WO2004024120A2 - Medicated skin cleansing products comprising an antimycotic agent - Google Patents

Medicated skin cleansing products comprising an antimycotic agent Download PDF

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Publication number
WO2004024120A2
WO2004024120A2 PCT/IL2003/000738 IL0300738W WO2004024120A2 WO 2004024120 A2 WO2004024120 A2 WO 2004024120A2 IL 0300738 W IL0300738 W IL 0300738W WO 2004024120 A2 WO2004024120 A2 WO 2004024120A2
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WO
WIPO (PCT)
Prior art keywords
group
skin cleansing
acid
mixtures
product according
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Application number
PCT/IL2003/000738
Other languages
French (fr)
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WO2004024120A3 (en
WO2004024120B1 (en
Inventor
Gil Bianco
Stephen Cherkez
Marcel Friedman
Original Assignee
Gil Bianco
Stephen Cherkez
Marcel Friedman
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Priority claimed from IL15168602A external-priority patent/IL151686A0/en
Priority claimed from IL15758503A external-priority patent/IL157585A0/en
Application filed by Gil Bianco, Stephen Cherkez, Marcel Friedman filed Critical Gil Bianco
Priority to AU2003259539A priority Critical patent/AU2003259539A1/en
Publication of WO2004024120A2 publication Critical patent/WO2004024120A2/en
Publication of WO2004024120A3 publication Critical patent/WO2004024120A3/en
Publication of WO2004024120B1 publication Critical patent/WO2004024120B1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/40Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
    • A61K8/41Amines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/4906Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with one nitrogen as the only hetero atom
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00Cosmetics or similar toiletry preparations
    • A61K8/18Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/49Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
    • A61K8/494Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds with more than one nitrogen as the only hetero atom
    • A61K8/4946Imidazoles or their condensed derivatives, e.g. benzimidazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00Preparations for care of the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q17/00Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
    • A61Q17/005Antimicrobial preparations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00Preparations for care of the skin
    • A61Q19/10Washing or bathing preparations

