NZ617164B2 - Avian-based treatment for microbial infections - Google Patents
Avian-based treatment for microbial infections Download PDFInfo
- Publication number
- NZ617164B2 NZ617164B2 NZ617164A NZ61716412A NZ617164B2 NZ 617164 B2 NZ617164 B2 NZ 617164B2 NZ 617164 A NZ617164 A NZ 617164A NZ 61716412 A NZ61716412 A NZ 61716412A NZ 617164 B2 NZ617164 B2 NZ 617164B2
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- NZ
- New Zealand
- Prior art keywords
- composition
- extract
- cacatua
- avian
- microbial skin
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/56—Materials from animals other than mammals
- A61K35/57—Birds; Materials from birds, e.g. eggs, feathers, egg white, egg yolk or endothelium corneum gigeriae galli
-
- 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
Abstract
The disclosure relates to a the use of a composition comprising avian extract EP-2 in a therapeutically effective concentration together with a pharmaceutically acceptable carrier and/or diluent for treating or preventing microbial skin infections. The avian extract EP-2 may be isolated from the tail feathers a bird of the order Psittaciformes (parrot), such as sulphur-crested cockatoo (Cacatua galerita), the galah (Cacatua roseicapilla), the Major Mitchell cockatoo (Cacatua leadbeateri leadbeateri) using an organic solvent. The microbial skin infection may be herpes oral cold sore (Type I), a type of wart, impetigo, cellulitis, tinea, intertrigo, scabies, mange, pediculosis (including pediculosis capitis) cutaneous candidiasis or thrush. The disclosure also relates to the use of a synthetic form of EP-2, comprising two or more of nicotinamide, 2,4-ditert butyl phenol, palmitic acid, oleic acid and squalene, for treating or preventing microbial skin infections. l feathers a bird of the order Psittaciformes (parrot), such as sulphur-crested cockatoo (Cacatua galerita), the galah (Cacatua roseicapilla), the Major Mitchell cockatoo (Cacatua leadbeateri leadbeateri) using an organic solvent. The microbial skin infection may be herpes oral cold sore (Type I), a type of wart, impetigo, cellulitis, tinea, intertrigo, scabies, mange, pediculosis (including pediculosis capitis) cutaneous candidiasis or thrush. The disclosure also relates to the use of a synthetic form of EP-2, comprising two or more of nicotinamide, 2,4-ditert butyl phenol, palmitic acid, oleic acid and squalene, for treating or preventing microbial skin infections.
Description
AVIAN-BASED TREATMENT FOR MICROBIAL INFECTIONS
Field of the Invention
The present invention relates to a composition, method of preparation and
application of an extract derived from avian tail feathers for the treatment of a microbial skin
infection.
Background of the Invention
The skin has the largest surface area of all of the body organs and is the most
exposed organ. Although the skin is remarkably effective in providing protection against the
external environment, skin infections are nevertheless a common presentation in most family
practices.
Bacteria can colonize the skin surface; both the outer stratum corneum and the
underlying dermal layers to produce skin infections including erythrasma, impetigo, ecthyma,
folliculitis, erysipelas and cellulitis. Bacteria commonly causing skin infections include
Staphylococcus aureus, Streptococcus pyogenes, Corynebacterium minutissimum,
Pasteurella multocida, Eikenella corrodens, and Bacteroides species. Viruses can also
cause skin infections, such as the human papillomavirus (HPV) which causes focal areas of
epithelial hyperplasia referred to as warts (including common warts, plantar warts, juvenile
warts and condylomata). Indeed, selected types of HPV are capable of inducing malignant
transformation of the epithelium, including that of the cervix. Fungi and yeast are also
capable of causing many different forms of skin infections, broadly referred to as
dermatomycoses. Candida albicans and Trichophyton, Epidermophyton, Microsporum and
Malassezia spp are the most common infecting organisms and are often responsible for long
and protracted infections resulting from their ability to permeate deep into the dermal layers.
Infection with parasites such as those that cause scabies, mange or pediculosis can also
colonise skin and hair follicles and cause much distress.
Skin infections may also result from a break in the integrity of the skin barrier, which
allows the penetration of microorganisms through the normally protective skin layers to
underlying dermal tissues. Bacteria such as Staphylococcus aureus, Pasteurella multocida,
Eikenella corrodens, and Bacteroides species and viruses such as Haemophilus influenzae
type B may gain entry through puncture wounds, insect bites or abrasions, potentially
resulting in rapidly spreading and destructive cellulitis.
Although many treatments are available for skin infections, including physical means
such as debridement or burning (through heat or cold) of warts, lancing of carbuncles and
abscesses, antibiotics to treat bacterial and fungal infections, these have a number of
problems, such as pain associated with physical treatments and side effects and resistance
associated with antibiotics.
Accordingly, there is a need for novel pharmaceutical compositions containing
bioactive substances which are able to treat or at least ameliorate microbial skin infections.
Summary of the Invention
In the first embodiment, the invention provides a composition comprising an extract
(hereafter known as EP-2) from the feathers of birds in a therapeutically effective
concentration together with a pharmaceutically acceptable carrier for the treatment or
prevention of a microbial skin infection.
According to a further embodiment, the invention provides a method for the treatment
or prevention of a microbial skin infection, wherein the method comprises administering to a
subject in need thereof a composition comprising a therapeutically effective amount of EP-2
together with a pharmaceutically acceptable carrier and/or diluent.
Detailed Description of the Invention
General
Those skilled in the art will appreciate that the invention described herein is
susceptible to variations and modifications other than those specifically described herein and
for the purpose of completeness these are included. The invention also includes all of the
steps, features, compositions and compounds referred to or indicated in the specification,
individually or collectively and any and all combinations or any two or more of the steps or
features.
