EP1284601A2 - Hautschutzcreme enthaltend allantoin - Google Patents

Hautschutzcreme enthaltend allantoin

Info

Publication number
EP1284601A2
EP1284601A2 EP01935174A EP01935174A EP1284601A2 EP 1284601 A2 EP1284601 A2 EP 1284601A2 EP 01935174 A EP01935174 A EP 01935174A EP 01935174 A EP01935174 A EP 01935174A EP 1284601 A2 EP1284601 A2 EP 1284601A2
Authority
EP
European Patent Office
Prior art keywords
composition
oil
allantoin
group
methylparaben
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.)
Withdrawn
Application number
EP01935174A
Other languages
English (en)
French (fr)
Other versions
EP1284601A4 (de
Inventor
Elliott Farber
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.)
Alwyn Co Inc
Original Assignee
Alwyn Co Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US09/570,120 external-priority patent/US6531500B2/en
Priority claimed from US09/758,781 external-priority patent/US6864274B2/en
Application filed by Alwyn Co Inc filed Critical Alwyn Co Inc
Priority to EP07021279A priority Critical patent/EP2172106A1/de
Publication of EP1284601A2 publication Critical patent/EP1284601A2/de
Publication of EP1284601A4 publication Critical patent/EP1284601A4/de
Withdrawn legal-status Critical Current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
    • 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
    • A61K8/06—Emulsions
    • 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
    • A61K8/06—Emulsions
    • A61K8/062—Oil-in-water emulsions
    • 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
    • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/494—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with more than one nitrogen as the only hetero atom
    • A61K8/4946—Imidazoles or their condensed derivatives, e.g. benzimidazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/16—Emollients or protectives, e.g. against radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin

Definitions

  • This invention is directed to a skin cream containing allantoin in an oil-in- water emulsion with improved stability.
  • Allantoin is a commonly used ingredient in cosmetic applications, particularly for skin creams, where it exerts a skin protective function.
  • Many such cosmetic compositions and other compositions are prepared as emulsions, particularly oil-in- water emulsions.
  • One emulsifier system used with such compositions is a combination of sodium lauryl sulfate and beeswax. Although solutions of sodium lauryl sulfate are alkaline with an approximate pH of 9.5, the simultaneous use of beeswax with its organic acids produces a complex and neutralized system with a pH of about 6.8 to about 7.5.
  • composition according to the present invention comprises an oil- in- water emulsion comprising:
  • allantoin and (2) at least one anionic or nonionic emulsifier that is substantially hydrophilic and is soluble in water.
  • the pH of the composition is in a range of from about 3.0 to about 6.0. This pH range stabilizes the allantoin and makes storage of the composition for extended periods practical. Preferably, the pH of the composition is in a range of from about 5.0 to about 6.0.
  • the at least one anionic or nonionic emulsifier is selected from the group consisting of:
  • an acidic anionic polymer (2) an anionic emulsifier selected from the group consisting of sodium lauryl sulfate, sodium laureth sulfate, sodium oleyl succinate, sodium dodecylbenzenesulfonate, and sodium lauryl sarcosinate;
  • a nonionic emulsifier that is an ethoxylated ether or an ethoxylated ester whose chain length ranges from 8 to 22 carbon atoms;
  • a nonionic emulsifier that is an ethoxylated ether or an ethoxylated ester whose chain length ranges from 8 to 22 carbon atoms;
  • glyceryl stearate a nonionic emulsifier that is an ethoxylated ether or an ethoxylated ester whose chain length ranges from 8 to 22 carbon atoms
  • composition can further comprise a carbohydrate polymer selected from the group consisting of galactoarabinan, polygalactose, and polyarabinose.
  • carbohydrate polymer is galactoarabinan.
  • the pH of the composition is from about 3.0 to about 6.0. Preferably, the pH of the composition is from about 5.0 to about 6.0.
  • the acidic anionic polymer is a carboxypolymethylene polymer.
  • the composition can further comprise a carbohydrate polymer.
  • the carbohydrate polymer is selected from the group consisting of galactoarabinan, polygalactose, and polyarabinose.
  • the carbohydrate polymer is galactoarabinan.
  • compositions comprising an oil-in-water emulsion comprising: (1) allantoin; and (2) an emulsifier system comprising:
  • an anionic emulsifier that is substantially hydrophilic and is soluble in water, the pH of the composition being adjusted to a range of from about 3.0 to about 6.0.
  • the pH of the composition is adjusted to a range of from about 5.0 to about 6.0.
  • the anionic emulsifier can be selected from the group consisting of sodium lauryl sulfate, sodium laureth sulfate, sodium oleyl succinate, sodium dodecylbenzenesulfonate, and sodium lauryl sarcosinate.
  • the anionic emulsifier is sodium lauryl sulfate.
  • composition can further comprise a carbohydrate polymer selected from the group consisting of galactoarabinan, polygalactose and polyarabinose.
  • carbohydrate polymer is galactoarabinan.
  • an emulsifier system comprising an acidic anionic polymer
  • a base to adjust the pH of the composition to a value in a range from about
  • the pH of the composition is from about 5.0 to about 5.5.
  • the acidic anionic polymer is a carboxypolymethylene polymer.
  • the base is an organic base such as triethanolamine.
  • composition comprises an oil-in-water emulsion comprising:
  • an emulsifier system comprising: (a) an acidic anionic polymer
  • a nonionic emulsifier that is an ethoxylated ether or an ethoxylated ester whose carbon chain length ranges from 8 to 22 carbon atoms, wherein the pH of the composition is from about 3.0 to about 6.0.
  • the pH of the composition is from about 5.0 to about 6.0.
  • the emulsifier system can further comprise glyceryl stearate.
  • composition comprising an oil-in-water emulsion comprising: (1) allantoin; (2) an emulsifier system comprising:
  • At least one nonionic emulsifier selected from the group consisting of a nonionic emulsifier that is an ethoxylated ether or an ethoxylated ester whose carbon chain length ranges from 8 to 22 carbon atoms; and
  • an acid to adjust the pH to a range of from about 3.0 to about 6.0.
  • the pH is adjusted to a range of from 5.0 to about 5.8.
  • the acid is citric acid.
  • allantoin and (2) an emulsifier system comprising at least one polyethyleneglycol ether of cetearyl alcohol, wherein the number of polyethylene glycol moieties in the polyethyleneglycol ether of cetearyl alcohol is from 6 to 40; and
  • the acid is typically also citric acid.
  • the emulsifier system typically comprises ceteareth-25 and ceteareth-6.
  • an emulsifier system comprising: (a) a polyethylene glycol ester of stearic acid; and
  • an acid to adjust the pH of the composition to a range of from about 3.0 to about 6.0.
  • the pH is adjusted to a range of from about 5.0 to about 5.8.
  • the number of ethylene glycol moieties in the polyethylene glycol ester of stearic acid is from 25 to 100.
  • the polyethylene glycol ester of stearic acid is PEG- 100 stearate.
  • the acid is citric acid.
  • an anionic emulsifier that is substantially hydrophilic and is soluble in water; wherein the pH of the composition is in a range from about 3.0 to about 6.0.
  • the pH is in the range of from about 5.0 to about 6.0.
  • the carbohydrate polymer in this embodiment is as described above.
  • the anionic emulsifier that is substantially hydrophilic and soluble in water is selected from the group consisting of sodium lauryl sulfate, sodium laureth sulfate, sodium oleyl succinate, sodium dodecylbenzenesulfonate, and sodium lauryl sarcosinate.
  • the anionic emulsifier is sodium lauryl sulfate.
  • composition can further comprise citric acid to adjust the pH.
  • the composition can comprise one or more additional ingredients as described below.
  • the composition can comprise an emollient component comprising at least one emollient selected from the group consisting of lanolin oil, cetyl alcohol, stearyl alcohol, and cod liver oil.
  • composition can comprise an emollient such as butylated hydroxytoluene.
