, about 25, or about 30, to about 35, about 40, about 45, or about 50% by weight (e.g., about 20 to about 50%, or about 25 to about 45% by weight).
  • the amount of filler is at least about 20% by weight, such as at least about 25%, or at least about 30%, or at least about 35%, or at least about 40%, based on the total weight of the composition.
  • fillers are porous particulate materials and are cellulose-based.
  • suitable fillers are any non-tobacco plant material or derivative thereof, including cellulose materials derived from such sources.
  • cellulosic non-tobacco plant material include cereal grains (e.g., maize, oat, barley, rye, buckwheat, and the like), sugar beet (e.g., FIBREX ® brand filler available from International Fiber Corporation), bran fiber, and mixtures thereof.
  • Non-limiting examples of derivatives of non-tobacco plant material include starches (e.g., from potato, wheat, rice, com), natural cellulose, and modified cellulosic materials.
  • Additional examples of potential fillers include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose, mannitol, xylitol, and sorbitol. Combinations of fillers can also be used.
  • Starch as used herein may refer to pure starch from any source, modified starch, or starch derivatives. Starch is present, typically in granular form, in almost all green plants and in various types of plant tissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers, shoots, fruits, grains, and stems). Starch can vary in composition, as well as in granular shape and size. Often, starch from different sources has different chemical and physical characteristics. A specific starch can be selected for inclusion in the composition based on the ability of the starch material to impart a specific organoleptic property to composition. Starches derived from various sources can be used.
  • starch major sources include cereal grains (e.g., rice, wheat, and maize) and root vegetables (e.g., potatoes and cassava).
  • sources of starch include acorns, arrowroot, arracacha, bananas, barley, beans (e.g., favas, lentils, mung beans, peas, chickpeas), breadfruit, buckwheat, canna, chestnuts, colacasia, katakuri, kudzu, malanga, millet, oats, oca, Polynesian arrowroot, sago, sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, water chestnuts, and yams.
  • modified starches are modified starches.
  • a modified starch has undergone one or more structural modifications, often designed to alter its high heat properties.
  • Some starches have been developed by genetic modifications, and are considered to be “genetically modified” starches.
  • Other starches are obtained and subsequently modified by chemical, enzymatic, or physical means.
  • modified starches can be starches that have been subjected to chemical reactions, such as esterification, etherification, oxidation, depolymerization (thinning) by acid catalysis or oxidation in the presence of base, bleaching, transglycosylation and depolymerization (e.g., dextrinization in the presence of a catalyst), cross-linking, acetylation, hydroxypropylation, and/or partial hydrolysis.
  • Enzymatic treatment includes subjecting native starches to enzyme isolates or concentrates, microbial enzymes, and/or enzymes native to plant materials, e.g., amylase present in com kernels to modify com starch.
  • Other starches are modified by heat treatments, such as pregelatinization, dextrinization, and/or cold water swelling processes.
  • modified starches include monostarch phosphate, distarch glycerol, distarch phosphate esterified with sodium trimetaphosphate, phosphate distarch phosphate, acetylated distarch phosphate, starch acetate esterified with acetic anhydride, starch acetate esterified with vinyl acetate, acetylated distarch adipate, acetylated distarch glycerol, hydroxypropyl starch, hydroxypropyl distarch glycerol, and starch sodium octenyl succinate.
  • the filler comprises or is a mixture of glucose and starch-derived polysaccharides.
  • One such suitable mixture of glucose and starch-derived polysaccharides is EMDEX ® , available from JRS PHARMA LP, USA, 2981 Route 22, Patterson, NY 12563-2359.
  • the filler comprises one or more sugar alcohols.
  • Sugar alcohols are polyols derived from monosaccharides or disaccharides that have a partially or fully hydrogenated form.
  • Sugar alcohols have, for example, about 4 to about 20 carbon atoms and include erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g., hydrogenated starch hydrolysates).
  • Isomalt is an equimolar mixture of two disaccharides, each composed of two sugars as follows: glucose and mannitol (a-D-glucopyranosido-1, 6-mannitol); and glucose and sorbitol (a-D-glucopyranosido- 1,6-sorbitol).
  • the one or more sugar alcohols comprise isomalt. In some embodiments, the one or more sugar alcohols is isomalt.
  • the filler comprises a combination of isomalt and EMDEX ® .
  • the one or more sugar alcohols is a combination of isomalt and EMDEX ® .
  • the one or more sugar alcohols is a combination of two or even three sugar alcohols.
  • the combination of sugar alcohols comprises or is isomalt and maltitol.
  • the total amount of sugar alcohols can vary, but is typically greater than about 30%, and up to about 95% of the composition by weight, based on the total weight of the composition.
  • a typical range of sugar alcohols within the composition can be for example, from about 35, about 40, about 45, about 50, or about 55, to about 60, about 65, about 70, about 75, about 80, about 85, about 90, or about 95%, by weight.
  • the amount of sugar alcohol is at least about 50% by weight, such as is at least about 55% by weight, or at least about 60%, or at least about 65%, or at least about 70%, or at least about 75%, or at least about 80%, or at least about 85%, based on the total weight of the composition.
  • the sugar alcohol is isomalt in an amount of from about 35 to about 55% by weight, based on the total weight of the composition, such as from about 35, about 40, or about 45, to about 50 or about 55 % by weight.
  • the sugar alcohol is a combination of isomalt in an amount of from about 10 to about 25% by weight, such as about 10, about 15, about 20, or about 25% by weight; and maltitol in an amount of from about 50 to about 75% by weight, such as about 50, about 55, about 60, about 65%, about 70, about 75% by weight.
  • the filler is a combination of isomalt in an amount of from about 30 to about 50% by weight, based on the total weight of the composition, such as about 30, about 35, about 40, about 45, or about 50% by weight; and a glucose-polysaccharide blend (e.g., EMDEX ® ) in an amount of from about 35 to about 55% by weight, based on the total weight of the composition, such as about 35, about 40, about 45, or about 50% by weight.
  • EMDEX ® glucose-polysaccharide blend
  • the composition comprises a lipid.
  • Such compositions may, in some embodiments, be described as “meltable” or “melting” compositions, described further herein below.
  • the lipid of the composition is typically a fat, oil, or wax substance derived from animal or plant material (e.g., plant-derived fats), and typically comprises mostly triglycerides along with lesser amounts of free fatty acids and mono- or diglycerides.
  • the lipid is a solid or semi solid at room temperature (i.e., 25°C) and capable of at least partially liquefying when subjected to the temperature of the oral cavity of the user (i.e., "melting").
  • Example plant-derived fats are comprised primarily of saturated or unsaturated fatty acid chains (most of which are bound within triglyceride structures) having a carbon length of about 10 to about 26 carbon atoms, or about 14 to about 20 carbon atoms, or about 14 to about 18 carbon atoms.
  • the lipid comprises an oil and, in particular, a food grade oil, including fractionated oils.
  • oils include, but are not limited to, vegetable oils (e.g., acai oil, almond oil, amaranth oil, apricot oil, apple seed oil, argan oil, avocado oil, babassu oil, beech nut oil, ben oil, bitter gourd oil, black seed oil, blackcurrant seed oil, borage seed oil, bomeo tallow nut oil, bottle gourd oil, brazil nut oil, buffalo gourd oil, butternut squash seed oil, cape chestnut oil, canola oil, carob cashew oil, cocoa butter, cocklebur oil, coconut oil, com oil, cothune oil, coriander seed oil, cottonseed oil, date seed oil, dika oil, egus seed oil, evening primrose oil, false flax oil, flaxseed oil, grape seed oil, grapefruit seed oil, hazelnut oil, hemp oil, kapok seed oil,
  • the plant-derived fats of the present disclosure include palm oil, (including fractionated palm oil) palm kernel oil, soybean oil, cottonseed oil, and mixtures thereof.
  • the lipid is a blend of palm oil and palm kernel oil.
  • the lipid can be, for example, hydrogenated, partially hydrogenated, or non-hydrogenated.
  • Example embodiments of lipids can be purchased under the brand names CEBES ® , CISAO ® , or CONFAO ® , available from AarhusKarlshamn USA Inc.
  • the melting point of the lipid is typically about 29°C or above, such as about 29°C to about 49°C, or about 36° C to about 45° C, or about 38°C to about 41°C. In some embodiments, use of lipids with a melting point of less than about 36° C is not advantageous due to possible melting during product storage or handling.
  • One test for determining the melting point of lipids is the Mettler dropping point method (ASTM D3954-15, Standard Test Method for Dropping Point of Waxes, ASTM International, West Conshohocken, PA, 2015, www.astm.org.).
  • the amount of lipid within the composition may vary. In certain embodiments, the amount of lipid is at least about 10 percent, at least about 20 percent, or at least about 30 percent, on a dry weight basis of the composition. In certain embodiments, the amount of lipid is less than about 70 percent, less than about 60 percent, or less than about 50 weight percent, on a dry weight basis.
  • Example lipid weight ranges include about 10 to about 70 dry weight percent, such as about 35 to about 50 dry weight percent. In some embodiments, the amount of lipid is about 35, about 40, about 45, or about 50 percent by weight of the total composition.
  • the composition comprises a lipid.
