WO2018208173A1 - An antifungal formulation - Google Patents

An antifungal formulation Download PDF

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Publication number
WO2018208173A1
WO2018208173A1 PCT/NZ2018/050061 NZ2018050061W WO2018208173A1 WO 2018208173 A1 WO2018208173 A1 WO 2018208173A1 NZ 2018050061 W NZ2018050061 W NZ 2018050061W WO 2018208173 A1 WO2018208173 A1 WO 2018208173A1
Authority
WO
WIPO (PCT)
Prior art keywords
oil
use according
formulation
amount
ingredients
Prior art date
Application number
PCT/NZ2018/050061
Other languages
French (fr)
Inventor
David Roberts
Original Assignee
Neat Feat Products Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Neat Feat Products Limited filed Critical Neat Feat Products Limited
Publication of WO2018208173A1 publication Critical patent/WO2018208173A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/58Meliaceae (Chinaberry or Mahogany family), e.g. Azadirachta (neem)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/61Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9068Zingiber, e.g. garden ginger
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics

Definitions

  • a preferred form of the invention relates to an antifungal formulation for human use, preferably although not necessarily for spray-on application.
  • ingredients in the manufacture of a formulation for use on humans for treating skin conditions wherein the formulation comprises a combination of such ingredients
  • the surfactant comprises decyl glucoside and/or sorbitan oleate.
  • ingredients further comprise lavender oil and/or ginger oil.
  • ingredients include vinegar.
  • the ingredients include apple cider vinegar.
  • the ingredients include sodium chloride for controlling desired viscosity and stability characteristics.
  • the formulation is for containment within, and is for deliver as a spray from, a spray dispenser.
  • the tee tree oil is used in an amount of 4 - 6% by weight of the finished formulation.
  • the neem oil is used in an amount of 0.8 - 1 .2% by weight of the finished formulation.
  • the surfactant is used in an amount of 20 - 30% by weight of the finished formulation.
  • decyl glucoside is used in an amount of 15 - 25% by weight of the finished formulation.
  • sorbitan oleate is used in an amount of 4 - 6% by weight of the finished formulation.
  • Optionally lavender oil is used in an amount of 0.8 - 1 .2% by wight of the finished formulation.
  • ginger oil is used in an amount of 0.8 - 1 .2% by wt of the finished formulation.
  • apple cider vinegar is used in an amount of 1 - 1 .5% by weight of the finished formulation.
  • the formulation has the following ingredients in or about (approximately) the amounts indicated: Ingredient Amount
  • the formulation is produced by taking the steps:
  • lavender oil and/or ginger oil is mixed in at step a).
  • the formulation may include any or all of the other ingredients referred to above, optionally in any of the amounts stipulated.
  • the antifungal formulation uses tee tree oil and neem oil as active ingredients.
  • Lavender oil and ginger oil may be added (it is hypothesised that they may also contribute some antifungal activity).
  • All of the oils are mixed with glycerol as a solvent/solubilser to form a sludge (eg to 'wet-out' the oils).
  • Decyl glucoside is then added as a surfactant/solubilser with low energy mixing.
  • Sorbitan oleate is also added as a surfactant/solubilser with further low energy mixing. At this point the combination is in the form of a slurry.
  • a water and sodium chloride mixture is then added with low energy mixing to complete the formulation as a homogenous non-viscous liquid suitable for delivery by way of a hand-held spray dispenser. It can be sprayed onto human skin to treat fungal conditions.
  • vinegar may be added for pH adjustment after the above otherwise complete mixture has been formed.
  • any or all of the above ingredients may be varied in the amount used, depending on the desired characteristics for the end product.
  • decyl glucoside and sorbitan oleate are the preferred surfactants (eg solubilisers), in other embodiments they may be replaced by one or more other suitable surfactants, for example polyglyceryl-6 caprylate, polyglyceryl-4 caprate, polyglyceryl-4 cocoate and/or polyglyceryl-6 ricinoleate.
  • Peferred embodiments of the invention may be used for treating tinea, athletes' foot, Jock Itch and/or nail fungal infections While some preferred forms of the invention have been described by way of example it should be appreciated that modifications and improvements can occur without departing from the scope of the following claims.

Abstract

Many people suffer from fungal infection of the skin, especially of the feet. The infection may manifest with peeling, redness, itching, burning, blisters and sores. It is known to use various oils for treatment however formulating them into a convenient easy-to-apply watery product presents challenges given that oil and water normally do not mix well. It is an object of a preferred form of the invention to go at least some way towards addressing this by using tea tree oil, neem oil, glycerol, surfactant and water as ingredients in the manufacture of a formulation for use on humans for treating fungal skin conditions, wherein the formulation comprises a combination of such ingredients.

