EP3642274A1 - Composition auto-moussante en milieu acide et procédé de préparation - Google Patents

Composition auto-moussante en milieu acide et procédé de préparation

Info

Publication number
EP3642274A1
EP3642274A1 EP18737956.5A EP18737956A EP3642274A1 EP 3642274 A1 EP3642274 A1 EP 3642274A1 EP 18737956 A EP18737956 A EP 18737956A EP 3642274 A1 EP3642274 A1 EP 3642274A1
Authority
EP
European Patent Office
Prior art keywords
composition
composition according
hydrophilic polymer
crosslinking
formation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP18737956.5A
Other languages
German (de)
English (en)
French (fr)
Inventor
Jean-Michel Simon
Stéphane ROGER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Jellynov
Original Assignee
Jellynov
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 Jellynov filed Critical Jellynov
Publication of EP3642274A1 publication Critical patent/EP3642274A1/fr
Pending legal-status Critical Current

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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
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L5/00—Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
    • C08L5/04—Alginic acid; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K20/00—Accessory food factors for animal feeding-stuffs
    • A23K20/10—Organic substances
    • A23K20/163—Sugars; Polysaccharides
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
    • A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
    • A23L29/256—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin from seaweeds, e.g. alginates, agar or carrageenan
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/734—Alginic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00—Processes of treating or compounding macromolecular substances
    • C08J3/02—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques
    • C08J3/03—Making solutions, dispersions, lattices or gels by other methods than by solution, emulsion or suspension polymerisation techniques in aqueous media
    • C08J3/075—Macromolecular gels
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J9/00—Working-up of macromolecular substances to porous or cellular articles or materials; After-treatment thereof
    • C08J9/04—Working-up of macromolecular substances to porous or cellular articles or materials; After-treatment thereof using blowing gases generated by a previously added blowing agent
    • C08J9/06—Working-up of macromolecular substances to porous or cellular articles or materials; After-treatment thereof using blowing gases generated by a previously added blowing agent by a chemical blowing agent
    • C08J9/08—Working-up of macromolecular substances to porous or cellular articles or materials; After-treatment thereof using blowing gases generated by a previously added blowing agent by a chemical blowing agent developing carbon dioxide
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L89/00—Compositions of proteins; Compositions of derivatives thereof
    • C08L89/04—Products derived from waste materials, e.g. horn, hoof or hair
    • C08L89/06—Products derived from waste materials, e.g. horn, hoof or hair derived from leather or skin, e.g. gelatin
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2203/00—Foams characterized by the expanding agent
    • C08J2203/02—CO2-releasing, e.g. NaHCO3 and citric acid
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2205/00—Foams characterised by their properties
    • C08J2205/02—Foams characterised by their properties the finished foam itself being a gel or a gel being temporarily formed when processing the foamable composition
    • C08J2205/022—Hydrogel, i.e. a gel containing an aqueous composition
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2205/00—Foams characterised by their properties
    • C08J2205/02—Foams characterised by their properties the finished foam itself being a gel or a gel being temporarily formed when processing the foamable composition
    • C08J2205/026—Aerogel, i.e. a supercritically dried gel
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2205/00—Foams characterised by their properties
    • C08J2205/02—Foams characterised by their properties the finished foam itself being a gel or a gel being temporarily formed when processing the foamable composition
    • C08J2205/028—Xerogel, i.e. an air dried gel
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2207/00—Foams characterised by their intended use
    • C08J2207/10—Medical applications, e.g. biocompatible scaffolds
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2305/00—Characterised by the use of polysaccharides or of their derivatives not provided for in groups C08J2301/00 or C08J2303/00
    • C08J2305/04—Alginic acid; Derivatives thereof
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K3/00—Use of inorganic substances as compounding ingredients
    • C08K3/18—Oxygen-containing compounds, e.g. metal carbonyls
    • C08K3/24—Acids; Salts thereof
    • C08K3/26—Carbonates; Bicarbonates
    • C08K2003/262—Alkali metal carbonates
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K3/00—Use of inorganic substances as compounding ingredients
    • C08K3/18—Oxygen-containing compounds, e.g. metal carbonyls
    • C08K3/24—Acids; Salts thereof
    • C08K3/26—Carbonates; Bicarbonates
    • C08K2003/265—Calcium, strontium or barium carbonate

Definitions

  • the present invention relates to a self-foaming polymeric composition in an acid medium, to a process for obtaining it and to its use as a medicament, in particular in the treatment of obesity, overweight or in the context of preventive treatments for diabetes, both human an animal.
  • a self-foaming polymeric composition in an acid medium to a process for obtaining it and to its use as a medicament, in particular in the treatment of obesity, overweight or in the context of preventive treatments for diabetes, both human an animal.
  • Overweight affects 1, 4 billion people aged 20 and over worldwide (World Health Organization estimates worldwide). By 2030, the number of overweight people is expected to reach 3.3 billion. Overweight and obesity represent the fifth leading risk factor for death globally and claim at least 2.8 million lives each year (Source: World Health Organization - "Obesity and Overweight" - Fact Sheet # 311 ).
  • US 2010/0234233 A1 describes the preparation of hydrogel-type compositions from at least one hydrophilic polymer and by crosslinking with a poly-carboxylic acid, in particular citric acid, as well as their use in the treatment of 'obesity.
  • US Pat. No. 8,287,562 B2 describes the preparation of ingestible devices capable of swelling in the gastric medium. These devices are in the form of a self-inflating material, in particular a hydrogel that expands in the presence of water, encapsulated by a soluble composite membrane in a gastric medium. This type of device is advantageous in that the self-inflating compound does not swell until it reaches the stomach.
  • WO 2004/056343 A1 describes the use of modified polymers for the manufacture of easily degradable hydrogels in the intestinal medium but not in the gastric medium.
  • Hydrogel foams have also been developed in order to increase the capacity of hydrogels to absorb water thanks to a porous structure. These hydrogel foams are obtained by dissolving one or more polymers and introducing / bubbling a gas that is just trapped in the polymer matrix by crosslinking.
  • No. 6,018,033 describes the preparation of saccharide monomers for the manufacture of hydrogels and hydrogel foams by polymerization / crosslinking.
  • the hydrogel foams are obtained by the introduction of gas during the polymerization and by decomposition of a foaming agent such as sodium bicarbonate NaHCO 3 .
  • No. 5,750,585 describes the preparation of hydrogel type foam with superabsorbent properties by introducing a gas during the polymerization of a solution comprising at least one hydrophilic monomer of the olefinic type and a crosslinking agent of the multiolefinic type.
  • the gas is produced by decomposition of a foaming agent and in particular sodium bicarbonate NaHCO 3 .
  • US 6,271,278 B1 describes the preparation of super-porous hydrogel composites by polymerizing a composition comprising at least one ethylenically unsaturated monomer and a multi-olefinic crosslinking agent in the presence of particles of a disintegrating compound for improving the mechanical properties of the structure and a foaming agent, especially sodium bicarbonate NaHC0 3 to generate a gas during the polymerization.
  • the frothy structure of this type of device is obtained before ingestion by the patient, during the preparation of said device.
  • the use of these devices therefore involves the ingestion by the patient of a relatively large volume of hydrogel foam.
  • hydrogels and hydrogel foams described above are obtained by chemical crosslinking of the polymers.
  • This non-reversible crosslinking of the polymers has the disadvantage of making the previous devices difficult to digest.
  • US 2014/0087056 A1 discloses food supplements in the form of compositions comprising at least one cationic polymer and an anionic polymer gelable in acid medium, especially in a gastric environment.
  • These food supplements can in particular comprise basic compounds such as sodium or potassium (bi) carbonate used to delay the gelation of the system. Indeed, the amount of salts used is not sufficient to cause the formation of a foam.
  • the set of hydrogel-like devices and hydrogel foams previously described make it possible to provide the patient with a sensation of satiety by swelling of the device in the stomach, linked to a water absorption.
  • these devices have a relatively low efficiency and especially have a relatively long action time (several hours) to achieve the maximum swelling of the product.
  • many of these products require taking the product orally 30 to 60 minutes before the meal.
  • US 2005/0137272 discloses the preparation of foams based on gelled biopolymers. These foams can be used in the biomedical field but also in the field of personal care or in food.
  • Chhavi Sharma et al Journal of Applied Polymer Science, 2013, p.3228-3241, discloses the preparation of a chitosan, gelatin and alginate composite material by foaming.