  • the composition can comprise herbal extracts such as one or more of St. John's wort extract, witch hazel extract, chamomile extract, and arnica extract.
  • herbal extracts such as one or more of St. John's wort extract, witch hazel extract, chamomile extract, and arnica extract.
  • the composition can comprise a preservative component comprising at least one preservative selected from the group consisting of methylparaben, propylparaben, and diazolidinyl urea.
  • the composition can comprise a chelating agent such as tetrasodium EDTA.
  • the composition can comprise a solvent component comprising at least one solvent selected from the group consisting of propylene glycol, butylene glycol and glycerin.
  • the solvent component is propylene glycol.
  • composition according to the present invention comprises an oil-in-water emulsion comprising:
  • the composition can further, include other ingredients, such as a chelating agent to bind metal ions that might accelerate degradation of the composition.
  • a chelating agent to bind metal ions that might accelerate degradation of the composition.
  • a particularly preferred chelating agent is EDTA.
  • the EDTA can be added in various acid or salt forms depending on the pH of the composition, such as EDTA itself, disodium EDTA, or tetrasodium EDTA.
  • the pH of the composition is in a range of from about 3.0 to about 6.0. This pH range stabilizes the allantoin and makes storage of the composition for extended periods practical. Preferably, the pH is in a range of from about 5.0 to about 6.0.
  • the at least one anionic or nonionic emulsifier is selected from the group consisting of: (1) an acidic anionic polymer;
  • an anionic emulsifier selected from the group consisting of sodium lauryl sulfate, sodium laureth sulfate, sodium oleyl succinate, sodium dodecylbenzenesulfonate, and sodium lauryl sarcosinate;
  • an nonionic emulsifier that is an ethoxylated ether or an ethoxylated ester whose chain length ranges from 8 to 22 carbon atoms;
  • composition can further comprise a carbohydrate polymer selected from the group consisting of galactoarabinan, polygalactose, and polyarabinose.
  • carbohydrate polymer is galactoarabinan.
  • the pH of the composition is adjusted to a range of from about 3.0 to about 6.0.
  • the pH is adjusted to a range of from about 5.0 to about 6.0.
  • the pH is adjusted with sodium hydroxide or other base as required.
  • the acidic anionic polymer is preferably a carboxypolymethylene polymer.
  • Such polymers are marketed under the brand names "Carbomer” and "Carbopol.”
  • a suitable carboxypolymethylene polymer is marketed by B.F. Goodrich under the brand name "Carbomer.”
  • This is a slightly cross-linked polyacrylic acid that is from 1% to 2% cross- linked by allylsucrose or allylpentaerythritol with the polyacrylic acid.
  • the resulting molecular weight range of this polymer is from about 2 x 10 6 daltons to about 1 x 10 9 daltons.
  • the average molecular weight of this polymer is about 4 x 10 6 daltons.
  • the concentration of the carboxypolymethylene polymer is from about 0.5 percent to about 2 percent of the composition.
  • the composition can further comprise a carbohydrate polymer.
  • the carbohydrate polymer is galactoarabinan.
  • Galactoarabinan is derived from trees of the genus Larix (larch) and is a hemicellulosic product easily extractable by water in a pure form. Galactoarabinan has been consumed by humans in common foods such as carrots, tomatoes, maple syrup, soybeans, and wheat flour, among others.
  • the molecular weight of the galactoarabinan is about 20,000.
  • a suitable source of galactoarabinan is Larex, Inc (White Bear Lake, MN).
  • the composition contains from about 1 percent to about 25 percent of galactoarabinan.
  • the composition contains from about 2 percent to about 10 percent of the carbohydrate polymer.
  • compositions according to the present invention can further include other ingredients.
  • the composition can include an emollient component for smoothness.
  • the emollient component can include at least one emollient selected from the group consisting of lanolin oil, cetyl alcohol, stearyl alcohol, and cod liver oil.
  • the composition can also include an antioxidant to prevent rancidity of ingredients such as cod liver oil.
  • a preferred antioxidant is butylated hydroxytoluene (BHT).
  • the composition can further include a solvent component.
  • the solvent component can include at least one solvent selected from the group consisting of propylene glycol, glycerin, or butylene glycol.
  • the solvent component is propylene glycol.
  • the composition can further include a preservative component.
  • the preservative component can comprise at least one preservative selected from the group consisting of methylparaben, propylparaben, and diazolidinyl urea.
  • the preservative component comprises methylparaben, propylparaben, and diazolidinyl urea.
  • composition can further include fragrance.
  • fragrance is well known in the cosmetic art and in the art of over-the-counter drug formulation, and many suitable fragrances are known in the art.
  • the stability and function of the cream is not altered by the presence or absence of fragrance.
  • this embodiment of the composition can further include herbal extracts.
  • the herbal extracts can include one or more of St. John's wort extract, witch hazel extract, chamomile extract, and arnica extract. However, these herbal extracts are typically omitted in this embodiment.
  • composition can optionally further include other components, such as proteins, humectants, other preservatives, essential oils, other vitamins, colorants, hydroxyacids, other plant extracts, chelators, sunscreens, sodium hyaluronate, lipids, fatty acids, thickeners, panthenol, and the like.
  • other components such as proteins, humectants, other preservatives, essential oils, other vitamins, colorants, hydroxyacids, other plant extracts, chelators, sunscreens, sodium hyaluronate, lipids, fatty acids, thickeners, panthenol, and the like.
  • sunscreens are octyl methoxycinnamate and benzophenone-3.
  • Water can comprise from about 50.0% to about 90.0% of this embodiment of the composition.
  • water comprises from about 60.0% to about 85.0% of this embodiment of the composition.
  • An optimum concentration of water in this embodiment of the composition is about 69.95%.
  • the carboxypolymethylene polymer can comprise from about 0.30% to about
  • the carboxypolymethylene polymer comprises from about 0.50% to about 2.0% of this embodiment of the composition.
  • An optimum concentration of the carboxypolymethylene polymer is about 0.85% of this embodiment of the composition.
  • Propylene glycol can comprise from about 2.0% to about 9.0%o of this embodiment of the composition.
  • propylene glycol comprises from about 4.0% to about 7.0% of this embodiment of the composition.
  • An optimum concentration of propylene glycol is about 5.70% of this embodiment of the composition.
  • PEG- 100 stearate can comprise from about 0.25% to about 2.5% of this embodiment of the composition.
  • PEG-100 stearate comprises from about 0.50% to about 2.0% of this embodiment of the composition.
  • An optimum concentration of PEG- 100 stearate is about 1.50% of this embodiment of the composition.
  • Lanolin oil can comprise from about 5.0% to about 15.0% of this embodiment of the composition.
  • lanolin oil comprises from about 8.0% to about 12.0% of this embodiment of the composition.
  • An optimum concentration of lanolin oil is about 10.60% of this embodiment of the composition.
  • Cetyl alcohol can comprise from about 1.0% to about 8.0% of this embodiment of the composition.
  • a preferred concentration of cetyl alcohol is from about 2.0%) to about 7.0% of this embodiment of the composition.
  • An optimum concentration of cetyl alcohol is about 4.20% of this embodiment of the composition.
  • Stearyl alcohol can comprise from , about 0.5% to about 6.0% of this embodiment of the composition.
  • a preferred concentration of stearyl alcohol is from about 0.75% to about 5.0% of this embodiment of the composition.
  • An optimum concentration of stearyl alcohol is about 1.50% of this embodiment of the composition.
  • Cod liver oil can comprise from about 1.0% to about 7.0% of this embodiment of the composition.
  • cod liver oil comprises from about 1.0% to about 4.0% of this embodiment of the composition.
  • An optimum concentration of cod liver oil is about 2.00% of this embodiment of the composition.
  • Butylated hydroxytoluene can comprise from about 0.10% to about 1.0% of this embodiment of the composition.
  • butylated hydroxytoluene comprises from about 0.20% to about 0.80% of this embodiment of the composition.
