WO2009007768A1 - Comprimé comprenant un polyol - Google Patents

Comprimé comprenant un polyol Download PDF

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Publication number
WO2009007768A1
WO2009007768A1 PCT/IB2007/001899 IB2007001899W WO2009007768A1 WO 2009007768 A1 WO2009007768 A1 WO 2009007768A1 IB 2007001899 W IB2007001899 W IB 2007001899W WO 2009007768 A1 WO2009007768 A1 WO 2009007768A1
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WO
WIPO (PCT)
Prior art keywords
compressed
tablet
tablet according
compressed tablet
agents
Prior art date
Application number
PCT/IB2007/001899
Other languages
English (en)
Inventor
Bitten Thorengaard
Carsten Andersen
Original Assignee
Gumlink A/S
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
Application filed by Gumlink A/S filed Critical Gumlink A/S
Priority to PCT/IB2007/001899 priority Critical patent/WO2009007768A1/fr
Publication of WO2009007768A1 publication Critical patent/WO2009007768A1/fr

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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
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/0002—Processes of manufacture not relating to composition and compounding ingredients
    • A23G3/0004—Processes specially adapted for manufacture or treatment of sweetmeats or confectionery
    • A23G3/0019—Shaping of liquid, paste, powder; Manufacture of moulded articles, e.g. modelling, moulding, calendering
    • A23G3/0025—Processes in which the material is shaped at least partially in a mould in the hollows of a surface, a drum, an endless band, or by a drop-by-drop casting or dispensing of the material on a surface, e.g. injection moulding, transfer moulding
    • A23G3/004—Compression moulding of paste, e.g. in the form of a ball or rope or other preforms, or of a powder or granules
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G4/00—Chewing gum
    • A23G4/02—Apparatus specially adapted for manufacture or treatment of chewing gum
    • A23G4/04—Apparatus specially adapted for manufacture or treatment of chewing gum for moulding or shaping
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G4/00—Chewing gum
    • A23G4/06—Chewing gum characterised by the composition containing organic or inorganic compounds
    • A23G4/10—Chewing gum characterised by the composition containing organic or inorganic compounds characterised by the carbohydrates used, e.g. polysaccharides
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G4/00—Chewing gum
    • A23G4/06—Chewing gum characterised by the composition containing organic or inorganic compounds
    • A23G4/12—Chewing gum characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G4/00—Chewing gum
    • A23G4/18—Chewing gum characterised by shape, structure or physical form, e.g. aerated products
    • A23G4/20—Composite products, e.g. centre-filled, multi-layer, laminated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat

Definitions

  • the invention relates to a compressed tablet according to the provisions of claim 1.
  • compressed tablets have been known for decades and prior art documents have indicated that compressed tablets have the advantage of being especially suitable for delivery of active ingredients.
  • Another problem related to active ingredients in compressed chewing gum is that the use of active ingredients in compressed chewing gum may require several considerations with respect to the active ingredients when incorporated into the chewing gum.
  • the invention relates to a compressed tablet for release of active ingredients, the tablet comprising at least one polyol sweetener, at least one active ingredient and compressed particles of chewing gum base material, wherein the content of polyol is between 21 and 95% by weight of the tablet, and wherein the tablet being compressed at an ambient temperature of below 25 degrees Celsius and a maximum relative humidity of 55.
  • a compressed tablet which possesses acceptable stability of the active ingredient and furthermore has improved taste-masking or taste-matching abilities with respect to active ingredients.
  • This is obtained through the addition of large amounts of polyol sweeteners in the tablet in combination with certain conditions of the compression process, namely appropriate relative humidity and temperature conditions as it has been determined that a strict process requirement with respect to stability may in fact loosen the requirements in particular with respect to polyol sweetener(s) thereby obtaining significant improvement of taste due to increased and more appropriate use of bulk sweetening polyols.
  • polyols may be applicable in larger amounts than expected even when applying hygroscopic polyol(s) which are more cost-efficient than low- hygroscopic sweeteners traditionally used to avoid moisture levels in the tablet affecting the active ingredients.
  • the tablet is compressed at an ambient temperature of below 20°C.
  • a higher temperature during the compression process may lead to a higher tendency of sticking between the particles/tablet and the machinery. Therefore, the temperature may not be too high in order to minimize downtime for the machinery due to cleaning and to avoid slightly deformed tablets.
  • the tablet is compressed at an ambient temperature of above 0°C, preferably above 5°C.
  • the tablet is compressed at an ambient temperature above 10°C to ensure being above the dewpoint of the room of compression process.
  • the tablet is compressed at an ambient temperature of 0-25 0 C, preferably 10-20°C, most preferably 15-20°C.
  • the content of polyol sweetener is between 25 and 95% by weight of the tablet.
  • a high content of polyol sweetener may thus result in an advantageous possibility of taste regulation as release of polyol sweeteners from a chewing gum as an attractive and cost-efficient way of obtaining a certain desired taste profile.
  • the content of polyol sweetener is between 30 and 95% by weight of the tablet.
  • said polyol sweetener is selected from the group consisting of sorbitol, maltitol, mannitol, xylitol, erythritol, lactitol and isomalt and variations thereof.
  • sweetening agents may be applied within the scope of the invention.
  • Mannitol is known to be a low-hygroscopic polyol and hence useable as sweetener to avoid too high a moisture content of the final product.
  • mannitol is also known to possess less sweetening effect than most other polyols and is therefore not considered suitable as the single sweetening agent of the product.
  • Mannitol may be used as a sweetener in a tablet according to the present invention but in order to obtain a satisfying product it is mostly preferred that the use of mannitol implies a combination with another polyol.
  • said polyol sweetener is combined with a further non-polyol sweetener.
  • non-polyol sweeteners are high-intensity sweeteners, sugar containing sweeteners, sucrose, dextrose or the like.
  • the tablet is compressed with a compression force above 15kN.
  • the tablet is compressed with a compression force above 2OkN. It has been shown that the use of a higher compression pressure leads to an improved crunch feel when chewing the tablet. Hence, in most embodiments it may be advantageous to use a compression force above 2OkN.
  • the tablet is compressed with a compression force above 15kN and below 12OkN.
  • the applied compression force is commercially attractive as the pressure may be obtained by generally available machinery without requirement for significant design modifications.
  • the amount of water is below 2% by weight of the compressed tablet prior to compression.
  • the amount of water is below 2% by weight of the compressed tablet after compression.
  • the amount of water is below 2% by weight of the compressed tablet after further storage.
  • the amount of water is below 2% by weight of the compressed tablet after 180 days of storage.
  • Moisture is preferably kept low both prior to compression and after compression and storage in order to avoid a deterioration of the resulting tablet.
  • Hygroscopic polyols are known to attract moisture and use of these in higher amounts is therefore expected to result in high moisture content of the resulting tablet.
  • the invention relates to a compressed tablet comprising a first compressed module according to any of the preceding claims cohered to a second compressed module including mainly tablet material.
  • Tablet material in this document may be combinations of e.g. filler, coloring agent, flavoring agent, high-intensity sweetener, bulk sweetener, softener, emulsif ⁇ er, acidulant, antioxidant and more.
  • the invention relates to a compressed tablet comprising a first compressed gum base-containing module according to any of the preceding claims cohered to a second compressed module including mainly tablet material and substantially free of gum base.
  • the tablet comprising at least 5% gum base by weight of the tablet.
  • the tablet comprising at least 10% gum base by weight of the tablet.
  • the second compressed module comprising at least 0.02% by weight of mint.
  • the first compressed module comprising at least 0.5% by weight of mint.
  • said second compressed module comprises said active ingredient.
  • said first and second compressed module comprises active ingredients.
  • Active ingredients such as pharmaceutically active ingredients, flavor, sweeteners, . etc. may be applied in tablet modules having different content or concentration of gum base, thereby obtaining a regulation of the release profile.
  • prolongation of release of an active ingredient during chew may be obtained when incorporating the active ingredients into a gum base-containing gum base-containing layer.
  • a modifying release profile may be obtained by adding active ingredients to modules having the desired release tendency based on gum base content.
  • said first compressed module is substantially free of pharmaceutically active ingredient.
  • the first compressed module is substantially free of active ingredient(s). This is particularly relevant when the active ingredient(s) are pharmaceuticals, for which a precise dosage may be extremely important and it may be easier to establish the intended dosage in the second compressed module.
  • the active ingredients are e.g. high-intensity sweeteners placing them in both the first and the second compressed module may be relevant.
  • said tablet consists of one module, such as a one- layered tablet.
  • the tablet comprises at least two modules and wherein at least one of said modules comprises a chewing gum tablet module comprising at least one active ingredient and less than 5% gum base by weight of the module.
  • said compressed tablet comprises more than two compressed modules.
  • more than two modules such as three, four, five or six, may be applied in tablets.
  • said active ingredient is part of an encapsulation or inclusion complex.
  • An inclusion complex may advantageously be applied for the purpose of controlling the stability, release and effect of a relevant active ingredient.
  • said active ingredient is part of an inclusion complex within cyclodextrin.
  • said active ingredient comprises one or more high-intensity sweeteners.
  • one or more high-intensity sweeteners such as aspartame or acesulfame K may advantageously be applied in tablets.
  • said tablet comprises at least 0.05% by weight of high-intensity sweeteners.
  • said active ingredient is selected from the group consisting of cetirizine, nicotine, metformin, metformin-HCL, phenylephrine, deca- peptide KSL-W, acesulfame K, aspartame, citric acid, malic acid, vitamin C, resveratrol, any variation thereof or any combination thereof.
  • said active ingredient is a pharmaceutically active ingredient.
  • said active ingredient is selected from the group consisting of pharmaceuticals, nutraceuticals, medicaments, nutrients, nutritional supplements, drugs, dental care agents, herbals, and the like and combinations thereof.
  • Booster Fiber, Probiotics, Prebiotics, Antimicrobial agent, NSAID, Anti-tussives, Decongestants, Anti-histamines, Anti-diarrheals, Hydrogen antagonists, Proton pump inhibitors, General nonselective CNS depressants, General nonselective CNS stimulants, Selectively CNS function modifying drugs, Antiparkinsonism, Narcotic- analgetics, Analgetic-antipyretics, Psychopharmacological drugs, diagnostica sex hormones allergens, antifungal agents, Chronic Obstructive Pulmonary Disease (COPD) or any combination thereof.
  • COPD Chronic Obstructive Pulmonary Disease
  • said active ingredient is selected from the group consisting of: ace-inhibitors, antianginal drugs, antiarrhythrmas, anti-asthmatics, anti-cholesterolemics, analgesics, anesthetics, anticonvulsants, anti-depressants, anti- diabetic agents, anti-diarrhea preparations, antidotes, anti-histamines, antihypertensive drugs, anti-inflammatory agents, anti-lipid agents, antimanics, anti- nauseants, anti-stroke agents, anti-thyroid preparations, anti-tumor drugs, anti-viral agents, acne drugs, alkaloids, amino acid preparations, anti-tussives, antiuricemic drugs, anti-viral drugs, anabolic preparations, systemic and non-systemic antiinfective agents, anti-neoplasties, antiparkinsonian agents, anti-rheumatic agents, appetite stimulants, biological response modifiers, blood modifiers, bone metabolism regulators,
  • said active ingredient is selected from the group consisting of metformin, cetirizine, levo cetirizine, phenylephrine, flurbiprofen, nicotine, nicotine bitartrate, nicotine polacrilex, nicotine in combination with alkaline agents, nicotine in combination with caffeine, sodium picosulfate, fluor, fluor in combination with fruit acids, chlorhexidine, or any derivatives thereof, salts thereof, isomers thereof, nicotine antagonists, combinations thereof or compounds comprising one or more of these.
  • said active ingredient is selected from the group consisting of ephedrine, pseudo ephedrine, caffeine, loratadine, sildenafil, simvastatin, sumatriptan, acetaminophen, calcium carbonate, vitamin D, ibuprofen, aspirin, alginic acid in combination with aluminum hydroxide and sodium bicarbonate, ondansetron, Tibolon, Rimonabant, Varenicline, allergenes, sitagliptin or any derivatives thereof, salts thereof, isomers thereof, combinations thereof or compounds comprising one or more of these.
  • said active ingredient is selected from the group consisting of phytochemicals, such as resveratrol and anthocyanine; herbals, such as green tea or thyme; antioxidants, such as polyphenols; micronutrients; mouth moisteners, such as acids; throat soothing ingredients; appetite suppressors; breath fresheners, such as zinc compounds or copper compounds; diet supplements; cold suppressors; cough suppressors; vitamins, such as vitamin A, vitamin C or vitamin E; minerals, such as chromium; metal ions; alkaline materials, such as carbonates; salts; herbals, dental care agents, such as remineralisation agents, antibacterial agents, anti- caries agents, plaque acid buffering agents, tooth whiteners, stain removers or desensitizing agents; and combinations thereof.
  • phytochemicals such as resveratrol and anthocyanine
  • herbals such as green tea or thyme
  • antioxidants such as polyphenols
  • mouth moisteners such as acids
  • throat soothing ingredients such as acids
  • said active ingredient is selected from the group consisting of di-peptides, tri-peptides, oligo-peptides, deca-peptides, deca-peptide KSL, deca-peptide KSL-W, amino acids, proteins, or any combination thereof.