  • the material obtained can be used for the manufacture of support materials for tissue engineering.
  • WO 2005/044026 discloses the preparation of a filler material for use in smoking articles.
  • the filling material is obtained from an agent foaming agent, an agent capable of crosslinking by the formation of chemical bonds and a crosslinking agent.
  • WO 2008/157318 discloses a composite material comprising a foam whose pores are filled with a polysaccharide gel, said material being coated with a polysaccharide layer. This material has many applications particularly in the field of biomedical, personal care and food.
  • WO 2007/103208 teaches the preparation of an absorbent foam in dry form and having an open porosity.
  • This absorbent foam is obtained by foaming an aqueous dispersion comprising an enzymatically degradable biopolymer and a foaming agent, followed by a drying step.
  • US 2007/0248642 teaches the preparation of a gelled foam by aeration of a dispersion comprising a polysaccharide, ions capable of causing gelation of the polysaccharide and optionally a plasticizer compound.
  • US 2003/0021832 teaches the preparation of foam products from silver alginate.
  • the foam products obtained can be used for the manufacture of medical and / or veterinary dressings.
  • the present invention is based on the formulation of a polymeric composition capable of being converted into a hydrogel foam in a very rapid manner, in which this hydrogel foam has a very high degree of swelling within a few minutes. minutes. More particularly, the present invention relates to a composition capable of being converted into a hydrogel foam after it has been introduced into or brought into contact with an acidic medium, in particular at a pH of less than or equal to 5, preferably ranging from from 0.5 to 5.
  • the composition of the present invention can be used as a dietary supplement or as a drug in the context of the fight against obesity or as part of the preventive treatment of diabetes for both man and for animals. This material is resorbable and its resorption can be controlled, which allows it to pass the pylorus without risk of intestinal obstruction.
  • the invention firstly relates to a composition comprising:
  • At least one hydrophilic polymer chosen from polysaccharides, their derivatives and their mixtures,
  • At least one compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds at least one compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds
  • At least one foam stabilizing agent at least one foam stabilizing agent.
  • composition according to the invention preferably comprises:
  • At least one hydrophilic polymer chosen from polysaccharides, their derivatives and their mixtures,
  • At least one compound capable of cross-linking the hydrophilic polymer by the formation of ionic bonds chosen from divalent cation salts, trivalent cation salts and mixtures thereof,
  • At least one foaming agent chosen from salts capable of decomposing into gases and monovalent cations
  • At least one foam stabilizing agent at least one foam stabilizing agent.
  • the hydrophilic polymer present in the composition according to the invention is preferably chosen from alginates.
  • the composition according to the invention has a hydrophilic polymer mass content ranging from 10% to 99.5%, preferably ranging from 15% to 99%, and still more preferably ranging from 15% to 80% relative to to the total mass of the composition, the contents being expressed as mass of dry matter.
  • the compound capable of cross-linking the hydrophilic polymer by the formation of ionic bonds is chosen from divalent cations, trivalent cations and their mixtures, preferably chosen from divalent cations, more preferentially chosen from calcium (II), manganese (II), silver (II), iron (II), copper (II), magnesium (II) and mixtures thereof, and even more preferentially is calcium (II).
  • the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds comprises at least one metal salt, preferably at least one metal salt having a pKa of less than or equal to 6, preferably less than or equal to 5. Even more preferentially, the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds is present in the composition in the form of CaCO 3 calcium carbonate.
  • the foaming agent is preferably selected from monovalent cation salts.
  • the foaming agent comprises at least one metal salt, preferably at least one metal salt having a pKa of less than or equal to 6, and even more preferably less than or equal to 5.
  • the foaming agent is chosen from carbonate salts, bicarbonate salts and their mixtures, preferably it is sodium bicarbonate NaHCO 3 .
  • the ratio between the amount of divalent and / or trivalent cations and the amount of monovalent cations is greater than or equal to 0.05, preferably greater than or equal to 0.5, the amounts of cations being expressed in moles. More preferably, the ratio between the amount of divalent cations and the amount of monovalent cations is greater than or equal to 0.05, preferably greater than or equal to 0.5, the amounts of cations being expressed in moles.
  • the foam stabilizing agent is chosen from structuring agents, surfactant compounds and mixtures thereof.
  • the foam stabilizing agent is chosen from structuring agents, preferably from proteins, their salts and mixtures, and even more preferably from gelatin, albumin, ovalbumin, casein of milk, lecithin, sodium caseinate, and mixtures thereof.
  • the foam stabilizing agent is chosen from nonionic surfactant compounds.
  • the composition according to the invention further comprises at least one non-cross-linkable hydro-swelling polymer by the formation of ionic bonds, preferably chosen from starch, agar-agar and carrageenan ⁇ . (lambda), non-crosslinkable celluloses and mixtures thereof.
  • the composition according to the invention is a hydrogel.
  • the composition according to the invention is in dry form, and in particular is a xerogel, an airgel or a cryogel.
  • the invention also relates to a method of manufacturing a composition according to the invention comprising the introduction into an aqueous medium:
  • the compound capable of crosslinking the polymer by the formation of ionic bonds and the stabilizing agent for the foams.
  • this method comprises the following steps: (1) the solubilization or dispersion of the hydrophilic polymer in water and with stirring,
  • the invention also relates to a core / shell structure capsule comprising at least one core consisting of a composition according to the invention and at least one coating layer covering all or part of the core.
  • the invention also relates to a composition according to the invention for its use as a medicament, preferably for the prevention and / or treatment of obesity.
  • the invention also relates to a food kit comprising at least two separate parts of the same package:
  • the invention also relates to a food composition for animals in the form of kibble, snack or biscuit comprising a composition according to the invention and a food portion.
  • the invention finally relates to an oral delivery device comprising a syringe whose body is filled with a composition according to the invention.
  • the invention is advantageous in that it provides polymeric compositions useful for the prevention and / or treatment of obesity which are non-invasively usable and allow for a sustained and controlled reduction of gastric volume.
  • the invention is also advantageous in that it provides a composition which has a high degree of swelling, thereby reducing the gastric volume by ingestion of a limited amount of the composition.
  • the invention is also advantageous in that the maximum swelling of the composition is achieved quickly. This rapid swelling has the consequence that the patient feels a feeling of satiety in a very short time after ingestion of the composition. This results in a faster appetite suppressant and therefore more effective.
  • the invention is also advantageous in that the device is easily removable by the body through a crosslinking predominantly, preferably substantially ionic.
  • the invention is also advantageous in that it does not require the prior ingestion of a liquid and in particular water.
  • the invention is also advantageous in that the composition is low in calories and therefore suitable for treating and / or preventing obesity, including in persons suffering from diabetes.
  • the invention is advantageous in that the composition is resorbable and in that its resorption is controllable.
  • the expression "between X and Y" includes the terminals, unless explicitly stated otherwise. This expression therefore means that the target range includes X, Y values and all values from X to Y.
  • polymer is intended to mean oligomers, prepolymers, homopolymers and also copolymers.
  • hydrogel is meant a gel whose dispersion medium is water.
  • hydrophilic polymer is meant a polymer which is capable of absorbing water or which is soluble in water.
  • the present invention relates to a self-foaming composition capable of forming in acid medium a hydrogel foam.
  • the invention also relates to a process for the preparation of such a composition and its use as a medicament for the prevention / and treatment of obesity.
  • the term "self-foaming composition in an acid medium” is intended to mean a composition which is capable of forming a foam when it is introduced into or brought into contact with an aqueous medium having an acidic pH. , preferably a pH of less than or equal to 5, more preferably from 0.5 to 5, advantageously from 1 to 5, and even more advantageously from 1 to 4. Foaming of such a composition does not require either gas injection or the application of mechanical agitation.
  • the present invention relates to a composition
  • a composition comprising:
  • At least one compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds at least one compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds
  • At least one foam stabilizing agent at least one foam stabilizing agent.
  • composition according to the invention comprises, or better consists essentially of:
  • composition according to the invention comprises, or better consists essentially of:
  • hydrophilic polymer from 0.5% to 40% by weight of hydrophilic polymer, from 0.1% to 20% by weight of compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds,
  • composition according to the invention comprises, or better consists essentially of:
  • composition according to the invention comprises, or better consists essentially of:
  • composition according to the invention comprises, or better consists essentially of:
  • composition according to the invention comprises, or better consists essentially of:
  • composition according to the invention comprises from 0.1% to 100% by mass of dry matter relative to the total mass of the composition, preferably from 1% to 50% and even more preferably from 2% to 20%, the remainder of the composition being water.
