EP4312968A2 - Composition pour application topique sur un sujet - Google Patents

Composition pour application topique sur un sujet

Info

Publication number
EP4312968A2
EP4312968A2 EP22720591.1A EP22720591A EP4312968A2 EP 4312968 A2 EP4312968 A2 EP 4312968A2 EP 22720591 A EP22720591 A EP 22720591A EP 4312968 A2 EP4312968 A2 EP 4312968A2
Authority
EP
European Patent Office
Prior art keywords
composition
composition according
polymer
weight
polyol
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
EP22720591.1A
Other languages
German (de)
English (en)
Inventor
Marianne Boskamp
Andreas Gerber
Thomas Zimmeck
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.)
G Pohl Boskamp GmbH and Co KG
Original Assignee
G Pohl Boskamp GmbH and Co KG
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 G Pohl Boskamp GmbH and Co KG filed Critical G Pohl Boskamp GmbH and Co KG
Publication of EP4312968A2 publication Critical patent/EP4312968A2/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
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A61K8/735—Mucopolysaccharides, e.g. hyaluronic acid; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/22—Peroxides; Oxygen; Ozone
    • 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
    • A61K8/72—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
    • 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
    • A61K8/81—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions involving only carbon-to-carbon unsaturated bonds
    • A61K8/8141—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by only one carboxyl radical, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers
    • A61K8/8147—Homopolymers or copolymers of acids; Metal or ammonium salts thereof, e.g. crotonic acid, (meth)acrylic acid; Compositions of derivatives of such polymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Definitions