  • said active ingredient comprises a probiotic bacteria, such as lactobacilli, bifidobacteria, lactococcus, streptococcus, leuconostoccus, pediococcus or enterococcus.
  • said active ingredient comprises a prebiotic, such as fructose, galactose, mannose, insulin or soy.
  • the diameter of said tablet is above 10mm.
  • the content of gum base is at least 6% by weight of the tablet
  • a compressed chewing gum tablet should at least comprise 6% of gum base by weight in order to perform as a chewing gum with respect to texture and release properties when chewed.
  • more gum base may be applied as the gum base ends up forming the residue the chewer is chewing on when the main part of the chewing gum ingredients have been released. This part of the chewing should not be too small.
  • the content of gum base is at least 8% by weight of the tablet.
  • the gum base content is above about 6 to 8% by weight of the chewing gum tablet in order to establish a chewing gum which does not disintegrate during the initial or subsequent chewing phase.
  • the content of gum base is at least 10% by weight of the tablet.
  • more than 10% gum base by weight of the tablet may be applied as the gum base ends up forming the residue the chewer is chewing on when the main part of the chewing gum ingredients have been released
  • the particles have average particle sizes within the range of 200 - 5000 ⁇ m, preferably in the range of 200 - 2000 ⁇ m.
  • the gum base contained in the particles comprises in the range of 20 % to 90 % by weight of the particles.
  • the compressed tablet has a volume above 0.15 cm 3 .
  • the compressed tablet is compressed at a pressure of more than 10 kN/cm 2
  • said compressed tablet is packed in a controlled atmosphere.
  • the compressed tablet is in a form selected from the group consisting of a pellet, a cushion-shaped pellet, a stick, a tablet, a chunk, a pastille, a pill, a ball and a sphere, a figure, a box-shaped product, an edged product, a rounded product or any combination thereof.
  • the tablet is provided with an outer coating.
  • the chewing gum tablet comprises i) a first module of compressed chewing gum granules containing gum base, ii) a second module of compressed material, and iii) a centre filling of liquid, semi-liquid or solid material, said filling being a separate compartment located between said first and second layer and said filling being fully encapsulated within said compressed chewing gum tablet.
  • said chewing gum base material comprises softener, flavor, sweetener and optionally filler.
  • the tablet is enclosed by an exterior protective barrier.
  • the protective barrier should form a humidity barrier.
  • the protective barrier should form a humidity barrier for the enclosed tablet to minimize the risk of subsequent moisture absorption.
  • the exterior protective barrier is a blister pack, can, etc.
  • said tablet comprises a compressible chewing gum composition
  • a compressible chewing gum composition comprising i) chewing gum granules containing gum base ii) particles of one or more encapsulation delivery systems comprising at least one encapsulation material and at least one active ingredient being encapsulated by the encapsulation material, wherein the encapsulation material comprises at least one natural resin.
  • the invention relates to a method of manufacturing a compressed tablet according to any of the claims 1-59, the tablet being compressed at an ambient temperature of below 25 °C and a maximum relative humidity of 55 %. Moreover the invention relates to a method of manufacturing a compressed tablet according to any of the claims 1-59, wherein the tablet is formed by compression of particles of chewing gum base material, wherein the content of gum base is at least 5% by weight of the tablet and wherein the chewing gum tablet is compressed at a pressure of more than 12 kN/cm 2 and wherein the chewing gum tablet has a volume above 0.15 cm 3 .
  • the particles of chewing gum base material are produced by means of cutting during an extrusion process.
  • the particles of chewing gum base material are produced by means of particulating a cooled chewing gum or gum base material.
  • granule and particle are used interchangeably in the sense that a granule or particle for use in a compression process is regarded to be a relatively small object, which together with other granules or particles may be compressed into a stable chewing gum tablet.
  • the granules or particles may be produced in several different ways.
  • a gum base-containing granule of particle may typically be produced substantially into the desired shape or size by means of an extrusion process or alternatively be produced on the basis of a gum base-containing mass which is subsequently separated into particles of a smaller size.
  • Several different processes are also within the scope of the present invention.
  • these particles or granules may be produced as indicated above or e.g. by an agglomeration process of very small particles into the desired shape and size.
  • taste masking is a well-known reference to the application of one taste excipient applied for masking an unwanted taste. This unwanted taste may e.g. relate to a taste of a pharmaceutical ingredient.
  • Taste matching is rather understood as taste provider enhancing a desired taste obtained through an active ingredient, such as flavor, high-intensity sweetener, etc.
  • a typical example of such matching is the use of polyol sweetener together with high-intensity sweetener.
  • a taste masking or matching may be more or less complete and e.g. subject to further taste regulating provisions.
  • the applied gum base had the following composition and was prepared as gum base pellets in a conventional mixing process.
  • elastomer 19% by weight natural resin: 20% by weight synthetic resin: 20% by weight fat/fillers: 26% by weight wax: 15% by weight
  • gum base may be prepared by other processes such as a one-step process or any other conventional process.
  • the gum base of example 1 was used in the manufacture of chewing gum products according to embodiments of the invention.
  • Gum base in the form of pellets and aspartame powder (Aspartame, available from Holland Sweetener Company), in an amount of 1% by weight were added to a hopper at a first inlet of the extruder.
  • Menthol flavor crystals (MENTHOL BPIUSP, available from SHARP MENTHOL INDIA LIMITED, India), in an amount of 3% by weight was dosed to a second inlet and mixed to the gum composition in the extruder.
  • the gum composition had the composition as shown in table 1.
  • the extruder delivered the composition at a feed rate of 400 kg/h to the die plate.
  • the extruder screw speed was 247 rpm.
  • the minimum temperature in the extruder was 44°C and a temperature of less than 70°C was maintained along about 3 A of the extruder barrel length, until the composition passed the heating device in the outlet end of the extruder.
  • the composition was heated to an extruder exit temperature of 109°C.
  • the extruder and the granulator produced a pressure difference of 71 bar.
  • the composition was extruded through the die plate, which was heated to a temperature of 177°C and had 696 holes with a diameter of 0.36mm.
  • the extruded composition was cut to granules by a cutter with 8 blades and cutter speed 1999 rpm.
  • the particles were cooled and transported to the strainer unit (a centrifugal dryer TWS 20, available from GALA GmbH, Germany) in water with temperature 11°C and flow 22 m 3 /h.
  • the average cooling and transport time in water was approx. 60 seconds.
  • the particle rate was 400 kg/h and the average diameter of the obtained particles was 0.93mm.
  • the cooling and transport stage carried out in water in this example could be carried out in other media as well such as e.g. air.
  • talc was attached to the granules in between de-watering and conveyance to the tablet pressing apparatus or storing or packaging e.g. for transportation.
  • an alternative method for the manufacturing of gum base-containing granules may be a conventional process involving that an initial gum base-containing mass is cooled to a low temperature, preferably to a temperature below 0°C and the mechanically particulated into small relatively irregular gum base-containing granules. If desired, these particles may be sieved or further processed to obtain a homogeneous granule blend.
  • An example of such alternative process is disclosed in WO 2004/073691 as applied in a multi-layer tablet, hereby incorporated by reference.
  • composition of particles from example 2 was compressed into a tablet according to the following process:
  • composition of particles were mixed into a homogenous blend of particles in a standard mixer with sweeteners (high-intensity sweeteners: aspartame powder and acesulfame K; bulk sweetener: sorbitol, available from CERESTAR Scandinavia NS, Denmark), the active ingredient in this example being the high-intensity sweeteners aspartame powder and acesulfame K.
  • sweeteners high-intensity sweeteners: aspartame powder and acesulfame K; bulk sweetener: sorbitol, available from CERESTAR Scandinavia NS, Denmark
  • active ingredient in this example being the high-intensity sweeteners aspartame powder and acesulfame K.
  • the mixtures passed a standard horizontal vibration sieve removing particles larger than 2.6mm.
  • the mixture was lead to a standard tablet pressing machine comprising dosing apparatus (P 3200 C, available from Fette GmbH, Germany) and pressed into compressed tablets.
  • the tablets were precompressed and then main compressed to a diameter of 16.0mm and a center height of 9mm using a pressing pressure of 33 kN.
  • the precompression step may in this example and the following examples optionally be omitted in some embodiments.
  • a tablet is prepared by use of the composition of particles of example 2 and according to a conventional mechanical mixing procedure as described below.
  • the gum base particles were mixed in a standard mixer with addition of the other ingredients according to a specified time schedule.
  • Nicotine is added in the first half of the mixing process and can e.g. be added as as a nicotine salt or bound to an ion exchange resin, e.g. Amberlite IRP 64.
  • Active ingredients are in this case both high-intensity sweeteners aspartame and acesulfame K and resin-bonded nicotine and flavor.
  • the mixtures passed a standard horizontal vibration sieve removing particles larger than 2.6mm.
  • the mixture was lead to a standard tablet pressing machine comprising dosing apparatus (P 3200 C, available from Fette GmbH, Germany) and pressed into compressed tablets.
  • the filling depth was 7.5mm and the diameter 16.0mm.
  • the tablets were precompressed and then main compressed to a center height of 9mm using a pressing pressure of 33 kN.
  • composition from example 4 was used as a first gum base-containing layer in a double layer tablet in which the second gum base-free layer comprised
  • the high-intensity sweeteners here aspartame and acesulfame K are in this example placed in both the gum base-containing layer and the gum base-free layer.
  • the gum base-containing granules forming the first layer were lead to the mould of a standard tablet pressing machine comprising dosing apparatus (P 3200 C, available from Fette GmbH, Germany). The mixture was then pre-compressed with a force of 15 kN to give a pre-compressed first layer with thickness of approximately 3.5mm.
  • P 3200 C dosing apparatus
  • the gum base-free layer was fed into the mould of the tabletting machine onto the first pre-compressed layer as a homogenous mixture of the above-mentioned ingredients to form a second layer.
  • the first and second layers were then compressed with a force of about 33 kN to form the layered tablet.
  • the individual compressed tablets had a diameter of 16.0mm.
  • composition from example 4 was used as a first gum base-containing layer in a double layer tablet in which the second gum base-free layer comprised
  • Nicotine is in this case added as bound to an ion exchange resin (Amberlite IRP 64), however, it might also be added as a nicotine salt or bound to other ion exchange resins.
  • the active ingredients are in this example both placed in the gum base- containing layer as the high-intensity sweeteners aspartame and acesulfame K and in the gum base-free layer as nicotine and high-intensity sweeteners aspartame and acesulfame K.
  • the gum base-containing granules forming the first layer were lead to the mould of a standard tablet pressing machine comprising dosing apparatus (P 3200 C, available from Fette GmbH, Germany). The mixture was then pre-compressed with a force of 15 kN to give a pre-compressed first layer with thickness of approximately 3.5mm.
  • P 3200 C dosing apparatus
  • the gum base-free layer was fed into the mould of the tabletting machine onto the first pre-compressed layer as a homogenous mixture of particles of the above- mentioned ingredients to form a second layer.
  • the first and second layers were then compressed with a force of about 33 kN to form the layered tablet.
  • the individual compressed tablets had a diameter of 16.0mm.
  • the compression step was performed with various ambient temperatures for investigating the effect of different temperatures, as seen in table 4.
  • the composition comprised about 54% by weight of sorbitol whereas the gum base content has been adjusted to a total of 100% by weight by reducing the gum base content from 40.4% to 33.9% by weight of the tablet.
  • example 4 comprising nicotine was used with the amount and type of polyol varied.
  • the sorbitol was exchanged with mannitol as seen in table 5 and as above, adjustment to 100% of the composition given in example 4 was obtained through adjustment of the gum base content.
  • a total content of mannitol of 20% by weight as in tablet I an inferior masking of the nicotine taste was observed.
  • the addition of more of the low-hygroscopic polyol mannitol as in tablet J resulted in a slightly better masking.
  • the inferior taste-masking in example 8 was concluded to be the result of both a low content of the polyol but especially also the low solubility of mannitol.
  • the water- solubility at 20°C is almost 10 times higher for sorbitol than for mannitol, thereby affecting the possible taste-masking since some amounts of mannitol may proceed into the throat without influencing the perceived sweet taste.
  • Example 9
  • the composition of example 3 was used with an amount of sorbitol varying as indicated in table 6. Again, the gum base content was modified to compensate the variation in sorbitol in order to maintain the percentage of the other compounds of the composition. With a total content of sorbitol of 21% by weight as in tablet K an acceptable matching in taste between high-intensity sweetener and polyol sweetener was established. The addition of more of the high-hygroscopic polyol sorbitol as in tablets L-O resulted in improved overall taste. Generally, an improved taste was observed when the amount of sorbitol was increased as indicated by the "acceptable +"-marking. For all the tablets K-O it was seen that high amounts of sorbitol in the tablet could be used and still result in satisfying properties of the resulting tablet regarding taste- matching, texture, release and low moisture absorption.
  • composition of example 4 comprising nicotine was used with an amount of sorbitol varying as indicated in table 7. Again, the gum base content was modified to compensate the variation in sorbitol in order to maintain the percentage of the other compounds of the composition. With a total content of sorbitol of 21% by weight as in tablet P an acceptable masking of the nicotine taste was observed. The addition of more of the high-hygroscopic polyol sorbitol as in tablets Q-T resulted in better masking of the nicotine taste in spite of the fact that nicotine is one of the active ingredients which is most difficult to mask. Generally, an improved taste masking was observed when the amount of sorbitol was increased.