Neither is the present invention to be limited in scope by the specific
embodiments described herein, which are intended for the purpose of illustration and
exemplification only. Functionally equivalent products, compositions and methods whether
occurring naturally from birds or manufactured chemically to replicate the components of the
avian extract are clearly within the scope of the invention as described herein.
The entire disclosures of all publications (including patents, patent
applications, journal articles, laboratory manuals, books, or other documents) cited herein
are hereby incorporated for reference only. No admission is made that any of the references
constitute prior art or are part of the common general knowledge of those working in the field
to which this invention relates.
Throughout this specification, unless the context requires otherwise, the
words "comprise", "comprises" or "comprising", will be understood to imply the inclusion of a
stated integer or group of integers but not the exclusion of any other integer or group of
integers.
Definitions for selected terms used herein may be found within the detailed
description of the invention and apply throughout. Unless otherwise defined, all other
scientific and technical terms used herein have the same meaning as commonly understood
to one of ordinary skill in the art to which the invention belongs.
Detailed Description of the Preferred Embodiments
The inventors of the present invention have surprisingly found that an extract
from the skin and feathers of birds can be used to treat various microbial skin infections.
Thus, the present invention provides a composition comprising an avian extract (hereafter
known as EP-2) from the skin and feathers of birds in a therapeutically effective
concentration together with a pharmaceutically acceptable carrier for the treatment or
prevention of a microbial skin infection. Reference in this invention to ‘feathers’ may be
taken to mean ‘feathers and skin’ together, or ‘feathers’ or ‘skin’ individually. It is believed
that the active components of the extract of the present invention are provided on both the
skin and the feathers of the bird and may spread from one area to another (e.g. from the skin
of the bird along the feather shaft). The extract may be taken from whichever region of the
bird is most convenient to collect from.
Whilst a similar extract has been disclosed by Chamberlain in
“Avian-based Insect Repellent”, this extract was used solely as an
insect repellent. The present invention surprisingly finds that the extract disclosed in
may be used in the treatment or prevention of a microbial skin
infection such as a bacterial, fungal (including yeast), viral or parasitic skin infection.
There is therefore provided a method for treating or preventing microbial skin
infections comprising the step of: administering to a subject in need thereof a composition
comprising avian extract EP-2 in a therapeutically effective concentration together with a
pharmaceutically acceptable carrier and/or diluent.
Preferably, the avian-based EP-2 extract is obtained from birds of the order
Psittaciformes (parrots). Suitable examples of such birds include Australian native parrots,
such as the sulphur-crested cockatoo (Cacatua galerita), the galah (Cacatua roseicapilla),
and the Major Mitchell cockatoo (Cacatua leadbeateri leadbeateri). Preferably, EP-2 is
obtained from the skin and feathers of such parrots, in particular tail feathers. In a most
preferred embodiment, the EP-2 is obtained from the tail feathers of the sulphur-crested
cockatoo.
The term "extract" as used herein refers to one or more compounds, typically
in concentrated form, obtained by treating a material from which the extract is isolated with a
solvent, after which the solvent is preferably removed. The term "extract" will also be
understood to encompass one or more compounds obtained by subjecting a primary extract
to subsequent purification processes known to those skilled in the art.
The avian-based extract may be extracted from bird feathers, in particular tail
feathers, by treating the feathers with any one or more of a range of organic solvents.
Suitable examples of organic solvents include, but are not limited to: hydrocarbons (for
example butane, pentane, hexane, heptane and octane); halogenated hydrocarbons (for
example, methylene chloride, chloroform, trichloroethylene, carbon tetrachloride,
trichloroethane, or trifluormethane); ethers (for example n-hexyl ether, methyl phenyl ether,
ethyl phenyl ether and ethyl benzyl ether); ketones and aldehydes (for example acetone,
acetonyl-acetone, benzaldehyde, acetophenone); alcohols such as ethyl alcohol,
isopropanol; glycols such as diethylene glycol, ethylene glycol; and oils such as vegetable or
mineral oils. The organic solvent can then be removed by techniques well understood to
those skilled in the art, leaving a neat concentrate of EP-2.
Alternatively, EP-2 may be extracted derived from the tail feathers of a bird by
aqueous extraction, any other form of solvent extraction or physical dusting.
Preferably, the avian-based extract EP-2 is extracted into 95% organic
solvent. Solvents which may be used include Ethanol 95%, Dimethyl Sulfoxide (DMSO), or
Dimethyl Formamide (DMF). More preferably, ethanol 95% is used as the organic solvent.
The avian extract EP-2 may also be replicated in a synthetic form by
combining two or more of the components of naturally occurring EP-2. This could be in the
form of a single entity selected from the components of the avian extract, or a combination of
two or more components. Preferably, the two or more components are in a synergistic
relationship. The term “extract” will also be understood to mean any replicate formulation
composed of one of more of the components that can be isolated from the avian extract or
manufactured by chemical synthesis to resemble one of more of the compounds found in the
extract. Thus, the term “extract” can be understood to mean the Synthetic Mixture also
referred to in this patent.
For example the compounds TPP, Norpinene, Palmitic acid, Oleic acid,
Benzoic acid, Napthalene, Nonanoinc acid, derivatives of Butylphenol, esters such as
Hexadecanyl ester, phalates such as Iso- or Butyl- derivatives and Dioctadecyl phosphates
have all been isolated as part of the EP-2 extract. Formulations that comprise combinations
of one or more chemical equivalents which may be available commercially and therefore
economically of advantage to use to deliver an equivalent therapeutically effective dose are
also considered part of this invention.
The Synthetic Mixture preferably comprises the following compounds:
nicotinamide 1-10%, 2,4-ditert butyl phenol 1-10%, palmitic acid 5-40%, oleic acid 2-20%,
and/or squalene 5-30%. Alternatively, the Synthetic Mixture may comprise the following
compounds: nicotinamide at about 5.9%, 2,4-ditert butyl phenol at about 2.5%, palmitic acid
at about 19.8%, oleic acid at about 7.6%, and/or squalene at about 12.1%.