  • the lipid is an oil selected from the group consisting of palm oil, palm kernel oil, soybean oil, sunflower oil, cottonseed oil, coconut oil, and combinations thereof, wherein the oil may be hydrogenated, partially hydrogenated, or non-hydrogenated.
  • the lipid is a trans -hydrogenated filling fat of medium hardness such as Confao ® 5, available from AarhusKarlshamn USA Inc., 131 Marsh Street, Port Newark, NJ 071 14.
  • composition as disclosed herein includes one or more active ingredients.
  • an "active ingredient” refers to one or more substances belonging to any of the following categories: API (active pharmaceutical ingredient), food additives, natural medicaments, and naturally occurring substances that can have an effect on humans.
  • Example active ingredients include any ingredient known to impact one or more biological functions within the body, such as ingredients that furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or which affect the structure or any function of the body of humans (e.g., provide a stimulating action on the central nervous system, have an energizing effect, an antipyretic or analgesic action, or an otherwise useful effect on the body).
  • the active ingredient may be of the type generally referred to as dietary supplements, nutraceuticals, "phytochemicals” or “functional foods.”
  • dietary supplements e.g., nutraceuticals, "phytochemicals” or “functional foods.”
  • Non-limiting examples of active ingredients include those falling in the categories of botanical ingredients, stimulants, amino acids, nicotine components, and/or pharmaceutical, nutraceutical, and medicinal ingredients (e.g., vitamins, such as A, B3, B6, B12, and C, and/or cannabinoids, such as tetrahydrocannabinol (THC) and cannabidiol (CBD)). Each of these categories is further described herein below.
  • the particular choice of active ingredients will vary depending upon the desired flavor, texture, and desired characteristics of the particular product.
  • an active ingredient or combination thereof is present in a total concentration of at least about 0.001% by weight of the composition, such as in a range from about 0.001% to about 20%.
  • the active ingredient or combination of active ingredients is present in a concentration from about 0.1% w/w to about 10% by weight, such as, e.g., from about from about 0.5% w/w to about 10%, from about 1% to about 10%, from about 1% to about 5% by weight, based on the total weight of the composition.
  • the active ingredient or combination of active ingredients is present in a concentration of from about 0.001%, about 0.01%, about 0.1% , or about 1%, up to about 20% by weight, such as, e.g., from about from about 0.001%, about 0.002%, about 0.003%, about 0.004%, about 0.005%, about 0.006%, about 0.007%, about 0.008%, about 0.009%, about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 16%, about 17%, about 18
  • the active ingredient comprises a botanical ingredient.
  • botanical ingredient refers to any plant material or fungal-derived material, including plant material in its natural form and plant material derived from natural plant materials, such as extracts or isolates from plant materials or treated plant materials (e.g., plant materials subjected to heat treatment, fermentation, bleaching, or other treatment processes capable of altering the physical and/or chemical nature of the material).
  • a “botanical” includes, but is not limited to, "herbal materials,” which refer to seed-producing plants that do not develop persistent woody tissue and are often valued for their medicinal or sensory characteristics (e.g., teas or tisanes).
  • compositions as disclosed herein can be characterized as free of any tobacco material (e.g., any embodiment as disclosed herein may be completely or substantially free of any tobacco material).
  • substantially free is meant that no tobacco material has been intentionally added.
  • certain embodiments can be characterized as having less than 0.001% by weight of tobacco, or less than 0.0001%, or even 0% by weight of tobacco.
  • a botanical When present, a botanical is typically at a concentration of from about 0.01% w/w to about 10% by weight, such as, e.g., from about from about 0.01% w/w, about 0.05%, about 0.1%, or about 0.5%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight, based on the total weight of the composition.
  • the botanical materials useful in the present disclosure may comprise, without limitation, any of the compounds and sources set forth herein, including mixtures thereof. Certain botanical materials of this type are sometimes referred to as dietary supplements, nutraceuticals, "phytochemicals” or “functional foods.” Certain botanicals, as the plant material or an extract thereof, have found use in traditional herbal medicine, and are described further herein.
  • Non-limiting examples of botanicals or botanical-derived materials include ashwagandha, Bacopa monniera, baobab, basil, Centella asiatica, Chai-hu, chamomile, cherry blossom, chlorophyll, cinnamon, citrus, cloves, cocoa, cordyceps, curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essential oils, eucalyptus, fennel, Galphimia glauca, ginger, Ginkgo biloba, ginseng (e.g., Panax ginseng), green tea, Griffonia simplicifolia, guarana, cannabis, hemp, hops, jasmine, Kaempferia parviflora (Thai ginseng), kava, lavender, lemon balm, lemongrass, licorice, lutein, maca, matcha, Nardostachys chinensis, oil-based extract of Viola odorata, peppermint, quercetin,
  • the active ingredient comprises lemon balm.
  • Lemon balm ( Melissa officinalis ) is a mildly lemon-scented herb from the same family as mint (Lamiaceae). The herb is native to Europe, North Africa, and West Asia. The tea of lemon balm, as well as the essential oil and the extract, are used in traditional and alternative medicine.
  • the active ingredient comprises lemon balm extract.
  • the lemon balm extract is present in an amount of from about 1 to about 4% by weight, based on the total weight of the composition.
  • the active ingredient comprises ginseng.
  • Ginseng is the root of plants of the genus Panax, which are characterized by the presence of unique steroid saponin phytochemicals (ginsenosides) and gintonin. Ginseng finds use as a dietary supplement in energy drinks or herbal teas, and in traditional medicine. Cultivated species include Korean ginseng (P. ginseng), South China ginseng (P. notoginseng ), and American ginseng (71 quinquefolius). American ginseng and Korean ginseng vary in the type and quantity of various ginsenosides present. In some embodiments, the ginseng is American ginseng or Korean ginseng. In specific embodiments, the active ingredient comprises Korean ginseng. In some embodiments, ginseng is present in an amount of from about 0.4 to about 0.6% by weight, based on the total weight of the composition.
  • the active ingredient comprises one or more stimulants.
  • stimulants refers to a material that increases activity of the central nervous system and/or the body, for example, enhancing focus, cognition, vigor, mood, alertness, and the like.
  • Non-limiting examples of stimulants include caffeine, theacrine, theobromine, and theophylline.
  • Theacrine (1,3, 7,9- tetramethyl uric acid) is a purine alkaloid which is structurally related to caffeine, and possesses stimulant, analgesic, and anti-inflammatory effects.
  • Present stimulants may be natural, naturally derived, or wholly synthetic.
  • certain botanical materials may possess a stimulant effect by virtue of the presence of e.g., caffeine or related alkaloids, and accordingly are “natural” stimulants.
  • the stimulant e.g., caffeine, theacrine
  • caffeine can be obtained by extraction and purification from botanical sources (e.g., tea).
  • whole synthetic it is meant that the stimulant has been obtained by chemical synthesis.
  • the active ingredient comprises caffeine.
  • the caffeine is present in an encapsulated form.
  • Vitashure ® available from Balchem Corp., 52 Sunrise Park Road, New Hampton, NY, 10958.
  • a stimulant or combination of stimulants is typically at a concentration of from about 0.1% w/w to about 15% by weight, such as, e.g., from about from about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight, based on the total weight of the composition.
  • the composition comprises caffeine in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition;
  • the active ingredient comprises an amino acid.
  • amino acid refers to an organic compound that contains amine (-NH2) and carboxyl (-COOH) or sulfonic acid (SO 3 H) functional groups, along with a side chain (R group), which is specific to each amino acid.
  • Amino acids may be proteinogenic or non-pro teinogenic. By “proteinogenic” is meant that the amino acid is one of the twenty naturally occurring amino acids found in proteins.
  • the proteinogenic amino acids include alanine, arginine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, and valine.
  • non-pro teinogenic is meant that either the amino acid is not found naturally in protein, or is not directly produced by cellular machinery (e.g., is the product of post- tranlational modification).
  • Non-limiting examples of non-proteinogenic amino acids include gamma- aminobutyric acid (GABA), taurine (2-aminoethanesulfonic acid), theanine (L-y-glutamylethylamide), hydroxyproline, and beta-alanine.
  • the active ingredient comprises theanine.
  • the active ingredient comprises GABA.
  • the active ingredient comprises a combination of theanine and GABA.
  • the active ingredient is a combination of theanine, GABA, and lemon balm.
  • the active ingredient comprises a combination of theanine and tryptophan.
  • the active ingredient comprises a combination of theanine and one or more B vitamins.
  • the active ingredient is a combination of caffeine, theanine, and optionally, ginseng.
  • the active ingredient comprises taurine.
  • the active ingredient is a combination of caffeine and taurine.
  • amino acids such as theanine, tryptophan, GABA, or taurine
  • GABA GABA
  • taurine can have beneficial impact on mood, anxiety level, focus, or cognitive performance, particularly when combined with other active ingredients, such as caffeine or certain botanicals.
  • an amino acid or combination of amino acids is typically at a concentration of from about 0.01% w/w to about 15% by weight, such as, e.g., from about from about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight, based on the total weight of the composition.
  • the at least one active ingredient comprises tryptophan in an amount by weight from about 0.03% to about 1%, or from about 0.05% to about 0.5%.
  • Vitamins in some embodiments, the active ingredient comprises a vitamin or combination of vitamins.
