AU2007200216A1 - Skin formulation usable as a therapeutic application for the treatment of general skin disorders and a method of preparation thereof - Google Patents

Description

19/01 2007 16:14 FAX COLLISON CO IP AUST CANBERRA a012/078 56945 JOM:FKD SP/00/011 Regulation 3.2

AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION SFOR A STANDARD PATENT 0 0

ORIGINAL

0 Name of Applicant: BELINDA RILEY Actual Inventor: BELINDA RILEY Address for Service: COLLISON CO.,117 King William Street, Adelaide, S.A. 5000 Invention Title: SKIN FORMULATION USABLE AS A THERAPEUTIC APPLICATION FOR THE TREATMENT OF GENERAL SKIN DISORDERS AND A METHOD OF PREPARATION THEREOF Details of Associated Provisional Application(s): Australian Patent Application No. 2006900256 Dated 19 January 2006 The following statement is a full description of this Invention, including the best method of performing it known to us: COMS ID No: SBMI-05987235 Received by IP Australia: Time 17:02 Date 2007-01-19 19/01 2007 16:14 FAX COLLISON CO IP AUST CANBERRA lI013/078 8 2 This invention relates to a composition for topical applications for treatment of Oskin disorders and skin diseases, notably eczema. In particular this invention relates to a natural formulation useful as a therapeutic treatment of general skin disorders such as eczema.

It is well known that the human skin is biologically created to act as a barrier between the body and the external environment so as to maintain a controlled dynamic equilibrium of body functions. Body functions, genetics and also Sstresses imposed by the environment can act degeneratively against the skin making the skin susceptible to various disorders and diseases, as the skin's micro organisms become exposed to radiation, contact with irritating material or destabilized through the loss of water.

Reoccurring rashes, moderate to severe itching of the skin, skin weeping, leathery skin, red, rough and patchy skin are all common symptoms of skin disorders. A majority of these commonly occurring skin disorders and diseases, such as eczema, are the result of inflammation of the skin which is producing a dryness, flakiness, heating and itch sensation of the sufferer.

As the skin disorder is associated with inflammation, it is well known to treat such conditions with pharmaceutical creams that possess anti inflammatory, anti allergic and wound healing properties.

Nonetheless, pharmaceutical creams, normally relate to oily and water emulsions of various viscosity including as the active ingredient synthetically derived active ingredients such as cortisone and the like.

It is recognised that prolonged contact with the skin of synthetic active ingredients that produce the anti inflammatory effect provided for in pharmaceutical creams, can in itself lead to further skin complications, or at the COMS ID No: SBMI-05987235 Received by IP Australia: Time 17:02 Date 2007-01-19 18/01 2007 18:14 FAX COLLISON CO IP AUST CANBERRA I014/078 0 0 3 F1 very least reduce the effectiveness of such skin care, the more such application is applied.

Furthermore, such pharmaceutical creams and their related active ingredient s0 are more commonly applied to treat the symptoms rather than the specific C 5 cause of the skin disorder or disease.

0 t It is well recognised that primary prescription treatment of eczema contains Stopical corticosteroids which may have adverse effects on the skin which are

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both severe and irreversible. Adverse side effects of topical steroids can include thinning of the skin which can lead to decrease connective tissue synthesis, resulting in the weakened blood cell vessels due to the diminished connective tissue support, bone loss and increased possibility of further infection as the skin deteriorates under such treatment.

It is well known that topical steroids have a wide variety of side effects, not the least skin atrophy which makes the skin lax, wrinkled and shiny. Further, repeated use of topical steroids can also produce stretch marks on the skin, particularly in body locations such as the groin and armpits, Still even further, as topical steroids have the ability to alter the immune system functions, they can also consequently inhibit the skins functionality to fight off bacteria or other fungal infections.

Still even further, topical steroid compositions, produce an allergic reaction in certain people.

Again, still even further, there is evidence that suggests that long term use of topical steroids, around the eyes may be damaging to the optic nerve is enough such steroid is absorbed into the eye.

COMS ID No: SBMI-05987235 Received by IP Australia: Time 17:02 Date 2007-01-19 19/01 2007 16:15 FAX COLLISON CO IP AUST CANBERRA l015/078 0 O 4 0 Therefore, in the relevant field of the treatment of skin disorders, notably eczema, there is still the requirement to provide a suitable natural formulation Ouseful as a therapeutic treatment for general skin disorders, that does not rely on the active ingredients contained in well known pharmaceutical creams that overcomes the difficulties and drawbacks referred to above with respect to skin S disorders.

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~It is therefore an object of this invention to provide a natural cream emulsion 0 o which is adapted to be applied to the human skin, to ameliorate at least one skin disorder, notably eczema.

Further objects and advantages of the invention will become apparent from a complete reading of this specification.