The Synthetic Mixture may optionally also include BHT-aldehyde at about
0.05-2% and/or cholestenol at about 1-10%. Alternatively, the Synthetic Mixture may
optionally comprise BHT-aldehyde at about 0.2% and/or cholestenol at about 4.0%.
The Synthetic Mixture can be dissolved in methanol as the solvent, or in
water as the solvent to generate a solution for use as an extract.
The avian extract EP-2 of the present invention may be further processed into
a powder form by, for example, air drying or freeze drying to remove moisture or the
extraction solvent. Such dried compositions may be reconstituted in a suitable carrier or
diluents for later application to the skin. Preferably, the extracted EP-2 is dried under
vacuum until less than 1% moisture remains. The extract may then be reconstituted using
an organic solvent, for example Ethanol 95%, Dimethyl Sulfoxide (DMSO) or Dimethyl
Formamide (DMF) which will aid in delivering an effective therapeutic dose. For example,
DMSO is well known to those skilled in the art to aid in the penetration of topical
therapeutics.
The composition EP-2 of the present invention may be used to treat or
prevent a wide range of microbial skin infections.
Generally, the terms “treat”, "treating" and "treatment" and derivatives used
herein have the meaning to affect a subject, tissue or cell to produce a desired
pharmacological and/or physiological effect. The treatment may be therapeutic in terms of a
partial or complete resolution of the infection or the relief from the symptoms and clinical
effects of the infection.
"Preventing" or "prevention" and derivative terms relate to the partial or
complete prevention of a skin infection or its symptoms in a subject who: has not yet been
diagnosed with a skin infection; has the skin infection on some but not all of their skin and
wishes to prevent it developing on new regions; has had a skin infection and may be in
remission and wishes to prevent re-occurrence; or has been diagnosed as being at risk of
developing a skin infection.
For example, the extract may be used in a method to treat skin infections
caused by viruses, bacteria, parasites and/or fungi as either single causative agents or as
combined causative agents in extreme skin infections.
Preferably the invention relates to the treatment using EP-2 of skin infections
caused by a virus such as: Herpes virus (Types I and II), Human papillomavirus (HPV),
poxviruses, Epstein-Barr, Herpes simplex virus, Molluscum contagiosum, Varicella viruses.
Such virus may cause infections such as herpes cold sores (oral or genital), erythrasma,
impetigo, ecthyma, folliculitis, erysipelas and cellulitis, warts (including common warts,
Palmar, plantar, filiform, flat, refractory or periungual warts, or more specialized forms such
as Bowenoid papulosis, Buschke-Löwenstein tumor, Butcher's (meat handler's) wart and
condylomata), fifth disease, shingles, measles, roseola, rubella, German measles, chicken
pox, Haemophilus influenzae type B or oral focal epithelial hyperplasia (Heck's disease).
Most preferably the skin infection to be treated with EP-2 is a type of herpes
oral cold sore (Type I) or a type of wart.
In another preferred embodiment, the extract of the present invention is used
to treat or prevent infection by a bacterium. For example, EP-2 may be used to treat an
infection by Staphylococcus aureus, other Staphylococcus spp. such as S. epidermidis,
Streptococcus spp such as S. pyogenes, Pasteurella multocida, Eikenella corrodens,
Corynebacterium minutissimum, Bacteroides species and Corynebacterium spp. These and
other bacteria are responsible for infections such as cellulitis, folliculitis, furuncles,
carbuncles, impetigo, erysipelas, and intertrigo.
Preferably, the extract of the present invention is used to treat or prevent
impetigo or cellulitis.
In yet another preferred embodiment, the avian EP-2 extract of the present
invention is used to treat or prevent a microbial skin disease caused by infection with a
fungal causative agent, including a yeast fungal agent. Such agents include the yeast
Candida albicans and fungi such as Trichophyton, Epidermophyton, Microsporum and
Malassezi spp. that cause dermatomycoses such as thrush, cutaneous candidiasis, tinea
(including but not limited to tinea versicolour; tinea cruris or jock itch; tinea capitis; tinea
corporis or ringworm; tinea pedis or Athlete’s foot ) and intertrigo.
Most preferably, the extract of the present invention is used to treat tinea,
intertrigo, cutaneous candidiasis or thrush.
In another embodiment, the microbial infection to be treated by the extract is
a parasitic infection, such as those that cause scabies, mange or pediculosis (including
pediculosis capitis).
In another embodiment, the EP-2 avian extract may be used to prevent the
development of a microbial skin infection in a subject who has not been diagnosed with a
microbial skin infection. Such subjects may, however, have been diagnosed as being at risk
or susceptible to a microbial skin infection due to some other prevailing medical condition or
event rendering them more susceptible. Alternatively, the subject may not be currently
suffering from a microbial skin infection, but may suffer from recurring bouts of such
infections and may wish to prevent the recurrence of another bout.
Preferably, the subject to be administered the composition of the present
invention is a warm blooded vertebrate, for example a human, a companion animal such as
dog or cat, domestic animal such as horse, cattle and sheep, or zoo animal such as non-
human primate, canids, bovids, felids and ungulates. Alternatively, the subject in need of
treatment may be avian. Most preferably the subject will be a human.
The present invention further provides a composition comprising a
therapeutically effective amount of avian extract EP-2 and one or more pharmaceutically
acceptable additives, excipients carriers and/or diluents. As used herein, the term
"therapeutically effective amount" means an amount of EP-2 effective to yield a desired
therapeutic response, for example to prevent or treat a microbial skin infection. The specific
therapeutically effective amount will of course vary with such factors as the particular
infection being treated, the physical condition and clinical history of the subject, the type of
animal being treated, the duration of the treatment, the nature of concurrent therapy (if any),
the specific formulations employed and the structure of the composition.