  • An " optimum concentration of butylated hydroxytoluene is about 0.50% of this embodiment of the composition.
  • Methylparaben can comprise from about 0.10% to about 0.50% of this embodiment of the composition.
  • a preferred concentration of methylparaben is from about 0.15% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of methylparaben is about 0.30% of this embodiment of the composition.
  • Propylparaben can comprise from about 0.10% to about 0.50% of this embodiment of the composition.
  • propylparaben comprises from about 0.15% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of propylparaben is about 0.25% of this embodiment of the composition.
  • Diazolidinyl urea can comprise from about 0.05% to about 0.25% of this embodiment of the composition.
  • diazolidinyl urea comprises from about 0.10% to about 0.20% of this embodiment of the composition.
  • An optimum concentration of diazolidinyl urea is about 0.15% of this embodiment of the composition.
  • Allantoin can comprise from about 0.50% to about 2.0% of this embodiment of the composition.
  • a preferred concentration of allantoin is from about 1.0% to about 2.0% of this embodiment of the composition.
  • An optimum concentration of allantoin is about 1.50% of this embodiment of the composition.
  • Fragrance can comprise from about 0.05% to about 0.50% of this embodiment of the composition.
  • fragrance comprises from about 0.10% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of fragrance is about 0.20% of the composition.
  • fragrance can be omitted, and it may be desirable to omit fragrance in circumstances in which the composition is intended for use on sensitive individuals or individuals who may undergo an allergic reaction to fragrance.
  • Triethanolamine can comprise from about 0.05% to about 3.0% of this embodiment of the composition to adjust the pH.
  • a preferred concentration of triethanolamine is from about 0.20% to about 2.0% of this embodiment of the composition.
  • An optimum concentration of triethanolamine is about 0.80% of this embodiment of the composition.
  • the emulsifier can be an anionic emulsifier that is substantially hydrophilic and is soluble in water.
  • the anionic emulsifier replaces the polyethylene glycol ester of stearic acid.
  • This embodiment further includes the acidic anionic polymer such as carboxypolymethylene.
  • this alternative embodiment of the composition includes the carbohydrate polymer such as galactoarabinan.
  • the anionic emulsifier that is substantially hydrophilic and soluble in water can be selected from the group consisting of sodium lauryl sulfate, sodium laureth sulfate, sodium oleyl succinate, sodium dodecylbenzenesulfonate, and sodium lauryl sarcosinate.
  • a particularly preferred anionic emulsifier is sodium lauryl sulfate.
  • sodium lauryl sulfate contain sufficient excess sodium hydroxide so that they have a pH of about 10.0.
  • This sodium hydroxide can be used to adjust the pH when the anionic emulsifier is sodium lauryl sulfate; in this alternative, no additional alkali may be needed. When another anionic emulsifier is used, additional alkali may be required to adjust the pH.
  • the emulsifier system comprises the acidic anionic polymer as described above and a nonionic emulsifier that is an ethoxylated ether or an ethoxylated ester whose carbon chain length ranges from 8 to 22 carbon atoms.
  • the acidic anionic polymer is carboxypolymethylene as described above.
  • composition can further include glyceryl stearate in the emulsifier system.
  • This embodiment of the composition has a pH from about 3.0 to 6.0, adjusted as necessary, typically with an acid.
  • the acid can be an organic acid, an inorganic acid, or a mixture of both.
  • the pH is from about 5.0 to about 6.0.
  • composition can further comprise a carbohydrate polymer such as galactoarabinan as described above.
  • preferred organic acids include organic acids whose carbon chain length ranges from 2 to 22 carbon atoms and can be monocarboxylic, dicarboxylic, or tricarboxylic acids.
  • the acids can be aliphatic or aromatic.
  • Particularly preferred organic acids include citric acid, ascorbic acid, glycolic acid, lactic acid, benzoic acid, and salicylic acid.
  • a most particularly preferred organic acid is citric acid.
  • the inorganic acid is a strong acid. It can be a monoprotic, diprotic, or triprotic acid. Particularly preferred inorganic acids include hydrochloric acid, sulfuric acid, and phosphoric acid.
  • composition can further include other ingredients as described above, including an emollient component, an antioxidant, a solvent component, a chelating agent, herbal extracts, a preservative, and fragrance.
  • an emollient component an antioxidant, a solvent component, a chelating agent, herbal extracts, a preservative, and fragrance.
  • the composition can further include other components, such as proteins, humectants, other preservatives, essential oils, other vitamins, colorants, hydroxyacids, other plant extracts, sunscreens, sodium hyaluronate, lipids, fatty acids, thickeners, panthenol, and the like.
  • components such as proteins, humectants, other preservatives, essential oils, other vitamins, colorants, hydroxyacids, other plant extracts, sunscreens, sodium hyaluronate, lipids, fatty acids, thickeners, panthenol, and the like.
  • sunscreens sodium hyaluronate, lipids, fatty acids, thickeners, panthenol, and the like.
  • the emulsifier system comprises the acidic anionic polymer described above; one example of this acidic anionic polymer is marketed as Carbomer.
  • the pH is adjusted with an organic or inorganic base to a range of from about 3.0 to about 6.0.
  • the pH is adjusted to a range of from about 5.0 to about 5.5.
  • a preferred organic base is triethanolamine.
  • a preferred inorganic base is sodium hydroxide. In general, it is preferred to use an organic base such as triethanolamine.
  • this embodiment can further comprise other ingredients.
  • this embodiment of the invention can further comprise a solvent component.
  • the solvent component comprises at least one solvent selected from the group consisting of propylene glycol, glycerin, or butylene glycol.
  • the solvent component is propylene glycol.
  • This embodiment of the invention can further comprise an emollient component.
  • the emollient component can comprise at least one solvent selected from the group consisting of lanolin oil, cetyl alcohol, and cod liver oil.
  • the emollient component comprises all of lanolin oil, cetyl alcohol, and cod liver oil.
  • This embodiment of the composition can also include an antioxidant.
  • a preferred antioxidant is butylated hydroxytoluene.
  • This embodiment of the invention can further comprise a preservative component.
  • the preservative component can comprise at least one preservative selected from the group consisting of methylparaben and propylparaben.
  • the preservative component comprises both methylparaben and propylparaben.
  • compositions can further include fragrance as described above.
  • the stability and function of the cream are not altered by the presence or absence of fragrance. As indicated above, it may be desirable to omit fragrance in some cases.
  • the following discussion describes ranges, preferred concentrations and optimum concentrations for preferred compositions according to this embodiment of the present invention where the pH is from about 5.0 to about 5.5.
  • Water can comprise from about 50.0% to about 90.0% of this embodiment of the composition.
  • water comprises firom about 60.0% to about 80.0% of this embodiment of the composition.
  • An optimum concentration of water is about 73.55% of this embodiment of the composition.
  • the carboxypolymethylene polymer can comprise from about 0.40% to about
  • the carboxypolymethylene polymer comprises from about 0.5% to about 2.0% of this embodiment of the composition.
  • An optimum concentration of the carboxypolymethylene polymer is about 1.00% of the composition.
  • Propylene glycol can comprise from about 2.0% to about 9.0%> of this embodiment of the composition.
  • the propylene glycol comprises from about 4.0% to about 7.0% of this embodiment of the composition.
  • An optimum concentration of the propylene glycol is about 5.70% of this embodiment of the composition.
  • Lanolin oil can comprise from about 5.0% to about 15.0% of this embodiment of the composition.
  • lanolin oil comprises from about 8.0% to about 12.0% of this embodiment of the composition.
  • An optimum concentration of lanolin oil is about 10.0% of this embodiment of the composition.
  • Cetyl alcohol can comprise from about 1.0% to about 8.0% of this embodiment of the composition.
  • cetyl alcohol comprises from about 2.0% to about 7.0%) of this embodiment of the composition.