  • vitamin refers to an organic molecule (or related set of molecules) that is an essential micronutrient needed for the proper functioning of metabolism in a mammal.
  • vitamins required by human metabolism which are: vitamin A (as all-trans-retinol, all-trans-retinyl- esters, as well as all-trans -beta-carotene and other provitamin A carotenoids), vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B7 (biotin), vitamin B9 (folic acid or folate), vitamin B12 (cobalamins), vitamin C (ascorbic acid), vitamin D (calciferols), vitamin E (tocopherols and tocotrienols), and vitamin K (quinones).
  • the active ingredient comprises vitamin C.
  • the active ingredient is a combination of vitamin C, caffeine, and taurine. In some embodiments, the active ingredient comprises one or more of vitamin B6 and B12. In some embodiments, the active ingredient comprises theanine and one or more of vitamin B6 and B12.
  • a vitamin or combination of vitamins is typically at a concentration of from about 0.0001% to about 6% by weight, such as, e.g., from about 0.0001, about 0.001, about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, or about 0.1% w/w, to about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 2%, about 3%, about 4%, about 5% , or about 6% by weight, based on the total weight of the composition.
  • the active ingredient comprises vitamin B6 in an amount from about 0.008% to about 0.06% by weight, or from about 0.01% to about 0.04% by weight.
  • the active ingredient comprises vitamin B12 in an amount from about 0.0001% to about 0.007% by weight, or from about 0.0005% to about 0.001% by weight.
  • the active ingredient comprises a combination of vitamin B6 and vitamin B12 in a total amount by weight from about 0.008% to about 0.07%.
  • the active ingredient comprises one or more antioxidants.
  • antioxidant refers to a substance which prevents or suppresses oxidation by terminating free radical reactions, and may delay or prevent some types of cellular damage. Antioxidants may be naturally occurring or synthetic. Naturally occurring antioxidants include those found in foods and botanical materials. Non-limiting examples of antioxidants include certain botanical materials, vitamins, polyphenols, and phenol derivatives.
  • Examples of botanical materials which are associated with antioxidant characteristics include without limitation acai berry, alfalfa, allspice, annatto seed, apricot oil, basil, bee balm, wild bergamot, black pepper, blueberries, borage seed oil, bugleweed, cacao, calamus root, catnip, catuaba, cayenne pepper, chaga mushroom, chervil, cinnamon, dark chocolate, potato peel, grape seed, ginseng, gingko biloba, Saint John's Wort, saw palmetto, green tea, black tea, black cohosh, cayenne, chamomile, cloves, cocoa powder, cranberry, dandelion, grapefruit, honeybush, echinacea, garlic, evening primrose, feverfew, ginger, goldenseal, hawthorn, hibiscus flower, jiaogulan, kava, lavender, licorice, marjoram, milk thistle, mints (menthe), oo
  • Such botanical materials may be provided in fresh or dry form, essential oils, or may be in the form of an extracts.
  • the botanical materials (as well as their extracts) often include compounds from various classes known to provide antioxidant effects, such as minerals, vitamins, isoflavones, phytoesterols, allyl sulfides, dithiolthiones, isothiocyanates, indoles, lignans, flavonoids, polyphenols, and carotenoids.
  • Examples of compounds found in botanical extracts or oils include ascorbic acid, peanut endocarb, resveratrol, sulforaphane, beta-carotene, lycopene, lutein, co-enzyme Q, carnitine, quercetin, kaempferol, and the like. See, e.g., Santhosh et ah, Phytomedicine, 12(2005) 216-220, which is incorporated herein by reference.
  • Non-limiting examples of other suitable antioxidants include citric acid, Vitamin E or a derivative thereof, a tocopherol, epicatechol, epigallocatechol, epigallocatechol gallate, erythorbic acid, sodium erythorbate, 4-hexylresorcinol, theaflavin, theaflavin monogallate A or B, theaflavin digallate, phenolic acids, glycosides, quercitrin, isoquercitrin, hyperoside, polyphenols, catechols, resveratrols, oleuropein, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), tertiary butylhydroquinone (TBHQ), and combinations thereof.
  • a tocopherol epicatechol, epigallocatechol, epigallocatechol gallate
  • erythorbic acid sodium erythorbate
  • 4-hexylresorcinol theaf
  • an antioxidant is typically at a concentration of from about 0.001% w/w to about 10% by weight, such as, e.g., from about from about 0.001%, about 0.005%, about 0.01% w/w, about 0.05%, about 0.1%, or about 0.5%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10%, based on the total weight of the composition.
  • the active ingredient comprises a nicotine component.
  • nicotine component is meant any suitable form of nicotine (e.g., free base or salt) for providing oral absorption of at least a portion of the nicotine present.
  • the nicotine component is selected from the group consisting of nicotine free base and a nicotine salt.
  • the nicotine component is nicotine in its free base form, which easily can be adsorbed in for example, a microcrystalline cellulose material to form a microcrystalline cellulose-nicotine carrier complex. See, for example, the discussion of nicotine in free base form in US Pat. Pub. No. 2004/0191322 to Hansson, which is incorporated herein by reference.
  • the nicotine component can be employed in the form of a salt.
  • Salts of nicotine can be provided using the types of ingredients and techniques set forth in US Pat. No. 2,033,909 to Cox et al. and Perfetti, Beitrage Tabak Kauutz Int., 12: 43-54 (1983), which are incorporated herein by reference. Additionally, salts of nicotine are available from sources such as Pfaltz and Bauer, Inc. and K&K Laboratories, Division of ICN Biochemicals, Inc.
  • the nicotine component is selected from the group consisting of nicotine free base, a nicotine salt such as hydrochloride, dihydrochloride, monotartrate, bitartrate, sulfate, salicylate, and nicotine zinc chloride.
  • the nicotine can be in the form of a resin complex of nicotine, where nicotine is bound in an ion-exchange resin, such as nicotine polacrilex, which is nicotine bound to, for example, a polymethacrilic acid, such as Amberlite IRP64, Purolite Cl 15HMR, or Doshion P551.
  • an ion-exchange resin such as nicotine polacrilex
  • a polymethacrilic acid such as Amberlite IRP64, Purolite Cl 15HMR, or Doshion P551.
  • a nicotine-polyacrylic carbomer complex such as with Carbopol 974P.
  • nicotine may be present in the form of a nicotine polyacrylic complex.
  • the nicotine component when present, is in a concentration of at least about 0.001% by weight of the composition, such as in a range from about 0.001% to about 10%.
  • the nicotine component is present in a concentration from about 0.1% w/w to about 10% by weight, such as, e.g., from about from about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% by weight, calculated as the free base and based on the total weight of the composition.
  • the nicotine component is present in a concentration from about 0.1% w/w to about 3% by weight, such as, e.g., from about from about 0.1% w/w to about 2.5%, from about 0.1% to about 2.0%, from about 0.1% to about 1.5%, or from about 0.1% to about 1% by weight, calculated as the free base and based on the total weight of the composition.
  • the products or compositions of the disclosure can be characterized as free of any nicotine component (e.g., any embodiment as disclosed herein may be completely or substantially free of any nicotine component).
  • substantially free is meant that no nicotine has been intentionally added, beyond trace amounts that may be naturally present in e.g., a botanical material.
  • certain embodiments can be characterized as having less than 0.001% by weight of nicotine, or less than 0.0001%, or even 0% by weight of nicotine, calculated as the free base.
  • the active ingredient comprises a nicotine component (e.g., any product or composition of the disclosure, in addition to comprising any active ingredient or combination of active ingredients as disclosed herein, may further comprise a nicotine component).
  • a nicotine component e.g., any product or composition of the disclosure, in addition to comprising any active ingredient or combination of active ingredients as disclosed herein, may further comprise a nicotine component.
  • the active ingredient comprises one or more cannabinoids.
  • cannabinoid refers to a class of diverse chemical compounds that acts on cannabinoid receptors, also known as the endocannabinoid system, in cells that alter neurotransmitter release in the brain. Ligands for these receptor proteins include the endocannabinoids produced naturally in the body by animals; phytocannabinoids, found in cannabis; and synthetic cannabinoids, manufactured artificially.
  • Cannabinoids found in cannabis include, without limitation: cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabinolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A).
  • CBD cannabigerol
  • the cannabinoid is selected from tetrahydrocannabinol (THC), the primary psychoactive compound in cannabis, and cannabidiol (CBD) another major constituent of the plant, but which is devoid of psychoactivity. All of the above compounds can be used in the form of an isolate from plant material or synthetically derived.
  • the active ingredient can be a cannabimimetic, which is a class of compounds derived from plants other than cannabis that have biological effects on the endocannabinoid system similar to cannabinoids.
  • cannabimimetic is a class of compounds derived from plants other than cannabis that have biological effects on the endocannabinoid system similar to cannabinoids. Examples include yangonin, alpha-amyrin or beta-amyrin (also classified as terpenes), cyanidin, curcumin (tumeric), catechin, quercetin, salvinorin A, N-acylethanolamines, and N- alkylamide lipids.
  • a cannabinoid e.g., CBD
  • cannabimimetic is typically in a concentration of at least about 0.1% by weight of the composition, such as in a range from about 0.1% to about 30%, such as, e.g., from about from about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 15%, about 20%, or about 30% by weight, based on the total weight of the composition.