The term “pharmaceutically”, “physiologically”, or “veterinary acceptable” as
used herein refers to pharmaceutically active agents, physiologically active agents,
veterinary active agents, or inert ingredients which are suitable for use in contact with the
skin of animals, including humans, without undue toxicity, incompatibility, instability, irritation,
allergic response, and the like, commensurate with a reasonable benefit/risk ratio.
Additives, excipients carriers and diluents for use in the compositions of the
present invention include, without limitation: water, saline, ethanol, dextrose, glycerol,
glycerol and polyhydric alcohols, milk protein, vitamins, animal and vegetable oils,
polyethylene glycols, lactose, dextrose, sucrose sorbitol, mannitol and other sugars,
starches, gum acacia, calcium phosphates, alginate, tragacanth, gelatine, calcium silicate,
cellulose and its derivatives such as microcrystalline cellulose and methyl cellulose,
polyvinylpyrrolidone, water syrup, methyl and propylhydroxybenzoates, talc, magnesium
carbonate, titanium dioxide, magnesium stearate and mineral oil or combinations thereof.
The formulations can additionally include lubricating agents, dispersion
media, pH buffering agents, wetting agents, emulsifying and suspending agents, solvents,
preserving agents, sweetening agents or flavouring agents, antifoaming agents, polymers,
antioxidants, chelating agents, viscomodulators, tonicifiers, flavorants, colorants, odorants,
opacifiers, suspending agents, binders, fillers, plasticizers, lubricants, absorption-promoting
agents and mixtures thereof. Preservatives include antimicrobial, antibacterial and
antifungal agents, anti-oxidants, chelating agents and inert gases. The particular selection
of constituent that can be included in the compositions described herein will generally
depend on the type of preparation.
Suitable solvents include, without limitation, ethyl alcohol, isopropanol,
acetone, diethylene glycol, ethylene glycol, dimethyl sulfoxide, and dimethyl formamide.
Suitable humectants include, but are not limited to, acetyl arginine, algae extract, aloe
barbadensis leaf extract, 2, 3-butanediol, chitosan lauroyl glycinate, diglycereth-7 malate,
diglycerin, diglycol guanidine succinate, erythritol, fructose, glucose, glycerin, honey,
hydrolyzed wheat protein/polyethylene glycol-20 acetate copolymer,
hydroxypropyltπmonium hyaluronate, inositol, lactitol, maltitol, maltose, mannitol, mannose,
methoxy polyethylene glycol, myristamidobutyl guanidine acetate, polyglyceryl sorbitol,
potassium pyrollidone carboxylic acid (PCA) , propylene glycol, sodium pyrollidone
carboxylic acid.
The EP-2 composition of the present invention can further contain one or
more additives, provided that they do not detrimentally affect the therapeutic effect afforded
by the avian-based extract. In one embodiment, the additive is a colourant. In alternative
embodiments, the additive is a preservative such as a mould inhibitor or an anti-oxidant, a
fragrance, or a stabiliser. In another embodiment the additive is a surfactant or an
absorption-promoting agent such as dimethyl sulphoxide (DMSO).The additional additives
may also be agents that render the composition an emulsion, a micro-emulsion or a nano-
emulsion.
Additionally, the compositions may include surfactants or emulsifiers.
Examples of surfactants include ethoxylated fatty acid glycerides, esters of fatty acids with
polyols such as, for example, pentaerythritol or trimethylpropane, fatty alcohol ethoxylates or
alkyl oligoglucosides, and electrolytes, such as sodium chloride and ammonium chloride.
Examples of suitable emulsifiers include, but are not limited to, stearic acid, cetyl alcohol,
PEG-100, stearate and glyceryl stearate, cetearyl glucoside, polysorbate 20,
methylcellulose, sodium carboxymethylcellulose, glycerin, bentonite, ceteareth-20, cetyl
alcohol, cetearyl alcohol, lanolin alcohol, riconyl alcohol, self-emulsifying wax (e.g., Lipowax
P), cetyl palmitate, stearyl alcohol, lecithin, hydrogenated lecithin, steareth-2, steareth-20,
and polyglyceryl-2 stearate. Such surfactants and/or emulsifiers may be used for the
formation of emulsions. Either a water-in-oil or oil-in-water emulsion may be formulated.
In the preferred embodiments, the composition is formulated to enable ready
location and retention of the active ingredient(s) of the EP-2 extract in the area required to
deliver the therapeutic effect while at the same time not significantly interfering with the
efficacy of the EP-2 extract. It will be understood, therefore, that the therapeutically effective
composition may be formulated differently based on the area of treatment and how the
composition is to be applied.
There are a range of reference sources for the development of cosmetic and
pharmaceutical compositions which may be referred to by the skilled person when
developing formulations comprising EP-2, such as “A Formulary of Cosmetic Preparations;
Volume 1 - Decorative Cosmetics”, Hunting L.L. (2003); “A Formulary of Cosmetic
Preparations; Volume 2 - Creams, Lotions and Milks”, Hunting L.L. (2004) and “Remington's
Pharmaceutical Sciences”, 21st Edition (2009), Mack Publishing Company, Easton,
Pennsylvania, USA, all the contents of which are incorporated herein. Other suitable
guidebooks include Cosmetics and Toiletries Magazine, Vol. 111 (March, 1996); Formulary:
Ideas for Personal Care; Croda, Inc, Parsippany, N.J. (1993); and Cosmeticon: Cosmetic
Formulary, BASF, which are hereby incorporated in their entirety by reference.