  • composition for topical application to a subject A composition for topical application to a subject
  • the invention relates to compositions for topical application to a subject.
  • the invention relates to compositions for topical application to the oropharynx, such as as a gargle, or as a mouthwash.
  • the treatment of diseases of the skin or mucous membranes is often dependent on the triggering event, e.g. B. antibiotics or antivirals.
  • treatment is generally carried out using topical and, if necessary, additional systemic therapy.
  • antibiotics are administered systemically in severe cases
  • antiseptics and anti-inflammatory substances e.g. antiphlogistics, anti-inflammatory agents, local antibiotics, etc.
  • the therapy can be carried out, for example, by administering throat rinses, gargling solutions, sprays or lozenges.
  • Disadvantages of commercially available products with antiseptics are, depending on the substance, sensitizing and allergenic potential, irritation such as burning on the skin or mucous membranes and, in the case of solutions for use in the oral cavity, a bitter or unpleasant taste (e.g. when using products containing povidone-iodine ) or discoloration of the tooth enamel (e.g. when using products containing chlorhexidine digluconate).
  • a well-established in medical practice means with antiseptic and antiviral effects are aqueous solutions with hydrogen peroxide as an active agent.
  • Disadvantages of products containing hydrogen peroxide that have been available to date include limited effectiveness due to the short residence time on the skin or mucous membrane and limited stability of the aqueous solutions and preparations due to premature decomposition.
  • the object of the present invention is, for example, to provide such improved compositions for topical application which are highly effective, well tolerated and/or easy to handle.
  • composition for topical application to a subject comprising:
  • At least one polymer wherein the at least one polymer is selected from sodium hyaluronate, polyacrylic acid (carbomer), xanthan or a mixture thereof, and
  • a topical application means a local application of the composition at its site of action.
  • the site of action can be the skin or the mucous membrane.
  • the site of action can be the mouth and throat, in particular the mucous membranes of the mouth and throat.
  • the topical application can be done by a spray, a brush, a swab, or by supplying it using a suitable vessel, such as a bottle, a drinking vessel (e.g. a mug or a glass), etc.
  • the subject is preferably a mammal, in particular a human subject.
  • the composition according to the invention comprises, inter alia, hydrogen peroxide (H2O2).
  • the hydrogen peroxide is preferably prepared by diluting a 30 to 35 percent aqueous hydrogen peroxide solution with water.
  • composition according to the invention comprises at least one polyol.
  • a polyol is an organic compound with at least two hydroxy groups (-OH groups).
  • Polyols can be both cyclic and linear.
  • composition according to the invention comprises at least one polymer, wherein the at least one polymer is selected from sodium hyaluronate, polyacrylic acid (carbomer), xanthan or a mixture thereof.
  • composition of the invention also includes water.
  • composition of the invention is an aqueous composition.
  • a composition according to the invention comprises 0.1% by weight to 5.0% by weight of the at least one polymer based on the total weight of the composition. In a further embodiment, a composition according to the invention comprises 0.2% by weight to 1.0% by weight of the at least one polymer, based on the total weight of the composition. In yet another embodiment, a composition according to the invention comprises from 0.4% to 0.8%, for example 0.7%, by weight of the at least one polymer, based on the total weight of the composition.
  • the polymer of a composition according to the invention is selected from sodium hyaluronate, polyacrylic acid (carbomer), xanthan or a mixture thereof.
  • Sodium hyaluronate is the sodium salt of hyaluronic acid, a glycosaminoglycan.
  • Polyacrylic acid also known as carbomer, is a high-molecular polymer of acrylic acid and is usually produced synthetically.
  • Carbomer homopolymer according to the US Pharmacopoeia USPNF34 is preferably used. This is a polymer of acrylic acid with a high molecular weight, which is cross-linked with allyl ethers of polyalcohols and, based on the dried substance, contains between 56 and 68% carboxyl groups (-COOH). With the carbomer homopolymer, a distinction is made between variants A, B and C, which each have different viscosities. The somewhat lower-viscosity types A and B are preferred, and the carbomer types Carbopol 971 P and Carbopol 71 G (type A according to USPNF34) are particularly preferred.
  • Xanthan is also interchangeably referred to herein as xanthan gum.
  • Xanthan gum is a naturally occurring polysaccharide. It is usually obtained from substrates containing sugar with the help of bacteria of the genus Xanthomonas and is used as a food additive (E415) and in pharmacy and cosmetics as a thickening and gelling agent.
  • the polymer can function as a gelling agent in the composition of the invention.
  • Gelling agents are substances that increase the viscosity of a solution.
  • Gel formers including gel formers for use on a subject, are well known to those skilled in the art, as are gels.
  • the polymer of one embodiment of the invention may be a mixture of sodium hyaluronate and xanthan gum.
  • the weight of the polymer based on the total weight of the composition is the total weight of the sodium hyaluronate and xanthan gum mixture in this embodiment.
  • the total weight of the mixture of sodium hyaluronate and xanthan can range from 0.2% by weight to 1.0% by weight, preferably 0.4% by weight to 0.8% by weight, more preferably 0.7% by weight to the total weight of the composition.
  • the polymer is xanthan.
  • a composition according to the invention comprises hydrogen peroxide.
  • the composition comprises from 0.05% to 5% by weight hydrogen peroxide based on the total weight of the composition.
  • the composition comprises from 0.01% to 1% by weight hydrogen peroxide based on the total weight of the composition.
  • the composition comprises from 0.1% to 0.5% by weight hydrogen peroxide based on the total weight of the composition.