Definitions

  • the present invention relates to a medicated skin cleansing product. More particularly, the present invention relates to soap or soap-free skin cleansing products for treatment or prevention of skin disorders having a pH of about between 3.5 to 6.0 and containing an antimycotic agent .
  • vaginal products a pH of between 3.5 to 6.0, that does not disturb the physiological equilibrium of the natural bacterial flora, has to be targeted since a product with a pH of 6 to 10 will disturb the natural physiological pH, raising the vaginal pH from 3.5-4.5 to higher than 6 for a certain period of time, from minutes to hours, depending on the pH of the product (the higher the worse). During this time the overgrowth of the fungi will be accelerated.
  • a pH of 3.5 to 6.0 will create the best medium for the antimycotic activity of an antimycotic agent such as terbinafine or ciclopirox or an imidazole such as clotrimazole or miconazole.
  • Alkaline metal soaps have a relatively high pH, being salts of weak acids with a strong base.
  • Antimycotic agents such as Imidazoles or terbinafine or ciclopirox are not stable in liquid soap environments, and therefore cannot be formulated in the form of liquid soaps with regular (alkaline) soap.
  • medicated skin cleansing products for the treatment or prevention of skin disorders containing an antimycotic agent and having a pH between 3.5-6.0 wherein said antimycotic agent is selected from the group consisting of terbinafine or ciclopirox or an imidazole.
  • said products are soap-free however combination products including alkaline soap of animal or vegetable origin are also contemplated for use according to the present invention.
  • said product is in the form of a cleansing bar while in other embodiments said product is in the form of a liquid soap-free soap.
  • the medicated soap or soap-free products of the present invention can be used for the treatment or prevention of skin -disorders wherein the skin disorder is selected from the group consisting of mycotic, fungal, itching, rash, dermatitis, tinea crusis, body tinea, eczema, pruritus, dermatophytosis, and the microorganisms comprise dermatophytes (like t chophyton, epidermophyton floccosum, microsporum species), aspergillus moulds, malassezia furfur, corynebacteria minutissimum and gram-positive bacteria like staphylococci, streptoccoci.
  • the skin disorder is selected from the group consisting of mycotic, fungal, itching, rash, dermatitis, tinea crusis, body tinea, eczema, pruritus, dermatophytosis
  • the microorganisms comprise dermatophytes (like t chophyton
  • the imidazole used in the product of the present invention is selected from the group consisting of Clotrimazole, miconazole, metronidazole, bifonazole, ketoconazole, terconazole, econazole or mixtures thereof.
  • said imidazole is Clotrimazole.or Miconazole.
  • Said imidazole is preferably provided in a concentration of between 0.5 and 2.0%. Additional antimycotic agents are terbinafine and Ciclopirox.
  • composition of the basic soap-free cleansing bar is based on a clinically proven, dermatologically tested product containing allergy-screened ingredients.
  • the cleansing bars according to the present invention have been shown to have better substantivity properties, so that the quantity of the antimycotic agent left on the skin is relatively high.
  • the medicated skin cleansing product is soap-free or is primarily soap-free, e.g., is in the form of a combination bar having up to 10% of a soap product and having at least 90% of a soap-free product containing the antimycotic component.
  • novel antifungal solid preparations are advantageously prepared by heating the various ingredients together at an elevated temperature as to obtain an intimate fluid or semi-fluid mixture, cooling down the mixture to a lower temperature so as to remain still in a semi-fluid extrudable state, adding thereto the antimycotic agent , and extruding, casting or shaping by other means a desired shape, such as bar, stick or the like.
  • the pH of the preparation is advantageously adjusted to a pH in the said range.
  • the pH can be adjusted by the addition of suitable physiologically acceptable acids.
  • Various organic acids are suited for this purpose, such as lactic, citric and phosphoric acid.
  • a skin cleansing bar composition containing: i. 20-70% of anionic surfactants chosen from a large variety of mild surfactants such as: disodium alkyl sulfosuccinates (Cio-Ci ⁇ ), sodium/potassium long chain alkyl sulfate (C10-C 20 ), sodium cocoyl isethionate, sodium alkyl sulfoacetate, acyl taurates, acyl sarcosinates, acyl glutamate, alkyl glyceryl ether sulfonates, and mixtures thereof; ii.
  • anionic surfactants chosen from a large variety of mild surfactants such as: disodium alkyl sulfosuccinates (Cio-Ci ⁇ ), sodium/potassium long chain alkyl sulfate (C10-C 20 ), sodium cocoyl isethionate, sodium alkyl sulfoacetate, acyl taurates, acy
