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EP4580585A1 - Procédé de fabrication d'une composition non aqueuse - Google Patents

Procédé de fabrication d'une composition non aqueuse

Info

Publication number
EP4580585A1
EP4580585A1 EP23757240.9A EP23757240A EP4580585A1 EP 4580585 A1 EP4580585 A1 EP 4580585A1 EP 23757240 A EP23757240 A EP 23757240A EP 4580585 A1 EP4580585 A1 EP 4580585A1
Authority
EP
European Patent Office
Prior art keywords
mix
process according
composition
temperature
rapid cooling
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
EP23757240.9A
Other languages
German (de)
English (en)
Inventor
Matthew Edward Creswick
Jonathan James O'SULLIVAN
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.)
Unilever Global IP Ltd
Unilever IP Holdings BV
Original Assignee
Unilever Global IP Ltd
Unilever IP Holdings BV
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 Unilever Global IP Ltd, Unilever IP Holdings BV filed Critical Unilever Global IP Ltd
Publication of EP4580585A1 publication Critical patent/EP4580585A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/24—Phosphorous; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/04—Dispersions; Emulsions
    • A61K8/042—Gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/25—Silicon; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/345—Alcohols containing more than one hydroxy group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/46—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur
    • A61K8/463—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur containing sulfuric acid derivatives, e.g. sodium lauryl sulfate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/20—Chemical, physico-chemical or functional or structural properties of the composition as a whole
    • A61K2800/28—Rubbing or scrubbing compositions; Peeling or abrasive compositions; Containing exfoliants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/20—Chemical, physico-chemical or functional or structural properties of the composition as a whole
    • A61K2800/30—Characterized by the absence of a particular group of ingredients
    • A61K2800/31—Anhydrous