An avian extract EP-2 containing composition may be administered using
standard procedures, for example: topically, parenterally, intraorbitally, ophthalmically,
intraventricularly, intracranially, intracapsularly, intraspinally, intracisternally,
intraperitoneally, buccally, rectally, vaginally, intranasally, orally or by aerosol administration
and/or inhalation spray or via an implanted reservoir.
In a preferred embodiment the extract is applied topically for the treatment of
a microbial skin infection. The topical application may be in the form of directly laying or
spreading the composition comprising the extract on the area of the proliferative skin
disorder (or at least near or adjacent the proliferative skin disorder) using an applicator, such
as a brush or a sponge, by spraying the composition directly onto the area, or by rubbing the
composition onto the area. Alternatively, the EP-2 may be topically applied to an area of
skin which does not yet suffer from a microbial skin infection.
Pharmaceutically acceptable carriers, adjuvants and vehicles that may be
used in topical compositions may include: ion exchangers; alumina; aluminium stearate;
lecithin; self-emulsifying drug delivery systems such as alpha-tocopherol polyethylene glycol
1000 succinate, or other similar polymeric delivery matrices or systems such as
nanoparticles; serum proteins such as human serum albumin; buffer substances such as
phosphates; glycine; sorbic acid; potassium sorbate; partial glyceride mixtures of saturated
vegetable fatty acids; water; salts or electrolytes, such as protamine sulfate, disodium
hydrogen phosphate, potassium hydrogen phosphate, sodium chloride, zinc salts; colloidal
silica; magnesium trisilicate; polyvinyl pyrrolidone; cellulose-based substances; polyethylene
glycol; sodium carboxymethylcellulose; polyacrylates; polyethylene-polyoxypropylene-block
polymers; and wool fat.
The topical compositions may also be formulated with liquid or solid
emollients, solvents, thickeners, or humectants. Emollients include, but are not limited to,
stearyl alcohol, mink oil, cetyl alcohol, oleyl alcohol, isopropyl laurate, polyethylene glycol,
olive oil, petroleum jelly, palmitic acid, oleic acid, and myristyl myrstate. Emollients may also
include natural butters extracted from various plants, trees, roots, or seeds. Examples of
such butters include, but are not limited to, shea butter, cocoa butter, avocado butter, aloe
butter, coffee butter, mango butter, or combinations thereof. Suitable thickeners include, but
are not limited to, polysaccharides, in particular xantham gum, guar-guar, agar-agar,
alginates, carboxymethylcellulose, relatively high molecular weight polyethylene glycol
mono- and diesters of fatty acids, polyacrylates, polyvinyl alcohol and polyvinylpyrrolidone.
The composition may further comprise one or more penetrants, compounds facilitating
penetration of active ingredients into the skin of a patient. Non-limiting examples of suitable
penetrants include isopropanol, polyoxyethylene ethers, terpenes, cis-fatty acids (oleic acid,
palmitoleic acid), acetone, laurocapram dimethyl sulfoxide, 2-pyrrolidone, oleyl alcohol,
glyceryl stearate, cholesterol, myristic acid isopropyl ester, and propylene glycol .
Compositions of the present invention may further comprise vitamins, anti-
inflammatory agents, non-steroidal cosmetic soothing agents, skin lightening agents, anti-
wrinkle agents, anti-itching agents, antioxidants, fragrances, conditioners, and other agents
or any combination thereof. Those skilled in the art will readily appreciate that substances
other than those listed may also be employed. Examples of useful vitamins include, but are
not limited to, vitamin A, vitamin B, biotin, vitamin C, pantothenic acid, vitamin K, vitamin D,
vitamin E and mixtures thereof.
More specifically and by way of example, a suitable vehicle for topical
administration of EP-2 to the skin surface might include DMSO (dimethyl sulfoxide), ethanol,
acetone, phosphatidyl choline and isopropanol gels. Additional additives may include a
synergistic additive such as vitamin E to nutrify the skin, lanolin or aloe vera to soothe the
skin, etc. Other suitable additives would be known to those skilled in the art of
pharmaceutical or cosmetic formulation.
The composition may be adapted for topical application and may be in a form
selected from the group comprising cosmetically acceptable liquids, creams, oils, lotions,
ointments, gels, roll-on liquids, skin patches, sprays, glass bead dressings, synthetic
polymer dressings impregnated with basic milk factors, solids, conventional cosmetic night
creams, foundation creams, suntan lotions, hand lotions, make-up, make-up bases and
masks. Except insofar as any conventional medium or agent is incompatible with the active
ingredient, use thereof in the cosmetic compositions of the present invention is
contemplated. Compositions of the present invention adapted for topical delivery will
desirably possess bioadhesive or mucoadhesive properties.
In another example, if the composition is used as a skin moisturiser it may
preferably be of an ointment consistency. If the composition is used as a lip balm, the
viscosity of the composition may preferably be increased to make a firmer product. The
changes in viscosity of the composition may be achieved, for example, by adjusting the
amount of beeswax. This and other methods will be familiar to those skilled in the art and
further methods are described by Hunting, (2003); (2004) and Remington, (2009).
If the formulation is to be delivered as a spray or aerosol, the composition
may also include a propellant. Preferably, hydrofluoroalkanes (HFA) such as either HFA
134a (1,1,1,2,- tetrafluoroethane) or HFA 227 (1,1,1,2,3,3,3- heptafluoropropane) or
combinations of the two, may be used since they are widely used in medical applications .
Other suitable propellants include, but are not limited to, mixtures of volatile hydrocarbons,
typically propane, n- butane and isobutane, dimethyl ether (DME), methylethyl ether, nitrous
oxide, and carbon dioxide.