  • taste masking or matching evaluation has been focused strictly on sweetening masking or matching obtained through release of polyol sweeteners. It should also be noted that further improvement by the application of supplementary taste masking or matching measures, such as flavor, high-intensity sweetener, encapsulation techniques, etc. may be highly advantageous in combination with the provisions of the present invention.
  • examples were provided of a double-layer tablet with a gum base-free layer substantially consisting of a polyol. Again, the gum base content was modified to compensate the variation in polyol in order to maintain the percentage of the other compounds of the composition. Satisfying results with regard to taste- masking were obtained for total polyol content of the double-layer tablet of 25, 35, 45, 55, 65, 75, 85% by weight of the tablet.
  • a buffering system was applied in combination with the resin-bonded nicotine.
  • the tablets U-Y all showed satisfying results regarding masking of the nicotine taste.
  • More polyols could also be possible in combination with the polyol sweeteners mentioned here or others.
  • Example 13 Some combinations of different polyols in the same layer may be possible as well. However, for some combinations a reaction may occur between different polyols in the same layer, which is not desirable.
  • all tablets BA-BH comprises high-intensity sweeteners in the gum base-containing layer, which according to some embodiments of the invention may be omitted in order to obtain tablets comprising only one active ingredient. Further the mentioned different active ingredients may be combined in both the gum base-containing layer and the gum base-free layer.
  • polyol sweeteners may be applied in relatively large amounts as moisture absorption is relatively low even over a long period of time if the storing conditions are controlled appropriately.
  • Chewing gum of the present invention typically comprises a water-soluble portion, a water-insoluble chewable gum base portion and flavouring agents.
  • the water-soluble portion dissipates with a portion of the flavouring agent over a period of time during chewing.
  • the gum base portion is retained in the mouth throughout the chew.
  • the term chewing gum refers to both a chewing and bubble type gum in its general sense.
  • the gum base is the masticatory substance of the chewing gum, which imparts the chew characteristics to the final product.
  • the gum base typically defines the release profile of flavors and sweeteners and plays a significant role in the gum product.
  • the insoluble portion of the gum typically may contain any combination of elastomers, vinyl polymers, elastomer plasticizers, waxes, softeners, fillers and other optional ingredients such as colorants and antioxidants.
  • composition of gum base formulations can vary substantially depending on the particular product to be prepared and on the desired masticatory and other sensory characteristics of the final product.
  • typical ranges (% by weight) of the above gum base components are: 5 to 80% by weight elastomeric compounds, 5 to 80% by weight elastomer plasticizers, 0 to 40% by weight of waxes, 5 to 35% by weight softener, 0 to 50% by weight filler, and 0 to 5% by weight of miscellaneous ingredients such as antioxidants, colourants, etc.
  • the gum base may comprise about 5 to about 95 percent, by weight, of the chewing gum, more commonly, the gum base comprises 10 to about 60 percent of the gum.
  • Elastomers provide the rubbery, cohesive nature to the gum, which varies depending on this ingredient's chemical structure and how it may be compounded with other ingredients.
  • Elastomers suitable for use in the gum base and gum of the present invention may include natural or synthetic types.
  • Elastomer plasticizers vary the firmness of the gum base. Their specificity on elastomer inter-molecular chain breaking (plasticizing) along with their varying softening points cause varying degrees of finished gum firmness and compatibility when used in base. This may be important when one wants to provide more elastomeric chain exposure to the alkanic chains of the waxes.
  • the elastomer compounds may be of natural origin but are preferably of synthetic origin, preferably synthetic polyesters.
  • gum base or gum granules may also include components typically referred to as chewing gum ingredients.
  • the chewing gum may, according to embodiments of the invention, comprise conventionally non-biodegradable polymers, such as natural resins, synthetic resins and/or synthetic or natural elastomers.
  • At least a part of the polymers of the chewing gum are biodegradable.
  • the chewing gum may comprise combinations of biodegradable polymers and polymers generally regarded as non-biodegradable, such as natural resins, synthetic resins and/or synthetic/natural elastomers.
  • said natural resin comprises terpene resins, e.g. derived from alpha-pinene, beta-pinene, and/or d-limonene, natural terpene resins, glycerol esters of gum rosins, tall oil rosins, wood rosins or other derivatives thereof such as glycerol esters of partially hydrogenated rosins, glycerol esters of polymerized rosins, glycerol esters of partially dimerised rosins, pentaerythritol esters of partially hydrogenated rosins, methyl esters of rosins, partially hydrogenated methyl esters of rosins or pentaerythritol esters of rosins and combinations thereof.
  • terpene resins e.g. derived from alpha-pinene, beta-pinene, and/or d-limonene
  • natural terpene resins e.g. derived from alpha
  • Materials to be used for the above-mentioned encapsulation methods might e.g. include Gelatine, Wheat protein, Soya protein, Sodium caseinate, Caseine, Gum arabic, Mod. starch, Hydrolyzed starches (maltodextrines), Alginates, Pectin, Carregeenan, Xanthan gum, Locus bean gum, Chitosan, Bees wax, Candelilla wax, Carnauba wax, Hydrogenated vegetable oils, Zein and/or Sucrose.
  • non-biodegradable synthetic resins examples include polyvinyl acetate, vinyl acetate- vinyl laurate copolymers and mixtures thereof.
  • nonbiodegradable synthetic elastomers include, but are not limited to, synthetic elastomers listed in Food and Drug Administration, CFR, Title 21, Section 172,615, the Masticatory Substances, Synthetic) such as polyisobutylene. e.g. having a gel permeation chromatography (GPC) average molecular weight in the range of about 10,000 to 1,000,000 including the range of 50,000 to 80,000, isobutylene-isoprene copolymer (butyl elastomer), styrene-butadiene copolymers e.g.
  • GPC gel permeation chromatography
  • polyvinyl acetate e.g. having a GPC average molecular weight in the range of 2,000 to 90,000 such as the range of 3,000 to 80,000 including the range of 30,000 to 50,000, where the higher molecular weight polyvinyl acetates are typically used in bubble gum base, polyisoprene, polyethylene, vinyl acetate-vinyl laurate copolymer e.g. having a vinyl laurate content of about 5 to 50% by weight such as 10 to 45% by weight of the copolymer, and combinations hereof.
  • PVA polyvinyl acetate
  • the elastomers (rubbers) employed in the gum base may vary depending upon various factors such as the type of gum base desired, the texture of gum composition desired and the other components used in the composition to make the final chewing gum product.
  • the elastomer may be any water-insoluble polymer known in the art, and includes those gum polymers utilized for chewing gums and bubble gums.
  • suitable polymers in gum bases include both natural and synthetic elastomers.
  • those polymers which are suitable in gum base compositions include, without limitation, natural substances (of vegetable origin) such as chicle gum, natural rubber, crown gum, nispero, rosidinha, jelutong, perillo, niger gutta, tunu, balata, guttapercha, lechi capsi, sorva, gutta kay, and the like, and mixtures thereof.
  • synthetic elastomers include, without limitation, styrene-butadiene copolymers (SBR), polyisobutylene, isobutylene-isoprene copolymers, polyethylene, polyvinyl acetate and the like, and mixtures thereof.
  • Natural resins are: Natural rosin esters, often referred to as ester gums including as examples glycerol esters of partially hydrogenated rosins, glycerol esters of polymerized rosins, glycerol esters of partially dimerized rosins, glycerol esters of tally oil rosins, pentaerythritol esters of partially hydrogenated rosins, methyl esters of rosins, partially hydrogenated methyl esters of rosins, pentaerythritol esters of rosins, synthetic resins such as terpene resins derived from alpha-pinene, beta- pinene, and/or d-limonene, and natural terpene resins.
  • synthetic resins such as terpene resins derived from alpha-pinene, beta- pinene, and/or d-limonene, and natural terpene resins.
  • the chewing gum according to the invention may be provided with an outer coating.
  • the applicable hard coating may be selected from the group comprising of sugar coating and a sugarless coating and a combination thereof.
  • the hard coating may e.g. comprise 50 to 100% by weight of a polyol selected from the group consisting of sorbitol, maltitol, mannitol, xylitol, erythritol, lactitol and Isomalt and variations thereof.
  • the outer coating is an edible film comprising at least one component selected from the group consisting of an edible film-forming agent and a wax.
  • the film-forming agent may e.g.
  • the outer coating comprises at least one additive component selected from the group comprising of a binding agent, a moisture- absorbing component, a film-forming agent, a dispersing agent, an antisticking component, a bulking agent, a flavoring agent, a coloring agent, a pharmaceutically or cosmetically active component, a lipid component, a wax component, a sugar, an acid and an agent capable of accelerating the after-chewing degradation of the degradable polymer.
  • the ingredients may be mixed by first melting the gum base and adding it to the running mixer. Colors, active agents and/or emulsifiers may also be added at this time. A softener such as glycerin may also be added at this time, along with syrup and a portion of the bulking agent/sweetener. Further portions of the bulking agent/sweetener may then be added to the mixer. A flavoring agent is typically added with the final portion of the bulking agent/sweetener. A high-intensity sweetener is preferably added after the final portion of bulking agent and flavor has been added.
  • Chewing gums are formed by extrusion, compression, rolling and may be centre filled with liquids and/or solids in any form.
  • the chewing gum according to the present invention may also be provided with an outer coating, which may be a hard coating, a soft coating, a film coating, or a coating of any type that is known in the art, or a combination of such coatings.
  • the coating may typically constitute 0.1 to 75% by weight of a coated chewing gum piece.
  • One preferred outer coating type is a hard coating, which term is including sugar coatings and sugar-free (or sugarless) coatings and combinations thereof.
  • the object of hard coating is to obtain a sweet, crunchy layer, which is appreciated by the consumer and to protect the gum centers.
  • the gum centers are successively treated in suitable coating equipment with aqueous solutions of crystallizable sugar such as sucrose or dextrose, which, depending on the stage of coating reached, may contain other functional ingredients, e.g. fillers, colors, etc.
  • aqueous solutions of crystallizable sugar such as sucrose or dextrose, which, depending on the stage of coating reached, may contain other functional ingredients, e.g. fillers, colors, etc.
  • the coating agent applied in a hard coating process is a sugarless coating agent, e.g. a polyol including as examples sorbitol, maltitol, mannitol, xylitol, erythritol, lactitol and isomalt or e.g. a mono- di-saccha- ride including as example trehalose.
  • a sugarless coating agent e.g. a polyol including as examples sorbitol, maltitol, mannitol, xylitol, erythritol, lactitol and isomalt or e.g. a mono- di-saccha- ride including as example trehalose.
  • a sugar-free soft coating e.g. comprising alternately applying to the centers a syrup of a polyol or a mono- di-saccharide, including as examples sorbitol, maltitol, mannitol, xylitol, erythritol, lactitol, isomalt and trehalose.
  • a film coating is provided by film-forming agents such as a cellulose derivative, a modified starch, a dextrin, gelatine, zein, shellec, gum arabic, a vegetable gum, a synthetic polymer, etc. or a combination thereof.
  • film-forming agents such as a cellulose derivative, a modified starch, a dextrin, gelatine, zein, shellec, gum arabic, a vegetable gum, a synthetic polymer, etc. or a combination thereof.
  • the outer coating comprises at least one additive component selected from the group comprising a binding agent, a moisture- absorbing component, a film-forming agent, a dispersing agent, an antisticking component, a bulking agent, a flavoring agent, a coloring agent, a pharmaceutically or cosmetically active component, a lipid component, a wax component, a sugar, and an acid.
  • a coated chewing gum center according to the invention may have any form, shape or dimension that permits the chewing gum center to be coated using any conventional coating process.
  • the glass transition temperature (T g ) may be determined by for example DSC (DSC: differential scanning calorimetry).
  • the DSC may generally be applied for determining and studying of the thermal transitions of a polymer and specifically, the technique may be applied for the determination of a second order transition of a material, i.e. a thermal transition that involves a change in heat capacity, but does not have a latent heat.
  • the glass transition is a second-order transition.
  • composition of gum base formulations can vary substantially depending on the particular product to be prepared and on the desired masticatory and other sensory characteristics of the final product.
  • typical ranges of the above gum base components are: 5 to 80% by weight of elastomeric compounds, 5 to 80% by weight of elastomer plasticizers, 0 to 40% by weight of waxes, 5 to 35% by weight of softener, 0 to 50% by weight of filler, and 0 to 5% by weight of miscellaneous ingredients such as antioxidants, colorants, etc.
  • the gum base may comprise about 5 to about 95% by weight of the chewing gum, more commonly; the gum base comprises 10 to about 60% by weight of the gum.
  • Elastomers provide the rubbery, cohesive nature to the gum, which varies depending on this ingredient's chemical structure and how it may be compounded with other ingredients.
  • Elastomers suitable for use in the gum base and gum of the present invention may include natural or synthetic types.
  • Elastomer plasticizers vary the firmness of the gum base. Their specificity on elastomer inter-molecular chain breaking (plasticizing) along with their varying softening points cause varying degrees of finished gum firmness and compatibility when used in gum base. This may be important when one wants to provide more elastomeric chain exposure to the alkanic chains of the waxes.
  • conventional elastomers or resins may be supplemented or substituted by biodegradable polymers.
  • Biodegradable polymers that may be used in the chewing gum of the present invention may be homopolymers, copolymers or terpolymers, including graft- and block-polymers.