  • An optimum concentration of cetyl alcohol is about 3.00% of this embodiment of the composition.
  • Cod liver oil can comprise from about 1.0% to about 7.0% of this embodiment of the composition.
  • cod liver oil comprises from about 1.0% to about 4.0% of this embodiment of the composition.
  • An optimum concentration of cod liver oil is about 2.00% of this embodiment of the composition.
  • Butylated hydroxytoluene can comprise from about 0.10% to about 1.0% of this embodiment of the composition.
  • butylated hydroxytoluene comprises from about 0.30% to about 0.80% of this embodiment of the composition.
  • An optimum concentration of butylated hydroxytoluene is about 0.50% of this embodiment of the composition.
  • Methylparaben can comprise from about 0.10% to about 0.50% of this embodiment of the composition.
  • methylparaben comprises from about 0.15% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of methylparaben is about 0.30% of this embodiment of the composition.
  • Propylparaben can comprise from about 0.10% to about 0.50% of this embodiment of the composition.
  • propylparaben comprises from about 0.15% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of propylparaben is about 0.25% of this embodiment of the composition.
  • Allantoin can comprise from about 0.50% to about 2.0% of this embodiment of the composition. Preferably, allantoin comprises from about 1.0% to about 2.0% of this embodiment of the composition. An optimum concentration of allantoin is about 1.50% of this embodiment of the composition.
  • Fragrance if present, can comprise from about 0.05% to about 0.50% of this embodiment of the composition.
  • fragrance comprises from about 0.10% to about 0.40% of this embodiment of the composition.
  • Triethanolamine as a 95% solution, can comprise from about 0.05% to about
  • triethanolamine comprises from about 0.20% to about 2.0%) of this embodiment of the composition to adjust the pH as indicated.
  • An optimum concentration of triethanolamine is about 0.80% of the composition to adjust the pH as indicated.
  • the pH is adjusted to a range of from about 3.0 to about
  • the weak organic base can be an amine-containing base such as ethanolamine, diethanolamine, or triethanolamine.
  • a preferred organic base is triethanolamine.
  • this embodiment can further comprise other ingredients.
  • this embodiment of the invention can further comprise a solvent component.
  • the solvent component comprises at least one solvent selected from the group consisting of propylene glycol, glycerin, or butylene glycol.
  • the solvent component is propylene glycol.
  • This embodiment of the invention can further comprise an emollient component.
  • the emollient component can comprise at least one solvent selected from the group consisting of lanolin oil, cetyl alcohol, and cod liver oil.
  • the emollient component comprises all of lanolin oil, cetyl alcohol, and cod liver oil.
  • This embodiment of the composition can also include an antioxidant.
  • a preferred antioxidant is butylated hydroxytoluene.
  • This embodiment of the invention can further comprise a preservative component.
  • the preservative component can comprise at least one preservative selected from the group consisting of methylparaben and propylparaben.
  • the preservative component comprises both methylparaben and propylparaben.
  • This embodiment of the composition can further include fragrance as described above.
  • the stability and function of the cream is not altered by the presence or absence of fragrance. As indicated above, it may be desirable to omit fragrance in some cases.
  • Water can comprise from about 50.0% to about 90.0% of this embodiment of the composition.
  • water comprises from about 60.0% to about 85-0% of this embodiment of the composition.
  • An optimum concentration of water is about 71.70% of this embodiment of the composition.
  • Propylene glycol can comprise from about 2.0% to about 9.0% of this embodiment of the composition.
  • propylene glycol comprises from about 4.0% to about 7.0% of this embodiment of the composition.
  • An optimum concentration of propylene glycol is about 5.70% of this embodiment of the composition.
  • Triethanolamine can comprise from about 0.2%> to about 4.0% of this embodiment of the composition.
  • triethanolamine comprises from about 0.5% to about 3.0% of this embodiment of the composition.
  • An optimum concentration of triethanolamine is about 1.25% of this embodiment of the composition.
  • Lanolin oil can comprise from about 5.0% to about 15.0% of this embodiment of the composition.
  • lanolin oil comprises from about 8.0%) to about 12.0% of this embodiment of the composition.
  • An optimum concentration of lanolin oil is about 10.60% of this embodiment of the composition.
  • Cetyl alcohol can comprise from about 1.0% to about 7.0% of this embodiment of the composition.
  • cetyl alcohol comprises from about 2.0% to about 6.0% of this embodiment of the composition.
  • An optimum concentration of cetyl alcohol is about 3.50% of this embodiment of the composition.
  • Stearic acid can comprise from about 0.50% to about 5.0% of this embodiment of the composition.
  • stearic acid comprises from about 1.0% to about 4.0% of this embodiment of the composition.
  • An optimum concentration of stearic acid is about 2.50%o of this embodiment of the composition.
  • Cod liver oil can comprise from about 1.0% to about 7.0% of this embodiment of the composition.
  • cod liver oil comprises from about 1.50% to about 5.0% of this embodiment of the composition.
  • An optimum concentration of cod liver oil is about 2.0% of this embodiment of the composition.
  • butylated hydroxytoluene can comprise from about 0.1% to about 1.0% of this embodiment of the composition.
  • butylated hydroxytoluene comprises from about 0.2% to about 0.8%) of this embodiment of the composition.
  • An optimum concentration of butylated hydroxytoluene is about 0.50% of this embodiment of the composition.
  • Methylparaben can comprise from about 0.10% to about 0.50% of this embodiment of the composition.
  • methylparaben comprises from about 0.15% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of methylparaben is about 0.30% of this embodiment of the composition.
  • Propylparaben can comprise from about 0.10% to about 0.50% of this embodiment of the composition.
  • propylparaben comprises from about 0.15% to about 0.40% of the composition.
  • An optimum concentration of propylparaben is about 0.25% of this embodiment of the composition.
  • Allantoin can comprise from about 0.50% to about 2.0% of this embodiment of the composition. Preferably, allantoin comprises from about 1.0% to about 2.0% of this embodiment of the composition. An optimum concentration of allantoin is about 1.50% of this embodiment of the composition.
  • fragrance can comprise from about 0.05% to about 0.50% of this embodiment of the composition.
  • fragrance comprises from about 0.10%) to about 0.40% of this embodiment of the composition.
  • An optimum concentration of fragrance is about 0.20% of this embodiment of the composition.
  • At least one nonionic emulsifier selected from the group consisting of a nonionic emulsifier that is an ethoxylated ether or an ethoxylated ester whose carbon chain length ranges from 8 to 22 carbon atoms.
  • Sodium stearoyl lactylate is the sodium salt of the stearic acid ester of lactyl lactate.
  • Sodium isostearoyl lactylate is the sodium salt of the isostearic acid ester of lactyl lactate.
  • the composition further comprises an acid to adjust the pH to a range of from about 3.0 to about 6.0.
  • the pH is adjusted to a range of from about 5.0 to about 5.8.
  • the acid can be an inorganic or an organic acid as described above.
  • the acid is a weak organic acid.
  • the acid is citric acid.
  • this embodiment can further comprise other ingredients.
  • this embodiment of the invention can further comprise a solvent component.
  • the solvent component comprises at least one solvent selected from the group consisting of propylene glycol, glycerin, or butylene glycol.
  • the solvent component is propylene glycol.
  • This embodiment of the invention can further comprise an emollient component.
  • the emollient component can comprise at least one emollient selected from the group consisting of lanolin oil, cetyl alcohol, and cod liver oil.
  • the emollient component comprises all of lanolin oil, cetyl alcohol, and cod liver oil.
  • This embodiment of the invention can further comprise a chelator component.
  • the chelator component is tetrasodium ethylenediaminetetraacetic acid.
  • This embodiment of the invention can further comprise a preservative component.
  • the preservative component can comprise at least one preservative selected from the group consisting of methylparaben and propylparaben.
  • the preservative component comprises both methylparaben and propylparaben.
  • This embodiment of the composition can also include an antioxidant.