  • the weight of hydrogen peroxide is the weight of H2O2 and not the weight of a hydrogen peroxide solution.
  • a composition comprises from 0.1% to 20% by weight of the at least one polyol based on the total weight of the composition. In another embodiment, a composition comprises from 0.1% to 10% by weight of the at least one polyol based on the total weight of the composition. In yet another embodiment, a composition comprises from 1% to 6% by weight of the at least one polyol based on the total weight of the composition. In yet another embodiment, a composition comprises from 2% to 4% by weight of the at least one polyol based on the total weight of the composition.
  • the at least one polyol can be a sugar alcohol.
  • a sugar alcohol is a carbon compound that has a hydroxyl group (-OH group) on each carbon atom.
  • the sugar alcohol can be a C4-Ci2 sugar alcohol. In particular, it can be a linear sugar alcohol.
  • the at least one polyol is selected from xylitol, mannitol, sorbitol, isomalt or glycerol (propane-1,2,3-triol).
  • the at least one polyol can also be a mixture of polyols, e.g. B. a mixture of at least two compounds of xylitol, mannitol, sorbitol, isomalt and glycerol.
  • the at least one polyol is xylitol.
  • the at least one polyol is mannitol. In one embodiment, the at least one polyol is isomalt.
  • the at least one polyol is glycerin.
  • composition as polymer xanthan and as polyol xylitol.
  • a composition according to the invention comprises xanthan as the polymer and mannitol as the polyol.
  • composition as a polymer xanthan and as a polyol isomalt.
  • a composition according to the invention can also further comprise at least one pharmaceutically acceptable excipient.
  • a pharmaceutically acceptable excipient is, in particular, a pharmacologically and toxicologically harmless substance.
  • the pharmaceutically acceptable excipient preferably has properties that have a positive effect on the use of a composition according to the invention.
  • the pharmaceutically acceptable excipient may have an impact on the odor, taste, manufacturability, or storage of a composition of the invention.
  • Conceivable pharmaceutically acceptable excipients are fillers, solvents, humectants, emulsifiers, buffers, solubilizers, thickeners and binders, gelling agents, antioxidants, preservatives, sweeteners, flavorings, care products, etc..
  • a composition according to the invention can also comprise dexpanthenol, at least one buffering substance and/or at least one sweetener.
  • Dexpanthenol (+)-(R)-2,4-dihydroxy-/V-(3-hydroxypropyl)-3,3-dimethylbutyramide) is a provitamin and is used, for example, as a care product.
  • it has proven particularly useful in the topical treatment of diseases of the skin and mucous membranes in medical skin care and in cosmetics.
  • a composition according to the invention may comprise a buffer.
  • Buffers particularly buffers for application to a subject, are well known to those skilled in the art. They stabilize the pH of a preparation.
  • the preparation according to the invention preferably has a pH of below 7, particularly preferably a pH of 4.0-6.0.
  • a buffer which buffers at the preferred pH values mentioned is preferably used herein.
  • a specific preferred buffer is the citric acid phosphate buffer.
  • a composition according to the invention can have a preservative as a further component.
  • Preservatives particularly preservatives for use in a subject, are well known to those skilled in the art.
  • preservatives which are used in the field of cosmetics can also be used.
  • the composition according to the invention is characterized in that the preservative is selected from the group consisting of benzoic acid and its salts, sorbic acid and its salts, 2-phenoxyethanol, 2-phenylethanol, pentylene glycol, caprylyl glycol, ethylhexylglycerol and mixtures of the aforementioned substances .
  • the preservative can also be selected from pentylene glycol, caprylyl glycol and a mixture thereof.
  • the composition according to the invention can also contain pentylene glycol and caprylyl glycol as preservatives.
  • composition according to the invention particularly preferably contains 94% water, 0.6% xanthan gum, 0.1% sodium hyaluronate, 3% xylitol, 0.6% sodium monohydrogen phosphate dihydrate, 0.4% citric acid, 0.5%
  • composition of the invention containing 94.54% water, 0.6% xanthan gum, 0.1% sodium hyaluronate, 3% xylitol, 0.6% disodium phosphate dihydrate, 0.4% citric acid, 0.5%
  • composition according to the invention can be used as a cosmetic, as a medical product, or as a drug.
  • the invention thus also includes a cosmetic that includes a composition according to the invention.
  • a medical product is also conceivable which comprises a composition according to the invention.
  • a medicinal product is also conceivable which comprises a composition according to the invention.
  • a cosmetic can be an agent used in beauty and body care. In particular, a certain state should be maintained improved or added.
  • a cosmetic are skin care products, mucous membrane care products, products for producing the hydro-lipid film of the skin or the mucous membrane, oral and dental care products, such as mouthwash.
  • a medical device is a product that is used in particular for therapeutic and diagnostic purposes, with the effect preferably occurring through a physical or physicochemical influence.
  • the medical device is intended to be used specifically in the treatment and alleviation of a disease or injury in a subject.
  • a drug or medicament is a product that is used in particular for therapeutic and diagnostic purposes, the effect being pharmacological, metabolic or immunological.
  • the invention also relates to a composition according to the invention for topical application in the oropharynx, in particular in the oropharynx of a subject, such as a human subject. It can be applied by spraying, brushing or gargling.
  • Gargling is used, for example, to clean the pharynx or to treat inflammation or diseases of the throat or pharynx.
  • the invention also relates to a composition according to the invention for use as a gargle solution and/or as a mouthwash.
  • a composition of the present invention is used as a gargling solution.
  • a composition according to the invention can also be used as an aqueous gargle, in particular as an aqueous viscous gargle. This can be a cosmetic as well as a medical use.