  • CBD cannabinoid
  • cannabimimetic is typically in a concentration of at least about 0.1% by weight of the composition, such as in a range from about 0.1% to about 30%, such as, e.g., from about from about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%
  • terpenes Active ingredients suitable for use in the present disclosure can also be classified as terpenes, many of which are associated with biological effects, such as calming effects.
  • Terpenes are understood to have the general formula of (C5Hg) and include mono terpenes, sesquiterpenes, and diterpenes.
  • Terpenes can be acyclic, monocyclic or bicyclic in structure. Some terpenes provide an entourage effect when used in combination with cannabinoids or cannabimimetics.
  • Examples include beta-caryophyllene, linalool, limonene, beta-citronellol, linalyl acetate, pinene (alpha or beta), geraniol, carvone, eucalyptol, menthone, iso-menthone, piperitone, myrcene, beta-bourbonene, and germacrene, which may be used singly or in combination.
  • the active ingredient comprises an active pharmaceutical ingredient (API).
  • API can be any known agent adapted for therapeutic, prophylactic, or diagnostic use. These can include, for example, synthetic organic compounds, proteins and peptides, polysaccharides and other sugars, lipids, phospholipids, inorganic compounds (e.g., magnesium, selenium, zinc, nitrate), neurotransmitters or precursors thereof (e.g., serotonin, 5-hydroxytryptophan, oxitriptan, acetylcholine, dopamine, melatonin), and nucleic acid sequences, having therapeutic, prophylactic, or diagnostic activity.
  • synthetic organic compounds proteins and peptides, polysaccharides and other sugars, lipids, phospholipids, inorganic compounds (e.g., magnesium, selenium, zinc, nitrate), neurotransmitters or precursors thereof (e.g., serotonin, 5-hydroxytryptophan, oxitriptan, acetylcho
  • Non-limiting examples of APIs include analgesics and antipyretics (e.g., acetyls alicylic acid, acetaminophen, 3-(4-isobutylphenyl)propanoic acid), phosphatidylserine, myoinositol, docosahexaenoic acid (DHA, Omega-3), arachidonic acid (AA, Omega-6), S-adenosylmethionine (SAM), beta-hydroxy- beta-methylbutyrate (HMB), citicoline (cytidine-5'-diphosphate-choline), and cotinine.
  • the active ingredient comprises citicoline.
  • the active ingredient is a combination of citicoline, caffeine, theanine, and ginseng. In some embodiments, the active ingredient comprises sunflower lecithin. In some embodiments, the active ingredient is a combination of sunflower lecithin, caffeine, theanine, and ginseng.
  • an API when present, is typically at a concentration of from about 0.001% w/w to about 10% by weight, such as, e.g., from about from about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, about 0.9%, or about 1%, to about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% by weight, based on the total weight of the composition.
  • the composition is substantially free of any API.
  • substantially free of any API means that the composition does not contain, and specifically excludes, the presence of any API as defined herein, such as any Food and Drug Administration (FDA) approved therapeutic agent intended to treat any medical condition.
  • FDA Food and Drug Administration
  • the active ingredient is selected from the group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, and combinations thereof.
  • the active ingredient can include a combination of caffeine, theanine, and optionally ginseng.
  • the active ingredient includes a combination of theanine, gamma-amino butyric acid (GABA), and optionally lemon balm extract.
  • the active ingredient includes theanine, theanine and tryptophan, theanine and one or more of B vitamin B6 and vitamin B12, or tryptophan, theanine and one or more of B vitamin B6 and vitamin B12.
  • the active ingredient includes a combination of caffeine, taurine, and vitamin C, optionally further including one or more B vitaimins (e.g., vitamin B6 or B12).
  • a magnesium salt e.g., magnesium gluconate
  • the moisture content (e.g., water content) of the composition, prior to use by a consumer of the product, may vary according to the desired properties.
  • the composition, prior to insertion into the mouth of the user is less than about 60% by weight of water, and generally is from about 1 to about 60% by weight of water, for example, from about 5 to about 55%, about 10 to about 50%, about 20 to about 45%, or about 25 to about 40% water by weight, including water amounts of at least about 5% by weight, at least about 10% by weight, at least about 15% by weight, and at least about 20% by weight.
  • the composition comprises a salt (e.g., an alkali metal salt), typically employed in an amount sufficient to provide desired sensory attributes to the composition.
  • a salt e.g., an alkali metal salt
  • suitable salts include sodium chloride, potassium chloride, ammonium chloride, flour salt, sodium acetate, sodium citrate, calcium citrate, and the like.
  • the salt is sodium chloride, ammonium chloride, or a combination thereof.
  • the salt is trisodium citrate, calcium citrate, or a combination thereof.
  • a representative amount of salt is about 0.1% by weight or more, about 0.5% by weight or more, about 1.0% by weight or more, or about 1.5% by weight or more, but will typically make up about 10% or less of the total weight of the composition, or about 7.5% or less, or about 5% or less (e.g., from about 0.1 to about 5% by weight).
  • sweeteners may be added.
  • the sweeteners can be any sweetener or combination of sweeteners, in natural or artificial form, or as a combination of natural and artificial sweeteners.
  • natural sweeteners include fructose, sucrose, glucose, maltose, isomaltulose, mannose, galactose, lactose, stevia, honey, and the like.
  • artificial sweeteners include sucralose, maltodextrin, saccharin, aspartame, acesulfame K, neotame, and the like.
  • the sweetener comprises one or more sugar alcohols.
  • Sugar alcohols are polyols derived from monosaccharides or disaccharides that have a partially or fully hydrogenated form.
  • Sugar alcohols have, for example, about 4 to about 20 carbon atoms and include erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g., hydrogenated starch hydrolysates).
  • the sweetener is sucralose, acesulfame K, or a combination thereof.
  • a sweetener or combination of sweeteners may make up from about 0.01 to about 20% or more of the of the composition by weight, for example, from about 0.01 to about 0.1, from about 0.1 to about 1%, from about 1 to about 5%, from about 5 to about 10%, or from about 10 to about 20% by weight, based on the total weight of the composition.
  • a combination of sweeteners is present at a concentration of from about 0.01% to about 0.1% by weight of the composition, such as about 0.01, about 0.02, about 0.03, about 0.04, about 0.05, about 0.06, about 0.07, about 0.08, about 0.09, or about 0.1% by weight of the composition.
  • a combination of sweeteners is present at a concentration of from about 0.1% to about 0.5% by weight of the composition, such as about 0.1, about 0.2, about 0.3, about 0.4, or about 0.5% by weight of the composition. In some embodiments, a combination of sweeteners is present at a concentration of from about 1% to about 3% by weight of the composition.
  • the composition comprises a flavoring agent.
  • a flavoring agent is any flavorful or aromatic substance capable of altering the sensory characteristics associated with the oral product.
  • sensory characteristics include taste, mouthfeel, moistness, coolness/heat, and/or fragrance/aroma.
  • Flavoring agents may be natural or synthetic, and the character of the flavors imparted thereby may be described, without limitation, as fresh, sweet, herbal, confectionary, floral, fruity, or spicy.
  • flavors include, but are not limited to, vanilla, coffee, chocolate/cocoa, cream, mint, spearmint, menthol, peppermint, wintergreen, eucalyptus, lavender, cardamom, nutmeg, cinnamon, clove, cascarilla, sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, cherry, strawberry, trigeminal sensates, terpenes, and any combinations thereof. See also, Leffingwell et al., Tobacco Flavoring for Smoking Products, R. J. Reynolds Tobacco Company (1972), which is incorporated herein by reference.
  • Flavoring agents also may include components that are considered moistening, cooling or smoothening agents, such as eucalyptus. These flavors may be provided neat (i.e., alone) or in a composite, and may be employed as concentrates or flavor packages (e.g., spearmint and menthol, orange and cinnamon; lime, pineapple, and the like). Representative types of components also are set forth in US Pat. No. 5,387,416 to White et al.; US Pat. App. Pub. No. 2005/0244521 to Strickland et al.; and PCT Application Pub. No. WO 05/041699 to Quinter et al., each of which is incorporated herein by reference. In some instances, the flavoring agent may be provided in a spray-dried form or a liquid form.
  • the amount of flavoring agent utilized in the composition can vary, but is typically up to about 10% by weight, and certain embodiments are characterized by a flavoring agent content of at least about 0.1% by weight, such as about 0.5 to about 10%, about 1 to about 5%, or about 2 to about 4% weight, based on the total weight of the composition.
  • the composition may include one or more taste modifying agents ("taste modifiers") which may serve to mask, alter, block, or improve e.g., the flavor of a composition as described herein.
  • taste modifiers include analgesic or anesthetic herbs, spices, and flavors which produce a perceived cooling (e.g., menthol, eucalyptus, mint), warming (e.g., cinnamon), or painful (e.g., capsaicin) sensation.
  • Certain taste modifiers fall into more than one overlapping category.
  • the taste modifier modifies one or more of bitter, sweet, salty, or sour tastes.
  • the taste modifier targets pain receptors.
  • the composition comprises an active ingredient having a bitter taste, and a taste modifier which masks or blocks the perception of the bitter taste.