  • Useful biodegradable polymers which may be applied as gum base polymers in the chewing gum of the present invention, may generally be prepared by step-growth polymerization of di-, tri- or higher-functional alcohols or esters thereof with di-, tri- or higher-functional aliphatic or aromatic carboxylic acids or esters thereof.
  • hydroxy acids or anhydrides and halides of polyfunctional carboxylic acids may be used as monomers.
  • the polymerization may involve direct polyesterification or transesterification and may be catalyzed.
  • the usually preferred polyfunctional alcohols contain 2 to 100 carbon atoms as for instance polyglycols and polyglycerols.
  • Gum base polymers may both be resinous and elastomeric polymers.
  • alcohols which may be employed as such or as derivatives thereof, include polyols such as ethylene glycol, 1 ,2- propanediol, 1,3 -propanediol, 1,3-butanediol, 1 ,4-butanediol, 1 ,6-hexanediol, diethylene glycol, 1,4-cyclohexanediol, 1 ,4-cyclohexanedimethanol, neopentyl glycol, glycerol, trimethylolpropane, pentaerythritol, sorbitol, mannitol, etc.
  • polyols such as ethylene glycol, 1 ,2- propanediol, 1,3 -propanediol, 1,3-butanediol, 1 ,4-butanediol, 1 ,6-hexanediol, diethylene glycol, 1,4-cyclohexan
  • Suitable examples of environmentally or biologically degradable chewing gum base polymers include degradable polyesters, polycarbonates, polyester amides, polyesterurethanes, polyamides, prolamine, polypeptides, homopolymers of amino acids such as polylysine, and proteins including derivatives hereof such as e.g. protein hydrolysates including a zein hydrolysate.
  • Polyesters which may be applied in accordance with the gum base of the present invention may e.g. be as seen in EP 1 545 234 or EP 0 711 506 as incorporated herein by reference.
  • polymers which may be used in the gum base according to embodiments of the invention comprise: enzymatically hydrolyzed zein, plasticized poly(D,L-lactic acid) and poly(D,L-lactic acid-co-glycolic acid), polyhydroxyalkanoates having side chain lengths of C 4 to C 30 , poly(lactic acid) copolymers selected from the group consisting of poly(lactic acid- dimer fatty acid-oxazoline) copolymers and poly(lactic acid-diol-urethane) copolymers, at least one polyester wherein the polyester includes monomers selected from the group consisting of lactic acid, lactide, glycolic acid, glycolide, citric acid, adipic acid, caprolactone, ethylene oxide, ethylene glycol, propylene oxide, and propylene glycol, and combinations thereof, at least one polyester that is produced through a reaction of glycerol and at least one acid chosen from the group consisting of citric acid, fumaric acid, adipic acid,
  • polyesters formed on the basis of di- or polyfunctional acids and di- or polyfunctional alcohols may be produced according to known methods, one of which includes US2007/043200, hereby incorporated by reference.
  • the prolamine may e.g. be selected from the group consisting of zein, corn gluten meal, wheat gluten, gliadin, glutenin and any combination thereof. Methods of providing such a polymer are disclosed in US2004/001903, hereby incorporated by reference.
  • protein based compounds include but are not limited to prolamine, zein, corn gluten meal, wheat gluten, gliadin, glutenin and combinations thereof.
  • Such suitable biodegradable gum base polymers include polyesters, polycarbonates, polyesteramides, polyesterurethanes, polyamides, prolamine, and combinations thereof.
  • Polycarbonates may typically be co-polymerized with polyesters.
  • Some typically preferred cyclic carbonates which may be used as starting material, may e.g. comprise trimethylene carbonate, 2,2-dimethyltrimethylene carbonate, 2- methyltrimethylene carbonate, 3-methyltrimethylene carbonate, 2,3- dimethyltrimethylene carbonate, 2,4-dimethyltrimethylene carbonate, 2,3,4- trimethyltrimethylene carbonate, 2,3,3 ,4-tetramethyltrimethylene carbonate, etc.
  • suitable polyesteramides can be constructed from monomers of the following groups: dialcohols, such as ethylene glycol, 1,4-butanediol, 1,3- propanediol, 1,6-hexanediol diethylene glycol and others; and/or dicarboxylic acid, such as oxalic acid, succinic acid, adipic acid and others, including those in the form of their respective esters (methyl, ethyl, etc.); and/or hydroxycarboxylic acids and lactones, such as caprolactone and others; and/or amino alcohols, such as ethanolamine, propanolamine, etc.; and/or cyclic lactams, such as .epsilon.- caprolactam or laurolactam, etc.; and/or .omega.
  • dialcohols such as ethylene glycol, 1,4-butanediol, 1,3- propanediol, 1,6-hexanediol
  • -aminocarboxylic acids such as aminocaproic acid, etc.
  • dicarboxylic acids such as adipic acid, succinic acid etc.
  • diamines such as hexamethyl enediamine, diaminobutane, etc.
  • polystyrene resin In the case where the polymer mixture is based extensively on thermoplastic starch and an aromatic polyester, an aliphatic-aromatic copolyester, or a polyesteramide, it may be advantageous to add an aliphatic polyester or copolyester, such as for example polycapro lactone, as a further component.
  • an aliphatic polyester or copolyester such as for example polycapro lactone
  • a polymer mixture consisting of thermoplastic starch, at least one polyethylene terephthalate (PET) or a polyalkylene terephthalate, and polycaprolactone.
  • PET polyethylene terephthalate
  • Other examples of aliphatic polyesters or copolyesters are polylactic acid, polyhydroxybutyric acid, polyhydroxybutyric acid-hydroxyvaleric acid copolymer, and/or mixtures thereof.
  • Suitable polyesters may be obtained through polycondensation polymerization or ring-opening polymerization reactions. Some preferred polyesters include those polymerized from at least one carboxylic acid and at least one aliphatic di- or polyfunctional alcohols.
  • the carboxylic acids may include aromatic dicarboxylic acids and aliphatic di- or polyfuncional carboxylic acids. In some preferred embodiments, the majority of the carboxylic acids are aliphatic.
  • Some of the preferred polyesters according to the invention may e.g. be prepared by step-growth polymerization of di-, tri- or higher-functional alcohols or esters thereof with di-, tri- or higher-functional aliphatic or aromatic carboxylic acids or esters thereof.
  • hydroxy acids or anhydrides and halides of polyfunctional carboxylic acids may be used as monomers.
  • the polymerization may involve direct polyesterification or transesterification and may be catalyzed.
  • Use of branched monomers suppresses the crystallinity of the polyester polymers. Mixing of dissimilar monomer units along the chain also suppresses crystallinity.
  • polyesters examples include oxalic, malonic, citric, succinic, malic, tartaric, fumaric, maleic, glutaric, glutamic, adipic, glucaric, pimelic, suberic, azelaic, sebacic, dodecanedioic acid, etc.
  • aromatic polyfunctional carboxylic acids may be terephthalic, isophthalic, phthalic, trimellitic, pyromellitic and naphthalene 1,4-, 2,3-, 2,6-dicarboxylic acids and the like.
  • aliphatic dicarboxylic acids applied in the polyesters are selected from aliphatic dicarboxylic acids having from 4 to 12 carbons, such as succinic acid, glutaric acid, 2-methylglutaric acid, 3-methylglutaric acid, 2,2- dimethylglutaric acid, adipic acid, pimelic acid, suberic acid, azelaic acid and sebacic acid, higher homologues and stereoisomers and mixtures thereof.
  • Preferred aliphatic dicarboxylic acids in this embodiment are succinic acid, glutaric acid, adipic acid, pimelic acid, azelaic acid and sebacic acid, and mixtures thereof.
  • aromatic dicarboxylic acids applied in the polyesters contain two carboxyl groups which are bound to one aromatic system.
  • the aromatic system is carboaromatic, such as phenyl or naphthyl.
  • the two carboxyl groups may be bound to the same ring or different rings.
  • the aromatic system can also have one or more alkyl groups, for example methyl groups.
  • the aromatic dicarboxylic acid is then generally selected from aromatic dicarboxylic acids having from 8 to 12 carbons, such as phthalic acid, isophthalic acid, terephthalic acid, 1,5- and 2,6-naphthalenedicarboxylic acid.
  • Preferred aromatic dicarboxylic acids in this embodiment are terephthalic acid, isophthalic acid and phthalic acid and mixtures thereof.
  • some usually preferred polyfunctional alcohols suitable for preparing advantageous polyesters according to the invention contain 2 to 100 carbon atoms as for instance polyglycols and polyglycerols.
  • Suitable examples of alcohols which may be employed in the polymerization process as such or as derivatives thereof, includes polyols such as ethylene glycol, 1 ,2-propanediol, 1,3-propanediol, 1,3- butanediol, 1,4-butanediol, 1,6-hexanediol, diethylene glycol, 1 ,4-cyclohexanediol, 1,4-cyclohexanedimethanol, neopentyl glycol, glycerol, trimethylolpropane, pentaerythritol, sorbitol, mannitol, etc.
  • some examples of alcohol derivatives include triacetin, glycerol palmitate, glycerol se
  • chain-stoppers sometimes used are monofunctional compounds. They are preferably either monohydroxy alcohols containing 1-20 carbon atoms or monocarboxylic acids containing 2-26 carbon atoms.
  • General examples are medium or long-chain fatty alcohols or acids, and specific examples include monohydroxy alcohols such as methanol, ethanol, butanol, hexanol, octanol, etc., and lauryl alcohol, myristyl alcohol, cetyl alcohol, stearyl alcohol, stearic alcohol, etc., and monocarboxylic acids such as acetic, lauric, myristic, palmitic, stearic, arachidic, cerotic, dodecylenic, palmitoleic, oleic, linoleic, linolenic, erucic, benzoic, naphthoic acids and substituted napthoic acids, l-methyl-2 naphthoic acid and 2-isopropyl-l -naphthoic acid, etc.
  • monohydroxy alcohols such as methanol, ethanol, butanol, hexanol, octanol, etc., and
  • an acid catalyst or a transesterif ⁇ cation catalyst may be used in such polyester polymerization processes, and non-limiting examples of those are the metal catalysts such as acetates of manganese, zinc, calcium, cobalt or magnesium, and antimony(III)oxide, germanium oxide or halide and tetraalkoxygermanium, titanium alkoxide, zinc or aluminum salts.
  • the metal catalysts such as acetates of manganese, zinc, calcium, cobalt or magnesium, and antimony(III)oxide, germanium oxide or halide and tetraalkoxygermanium, titanium alkoxide, zinc or aluminum salts.
  • the polyesters can for example include copolymers containing any combination of the monomers lactic acid, lactide, glycolic acid, glycolide, citric acid, adipic acid, caprolactone, ethylene oxide, ethylene glycol, propylene oxide, propylene glycol and combinations thereof.
  • polyesters comprising combinations of cyclic monomers including the following:
  • polyester gum base polymers include poly (L- lactide-co-trimethylenecarbonate); poly (L-lactide-co-epsilon-caprolactone); poly (D, L-lactide-co-trimethylenecarbonate); poly (D, L-lactide-co-epsilon-caprolactone); poly (meso-lactide-co-trimethylenecarbonate); poly (mesolactide-co-epsilon- caprolactone); poly (glycolide-cotrimethylenecarbonate); poly (glycolide-co-epsilon- caprolactone), etc.
  • Suitable polyesters are also disclosed in WO 2004/028270, hereby incorporated by reference.
  • the polyesters may be obtained by the reaction between at least one dimer acid and at least one glycol or alcohol.
  • glycols can include, for example, glycerin, propylene glycol, ethylene glycol, poly(ethylene glycol), poly(propylene glycol), poly(ethylene glycol-co-propylene glycol), while such alcohols can include, for example, methanol, ethanol, propanol, and butanol, and such dimer acids can include, for example, adipic acid and citric acid, etc.
  • polyesters include poly(lactic acid), polylactide, poly(glycolic acid), polyglycolide, poly(citric acid), polycaprolactone, polyhydroxyalkanoate, and combinations thereof.
  • prolamines include zein, corn gluten meal, wheat gluten, gliadin, glutenin and combinations thereof.
  • blends of prolamine with polyester such as those disclosed in US 6,858,238, hereby included by reference, may be useful in chewing gum according to the invention.
  • Agglomeration which may be used on e.g. tablet material and active ingredients in an embodiment of the invention may be performed for instance by fluid bed agglomeration, a process known to the person skilled in the art.
  • the chewing gum may include any component known in the chewing gum art.
  • the chewing gum may include elastomers, bulking agents, waxes, elastomer solvents, emulsifiers, plasticizers, fillers, and mixtures thereof.
  • the chewing gum according to the invention may comprise coloring agents.
  • the chewing gum may comprise color agents and whiteners such as FD&C-type dyes and lakes, fruit and vegetable extracts, titanium dioxide and combinations thereof.
  • Further useful chewing gum base components include antioxidants, e.g. butylated hydroxytoluene (BHT), butyl hydroxyanisol (BHA), propylgallate and tocopherols, and preservatives.
  • antioxidants e.g. butylated hydroxytoluene (BHT), butyl hydroxyanisol (BHA), propylgallate and tocopherols, and preservatives.