If the formulation is to be delivered topically, a range of different formulations
may be developed to provide the avian extract EP-2 to the skin. For example, the EP-2 may
be delivered as: a spray with ethanol or propylene glycol; a lotion with cetomacrogol lotion,
aminobenzoic acid lotion or alcohol; a gel with poloxamer gel 8E, poloxamer gel 8C,
chlorhexidine gel or Lutrol® F127; an ointment with liquid paraffin or white soft paraffin; or a
buffered cream with emulsifying ointment, glycerol, cetomacrogol emulsifying wax 15 or
propylene glycol.
Alternative formulations include gels, liquids, liquid solvents, dips, pastes,
sprays, aerosols, and other solid formulations such as, for example, a wax-based solid.
Other compositions can be formulated by those of ordinary skill in the art.
For example, the EP-2 extract may be formulated into:
a spray for the treatment of microbial skin infections, comprising EP-2 extract qs
together with 75% ethanol 95%, 5% propylene glycol and water to 100%; formulated
in a fashion that will be familiar to those skilled in the art or as described in
Remington, 2009. The pH and exact concentration of the various components of the
composition are adjusted according to routine skills in the art.
a lotion for the treatment of microbial skin infections, comprising EP-2 extract
together with any one of the following: cetomacrogol lotion, aminobenzoic acid lotion
or alcohol such as Lotion BPC containing EP-2 extract qs, 20% Glycerol, 60%
Alcohol 95%, distilled water to 100%, with or without cetomacrogol emulsifying wax,
aminobenzoic acid and/or liquid paraffin, formulated in a fashion that will be familiar
to those skilled in the art or as described in Hunting, 2004 and Remington, 2009.
The pH and exact concentration of the various components of the composition are
adjusted according to routine skills in the art.
a gel for the treatment of microbial skin infections, comprising EP-2 qs together with
any one of the following: poloxamer gel 8E, poloxamer gel 8C, chlorhexidine gel or
Lutrol F127; formulated in a fashion that will be familiar to those skilled in the art or
as described in Hunting, 2003; 2004 and Remington, 2009. The pH and exact
concentration of the various components of the composition are adjusted according
to routine skills in the art.
an ointment for the treatment of microbial skin infections, comprising EP-2 qs, 30%
emulsifying wax and 50% liquid paraffin or white soft paraffin formulated in a fashion
that will be familiar to those skilled in the art or as described in Remington, 2009.
The pH and exact concentration of the various components of the composition are
adjusted according to routine skills in the art.
an Aqueous Cream APF for the treatment of microbial skin infections, comprising EP-
2 qs, 30% emulsifying ointment, 5% Glycerol, 1% Phenoxyethanol, 5% Vitamin E,
and water to 100%, formulated in a fashion that will be familiar to those skilled in the
art or as described in Hunting, 2004 and Remington, 2009. The pH and exact
concentration of the various components of the composition are adjusted according
to routine skills in the art.
Alternative carrier vehicles comprise gels, liquids, liquid solvents, dips,
pastes, sprays, aerosols, and other solid formulations such as, for example, a wax-based
solid. Other carrier vehicles can be formulated by those of ordinary skill in the art.
In another preferred embodiment, the composition is adapted for personal
care topical applications for the treatment or prevention of microbial skin infections. For
example, the composition may be used by subjects who have a microbial skin infection and
wish to treat it or who do not have a microbial skin infection but wish to prevent the
occurrence of such an infection. The composition may also be used by subjects who have
mild skin infections and wish to treat the infection prior to diagnosis. Such subjects may find
relief from a therapeutically effective amount of EP-2 extract delivered in any one of
commonly used cosmetic or toiletry formulations which will be available to those skilled in
the art. In particular, for subjects wishing to treat a microbial skin infection, the EP-2 is
formulated into a composition adapted for cosmetic skin care, such as sun burn cream, gels
lotion, makeup preparations, lotions, creams, sticks, roll-ons formulations, mousses, aerosol
sprays, pad-applied formulations, and film-forming formulations as described by Hunting,
2003; 2004. In a preferred form, the amount of EP-2 extract will be lesser than a prescriptive
therapeutic does (for example between 1% and 50% volume/volume of the formulation).
The precise concentration may be devised to suit the particular nature and extent of the
infection and the causative agent.
In another embodiment, the extract is delivered parenterally, preferably by
injection, for example subcutaneously or intramuscularly. However, delivery may also be
intra-arterially, intraperitoneally, intracavital, or intranasally for the treatment of a microbial
skin infection.
Pharmaceutically acceptable carriers, adjuvants and vehicles that may be
used in injection compositions and may include but are not limited to: ion exchangers;
alumina; aluminium stearate; lecithin; self-emulsifying drug delivery systems (SEDDS) such
as alpha-tocopherol polyethyleneglycol 1000 succinate, or other similar polymeric delivery
matrices or systems such as nanoparticles; serum proteins such as human serum albumin;
buffer substances such as phosphates; glycine; sorbic acid; potassium sorbate; partial
glyceride mixtures of saturated vegetable fatty acids; water; salts or electrolytes, such as
protamine sulfate, disodium hydrogen phosphate, potassium hydrogen phosphate, sodium
chloride, zinc salts; colloidal silica; magnesium trisilicate; polyvinyl pyrrolidone; cellulose-
based substances.
The formulation may be in the form of a sterile injectable preparation, for
example, as a sterile injectable suspension for the treatment of proliferative skin conditions,
including pre-cancers and skin cancer. This suspension may be formulated according to
techniques known in the art using suitable dispersing agents, surfactants, and suspending
agents (e.g. Tween 80). The sterile injectable preparation may also be a sterile injectable
solution or suspension in a non-toxic parenterally-acceptable diluent or solvent (e.g. 1, 2-
propanediol). Acceptable vehicles and solvents may include mannitol, water, Ringers
solution and isotonic sodium chloride solution with buffer. Furthermore, sterile, fixed oils
may be employed as a solvent or a suspending medium. For this purpose, any bland fixed
oil may be employed including mono- or diglycerides. Fatty acids, such as oleic acid and its
glyceride derivatives, and natural pharmaceutically acceptable oils, such as polyoxyethylated
olive oil or castor oil, may also be used in the preparation of injectables.