  • a preferred antioxidant is butylated hydroxytoluene.
  • composition can further include fragrance as described above.
  • fragrance as described above.
  • the stability and function of the cream are not altered by the presence or absence of fragrance. As indicated above, it may be desirable to omit fragrance in some cases.
  • Water can comprise from about 50.0% to about 90.0% of this embodiment of the composition.
  • water comprises from about 60.0% to about 80.0% of this embodiment of the composition.
  • An optimum concentration of water is about 73.72% of this embodiment of the composition.
  • Propylene glycol can comprise from about 2.0% to about 9.0%> of this embodiment of the composition.
  • propylene glycol comprises from about 4.0% to about 7.0% of this embodiment of the composition.
  • An optimum concentration of propylene glycol is about 5.70% of this embodiment of the composition.
  • Citric acid can comprise from about 0.05% to about 0.50% of this embodiment of the composition.
  • citric acid comprises from about 0.10% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of citric acid is about 0.18% of this embodiment of the composition.
  • Sodium stearoyl lactylate can comprise from about 0.30% to about 3.0% of this embodiment of the composition.
  • sodium stearoyl lactylate comprises from about 0.50%) to about 2.50% of this embodiment of the composition.
  • An optimum concentration of sodium stearoyl lactylate is about 1.00% of this embodiment of the composition.
  • Sodium isostearoyl lactylate can comprise from about 0.05% to about 1.0% of this embodiment of the composition.
  • sodium isostearoyl lactylate comprises from about 0.10% to about 0.70% of this embodiment of the composition.
  • An optimum concentration of sodium isostearoyl lactylate is about 0.25% of this embodiment of the composition.
  • Tetrasodium EDTA can comprise from about 0.05% to about 0.25% of this embodiment of the composition.
  • tetrasodium EDTA comprises from about 0.10% to about 0.20% of this embodiment of the composition.
  • An optimum concentration of tetrasodium EDTA is about 0.15% of this embodiment of the composition.
  • Lanolin oil can comprise from about 5.0% to about 15.0% of this embodiment of the composition.
  • lanolin oil comprises from about 8.0% to about 12.0% of this embodiment of the composition.
  • An optimum concentration of lanolin oil is about 10.60% of this embodiment of the composition.
  • Cetyl alcohol can comprise from about 1.0% to about 8.0% of this embodiment of the composition.
  • cetyl alcohol comprises from about 2.0% to about 7.0% of this embodiment of the composition.
  • An optimum concentration of cetyl alcohol is about 3.80% of this embodiment of the composition.
  • Cod liver oil can comprise from about 1.0% to about 7.0%) of this embodiment of the composition.
  • cod liver oil comprises from about 1.0% to about 4.0% of this embodiment of the composition.
  • An optimum concentration of cod liver oil is about 2.0% of this embodiment of the composition.
  • Butylated hydroxytoluene can comprise from about 0.10%> to about 1.0% of this embodiment of the composition.
  • butylated hydroxytoluene comprises from about 0.20% to about 0.80% of this embodiment of the composition.
  • An optimum concentration of butylated hydroxytoluene is about 0.50% of this embodiment of the composition.
  • Methylparaben can comprise from about 0.10% to about 0.50% of this embodiment of the composition.
  • methylparaben comprises from about 0.15% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of methylparaben is about 0.30% of this embodiment of the composition.
  • Propylparaben can comprise from about 0.10% to about 0.50% of this embodiment of the composition.
  • propylparaben comprises from about 0.15% to about 0.40% of the composition.
  • An optimum concentration of propylparaben is about 0.25% of this embodiment of the composition.
  • Allantoin can comprise from about 0.50% to about 2.0% of this embodiment of the composition. Preferably, allantoin comprises from about 1.0% to about 2.0% of this embodiment of the composition. An optimum concentration of allantoin is about 1.50%) of this embodiment of the composition.
  • fragrance can comprise from about 0.05% to about 0.50% of this embodiment of the composition.
  • fragrance comprises from about 0.10% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of fragrance is about 0.20%) of this embodiment of the composition.
  • compositions according to the present invention are compositions comprising an oil-in-water emulsion comprising: (1) allantoin; and
  • an emulsifier system comprising at least one polyethyleneglycol ether of cetearyl alcohol.
  • the emulsifier system comprises both ceteareth-25 and ceteareth-6, i.e., polyethylene glycol ethers of cetearyl alcohol with 25 and 6 ethylene glycol units respectively.
  • the composition further comprises an acid to adjust the pH to a range of from about 3.0 to about 6.0.
  • the pH is adjusted to a range of from about 5.0 to about 5.8.
  • the acid can be an inorganic or an organic acid as described above.
  • the acid is a weak organic acid.
  • the acid is citric acid.
  • this embodiment can further comprise other ingredients.
  • this embodiment of the invention can further comprise a solvent component.
  • the solvent component comprises at least one solvent selected from the group consisting of propylene glycol, glycerin, or butylene glycol.
  • the solvent component is propylene glycol.
  • This embodiment of the invention can further comprise a chelator component.
  • the chelator component is tetrasodium ethylenediaminetetraacetic acid.
  • This embodiment of the invention can further comprise an emollient component.
  • the emollient component can comprise at least one emollient selected from the group consisting of lanolin oil, cetyl alcohol, stearyl alcohol, and cod liver oil.
  • the emollient component comprises all of lanolin oil, cetyl alcohol, stearyl alcohol, and cod liver oil.
  • This embodiment of the composition can also include an antioxidant.
  • a preferred antioxidant is butylated hydroxytoluene.
  • This embodiment of the invention can further comprise a preservative component.
  • the preservative component can comprise at least one preservative selected from the group consisting of methylparaben, propylparaben, and diazolidinyl urea.
  • the preservative component comprises all of methylparaben, propylparaben, and diazolidinyl urea.
  • composition can further include fragrance as described above.
  • fragrance as described above.
  • the stability and function of the cream are not altered by the presence or absence of fragrance. As indicated above, it may be desirable to omit fragrance in some cases.
  • Water can comprise from about- 50.0% to about 90.0% of this embodiment of the composition.
  • water comprises from about 55.0% to about 75.0% of this embodiment of the composition.
  • An optimum concentration of water is about 66.33% of this embodiment of the composition.
  • Propylene glycol can comprise from about 2.0% to about 9.0% of this embodiment of the composition.
  • propylene glycol comprises from about 4.2% to about 7.0% of this embodiment of the composition.
  • An optimum concentration of propylene glycol is about 5.70% of this embodiment of the composition.
  • Tetrasodium EDTA can comprise from about 0.05% to about 0.50% of this embodiment of the composition.
  • tetrasodium EDTA comprises from about 0.10% to about 0.30% of this embodiment of the composition.
  • An optimum concentration of tetrasodium EDTA is about 0.15% of this embodiment of the composition.
  • Ceteareth-25 can comprise from about 0.50% to about 4.0% of this embodiment of the composition.
  • ceteareth-25 comprises from about 2.0% to about 3.5% of this embodiment of the composition.
  • An optimum concentration of ceteareth- 25 is about 2.60% of this embodiment of the composition.
  • Citric acid can comprise from about 0.04% to about 0.40% of this embodiment of the composition.
  • citric acid comprises from about 0.10% to about 0.30% of this embodiment of the composition.
  • An optimum concentration of citric acid is about 0.12% of this embodiment of the composition.
  • Lanolin oil can comprise from about 5.0% to about 15.0% of this embodiment of the composition.
  • lanolin oil comprises from about 8.0% to about 12.0% of this embodiment of the composition.
  • An optimum concentration of lanolin oil is about 10.60% of this embodiment of the composition.
  • Cetyl alcohol can comprise from about 3.0% to about 10.0% of this embodiment of the composition.
  • cetyl alcohol comprises from about 3.5% to about 7.5% of this embodiment of the composition.
  • An optimum concentration of cetyl alcohol is about 4.30% of this embodiment of the composition.