  • a gum base formulation may, in accordance with the present invention, comprise one or more softening agents e.g. sucrose esters including those disclosed in WO 00/25598, which is incorporated herein by reference, tallow, hydrogenated tallow, hydrogenated and partially hydrogenated vegetable oils, cocoa butter, degreased cocoa powder, glycerol monostearate, glyceryl triacetate, lecithin, mono-, di- and triglycerides, acetylated monoglycerides, lanolin, sodium stearate, potassium stearate, glyceryl lecithin, propylene glycol monostearate, glycerine, fatty acids (e.g.
  • sucrose esters including those disclosed in WO 00/25598, which is incorporated herein by reference, tallow, hydrogenated tallow, hydrogenated and partially hydrogenated vegetable oils, cocoa butter, degreased cocoa powder, glycerol monostearate, glyce
  • softener designates an ingredient, which softens the gum base or chewing gum formulation and encompasses waxes, fats, oils, emulsif ⁇ ers, surfactants and solubilisers.
  • one or more emulsifiers is/are usually added to the composition, typically in an amount of 0 to 18% by weight, preferably 0 to 12% by weight of the gum base.
  • Useful emulsifiers can include, but are not limited to, glyceryl monostearate, propylene glycol monostearate, mono- and diglycerides of edible fatty acids, lactic acid esters and acetic acid esters of mono- and diglycerides of edible fatty acids, acetylated mono and diglycerides, sugar esters of edible fatty acids, Na-, K-, Mg- and Ca-stearates, lecithin, hydroxylated lecithin and the like and mixtures thereof are examples of conventionally used emulsifiers which can be added to the chewing gum base.
  • the formulation may comprise certain specific emulsifiers and/or solubilisers in order to disperse and release the active ingredient.
  • Waxes and fats are conventionally used for the adjustment of the texture and for softening of the chewing gum base when preparing chewing gum bases.
  • any conventionally used and suitable type of natural and synthetic wax and fat may be used, such as for instance rice bran wax, polyethylene wax, petroleum wax (refined paraffin and microcrystalline wax), sorbitan monostearate, tallow, propylene glycol, paraffin, beeswax, carnauba wax, candelilla wax, cocoa butter, degreased cocoa powder and any suitable oil or fat, as e.g. completely or partially hydrogenated vegetable oils or completely or partially hydrogenated animal fats.
  • a chewing gum base formulation may, if desired, include one or more fillers/texturisers including as examples, magnesium and calcium carbonate, sodium sulphate, ground limestone, silicate compounds such as magnesium and aluminum silicate, kaolin and clay, aluminum oxide, silicium oxide, talc, titanium oxide, mono-, di- and tri-calcium phosphates, cellulose polymers, such as wood, and combinations thereof.
  • fillers/texturisers including as examples, magnesium and calcium carbonate, sodium sulphate, ground limestone, silicate compounds such as magnesium and aluminum silicate, kaolin and clay, aluminum oxide, silicium oxide, talc, titanium oxide, mono-, di- and tri-calcium phosphates, cellulose polymers, such as wood, and combinations thereof.
  • a typical chewing gum includes a water soluble bulk portion and one or more flavoring agents.
  • the water-soluble portion may include bulk sweeteners, high-intensity sweeteners, flavoring agents, softeners, emulsifiers, colors, acidulants, buffering agents, fillers, antioxidants, and other components that provide desired attributes.
  • Combinations of sugar and/or non-sugar sweeteners can be used in the chewing gum formulation processed in accordance with the invention. Additionally, the softener may also provide additional sweetness such as aqueous sugar or alditol solutions.
  • Useful sugar sweeteners are saccharide-containing components commonly known in the chewing gum art including, but not limited to, sucrose, dextrose, maltose, dextrins, trehalose, D-tagatose, dried invert sugar, fructose, levulose, galactose, corn syrup solids, and the like, alone or in combination.
  • Sorbitol can be used as a non-sugar sweetener.
  • Other useful non-sugar sweeteners include, but are not limited to, other sugar alcohols such as mannitol, xylitol, maltitol, isomalt, erythritol, lactitol and the like, alone or in combination.
  • High-intensity artificial sweetening agents can also be used alone or in combination with the above sweeteners.
  • Preferred high-intensity sweeteners include, but are not limited to sucralose, aspartame, salts of acesulfame, alitame, neotame, twinsweet, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, stevioside and the like, alone or in combination.
  • Encapsulation of sweetening agents can also be provided using another chewing gum component such as a resinous compound.
  • usage level of the high-intensity artificial sweetener will vary considerably and will depend on factors such as potency of the sweetener, rate of release, desired sweetness of the product, level and type of flavor used and cost considerations.
  • the active level of high-potency artificial sweetener may vary from about 0 to about 8% by weight, preferably 0.001 to about 5% by weight.
  • the usage level of the encapsulated sweetener will be proportionately higher.
  • a low-caloric bulking agent can be used.
  • low caloric bulking agents include polydextrose, Raftilose, Raftilin, fructooligosaccharides (NutraFlora ® ), palatinose oligosaccharides; guar gum hydrolysates (e.g. Sun Fiber ® ) or indigestible dextrins (e.g. Fibersol ® ).
  • other low-calorie bulking agents can be used.
  • the chewing gum according to the present invention may contain aroma agents and flavoring agents including natural and synthetic flavorings e.g. in the form of natural vegetable components, essential oils, essences, extracts, powders, including acids and other substances capable of affecting the taste profile.
  • liquid and powdered flavorings include coconut, coffee, chocolate, vanilla, grape fruit, orange, lime, menthol, liquorice, caramel aroma, honey aroma, peanut, walnut, cashew, hazelnut, almonds, pineapple, strawberry, raspberry, tropical fruits, cherries, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint, fruit essence such as from apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, and plum essence.
  • the essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils of the fruits mentioned above.
  • the chewing gum flavor may be a natural flavoring agent, which is freeze-dried, preferably in the form of a powder, slices or pieces or combinations thereof.
  • the particle size may be less than 3mm, less than 2mm or more preferred less than lmm, calculated as the longest dimension of the particle.
  • the natural flavoring agent may be in a form where the particle size is from about 3 ⁇ m to 2mm, such as from 4 ⁇ m to lmm.
  • Preferred natural flavoring agents include seeds from fruit e.g. from strawberry, blackberry and raspberry.
  • the aroma agent may be used in quantities smaller than those conventionally used.
  • the aroma agents and/or flavors may be used in the amount from 0.01 to about 30% by weight of the final product depending on the desired intensity of the aroma and/or flavor used.
  • the content of aroma/flavor is in the range of 0.2 to 3% by weight of the total composition.
  • the flavoring agents comprise natural and synthetic flavorings in the form of natural vegetable components, essential oils, essences, extracts, powders, including acids and other substances capable of affecting the taste profile.
  • the flavor may be used as taste masking in chewing gum comprising active ingredients, which by themselves have undesired taste or which alter the taste of the formulation.
  • compositions according to the invention include surfactants and/or solubilisers, especially when pharmaceutically or biologically active ingredients are present.
  • surfactants include solubilisers, especially when pharmaceutically or biologically active ingredients are present.
  • solubilisers include H.P. Fiedler, Lexikon der Hilfstoffe fur Pharmacie, Kosmetik und Angrenzende Gebiete, pages 63-64 (1981) and the lists of approved food emulsifiers of the individual countries.
  • Anionic, cationic, amphoteric or non-ionic solubilisers can be used.
  • Suitable solubilisers include lecithin, polyoxyethylene stearate, polyoxyethylene sorbitan fatty acid esters, fatty acid salts, mono and diacetyl tartaric acid esters of mono and diglycerides of edible fatty acids, citric acid esters of mono and diglycerides of edible fatty acids, saccharose esters of fatty acids, polyglycerol esters of fatty acids, polyglycerol esters of interesterified castor oil acid (E476), sodium stearoyllatylate, sodium lauryl sulfate and sorbitan esters of fatty acids and polyoxyethylated hydrogenated castor oil (e.g.
  • CREMOPHOR block copolymers of ethylene oxide and propylene oxide (e.g. products sold under trade names PLURONIC and POLOXAMER), polyoxyethylene fatty alcohol ethers, polyoxyethylene sorbitan fatty acid esters, sorbitan esters of fatty acids and polyoxyethylene steraric acid esters.
  • solubilisers are polyoxyethylene stearates, such as for instance polyoxyethylene(8)stearate and polyoxyethylene(40)stearate, the polyoxyethylene sorbitan fatty acid esters sold under the trade name TWEEN, for instance TWEEN 20 (monolaurate), TWEEN 80 (monooleate), TWEEN 40 (monopalmitate), TWEEN 60 (monostearate) or TWEEN 65 (tristearate), mono and diacetyl tartaric acid esters of mono and diglycerides of edible fatty acids, citric acid esters of mono and diglycerides of edible fatty acids, sodium stearoyllatylate, sodium laurylsulfate, polyoxyethylated hydrogenated castor oil, blockcopolymers of ethylene oxide and propyleneoxide and polyoxyethylene fatty alcohol ether.
  • the solubiliser may either be a single compound or a combination of several compounds.
  • the chewing gum may preferably also
  • Active ingredients may advantageously be applied in a chewing gum according to the invention.
  • Active ingredients generally refer to those ingredients that are included in a delivery system and/or compressible chewing gum composition for the desired end benefit they provide to the user.
  • active ingredients can include medicaments, nutrients, nutraceuticals, herbals, nutritional supplements, pharmaceuticals, drugs, and the like and combinations thereof.
  • active ingredients may refer to flavor components, high-intensity sweeteners or other taste establishing components.
  • Active ingredients may be classified according to The Anatomical Therapeutic Chemical (ATC) classification system, which is a system for classification of medicinal products according to their primary constituent and to the organ or system on which they act and their chemical, pharmacological and therapeutic properties.
  • ATC Anatomical Therapeutic Chemical
  • the first level of the ATC is split into 14 main groups based on the anatomical group: A: Alimentary tract and metabolism
  • H Systemic hormonal preparations, excl. sex hormones and insulins
  • each active ingredient has been given a unique ATC identification code indicating where the active ingredient may be useful.
  • some of the active ingredients mentioned in this document belong to two or more of the mentioned groups, e.g. phenylephrine, which has an ATC identification code in both C, R, and S, i.e. both C01CA06, R01AA04, ROlABOl, R01BA03, SOlFBOl, and S01GA05 are ATC identification codes identifying phenylephrine.
  • active ingredients which can be classified according to the ATC classification mentioned above and which are active ingredients which may be used in a chewing gum granule or a compressed chewing gum according to the invention: Ephedrine, Magaldrate, Pseudoephedrine, Sildenafil, Xylocaine, Benzalconium chloride, Caffeine, Phenylephrine, Amfepramone, Orlistat, Sibutramine, Acetaminophen, Aspirin, Aluminum amino acetate, Aluminum amino acetate in combination with Magnesium oxide, Aluminum oxide hydrate in combination with Magnesiumoxide, Calcium carbonate in combination with Magnesium hydroxide, Calciumcarbonate, Dihydroxy Aluminum sodium carbonate, Magnesiumoxide, Glitazones, Metformin, Chlorpromazine, Dimenhydrinat, Domperidone, Meclozine, Metoclopramide, Odansetron, Prednisolone, Promethazine, A
  • Cimetidine Nizatidine, Ranitidine, Acetylsalicylic acid, Clopidogrel, Acetylcysteine, Bromhexine, Codeine, Dextromethorphan, Diphenhydramine, Noscapine, Phenylpropanolamine, vitamin D, Simvastatin, Bisacodyl, Lactitol, Lactulose, Magnesium oxide, Sodium picosulfate, Senna glycosides, Benzocaine, Lidocaine, Tetracaine, Almotriptan, Eletriptan, Naratriptan, Rizatriptan, Sumatriptan,
  • ChL Chlorhexidine, Fluoride, Lidocaine, Amphotericin, Miconazole, Nystatin, Fish oil, Ginkgo Biloba, Ginseng, Ginger, Purple coneflower, Saw Palmetto, Cetirizine, Levocetirizine, Loratadine, Diclofenac, Flurbiprofen, Acrivastine Pseudoephedrine, Loratadine Pseudoephedrine, Glucosamine, hyaluronic acid, Decapeptide KSL-W, Decapeptide KSL, Resveratrol, Misoprostol, Bupropion, Nicotine, Ondansetron HCl, Esomeprazole, Lansoprazole, Omeprazole, Pantoprazole, Rabeprazole, Bacteria and the like, Loperamide, Simethicone, Acetylsalicylic acid and others, Sucralfate, Vitamin A, Vitamin Bl, Vitamin B 12,
  • Felodipine Nifedipine, Verapamil, Finasteride, Minoxidil, Cocaine, Buphrenorphin, Clonidine, Methadone, Naltrexone, Calciumantagonists, Clonidine, Ergotamine, ⁇ - blockers, Aceclofenac, Celecoxib, Dexiprofen, Etodolac, Indometacin, Ketoprofen, Ketorolac, Lornoxicam, Meloxicam, Nabumetone, Oiroxicam, Parecoxib, Phenylbutazone, Piroxicam, Tiaprofenic acid, Tolfenamic acid, Aripiprazole, Chlorpromazine, Chlorprothixene, Clozapine, Flupentixol, Fluphenazine, Haloperidol, Lithium carbonate, Lithium citrate, Melperone, Penfluridol, Periciazine, Perphenazine, Pimozide, Pipamperone, Pro
  • active ingredients include active ingredients selected from the therapeutical groups comprising: Analgesic, Anaestetic, Antipyretic, Anti allergic, Anti-arrytmic, Appetite suppressant, Antifungal, Anti-inflammatory, Broncho dilator, Cardiovascular drugs, Coronary dilator, Cerebral dilator, Peripheral vasodilator, Anti-infective, Psychotropic, Anti- manic, Stimulant, Antihistamine, Laxative, Decongestant, Gastro-intestinal sedative, sexual dysfunction agent, Desinfectants, Anti-diarrheal, Anti-anginal substance, Vasodilator, Anti-hypertensive agent, Vasoconstrictor, Migraine treating agent, Antibiotic, Tranquilizer, Ntipsychotic, Anti-tumor drug, Anticoagulant, Antithrombotic agent, Hypnotic, Sedative, Anti-emetic, Anti-, auseant, Anticonvulsant, Neuromuscular agent, Hyper and hypo
  • Examples of useful active ingredients include: Casein glyco-macro-peptide (CGMP), Nicotine, Nicotine bitartrate, Nicotine sulphate, Nicotine tartrate, Nicotine pftalate, Nicotine lactate, Nicotinecitrate, Nicotine polacrilex, Triclosan, Cetyl pyridinium chloride, Domiphen bromide, Quarternary ammonium salts, Zinc components, Sanguinarine, Fluorides, Alexidine, Octonidine, EDTA, Aspirin, Acetaminophen, Ibuprofen, Ketoprofen, Diflunisal, Fenoprofen calcium, Naproxen, Tolmetin sodium, Indomethacin, Benzonatate, Caramiphen edisylate, Menthol, Dextromethorphan hydrobromide, Theobromine hydrochloride, Chlophendianol Hydrochloride, Pseudoephedrine Hydrochloride, Phenylephrine, Phen
  • useful active ingredients include active ingredients selected from the groups of ace-inhibitors, antianginal drugs, anti- arrhythmias, anti-asthmatics, anti- cholesterolemics, analgesics, anesthetics, anticonvulsants, anti-depressants, antidiabetic agents, anti-diarrhea preparations, antidotes, anti-histamines, anti- hypertensive drugs, anti-inflammatory agents, anti-lipid agents, anti- manics, anti- nauseants, anti-stroke agents, anti-thyroid preparations, anti-tumor drugs, anti- viral agents, acne drugs, alkaloids, amino acid preparations, anti-tussives, anti- uricemic drugs, anti- viral drugs, anabolic preparations, systemic and non-systemic anti- infective agents, anti-neoplasties, antiparkinsonian agents, anti-rheumatic agents, appetite stimulants, biological response modifiers, blood modifiers, bone metabolism regulators, cardiovascular agents, central nervous system
  • active ingredients contemplated for use in the present invention can include antacids, H2-antagonists, and analgesics.