  • a composition according to the invention is used as a mouthwash.
  • a composition according to the invention can also be used as an aqueous mouthwash, in particular as an aqueous, viscous mouthwash. This can be a cosmetic as well as a medical use.
  • the invention also relates to a composition according to the invention for use in the treatment of inflammatory diseases in the oropharynx.
  • Inflammatory diseases in the oropharynx often manifest themselves as swelling and/or redness in the affected area as well as a sore throat.
  • the diseases are often caused by bacterial or viral infections.
  • Exemplary diseases of the oropharynx are stomatitis, pharyngitis and sore throat.
  • a composition according to the invention, as well as a product comprising a composition according to the invention, such as a cosmetic, a medicinal product or a drug, can be used even when at least one symptom of a disease occurs, in particular a disease of the oropharynx.
  • a composition according to the invention, as well as a product that comprises a composition according to the invention, such as a cosmetic, a medicinal product, or a drug, can also be used for prophylaxis, in particular for diseases of the oropharynx.
  • composition according to the invention in the case of injuries to the mouth and throat, such as can occur, for example, as a result of surgical interventions.
  • composition can be used, for example, in principle once or several times a day.
  • the application is not limited in time and can therefore in principle take place over several days, weeks or months.
  • a composition according to the invention as well as products that comprise a composition according to the invention, such as cosmetics, medicinal products, or pharmaceuticals, particularly advantageously have an increased viscosity and in particular an increased viscosity that is stable over a certain period of time, such as over two years.
  • increased viscosity means a viscosity of at least 40 mPas, preferably at least 65 mPas, more preferably at least 90 mPas, measured on a cone-plate rotational viscometer at a shear rate of 100/s at 20.degree.
  • Commercially available gargling solutions generally have a low viscosity (see Table 1) and have a water-like appearance.
  • Viscosity was determined by a cone and plate viscometer at a shear rate of 100/s at 20°C.
  • the invention thus generally also relates to the use of viscous solutions for gargling.
  • An increased viscosity can have advantages in use, among other things. For example, the residence time at the site of action can be longer as a result of increased viscosity compared to low-viscosity compositions. As a result, an exposure time of treating ingredients or healing ingredients can be increased.
  • a protective film can also form on the site of action. Without being bound to this theory, the cause is believed to be that less of the gargling solution is spat out due to the viscosity of the solution and the affinity of the polymers to the mucous membrane.
  • the term “at least one” can be replaced by “one, two, or three” or “one to three” according to certain embodiments, as well as by “one or two” according to certain embodiments, as well as by “two” according to certain embodiments. , and in particular also be replaced by "a”.
  • composition is replaced by “composition for use in a method for the prophylaxis and/or treatment of oropharyngeal disorders.”
  • kits that correspond to the embodiments described above, but in which the term “medicinal device” is replaced by “medicinal device for use in a method for the prophylaxis and/or treatment of diseases of the oropharynx”.
  • embodiments of the invention are also provided which result from any combinations of the embodiments mentioned herein.
  • this also relates to embodiments and combinations of the above embodiments that contain negative features.
  • this also relates to embodiments and combinations of embodiments that result from the examples herein.
  • the viscosity stated in the following examples was determined using a cone and plate rotational viscometer at a shear rate of 100/s at 20.degree.
  • a solution according to the invention is prepared by initially introducing 955 g of water and successively adding 5.5 g of xanthan gum, 1.5 g of sodium hyaluronate, 20 g of xylitol, 6.0 g of sodium monohydrogen phosphate dihydrate, 4.0 g of citric acid and 8.0 g of hydrogen peroxide solution 30 % are dissolved therein with stirring. It is filled into 150 ml PET bottles with a plastic cap for storage.
  • a 54-year-old man who complained of a sore throat and whose throat was clearly red was given a bottle of gargling solution according to Example 6 with instructions to gargle several times a day after meals and before going to bed with 10 ml of solution each time for at least 60 seconds. The following day, he reported that he experienced significant symptom relief immediately after the first application. The redness of the throat had gone down. After the second day of treatment, the symptoms had subsided. In addition, he reported that he found the gargling solution to be pleasant-tasting and non-irritating, particularly when compared to commercial solutions he had used in previous episodes of sore throat.
  • a solution according to the invention is prepared by initially introducing 943 g of water and successively adding 5.0 g of xanthan gum, 1.0 g of carbomer (Carbopol 71 G), 0.5 g of sodium hyaluronate, 30 g of xylitol, 7.0 g of sodium monohydrogen phosphate dihydrate, 5 .0 g of citric acid monohydrate, 8.3 g of 30% hydrogen peroxide solution and 0.2 g of sucralose are dissolved therein with stirring. It is filled into 150 ml PET bottles with a plastic cap for storage.
  • the bottles are stored upright at 25 °C and 40 % relative humidity and regularly checked for viscosity and hydrogen peroxide content:
  • a solution according to the invention is prepared by initially introducing 940 kg of water and successively adding 6.0 kg of xanthan gum, 1.0 kg of sodium hyaluronate, 30 kg of xylitol, 6.0 kg of sodium monohydrogen phosphate dihydrate, 4.0 kg of citric acid, 5.0 kg of dexpanthenol, 0.2 kg sucralose and 8.0 kg hydrogen peroxide solution 30% are dissolved therein with stirring. For storage, it is filled into 200 ml PET bottles with a plastic cap.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Birds (AREA)
  • Emergency Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Cosmetics (AREA)