Preferably, the avian extract EP-2 comprises about 0.0001% to 10% by
weight of the composition administered to the subject having a microbial skin infection.
However, the exact amount of EP-2 in the composition will of course, depend on the route of
delivery, the nature of the infection, the therapeutically effective amount of EP-2 required
and the general nature and health of the subject to whom the composition is delivered. In
some cases, the amount of EP-2 in a composition may be 11-50%, or may be more than
50%, for example up to 60%, 70%, 80%, 90% or 95% of the composition. It is contemplated
that in some instances the composition will comprise 100% EP-2, i.e. the avian extract will
be administered directly to the subject as a neat extract.
Examples of suitable formulations include: a formulation comprising 50%
volume 95% ethanol and 25% EP-2 and a combination of other ingredients to soothe the
skin, emolliate the skin or 25% qs for topical application to the site of the microbial skin
infection; or a formulation comprising 25% volume DMSO and 75% EP-2 for topical
application to the site of the microbial skin infection.
Preferably the concentration of the avian extract EP-2 will be of sufficient
strength (qs) to provide a therapeutically effective dose to the target cells.
Preferably, the compositions of the present invention, comprising EP-2, are
adapted to be delivered to the subject in need once daily or less often. For example, if the
composition is adapted for topical delivery, the composition is preferably administered to the
skin once a day. However, it is contemplated that the topical composition can be
administered more frequently than this (for example, two or three times a day). Alternatively,
if the composition comprising EP-2 is in the form of an injectable formulation, it is preferable
that the composition be adapted for delivery once a week, or once a month.
A person with skill in the art will also know how to select a treatment regimen
for a specific condition. For example, the avian extract EP-2 may be applied once daily in
topical form, or may be applied more frequently (for example, 2, 3 or 4 times daily).
Alternatively, if the composition comprising EP-2 is in the form of an injectable formulation, it
is preferable that the composition be adapted for delivery once a week, or once a month. It
is foreseeable that the composition is administered over a period of time. The composition
may be applied for a day, multiple days, a week, multiple weeks, a month, or even multiple
months in severe circumstances.
The invention of the present application also provides for the use of avian
extract EP-2 in a therapeutically effective concentration together with a pharmaceutically
acceptable carrier and/or diluent in the manufacture of composition for the treatment or
prevention of microbial skin infections. Preferably, the avian extract EP-2 is isolated from tail
feathers of a sulphur-crested cockatoo (Cacatua galerita). Alternatively, the avian extract
EP-2 may be is a synthetic mixture comprising: nicotinamide 1-10%, 2,4-ditert butyl phenol
1-10%, palmitic acid 5-40%, oleic acid 2-20%, and/or squalene 5-30%.
The present invention further provides a kit comprising a composition
comprising EP-2 and instructions regarding the administration of the composition for the
treatment or prevention of a microbial skin infection. More preferably, the kit comprises a
composition comprising EP-2 formulated for topical delivery and instructions regarding the
topical application of the composition for the treatment of a microbial skin infection chosen
from the list comprising: viral, bacterial, fungal or parasitic skin infections. Most preferably,
the kit comprises a composition comprising EP-2 formulated for topical delivery and
instructions regarding the topical application of the composition for the treatment of a
microbial skin infection chosen from the list comprising: herpes oral cold sore (Type I), a type
of wart, impetigo, cellulitis, tinea, thrush or intertrigo.
There is also provided a kit comprising a composition comprising EP-2
formulated for parenteral delivery and instructions regarding the parenteral delivery of the
composition for the treatment of a microbial skin infection. More preferably, the kit
comprises a composition comprising EP-2 formulated for parenteral delivery and instructions
regarding the parenteral delivery of the composition for the treatment of a microbial skin
infection chosen from the list comprising: viral, bacterial, fungal or parasitic skin infections.
Most preferably, the kit comprises a composition comprising EP-2 formulated for parenteral
delivery and instructions regarding the parenteral delivery of the composition for the
treatment of a microbial skin infection chosen from the list comprising: herpes oral cold sore
(Type I), a type of wart, impetigo, cellulitis, tinea, thrush or intertrigo.
The kits of the present invention may comprise avian extract EP-2 isolated
from tail feathers of a sulphur-crested cockatoo (Cacatua galerita) or alternatively avian
extract EP-2 that is a synthetic mixture comprising: nicotinamide 1-10%, 2,4-ditert butyl
phenol 1-10%, palmitic acid 5-40%, oleic acid 2-20%, and/or squalene 5-30%.
Examples
The following examples are provided to further illustrate several embodiments
of the invention.
Example 1
The effect of a synthetic representative chemical derived from the avian
extract EP-2 (Triphenyl phosphate, TPP) was tested in vitro on Staphyloccus aureus and
Escherichia coli cells as representative organisms capable of causing skin infection. TPP
was investigated on the basis of the findings in Zurhaar WO2008/019452 “Insect Repellent”
that the insect repellent factor in an avian extract was TPP.
A composition comprising 5% TPP, 20% pine oil, 50% raw linseed oil and
% Recosol 150 in a 15% ethanol 95% carrier (w/w), was gently combined with an
aqueous cream base containing vitamin E at 10% (w/w). The sample was then diluted in
Tryptone Soya Broth (TSB), a broth that promotes the growth of microorganisms. Dilution
concentrations of 01%, 0.2%, 0.4%, 0.8%, 1.6%, 3.1%, 6.3%, 12.5%, 25% and 50% product
in TSB were tested. Dilutions were then inoculated with approximately 1 x 10 colony
forming units/ml and incubated for 48 hours at 37 C.