  • antacid dosages can be prepared using the ingredients calcium carbonate alone or in combination with magnesium hydroxide, and/or aluminum hydroxide.
  • antacids can be used in combination with H2-antagonists.
  • Analgesics include opiates and opiate derivatives, such as OxycontinTM, ibuprofen, aspirin, acetaminophen, and combinations thereof that may optionally include caffeine.
  • anti-diarrheals such as ImmodiumTM AD, anti-histamines, anti-tussives, decongestants, vitamins, and breath fresheners.
  • anxiolytics such as XanaxTM; anti-psychotics such as ClozarilTM and HaldolTM; non-steroidal antiinflammatories (NSAID's) such as ibuprofen, naproxen sodium, VoltarenTM and LodineTM, anti-histamines such as ClaritinTM, HismanalTM, RelafenTM, and TavistTM; antiemetics such as KytrilTM and CesametTM; bronchodilators such as BentolinTM, ProventilTM; anti-depressants such as ProzacTM, ZoloftTM, and PaxilTM; anti-migraines such as ImigraTM, ACE-inhibitors such as VasotecTM, CapotenTM and
  • H2 -antagonists which are contemplated for use in the present invention include cimetidine, ranitidine hydrochloride, famotidine, nizatidien, ebrotidine, mifentidine, roxatidine, pisatidine and aceroxatidine.
  • Active antacid ingredients can include, but are not limited to, the following: aluminum hydroxide, dihydroxyaluminum aminoacetate, aminoacetic acid, aluminum phosphate, dihydroxyaluminum sodium carbonate, bicarbonate, bismuth aluminate, bismuth carbonate, bismuth subcarbonate, bismuth subgallate, bismuth subnitrate, bismuth subsilysilate, calcium carbonate, calcium phosphate, citrate ion (acid or salt), amino acetic acid, hydrate magnesium aluminate sulfate, magaldrate, magnesium aluminosilicate, magnesium carbonate, magnesium glycinate, magnesium hydroxide, magnesium oxide, magnesium trisilicate, milk solids, aluminum mono-ordibasic calcium phosphate, tricalcium phosphate, potassium bicarbonate, sodium tartrate, sodium bicarbonate, magnesium aluminosilicates, tartaric acids and salts.
  • a variety of nutritional supplements may also be used as active ingredients including virtually any vitamin or mineral.
  • Examples of nutritional supplements that can be used as active ingredients are set forth in U.S. Patent Application Publication Nos.
  • Herbals are generally aromatic plants or plant parts and or extracts thereof that can be used medicinally or for flavoring. Suitable herbals can be used singly or in various mixtures. Commonly used herbs include Echinacea, Goldenseal, Calendula, Rosemary, Thyme, Kava Kava, Aloe, Blood Root, Grapefruit Seed Extract, Black Cohosh, Ginseng, Guarana, Cranberry, Ginko Biloba, St. John's Wort, Evening Primrose Oil, Yohimbe Bark, Green Tea, Ma Huang, Maca, Bilberry, Lutein, and combinations thereof.
  • the release profile of the ingredient can be managed for a compressible gum by managing various characteristics of the ingredient, delivery system containing the ingredient, and/or the compressible chewing gum containing the delivery system and/or how the delivery system is made.
  • characteristics might include one or more of the following: tensile strength of the delivery system, water solubility of the ingredient, water solubility of the encapsulating material, water solubility of the delivery system, ratio of ingredient to encapsulating material in the delivery system, average or maximum particle size of ingredient, average or maximum particle size of ground delivery system, the amount of the ingredient or the delivery system in the compressible chewing gum, ratio of different polymers used to encapsulate one or more ingredients, hydrophobicity of one or more polymers used to encapsulate one or more ingredients, hydrophobicity of the delivery system, the type or amount of coating on the delivery system, the type or amount of coating on an ingredient prior to the ingredient being encapsulated, etc.
  • the release profiles of one or more components of an effervescing system are managed for a compressible gum.
  • the effervescent system may include one or more edible acids and one or more edible alkaline materials.
  • the edible acid(s) and the edible alkaline material(s) may react together to generate effervescence.
  • the alkaline material(s) may be selected from, but is not limited to, alkali metal carbonates, alkali metal bicarbonates, alkaline earth metal carbonates, alkaline earth metal bicarbonates, and combinations thereof.
  • the edible acid(s) may be selected from, but is not limited to, citric acid, phosphoric acid, tartaric acid, malic acid, ascorbic acid, and combinations thereof.
  • an effervescing system may include one or more other ingredients such as, for example, carbon dioxide, oral care ingredients, flavorants, etc.
  • encapsulation of the one or more ingredients in an effervescing system will result in a delay in the release of the predominant amount of the one or more ingredients during consumption of a compressible chewing gum that includes the encapsulated one or more ingredients (e.g., as part of a delivery system added as an ingredient to the compressible chewing gum composition).
  • the release profile of the one or more ingredients can be managed for a compressible gum by managing various characteristics of the ingredient, delivery system containing the ingredient, and/or the compressible chewing gum containing the delivery system and/or how the delivery system is made.
  • characteristics might include one or more of the following: tensile strength of the delivery system, water solubility of the ingredient, water solubility of the encapsulating material, water solubility of the delivery system, ratio of ingredient to encapsulating material in the delivery system, average or maximum particle size of ingredient, average or maximum particle size of ground delivery system, the amount of the ingredient or the delivery system in the compressible chewing gum, ratio of different polymers used to encapsulate one or more ingredients, hydrophobicity of one or more polymers used to encapsulate one or more ingredients, hydrophobicity of the delivery system, the type or amount of coating on the delivery system, the type or amount of coating on an ingredient prior to the ingredient being encapsulated, etc.
  • the release profiles of one or more appetite suppressors are managed for a compressible gum.
  • Appetite suppressors can be ingredients such as fiber and protein that function to depress the desire to consume food.
  • Appetite suppressors can also include benzphetamine, diethylpropion, mazindol, phendimetrazine, phentermine, hoodia (P57), OlibraTM, ephedra, caffeine and combinations thereof.
  • Appetite suppressors are also known by the following trade names: AdipexTM, AdipostTM, BontrilTM PDM, BontrilTM Slow Release, DidrexTM, FastinTM, IonaminTM, MazanorTM, MelfiatTM, ObenixTM, PhendietTM, Phendiet-105TM, PhentercotTM, PhentrideTM, PlegineTM, Prelu-2TM, Pro-FastTM, PT 105TM, SanorexTM, TenuateTM, SanorexTM, TenuateTM, Tenuate DospanTM, Tepanil Ten-TabTM,
  • encapsulation of the appetite suppressor will result in a delay in the release of the predominant amount of the appetite suppressor during consumption of a compressible chewing gum that includes the encapsulated appetite suppressor (e.g., as part of a delivery system added as an ingredient to the compressible chewing gum).
  • the release profile of the ingredient e.g., the appetite suppressor
  • characteristics might include one or more of the following: tensile strength of the delivery system, water solubility of the ingredient, water solubility of the encapsulating material, water solubility of the delivery system, ratio of ingredient to encapsulating material in the delivery system, average or maximum particle size of ingredient, average or maximum particle size of ground delivery system, the amount of the ingredient or the delivery system in the compressible chewing gum, ratio of different polymers used to encapsulate one or more ingredients, hydrophobicity of one or more polymers used to encapsulate one or more ingredients, hydrophobicity of the delivery system, the type or amount of coating on the delivery system, the type or amount of coating on an ingredient prior to the ingredient being encapsulated, etc.
  • the release profiles of one or more breath fresheners are managed for a compressible gum.
  • Breath fresheners can include essential oils as well as various aldehydes, alcohols, and similar materials.
  • essential oils can include oils of spearmint, peppermint, wintergreen, sassafras, chlorophyll, citral, geraniol, cardamom, clove, sage, carvacrol, eucalyptus, cardamom, magnolia bark extract, marjoram, cinnamon, lemon, lime, grapefruit, and orange.
  • aldehydes such as cinnamic aldehyde and salicylaldehyde can be used.
  • chemicals such as menthol, carvone, iso- garrigol, and anethole can function as breath fresheners. Of these, the most commonly employed are oils of peppermint, spearmint and chlorophyll.
  • breath fresheners can include but are not limited to zinc citrate, zinc acetate, zinc fluoride, zinc ammonium sulfate, zinc bromide, zinc iodide, zinc chloride, zinc nitrate, zinc flurosilicate, zinc gluconate, zinc tartarate, zinc succinate, zinc formate, zinc chromate, zinc phenol sulfonate, zinc dithionate, zinc sulfate, siliver nitrate, zinc salicylate, zinc glycerophosphate, copper nitrate, chlorophyll, copper chlorophyll, chlorophyllin, hydrogenated cottonseed oil, chlorine dioxide, beta cyclodextrin, zeolite, silica-based materials, carbon-based materials, enzymes such as laccase, and combinations thereof.
  • the release profiles of probiotics can be managed for a compressible gum including, but not limited to lactic acid producing microorganisms such as Bacillus coagulans, Bacillus subtilis, Bacillus laterosporus, Bacillus laevolacticus, Sporolactobacillus inulinus, Lactobacillus acidophilus, Lactobacillus curvatus, Lactobacillus plantarum, Lactobacillus jenseni, Lactobacillus casei, Lactobacillus fermentum, Lactococcus lactis, Pedioccocus acidilacti, Pedioccocus pentosaceus, Pedioccocus urinae, Leuconostoc mesenteroides, Bacillus coagulans, Bacillus subtilis, Bacillus laterosporus, Bacillus laevolacticus,
  • lactic acid producing microorganisms such as Bacillus coagulans, Bacillus subtilis, Bacillus laterosporus,
  • encapsulation of the breath-freshening ingredient will result in a delay in the release of the predominant amount of the active during consumption of a compressible chewing gum that includes the encapsulated breath-freshening ingredient (e.g., as part of a delivery system added as an ingredient to the compressible chewing gum composition).
  • the release profile of the ingredient e.g., the breath-freshening ingredient
  • characteristics might include one or more of the following: tensile strength of the delivery system, water solubility of the ingredient, water solubility of the encapsulating material, water solubility of the delivery system, ratio of ingredient to encapsulating material in the delivery system, average or maximum particle size of ingredient, average or maximum particle size of ground delivery system, the amount of the ingredient or the delivery system in the compressible chewing gum, ratio of different polymers used to encapsulate one or more ingredients, hydrophobicity of one or more polymers used to encapsulate one or more ingredients, hydrophobicity of the delivery system, the type or amount of coating on the delivery system, the type or amount of coating on an ingredient prior to the ingredient being encapsulated, etc.