Accordingly, in one form of the invention, there is provided a leave on cream emulsion, adapted to be applied to the human skin and to be left on said skin for a time sufficient to moisture said skin and for said skin to substantially completely absorb or at least an active ingredient in said cream emulsion, wherein said cream emulsion includes as the active ingredient coconut oil.

Advantageously, such a cream emulsion containing natural coconut oil provides a topical skin preparation that is effective in the substantial therapy for the treatment of skin disorders notably eczema and dermatitis and other related skin ailments.

Advantageously, the plant oil of coconut provides for a natural anti biotic which is adapted to relieve symptoms of infection, fungal and bacterial associated with skin disorders such as eczema and dermatitis.

Advantageously, the coconut oil contains the active ingredient within the cream emulsion adapted to protect the skin from bacterial, protozoal and viral infection.

COMS ID No: SBMI-05987235 Received by IP Australia: Time 17:02 Date 2007-01-19 19/01 2007 16:15 FAX COLLISOH CO 1 IP AUST CANBERRA j016/078 Advantageously, as coconut oil is made up predominantly of lauric acid, which is prominent in the saturated fat of human breast milk, provides for immune ON building properties, which are required during growth development, particularly at an early age.

\0 ci 5 Still further, advantageously the cream emulsion provided for in this invention Shas an active ingredient that is naturally derived, and as the coconut oil itself is characterized by containing its own natural antibiotics which can relieve the o symptoms of skin disorders such as eczema and dermatitis, there is no requirement for artificially created or synthetic antibiotics and cortisone preparations, that are included into pharmaceutical creams for the treatment of allergy proned skin.

In preference, the natural cream emulsion of the invention further includes plant extracts providing at least one oil selected from sweet orange oil, jasmine oil or benzoin tincture.

An advantage of such an arrangement is that the further addition to the natural cream emulsion of additional plant extracts such as sweet orange oil, jasmine oil and benzoin tincture provide for synergy of the ingredients within the cream emulsion that enhance the effectiveness of the cream emulsion towards the correction of the skin disorders and diseases such as eczema and dermatitis.

Advantageously, as these additional ingredients of sweet orange oil, jasmine oil and benzoin tincture are derived from natural plant extracts, rather than pharmaceutical prescription treatment of the disorder, means that there will be no adverse effects which are characterized by prolonged treatment of these pharmaceutical creams.

In preference, the cream emulsion further includes at least one moisturizing or humectant component, preferably glycerine.

COMS ID No: SBMI-05987235 Received by IP Australia: Time 17:02 Date 2007-01-19 19/01 2007 16:15 FAX COLLISO CO 1 IP AUST CANBERRA E017/078 o 6 F1 Advantageously, the inclusion of a natural moisturizer into the cream emulsion t such as glycerine, minimizes skin dehydration and reverses the effects thereof Soften developed during the skins exposure to the environment, particularly in extreme summer seasons, because of migration of water from innermost layers 5 and subsequent evaporation from outer skin surface in low and humid S environments.

Advantageously, the inclusion of the moisturizer in combination with the other Saforelisted ingredients included in the cream emulsion maintains the integrity of the skin by balancing water content in the skin layers which then promotes healing of fissures and the like that develop during skin dehydration.

In preference, the cream emulsion includes the proper selection of stabilizers, binders and/or surfactants if required to maintain a stable oil in water emulsion that is adapted to prolonged contact with the skin, with such cream being applied to the skin without the need to wipe it off in any way after application.

Preferably, the selected binders, stabilizers and/or surfactants would include at least one of stearic acid, cetyl stearyl alcohol or borax.

In preference, the cream emulsion includes a balance of water to provide for an adjusted pH that is non reactive with the skin surface.

Advantageously, not only can this cream emulsion be used as a therapeutic treatment for general skin disorders, as it includes moisturizes, humectants and other natural antibiotic ingredients such as coconut oil, sweet orange oil and jasmine oil, such moisturizing effects on the skin imparted by such ingredients makes the cream applicable for dry skin disorders in cosmetic therapy. As the ingredients have anti fungal activity they are applicable therefore for use against fungal infections on the skin as well.

COMS ID No: SBMI-05987235 Received by IP Australia: Time 17:02 Date 2007-01-19 19/01 2007 113:15 FAX COLLISON CO IP AUST CANBERRA j018/078 0 7 ci SAs the person skilled in the art will appreciate, the cream emulsion will preferably include recognized adjuvants including various excipients known in Othe art such as stabilizers, viscosity agents, preservatives of which their specific quantities and the like are not critical to the composition in so far as the NO 5 ingredients per se are not responsible for the actioning against the identified C skin disorder.