  • the taste modifier is a substance which targets pain receptors (e.g., vanilloid receptors) in the user's mouth to mask e.g., a bitter taste of another component (e.g., an active ingredient).
  • Suitable taste modifiers include, but are not limited to, capsaicin, gamma-amino butyric acid (GABA), adenosine monophosphate (AMP), lactisole, or a combination thereof.
  • a representative amount of taste modifier is about 0.01% by weight or more, about 0.1% by weight or more, or about 1.0% by weight or more, but will typically make up less than about 10% by weight of the total weight of the composition, (e.g., from about 0.01%, about 0.05%, about 0.1%, or about 0.5%, to about 1%, about 5%, or about 10% by weight of the total weight of the composition).
  • Binders e.g., from about 0.01%, about 0.05%, about 0.1%, or about 0.5%, to about 1%, about 5%, or about 10% by weight of the total weight of the composition.
  • a binder (or combination of binders) may be employed in certain embodiments, in amounts sufficient to provide the desired physical attributes and physical integrity to the composition, and binders also often function as thickening or gelling agents.
  • Typical binders can be organic or inorganic, or a combination thereof.
  • Representative binders include cellulose derivatives (e.g., cellulose ethers), povidone, sodium alginate, starch-based binders, pectin, gums, carrageenan, pullulan, zein, and the like, and combinations thereof.
  • the binder comprises pectin or carrageenan or combinations thereof.
  • the amount of binder utilized in the composition can vary based on the binder and the desired composition properties, but is typically up to about 30% by weight, and certain embodiments are characterized by a binder content of at least about 0.1% by weight, such as about 0.5 to about 30% by weight, or about 1 to about 10% by weight, based on the total weight of the composition.
  • the binder includes a gum, for example, a natural gum.
  • a natural gum refers to polysaccharide materials of natural origin that have binding properties, and which are also useful as a thickening or gelling agents.
  • Representative natural gums derived from plants, which are typically water soluble to some degree, include xanthan gum, guar gum, gum arabic, ghatti gum, gum tragacanth, karaya gum, locust bean gum, gellan gum, and combinations thereof.
  • natural gum binder materials are typically present in an amount of up to about 5% by weight, for example, from about 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, about 0.9, or about 1%, to about 2, about 3, about 4, or about 5% by weight, based on the total weight of the composition.
  • the binder comprises pectin.
  • Pectins are natural polymers related to carbohydrates and which are acidic heteropolysaccharides (polysaccharides comprising multiple monosaccharide units).
  • the pectin C-6 position contains a carboxylic acid (or corresponding methyl ester or carboxamide) group instead of a hydroxymethyl group.
  • the principal subunit is known as galacturonic acid, which can be copolymerized with L-rhamnose. Other sugars are featured as side-chain substituents.
  • Pectin acts as a thickening and gelling agent.
  • pectin isolated from sources such as apple pomace, citrus peels, sugarbeet waste from sugar manufacturing, sunflower heads discarded from seed harvesting, mango waste, and other commercially available pectins may be used.
  • pectins may provide a gel or gum consistency to compositions as disclosed herein.
  • the binder comprises low methoxy pectin. Suitable low methoxy pectins include, for example, "GENU ® pectin type LM-104 AS", available from CP Kelco, Atlanta, GA, USA.
  • the binder comprises low methoxy pectin in combination with a gelation agent.
  • the gelation agent comprises calcium ions, such as, but not limited to, calcium diphosphate.
  • the binder comprises a high methoxy pectin in combination with an organic acid, described herein below. In some embodiments, the binder comprises a high methoxy pectin in combination with citric acid.
  • a pectin binder is typically present in an amount of up to about 3% by weight, for example, from about 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, about 0.9, or about 1, to about 1.1, about 1.2, about 1.3, about 1.4, about 1.5, about 1.6, about 1.7, about 1.8. about 1.9, about 2, about 2.1, about 2.2, about 2.3. about 2.4, about 2.5, about 2.6, about 2.7, about 2.8, about 2.9, or about 3% by weight, based on the total weight of the composition.
  • the composition comprises an organic acid.
  • organic acid refers to an organic (i.e., carbon-based) compound that is characterized by acidic properties.
  • organic acids are relatively weak acids (i.e., they do not dissociate completely in the presence of water), such as carboxylic acids (-CO2H) or sulfonic acids (-SO2OH).
  • reference to organic acid means an organic acid that is intentionally added.
  • an organic acid may be intentionally added as a specific mixture ingredient as opposed to merely being inherently present as a component of another mixture ingredient (e.g., the small amount of organic acid which may inherently be present in a mixture ingredient such as a tobacco material).
  • the one or more organic acids are added neat (i.e., in their free acid, native solid or liquid form) or as a solution in, e.g., water. In some embodiments, the one or more organic acids are added in the form of a salt, as described herein below.
  • Suitable organic acids will typically have a range of lipophilicities (i.e., a polarity giving an appropriate balance of water and organic solubility). Lipophilicity is conveniently measured in terms of logP, the partition coefficient of a molecule between an aqueous and lipophilic phase, usually water and octanol, respectively. Typically, lipophilicities of organic acids may be between about -2 and about 6.5. In some embodiments, the organic acid may be more soluble in water than in octanol (i.e., having a negative logP value, such as from about -2 to about -1).
  • the organic acid may be about equally soluble in octanol than in water (i.e., having a logP value of about 0). In some embodiments, the organic acid may be more soluble in octanol than in water (i.e., having a positive logP value, such as from about 1 to about 6.5). In some embodiments, the organic acid has a logP value of from about 1.5 to about 5.0, e.g., from about 1.5, about 2.0, about 2.5, or about 3.0, to about 3.5, about 4.0, about 4.5, or about 5.0.
  • the organic acid is a carboxylic acid or a sulfonic acid.
  • the carboxylic acid or sulfonic acid functional group may be attached to any alkyl, cycloalkyl, heterocycloalkyl, aryl, or heteroaryl group having, for example, from one to twenty carbon atoms (C1-C20).
  • the organic acid is an alkyl, cycloalkyl, heterocycloalkyl, aryl, or heteroaryl carboxylic or sulfonic acid.
  • alkyl refers to any straight chain or branched chain hydrocarbon.
  • the alkyl group may be saturated (i.e., having all sp 3 carbon atoms), or may be unsaturated (i.e., having at least one site of unsaturation).
  • unsaturated refers to the presence of a carbon-carbon, sp 2 double bond in one or more positions within the alkyl group.
  • Unsaturated alkyl groups may be mono- or polyunsaturated.
  • Representative straight chain alkyl groups include, but are not limited to, methyl, ethyl, n-propyl, n-butyl, n-pentyl, and n-hexyl.
  • Branched chain alkyl groups include, but are not limited to, isopropyl, sec-butyl, isobutyl, tert-butyl, isopentyl, and 2-methylbutyl.
  • Representative unsaturated alkyl groups include, but are not limited to, ethylene or vinyl, allyl, 1-butenyl, 2-butenyl, isobutylenyl, 1- pentenyl, 2-pentenyl, 3 -methyl- 1-butenyl, 2-methyl-2-butenyl, 2,3-dimethyl-2-butenyl, and the like.
  • An alkyl group can be unsubstituted or substituted.
  • Cycloalkyl refers to a carbocyclic group, which may be mono- or bicyclic. Cycloalkyl groups include rings having 3 to 7 carbon atoms as a monocycle or 7 to 12 carbon atoms as a bicycle. Examples of monocyclic cycloalkyl groups include cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, cycloheptyl, and cyclooctyl. A cycloalkyl group can be unsubstituted or substituted, and may include one or more sites of unsaturation (e.g., cyclopentenyl or cyclohexenyl).
  • aryl refers to a carbocyclic aromatic group. Examples of aryl groups include, but are not limited to, phenyl and naphthyl. An aryl group can be unsubstituted or substituted.
  • Heteroaryl and “heterocycloalkyl” as used herein refer to an aromatic or non-aromatic ring system, respectively, in which one or more ring atoms is a heteroatom, e.g. nitrogen, oxygen, and sulfur.
  • the heteroaryl or heterocycloalkyl group comprises up to 20 carbon atoms and from 1 to 3 heteroatoms selected from N, O, and S.
  • a heteroaryl or heterocycloalkyl may be a monocycle having 3 to 7 ring members (for example, 2 to 6 carbon atoms and 1 to 3 heteroatoms selected from N, O, and S) or a bicycle having 7 to 10 ring members (for example, 4 to 9 carbon atoms and 1 to 3 heteroatoms selected from N, O, and S), for example: a bicyclo[4,5], [5,5], [5,6], or [6,6] system.
  • heteroaryl groups include by way of example and not limitation, pyridyl, thiazolyl, tetrahydrothiophenyl, pyrimidinyl, furanyl, thienyl, pyrrolyl, pyrazolyl, imidazolyl, tetrazolyl, benzofuranyl, thianaphthalenyl, indolyl, indolenyl, quinolinyl, isoquinolinyl, benzimidazolyl, isoxazolyl, pyrazinyl, pyridazinyl, indolizinyl, isoindolyl, 3H-indolyl, lH-indazolyl, purinyl, 4H-quinolizinyl, phthalazinyl, naphthyridinyl, quinoxalinyl, quinazolinyl, cinnolinyl, pteridinyl, 4aH-
  • heterocycloalkyls include by way of example and not limitation, dihydroypyridyl, tetrahydropyridyl (piperidyl), tetrahydrothiophenyl, piperidinyl, 4-piperidonyl, pyrrolidinyl, 2- pyrrolidonyl, tetrahydrofuranyl, tetrahydropyranyl, bis-tetrahydropyranyl, tetrahydroquinolinyl, tetrahydroisoquinolinyl, decahydroquinolinyl, octahydroisoquinolinyl, piperazinyl, quinuclidinyl, and morpholinyl. Heteroaryl and heterocyclo alkyl groups can be unsubstituted or substituted.