Description

TITLE
An Antifungal Formulation FIELD OF THE INVENTION
A preferred form of the invention relates to an antifungal formulation for human use, preferably although not necessarily for spray-on application.
BACKGROUND
Many people suffer from fungal infection of the skin, especially of the feet. The infection may manifest with peeling, redness, itching, burning, blisters and sores. It is known to use various oils for treatment however formulating them into a convenient easy-to-apply watery product presents challenges given that oil and water normally do not mix well. It is an object of an object of a preferred form of the invention to go at least some way towards addressing this problem.
The term "comprising" if and when used in this document in relation to a combination of features should not be taken to rule out the option of there being other features. It should not be interpreted in a necessarily limiting way.
SUMMARY OF THE INVENTION
According to one aspect of the invention there is provided the use of:
• tea tree oil;
• neem oil;
· glycerol;
• surfactant; and
• water;
as ingredients in the manufacture of a formulation for use on humans for treating skin conditions, wherein the formulation comprises a combination of such ingredients
Optionally the surfactant comprises decyl glucoside and/or sorbitan oleate.
Optionally wherein the ingredients further comprise lavender oil and/or ginger oil. Optionally wherein the ingredients include vinegar.
Optionally the ingredients include apple cider vinegar. Optionally the ingredients include sodium chloride for controlling desired viscosity and stability characteristics.
Optionally the formulation is for containment within, and is for deliver as a spray from, a spray dispenser.
Optionally the tee tree oil is used in an amount of 4 - 6% by weight of the finished formulation.
Optionally the neem oil is used in an amount of 0.8 - 1 .2% by weight of the finished formulation.
Optionally the surfactant is used in an amount of 20 - 30% by weight of the finished formulation. Optionally decyl glucoside is used in an amount of 15 - 25% by weight of the finished formulation.
Optionally sorbitan oleate is used in an amount of 4 - 6% by weight of the finished formulation.
Optionally lavender oil is used in an amount of 0.8 - 1 .2% by wight of the finished formulation.
Optionally ginger oil is used in an amount of 0.8 - 1 .2% by wt of the finished formulation.
Optionally apple cider vinegar is used in an amount of 1 - 1 .5% by weight of the finished formulation. Optionally the formulation has the following ingredients in or about (approximately) the amounts indicated: Ingredient Amount
Tea tree oil 50 mg/ml
Neem oil 10 mg/ml
Lavender oil 10 mg/ml
Ginger oil 10 mg/ml
Glycerol 50 mg/ml
Decyl glucoside 200 mg/ml
Sorbitan oleate 50 mg/ml
Sodium chloride 5 mg/ml
Apple cider vinegar 12.5 mg/ml
Purified water To volume
Optionally the formulation is produced by taking the steps:
a) mixing at least the tea tree oil and neem oil with the glycerol to form a sludge;
b) mixing in at least the surfactant to form a slurry; and
c) mixing in at least the water to form a homogenous spray-on liquid.
Optionally lavender oil and/or ginger oil is mixed in at step a).
According to a further aspect of the invention there is provided a formulation comprising:
• tea tree oil;
• neem oil;
· glycerol;
• surfactant; and
• water;
for use as an antifungal for treating fungal skin conditions in humans. The formulation may include any or all of the other ingredients referred to above, optionally in any of the amounts stipulated. DETAILED DESCRIPTION
In a preferred form of the invention the antifungal formulation uses tee tree oil and neem oil as active ingredients. Lavender oil and ginger oil may be added (it is hypothesised that they may also contribute some antifungal activity). All of the oils are mixed with glycerol as a solvent/solubilser to form a sludge (eg to 'wet-out' the oils). Decyl glucoside is then added as a surfactant/solubilser with low energy mixing. Sorbitan oleate is also added as a surfactant/solubilser with further low energy mixing. At this point the combination is in the form of a slurry. A water and sodium chloride mixture is then added with low energy mixing to complete the formulation as a homogenous non-viscous liquid suitable for delivery by way of a hand-held spray dispenser. It can be sprayed onto human skin to treat fungal conditions. In some embodiments vinegar may be added for pH adjustment after the above otherwise complete mixture has been formed.
In a particularly preferred embodiment of the invention the following ingredients are used in the amounts indicated:
Ingredient Function Amount
Tea tree oil Antifungal 50 mg/ml
(Melaleuca oil)
Neem oil Antifungal 10 mg/ml
(Azadirachta indica seed
oil)
Lavender oil Antifungal 10 mg/ml
Ginger oil Antifungal 10mg/ml
(Zingiber officinale flower
and/or leaf oil)
Glycerol Solvent / solubilising / wetting 50 mg/ml
agent
Decyl glucoside Surfactant / solubilising agent 200 mg/ml Sorbitan oleate Surfactant / solubilising agent 50 mg/ml
Sodium chloride Facilitates stability and provides 5 mg/ml
viscosity adjustment
Apple cider vinegar pH adjustment 12.5 mg/ml
Purified water Solvent To volume
In other embodiments of the invention any or all of the above ingredients may be varied in the amount used, depending on the desired characteristics for the end product.
While decyl glucoside and sorbitan oleate are the preferred surfactants (eg solubilisers), in other embodiments they may be replaced by one or more other suitable surfactants, for example polyglyceryl-6 caprylate, polyglyceryl-4 caprate, polyglyceryl-4 cocoate and/or polyglyceryl-6 ricinoleate.
Peferred embodiments of the invention may be used for treating tinea, athletes' foot, Jock Itch and/or nail fungal infections While some preferred forms of the invention have been described by way of example it should be appreciated that modifications and improvements can occur without departing from the scope of the following claims.