  • the composition according to the invention is a hydrogel.
  • the composition according to the invention can be dried in order to eliminate the water present in the hydrogel.
  • the composition according to the invention is in the form of a xerogel, a cryogel or an airgel.
  • the hydrophilic polymer is in the form of a xerogel, a cryogel or an airgel.
  • composition according to the invention comprises at least one hydrophilic polymer, that is to say a polymer which is capable of absorbing water or which is soluble in water.
  • hydrophilic polymer is water-soluble.
  • water-soluble polymer means a polymer which at room temperature has a solubility in water of greater than or equal to 0.1% by weight relative to a given volume of water.
  • the water-soluble polymer is a hydro-swelling polymer.
  • hydro-swelling polymer is intended to mean a polymer or copolymer capable of swelling by absorption of water.
  • the hydrophilic polymer used in the composition according to the invention is a polymer crosslinkable by the formation of ionic bonds.
  • the hydrophilic polymer is adapted to be ingested orally in humans and / or animals, especially in mammals.
  • the hydrophilic polymer is a low calorigenic polymer, preferably non-calorigenic.
  • low calorigenic polymer in the sense of the invention a polymer that provides few calories to the body during its digestion.
  • a low caloric hydrophilic polymer is particularly advantageous in the context of the use of a composition according to the invention as a medicine for the treatment of obesity, but also for the prevention of obesity in patients suffering from diabetes.
  • the hydrophilic polymer is chosen from anionic polymers.
  • the hydrophilic polymer is chosen from polysaccharides, their derivatives and their mixtures.
  • polysaccharides and their derivatives are understood to mean polymers and copolymers consisting of several oses units and / or several units derived from monosaccharides and linked together by osidic bonds.
  • the derived units may in particular be chosen from: ose units bearing a carboxylic and / or amine acid function and / or an alkyl amide group or an ester function of an alkyl carboxylic acid.
  • alkyl celluloses such as Ci-C 6 alkyl celluloses and in particular methyl cellulose, ethyl cellulose and ethyl methyl cellulose
  • substituted alkyl celluloses such as the hydroxyls of Ci-C 6 alkyl celluloses and Ci-C 6 hydroxyls of Ci-C 6 alkyl celluloses and especially n-propylcellulose hydroxide, hydroxypropylmethylcellulose, ethylhydroxyethylcellulose and carboxymethylcellulose
  • substituted dextrans such as dextran sulfate, dextran phosphate and diethylamine dextran
  • glycosaminoglycans including hyaluronic acid, chondroitin, and chondroitin sulfate
  • polymers and copolymers comprising uronic acid units comprising uronic acid units.
  • the hydrophilic polymer is chosen from carrageenan ⁇ (kappa), carrageenan ⁇ (iota), polysaccharides comprising uronic units and mixtures thereof, more preferably the hydrophilic polymer is chosen from polysaccharides comprising uronic units.
  • uronic units is intended to mean polymeric units derived from single oses obtained by oxidation of the carbon located at the end of the chain to a carboxylic acid function.
  • Said uronic units are, for example, mannuronic acid, guluronic acid, glucuronic acid, iururonic acid or even galacturonic acid.
  • the polymers and copolymers comprising uronic units are obtained by formation of osidic bonds with other monomers.
  • At least 50% of the ose units of the hydrophilic polymer are uronic units, preferably at least 80%.
  • the hydrophilic polymer consists essentially of uronic units.
  • the hydrophilic polymer is chosen from polysaccharides consisting essentially of ⁇ -D-galacturonic units, preferably chosen from pectins.
  • the hydrophilic polymer is chosen from polymers comprising mannuromic units, derived from mannuronic acid of formula (I), and guluronic units, derived from guluronic acid of formula (II).
  • the hydrophilic polymer is chosen from alginates.
  • alginates in the sense of the invention random or block polymers of formula (III) essentially consisting of mannuromic units and guluronic units.
  • the polymer of formula (III) consists of m mannuromic units and n guluronic units, m and n being two integers.
  • At least 15% by weight of the alginate consists of chain segments on which two guluronic units follow each other directly, preferably at least 25% by weight and even more preferably at least 50% by weight.
  • the hydrophilic polymer of the invention has a weight average molecular weight ranging from 10,000 g / mol to 500,000 g / mol, preferably from 30,000 g / mol to 200,000 g / mol, and even more preferentially ranging from from 50,000 g / mol to 100,000 g / mol.
  • the hydrophilic polymer is partially crosslinked before being introduced into the composition.
  • the hydrophilic polymer may be partially crosslinked by the formation of ionic bonds (partial physical crosslinking) or partially crosslinked by the formation of covalent bonds (partial chemical crosslinking) or partially crosslinked by the formation of ionic bonds and covalent bonds (partially mixed crosslinking). ).
  • the hydrophilic polymer is crosslinked by the formation of ionic bonds (partial physical crosslinking) before its introduction into the composition.
  • the hydrophilic polymer has a crosslinking index less than or equal to 50%>, preferably less than or equal to 30%>, even more preferably less than or equal to 10%>, before its introduction. in the composition.
  • crosslinking index is meant in the sense of the invention the ratio between the number of occupied crosslinking sites of a polymer chain on the number of possible crosslinking sites on the same polymer.
  • the crosslinking index is calculated taking into account the nature and amount of the monomers and crosslinking agents used. According to this first embodiment, advantageously, the hydrophilic polymer is partially crosslinked by the formation of ionic bonds.
  • the hydrophilic polymer is not crosslinked.
  • the composition according to the invention has a hydrophilic polymer content ranging from 10% to 99.5% by weight relative to the total mass of the composition, preferably ranging from 15% to 99%, and even more preferably ranging from from 15% to 80%, the percentages being expressed by mass of dry matter.
  • the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds is a hydrophilic polymer content ranging from 10% to 99.5% by weight relative to the total mass of the composition, preferably ranging from 15% to 99%, and even more preferably ranging from from 15% to 80%, the percentages being expressed by mass of dry matter.
  • composition according to the invention comprises at least one compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds.
  • the hydrophilic polymer is chosen from anionic polymers
  • the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds is chosen from divalent cations, trivalent cations and their mixtures.
  • divalent cations suitable for the invention mention may be made of: calcium (II), manganese (II), silver (II), iron (II), copper (II), magnesium (II) , and their mixtures.
  • the hydrogel obtained by crosslinking the hydrophilic polymer will have different physical properties, including a different stability.
  • a hydrogel obtained by the crosslinking of the hydrophilic polymer with magnesium ions will be relatively more mechanically fragile and will have a more limited life compared to hydrogels obtained from other cations.
  • hydrogel obtained by the crosslinking of the hydrophilic polymer with calcium ions will be mechanically stable over long periods of time.
  • the choice of the cation therefore makes it possible to modulate the life of the crosslinked gel in the stomach of the individual who has ingested the composition.
  • the divalent cation is calcium.
  • trivalent cations suitable for the invention mention may be made of: aluminum, iron (III) and mixtures thereof.
  • the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds is chosen from divalent cations.
  • the cation is calcium.
  • the crosslinking of the anionic hydrophilic polymer by the formation of ionic bonds is advantageous in that it is reversible.
  • the crosslinking is reversible. Reversibility is obtained by the addition in excess of monovalent cations, for example chosen from sodium, potassium and their mixtures.
  • acidic compounds capable of chelating divalent and trivalent cations include citric acid or ascorbic acid.
  • the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds is introduced into the composition according to the invention in the form of a salt of a divalent or trivalent cation and a counterion.
  • the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds is introduced into the composition in an inactive form.
  • non-active form in the sense of the invention in aqueous solution and at neutral pH and in particular at pH ranging from 6.5 to 7.5 said compound capable of crosslinking the hydrophilic polymer does not dissociate. More particularly, at neutral pH, especially at pH ranging from 6.5 to 7.5, the crosslinking of the hydrophilic polymer with this compound does not occur.
  • the compound By passing through an acidic medium and in particular an aqueous solution with a pH of less than or equal to 6.5, preferably less than or equal to 6 and even more preferentially at a pH of less than or equal to 5, the compound dissociates and releases the chemical species capable of to crosslink the hydrophilic polymer by the formation of ionic bonds.
  • the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds is chosen from divalent and / or trivalent cations, it is preferably introduced into the composition according to the invention in the form of a metal salt.