  • Substituted as used herein and as applied to any of the above alkyl, aryl, cycloalkyl, heteroaryl, heterocyclyl, means that one or more hydrogen atoms are each independently replaced with a substituent.
  • a group is described as “optionally substituted,” that group can be substituted with one or more of the above substituents, independently selected for each occasion.
  • the substituent may be one or more methyl groups or one or more hydroxyl groups.
  • the organic acid is an alkyl carboxylic acid.
  • alkyl carboxylic acids include formic acid, acetic acid, propionic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, dodecanoic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, and the like.
  • the organic acid is an alkyl sulfonic acid.
  • alkyl sulfonic acids include propanesulfonic acid and octanesulfonic acid.
  • the alkyl carboxylic or sulfonic acid is substituted with one or more hydroxyl groups.
  • Non-limiting examples include glycolic acid, 4-hydroxybutyric acid, and lactic acid.
  • an organic acid may include more than one carboxylic acid group or more than one sulfonic acid group (e.g., two, three, or more carboxylic acid groups).
  • Non-limiting examples include oxalic acid, fumaric acid, maleic acid, and glutaric acid.
  • organic acids containing multiple carboxylic acids e.g., from two to four carboxylic acid groups
  • one or more of the carboxylic acid groups may be esterified.
  • Non-limiting examples include succinic acid monoethyl ester, monomethyl fumarate, monomethyl or dimethyl citrate, and the like.
  • the organic acid may include more than one carboxylic acid group and one or more hydroxyl groups.
  • Non-limiting examples of such acids include tartaric acid, citric acid, and the like.
  • the organic acid is citric acid, sodium citrate, calcium citrate, or a combination thereof.
  • the organic acid is an aryl carboxylic acid or an aryl sulfonic acid.
  • aryl carboxylic and sulfonic acids include benzoic acid, toluic acids, salicylic acid, benzenesulfonic acid, and / olucncsul Ionic acid.
  • suitable organic acids include 2,2-dichloroacetic acid, 2- hydroxyethanesulfonic acid, 2-oxoglutaric acid, 4-acetamidobenzoic acid, 4-aminosalicylic acid, acetic acid, adipic acid, ascorbic acid (L), aspartic acid (L), camphoric acid (+), camphor- 10-sulfonic acid (+), capric acid, caproic acid, caprylic acid, cinnamic acid, cyclamic acid, decanoic acid, dodecylsulfuric acid, ethane- 1,2-disulfonic acid, ethanesulfonic acid, formic acid, fumaric acid, galactaric acid, gentisic acid, glucoheptonic acid, gluconic acid, glucuronic acid, glutamic acid, glycerophosphoric acid, glycolic acid, hippuric acid, isobutyric acid, lactobionic acid, lauric acid, malonic
  • the one or more organic acids is a single organic acid. In some embodiments, the one or more organic acids is a combination of several acids, such as two, three, or more organic acids.
  • the amount of organic acid present in the composition may vary. Generally, the mixture comprises from about 0.1 to about 10% by weight of organic acid, present as one or more organic acids, based on the total weight of the composition. In some embodiments, the composition comprises about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% organic acid by weight, based on the total weight of the composition.
  • the composition comprises from about 0.1 to about 0.5% by weight of organic acid, for example, about 0.1, about 0.15, about 0.2, about 0.25, about 0.3, about 0.35, about 0.4, about 0.45, or about 0.5% by weight, based on the total weight of the composition.
  • the composition comprises from about 0.25 to about 0.35% by weight of organic acid, for example, from about 0.25, about 0.26, about 0.27, about 0.28, about 0.29, or about 0.3, to about 0.31, about 0.32, about 0.33, about 0.34, or about 0.35% by weight, based on the total weight of the composition.
  • a salt of an organic acid e.g., sodium citrate
  • the percent by weight is calculated based on the weight of the free acid, not including any counter-ion which may be present.
  • Organic acids e.g., citric acid
  • the organic acid is added as a 50% aqueous solution.
  • the composition of the present disclosure can comprise pH adjusters or buffering agents.
  • pH adjusters and buffering agents that can be used include, but are not limited to, metal hydroxides (e.g., alkali metal hydroxides such as sodium hydroxide and potassium hydroxide), and other alkali metal buffers such as metal carbonates (e.g., potassium carbonate or sodium carbonate), or metal bicarbonates such as sodium bicarbonate, and the like.
  • suitable buffers include alkali metals acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, hydrogen carbonates, borates, or mixtures thereof.
  • the buffer is sodium bicarbonate.
  • the buffering agent is typically present in an amount less than about 5% by weight, based on the weight of the composition, for example, from about 0.1% to about 5%, such as, e.g., from about 0.1% to about 1%, or from about 0.1% to about 0.5% by weight, based on the total weight of the composition.
  • a colorant may be employed in amounts sufficient to provide the desired physical attributes to the composition.
  • colorants include various dyes and pigments, such as caramel coloring and titanium dioxide. Natural colorants such as curcumin, beet juice extract, spirulina; also a variety of synthetic pigments may also be used.
  • the amount of colorant utilized in the composition can vary, but when present is typically up to about 3% by weight, such as from about 0.1%, about 0.5%, or about 1%, to about 3% by weight, based on the total weight of the composition.
  • one or more humectants may be employed in the composition.
  • humectants include, but are not limited to, glycerin, propylene glycol, and the like.
  • the humectant is typically provided in an amount sufficient to provide desired moisture attributes to the composition.
  • the humectant may impart desirable flow characteristics to the composition for depositing in a mold.
  • a humectant will typically make up about 5% or less of the weight of the composition (e.g., from about 0.1 to about 5% by weight), for example, from about 0.1% to about 1% by weight, or about 1% to about 5% by weight, based on the total weight of the composition.
  • the composition comprises an oral care ingredient (or mixture of such ingredients).
  • Oral care ingredients provide the ability to inhibit tooth decay or loss, inhibit gum disease, relieve mouth pain, whiten teeth, or otherwise inhibit tooth staining, elicit salivary stimulation, inhibit breath malodor, freshen breath, or the like.
  • effective amounts of ingredients such as thyme oil, eucalyptus oil and zinc (e.g., such as the ingredients of formulations commercially available as ZYTEX® from Discus Dental) can be incorporated into the composition.
  • ingredients that can be incorporated in desired effective amounts within the present composition can include those that are incorporated within the types of oral care compositions set forth in Takahashi et ah, Oral Microbiology and Immunology, 19(1), 61-64 (2004); U.S. Pat. No. 6,083,527 to Thistle; and US Pat. Appl. Pub. Nos. 2006/0210488 to Jakubowski and 2006/02228308 to Cummins et al.
  • Other exemplary ingredients of tobacco containing-formulation include those contained in formulations marketed as MALTISORB® by Roquette and DENTIZYME® by NatraRx.
  • a representative amount of oral care additive is at least about 1%, often at least about 3%, and frequently at least about 5% of the total dry weight of the composition.
  • the amount of oral care additive within the composition will not typically exceed about 30%, often will not exceed about 25%, and frequently will not exceed about 20%, of the total dry weight of the composition.
  • a flow aid can also be added to the composition in order to enhance flowability of the composition.
  • the composition e.g., melt and chew forms
  • Exemplary flow aids include microcrystalline cellulose, silica, polyethylene glycol, stearic acid, calcium stearate, magnesium stearate, zinc stearate, sodium stearyl fumarate, canauba wax, and combinations thereof.
  • the flow aid is sodium stearyl fumarate.
  • a representative amount of flow aid may make up at least about 0.5 percent or at least about 1 percent, of the total dry weight of the composition.
  • the amount of flow aid within the composition will not exceed about 5 percent, and frequently will not exceed about 3 percent, of the total dry weight of the composition.
  • an emulsifier may be added.
  • the emulsifier is lecithin.
  • lecithin e.g., soy lecithin or sunflower lecithin
  • Emulsifiers can be used in an amount of about 0.01 to about 5% by dry weight of the composition, such as from about 0.1 to about 2.5%, or from about 0.1 to about 1.0% based on the total weight of the composition.
  • additives can be included in the disclosed composition.
  • the composition can be processed, blended, formulated, combined, and/or mixed with other materials or ingredients.
  • the additives can be artificial, or can be obtained or derived from herbal or biological sources.
  • further types of additives include thickening or gelling agents (e.g., fish gelatin), emulsifiers, preservatives (e.g., potassium sorbate and the like), disintegration aids, zinc or magnesium salts selected to be relatively water soluble for compositions with greater water solubility (e.g., magnesium or zinc gluconate) or selected to be relatively water insoluble for compositions with reduced water solubility (e.g., magnesium or zinc oxide), or combinations thereof.