Claims

The use of:
• tea tree oil;
• neem oil;
• glycerol;
• surfactant; and
• water;
as ingredients in the manufacture of a formulation for use on humans for treating fungal skin conditions, wherein the formulation comprises a combination of such ingredients.
A use according to claim 1 , wherein the surfactant comprises decyl glucoside and/or sorbitan oleate.
A use according to claim 1 or 2, wherein the ingredients further comprise lavender oil and/or ginger oil.
A use according to claim 1 , 2 or 3, wherein the ingredients include vinegar.
A use according to claim 1 , 2 or 3, wherein the ingredients include apple cider vinegar.
A use according to any one of the preceding claims, wherein the ingredients include sodium chloride for controlling desired viscosity and stability
characteristics.
A use according to any one of the preceding claims, wherein the formulation is for containment within, and is for deliver as a spray from, a spray dispenser.
A use according to any one of the preceding claims, wherein the tee tree oil is used in an amount of 4 - 6% by weight of the finished formulation.
A use according to any one of the preceding claims, wherein the neem oil is used in an amount of 0.8 - 1 .2% by weight of the finished formulation.
10. A use according to any one of the preceding claims, wherein the surfactant is used in an amount of 20 - 30% by weight of the finished formulation.
11. A use according to any one of the preceding claims, wherein decyl glucoside is used in an amount of 15 - 25% by weight of the finished formulation.
12. A use according to any one of the preceding claims, wherein sorbitan oleate is used in an amount of 4 - 6% by weight of the finished formulation. 13. A use according to any one of the preceding claims, wherein lavender oil is used in an amount of 0.8 - 1 .2% by wight of the finished formulation.
14. A use according to any one of the preceding claims, wherein ginger oil is used in an amount of 0.8 - 1 .2% by wt of the finished formulation.
15. A use according to any one of the preceding claims, wherein apple cider vinegar is used in an amount of 1 - 1 .5% by weight of the finished formulation.
16. A use according to claim 1 , such that the formulation has the following
ingredients in or approximately the amounts indicated:
Ingredient Amount
Tea tree oil 50 mg/ml
Neem oil 10 mg/ml
Lavender oil 10 mg/ml
Ginger oil 10 mg/ml
Glycerol 50 mg/ml
Decyl glucoside 200 mg/ml
Sorbitan oleate 50 mg/ml
Sodium chloride 5 mg/ml
Apple cider vinegar 12.5 mg/ml Purified water To volume
17. A use according to any one of the preceding claims, wherein the formulation is produced by taking the steps:
a) mixing at least the tea tree oil and neem oil with the glycerol to form a sludge;
b) mixing in at least the surfactant to form a slurry; and
c) mixing in at least the water to form a homogenous spray-on liquid.
18. A use according to claim 17, wherein lavender oil and/or ginger oil is mixed in at step a).
19. A method of treating a fungal skin condition comprising spraying the skin of a human with a formulation formed according to the use of any one claims 1 -18.
20. A formulation comprising:
• tea tree oil;
• neem oil;
• glycerol;
• surfactant; and
• water;
for use as an antifungal for treating fungal skin conditions in humans.
PCT/NZ2018/050061 2017-05-09 2018-05-03 An antifungal formulation WO2018208173A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
NZ73173917 2017-05-09
NZ731739 2017-05-09

Publications (1)

Publication Number Publication Date
WO2018208173A1 true WO2018208173A1 (en) 2018-11-15

Family

ID=64105699

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/NZ2018/050061 WO2018208173A1 (en) 2017-05-09 2018-05-03 An antifungal formulation

Country Status (1)

Country Link
WO (1) WO2018208173A1 (en)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140057881A1 (en) * 2010-12-20 2014-02-27 Andrew Tuan Anh Le Composition for the Treatment of Skin Conditions
WO2015183799A1 (en) * 2014-05-28 2015-12-03 Macular Health, Llc Ocular eyelid scrub composition for the treatment of demodex blepharitis

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140057881A1 (en) * 2010-12-20 2014-02-27 Andrew Tuan Anh Le Composition for the Treatment of Skin Conditions
WO2015183799A1 (en) * 2014-05-28 2015-12-03 Macular Health, Llc Ocular eyelid scrub composition for the treatment of demodex blepharitis

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* Cited by examiner, † Cited by third party
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