  • Stearyl alcohol can comprise from about 1.0% to about 5.0% of this embodiment of the composition.
  • stearyl alcohol comprises from about 2.0% to about 4.0% of this embodiment of the composition.
  • An optimum concentration of stearyl alcohol is about 3.50% of this embodiment of the composition.
  • Ceteareth-6 can comprise from about 0.5% to about 4.0% of this embodiment of the composition. Preferably, ceteareth-6 comprises from about 1.0% to about 3.0% of this embodiment of the composition. An optimum concentration of ceteareth-6 is about 1.80% of this embodiment of the composition.
  • Cod liver oil can comprise from about 1.0% to about 7.0% of this embodiment of the composition.
  • cod liver oil comprises from about 1.0% to about 4.0% of this embodiment of the composition.
  • An optimum concentration of cod liver oil is about 2.00% of this embodiment of the composition.
  • Butylated hydroxytoluene can comprise from about 0.10% to about 1.0% of this embodiment of the composition.
  • butylated hydroxytoluene comprises from about 0.20% to about 0.80% of this embodiment of the composition.
  • An optimum concentration of butylated hydroxytoluene is about 0.50% of this embodiment of the composition.
  • Methylparaben can comprise from about 0.10% to about 0.50% of this embodiment of the composition.
  • methylparaben comprises from about 0.15% to 0.40% of this embodiment of the composition.
  • An optimum concentration of methylparaben is about 0.30%) of this embodiment of the composition.
  • Propylparaben can comprise from about 0.10% to about 0.50%> of this embodiment of the composition.
  • propylparaben comprises from about 0.15% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of propylparaben is about 0.25% of this embodiment of the composition.
  • Diazolidinyl urea can comprise from about 0.05% to about 0.50% of this embodiment of the composition.
  • diazolidinyl urea comprises from about 0.10% to about 0.30% of this embodiment of the composition.
  • An optimum concentration of diazolidinyl urea is about 0.15% of this embodiment of the composition.
  • Allantoin can comprise from about 0.50% to about 2.0% of this embodiment of the composition.
  • allantoin comprises from about 1.0% to about 2.0%> of this embodiment of the composition.
  • An optimum concentration of allantoin is about 1.50% of this embodiment of the composition.
  • fragrance can comprise from about 0.05% to about 0.50%> of this embodiment of the composition.
  • fragrance comprises from about 0.10% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of fragrance is about 0.20% of this embodiment of the composition.
  • an emulsifier system comprising: (a) a polyethylene glycol ester of stearic acid; and
  • the number of ethylene glycol moieties in the polyethylene glycol ester of stearic acid is from 25 to 100.
  • Two preferred polyethylene glycol esters of stearic acid for use in this embodiment of compositions according to the present invention are PEG- 40 stearate and PEG- 100 stearate, with 40 and 100 ethylene glycol moieties respectively.
  • a particularly preferred polyethylene glycol ester of stearic acid is PEG- 100 stearate.
  • the composition further comprises an acid to adjust the pH to a range of from about 3.0 to about 6.0.
  • the pH is adjusted to a range of from about 5.0 to about 5.8.
  • the acid can be an inorganic or an organic acid as described above.
  • the acid is a weak organic acid.
  • the acid is citric acid.
  • this embodiment can further comprise other ingredients.
  • this embodiment of the invention can further comprise a solvent component.
  • the solvent component is one or more of propylene glycol, glycerin, or butylene glycol.
  • the solvent component is propylene glycol.
  • This embodiment of the invention can further comprise a chelator component.
  • the chelator component is tetrasodium ethylenediaminetetraacetic acid.
  • This embodiment of the invention can further comprise an emollient component.
  • the emollient component can comprise at least one emollient selected from the group consisting of lanolin oil, cetyl alcohol, stearyl alcohol, and cod liver oil.
  • the emollient component comprises all of lanolin oil, cetyl alcohol, stearyl alcohol, and cod liver oil.
  • This embodiment of the composition can also include an antioxidant.
  • a preferred antioxidant is butylated hydroxytoluene.
  • This embodiment of the invention can further comprise a preservative component.
  • the preservative component can comprise at least one preservative selected from the group consisting of methylparaben, propylparaben, and diazolidinyl urea.
  • the preservative component comprises all of methylparaben, propylparaben, and diazolidinyl urea.
  • This embodiment of the composition can further include fragrance as described above.
  • the stability and function of the cream are not altered by the presence or absence of fragrance. As indicated above, it may be desirable to omit fragrance in some cases.
  • Water can comprise from about 50.0% to about 90.0% of this embodiment of the composition. Preferably, water comprises from about 55.0% to about 80.0% of this embodiment of the composition. An optimum concentration of water is about 67.86% of this embodiment of the composition.
  • Propylene glycol can comprise from about 2.0% to about 9.0% of this embodiment of the composition.
  • propylene glycol comprises from about 4.30% to about 7.00% of this embodiment of the composition.
  • An optimum concentration of propylene glycol is about 5.70% of this embodiment of the composition.
  • Tetrasodium EDTA can comprise from about 0.05% to about 0.50% of this embodiment of the composition.
  • tetrasodium EDTA comprises from about 0.10% to about 0.30% of this embodiment of the composition.
  • An optimum concentration of tetrasodium EDTA is about 0.15% of this embodiment of the composition.
  • Citric acid can comprise from about 0.04% to about 0.40% of this embodiment of the composition.
  • citric acid comprises from about 0.10% to about 0.30% of this embodiment of the composition.
  • An optimum concentration of citric acid is about 0.14% of this embodiment of the composition.
  • PEG- 100 stearate can comprise from about 1.0% to about 5.0% of this embodiment of the composition.
  • PEG-100 stearate comprises from about 1.50%> to about 3.00% of this embodiment of the composition.
  • An optimum concentration of PEG- 100 stearate is about 2.60% of this embodiment of the composition.
  • Lanolin oil can comprise from about 5.0% to about 15.0% of this embodiment of the composition.
  • lanolin oil comprises from about 8.0% to about 12.0% of this embodiment of the composition.
  • An optimum concentration of lanolin oil is about 10.60% of this embodiment of the composition.
  • Cetyl alcohol can comprise from about 2.0% to about 10.0% of this embodiment of the composition.
  • cetyl alcohol comprises from about 2.50% to about 7.50% of this embodiment of the composition.
  • An optimum concentration of cetyl alcohol is about 3.00% of this embodiment of the composition.
  • Stearyl alcohol can comprise from about 1.0% to about 4.0% of this embodiment of the composition.
  • stearyl alcohol comprises from about 1.0% to about 3.5% of this embodiment of the composition.
  • An optimum concentration of stearyl alcohol is about 2.50% of this embodiment of the composition.
  • Glyceryl stearate can comprise from about 1.0% to about 5.0% of this embodiment of the composition.
  • glyceryl stearate comprises from about 2.0% to about 4.0% of this embodiment of the composition.
  • An optimum concentration of glyceryl stearate is about 2.50% of this embodiment of the composition.
  • Cod liver oil can comprise from about 1.0% to about 7.0% of this embodiment of the composition.
  • cod liver oil comprises from about 1.0% to about 4.0% of this embodiment of the composition.
  • An optimum concentration of cod liver oil is about 2.00% of this embodiment of the composition.
  • butylated hydroxytoluene can comprise from about 0.10% to about 1.0% of this embodiment of the composition.
  • butylated hydroxytoluene comprises from about 0.20%) to about 0.80% of this embodiment of the composition.
  • An optimum concentration of butylated hydroxytoluene is about 0.50% of this embodiment of the composition.
  • Methylparaben can comprise from about 0.10% to about 0.50% of this embodiment of the composition.
  • methylparaben comprises from about 0.15% to 0.40% of this embodiment of the composition.
  • An optimum concentration of methylparaben is about 0.30% of this embodiment of the composition.
  • Propylparaben can comprise from about 0.10% to about 0.50% of this embodiment of the composition.