  • thickening or gelling agents e.g., fish gelatin
  • emulsifiers e.g., preservatives (e.g., potassium sorbate and the like)
  • disintegration aids e.g., zinc or magnesium salts selected to be relatively water
  • the composition comprises a magnesium salt.
  • a non-limiting example of a suitable magnesium salt is magnesium gluconate.
  • the composition comprises magnesium in an amount by weight from about 0.1% to about 2%, or from about 0.2 to about 1%, based on elemental magnesium.
  • additives can be employed together (e.g., as additive formulations) or separately (e.g., individual additive components can be added at different stages involved in the preparation of the final composition).
  • aforementioned types of additives may be encapsulated as provided in the final product or composition. Exemplary encapsulated additives are described, for example, in WO2010/132444 to Atchley, which has been previously incorporated by reference herein.
  • composition configured for oral use.
  • the term "configured for oral use” as used herein means that the composition is provided in a form such that during use, saliva in the mouth of the user causes one or more of the components of the composition (e.g., flavoring agents and/or active ingredients) to pass into the mouth of the user.
  • the composition is adapted to deliver components to a user through mucous membranes in the user's mouth, the user's digestive system, or both, and, in some instances, said component is an active ingredient (including, but not limited to, for example, a stimulant, vitamin, an amino acid, a botanical, or combinations thereof) that can be absorbed through the mucous membranes in the mouth or absorbed through the digestive tract when the product is used.
  • compositions configured for oral use as described herein may take various forms, including gels, pastilles, gums, chews, melts, tablets, lozenges, powders, and pouches.
  • Gels can be soft or hard.
  • Certain compositions configured for oral use are in the form of pastilles.
  • the term "pastille” refers to a dissolvable oral composition made by solidifying a liquid or gel composition so that the final composition is a somewhat hardened solid gel. The rigidity of the gel is highly variable.
  • Certain compositions of the disclosure are in the form of solids.
  • Certain compositions can exhibit, for example, one or more of the following characteristics: crispy, granular, chewy, syrupy, pasty, fluffy, smooth, and/or creamy.
  • the desired textural property can be selected from the group consisting of adhesiveness, cohesiveness, density, dryness, fracturability, graininess, gumminess, hardness, heaviness, moisture absorption, moisture release, mouthcoating, roughness, slipperiness, smoothness, viscosity, wetness, and combinations thereof.
  • the compositions as disclosed herein can be formed into a variety of shapes, including pills, tablets, spheres, strips, films, sheets, coins, cubes, beads, ovoids, obloids, cylinders, bean-shaped, sticks, or rods.
  • Cross-sectional shapes of the composition can vary, and example cross-sectional shapes include circles, squares, ovals, rectangles, and the like. Such shapes can be formed in a variety of manners using equipment such as moving belts, nips, extruders, granulation devices, compaction devices, and the like.
  • compositions of the present disclosure may be dissolvable.
  • dissolvable refers to compositions having aqueous-soluble components that interact with moisture in the oral cavity and enter into solution, thereby causing gradual consumption of the composition.
  • the dissolvable composition is capable of lasting in the user’s mouth for a given period of time until it completely dissolves. Dissolution rates can vary over a wide range, from about 1 minute or less to about 60 minutes.
  • fast release compositions typically dissolve and/or release the desired component(s) (e.g., active ingredient, flavor, and the like) in about 2 minutes or less, often about 1 minute or less (e.g., about 50 seconds or less, about 40 seconds or less, about 30 seconds or less, or about 20 seconds or less).
  • Dissolution can occur by any means, such as melting, mechanical disruption (e.g., chewing), enzymatic or other chemical degradation, or by disruption of the interaction between the components of the composition.
  • the products do not dissolve during the product’s residence in the user’s mouth.
  • the composition can be chewable, meaning the composition has a mild resilience or "bounce" upon chewing, and possesses a desirable degree of malleability.
  • a composition in chewable form may be entirely dissolving, or may be in the form of a non-dissolving gum in which only certain components (e.g., active ingredients, flavor, sweetener) dissolve, leaving behind a non -dissolving matrix.
  • Chewable embodiments generally include a binder, such as a natural gum or pectin.
  • the composition in chewable form comprises pectin and an organic acid, along with one or more sugar alcohols in an amount by weight of at least 50%, based on the total weight of the composition. Generally, the pectin is present in an amount of from about 1 to about 3% by weight, based on the total weight of the composition.
  • the composition can be meltable as discussed, for example, in US Patent App. Pub. No. 2012/0037175 to Cantrell et ak, incorporated by reference herein in its entirety.
  • “melt,” “melting,” and “meltable” refer to the ability of the composition to change from a solid state to a liquid state. That is, melting occurs when a substance (e.g., a composition as disclosed herein) changes from solid to liquid, usually by the application of heat.
  • the application of heat in regard to a composition as disclosed herein is provided by the internal temperature of a user's mouth.
  • meltable compositions refers to a composition that is capable of liquefying in the mouth of the user as the composition changes phase from solid to liquid, and is intended to distinguish compositions that merely disintegrate in the oral cavity through loss of cohesiveness within the composition that merely dissolve in the oral cavity as aqueous-soluble components of the composition interact with moisture.
  • meltable compositions comprise a lipid as described herein above.
  • the composition in meltable form comprises a lipid in an amount of from about 35 to about 50% by weight, based on the total weight of the composition, and a sugar alcohol in an amount of from about 35 to about 55% by weight, based on the total weight of the composition.
  • the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or a combination thereof. In some embodiments, the sugar alcohol is isomalt.
  • the composition is in the form of a compressed or molded pellet.
  • Example pellet weights range from about 250 mg to about 1500 mg, such as about 250 mg to about 700 mg, or from about 700 mg to about 1500 mg.
  • the pellet can have any of a variety of shapes, including traditional pill or tablet shapes.
  • the composition in tablet form comprises a glucose- polysaccharide blend and a sugar alcohol.
  • the glucose-polysaccharide blend is present in an amount of from about 35 to about 50% by weight, based on the total weight of the composition; and the sugar alcohol is present in an amount of from about 30 to about 45% by weight, based on the total weight of the composition.
  • the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or a combination thereof. In some embodiments, the sugar alcohol is isomalt.
  • compositions of the disclosure are prepared, for example, by dry-blending dry ingredients, such as filler, sweeteners, salts, and the like.
  • dry ingredients such as filler, sweeteners, salts, and the like.
  • water can be added to the dry blend at this stage.
  • the various components of the composition may be contacted, combined, or mixed together using any mixing technique or equipment known in the art.
  • Any mixing method that brings the composition ingredients into intimate contact can be used, such as a mixing apparatus featuring an impeller or other structure capable of agitation.
  • mixing equipment include casing drums, conditioning cylinders or drums, liquid spray apparatus, conical-type blenders, ribbon blenders, mixers available as FKM130, FKM600, FKM1200, FKM2000 and FKM3000 from Littleford Day, Inc., Plough Share types of mixer cylinders, Hobart mixers, and the like. See also, for example, the types of methodologies set forth in US Pat. Nos.
  • the components forming the composition are prepared such that the mixture thereof may be used in a starch molding process for forming the composition. Manners and methods for formulating compositions will be apparent to those skilled in the art. See, for example, the types of methodologies set forth in US Pat. No. 4,148,325 to Solomon et al.; US Pat. No. 6,510,855 to Korte et al.; and US Pat. No. 6,834,654 to Williams, US Pat. Nos. 4,725,440 to Ridgway et al., and 6,077,524 to Bolder et al., each of which is incorporated herein by reference.
  • the composition is in the form of a compressed pellet or tablet.
  • the process for making the pellet or tablet involves first mixing the bulk filler (e.g., EMDEX ® ) and the active ingredients. The remaining composition ingredients (e.g., sugar alcohol and any other desired components, such as binders, colorants, sweeteners, flavors, and the like) are then added.
  • a colorant can may be added to one of the composition components in a separate step prior to mixing with the remaining components of the composition.
  • the mixing of the composition can be accomplished using any mixing device.
  • the final composition is then compressed into pellet or tablet form using conventional tableting techniques and optionally coated.
  • Compressed composition pellets can be produced by compacting the composition, including any associated formulation components, in the form of a pellet, and optionally coating each pellet with an overcoat material.
  • Example compaction devices such as compaction presses, are available as Colton 2216 and Colton 2247 from Vector Corporation and as 1200i, 2200i, 3200, 2090, 3090 and 4090 from Fette Compacting.
  • Devices for providing outer coating layers to compacted pelletized compositions are available as CompuLab 24, CompuLab 36, Accela-Cota 48 and Accela-Cota 60 from Thomas Engineering.
  • a coating typically comprises a film-forming polymer, such as a cellulosic polymer, an optional plasticizer, and optional flavorants, colorants, salts, sweeteners or other additives of the types set forth herein.
  • the coating compositions are usually aqueous in nature and can be applied using any pellet or tablet coating technique known in the art, such as pan coating.
  • Example film-forming polymers include cellulosic polymers such as methylcellulose, hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), hydroxyethyl cellulose, and carboxy methylcellulose.
  • Example plasticizers include aqueous solutions or emulsions of glyceryl monostearate and triethyl citrate. Additional potential coatings include food grade shellac, waxes such as camuaba wax, and combinations thereof.