  • the metal salt is preferably selected from divalent cation salts, trivalent cation salts and mixtures thereof.
  • the metal salt is chosen from the salts which can decompose in an aqueous medium on the one hand into divalent and / or trivalent cations and on the other hand into an acid-base species, in the Bronsted sense.
  • the acid-base species, in the Bronsted sense, released by the decomposition of the metal salt in an aqueous medium preferably has a pKa of less than or equal to 7, preferably less than or equal to 6.5.
  • the acid-base species released by the decomposition of the metal salt in an aqueous medium is chosen from the hydrogen carbonate or bicarbonate ion HCO 3 " , the carbonate ion CO 3 2" and mixtures thereof.
  • these hydrogen carbonate or bicarbonate HCO 3 - and / or CO 3 2 - carbonate ions are converted into H 2 CO 3 carbonic acid, which decomposes into carbon dioxide C0 2 .
  • the metal salt is chosen from water insoluble salts at room temperature and at neutral pH, especially at a pH ranging from 6.5 to 7.5.
  • the metal salt has a solubility in water at neutral pH, especially at a pH ranging from 6.5 to 7.5, determined at 20 ° C., less than or equal to 0.5 g / L, even more preferably less than 0.1 g / L.
  • the metal salt is chosen from the salts:
  • 6.5 to 7.5 determined at 20 ° C, less than or equal to 0.5 g / l, more preferably less than 0.1 g / l.
  • this preferred embodiment is advantageous in that the metal salt is insoluble in water at neutral pH and remains in a non-active form.
  • the passage in an acid medium in particular at a pH below the pKa of the acid / base pair defined above, causes the dissolution of the metal salt, thus allowing the release of the divalent or trivalent cations and their availability for the ionic crosslinking of the hydrophilic polymer.
  • this metal salt has a pKa of less than or equal to 7, preferably less than or equal to 6.5, more preferably less than or equal to 6, and advantageously less than or equal to 5.
  • the metal salt is advantageously chosen from calcium carbonate CaCO 3 , manganese carbonate MnCO 3 , carbonate of carbon silver AgC0 3 , iron carbonate FeCO 3 , copper carbonate CuCO 3 , magnesium carbonate MgCO 3 , hydroxyapatite Ca 1 O (PO 4 ) 6 OH 2 and mixtures thereof.
  • the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds is chosen from divalent cations, it is introduced into the composition according to the invention in the form of one or more carbonate salts and a divalent metal cation.
  • the metal salt is advantageously chosen from Al 3+ aluminum salts, for example aluminum A1 2 (C0 3) carbonate. ) 3; Fe 3+ ferric salts, and mixtures thereof.
  • the metal salt is selected from the metal salts that are ingested by humans and animals, and in particular mammals.
  • metal salts which can be ingested by humans and animals, in particular calcium carbonate CaCO 3 , magnesium carbonate MgCO 3 , hydroxyapatite Ca 2 O (PO 4 ) 6 OH 2 and iron carbonate FeCO 3. aluminum carbonate A1 2 (CO 3 ) 3 and mixtures thereof.
  • the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds is introduced into the composition according to the invention in the form of a salt of a divalent metal cation, more preferably in the form of a carbonate salt. and a divalent metal cation.
  • the metal salt is calcium carbonate CaCO 3 .
  • the carbonate salts and especially calcium carbonate are advantageous in that they contribute to the gas evolution and thus to the formation of the foam. They are also advantageous in that they leave no residue in the stomach: the majority of cations and gas released contribute to the formation of the foam.
  • the counter-ion of the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds is chosen from a nutritive substance such as a vitamin.
  • the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds is advantageously introduced into the composition in an amount such that the crosslinked polymer, after passage through an acidic medium, in particular at a pH of less than or equal to 5, preferably ranging from 0 , 5 to 5, even more preferably ranging from 1 to 5, and advantageously ranging from 1 to 4, at a degree of crosslinking less than or equal to 100%, preferably less than or equal to 95%, and even more preferably less than or equal to at 90%.
  • the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds is advantageously introduced into the composition in an amount such that the crosslinked polymer, after passage through an acidic medium, in particular at a pH of less than or equal to 5, preferably ranging from 0 , 5 to 5, even more preferably ranging from 1 to 5, and advantageously from 1 to 4, at a degree of crosslinking greater than or equal to 5%, preferably greater than or equal to 10%, even more preferably greater than or equal to 15%, and advantageously greater than or equal to 20%.
  • a too low degree of crosslinking is not suitable for the present invention in that it does not allow the formation of a sufficiently stable foam mechanically.
  • the gas produced in the hydrogel by the decomposition of the foaming agent can not be sufficiently retained by the gelled structure, the gas escapes and the foamy structure is not formed or has a character that is too ephemeral to affect the feeling of satiety.
  • composition according to the invention comprises at least one foaming agent.
  • the foaming agent is defined in the invention as any substance or combination of substances capable of producing or decomposing / dissociating into gas under the action of an environmental factor or a chemical compound.
  • the foaming agent is distinct from the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds.
  • the foaming agent used in the composition according to the invention is a chemical foaming agent.
  • Chemical foaming agents include compounds having the property of reacting or decomposing to form a gas when exposed to a reagent or to specific environmental conditions (temperature, pH, ).
  • the foaming agent is advantageously introduced into the composition according to the invention in an inactive form.
  • non-active form within the meaning of the invention in aqueous solution at neutral pH and in particular at a pH ranging from 6.5 to 7.5 and at room temperature, the foaming agent does not decompose and more particularly does not break down into gas.
  • the gas decomposition of the foaming agent is initiated by passage in an acidic medium, preferably at a pH of less than or equal to 5, more preferably ranging from 0.5 to 5, even more preferably ranging from 1 to 5, and advantageously ranging from 1 to 4.
  • the foaming agent Placed in an acidic medium, the foaming agent decomposes into gas, preferably carbon dioxide C0 2 .
  • the decomposition of the foaming agent into gas is initiated at a pH of less than or equal to 6.5, preferably less than or equal to 6, and more preferably to a pH of less than or equal to 5.
  • the foaming agent is introduced into the composition according to the invention in the form of a salt, preferably in the form of a metal salt.
  • the salt is preferably chosen from monovalent cation salts, even more preferably from monovalent metal cation salts, advantageously from alkali metal cation salts.
  • the salt is chosen from the salts which can decompose in an aqueous medium and at a neutral pH, in particular at a pH ranging from 6.5 to 7.5, on the one hand in monovalent cations and on the other hand in a acido-basic species, in the sense of Brônsted.
  • the acid-base species, in the Bronsted sense, released by the decomposition of the salt in an aqueous medium has a pKa of less than or equal to 7, preferably less than or equal to 6.5.
  • the acid-base species released by the decomposition of the salt in an aqueous medium reacts to form conjugated Brönsted acid.
  • the conjugated Bronsted acid is preferably chosen from compounds which are capable of decomposing into a gas, more preferably of carbon dioxide C0 2 .
  • the acid-base species released by the decomposition of the salt in an aqueous medium is chosen from the hydrogen carbonate or bicarbonate ion HCO 3 " , the carbonate ion CO 3 2" and mixtures thereof.
  • the conjugated Bronsted acid is then the carbonic acid H 2 CO 3 which decomposes to carbon dioxide C0 2 .
  • the salt preferably the metal salt, is chosen from salts with a pKa of less than or equal to 7, preferably less than or equal to 6.5, more preferably less than or equal to 6, and advantageously less than or equal to 5.
  • the salt is preferably selected from carbonates and bicarbonates of monovalent cations, alone or in mixtures, preferably from carbonates and bicarbonates of alkali metal cations.
  • the salt is chosen from sodium carbonate Na 2 CC "3, sodium bicarbonate NaHCC, ammonium bicarbonate NH 4 CO 3 , potassium bicarbonate KHCO 3 and mixtures thereof.
  • the salts mentioned above decompose into monovalent cations (Na + , NH 4 + or K + ) and bicarbonate ions HCO 3 "
  • an acidic medium in particular at a pH of less than or equal to 5, preferably ranging from 0.5 to 5, more preferably ranging from 1 to 5 and advantageously ranging from 1 to 4, the bicarbonate ions HCO 3 " react to form the carbonic acid ELCO 3 which is then decomposed into carbon dioxide C0 2 .
  • the salt is chosen from the ingestible salts by humans and animals and in particular by mammals.