In preference, the cream emulsion also includes environmentally acceptable Samounts of preservatives. Preferably the preservatives include ionisable salts, Sorganic compound and/or mixtures thereoflO Preferably, the preservative can also include organic compounds, for example ethanol present within the final formulations, and amounts that are non reactive to the surface skin condition.

In preference, the cream emulsion further includes the active ingredient coconut oil in a range of 15 to 35% by weight of said cream emulsion.

Preferably, the coconut oil comprises up to 25% weight of said cream emulsion.

In a further form of the invention there is provided a leave on cream emulsion, adapted to be applied to the human skin to be left on said skin for a time sufficient to moisture said skin and for said skin to substantially absorb at least an active ingredient in said emulsion that includes the active ingredient comprising about 15 to 30% weight per cent of coconut oil suspension, wherein the amount of said active ingredient is sufficient to retain moisture in said skin and is sufficient to ameliorate at least the skin disorder of eczema.

In a further form of the invention there is a method for the preparation of a leave on cream emulsion that is adapted to ameliorate at least one skin disorder condition in a human and is adapted to moisture said skin comprising preparing COMS ID No: SBMI-05987235 Received by IP Australia: Time 17:02 Date (YCI-M-d) 2007-01-19 19/01 2007 16'.16 FAX COLLISON CO IP AUST CANBERRA 12019/078 r- S8 F1 an oil in water emulsion with at least one non ionic emulsifier and adding about c- 15-30% weight percentage of coconut oil to said emulsion.

Preferably, said method for the preparation of the natural cream emulsion IsO referred to above wherein at least one of non toxic emulsifier is selected from a C- 5 group of sorbitan esters, ethoxilated alcohols, or fatty acids, and mono-and-di- 0 Sglycerides.

In a further form of the invention there is a method of ameliorating at least one Sskin disorder condition such as eczema or dermatitis that includes, applying a natural cream emulsion, comprising about 15-30 weight per cent of a suspension of active ingredient of coconut oil, to skin suffering from said disorder, and leaving said cream emulsion on said skin until at least substantially all of the coconut oil has been absorbed by the skin and said disorder has been ameliorated through such application.

Preferably, the application of the cream emulsion to the skin are administered 3 to 5 times per day.

The following example illustrates various aspects of the present invention, however the listed formulation of the preferred cream emulsion of this invention is not to be construed to limit the broader aspect of this invention in any manner whatsoever.

Example 1 A preferred formulation for the leave on cream emulsion of this invention, adapted to be applied to human skin and to be left on said skin for sufficient time to moisturize said skin and for said skin to substantially absorb the active ingredient in said emulsion, where said emulsion includes the active ingredient of coconut oil, would be preferably the following: COMS ID No: SBMI-05987235 Received by IP Australia: Time 17:02 Date 2007-01-19 19/01 2007 16:16 FAX COLLISON CO IP AUST CANBERRA a020/078 S9 0 Formulation and Method of preparing thereof ct O> The "oil phase" includes all oil-soluble ingredients D The "water phase" includes all the water-soluble ingredients O "Third Phase" consists of all the ingredients you want to add after the Ci 5 emulsion has cooled to 50 degrees C or less.

0 0 Heat both water and oil phases separately and they must be at least 65-70 degrees C. After combining the oil and water phase, blend till the emulsion has cooled to 50 degrees C.

Add preservatives.

o1 Phase One (oil phase) 8.64% Stearic acid 8.64% Cetyl Stearyl Acid 23.75% Coconut Oil Phase Two (Water phase) 45.45% Water 1.08% Borax Phase Three 10.80% Glycerine 1.70% Benzoin Tincture COMS ID No: SBMI-05987235 Received by IP Australia: Time 17:02 Date 2007-01-19 19/01 2007 16:16 FAX COLLISON CO IP AUST CANBERRA i021/078 810 Comfrey OThe following details provide data of a trial conducted in respect to the present invention. The natural cream emulsion of the present invention has been tried Nfor the treating of eczema and the study of this trial indicates that the cream emulsion has the healing properties described and referred to above.

0 C The effect of the cream emulsion was observed by a user who after years of O suffering from severe eczema found relief from the application of the cream Nemulsion referred to in this invention. The sufferer of this severe eczema was a 26 year old woman, whom upon application of the cream emulsion including the active ingredient of coconut oil, led to the relief of the skin disorder eliminating the itching and weeping as well as returning the skin discoloration back to normal.

Advantageously, the application of the cream emulsion described in this invention to the 26 year old woman sufferer of eczema substantially removed all red dryness including those hard to combat areas of the human body such as behind the knees, the joints in the elbows as well as back of the body.

The following herewith provides further trials conducted in respect to the present invention, whereby the effects of the cream emulsion were observed in healing the skin disorder of eczema, whereby the cream emulsion was applied to an infant having severe skin rashing and inflammation particularly to the male infants cheeks, temple and then thereafter legs and arms. This constant itching, irritation and broken skin on the arms, legs and face of the infant caused bleeding, which not only was distressing to the child but as is to be expected the carers of the infant.