Definitions

  • the present invention relates to a process of manufacturing a non-aqueous compositions.
  • Paste compositions that are non-aqueous can prove difficult to manufacture in that the rheology of the paste is difficult to control.
  • the stability of non-aqueous paste can also be problematic.
  • EP 2 089040 describes oral care compositions which remineralises eroded teeth and/or whitens the teeth.
  • the composition can be a dual phase composition comprising a source of calcium ions, a source of phosphate ions. With such systems it is preferable if the level of water within the composition is low.
  • non-aqueous pastes in particular oral care toothpastes that have excellent rheology such as viscosity, are stable and preferably comprises a high level of materials that can remineralise tooth enamel.
  • composition of the invention is used to preferably used to clean the surfaces of the oral cavity and is known as an oral care composition. Accordingly, preferred product forms for compositions of the invention are those which are suitable for brushing and/or rinsing the surfaces of the oral cavity.
  • the composition of the invention is most preferably in the form of a dentifrice.
  • dentifrice denotes an oral composition which is used to clean the surfaces of the oral cavity. Such a composition is not intentionally swallowed for purposes of systemic administration of therapeutic agents, but is applied to the oral cavity, used to treat the oral cavity and then expectorated. Typically such a composition is used in conjunction with a cleaning implement such as a toothbrush, usually by applying it to the bristles of the toothbrush and then brushing the accessible surfaces of the oral cavity.
  • the dentifrice/toothpaste is in the form of an extrudable semi-solid such as a cream, paste or gel (or mixture thereof).
  • the rheological behaviour compositions prepared by this process can be well controlled to achieve the desired sensory effects.
  • a further particular advantage of the composition of the invention is its storage stability.
  • the composition of the invention is non-aqueous.
  • non-aqueous it is generally meant that water is not deliberately added to the composition in any significant quantity.
  • nonaqueous does not mean that small amounts of water cannot be present, for example as a consequence of its association with hygroscopic raw materials.
  • the term “non-aqueous” generally means that water is present in an amount no greater than about 5%, more preferably no greater than about 3% by weight based on the total weight of the composition.
  • composition of the invention comprises an organic polyol.
  • Polyols for use in the invention comprise glycerol and /or Other polyols may be present such as , xylitol, mannitol, lactitol, maltitol, erythritol, and hydrogenated partially hydrolyzed polysaccharides. I. Mixtures of any of the above described materials may also be used.
  • organic polyol will depend on the particular type chosen, but generally ranges from about 20 to 90% by weight based on the total weight of the composition.
  • the amount of organic polyol suitably ranges from 35 to 75%, more preferably from 45 to 70% by total weight organic polyol based on the total weight of the composition.
  • organic polyol means that the composition is not oil-based or water-based, but instead, organic polyols (as defined above) are a principal component in the composition.
  • principal component is meant that the organic polyols (as defined above) when taken together, make up a higher portion of the composition's weight than any other compound.
  • the composition of the invention is glycerol-based (i.e glycerol makes up a higher portion of the composition's weight than any other compound) and contains from 45 to 70% by weight glycerol based on the total weight of the composition.
  • the invention of the composition comprises a structurant.
  • a preferred structurant is crystals of one or more solid polyethylene glycols having a melting point of 25°C or above. Preferably the melting point ranges from 35 to 65°C, more preferably from 55 to 60°C.
  • the average molecular weight suitably ranges from about 950 to 11 ,250, preferably from about 1800 to 6600, more preferably from about 1400 to 4400, most preferably from about 2700 to 3700 g/mol.
  • Suitable commercially available materials include for example Polyglykol® 3000 (ex Clariant). Mixtures of any of the above described materials may also be used.
  • Gantrez MS-955 molecular weight 1,060,000; calcium/sodium salt.
  • compositions according to the invention may comprise a tooth whitening agent.
  • the whitening agent preferably comprises a green and/or a blue pigment.
  • a pigment is generally understood to be a shade/material which is insoluble in the relevant medium, at the relevant temperature. This is in contrast to dyes which are soluble.
  • the "relevant medium” is human saliva, the liquid medium in which the composition is used, at the temperature of the oral cavity during brushing of the teeth, i.e. up to 37 Degrees C. As a reasonable approximation, the relevant medium may be considered to be water and the relevant temperature to be 25 Degrees C.
  • the blue pigment is Pigment Blue 15, more preferably Pigment Blue 15:1 , 15:2, 15:3, 15:4, 15:5 or 15:6, most preferably 15:1.
  • a preferred pigment is blue pigment is Phthalocyanine Blue Pigment, Cl No. 74160, blue covarine.
  • the preferred Green pigment is Phthalocyanine Green, preferably Phthalocyanine Green CI-74260.
  • the total level of pigment in the composition is from 0.01 wt% to 3 wt, more preferably from 0.02 to 2 wt%.
  • composition is a toothpaste it may be a dual phase paste, with the whitening pigments present in one phase.
  • compositions according to the invention may comprise water-soluble or sparingly water-soluble sources of metal salts
  • zinc ions such as zinc chloride, zinc acetate, zinc gluconate, zinc sulphate, zinc fluoride, zinc citrate, zinc lactate, zinc oxide, zinc monoglycerolate, zinc tartrate, zinc pyrophosphate and zinc maleate
  • stannous ions such as stannous fluoride and stannous chloride.
  • compositions according to the invention may comprise oral care enzyme systems such as hydrogen peroxide producing enzyme systems (e.g. the oxidoreductase enzyme glucose oxidase), amyloglucosidase, dextranase and/or mutanase, (optionally in the presence of zinc ion providing compounds and/or 8- hydroxyquinoline derivatives), lactoperoxidase, lactoferrin, lysozyme and mixtures thereof.
  • hydrogen peroxide producing enzyme systems e.g. the oxidoreductase enzyme glucose oxidase
  • amyloglucosidase e.g. the oxidoreductase enzyme glucose oxidase
  • dextranase and/or mutanase e.g. the oxidoreductase enzyme glucose oxidase
  • mutanase e.g. the mutanase
  • lactoperoxidase e.g. the
  • Compositions of the invention may comprises fluoride sources such as sodium fluoride, stannous fluoride, sodium monofluorophosphate, zinc ammonium fluoride, tin ammonium fluoride, calcium fluoride, cobalt ammonium fluoride and mixtures thereof;
  • fluoride sources such as sodium fluoride, stannous fluoride, sodium monofluorophosphate, zinc ammonium fluoride, tin ammonium fluoride, calcium fluoride, cobalt ammonium fluoride and mixtures thereof;