  • the salt is chosen from monovalent metal cation salts, more preferably from sodium carbonate Na 2 CO 3 , sodium bicarbonate NaHCO 3 , potassium bicarbonate KHCO 3 and mixtures thereof.
  • the salt is selected from bicarbonate salts and monovalent metal cations.
  • the salt is sodium bicarbonate NaHCO 3 .
  • the amount of foaming agent introduced into the composition according to the invention is determined relative to the amount introduced into the same composition of compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds.
  • the amount of foaming agent is in particular determined by taking into account the possible contribution of the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds at the gas evolution and thus the formation of the foam.
  • the foaming agent is chosen from metal salts decomposing in monovalent cations and the compound capable of crosslinking the hydrophilic polymer by ionic bond formation is chosen from divalent and / or trivalent cations. .
  • the foaming agent when it is a metal salt decomposing into monovalent cations, it is introduced into the composition according to the invention in an amount such that the ratio between the amount of divalent and / or trivalent cations and the amount of monovalent cations introduced into the composition is greater than or equal to 0.05, preferably greater than or equal to 0.5, the amounts of cations being expressed in moles.
  • the monovalent cation released by the foaming agent is present in such proportions that it does not compete with the divalent and / or trivalent, especially divalent, cations responsible for the crosslinking of the polymer. hydrophilic to the point of significantly degrade the crosslinking of the hydrophilic polymer.
  • the foaming agent when it is a metal salt decomposing into monovalent cations, it is introduced into the composition according to the invention in an amount such that the ratio between the amount of divalent cations and the amount of monovalent cations introduced into the composition is greater than or equal to 0.05, preferably greater than or equal to 0.5, the amounts of cations being expressed in moles.
  • the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds is introduced into the composition according to the invention in the form of calcium carbonate and the foaming agent is sodium bicarbonate.
  • calcium carbonate and sodium bicarbonate are introduced into the composition according to the invention in a molar ratio ranging from 1: 1 to 1: 10, preferably from 1: 1 to 1: 5.
  • the release of gas into the polymer matrix provides a large number of cells for the most part connected to form an open cell foam.
  • the quantity of gas trapped in the matrix depends on the viscosity of the medium before crosslinking, the amount of crosslinking agent and therefore the level of crosslinking, the amount and type of foaming agent introduced into the matrix, the amount and of the nature of the foam stabilizing agent.
  • the release of gas and the crosslinking of the hydrophilic polymer are carried out simultaneously so as to trap the gas formed inside the polymer matrix and allow the formation of a foam, in particular a stable foam.
  • composition according to the invention comprises at least one foam stabilizing agent.
  • the term "foam stabilizing agent” is intended to mean a compound capable of reducing the surface tension at the interface of two different media and in particular at the interface separating a liquid medium from a gaseous medium.
  • the foam stabilizing agent is chosen from structuring agents, surfactant compounds and mixtures thereof.
  • the term "structuring agent” means a chemical compound capable of stabilizing the structure of a foam.
  • the structuring agents are classified in 2 categories according to their chemical nature: peptides and proteins, and
  • the structuring agent is chosen from peptides and proteins.
  • peptide or protein is meant in the sense of the invention a chain of several amino acids linked together by peptide bonds.
  • peptide when the number of amino acids present in the chain is less than 50. It is called protein when the number of amino acids present in the chain is greater than or equal to 50.
  • the structuring agent is chosen from proteins.
  • the protein is chosen from gelatins, albumin, ovalbumin, milk casein, lecithin, their salts, for example sodium caseinate, and mixtures thereof.
  • saccharides in the sense of the invention organic compounds comprising one or more simple monosaccharides.
  • the stabilizing saccharides of the foams are chosen from xanthan gum, glucomannan gum, gum arabic and locust bean gum and mixtures thereof.
  • surfactant compound means an amphiphilic compound comprising a hydrophobic part, in particular a long carbon chain, and a hydrophilic part.
  • the surfactants are classified in 4 categories according to the nature of the hydrophilic group:
  • nonionic surfactants are nonionic surfactants.
  • the surfactant compound is selected from amphoteric surfactants and nonionic surfactants. Zwitterionic or amphoteric surfactants
  • zwitterionic or amphoteric surfactant is intended to mean a surfactant compound whose hydrophilic part consists of an acid-base group.
  • the hydrophilic group is positively charged.
  • the hydrophilic group is negatively charged.
  • zwitterionic or amphoteric surfactant compounds which are suitable for the invention, mention may notably be made of betaines, imidazoline derivatives, phospholipids and their mixtures.
  • phospholipid means a lipid containing at least one phosphoric acid function.
  • Phospholipids include, in particular, phosphatic acids and phosphoglycerides.
  • nonionic surfactant means a surfactant compound in which the hydrophilic part is not charged.
  • nonionic surfactant compounds that may be mentioned for example: polymers and copolymers of ethylene glycol and propylene glycol, esters of fatty acid and of (poly) ethylene oxide, ethers of fatty alcohols and of (poly) ethylene oxide, (poly) oxyethylenated polyol ethers, fatty acid and polyol esters, especially fatty acid esters of sugars, optionally (poly) oxyethylenated, fatty acid glycerides, oxyethylenated glycerol ethers, glycerol ethers and fatty alcohols, fatty acids.
  • fatty acid is understood to mean a compound of carboxylic acid type comprising a linear hydrocarbon-based chain ranging from 10 to 30 carbon atoms.
  • ethoxylated in the sense of the invention a chemical compound having undergone an ethoxylation step by reaction with ethylene oxide.
  • the nonionic surfactant is chosen from poly (ethylene oxide) hydrocarbons, preferably chosen from polyoxyethylene glycol ethers and esters, fatty acid and polyol esters, fatty acids and ethoxylated polyols and mixtures thereof.
  • the nonionic surfactant may be chosen from ethoxylated sorbitans, ethoxylated isosorbides, esters of ethoxylated fatty acids and sorbitans, ethoxylated fatty acid and isosorbide esters, fatty acid and sorbitan esters, fatty acid and isosorbide esters, and mixtures thereof.
  • SPAN ® fatty acid esters of sorbitans
  • SPAN ® 20 Span ® 40 or SPAN 80 ® marketed by Croda Inc.
  • Tween ® eg Tween ® 20, Tween ® 60 or Tween ® 80 marketed by Croda Inc.
  • the nonionic surfactant compound is chosen from fatty acids, and even more preferentially is linoleic acid.
  • the foam stabilizing agent may be a mixture of different stabilizing agents and / or different surfactant compounds.
  • the composition according to the invention has a content of stabilizing agent for foams ranging from 0.01% to 5% by weight relative to the total mass of the composition, preferably ranging from 0.05% to 2% by weight. mass and even more preferably ranging from 0.1% to 1% by weight, the percentages being expressed by mass of dry matter.
  • composition according to the invention may comprise a second hydro-swelling polymer.
  • This second hydro-swelling polymer differs from the hydrophilic polymer described above in that it is not crosslinkable by the formation of ionic bonds.
  • compositions according to the invention are advantageous in that it makes it possible to obtain foams of greater volume, thus increasing the degree of swelling of the composition.
  • the non-crosslinkable hydro-swelling polymer by the formation of ionic bonds is chosen from starch, agar-agar, carrageenan ⁇ (lambda), non-crosslinkable celluloses and mixtures thereof.
  • the hydro-swelling polymer is unmanageable by humans and animals, especially mammals.
  • hydro-bulking polymers that can be ingested by humans and animals, and in particular mammals, there may be mentioned agar-gar, carrageenan ⁇ (lambda), non-crosslinkable celluloses and mixtures thereof.
  • the composition according to the invention has a swelling polymer content ranging from 0% to 50% by weight relative to the total weight of the composition, preferably ranging from 1% to 30% and even more preferably ranging from 5% to 20%, the percentages being expressed as mass of dry matter.
  • composition according to the invention may further comprise and non-exhaustively additives selected from: dyes, flavors, vitamins, dietary fiber.
  • the composition according to the invention further comprises a palatability product in the form of a mixture of at least one flavoring and at least one flavor enhancer.
  • limonene or citral obtained by extraction from citrus peel such as orange and lemon.
  • Artificial or synthetic flavors include vanillin or 3-methoxy-4-hydroxybenzaldehyde, ethyl vanillin or 3-ethyl-4-hydroxybenzaldehyde.
  • composition intended to be ingested by an animal and in particular a mammal, mention may also be made of recycled vegetable or animal oils, waste from the agri-food and restaurant industries, hydrolysates of poultry liver or products of fish fermentation. .