  • propylparaben comprises from about 0.15% to about 0.40%) of this embodiment of the composition.
  • An optimum concentration of propylparaben is about 0.25% of this embodiment of the composition.
  • Diazolidinyl urea can comprise from about 0.05% to about 0.50% of this embodiment of the composition.
  • diazolidinyl urea comprises from about 0.10% to about 0.30% of this embodiment of the composition.
  • An optimum concentration of diazolidinyl urea is about 0.20% of this embodiment of the composition.
  • Allantoin can comprise from about 0.50% to about 2.0% of this embodiment of the composition. Preferably, allantoin comprises from about 1.0% to about 2.0% of this embodiment of the composition. A preferred concentration of allantoin is about 1.50% of this embodiment of the composition.
  • fragrance can comprise from about 0.05% to about 0.50% of this embodiment of the composition.
  • fragrance comprises from about 0.10% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of fragrance is about 0.20% of this embodiment of the composition.
  • the carbohydrate polymer is typically selected from the group consisting of galactoarabinan, polygalactose, and polyarabinose.
  • the carbohydrate polymer is galactoarabinan.
  • the anionic emulsifier that is substantially hydrophilic and soluble in water can be selected from the group consisting of sodium lauryl sulfate, sodium laureth sulfate, sodium oleyl succinate, sodium dodecylbenzenesulfonate, and sodium lauryl sarcosinate.
  • a particularly preferred anionic emulsifier is sodium lauryl sulfate.
  • the pH of the composition is adjusted to a range of between about 3.0 and about 6.0, typically with an acid.
  • the pH is adjusted to a range of from about 5.0 to about 6.0.
  • the acid can be an inorganic or an organic acid as described above.
  • the acid is a weak organic acid.
  • the acid is citric acid.
  • this embodiment can further comprise other ingredients.
  • this embodiment of the invention can further comprise a solvent component.
  • the solvent component comprises at least one solvent selected from the group consisting of propylene glycol, glycerin, or butylene glycol.
  • the solvent component is propylene glycol.
  • This embodiment of the invention can further comprise a chelator component.
  • the chelator component is tetrasodium ethylenediaminetetraacetic acid.
  • This embodiment of the invention can further comprise an emollient component.
  • the emollient component can comprise at least one emollient selected from the group consisting of lanolin oil, cetyl alcohol, stearyl alcohol, and cod liver oil.
  • the emollient component comprises all of lanolin oil, cetyl alcohol, stearyl alcohol, and cod liver oil.
  • This embodiment of the composition can also include an antioxidant.
  • a preferred antioxidant is butylated hydroxytoluene.
  • This embodiment of the invention can further comprise a preservative component.
  • the preservative component can comprise one or more of methylparaben or propylparaben.
  • the preservative component comprises methylparaben and propylparaben.
  • composition can further include fragrance as described above.
  • fragrance as described above.
  • the stability and function of the cream are not altered by the presence or absence of fragrance. As indicated above, it may be desirable to omit fragrance in some cases.
  • Water can comprise from about 50.0% to about 90.0% of this embodiment of the composition.
  • water comprises from about 60.0% to about 80.0% of this embodiment of the composition.
  • An optimum concentration of water is about 61.65% of this embodiment of the composition.
  • Propylene glycol can comprise from about 2.0% to about 9.0% of this embodiment of the composition.
  • propylene glycol comprises from about 4.0% to about 7.0%) of this embodiment of the composition.
  • An optimum concentration of propylene glycol is about 5.70% of this embodiment of the composition.
  • Sodium lauryl sulfate as a 30% solution, can comprise from about 0.50% to about 5.0% of this embodiment of the composition.
  • sodium lauryl sulfate, as a 30% solution comprises from about 1.0% to about 3.0% of this embodiment of the composition.
  • An optimum concentration of sodium lauryl sulfate, as a 30% solution, is about
  • Tetrasodium EDTA can comprise from about 0.05% to about 0.30% of this embodiment of the composition.
  • tetrasodium EDTA comprises from about 0.10% to about 0.20% of this embodiment of the ' composition.
  • An optimum concentration of tetrasodium EDTA is about 0.15% of this embodiment of the composition.
  • Galactoarabinan can comprise from about 1.0% to about 25.0% of this embodiment of the composition.
  • galactoarabinan comprises from about 3.0%> to about 15.0% of this embodiment of the composition.
  • An optimum concentration of galactoarabinan is about 5.00% of this embodiment of the composition.
  • Citric acid can comprise from about 0.05% to about 0.25% of this embodiment of the composition.
  • citric acid comprises from about 0.10% to about 0.20% of this embodiment of the composition.
  • An optimum concentration of citric acid is about 0.15% of this embodiment of the composition.
  • Lanolin oil can comprise from about 5.0% to about 15.0% of this embodiment of the composition.
  • lanolin oil comprises from about 8.0% to about 12.0% of this embodiment of the composition.
  • An optimum concentration of lanolin oil is about 10.60% of this embodiment of the composition.
  • Cetyl alcohol can comprise from about 1.0% to about 8.0% of this embodiment of the composition.
  • cetyl alcohol comprises from about 2.0% to about 7.0% of this embodiment of the composition.
  • An optimum concentration of cetyl alcohol is about 4.20% of this embodiment of the composition.
  • Stearyl alcohol can comprise from about 0.50%) to about 6.0%> of this embodiment of the composition.
  • stearyl alcohol comprises from about 1.0% to about 4.0% of this embodiment of the composition.
  • An optimum concentration of stearyl alcohol is about 2.00% of this embodiment of the composition.
  • Beeswax can comprise from about 0.50% to about 5.0% of this embodiment of the composition.
  • beeswax comprises from about 1.0% to about 3.0% of this embodiment of the composition.
  • An optimum concentration of beeswax is about 1.90% of this embodiment of the composition.
  • Cod liver oil can comprise from about 0.50% to about 15.0% of this embodiment of the composition.
  • cod liver oil comprises from about 1.0% to about 10.0% of this embodiment of the composition.
  • An optimum concentration of cod liver oil is about 2.00% of this embodiment of the composition.
  • Butylated hydroxytoluene can comprise from about 0.1% to about 3.0% of this embodiment of the composition.
  • butylated hydroxytoluene comprises from about 0.25% to about 2.50% of this embodiment of the composition.
  • An optimum concentration of butylated hydroxytoluene is about 0.50% of this embodiment of the composition.
  • Methylparaben can comprise from about 0.10% to about 0.50% of this embodiment of the composition.
  • methylparaben comprises from about 0.15% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of methylparaben is about 0.30% of this embodiment of the composition.
  • Propylparaben can comprise from about 0.10% to about 0.50% of this embodiment of the composition.
  • propylparaben comprises from about 0.15% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of propylparaben is about 0.25% of this embodiment of the composition.
  • Allantoin can comprise from about 0.50% to about 2.0% of this embodiment of the composition. Preferably, allantoin comprises from about 1.0% to about 2.0% of this embodiment of the composition. An optimum concentration of allantoin is about 1.50% of this embodiment of the composition.
  • fragrance can comprise from about 0.05% to about 0.50% of this embodiment of the composition.
  • fragrance can comprise from about 0.10% to about 0.40% of this embodiment of the composition.
  • An optimum concentration of fragrance is about 0.20% of this embodiment of the composition.
  • the composition is prepared by standard mixing techniques, such as are conventional in the cosmetic art and in the art of over-the-counter drug formulation for blending lipid-soluble components and water-soluble components. These mixing techniques include both manual and mechanical mixing, and include homogenization mixing and sweep mixing.
  • the mixing techniques to be used can be chosen by one of ordinary skill in the art based on variables such as the viscosity of the components to be mixed and the volume of those components, as well as the relative proportion of lipid-soluble and water-soluble ingredients.
  • the composition can be mixed in two or more batches, such as one batch containing lipid-soluble ingredients and another batch containing water-soluble ingredients, and the batches can then be mixed at the final stage of preparation.