  • the release profiles of one or more dental care ingredients may be managed for a compressible gum.
  • dental care ingredients also known as oral care ingredients
  • Non-limiting examples of such ingredients can include, hydrolytic agents including proteolytic enzymes, abrasives such as hydrated silica, calcium carbonate, sodium bicarbonate and alumina, other active stain-removing components such as surface-active agents, including, but not limited to anionic surfactants such as sodium stearate, sodium palminate, sulfated butyl oleate, sodium oleate, salts of fumaric acid, glycerol, hydroxylated lecithin, sodium lauryl sulfate and chelators such as polyphosphates, which are typically employed as tartar control ingredients.
  • hydrolytic agents including proteolytic enzymes, abrasives such as hydrated silica, calcium carbonate, sodium bicarbonate and alumina
  • other active stain-removing components such as surface-active agents, including, but not limited to anionic surfactants such as sodium stearate, sodium palminate, sulfated butyl oleate, sodium oleate, salts of fum
  • dental care ingredients can also include tetrasodium pyrophosphate and sodium tri-polyphosphate, sodium bicarbonate, sodium acid pyrophosphate, sodium tripolyphosphate, xylitol, sodium hexametaphosphate.
  • peroxides such as carbamide peroxide, calcium peroxide, magnesium peroxide, sodium peroxide, hydrogen peroxide, and peroxydiphospate are included.
  • potassium nitrate and potassium citrate are included.
  • examples can include casein glycomacropeptide, calcium casein peptone-calcium phosphate, casein phosphopeptides, casein phosphopeptide- amorphous calcium phosphate (CPP- ACP), and amorphous calcium phosphate.
  • Still other examples can include papaine, krillase, pepsin, trypsin, lysozyme, dextranase, mutanase, glycoamylase, amylase, glucose oxidase, and combinations thereof.
  • Further examples can include surfactants such as sodium stearate, sodium ricinoleate, and sodium lauryl sulfate surfactants for use in some embodiments to achieve increased prophylactic action and to render the dental care ingredients more cosmetically acceptable.
  • Surfactants can preferably be detersive materials which impart to the composition detersive and foaming properties.
  • Suitable examples of surfactants are water-soluble salts of higher fatty acid monoglyceride monosulfates, such as the sodium salt of the monosulfated monoglyceride of hydgrogenated coconut oil fatty acids, higher alkyl sulfates such as sodium lauryl sulfate, alkyl aryl sulfonates such as sodium dodecyl benzene sulfonate, higher alkyl sulfoacetates, sodium lauryl sulfoacetate, higher fatty acid esters of 1 ,2-dihydroxy propane sulfonate, and the substantially saturated higher aliphatic acyl amides of lower aliphatic amino carboxylic acid compounds, such as those having 12 to 16 carbons in the fatty acid, alkyl or acyl radicals, and the like.
  • dental care ingredients can include antibacterial agents such as, but not limited.to, triclosan, chlorhexidine, zinc citrate, silver nitrate, copper, limonene, and cetyl pyridinium chloride.
  • additional anticaries agents can include fluoride ions or fluorine-providing components such as inorganic fluoride salts.
  • soluble alkali metal salts for example, sodium fluoride, potassium fluoride, sodium fluorosilicate, ammonium fluorosilicate, sodium monofluorophosphate, as well as tin fluorides, such as stannous fluoride and stannous chloride can be included.
  • a fluorine-containing compound having a beneficial effect on the care and hygiene of the oral cavity, e.g., diminution of enamel solubility in acid and protection of the teeth against decay may also be included as an ingredient.
  • Examples thereof include sodium fluoride, stannous fluoride, potassium fluoride, potassium stannous fluoride (SnF.sub.2 -KF), sodium hexafluorostannate, stannous chlorofluoride, sodium fluorozirconate, and sodium monofluorophosphate.
  • urea is included. Further examples are included in the following U.S. patents and U.S. published patent applications, the contents of all of which are incorporated in their entirety herein by reference for all purposes: U.S. Patent Nos.
  • encapsulation of the active will result in a delay in the release of the predominant amount of the active during consumption of a compressible chewing gum that includes the encapsulated active (e.g., as part of a delivery system added as an ingredient to the compressible chewing gum composition).
  • the release profile of the ingredient e.g., the dental care active
  • characteristics might include one or more of the following: tensile strength of the delivery system, water solubility of the ingredient, water solubility of the encapsulating material, water solubility of the delivery system, ratio of ingredient to encapsulating material in the delivery system, average or maximum particle size of ingredient, average or maximum particle size of ground delivery system, the amount of the ingredient or the delivery system in the compressible chewing gum, ratio of different polymers used to encapsulate one or more ingredients, hydrophobicity of one or more polymers used to encapsulate one or more ingredients, hydrophobicity of the delivery system, the type or amount of coating on the delivery system, the type or amount of coating on an ingredient prior to the ingredient being encapsulated, etc.
  • the release profiles of one or more flavor potentiators can be managed for a compressible gum.
  • Flavor potentiators can consist of materials that may intensify, supplement, modify or enhance the taste and/or aroma perception of an original material without introducing a characteristic taste and/or aroma perception of their own.
  • potentiators designed to intensify, supplement, modify, or enhance the perception of flavor, sweetness, tartness, umami, kokumi, saltiness and combinations thereof can be included.
  • sweetness may be potentiated by the inclusion of monoammonium glycyrrhizinate, licorice glycyrrhizinates, citrus aurantium, maltol, ethyl maltol, vanilla, vanillin, and combinations thereof.
  • sugar acids, sodium chloride, potassium chloride, sodium acid sulfate, and combinations thereof may be included for flavor potentiation.
  • glutamates such as monosodium glutamate (MSG), monopotassium glutamate, hydrolyzed vegetable protein, hydrolyzed animal protein, yeast extract, and combinations thereof are included.
  • Further examples can include glutathione, and nucleotides such as inosine monophosphate (IMP), disodium inosinate, xanthosine monophosphate, guanylate monophosphate (GMP), and combinations thereof.
  • nucleotides such as inosine monophosphate (IMP), disodium inosinate, xanthosine monophosphate, guanylate monophosphate (GMP), and combinations thereof.
  • IMP inosine monophosphate
  • xanthosine monophosphate guanylate monophosphate
  • GMP guanylate monophosphate
  • combinations thereof for bitterness blocking or taste masking, ingredients that interact with bitterness receptors to suppress bitterness or off tastes may be included.
  • adenosine monophosphate (AMP) can be included for bitterness suppression.
  • Bitterness modification can also be accomplished by using sweetness or flavors with complementary bitter notes such as chocolate.
  • flavor potentiator compositions that impart kokumi are also included in U.S. Patent No. 5,
  • encapsulation of a flavor potentiator will result in a delay in the release of the predominant amount of the flavor potentiator during consumption of a compressible chewing gum that includes the encapsulated flavor potentiator (e.g., as part of a delivery system added as an ingredient to the compressible chewing gum composition).
  • the release profile of the ingredient e.g., the flavor potentiator
  • characteristics might include one or more of the following: tensile strength of the delivery system, water solubility of the ingredient, water solubility of the encapsulating material, water solubility of the delivery system, ratio of ingredient to encapsulating material in the delivery system, average or maximum particle size of ingredient, average or maximum particle size of ground delivery system, the amount of the ingredient or the delivery system in the compressible chewing gum, ratio of different polymers used to encapsulate one or more ingredients, hydrophobicity of one or more polymers used to encapsulate one or more ingredients, hydrophobicity of the delivery system, the type or amount of coating on the delivery system, the type or amount of coating on an ingredient prior to the ingredient being encapsulated, etc.
  • the release profiles of one or more acids may be managed for a compressible gum.
  • Acids can include, but are not limited to acetic acid, adipic acid, ascorbic acid, butyric acid, citric acid, formic acid, fumaric acid, glyconic acid, lactic acid, phosphoric acid, malic acid, oxalic acid, succinic acid, tartaric acid and combinations thereof.
  • encapsulation of a food acid will result in a delay in the release of the predominant amount of the active during consumption of a compressible chewing gum that includes the encapsulated food acid (e.g., as part of a delivery system added as an ingredient to the compressible chewing gum).
  • the release profile of the ingredient e.g., the food acid
  • characteristics might include one or more of the following: tensile strength of the delivery system, water solubility of the ingredient, water solubility of the encapsulating material, water solubility of the delivery system, ratio of ingredient to encapsulating material in the delivery system, average or maximum particle size of ingredient, average or maximum particle size of ground delivery system, the amount of the ingredient or the delivery system in the compressible chewing gum, ratio of different polymers used to encapsulate one or more ingredients, hydrophobicity of one or more polymers used to encapsulate one or more ingredients, hydrophobicity of the delivery system, the type or amount of coating on the delivery system, the type or amount of coating on an ingredient prior to the ingredient being encapsulated, etc.
  • the release profiles of one or more micronutrients can be managed for a compressible gum.
  • Micronutrients can include materials that have an impact on the nutritional wellbeing of an organism even though the quantity required by the organism to have the desired effect is small relative to macronutrients such as protein, carbohydrate, and fat.
  • Micronutrients can include, but are not limited to vitamins, minerals, enzymes, phytochemicals, antioxidants, and combinations thereof.
  • vitamins can include fat soluble vitamins such as vitamin A, vitamin D, vitamin E, and vitamin K and combinations thereof, in some embodiments, vitamins can include water soluble vitamins such as vitamin C (ascorbic acid), the B vitamins (thiamine or B 1 , riboflavoin or B2, niacin or B3, pyridoxine or B6, folic acid or B9, cyanocobalimin or B 12, pantothenic acid, biotin), and combinations thereof.
  • vitamins can include fat soluble vitamins such as vitamin A, vitamin D, vitamin E, and vitamin K and combinations thereof
  • vitamins can include water soluble vitamins such as vitamin C (ascorbic acid), the B vitamins (thiamine or B 1 , riboflavoin or B2, niacin or B3, pyridoxine or B6, folic acid or B9, cyanocobalimin or B 12, pantothenic acid, biotin), and combinations thereof.
  • minerals can include but are not limited to sodium, magnesium, chromium, iodine, iron, manganese, calcium, copper, fluoride, potassium, phosphorous, molybdenum, selenium, zinc, and combinations thereof.
  • micronutrients can include but are not limited to L- carnitine, choline, coenzyme QlO, alpha-lipoic acid, omega-3 -fatty acids, pepsin, phytase, trypsin, lipases, proteases, cellulases, and combinations thereof.
  • Antioxidants can include materials that scavenge free radicals.
  • antioxidants can include but are not limited to ascorbic acid, citric acid, rosemary oil, vitamin A, vitamin E, vitamin E phosphate, tocopherols, di-alpha- tocopheryl phosphate, tocotrienols, alpha lipoic acid, dihydrolipoic acid, xanthophylls, beta cryptoxanthin, lycopene, lutein, zeaxanthin, astaxanthin, beta- carotene, carotenes, mixed carotenoids, polyphenols, flavonoids, and combinations thereof.
  • phytochemicals can include but are not limited to cartotenoids, chlorophyll, chlorophyllin, fiber, flavanoids, anthocyanins, cyaniding, delphinidin, malvidin, pelargonidin, peonidin, petunidin, flavanols, catechin, epicatechin, epigallocatechin, epigallocatechingallate, theaflavins, thearubigins, proanthocyanins, flavonols, quercetin, kaempferol, myricetin, isorhamnetin, flavononeshesperetin, naringenin, eriodictyol, tangeretin, flavones, apigenin, luteolin, lignans, phytoestrogens, resveratrol, isoflavones, daidzein, genistein, glycitein, soy isoflavones, and combinations thereof.
  • encapsulation of the micronutrient will result in a delay in the release of the predominant amount of the active during consumption of a compressible chewing gum that includes the encapsulated micronutrient (e.g., as part of a delivery system added as an ingredient to the compressible chewing gum).
  • the release profile of the ingredient e.g., the micronutrient
  • characteristics might include one or more of the following: tensile strength of the delivery system, water solubility of the ingredient, water solubility of the encapsulating material, water solubility of the delivery system, ratio of ingredient to encapsulating material in the delivery system, average or maximum particle size of ingredient, average or maximum particle size of ground delivery system, the amount of the ingredient or the delivery system in the compressible chewing gum, ratio of different polymers used to encapsulate one or more ingredients, hydrophobicity of one or more polymers used to encapsulate one or more ingredients, hydrophobicity of the delivery system, the type or amount of coating on the delivery system, the type or amount of coating on an ingredient prior to the ingredient being encapsulated, etc.
  • the release profiles of one or more mouth moisteners can be managed for a compressible gum.
  • Mouth moisteners can include, but are not limited to, saliva stimulators such as acids and salts and combinations thereof.
  • acids can include acetic acid, adipic acid, ascorbic acid, butyric acid, citric acid, formic acid, fumaric acid, glyconic acid, lactic acid, phosphoric acid, malic acid, oxalic acid, succinic acid, tartaric acid and combinations thereof.
  • Mouth moisteners can also include hydrocolloid materials that hydrate and may adhere to oral surface to provide a sensation of mouth moistening.
  • Hydrocolloid materials can include naturally occurring materials such as plant exudates, seed gums, and seaweed extracts or they can be chemically modified materials such as cellulose, starch, or natural gum derivatives.