  • flavor enhancer in the sense of the invention a chemical substance that increases the intensity of the olfactory-taste perception of a food portion.
  • An enhancer has no particular flavor and does not change the taste of foods, it only intensifies the taste of foods.
  • flavor enhancers particular mention may be made of sodium glutamate, guanylates, inosinates, ribonucleotides, glycine, zinc acetate, trisodium pyrophosphate, phyllosilicates or glucomannans.
  • the flavor enhancer may be chosen from sodium glutamate, guanylates, inosinates, ribonucleotides, glycine and zinc acetate.
  • the flavor enhancer may be chosen from trisodium pyrophosphate, phyllosilicates or glucomannans.
  • the composition according to the invention preferably comprises from 0.1% to 5% by weight of palatability agents, preferably from 1% to 5% by weight, the percentages being expressed as mass of material dried.
  • the invention also relates to a method for preparing a composition according to the invention.
  • the process according to the invention comprises the introduction into an aqueous medium, in particular into water:
  • the aqueous medium is preferably at a neutral pH, in particular at a pH ranging from 6.5 to 7.5.
  • the order of introduction of the compounds defined above into the aqueous medium is arbitrary and generally has no consequence on the final composition.
  • the compounds defined above can thus be introduced into the aqueous medium simultaneously or by successive additions.
  • the method according to the invention comprises the following steps:
  • the method according to the invention comprises the following steps:
  • solubilizing or dispersing the foam stabilizing agent in water preferably at neutral pH, more preferably at a pH ranging from 6.5 to 7.5, and with stirring,
  • This second variant is particularly suitable when the foam stabilizing agent is in the form of a solid and therefore requires a prior step of dissolution and / or dispersion.
  • a stabilizing agent for foams in solid form is, for example, gelatin.
  • the composition is obtained directly after the preceding process.
  • the composition is obtained in the form of an aqueous dispersion.
  • the method may further comprise an additional drying step, in particular after step (3) or (2 ').
  • This additional drying step is carried out so as to eliminate all or part of the water present in the composition.
  • the drying step of the composition is carried out by the injection of pulsed hot air, by treatment with supercritical carbon dioxide C0 2 , by lyophilization or by atomization, even more preferably by treatment with carbon dioxide C0 2 supercritical .
  • the process according to the invention thus makes it possible to obtain compositions with a controlled water content, as a function of the duration and the intensity of the drying applied.
  • the process according to the invention allows the preparation of a composition in the form of an aqueous dispersion.
  • the method allows the preparation of a composition free of water and in the form of a xerogel, a cryogel or an airgel depending on the drying method used .
  • the composition when the composition is totally dried by the injection of pulsed hot air, the composition is obtained in the form of a xerogel.
  • the composition When the composition is totally dried by supercritical CO 2 carbon dioxide treatment, the composition is obtained in the form of an airgel.
  • the composition When the composition is totally dried by lyophilization, the composition is obtained in the form of a cryogel.
  • the process according to the invention makes it possible to obtain compositions having various consistencies: in solid or liquid, viscous or fluid forms, and in particular in the form of syrups.
  • the process according to the invention allows the preparation of compositions in the form of powders.
  • the powders obtained by drying a composition according to the invention have a particle size less than or equal to 2 mm, preferably less than or equal to 1 mm, even more preferably less than or equal to 0.8 mm.
  • the particle size of the powders is measured using a LASER granulometer
  • Mastersizer 3000® marketed by Malvern. It is equipped with a High Energy Venturi (HE), a grid placed on the sieve with a 5mm opening and a 10 mm ball facilitating the passage of the sample through this grid.
  • HE High Energy Venturi
  • 2 g to 10 g of powders are introduced into the hopper with a selected opening of 2 mm, a vibration rate of the hopper at 30-40%, a pressure ranging from 2 to 4 bars and an obscurity ranging from 2 to 15% according to the amount of material. Between 5 and 10 measurements are made by samples. The average diameter of a sphere of equivalent volume is then determined by measuring the average diameter of the most representative class (maximum Gaussian) by volume, considered as the average diameter of the particles studied. uses
  • the invention also relates to a composition according to the invention for its use as a medicament, in particular for the prevention and / or treatment of obesity.
  • composition according to the invention is in particular intended to be ingested by humans or animals, and especially by mammals, in order to produce an "appetite suppressant" effect in the patient, linked to the appearance of a sensation of satiety. .
  • This feeling of satiety in the patient, human or animal is obtained by swelling of the composition in the stomach, thereby causing a reduction in gastric volume.
  • composition according to the invention is a self-foaming composition in an acid medium, preferably at a pH of less than or equal to 5, more preferably ranging from 0.5 to 5, even more preferably ranging from 1 to 5, and advantageously ranging from 1 to 4.
  • the term "self-foaming composition in an acidic medium” is intended to mean a composition capable of expanding in the form of a foam when it is placed in an acidic medium, preferably at a pH less than or equal to 5, more preferably from 0.5 to 5, advantageously from 1 to 5, and even more advantageously from 1 to 4.
  • the foaming of a foaming composition according to the invention does not require the injection of gas or the application of mechanical agitation.
  • the composition according to the invention forms a foam when it is placed in an aqueous medium at a pH of less than or equal to 6, preferably less than or equal to 5, even more preferably less than or equal to 4.
  • the composition according to the invention forms a foam when it is placed in an aqueous medium at a pH greater than or equal to 0.5, preferably greater than or equal to 1.
  • the composition according to the invention expands, swells to form a foam.
  • the pH of the stomach is typically between 0.5 and 2.5. As a meal is taken, it gradually increases to reach a pH of 4 to 5 at the end of the meal.
  • composition according to the invention is thus advantageous in that it makes it possible to avoid any problems related to the ingestion of a composition according to the invention at the end of the meal, contrary to the recommended use protocols.
  • the ingestion of a composition according to the invention at the end of the meal is unlikely to lead to excessive swelling of the stomach of the patient who has already ingested a portion of food.
  • the swelling of the composition in an acidic medium is made possible by two phenomena: the foaming resulting from the gas decomposition of the foaming agent and the crosslinking of the polymer matrix, these two phenomena occurring simultaneously.
  • composition according to the invention advantageously makes it possible to obtain a closed foam.
  • closed foam in the sense of the invention a foam having:
  • Closed foam is advantageous in that the gas responsible for its formation remains trapped within the structure.
  • the gas released during the foaming of the composition remains trapped within the polymer matrix, thus preventing the release of gas inside the stomach.
  • a test for determining the closed or open nature of a foam may consist for example of:
  • the foam is said to be closed. In the opposite case, the foam has an open structure.
  • the foam obtained by swelling of the composition according to the invention preferably has a level of hydration as defined above less than or equal to 20%, more preferably less than or equal to 15%.
  • hydrophilic polymer present in the composition according to the invention then constitutes a continuous phase within the foamy structure and forms a three-dimensional network.
  • hydrogonflecting polymer non-crosslinkable by the formation of ionic bonds, forms a dispersed phase within the foamy structure.
  • the foam stabilizing agent is at the interface between the hydrophilic polymer and the gas bubbles trapped in the structure.
  • the formation of a foam is made possible by the decomposition of the foaming agent initiated by the passage in acid medium.
  • the compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds also contributes to gassing and foam formation.
  • the crosslinking of the polymeric matrix is made possible by the decomposition of the compound capable of crosslinking the hydrophilic polymer by formation of ionic bonds caused by the passage in an acid medium.
  • the swelling of the composition is measured by the swelling rate.
  • the degree of swelling is defined as the ratio of the difference between the volume of the expanded composition after foaming and the volume of the initial composition over the volume of the initial composition.
  • the swelling rate is measured as follows:
  • a composition according to the invention 2 ml of a composition according to the invention are placed in a class A test tube graduated from 0 to 100 ml. 50 ml of an aqueous solution whose pH was fixed by the addition of citric acid are then gently introduced into the class A test tube graduated from 0 to 100 ml. It is important to gently introduce the aqueous solution into the graduated cylinder to follow the evolution of the volume of the system.
  • the volume of the hydrogel is raised at regular intervals using a stopwatch, between 10s and 1 min depending on the measurement conditions.
  • the swelling of the self-inflating hydrogel is followed until the volume stabilizes and reaches a plateau.
  • the volume corresponding to this plateau is considered to be the maximum swelling of the hydrogel under the conditions studied.