  • composition according the invention will comprise further ingredients which are common in the art, such as: antimicrobial agents, e.g. chlorhexidine, sanguinarine extract, metronidazole, quaternary ammonium compounds, such as cetylpyridinium chloride; cetylpyridium chloride clay complex bis- guanides, such as chlorhexidine digluconate, hexetidine, octenidine, alexidine; and halogenated bisphenolic compounds, such as 2,2' methylenebis-(4-chloro-6-bromophenol); anti-inflammatory agents such as ibuprofen, flurbiprofen, aspirin, indomethacin etc.; anti-caries agents such as sodium- and stannous fluoride, aminefluorides, sodium monofluorophosphate, sodium trimeta phosphate and casein; plaque buffers such as urea, calcium lactate, calcium glycerophosphate and strontium polyacrylates; vitamins such as Vitamins A
  • starch starch, sucrose, water or water/alcohol systems etc.
  • surfactants such as anionic, nonionic, cationic and zwitterionic or amphoteric surfactants
  • Humectants such as glycerol, sorbitol, propyleneglycol, xylitol, lactitol etc.
  • binders and thickeners such as sodium carboxymethyl-cellulose, hydroxyethyl cellulose (Natrosol®), xanthan gum, gum arabic etc.
  • bleaching agents such as peroxy compounds e.g. potassium peroxydiphosphate, effervescing systems such as sodium bicarbonate/citric acid systems, colour change systems, and so on.
  • the process for the manufacture of a non-aqueous composition comprising the following sequential steps: i) heating a mix of structurant and organic polyol comprising sorbitol and/or glycerol to a temperature of 69 °C or above, ii) addition of an abrasive and other non-flavour ingredients to the mix, iii) rapid cooling the resulting mix at a cooling rate of 5°C/min or above to form a paste or gel. It is preferred if the process is carried out under vacuum.
  • the vacuum can be achieved by any suitable means, preferably by a standard a rotary vacuum pump capable of maintaining a vacuum of at least - 800 mbar(g), preferably - 950 mbar(g). An example of a suitable.
  • the rapid cooling rate can be achieved by any suitable means preferably by liquid nitrogen or carbon dioxide preferably the rapid cooling is achieved by the use of cardice (solid carbon dioxide.
  • cardice solid carbon dioxide.
  • the highly endothermic nature of this phase change dictates that it must be accompanied by the absorption of large quantities of heat from the material’s surroundings, enabling solid CO2 to act as an effective coolant.
  • the rate of sublimation is dependent on operating conditions of temperature, pressure, and thermal properties of the fluid it is being contacted with, as well as the surface area of the solid CO2 material.
  • sublimation rates When intimately mixed with product at elevated temperatures of 70°C within the mixer, sublimation occurs rapidly; sublimation rates of up to 32 kg h' 1 have been measured during pilot-plant operation. Sublimation rates can be significantly slowed with appropriate storage of material within insulated containers, yielding sublimation rates as low as 0.19 kg h' 1 .
  • CO2 is a preferred method of rapid cooling as it boasts several other properties which make it favourable for use as a directly added coolant.
  • Gaseous CO2 is non-flammable, colourless, odourless and readily recoverable from the mixing vessel via vacuum.
  • the coolant could be liquid nitrogen.
  • Nitrogen exists under atmospheric pressure as a colourless, low viscosity liquid at temperatures between 63.1 K and 77.3K (or -221 ,8°C and -195.9°C). It can be readily obtained from air, either via cryogenic distillation or pressure swing adsorption. The associated enthalpy change of vaporisation is +5.59 kJ mol' 1 (+199.6 kJ kg -1 ). It must be stored and transported in thermally insulated vacuum flasks to minimise evaporative losses and maintain cryogenic storage conditions.
  • the coolant could also be liquid carbon dioxide.
  • Carbon dioxide only exists as a liquid at pressures above 5.13 atm, and temperatures between -56.6°C (the triple point temperature of CO2) and 31.1°C (the critical temperature of CO2), so requires pressurised storage.
  • the associated enthalpy change of vaporisation is +16.7 kJ mol' 1 (+379.6 kJ kg' 1 ).
  • the process has an initial cooling rate of the liquid ii) of less than 2 °C/min (this is achieved by conventional cooling using a jacketed vessel, where the coolant temperature ranges from 20°C to -18°C) followed by rapid cooling at a rate of 5°C/min or above (this is achieved by direct addition into the mixing vessel of liquid carbon dioxide or nitrogen, or most preferably cardice).
  • the mix is cooled at an initial cooling rate of less than 2 °C/min to 50 °C to 40 °C, preferably followed by addition of temperature sensitive ingredients such as perfume and flavour. After the initial slow cooling the mix is rapid cooled at a rate of 5°C/min or above to a temperature of 30 °C or below.
  • the rapid cooling rate is 10°C/min, preferably 15°C/min, more preferably 20°C/min. Particularly preferred is a rapid cooling rate between 20°C/min and 30°C/min.
  • the perfume or flavour is added at a temperature of 45 °C or below.
  • the structuring components such as various forms of carrageenans, various grades of PEG, xanthan gum or a combination thereof, are either pre-mixed, or alternatively dissolved or dispersed in a portion of the bulk liquid, before they are added overhead into the mixing vessel along with the remainder of the bulk liquid phase.
  • the entire in-vessel manufacturing process takes place under vacuum of at least -800 mbar(g) to minimise air entrainment.
  • the liquid mixture in the vessel is first heated to an elevated temperature between 60 and 80°C and held for between 30 and 60 minutes to activate and/or sufficiently swell the structuring components. Next, the temperature may be maintained, or reduced as low as 50°C before several sequential overhead additions of the other solid active components and powdered abrasives. These are dispersed and suspended by providing appropriate levels of mixing and shear from the overhead agitators. Following the completion of all solid additions and mixing steps, the product is cooled from an elevated temperature.
  • rapid cooling is achieved via the direct addition of a mass of cardice equal to between 14% and 17% of the total mass of product.
  • flavourings and perfumes are added to the vessel immediately prior to the cardice, as part of the same overhead addition process.
  • Adding solid cardice pellets to the viscous, elevated temperature product causes their immediate and rapid sublimation, resulting in the formation of carbon dioxide gas and causing the temperature of the product to decrease rapidly, at a rapid cooling rate of between 10°C/min and 40°C/min. After cooling to the desired product filling temperature, the product underwenta further mixing stage to encourage deaeration.
  • cooling is achieved via the circulation of chilled silicon oil through the jacket surrounding the vessel.
  • Product is first cooled to an intermediate temperature, preferably 45°C, with a cooling rate of between 1.1 and 1 ,3°C/min.
  • Flavouring and perfumes are then added via a final overhead addition, before the product is further cooled to the required product filling temperature, (30°C) with a conventional cooling rate of between 0.6 and 0.8°C/min.
  • a viscosity measurement was taken using a Brookfield
  • Viscometer Model DV-I with a T bar type spindle of size E for 60 s at 5 RPM at 25°C.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Birds (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Dispersion Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Cosmetics (AREA)