  • hydrocolloid materials can include pectin, gum arabic, acacia gum, alginates, agar, carageenans, guar gum, xanthan gum, locust bean gum, gelatin, gellan gum, galactomannans, tragacanth gum, karaya gum, curdlan, konjac, chitosan, xyloglucan, beta glucan, furcellaran, gum ghatti, tamarin, bacterial gums, and combinations thereof.
  • modified natural gums such as propylene glycol alginate, carboxymethyl locust bean gum, low methoxyl pectin, and their combinations can be included.
  • modified celluloses can be included such as microcrystalline cellulose, carboxymethlcellulose (CMC), methylcellulose (MC), hydroxypropylniethylcellulose (HPCM), and hydroxypropylcellulose (MPC), and combinations thereof.
  • humectants which can provide a perception of mouth hydration can be included. Such humectants can include, but are not limited to glycerol, sorbitol, polyethylene glycol, erythritol, and xylitol.
  • fats can provide a perception of mouth moistening.
  • Such fats can include medium chain triglycerides, vegetable oils, fish oils, mineral oils, and combinations thereof.
  • encapsulation of a mouth moistening agent will result in a delay in the release of the predominant amount of the active during consumption of a compressible chewing gum that includes the encapsulated mouth moistening agent (e.g., as part of a delivery system added as an ingredient to the compressible chewing gum).
  • the release profile of the ingredient (e.g., the mouth moistening agent) can be managed for a compressible gum by managing various characteristics of the ingredient, delivery system containing the ingredient, and/or the compressible chewing gum containing the delivery system and/or how the delivery system is made.
  • characteristics might include one or more of the following: tensile strength of the delivery system, water solubility of the ingredient, water solubility of the encapsulating material, water solubility of the delivery system, ratio of ingredient to encapsulating material in the delivery system, average or maximum particle size of ingredient, average or maximum particle size of ground delivery system, the amount of the ingredient or the delivery system in the compressible chewing gum, ratio of different polymers used to encapsulate one or more ingredients, hydrophobicity of one or more polymers used to encapsulate one or more ingredients, hydrophobicity of the delivery system, the type or amount of coating on the delivery system, the type or amount of coating on an ingredient prior to the ingredient being encapsulated, etc.
  • the release profiles of one or more ingredients that soothe the throat can be managed for a compressible gum.
  • Throat soothing ingredients can include analgesics, anesthetics, demulcents, antiseptic, and combinations thereof.
  • analgesics/anesthetics can include menthol, phenol, hexylresorcinol, benzocaine, dyclonine hydrochloride, benzyl alcohol, salicyl alcohol, and combinations thereof.
  • demulcents can include but are not limited to slippery elm bark, pectin, gelatin, and combinations thereof.
  • antiseptic ingredients can include cetylpyridinium chloride, domiphen bromide, dequalinium chloride, and combinations thereof.
  • antitussive ingredients such as chlophedianol hydrochloride, codeine, codeine phosphate, codeine sulfate, dextromethorphan, dextromethorphan hydrobromide, diphenhydramine citrate, and diphenhydramine hydrochloride, and combinations thereof can be included.
  • throat soothing agents such as honey, propolis, aloe vera, glycerine, menthol and combinations thereof can be included.
  • cough suppressants can be included. Such cough suppressants can fall into two groups: those that alter the texture or production of phlegm such as mucolytics and expectorants; and those that suppress the coughing reflex such as codeine (narcotic cough suppressants), antihistamines, dextromethorphan and isoproterenol (non-narcotic cough suppressants).
  • ingredients from either or both groups can be included.
  • antitussives can include, but are not limited to, the group consisting of codeine, dextromethorphan, dextrorphan, diphenhydramine, hydrocodone, noscapine, oxycodone, pentoxyverine and combinations thereof.
  • antihistamines can include, but are not limited to, acrivastine, azatadine, brompheniramine, chlo[phi]heniramine, clemastine, cyproheptadine, dexbrompheniramine, dimenhydrinate, diphenhydramine, doxylamine, hydroxyzine, meclizine, phenindamine, phenyltoloxamine, promethazine, pyrilamine, tripelennamine, triprolidine and combinations thereof.
  • nonsedating antihistamines can include, but are not limited to, astemizole, cetirizine, ebastine, fexofenadine, loratidine, terfenadine, and combinations thereof.
  • expectorants can include, but are not limited to, ammonium chloride, guaifenesin, ipecac fluid extract, potassium iodide and combinations thereof.
  • mucolytics can include, but are not limited to, acetylcycsteine, ambroxol, bromhexine and combinations thereof.
  • analgesic, antipyretic and anti-inflammatory agents can include, but are not limited to, acetaminophen, aspirin, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, ketoprofen, ketorolac, nabumetone, naproxen, piroxicam, caffeine and mixtures thereof.
  • local anesthetics can include, but are not limited to, lidocaine, benzocaine, phenol, dyclonine, benzonotate and mixtures thereof.
  • nasal decongestants and ingredients that provide the perception of nasal clearing can be included.
  • nasal decongestants can include but are not limited to phenylpropanolamine, pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, and combinations thereof.
  • ingredients that provide a perception of nasal clearing can include but are not limited to menthol, camphor, bomeol, ephedrine, eucalyptus oil, peppermint oil, methyl salicylate, bornyl acetate, lavender oil, wasabi extracts, horseradish extracts, and combinations thereof.
  • a perception of nasal clearing can be provided by odoriferous essential oils, extracts from woods, gums, flowers and other botanicals, resins, animal secretions, and synthetic aromatic materials.
  • encapsulation of a throat care agent will result in a delay in the release of the predominant amount of the active during consumption of a compressible chewing gum that includes the encapsulated throat care agent (e.g. as part of a delivery system added as an ingredient to the compressible chewing gum).
  • the release profile of the ingredient e.g. the dental care active
  • characteristics might include one or more of the following: tensile strength of the delivery system, water solubility of the ingredient, water solubility of the encapsulating material, water solubility of the delivery system, ratio of ingredient to encapsulating material in the delivery system, average or maximum particle size of ingredient, average or maximum particle size of ground delivery system, the amount of the ingredient or the delivery system in the compressible chewing gum, ratio of different polymers used to encapsulate one or more ingredients, hydrophobicity of one or more polymers used to encapsulate one or more ingredients, hydrophobicity of the delivery system, the type or amount of coating on the delivery system, the type or amount of coating on an ingredient prior to the ingredient being encapsulated, etc.
  • one or more colors can be included. As classified by the United States Food, Drug, and Cosmetic Act (21 C.F.R. 73), colors can include exempt from certification colors (sometimes referred to as natural even though they can be synthetically manufactured) and certified colors (sometimes referred to as artificial), or combinations thereof.
  • exempt from certification or natural colors can include, but are not limited to annatto extract, (E 160b), bixin, norbixin, astaxanthin, dehydrated beets (beet powder), beetroot red/betanin (E 162), ultramarine blue, canthaxanthin (El 6 Ig), cryptoxanthin (E161c), rubixanthin (E161d), violanxanthin (E161e), rhodoxanthin (El ⁇ lf), caramel (E150(a-d)), ⁇ -apo- 8'-carotenal (E 16Oe), ⁇ -carotene (El 60a), alpha carotene, gamma carotene, ethyl ester of beta-apo-8 carotenal (E 16Of), fiavoxanthin (E161a), lutein (El 6 Ib), cochineal extract (E120); carmine (E132), carmoisine/azorub
  • certified colors can include, but are not limited to, FD&C blue #1, FD&C blue #2, FD&C green #3, FD&C red #3, FD&C red #40, FD&C yellow #5 and FD&C yellow #6, tartrazine (E 102), quinoline yellow (E 104), sunset yellow (El 10), ponceau (E 124), erythrosine (E 127), patent blue V (El 31), titanium dioxide (E171), aluminum (E173), silver (E174), gold (E175), pigment rubine/lithol rubine BK (El 80), calcium carbonate (El 70), carbon black (El 53), black PN/brilliant black BN (E151), green S/acid brilliant green BS (E142), and combinations thereof.
  • certified colors can include FD&C aluminum lakes. These consist of the aluminum salts of FD&C dyes extended on an insoluble substrate of alumina hydrate. Additionally, in some embodiments, certified colors can be included as calcium salts. Typically, encapsulation of a color will result in a delay in the release of the predominant amount of the active during consumption of a compressible chewing gum that includes the encapsulated color (e.g., as part of a delivery system added as an ingredient to the compressible chewing gum). In some embodiments, the release profile of the ingredient (e.g., the color) can be managed by managing various characteristics of the ingredient, delivery system containing the ingredient, and/or the compressible chewing gum containing the delivery system and/or how the delivery system is made.
  • characteristics might include one or more of the following: tensile strength of the delivery system, water solubility of the ingredient, water solubility of the encapsulating material, water solubility of the delivery system, ratio of ingredient to encapsulating material in the delivery system, average or maximum particle size of ingredient, average or maximum particle size of ground delivery system, the amount of the ingredient or the delivery system in the compressible chewing gum, ratio of different polymers used to encapsulate one or more ingredients, hydrophobicity of one or more polymers used to encapsulate one or more ingredients, hydrophobicity of the delivery system, the type or amount of coating on the delivery system, the type or amount of coating on an ingredient prior to the ingredient being encapsulated, etc.
  • a delivery system or compressible chewing gum may include two or more ingredients for which managed release from the compressible chewing gum during consumption of the compressible chewing gum is desired.
  • the ingredients may be encapsulated or otherwise included separately in different delivery systems.
  • the ingredients may be encapsulated or otherwise included in the same delivery system.
  • one or more of the ingredients may be free (e.g. unencapsulated) while one or more other ingredients may be encapsulated.
  • a compressible chewing gum may include a group of ingredients for which managed release of the group during consumption of the compressible chewing gum is desired.
  • Groups of two or more ingredients for which managed release from a compressible chewing gum during consumption of the compressible chewing gum may be desired include, but are not limited to: color and flavor, multiple flavors, multiple colors, cooling agent and flavor, warming agent and flavor, cooling agent and warming agent, cooling agent and high-intensity sweetener, warming agent and high-intensity sweetener, multiple cooling agents (e.g., WS-3 and WS-23, WS-3 and menthyl succinate), menthol and one or more cooling agents, menthol and one or more warming agents, multiple warming agents, high-intensity sweetener(s) and tooth whitening active(s), high- intensity sweetener(s) and breath-freshening active(s), an ingredient with some bitterness and a bitterness suppressor for the ingredient, multiple high-intensity sweeteners (e.g., ace-k and aspartame), multiple tooth whitening actives (e.g., an abrasive ingredient and an antimicrobial ingredient, a
  • encapsulation of the multiple ingredients will result in a delay in the release of the predominant amount of the multiple ingredients during consumption of a compressible chewing gum that includes the encapsulated multiple ingredients (e.g. as part of a delivery system added as an ingredient to the compressible chewing gum).
  • This may be particularly helpful in situations wherein separate encapsulation of the ingredients may cause them to release with different release profiles.
  • different high-intensity sweeteners may have different release profiles because they have different water solubilities or differences in other characteristics. Encapsulating them together may cause them to release more simultaneously.
  • the release profile of the multiple ingredients can be managed for a compressible gum by managing various characteristics of the multiple ingredients, the delivery system containing the multiple ingredients, and/or the compressible chewing gum containing the delivery system and/or how the delivery system is made in a manner as previously discussed above.
  • the active ingredients mentioned above are meant as examples of active ingredients which could be applicable in a chewing gum granule or compressed chewing gum, however, this list should not be considered as exhaustive.
  • Active ingredients to be applied in tablets according to embodiments of the invention may be applied as such or be included or bonded in different ways, such as being part of an inclusion complex e.g. as described in US 5,866,179, which is hereby incorporated by reference.
  • a resin-bonding of nicotine is described in e.g. WO 2006/000232 which is also incorporated herein by reference. Further conventional methods of applying active ingredients may obviously be applied within the scope of the invention.
  • the active ingredients may advantageously be applied in a gum base-containing module or a tablet-module substantially free of gum base depending on the applied type of active ingredient. If the active ingredient is of the pharmaceutical type, such ingredient may very often advantageously be comprised in a tablet module substantially free of gum base whereas taste relevant active ingredients advantageously may be added to the gum base-containing module and very often to both types of modules.
  • the taste relevant active ingredient may both be added as separate particles which are mixed and compressed with gum base-containing particles in one module and it may be incorporated into gum base-containing granules.
  • Multi-modular chewing gum tablet High volume compressed chewing gum tablet
  • Cosmetic gum granules for compressed chewing gum and “Compressed chewing gum comprising an encapsulation delivery system comprising natural resin” filed at the same date and hereby incorporated by reference.

Abstract

La présente invention concerne un comprimé pour la libération de principes actifs, le comprimé comprenant au moins un édulcorant à base de polyol, au moins un principe actif et des particules comprimées de substance à base de gomme à mâcher, la teneur en polyol se trouvant entre 21 et 95 % en poids du comprimé, et le comprimé étant comprimé à une température ambiante inférieure à 25°C et à une humidité relative maximum de 55 %. Un comprimé possédant une stabilité acceptable du principe actif et ayant en outre des capacités de masquage de goût ou de correspondance de goût par rapport aux principes actifs a été obtenu selon la présente invention.
PCT/IB2007/001899 2007-07-06 2007-07-06 Comprimé comprenant un polyol WO2009007768A1 (fr)

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