  • amphoteric and cationic surfactants such as alkylamido propyl betaine, alkyl betaine, alkyl sultaines, alkyl amine oxides and imidazolines and mixtures thereof; iii. 0-10% of nonionic surfactants such as alkyl polyglucosides, polyalkylene glycols, glyceryl monostearate, polyetoxylated fatty alcohols, polyhydroxy fatty acid amides and alkanolamides and mixtures thereof; iv.
  • binders and plasticizers such as cetostearyl alcohol, paraffin wax, stearic acid, palmitic acid, myristic acid, polyol esters, polyethylene glycols, fatty acid ethoxylate and mixtures thereof, wherein said plasticizers have a melting point from about 30 to 90 ° C;
  • v. 5-30% of moisturizing agents and emollients such as: stearic acid, cetostearyl alcohol, mineral oil, vegetable oil, urea, glycerine, propylene glycol, lactic acid, sodium lactate, polyols and mixtures thereof;
  • binding agents and processing aid agents such as maltodextrin, dextrin, starch, talc and mixtures thereof;
  • 0.2%-5% of an antimycotic agent preferably Clotrimazole/Miconazole
  • an antifungal soap-free cleansing bar comprising:
  • anionic surfactants preferably 30-50% 0-10% amphoteric surfactants, preferably 2-4% 0-10% nonionic surfactants, preferably 1-4%.
  • compositions further comprise deionized water in an amount of between 3% and 10% (m/m).
  • anionic surfactants chosen from a large variety of mild surfactants such as: disodium alkyl sulfosuccinates (Cio-Cis), sodium/potassium long chain alkyl sulfate (C10-C20), sodium cocoyl isethionate, sodium alkyl sulfoacetates, acyl taurates, acyl sarcosinates, acyl glutamat, alkyl glyceryl ether sulfonates, and mixtures thereof; 0-10% of amphoteric and cationic surfactants, such as alkylamido propyl betaine, alkyl betaine, imidazolines and mixtures thereof;
  • nonionic surfactants such as glyceryl monostearate, polyalkylene glycols, polyetoxylated fatty alcohos, polyhydroxy fatty acid amides, alkyl polyglucosides, alkanolamides and mixtures thereof;
  • soap of animal or vegetable origin such as, sodium * tallowate, sodium palmate, sodium cocoate, sodium stearate, sodium palm kemelate, as a processing aid agent and hardener;
  • plasticizers such as cetostearyl alcohol, paraffin wax, stearic acid, palmitic acid, myristic acid, wherein said plasticizers have a melting point from about 30 to 90°C;
  • moisturizing agents and emollients such as: stearic acid, cetostearyl alcohol, mineral oil, vegetable oil, urea, glycerine, propylene glycol, lactic acid, sodium lactate, polyols and mixtures thereof;
  • binding agents and processing aid agents such as maltodextrin, dextrin, starch, talc and mixtures thereof;
  • an antimycotic agent preferably Clotrimazole/Miconazole/ Terbinafine/Ciclopirox
  • pH adjusting acid agents such as lactic acid, phosphoric acid, citric acid, fumaric acid, tartaric acid and mixtures thereof.
  • an anti-fungal combination cleansing bar comprising:
  • anionic surfactants preferably 30-50%
  • soap preferably 3-6%
  • nonionic surfactants preferably 1 -4%;
  • amphoteric surfactants preferably 2-4%;
  • moisturizers 10-50%o moisturizers, emollients, plasticizers, preferably 15-35%;
  • binding and processing aid agents preferably 15-25%;
  • an antimycotic agent preferably 0.5-2%
  • compositions further comprise deionized water in an amount of between 5% and 13% (m/m).
  • a medicated liquid soap composition comprising: i. 5-25% of anionic surfactants chosen from a large variety of surfactants, such as sodium/triethanolamine alkyl sulfates sodium laureth sulfates, disodium lauryl ethoxy sulfosuccinates (Cto-Ci ⁇ ), sodium/ammonium cocoyl isethionate, sodium alkyl sulfoacetate; ii. 0-10% of nonionic surfactants such as alkyl polyglucosides, polymeric quaternary ammonium salt (polyquaternium), glycol distearate, cocamide
  • anionic surfactants chosen from a large variety of surfactants, such as sodium/triethanolamine alkyl sulfates sodium laureth sulfates, disodium lauryl ethoxy sulfosuccinates (Cto-Ci ⁇ ), sodium/ammonium cocoyl isethionate, sodium alkyl s
  • DEA glyceryl esters and various others
  • amphoteric and cationic surfactants such as of imidazoline type (preferably disodium cocamphodiacetate) and betaine type (preferably alkylamidopropyl betaine, alkyl betaine) and various others
  • emollients and moisturizing agents such as mineral oil, vegetal oil, silicone oil derivatives (such as dimethicone copolyol), glycerine, propylene glycol, sodium/ammonium lactate, lactic acid, urea
  • emollients and moisturizing agents such as mineral oil, vegetal oil, silicone oil derivatives (such as dimethicone copolyol), glycerine, propylene glycol, sodium/ammonium lactate, lactic acid, urea
  • foam boosters and viscosity improvers such as cocamides, ethoxylate fatty alcohols, sodium chloride; vi. 0.2-3% of an antimycotic agent, preferably Clotrimazole/Miconazole/
  • pH adjusting acid agents such as citric acid, lactic acid, phosphoric acid, fumaric acid, tartaric acid; viii. 0-1% fragrance, dye q.s.; and ix. 70-85% deionized water.
  • Anionic surfactants preferably 8-12%;
  • Amphoteric and cationic surfactants preferably 1 -4%;
  • Nonionic surfactants preferably 2-6%
  • Moisturizers and emollients preferably 0.5-2%;
  • an antimycotic agent preferably 0.5-2%