Abstract

La présente invention concerne une composition pour application topique sur un sujet, comprenant : du peroxyde d'hydrogène, au moins un polyol, au moins un polymère, le ou les polymères étant choisis parmi l'hyaluronate de sodium, l'acide polyacrylique (carbomère), le xanthane ou un mélange de ceux-ci, et de l'eau. La présente invention concerne en outre une composition selon l'invention destinée à être appliquée dans la cavité buccopharyngée.
EP22720591.1A 2021-03-31 2022-03-31 Composition pour application topique sur un sujet Pending EP4312968A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102021108264.1A DE102021108264A1 (de) 2021-03-31 2021-03-31 Zusammensetzung zur topischen Anwendung an einem Subjekt
PCT/EP2022/058660 WO2022207843A2 (fr) 2021-03-31 2022-03-31 Composition pour application topique sur un sujet

Publications (1)

Publication Number Publication Date
EP4312968A2 true EP4312968A2 (fr) 2024-02-07

Family

ID=81579483

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22720591.1A Pending EP4312968A2 (fr) 2021-03-31 2022-03-31 Composition pour application topique sur un sujet

Country Status (4)

Country Link
EP (1) EP4312968A2 (fr)
CA (1) CA3213446A1 (fr)
DE (1) DE102021108264A1 (fr)
WO (1) WO2022207843A2 (fr)

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0401113D0 (en) 2004-01-19 2004-02-18 Glaxo Group Ltd Tooth whitening composition
GB2412316A (en) * 2004-03-22 2005-09-28 Glaxo Group Ltd Peroxide tooth whitening composition
GB2412315A (en) * 2004-03-22 2005-09-28 Glaxo Group Ltd Peroxide tooth whitening composition
US20090068122A1 (en) 2007-09-06 2009-03-12 Shira Pilch Dentifrice Compositions for Treating Xerostomia
SI25540A (sl) * 2019-01-14 2019-05-31 Tompa Majcen Dominika Formulacije s spojinami aktivnega kisika in pripomočki za njihovo aplikacijo

Also Published As

Publication number Publication date
CA3213446A1 (fr) 2022-10-06
DE102021108264A1 (de) 2022-10-06
WO2022207843A2 (fr) 2022-10-06
WO2022207843A3 (fr) 2022-12-15

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