  • the composition is in chewable form.
  • pectin binder is pre-blended with a portion of the isomalt. Water is added, and the mixture heated to boiling with stirring. Maltitol syrup and any remaining isomalt are added to the boiling mixture, along with the active ingredients (e.g., caffeine, taurine, and vitamin C), followed by trisodium citrate. The mixture is cooked to 78 brix. Heat is removed, and sweetener (e.g., sucralose and acesulfame K) and flavorant added, along with the colorant and citric acid solution (or dicalcium phosphate), and the mixture thoroughly combined. The composition is deposited into starch molds for storage at ambient temperature.
  • the composition is in meltable form.
  • the lipid is typically heated to slightly above the melting temperature such that the lipid is liquefied.
  • active ingredients, flavoring agents, and/or lecithin can be added to the liquefied lipid at this stage.
  • all or a portion of the liquefied lipid can be blended with the dry blend and mixed until the composition reaches the desired level of homogeneity or until the desired textural properties are achieved.
  • the mixture is milled (e.g., in a dry roll mill) until the particle size is less than about 20 microns.
  • the milled isomalt-palm oil is combined with any remaining lipid, and the dry ingredients and flavor mixed in.
  • the base is generally warmed to a fluid consistency.
  • the composition can be divided into discrete portions, such as by pouring the composition into a sheet-like structure, cooling, and then cutting the structure into individual portions, or by depositing the composition into molds and allowing to cool.
  • Example 1 Tablet comprising theanine, GABA, and lemon balm.
  • a composition according to an embodiment of the present disclosure in tablet form was prepared from a composition containing a mixture of fillers, a mixture of theanine, GABA (gamma-aminobutyric acid), and lemon balm as the active ingredient, and additional components as disclosed herein (salt, sweeteners, processing aid).
  • the fillers, sweetener, salt, active ingredients, and processing aid were combined and mixed thoroughly.
  • the mixture was compressed and tableted using a Fette 1200i tablet press.
  • the tablets were coated with wax and shellac.
  • the ingredients of the composition and their concentrations in the composition in weight % are provided in Table 1.
  • the tablets each weighed 1000 mg.
  • Example 2 Tablet comprising caffeine, taurine, and vitamin C.
  • a composition according to an embodiment of the present disclosure in tablet form was prepared from a composition containing a mixture of fillers, a mixture of caffeine, taurine, and vitamin C as the active ingredient, and additional components as disclosed herein (salt, sweeteners, buffer, processing aid) using the method of Example 1.
  • the ingredients of the composition and their concentrations in the composition in weight % are provided in Table 2.
  • the tablets each weighed 1000 mg.
  • Example 3 Tablet comprising caffeine theanine. sunflower lecithin and ginseng.
  • a composition according to an embodiment of the present disclosure in tablet form was prepared from a composition containing a mixture of fillers, a mixture of caffeine, theanine, sunflower lecithin, and ginseng as the active ingredient, and additional components as disclosed herein (salt, sweeteners, buffer, processing aid) using the method of Example 1.
  • the ingredients of the composition and their concentrations in the composition in weight % are provided in Table 3.
  • the tablets each weighed 1000 mg.
  • a composition according to an embodiment of the present disclosure in chewable form was prepared from a composition containing a mixture of fillers, a mixture of caffeine, taurine, and vitamin C as the active ingredient, and additional components as disclosed herein (salt, sweeteners, flavoring agent, water, binder, citric acid, gelation agent).
  • additional components as disclosed herein (salt, sweeteners, flavoring agent, water, binder, citric acid, gelation agent).
  • the ingredients of the composition and their concentrations in the composition in weight% are provided in Table 4.
  • the pectin binder was pre-blended with a portion of the isomalt. Water was added, and the mixture heated to boiling with stirring. Maltitol syrup and any remaining isomalt were added to the boiling mixture, along with the active ingredients (e.g., caffeine, taurine, and vitamin C), followed by trisodium citrate. The mixture was cooked to 78 brix. Heat was removed, and sweetener (e.g., sucralose and acesulfame K, colorant and flavorant were added, along with the citric acid and dicalcium phosphate, and the mixture thoroughly combined, and the composition deposited into starch molds for storage at ambient temperature. The chews each weighed 2600 mg. Table 4 Chewable ingredients
  • Example 5 Chewable comprising theanine. GABA, and lemon balm.
  • a composition according to an embodiment of the present disclosure in chewable form was prepared from a composition containing a mixture of fillers, a mixture of theanine, GABA, and lemon balm as the active ingredient, and additional components as disclosed herein (salt, sweeteners, flavoring agent, water, binder, citric acid, gelation agent) using the method of Example 4.
  • additional components as disclosed herein (salt, sweeteners, flavoring agent, water, binder, citric acid, gelation agent) using the method of Example 4.
  • the ingredients of the composition and their concentrations in the composition in weight % are provided in Table 5.
  • the chews each weighed 2600 mg. Table 5.
  • a composition according to an embodiment of the present disclosure in chewable form was prepared from a composition containing a mixture of fillers, a mixture of caffeine, theanine, and ginseng as the active ingredient, and additional components as disclosed herein (salt, sweeteners, flavoring agent, water, binder, citric acid, gelation agent) using the method of Example 4.
  • additional components as disclosed herein (salt, sweeteners, flavoring agent, water, binder, citric acid, gelation agent) using the method of Example 4.
  • the ingredients of the composition and their concentrations in the composition in weight % are provided in Table 6.
  • the chews each weighed 2600 mg.
  • Example 7 Meltable comprising theanine. GABA and lemon balm.
  • a composition according to an embodiment of the present disclosure in meltable form was prepared from a composition containing a filler, a lipid, a mixture of theanine, GABA, and lemon balm as the active ingredient, and additional components as disclosed herein (salt, sweeteners, flavoring agent). The ingredients of the composition and their concentrations in the composition in weight % are provided in Table 7.
  • a portion of the palm oil was melted and mixed with the isomalt in a mixer. The mixture was transferred to a dry roll mill and milled until the particle size was less than 20 microns. In a mixer, the milled isomalt-palm oil was combined with the remaining portion of palm oil.
  • the base was warmed to a fluid consistency. Sunflower oil, the dry ingredients, and flavor were mixed in.
  • the isomalt-palm oil- ingredient mixture was transferred to a heated depositing funnel.
  • the appropriate weight of the samples was deposited into a shape mold. If needed, the mold was placed on a vibrator to ensure even filling. The product was allowed to cool and solidify, then removed from the mold. The melts each weighed 1300 mg.
  • Example 8 Meltable comprising theanine. caffeine and ginseng.
  • a composition according to an embodiment of the present disclosure in meltable form was prepared from a composition containing a filler, a lipid, a mixture of theanine, caffeine, and ginseng as the active ingredient, and additional components as disclosed herein (salt, sweeteners, flavoring agent, buffer) using the method of Example 7.
  • the ingredients of the composition and their concentrations in the composition in weight % are provided in Table 8.
  • the melts each weighed 1300 mg.
  • Example 9 Meltable comprising taurine, caffeine, and vitamin C.
  • a composition according to an embodiment of the present disclosure in meltable form was prepared from a composition containing a filler, a lipid, a mixture of taurine, caffeine, and vitamin C as the active ingredient, and additional components as disclosed herein (salt, sweeteners, flavoring agent, buffer, emulsifier) using the method of Example 7.
  • additional components as disclosed herein (salt, sweeteners, flavoring agent, buffer, emulsifier) using the method of Example 7.
  • the ingredients of the composition and their concentrations in the composition in weight % are provided in Table 9.
  • the melts each weighed 1300 mg.

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Abstract

L'invention concerne des compositions conçues pour une utilisation orale, les compositions comprenant au moins un principe actif choisi parmi la caféine, la taurine, le GABA, la théanine, le tryptophane, la vitamine B6, la vitamine B12, la vitamine C, un extrait de citronnelle, le ginseng, la citicoline, la lécithine de tournesol, ou des combinaisons de ceux-ci. Les compositions comprennent une ou plusieurs charges, comprenant un alcool de sucre, et facultativement, un lipide ou un liant. Les compositions peuvent être sous forme masticable, comprimée ou dispersible.
EP20825241.1A 2019-12-09 2020-12-04 Produits oraux à combinaisons de principes actifs Pending EP4072534A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US16/706,974 US20210169129A1 (en) 2019-12-09 2019-12-09 Lipid-containing oral composition
US202063036254P 2020-06-08 2020-06-08
PCT/IB2020/061472 WO2021116854A1 (fr) 2019-12-09 2020-12-04 Produits oraux à combinaisons de principes actifs

Publications (1)

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EP4072534A1 true EP4072534A1 (fr) 2022-10-19

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EP (1) EP4072534A1 (fr)
JP (1) JP2023504753A (fr)
AU (1) AU2020399281A1 (fr)
BR (1) BR112022010985A2 (fr)
CA (1) CA3161102A1 (fr)
MX (1) MX2022007020A (fr)

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BR112022010985A2 (pt) 2022-08-23
MX2022007020A (es) 2022-08-19
CA3161102A1 (fr) 2021-06-17
JP2023504753A (ja) 2023-02-06
AU2020399281A1 (en) 2022-07-07

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