Abstract

The invention provides a medicated skin cleansing product for the treatment or prevention of skin disorders containing an antimycotic agent and having a pH between 3.5-6.0 wherein the antimycotic agent is selected from the group consisting of terbinafine or ciclopirox or an imidazole.

Description

MEDICATED SKIN CLEANSING PRODUCTS
The present invention relates to a medicated skin cleansing product. More particularly, the present invention relates to soap or soap-free skin cleansing products for treatment or prevention of skin disorders having a pH of about between 3.5 to 6.0 and containing an antimycotic agent .
In British Patent 2342862 there is described and claimed a solid cleansing soap bar containing an anti-fungal agent for treatment of mycotic skin disorders wherein said chemical composition is defined as having a pH between 6-10 and being formed into a solid bar cake that is usable as a cleansing bar.
As the pH of healthy skin is acidic (4.5-5.5), it has been an object of the present invention to develop medicated products containing antimycotics and having a pH within the normal skin range.
In addition, it has now been found however that for vaginal products, a pH of between 3.5 to 6.0, that does not disturb the physiological equilibrium of the natural bacterial flora, has to be targeted since a product with a pH of 6 to 10 will disturb the natural physiological pH, raising the vaginal pH from 3.5-4.5 to higher than 6 for a certain period of time, from minutes to hours, depending on the pH of the product (the higher the worse). During this time the overgrowth of the fungi will be accelerated.
As will be described hereinafter it has now been found that the products of the present invention do not change the skin or the vaginal pH, leaving intact the competitive inhibition between the natural bacterial flora and fungi.
Furthermore, it has now been found that a pH of 3.5 to 6.0 will create the best medium for the antimycotic activity of an antimycotic agent such as terbinafine or ciclopirox or an imidazole such as clotrimazole or miconazole.
"Alkaline metal" soaps have a relatively high pH, being salts of weak acids with a strong base.
Antimycotic agents such as Imidazoles or terbinafine or ciclopirox are not stable in liquid soap environments, and therefore cannot be formulated in the form of liquid soaps with regular (alkaline) soap.
Thus, according to the present invention it has now been surprisingly found that these antifungal agents are stable in soap-free soap bar products. This new finding enables the use of imidazoles or terbinafine or ciclopirox , in the convenient form of bar soap. In addition, it has now been surprisingly found that antimycotic agents such as imidazoles or terbinafine or ciclopirox are stable also in liquid soap-free soaps, provided that the pH is kept in the range of 3.5-7.0.
Thus, according to the present invention there are now provided medicated skin cleansing products for the treatment or prevention of skin disorders containing an antimycotic agent and having a pH between 3.5-6.0 wherein said antimycotic agent is selected from the group consisting of terbinafine or ciclopirox or an imidazole.
In preferred embodiments of the present invention said products are soap-free however combination products including alkaline soap of animal or vegetable origin are also contemplated for use according to the present invention.
In especially preferred embodiments of the present invention said product is in the form of a cleansing bar while in other embodiments said product is in the form of a liquid soap-free soap.
The medicated soap or soap-free products of the present invention can be used for the treatment or prevention of skin -disorders wherein the skin disorder is selected from the group consisting of mycotic, fungal, itching, rash, dermatitis, tinea crusis, body tinea, eczema, pruritus, dermatophytosis, and the microorganisms comprise dermatophytes (like t chophyton, epidermophyton floccosum, microsporum species), aspergillus moulds, malassezia furfur, corynebacteria minutissimum and gram-positive bacteria like staphylococci, streptoccoci.
Preferably the imidazole used in the product of the present invention is selected from the group consisting of Clotrimazole, miconazole, metronidazole, bifonazole, ketoconazole, terconazole, econazole or mixtures thereof.
In especially preferred embodiments of the present invention said imidazole is Clotrimazole.or Miconazole.
Said imidazole is preferably provided in a concentration of between 0.5 and 2.0%. Additional antimycotic agents are terbinafine and Ciclopirox.
The composition of the basic soap-free cleansing bar is based on a clinically proven, dermatologically tested product containing allergy-screened ingredients.
The cleansing bars according to the present invention have been shown to have better substantivity properties, so that the quantity of the antimycotic agent left on the skin is relatively high. As stated hereinbefore in the preferred embodiments of the present invention the medicated skin cleansing product is soap-free or is primarily soap-free, e.g., is in the form of a combination bar having up to 10% of a soap product and having at least 90% of a soap-free product containing the antimycotic component.
The novel antifungal solid preparations are advantageously prepared by heating the various ingredients together at an elevated temperature as to obtain an intimate fluid or semi-fluid mixture, cooling down the mixture to a lower temperature so as to remain still in a semi-fluid extrudable state, adding thereto the antimycotic agent , and extruding, casting or shaping by other means a desired shape, such as bar, stick or the like.
Some of the preparations were initially heated to about 70-85°C, cooled to about 50-65°C, the antimycotic agent was added and the desired shape of the final product (of the desired shape) was prepared.
The pH of the preparation is advantageously adjusted to a pH in the said range. The pH can be adjusted by the addition of suitable physiologically acceptable acids. Various organic acids are suited for this purpose, such as lactic, citric and phosphoric acid.
In a first set of preferred embodiments of the present invention there is provided a skin cleansing bar composition containing: i. 20-70% of anionic surfactants chosen from a large variety of mild surfactants such as: disodium alkyl sulfosuccinates (Cio-Ciβ), sodium/potassium long chain alkyl sulfate (C10-C20), sodium cocoyl isethionate, sodium alkyl sulfoacetate, acyl taurates, acyl sarcosinates, acyl glutamate, alkyl glyceryl ether sulfonates, and mixtures thereof; ii. 0-10% of amphoteric and cationic surfactants, such as alkylamido propyl betaine, alkyl betaine, alkyl sultaines, alkyl amine oxides and imidazolines and mixtures thereof; iii. 0-10% of nonionic surfactants such as alkyl polyglucosides, polyalkylene glycols, glyceryl monostearate, polyetoxylated fatty alcohols, polyhydroxy fatty acid amides and alkanolamides and mixtures thereof; iv. 2-20% of binders and plasticizers, such as cetostearyl alcohol, paraffin wax, stearic acid, palmitic acid, myristic acid, polyol esters, polyethylene glycols, fatty acid ethoxylate and mixtures thereof, wherein said plasticizers have a melting point from about 30 to 90 ° C; v. 5-30% of moisturizing agents and emollients, such as: stearic acid, cetostearyl alcohol, mineral oil, vegetable oil, urea, glycerine, propylene glycol, lactic acid, sodium lactate, polyols and mixtures thereof; vi. 10-30% of binding agents and processing aid agents such as maltodextrin, dextrin, starch, talc and mixtures thereof; vii. 0.2%-5% of an antimycotic agent, preferably Clotrimazole/Miconazole