  • the swelling rate of self-inflating hydrogels is determined according to the following equation:
  • Vt determined volume at time t (in mL)
  • the initial volume of the composition after drying Vi is determined as follows: 2 ml of the initial composition are poured into an aluminum cup 2 cm in diameter and are placed in an oven at 70 ° C for 12 hours. The dry product is then in the form of a disc of 2 cm in diameter and whose thickness is measured by means of a micrometer caliper. The volume of this disc represents the initial volume of the composition after drying.
  • composition according to the invention advantageously has a degree of swelling greater than or equal to 200, preferably greater than or equal to 250, and even more preferably greater than or equal to 300.
  • composition according to the invention preferably has a swelling ratio of less than or equal to 500, preferably less than or equal to 400.
  • the composition according to the invention in its expanded form, obtained by passing through an acid medium is mechanically stable.
  • crosslinking of the polymeric matrix by the formation of ionic bonds is advantageous in that the crosslinked foamy structure is reversible.
  • the crosslinking is reversible under the action of monovalent cations in large excess.
  • the crosslinked foam structure can be disintegrated by ingestion of monovalent metal salts such as sodium chloride NaCl.
  • the polymer chains, in particular the polysaccharide or polysaccharide derivative chains are hydrolyzable by the action of gastric enzymes.
  • composition according to the invention is easily digestible and removable by the body via conventional digestion mechanisms.
  • the swelling of the composition is initiated by passage in the gastric medium, while in the oral cavity and the passage through the esophagus, the composition does not expand.
  • composition according to the invention expands.
  • a foam stabilizing agent makes it possible to obtain a mechanically stable foam over a period of a few hours corresponding to the time interval between taking two consecutive meals.
  • the mechanical stability of the foam can for example be observed visually.
  • composition according to the invention is intended to be ingested by humans and / or animals and in particular by mammals.
  • the composition according to the invention can be ingested in the form of a solid and especially in the form of powders, coated or uncoated tablets, or granules.
  • the composition according to the invention can be ingested in the form of a liquid and especially in the form of a viscous liquid or a gel and in particular a syrup.
  • the invention also relates to a core / shell structure capsule comprising at least one core consisting of a composition according to the invention and at least one coating layer covering all or part of the core surface.
  • the heart of the capsule is in the form of a powder.
  • the heart of the capsule is in the form of a viscous liquid or a gel.
  • the invention also relates to a food kit comprising, preferably in the same package, and packaged separately:
  • composition according to the invention in the form of a kit is advantageous in that it makes it possible to provide patients with pre-dosed and ready-to-use products corresponding to their needs for a meal.
  • the kit according to the invention may comprise a food portion adapted to the diet of the patient as well as a suitable dose of a composition according to the invention in amounts allowing to provoke the appearance in the patient of a feeling of satiety at the end of the meal.
  • kits are also suitable for a snack to fill a hunger between meals.
  • the kit comprises a low calorie food portion and a complementary dose of a composition according to the invention in an amount to cause the appearance in the patient of a feeling of satiety.
  • the invention also relates to an oral delivery device such as for example a feeding syringe comprising a composition according to the invention.
  • This type of device is particularly suitable for administering a composition according to the invention to animals and in particular to mammals.
  • the invention also relates to a food product for animals, and in particular for mammals, said food product comprising a composition according to the invention.
  • the animal food product can take any form known to those skilled in the art.
  • the animal food product may be in the form of a kibble, a snack, a treat or a biscuit.
  • the animal food product is in the form of a kibble.
  • the animal food product is preferentially soft.
  • the soft texture of a food product is advantageous in that it can provide a more effective "appetite suppressant" effect by promoting chewing and thus increasing the duration of a meal.
  • a soft texture can be obtained in the absence of aqueous binders such as glycerol, generally used as a preservative.
  • the animal food product according to the invention comprises a core and a coating layer.
  • the heart is in a food portion and the coating layer is in a composition according to the invention.
  • the core is in a composition according to the invention and the coating layer is a food portion.
  • the heart is in a food portion and the coating layer is a composition according to the invention.
  • a suitable food portion for an animal for example a dog, comprises, for example, from 20 to 30% by weight of crude protein and from 10 to 20% by weight of fats, the remainder being carbohydrates and in particular dietary fiber and ashes.
  • the other constituents of the food portion are not essential. Standard products can be incorporated.
  • the ingredients constituting the food portion adapted for an animal may be selected so as to provide the animal that ingests all the vitamins and minerals recommended for a complete and balanced meal.
  • the food portion adapted for an animal may include meat or a material derived from animals such as beef, chicken, turkey, lamb, fish, blood plasma, bone marrow. and their mixtures.
  • the food portion adapted for an animal may also not include meat and include a meat substitute such as soy, corn gluten or a soy product as a source of protein.
  • the food portion adapted for an animal may also include other sources of protein such as soy protein concentrates, milk proteins or gluten.
  • the adapted food portion for an animal may also comprise a source of starch in the form of cereals chosen in particular from wheat, corn, rice, oats, barley and mixtures thereof.
  • the food portion adapted for an animal comprises at least one fiber source.
  • the food portion adapted for an animal comprises from 1% to 6% by volume of a composition according to the invention, the percentages being expressed as total volume of the food product.
  • the invention also relates to a method of treating a human or animal patient to allow weight loss, said method comprising:
  • Oral ingestion of the composition allows the composition to reach the level of the patient's stomach.
  • the contacting of the composition with the gastric medium causes the swelling of the composition in contact with the gastric fluid.
  • the empty gastric volume is reduced and the patient experiences a feeling of satiety.
  • the treatment method according to the invention is advantageously applied before a meal is taken by the patient.
  • the patient takes the meal directly after oral ingestion of the dose of composition according to the invention.
  • composition according to the invention to be ingested by the patient is determined by a practitioner of medicine, and in particular by a dietitian according to the patient and his specific needs.
  • the dose of composition to be ingested by the patient is calculated according to his nutritional needs but also according to the volume of his stomach to cause him to appear a feeling of satiety at the end of the meal.
  • the patient has a volume of composition according to the invention and takes the dose that is adapted to him by means of a suitable sampling device.
  • the sampling device is for example a graduated container, a syringe, a measuring spoon or a balance.
  • the patient has the composition according to the invention in the form of a pre-metered composition corresponding exactly to his needs.
  • Figure la graphical representation of the variation of the swelling rate of different compositions (ordinate) versus time in minutes (abscissa).
  • Curve 1 represents the evolution of the swelling rate of a composition according to the invention and in which the foam stabilizing agent is Tween 80® (composition 1).
  • Curve 2 represents the evolution of the swelling rate of a composition according to the invention and in which the foam stabilizing agent is gelatin (composition 2).
  • Curve 3 represents the evolution of the swelling rate of a foam stabilizer-free composition (composition 3).
  • the curves 4 and 5 are combined and represent the evolution of the swelling ratio of two compositions without foaming agent (respectively compositions 4 and 5).
  • Curve 6 represents the evolution of the swelling rate of a hydrogel composition as described in the prior art (composition 8).
  • Figure lb is a zoom on Figure la corresponding to the time interval [0, 15 minutes].
  • Curve 1 represents the total occupied volume of the stomach (food and liquid), the feeling of satiety appearing in the patient when this curve reaches 100%.
  • Curve 2 represents the volume of food ingested by the patient.
  • Curve 3 represents the volume of food in the stomach.
  • Curve 4 represents the volume occupied by the ingested hydrogel.
  • Curve 5 represents the volume of liquids present in the stomach.
  • Curve 1 represents the total occupied volume of the stomach (food and liquid), the feeling of satiety appearing in the patient when this curve reaches 100%.
  • Curve 2 (in broken lines) represents the volume of food ingested by the patient.
  • Curve 3 (solid line) represents the volume of food in the stomach.
  • Curve 4 represents the volume occupied by the composition according to the ingested invention.
  • Curve 5 represents the volume of liquids present in the stomach.
  • water-soluble polymer of sodium alginate (CAS: 9005-38-3), commercially available from Sigma Aldrich under the reference A2033.
  • sodium bicarbonate NaHCO 3 (CAS: 144-55-8), commercially available from Sigma Aldrich under the reference S5761.
  • Citric acid (CAS: 77-92-9) in the form of a 2.6% aqueous solution.
  • the volume of the composition is raised at regular intervals using a stopwatch, between 10s and 1 min depending on the measurement conditions.
  • the swelling of the composition is followed until the volume stabilizes and reaches a plateau.