The TPP containing composition was found to completely inhibit the growth of
S. aureus and E. coli. Growth of S aureus was inhibited by 50% composition in TSB (2.5%
EP-2) whilst E. coli was inhibited by 3% composition (0.15% EP-2).
Example 2
30% (w/w) of an EP-2 extract (extracted using ethanol) was combined in a
base of natural oils in the approximate proportions of 50% (w/w) raw linseed oil and 20%
(w/w) pine oil to make a lotion.
The lotion was administered to a 15 year old boy with a history of developing
common warts which previous treatments available from pharmacy outlets had been
unsuccessful in treating. During previous treatments, the extent of an individual wart was
sometimes diminished but returned once the treatment was stopped. In other cases the
individual warts were effectively unchanged by the treatment.
Treatment with the EP-2 lotion twice per day completely resolved the
common warts within a seven day period and no return of the warts has occurred for at least
4 months.
Example 3
Avian extract EP-2 has also been applied to Herpes I Type infections of lips
representing as ‘cold sores’ in a patient with a history of cold sores, brought on by known
stress triggers. Previously, over-the-counter medications containing 5% (w/w) acyclovir were
used when cold sores had formed, or when an initial stage of their formation was detected
(for example as a tingling sensation of the skin). When such OTC medication was applied
topically, up to five times a day, the duration of the episode may well have been reduced as
a result, but the patient still suffered unsightly and painful cold sores for several days.
In the present case, the lotion of Example 2 application was applied up to
three times daily to an existing cold sore. Within a period of two days the cold sore blisters
had resolved and were observed to slough off as a dried skin leaving behind a mild pink
region. The pink region faded and disappeared within a five day period from the initial
application.
Numerous variations and modifications will suggest themselves to persons
skilled in the relevant art, in addition to those already described, without departing from the
basic inventive concepts. All such variations and modifications are to be considered within
the scope of the present invention, the nature of which is to be determined from the
foregoing description.
Claims (16)
1. Use of a composition comprising avian extract EP-2 in a therapeutically effective concentration together with a pharmaceutically acceptable carrier and/or diluent for the preparation of a medicament for treating or preventing microbial skin infections; wherein avian extract EP-2 is obtained by treating the feathers of a native Australian parrot (order Psittaciformes) with an organic solvent.
2. The use according to claim 1, wherein the parrot is selected from a group comprising sulphur-crested cockatoo (Cacatua galerita), the galah (Cacatua roseicapilla), the Major Mitchell cockatoo (Cacatua leadbeateri leadbeateri).
3. The use according to claim 1 or 2, wherein the extract is isolated from tail feathers.
4. The use according to claim 1 wherein the avian extract EP-2 is isolated from the tail feathers of a sulphur-crested cockatoo (Cacatua galerita).
5. The use according to claim 1, wherein the composition is selected from a group comprising: gels, liquids, dips, pastes, sprays, aerosols, and solid formulations.
6. The use according to claim 1 wherein the composition comprises about 5 volume% to about 75 volume% of avian extract EP-2 and about 95 volume% to about 25 volume% of a carrier and/or diluent.
7. The use of claim 1 wherein the microbial skin infection is caused by a microbe selected from the following: virus, bacteria, parasite or fungi.
8. The use of claim 1 wherein the microbial skin infection to be treated is selected from the following: herpes oral cold sore (Type I), a type of wart, impetigo, cellulitis, tinea, intertrigo, scabies, mange, pediculosis (including pediculosis capitis) cutaneous candidiasis or thrush.
9. Use of a composition comprising synthetic avian extract EP-2 in the form of a mixture comprising two or more of the following compounds: nicotinamide 1-10%, 2,4-ditert butyl phenol 1-10%, palmitic acid 5-40%, oleic acid 2-20%, and squalene 5-30% in a therapeutically effective concentration together with a pharmaceutically acceptable carrier and/or diluent in the manufacture of composition for the treatment or prevention of microbial skin infections.
10. The use of claim 9 wherein the synthetic avian extract EP-2 is a synthetic mixture comprising: nicotinamide 1-10%, 2,4-ditert butyl phenol 1-10%, palmitic acid 5-40%, oleic acid 2-20% and squalene 5-30%.
11. The use of claim 9 or 10 wherein the synthetic avian extract EP-2 comprises: nicotinamide at about 5.9%, 2,4-ditert butyl phenol at about 2.5%, palmitic acid at about 19.8%, oleic acid at about 7.6%, and squalene at about 12.1%.
12. The use of any one of claims 9 to 11 wherein the synthetic avian extract EP-2 further comprises: BHT-aldehyde at 0.05-2% and/or cholestenol at 1-10%.
13. The use according to claim 9 wherein the composition is selected from a group comprising: gels, liquids, dips, pastes, sprays, aerosols, and solid formulations.
14. The use according to claim 9 wherein the composition comprises about 5 volume% to about 75 volume% of the avian extract EP-2 and about 95 volume% to about 25 volume% of the carrier and/or diluent.
15. The use according to claim 9 wherein the microbial skin infection is caused by a microbe selected from the following: virus, bacteria, parasite or fungi.
16. The use according to claim 9 wherein the microbial skin infection to be treated is selected from the following: herpes oral cold sore (Type I), a type of wart, impetigo, cellulitis, tinea, intertrigo, scabies, mange, pediculosis (including pediculosis capitis) cutaneous candidiasis or thrush.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2011901619A AU2011901619A0 (en) | 2011-05-02 | Avian-Based Treatment for Microbial Infection | |
AU2011901619 | 2011-05-02 | ||
PCT/AU2012/000459 WO2012149600A1 (en) | 2011-05-02 | 2012-05-02 | Avian-based treatment for microbial infections |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ617164A NZ617164A (en) | 2015-06-26 |
NZ617164B2 true NZ617164B2 (en) | 2015-09-29 |
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