/Terbinafine/Ciclopirox . viii. 0.5%-5% of skin substantivity increasing agents such as quatemized polymers, sodium acrylates copolymer and cationic copolymers and mixtures thereof; and ix. 0.2-5% of pH adjusting acid agents such as lactic acid, phosphoric acid, citric acid, fumaric acid, tartaric acid and mixtures thereof. In further embodiments of the present invention there is provided an antifungal soap-free cleansing bar, comprising:
20-70% anionic surfactants, preferably 30-50% 0-10% amphoteric surfactants, preferably 2-4% 0-10% nonionic surfactants, preferably 1-4%. 10-50% moisturizers, emollients, plasticizers, preferably 15-35% 10-30% binding and processing aid agents, preferably 15-25% 0.2-5% antimycotic agent preferably 0.5-2% 3-10% water, preferably 5-8%.
Preferably said compositions further comprise deionized water in an amount of between 3% and 10% (m/m).
In further embodiments of the present invention there is provided a combination skin cleansing bar composition comprising:
20-60% of anionic surfactants chosen from a large variety of mild surfactants such as: disodium alkyl sulfosuccinates (Cio-Cis), sodium/potassium long chain alkyl sulfate (C10-C20), sodium cocoyl isethionate, sodium alkyl sulfoacetates, acyl taurates, acyl sarcosinates, acyl glutamat, alkyl glyceryl ether sulfonates, and mixtures thereof; 0-10% of amphoteric and cationic surfactants, such as alkylamido propyl betaine, alkyl betaine, imidazolines and mixtures thereof;
0-10% of nonionic surfactants such as glyceryl monostearate, polyalkylene glycols, polyetoxylated fatty alcohos, polyhydroxy fatty acid amides, alkyl polyglucosides, alkanolamides and mixtures thereof;
0-10% of soap, of animal or vegetable origin such as, sodium* tallowate, sodium palmate, sodium cocoate, sodium stearate, sodium palm kemelate, as a processing aid agent and hardener;
2-20% of binders and plasticizers, such as cetostearyl alcohol, paraffin wax, stearic acid, palmitic acid, myristic acid, wherein said plasticizers have a melting point from about 30 to 90°C;
5-30% of moisturizing agents and emollients, such as: stearic acid, cetostearyl alcohol, mineral oil, vegetable oil, urea, glycerine, propylene glycol, lactic acid, sodium lactate, polyols and mixtures thereof;
10-30% of binding agents and processing aid agents such as maltodextrin, dextrin, starch, talc and mixtures thereof;
0.2%-5% of an antimycotic agent, preferably Clotrimazole/Miconazole/ Terbinafine/Ciclopirox
0.5%-5% of skin substantivity increasing agents such as quatemized polymers, sodium acrylate copolymers, cationic copolymers and mixtures thereof; and
0.2-5% of pH adjusting acid agents such as lactic acid, phosphoric acid, citric acid, fumaric acid, tartaric acid and mixtures thereof.
In further preferred embodiments of the present invention there is provided ' an anti-fungal combination cleansing bar comprising:
20-60% anionic surfactants, preferably 30-50%;
0-10% soap preferably 3-6%;
0-10% nonionic surfactants preferably 1 -4%;
0-10% amphoteric surfactants, preferably 2-4%;
10-50%o moisturizers, emollients, plasticizers, preferably 15-35%;
10-30% binding and processing aid agents, preferably 15-25%;
0.2-5% an antimycotic agent preferably 0.5-2%; and
5-13% water, preferably 6-10%. Preferably said compositions further comprise deionized water in an amount of between 5% and 13% (m/m).
In yet further preferred embodiments of the present invention there is provided a medicated liquid soap composition comprising: i. 5-25% of anionic surfactants chosen from a large variety of surfactants, such as sodium/triethanolamine alkyl sulfates
Figure imgf000007_0001
sodium laureth sulfates, disodium lauryl ethoxy sulfosuccinates (Cto-Ciβ), sodium/ammonium cocoyl isethionate, sodium alkyl sulfoacetate; ii. 0-10% of nonionic surfactants such as alkyl polyglucosides, polymeric quaternary ammonium salt (polyquaternium), glycol distearate, cocamide
DEA, glyceryl esters and various others; iii. 0-10% of amphoteric and cationic surfactants such as of imidazoline type (preferably disodium cocamphodiacetate) and betaine type (preferably alkylamidopropyl betaine, alkyl betaine) and various others; iv. 1-8% of emollients and moisturizing agents, such as mineral oil, vegetal oil, silicone oil derivatives (such as dimethicone copolyol), glycerine, propylene glycol, sodium/ammonium lactate, lactic acid, urea; v. 1 -10% of foam boosters and viscosity improvers, such as cocamides, ethoxylate fatty alcohols, sodium chloride; vi. 0.2-3% of an antimycotic agent, preferably Clotrimazole/Miconazole/
Terbinafine/Ciclopirox vii. 0.2-5% of pH adjusting acid agents such as citric acid, lactic acid, phosphoric acid, fumaric acid, tartaric acid; viii. 0-1% fragrance, dye q.s.; and ix. 70-85% deionized water.
In further preferred embodiments of the present invention there is provided an anti-mycotic liquid soap composition comprising:
5-25% Anionic surfactants, preferably 8-12%;
0-10% Amphoteric and cationic surfactants preferably 1 -4%;
0-10% Nonionic surfactants, preferably 2-6%;
1-8% Moisturizers and emollients preferably 0.5-2%;
0.2-3% an antimycotic agent preferably 0.5-2%; and
70-85%o water preferably 76-82%. While the invention will now be described in connection with certain preferred embodiments in the following examples so that aspects thereof may be more fully understood and appreciated, it is not intended to limit the invention to these particular embodiments. On the contrary, it is intended to cover all alternatives, modifications and equivalents as may be included within the scope of the invention as defined by the appended claims. Thus, the following examples which include preferred embodiments will serve to illustrate the practice of this invention, it being understood that the particulars shown are by way of example and for purposes of illustrative discussion of preferred embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of product procedures as well as of the principles and conceptual aspects of the invention.
Examples of Soap-Free Bars
Figure imgf000008_0001
Figure imgf000009_0001
Exam les of Liquid Soaps
Figure imgf000009_0002
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative examples and that the present invention may be embodied in other specific forms without departing from the essential attributes thereof, and it is therefore desired that the present embodiments and examples be considered in all respects as illustrative and not restrictive, reference being made to the appended claims, rather than to the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