Abstract

L'invention concerne un procédé de fabrication d'une composition non aqueuse comprenant les étapes séquentielles suivantes : i) le chauffage d'un polyol organique et d'un structurant dans un mélange à une température de 69 °C ou plus, ii) l'ajout d'un abrasif et d'autres ingrédients non aromatiques au mélange iii) le refroidissement rapide du mélange résultant à une vitesse de refroidissement de 5 °C/min ou plus pour former une pâte ou un gel.
EP23757240.9A 2022-08-31 2023-08-15 Procédé de fabrication d'une composition non aqueuse Pending EP4580585A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP22193029 2022-08-31
PCT/EP2023/072418 WO2024046751A1 (fr) 2022-08-31 2023-08-15 Procédé de fabrication d'une composition non aqueuse

Publications (1)

Publication Number Publication Date
EP4580585A1 true EP4580585A1 (fr) 2025-07-09

Family

ID=83151744

Family Applications (1)

Application Number Title Priority Date Filing Date
EP23757240.9A Pending EP4580585A1 (fr) 2022-08-31 2023-08-15 Procédé de fabrication d'une composition non aqueuse

Country Status (3)

Country Link
EP (1) EP4580585A1 (fr)
CN (1) CN119894484A (fr)
WO (1) WO2024046751A1 (fr)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9414721D0 (en) 1994-07-21 1994-09-07 Smithkline Beecham Plc Dentifrice composition
CA2394865A1 (fr) * 1999-12-23 2001-06-28 Den-Mat Corporation Dentifrices non aqueux epaissis a l'amidon
BRPI0720183B1 (pt) 2006-12-05 2019-03-26 Unilever N.V. Produto para tratamento bucal, produto que compreende uma primeira composição e uso de uma primeira composição.
PH12012502361A1 (en) * 2010-06-23 2013-02-11 Unilever Ip Holdings B V Non-aqueous oral care compositions
BR112015016476B1 (pt) * 2013-02-14 2020-03-17 Unilever Nv Composição não aquosa para cuidados orais e processo de preparação de uma composição não aquosa
CN109890349B (zh) * 2016-10-10 2022-06-17 联合利华知识产权控股有限公司 非水性口腔护理组合物的制备方法

Also Published As

Publication number Publication date
WO2024046751A1 (fr) 2024-03-07
CN119894484A (zh) 2025-04-25

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