  • compositions according to the present invention can be formulated for the treatment of skin diseases and conditions.
  • skin diseases and conditions for which compositions according to the present invention can be formulated are epidermolysis bullosa, decubitus ulcers, pressure ulcers, diabetic ulcers, and milia.
  • Compositions according to the present invention can be formulated for treatment of other skin diseases and conditions.
  • the details of the composition can be varied according to the particular condition to be treated. For example, greater or lesser degrees of oil or lipid-soluble components can be included, and, in the case of compositions intended to be used on patients who may undergo allergic reactions, compounds that often generate allergic reactions, such as fragrance and coloring, can be excluded. Such details can readily be ascertained by one of ordinary skill in the art.
  • a skin protectant over-the-counter (OTC) cream was prepared in accordance with the formulation of Table 1.
  • OTC over-the-counter
  • the Part A ingredients were combined and heated to 175°F with mixing.
  • the ' Part B ingredients were combined and heated to 175°F with mixing.
  • the Part B mixture was then added to the Part A mixture with mixing.
  • the resulting mixture was then cooled to 120°F with continued mixing.
  • the Part C ingredients were then added with mixing.
  • the final emulsion was allowed to cool with continued mixing.
  • the resulting cream had a pH of 7.4.
  • Samples of the cream prepared from Example 1 were used for accelerated aging stability studies and analyzed for their allantoin concentration after a period of time at 40°C. The results are shown in Table 2.
  • An OTC skin cream containing allantoin was prepared using the ingredients in Table 3 to provide a cream with a lower pH.
  • the Part A ingredients were combined and heated to 175°F with mixing.
  • the Part B ingredients were combined and heated to 175°F with mixing.
  • the Part B mixture was added to the Part A mixture with mixing.
  • the resulting mixture was then cooled to 120°F with mixing at which time the Part C ingredients were added with mixing.
  • the final emulsion was allowed to cool with continue mixing.
  • the resulting cream had a pH of 5.3.
  • An allantoin-containing skin cream with ionic emulsifiers is prepared according to Table 5.
  • the preparation follows the method used in Example 2, with the ingredients in each of Part A, Part B, and Part C being combined separately and then Part B being added to Part A, with Part C then being added to the combination of Part A and Part B.
  • the pH is adjusted to a value in a range of from about 5.0 to about 5.8 by neutralizing the stearic acid with enough triethanolamine to reach this pH.
  • Other bases can be used instead of triethanolamine.
  • Triethanolamine (99%) 0.20 - 4.0 0.50-3.0 1.25
  • An allantoin-containing skin cream with the emulsifiers sodium stearoyl lactylate and sodium isostearoyl lactylate is prepared according to Table 6.
  • the preparation follows the method used in Example 3.
  • the pH is adjusted by the addition of the appropriate quantity of citric acid.
  • An allantoin-containing skin cream with carboxypolymethylene polymer is prepared according to Table 7.
  • the preparation follows the method used in Example 3, except that the triethanolamine (Part D) is added last, after the combining of Parts A, B, and C, to avoid thickening of the emulsion.
  • the triethanolamine is added to adjust the pH.
  • Triethanolamine (! 39%) 0.05 - 3.0 0.20-2.0 0.80
  • An allantoin-containing skin cream with polyethylene glycol ethers of cetearyl alcohol is prepared according to Table 8. The preparation follows the method used in Example 3. The citric acid is added to adjust the pH.
  • An allantoin-containing skin cream with a polyethylene glycol ester of stearic acid and glyceryl stearate is prepared according to Table 9. The preparation follows the method used in Example 3. The citric acid is added to adjust the pH.
  • PEG-100 Stearate 1.0-5.0 1.5-3.0 2.60
  • An allantoin-containing skin cream with a carboxypolymethylene polymer and a polyethylene glycol ester of stearic acid is prepared according to Table 10.
  • the preparation follows the method used in Example 5, with the triethanolamine (Part D) being added last.
  • the triethanolamine is added to adjust the pH.
  • Carboxypolymethylene Polymer 0.30-3.0 0.50-2.0 0.85 Propylene Glycol 2.0 - 9.0 4.0 - 7.0 5.70 PEG-100 Stearate 0.25 - 2.5 0.50-2.0 1.50
  • Triethanolamine (99%) 0.05-3.0 0.20 - 2.0 0.80
  • An allantoin-containing skin cream with galactoarabinan, sodium lauryl sulfate, and beeswax is prepared according to Table 11.
  • the preparation follows the method used in Example 3.
  • the citric acid is used to adjust the pH.
  • GALACTOARABINAN SODIUM LAURYL SULFATE.
  • the present invention provides an allantoin-containing composition that is an oil-water emulsion using either an acidic anionic polymer and an anionic emulsifier or an acidic anionic polymer and a nonionic emulsifier that is an ethoxylated ether or ethoxylated ester.
  • the composition can further include a carbohydrate polymer that can be polygalactose or polyarabinose. If an ethoxylated ether or ethoxylated ester is used, the composition can further comprise glyceryl stearate. The composition has improved thermal stability.
  • composition according to the present invention is useful for treatment of a number of skin diseases and conditions, including epidermolysis bullosa, pressure ulcers, diabetic ulcers, decubitus ulcers, and milia. Compositions according to the present invention are also useful as skin protectants even when these diseases are not present. Compositions according to the present invention are well tolerated and can be used with other treatments.

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EP01935174A 2000-05-12 2001-05-09 Hautschutzcreme enthaltend allantoin Withdrawn EP1284601A4 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP07021279A EP2172106A1 (de) 2000-05-12 2001-05-09 Allantoin enthaltende Hautecreme

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US570120 1984-01-12
US09/570,120 US6531500B2 (en) 1999-07-23 2000-05-12 Methods for treatment of inflammatory diseases
US09/758,781 US6864274B2 (en) 1999-07-23 2001-01-11 Allantoin-containing skin cream
US758781 2001-01-11
PCT/US2001/014899 WO2001087232A2 (en) 2000-05-12 2001-05-09 Allantoin-containing skin cream

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EP1284601A2 true EP1284601A2 (de) 2003-02-26
EP1284601A4 EP1284601A4 (de) 2005-02-09

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CA2726890C (en) * 2008-06-03 2015-08-04 Otsuka Pharmaceutical Co., Ltd. Creamy o/w emulsion composition and production process thereof
US20140135372A1 (en) 2010-02-02 2014-05-15 Elliott Farber Compositions and methods of treatment of inflammatory skin conditions using allantoin
CN102764204A (zh) * 2012-07-19 2012-11-07 福建省梦娇兰日用化学品有限公司 一种温和的具有改善皮肤功能的护肤霜及其制备方法
JP6232285B2 (ja) * 2013-12-27 2017-11-15 花王株式会社 化粧料
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CN104434686A (zh) * 2014-12-10 2015-03-25 唯美度科技（北京）有限公司 一种含红加仑提取物眼霜及其制备方法
WO2016101159A1 (en) * 2014-12-24 2016-06-30 L'oreal Cosmetic rinse-off skin care compositions and cosmetic methods using them
JP6851139B2 (ja) * 2016-03-25 2021-03-31 小林製薬株式会社 外用組成物
JP6735587B2 (ja) * 2016-03-25 2020-08-05 小林製薬株式会社 外用組成物
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US11207255B2 (en) 2019-07-30 2021-12-28 L'oreal Perfluoro-free self-foaming facial cleanser composition
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CN114522112B (zh) * 2021-12-20 2023-06-27 广州市瑞芬化妆品有限公司 即时提亮物理遮瑕长效组合物及膏霜及制备方法

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MXPA02011158A (es) 2004-08-19
WO2001087232A2 (en) 2001-11-22
JP2004513068A (ja) 2004-04-30
CN1444450A (zh) 2003-09-24
EP1284601A4 (de) 2005-02-09

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