Claims

WHAT IS CLAIMED IS:
1. A medicated skin cleansing product for the treatment or prevention of skin disorders containing an antimycotic agent and having a pH between 3.5-6.0 wherein the antimycotic agent is selected from the group consisting of terbinafine or ciclopirox or an imidazole.
2. A medicated skin cleansing product according to claim 1 wherein said product is soap-free.
3. A product according to claim 1 wherein said imidazole is selected from the group consisting of clotrimazole and miconazole and the product is in the form of a cleansing bar.
4. A product according to claim 1 in the form of a liquid soap-free soap.
5 A product according to claim 1 wherein said imidazole is selected from the group consisting of clotrimazole, miconazole, metronidazole, bifonazole, ketoconazole, terconazole, econazole or mixtures thereof.
6. A product according to claim 1 , wherein the concentration of said antimycotic agent is between 0.1 -5%.
7. A skin cleansing composition according to claim 1 whereing said antimycotic agent is selected from the group consisting of Clotrimazole or Miconazole or Terbinafine or Ciclopirox and the concentration thereof is between 0.5-2.0% for the treatment or prevention of skin disorders.
8. A soap-free medicated product according to claim 2 for the treatment or prevention of skin disorders in vaginal and anal areas, containing an antimycotic agent and having a pH between 3.5-6.0.
9. A medicated soap or soap-free product according to claim 1 for the treatment or prevention of skin disorders containing an antimycotic agent and having a pH between 3.5-6.0, wherein the skin disorder is selected form the group consisting of mycotic, fungal, itching, rash, dermatitis, tinea crusis, body tinea, eczema, pruritus and dermatophytosis.
10. A skin cleansing bar product comprising:
20-70% of anionic surfactants;
0-10% of amphoteric and cationic surfactants; 2-20% of binders and plasticizers, wherein said plasticizers have a melting point from about 30 to 90 ° C;
5-30% of moisturizing agents and emollients;
10-30% of binding and processing aid agents;
0.2%-5% of antimycotic agent;
0.5%-5% of skin substantivity increasing agents; and
0.2-5% of pH adjusting acid agents.
11. A skin cleansing bar product according to claim 10 wherein said anionic surfactants are selected from the group consisting of disodium alkyl sulfosuccinates (C10-C18), sodium/potassium long chain alkyl sulfate (C10-C20), sodium cocoyl isethionate, sodium alkyl sulfoacetate, acyl taurates, acyl sarcosinates, acyl glutamate, alkyl glyceryl ether sulfonates, and mixtures thereof.
12. A skin cleansing bar product according to claim 10 wherein said amphoteric and cationic surfactants are selected from the group consisting of alkylamido propyl betaine, alkyl betaine, alkyl sultaines, alkyl amine oxides and imidazolines and mixtures thereof.
13. A skin cleansing bar product according to claim 10 wherein said non-ionic surfactants are selected from the group consisting of alkyl polyglucosides, polyalkylene glycols, glyceryl monostearate, polyetoxylated fatty alcohols, polyhydroxy fatty acid amides and alkanolamides and mixtures thereof.
14. A skin cleansing bar product according to claim 10 wherein said binders and plasticizers are selected from the group consisting of cetostearyl alcohol, paraffin wax, stearic acid, palmitic acid, myristic acid, polyol esters, polyethylene glycols, fatty acid ethoxylate and mixtures thereof.
15. A skin cleansing bar product according to claim 10 wherein moisturizing agents and emollients are selected from the group consisting of stearic acid, cetostearyl alcohol, mineral oil, vegetable oil, urea, glycerine, propylene glycol, lactic acid, sodium lactate, and polyols and mixtures thereof.
16. A skin cleansing bar product according to claim 10 wherein said binding and processing aid agents are selected from the group consisting of maltodextrin, dextrin, starch and talc and mixtures thereof.
17. A skin cleansing bar product according to claim 10 wherein said pH adjusting agents are selected from the group consisting of lactic acid, phosphoric acid, citric acid, fumaric acid and tartaric acid and mixtures thereof.
18. A skin cleansing bar product according to claim 10 wherein said skin substantivity increasing agents are selected from the group consisting of quaternized polymers, sodium acrylate copolymers and cationic copolymers and mixtures thereof.
19. A skin cleansing bar product according to claim 10 wherein said antimycotic agent is selected from the group consisting of terbinafine or ciclopirox and an imidazole.
20. A skin cleansing bar product according to claim 19 wherein said imidazole is selected from the group consisting of clotrimazole and miconazole.
21. An antifungal soap-free cleansing bar, comprising:
20-70% anionic surfactants;
0-10% amphoteric surfactants;
0-10% nonionic surfactants;
10-50% moisturizers, emollients, plasticizers;
10-30% binding and processing aid agents;
0.2-5% an antimycotic agent ; and
3-10% water.
22. An antifungal soap-free cleansing bar according to claim 21 , comprising:
30-50% anionic surfactants;
2-4% amphoteric surfactants;
1 -4% nonionic surfactants;
15-35% moisturizers, emollients, plasticizers;
15-25% binding and processing aid agents;
0.5-2% an antimycotic agent ; and
5-8% water.
23. A skin cleansing composition according to claim 1 which further comprises stearic acid in an amount effective to serve as a moisturizing agent and/or emollient.
24. A skin cleansing composition according to claim 23, in which the stearic acid is present in a concentration of between 5 and 30%.
25. A chemical composition as claimed in any one of the preceding claims, which further comprises glycerin in an amount effective to serve as a lubricating and moisturizing agent.
26. A skin cleansing composition according to claim 25, in which the glycerin is present in a concentration of between 0.5 and 5%.
27. A skin cleansing composition according to claim 26, in which the glycerin is present in an amount of 2%.
28. A skin cleansing composition according to claim 1 , which further comprises propylene glycol in an amount effective to serve as a solvent for the components forming part of the composition.
29. A skin cleansing composition according to claim 28, in which the propylene glycol is present in a concentration of between 0.5% and 5%.
30. A skin cleansing composition according to claim 29, in which the propylene glycol is present in an amount of 1 %.
31. A skin cleansing composition according to claim 1 , which further comprises deionised water in an amount of between 3% and 10% (m/m).
32. A skin cleansing combination bar composition according to claim 1 comprising: i. 20-60% of anionic surfactants; ii. 0-10% of amphoteric and cationic surfactants; iii. 0-10% of nonionic surfactants; iv. 0.1 -10% of soap, of animal or vegetable origin; v. 2-20% of binders and plasticizers; vi. 5-30% of moisturizing agents and emollients; vii. 10-30% of binding agents and processing aid agents; viϋ. 0.2%-5% of an antimycotic agent; ix. 0.5%-5% of skin substantivity increasing agents; and x. 0.2-5% of pH adjusting acid agents