  • the volume corresponding to this plateau is considered to be the volume corresponds to the maximum swelling of the composition under the conditions studied.
  • the rate of swelling of the composition is determined according to the following equation:
  • Vt determined volume at time t (in mL)
  • initial volume of the composition after drying (in mL)
  • the initial volume of the composition after drying Vi is determined as follows: 2 ml of the initial composition are poured into an aluminum cup of 2 cm in diameter and placed in an oven at 70 ° C for 12h. The dry product is then in the form of a disc of 2 cm in diameter and whose thickness is measured by means of a micrometer caliper. The volume of this disc represents the initial volume of the composition after drying
  • Composition 1 (according to the invention):
  • a surfactant mixture (TWEEN 80®) is added to the dispersion.
  • Composition 2 (according to the invention):
  • composition 3 comparativng agent (gelatin):
  • Composition 4 (comparative, without foaming agent):
  • a surfactant mixture (TWEEN 80®) is added to the dispersion.
  • Composition 5 (comparative, without foaming agent):
  • composition 6 comparative, without compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds:
  • a surfactant mixture (TWEEN 80®) is added to the dispersion.
  • Composition 7 (comparative, without compound capable of crosslinking the hydrophilic polymer by the formation of ionic bonds):
  • a structuring agent (gelatin) is added to the dispersion.
  • Composition 8 (comparative, according to the prior art):
  • Composition 8 corresponds to a hydrogel-type composition obtained from polyacrylamide.
  • curve 1 represents the evolution of the swelling rate of composition 1, according to the invention
  • curve 2 represents the evolution of the swelling ratio of composition 2
  • curve 6 represents the evolution of the swelling rate of composition 8, according to the prior art.
  • composition 8 The maximum swelling observed for composition 8, according to the prior art, is reached in 240 minutes and corresponds to a swelling rate of 261.
  • the maximum swelling rate observed for composition 1, according to the invention is reached in 4 minutes in contact with the acid medium and corresponds to a swelling rate of 318.
  • composition 2 according to the invention The maximum swelling observed for the composition 2 according to the invention is reached in 2 minutes in contact with the acid medium and corresponds to a swelling rate of 381.
  • compositions 1 and 2 have a swelling rate greater than that of the composition 8, according to the prior art.
  • this higher swelling is achieved in a much shorter time: between 2 and 4 minutes for a composition according to the invention and about 4 hours for a composition according to the prior art
  • compositions 1 and 3 according to the invention are much faster than that of composition 8, according to the prior art.
  • the compositions 1 and 2, according to the invention are therefore likely to produce in the patient a sensation of satiety much faster than the hydrogel composition of the prior art.
  • Example 2 The results obtained in Example 2 were used to perform a simulation of the volume distribution of the contents of the stomach during the taking of a meal and after the ingestion in the first case of a hydrogel composition, according to the prior art (composition 8) and in the second case of a composition according to the invention (composition 1). The results obtained are shown in Figures 2 and 3.
  • composition 8 The duration of taking a meal, on average, is 30 minutes.
  • the proposed model is based on ingestion of hydrogel at the beginning of the meal, supplemented by ingestion of food until satiety is reached, the evaluation lasting 30 minutes.
  • Curve 1 represents the total occupied volume of the stomach.
  • Curve 2 represents the volume of food ingested by the patient.
  • Curve 3 represents the volume of food in the stomach.
  • Curve 4 represents the volume of the stomach occupied by the hydrogel, according to the prior art.
  • Curve 5 represents the volume of liquid present in the stomach. A feeling of satiety appears in the patient, when the entire volume of the stomach is occupied, or when the curve 1 reaches 100%.
  • the volume distribution of the stomach is as follows: - 23% o of the total volume of the stomach is occupied by the hydrogel (curve 4), and
  • Composition 1 is a composition of Composition 1:
  • Curve 1 represents the total occupied volume of the stomach.
  • Curve 2 (broken line) represents the volume of food ingested by the patient.
  • Curve 3 (solid line) represents the volume of food in the patient's stomach.
  • Curve 4 represents the volume occupied by the composition according to the invention.
  • Curve 5 represents the volume of liquid present in the stomach.
  • a feeling of satiety appears in the patient, when the entire volume of the stomach is occupied, or when the curve 1 reaches 100%.
  • the volume distribution of the stomach is as follows: 38% of the total volume of the stomach is occupied by the composition according to the invention.
  • the volume of food ingested by the patient and the volume of food in the stomach are almost equal: a very small amount of food has had time to pass into the intestine.
  • volume of liquid present in the stomach does not decrease throughout the meal.
  • the swelling of the composition according to the invention does not require the absorption of liquids.
  • compositions make it possible to reduce the volume of food ingested by a patient in order to feel a feeling of satiety.
  • Ingesting a composition according to the invention allows a greater decrease in the volume of food ingested by the patient.
  • the feeling of satiety is felt by the patient having ingested a composition according to the invention after 14 minutes.
  • the volume of food ingested by the patient represents at this precise moment 47% of the total volume of the stomach.
  • composition 8 a composition according to the prior art (composition 8) after 25 minutes.
  • the volume of food ingested by the patient represents at this moment 80% of the total volume of the stomach.
  • the composition according to the invention therefore makes it possible to reach the feeling of satiety more quickly.
  • composition according to the invention is a better "appetite suppressant" agent in that its ingestion at the beginning of a meal makes it possible to further reduce the volume of food to be ingested by a patient in order to feel a feeling of satiety.
  • compositions 1 and 2 were evaluated at neutral pH (compositions 1 and 2) and at pH 4 (composition 2 only).
  • the protocol for measuring the degree of swelling of the compositions is similar to that described above, the difference being that the aqueous composition is not at pH 2 but at pH 7 or 4.
  • compositions 1 and 2 are simply diluted with the aqueous solution.
  • composition according to the invention does not make it possible to obtain a hydrogel in the form of an expanded foam. * Swelling at pH equal to 4
  • composition according to the invention After 1 minute in contact with the acid medium, the composition according to the invention begins to swell.
  • composition obtained has a low swelling rate and the foam obtained is mechanically fragile. Placed in an acid medium with a pH of 4, the composition according to the invention makes it possible to obtain a hydrogel foam.
  • the swelling rate of the composition is relatively low and the swelling kinetics is slow.
  • composition 3 (counterexample, free of foam stabilizing agent) were evaluated from the protocol described above.
  • composition 3 The maximum swelling observed for composition 3 is reached after 2 minutes in contact with the acid medium and corresponds to a swelling rate of 126.
  • compositions 1 and 2 according to the invention have a degree of swelling 2.5 to 3 times higher than that of the composition 4 without a foam stabilizing agent.
  • compositions according to the invention thus makes it possible to obtain a self-sealing composition in an acidic medium having a degree of swelling of more than 2.5 times greater than that of a composition which would be exempt.
  • compositions 4 and 5 were evaluated from the protocol described above.
  • compositions 4 and 5 The maximum swelling observed for compositions 4 and 5 is reached after 5 minutes in contact with the acid medium and corresponds to a swelling rate of 79%.
  • the compositions 1 and 2 according to the invention have a swelling rate of more than four times that of the compositions 4 and 5 without foaming agent.
  • compositions according to the invention thus makes it possible to obtain a self-inflating composition in an acidic medium having a high degree of swelling, in particular more than 4 times greater than that of a composition which would be free.
  • Example 7 Influence of the agent capable of crosslinking the polymer by the formation of ionic bonds on the swelling rate of the composition
  • compositions 6 and 7 were evaluated from the protocol described above.
  • the foaming agent is released by passage in an acid medium. There is then observed the formation of a foam that collapses rapidly: the gas formed within the composition escapes from the hydrogel and does not allow to obtain a foamy structure.
  • compositions 6 and 7 are simply diluted with the aqueous solution.
  • compositions make it possible to obtain, in acidic medium, a hydrogel in the form of an expanded foam.

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FR3068039A1 (fr) 2018-12-28
FR3068039B1 (fr) 2020-07-10
MA49480A (fr) 2020-04-29
IL271316A (he) 2020-01-30
BR112019027561A2 (pt) 2020-07-07
MX2019015270A (es) 2020-08-17
US20200146980A1 (en) 2020-05-14
IL271316B1 (he) 2023-08-01
IL271316B2 (he) 2023-12-01
US20220409529A1 (en) 2022-12-29
CA3067189A1 (fr) 2018-12-27
US11471407B2 (en) 2022-10-18
WO2018234680A1 (fr) 2018-12-27

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