33. A skin cleansing combination bar product according to claim 32 wherein said anionic surfactants are selected from the group consisting of disodium alkyl sulfosuccinates (Cio-Ciβ), sodium/potassium long chain alkyl sulfate (C10-C20), sodium cocoyl isethionate, sodium alkyl sulfoacetates, acyl taurates, acyl sarcosinates, acyl glutamates, .alkyl glyceryl ether sulfonates, and mixtures thereof.
34. A skin cleansing bar product according to claim 32 wherein said amphoteric and cationic surfactants are selected from the group consisting of alkylamido propyl betaine, alkyl betaine, imidazolines and mixtures thereof.
35. A skin cleansing bar product according to claim 32 wherein said nonionic surfactants are selected from the group consisting of glyceryl monostearate, polyalkylene glycols, polyetoxylated fatty alcohos, polyhydroxy fatty acid amides, alkyl polyglucosides, alkanolamides and mixtures thereof.
36. A skin cleansing bar product according to claim 32 wherein said soap of animal or vegetable origin are selected from the group consisting of sodium tallowate, sodium palmate, sodium cocoate, sodium stearate, sodium palmkernelate, as a processing aid agent and hardener
37. A skin cleansing bar product according to claim 32 wherein said binders and plasticizers are selected from the group consisting cetostearyl alcohol, paraffin wax, stearic acid, palmitic acid, myristic acid, wherein said plasticizers have a melting point from about 30 to 90 ° C.
38. A skin cleansing bar product according to claim 32 wherein said moisturizing agents and emollients are selected from the group consisting of stearic acid, cetostearyl alcohol, mineral oil, vegetable oil, urea, glycerine, propylene glycol, lactic acid, sodium lactate, polyols and mixtures thereof.
39. A skin cleansing bar product according to claim 32 wherein said binding agents and processing aid agents are selected from the group consisting of maltodextrin, dextrin, starch, talc and mixtures thereof.
40. A skin cleansing bar product according to claim 32 wherein said antimycotic agent is selected from the group consisting of an terbinafine or ciclopirox and an imidazole.
41. A skin cleansing bar product according to claim 40 wherein said imidazole is selected from the group consisting of clotrimazole and miconazole.
42. A skin cleansing bar product according to claim 32 wherein said Ph adjusting acid agents are selected from the group consisting of lactic acid, phosphoric acid, citric acid, fumaric acid, tartaric acid and mixtures thereof.
43. A skin cleansing bar product according to claim 32 wherein said skin substantivity increasing agents are selected from the group consisting of quaternized polmers, sodium acrylate copolymers, cationic copolymers and mixtures thereof.
44. An antifungal combination bar comprising
20-60% anionic surfactants;
0-10% soap;
0-10% nonionic surfactants;
0-10% amphoteric surfactants;
10-50% moisturizers, plasticizers;
10-30% binding and processing aid agents;
0.2-5% an antimycotic agent ; and
5-13% water.
45. An antifungal combination bar according to claim 44 comprising:
30-50% anionic surfactants;
3-6% soap;
1 -4% nonionic surfactants;
2-4% amphoteric surfactants;
15-35% moisturizers, emollients, plasticizers;
15-25% binding and processing aid agents;
0.5-2% an antimycotic agent; and
6-10% water
46. A skin cleansing composition according to claim 45, which further comprises deionised water in an amount of between 5% and 13% (m/m).
47. A process for preparing antimycotic solid compositions of matter as defined in any of the preceeding claims which comprises melting together all the ingredients except the imidazole, cooling the mixture to about 50-65°C, adding the imidazole and extruding or casting the product into a desired shape.
48. A liquid soap composition, containing: i. 5-25% of anionic surfactants; ii. 0-10% of non-ionic surfactants; iii. 0-10% of amphoteric and cationic surfactants; iv. 1 -8% of emollients and moisturizing agents; v. 1 -10% of foam boosters and viscosity improvers; vi. 0.2-3% of antimycotic agent; vii. 0.2-5% pH adjusting acid agent; viii. 0-1 % fragrance, dye q.s; and ix. 70-85% deionized water.
49. A liquid soap composition according to claim 48 wherein said anionic surfactants are selected from the group consisting of sodium/triethanolamine alkyl sulfates (Cio-Ciβ), sodium laureth sulfates, disodium lauryl ethoxy sulfosuccinates (Cio-Ciβ), sodium/ammonium cocoyl isethionate, sodium alkyl sulfoacetate and mixtures thereof.
50. A liquid soap composition according to claim 48 wherein said non-ionic surfactants are selected from the group consisting of alkyl polyglucosides, polymeric quaternary ammonium salt (polyquaternium), glycol distearate, cocamide DEA, glyceryl esters and mixtures thereof.
51. A liquid soap composition according to claim 48 wherein said amphoteric and cationic surfactants are selected from the group consisting of imidazoline type and betaine type surfactants.
52. A liquid soap composition according to claim 48 wherein said amphoteric and cationic surfactants are selected from the group consisting of disodium cocamphodiacetate and alkylamidopropyl betaine and alkyl betaine.
53. A liquid soap composition according to claim 48 wherein said emollients and moisturizing agents are selected from the group consisting of mineral oil, vegetal oil, silicone oil derivatives (such as dimethicone copolyol), glycerine, propylene glycol, sodium/ammonium lactate, lactic acid, urea and mixtures thereof.
54. A liquid soap composition according to claim 48 wherein said foam boosters and viscosity improvers are selected from the group consisting of cocamides, ethoxylate fatty alcohols, sodium chloride and mixtures thereof.
55 A liquid soap composition according to claim 48 wherein said antimycotic agent is wherein said antimycotic agent is selected from the group consisting of a terbinafine or ciclopirox and an imidazole.
56. A liquid soap composition according to claim 55 wherein said imidazole is selected from the group consisting of clotrimazole and miconazole.
57. A liquid soap composition according to claim 48 wherein said pH adjusting acid agents are selected from the group consisting of citric acid, lactic acid, phosphoric acid, fumaric acid, tartaric acid and mixtures thereof.
58. An antimycotic liquid soap comprising:
5-25%o Anionic surfactants;
0-10% Amphoteric and cationic surfactants;
0-10% Nonionic surfactants;
1-8% Moisturizers and emollients;
0.2-3% an antimycotic agent; and
70-85% water.
59. An antimycotic liquid soap according to claim 58 comprising:
8-12% Anionic surfactants;
1 -4% Amphoteric and cationic surfactants;
2-6% Nonionic surfactants;
0.5-2% Moisturizers and emollients;
0.5-2% an antimycotic agent; and
76-82% water.
PCT/IL2003/000738 2002-09-11 2003-09-08 Medicated skin cleansing products comprising an antimycotic agent WO2004024120A2 (en)

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Applications Claiming Priority (4)

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IL151686 2002-09-11
IL15168602A IL151686A0 (en) 2002-09-11 2002-09-11 Medicated skin cleansing products
IL15758503A IL157585A0 (en) 2003-08-26 2003-08-26 Medicated skin cleansing products
IL157585 2003-08-26

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008035152A1 (en) * 2006-09-18 2008-03-27 Carlo Ghisalberti Cosmetic method to remove the dark undereye marks
CN103893176A (en) * 2014-04-03 2014-07-02 济川药业集团有限公司 Drug for treating itchy scalp and dandruff increase
GB2586092A (en) * 2019-07-10 2021-02-03 Henkel Ag & Co Kgaa Solid cosmetic cleansing agents

Citations (4)

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Publication number Priority date Publication date Assignee Title
WO1996029983A1 (en) * 1995-03-31 1996-10-03 Colgate-Palmolive Company Skin care products containing anti-itching/anti-irritant agents
US5989536A (en) * 1993-07-03 1999-11-23 The Procter & Gamble Company Personal cleansing compositions containing alkoxylated ether and cationic ammonium salt for deposition of active agent upon the skin
GB2342862A (en) * 1998-10-23 2000-04-26 Johannes Marthinus Snyman Solid cleansing soap bar containing an antifungal agent for treatment of mycotic skin disorders such as candida
WO2002017876A2 (en) * 2000-08-31 2002-03-07 Unilever Plc Foaming anti-bacterial cleansing skin product

Patent Citations (4)

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Publication number Priority date Publication date Assignee Title
US5989536A (en) * 1993-07-03 1999-11-23 The Procter & Gamble Company Personal cleansing compositions containing alkoxylated ether and cationic ammonium salt for deposition of active agent upon the skin
WO1996029983A1 (en) * 1995-03-31 1996-10-03 Colgate-Palmolive Company Skin care products containing anti-itching/anti-irritant agents
GB2342862A (en) * 1998-10-23 2000-04-26 Johannes Marthinus Snyman Solid cleansing soap bar containing an antifungal agent for treatment of mycotic skin disorders such as candida
WO2002017876A2 (en) * 2000-08-31 2002-03-07 Unilever Plc Foaming anti-bacterial cleansing skin product

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008035152A1 (en) * 2006-09-18 2008-03-27 Carlo Ghisalberti Cosmetic method to remove the dark undereye marks
CN103893176A (en) * 2014-04-03 2014-07-02 济川药业集团有限公司 Drug for treating itchy scalp and dandruff increase
GB2586092A (en) * 2019-07-10 2021-02-03 Henkel Ag & Co Kgaa Solid cosmetic cleansing agents
GB2586092B (en) * 2019-07-10 2022-02-16 Henkel Ag & Co Kgaa Solid cosmetic cleansing agents

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WO2004024120A3 (en) 2004-06-24
WO2004024120B1 (en) 2004-07-29
AU2003259539A1 (en) 2004-04-30

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