A various range of pharmaceuticals and other commercial creams, bath oils and lotions designed to stop skin disorders associated with itching, redness and dryness were tried with none being able to substantially remove the skin COMS ID No: SBMI-05987235 Received by IP Australia: Time 17:02 Date 2007-01-19 19/01 2007 16:16 FAX COLLISON CO IP AUST CANBERRA la022/078 0 0 11 F irritation. Pharmaceutical creams containing cortisone were also applied, however, prolonged indefinite use was required, as the rash would continually reappear.

SAdvantageously, the cream emulsion of this invention applied to the infant c 5 successfully moisturized the skin and reduced the irritation and effectively 0 otreated the eczema condition of the infant.

SStill further, the following details provide an additional clinical trial conducted C with respect to the present invention, whereby the effects of the cream emulsion containing the active ingredient coconut oil was administered to a sufferer of lo eczema for over 30 years. Said sufferer of the skin disorder eczema had been continually subjected to bleeding cracks, scaling, itching and bleeding of the skin. Said sufferer had used a variety of prescription medication that contained cortisone steroids which had been used for many years, resulting in side effects which were destroying the sufferers immune system.

Advantageously, upon application of the cream emulsion referred to in this invention, said cream emulsion provided for immediate relief from the burning and itching and was able to substantially control the eczema skin disorder of the sufferer.

COMS ID No: SBMI-05987235 Received by IP Australia: Time 17:02 Date 2007-01-19

Claims (19)

1. A natural leave on cream emulsion, adapted to be applied to the human skin and to be left on said skin for a time sufficient to moisture said skin and for said skin to substantially completely absorb or at least an active ingredient in said cream emulsion, wherein said cream emulsion includes as the active Cingredient coconut oil. 0S

2. The natural leave on cream emulsion of claim 1 further including plant extracts providing at least one oil selected from sweet orange oil, jasmine oil or benzoin tincture.

3. The natural leave on cream emulsion of claim 2 further including at least one moisturizing or humectant component.

4. The natural leave on cream emulsion of claim 3 wherein the moisturizing or humectant component is glycerine.

The natural leave on cream emulsion of claim 4 wherein the cream emulsion includes the proper selection of stabilizers, binders and/or surfactants if required to maintain a stable oil in water emulsion that is adapted to prolonged contact with the skin, with such cream being applied to the skin without the need to wipe it off in any way after application.

6. The natural leave on cream emulsion of claim 5 wherein the selected binders, stabilizers and/or surfactants would include at least one of stearic acid, cetyl stearyl alcohol or borax.

7. The natural leave on cream emulsion of claim 6 wherein the cream emulsion includes a balance of water to provide for an adjusted pH that is non reactive with the skin surface. COMS ID No: SBMI-05987235 Received by IP Australia: Time 17:02 Date 2007-01-19 19/01 2007 16:17 FAX COLLISON CO IP AUST CANBERRA a024/078 o 13 a

8. The natural leave on cream emulsion of claim 7 further including environmentally acceptable amounts of preservatives.

9. The natural leave on cream emulsion of claim 8 wherein the preservative includes an ionisable salts, organic compound and/or mixtures thereof.

The natural leave on cream emulsion of claim 9 wherein the preservative further includes organic compounds, for example ethanol present within the final 0 formulations, and amounts that are non reactive to the surface skin condition.

11. The natural leave on cream emulsion of claim 1 wherein the active ingredient coconut oil in a range of 15 to 35% by weight of said cream emulsion.

12. The natural leave on cream emulsion of claim 11 wherein the coconut oil comprises up to 25% weight of said cream emulsion.

13. A natural leave on cream emulsion, adapted to be applied to the human skin to be left on said skin for a time sufficient to moisture said skin and for said skin to substantially absorb at least an active ingredient in said emulsion that includes the active ingredient comprising about 15 to 30% weight per cent of coconut oil suspension, wherein the amount of said active ingredient is sufficient to retain moisture in said skin and is sufficient to ameliorate at least the skin disorder of eczema.

14. A method for the preparation of a leave on cream emulsion that is adapted to ameliorate at least one skin disorder condition in a human and is adapted to moisture said skin comprising preparing an oil in water emulsion with at least one non ionic emulsifier and adding about 15-30% weight percentage of coconut oil to said emulsion. COMS ID No: SBMI-05987235 Received by IP Australia: Time 17:02 Date 2007-01-19 19/01 2007 16:17 FAX COLLISON CO IP AUST CANBERRA lI025/078 r- 0 0 14 0

15. The method of claim 14 for the preparation of the natural cream emulsion wherein at least one of non toxic emulsifier is selected from a group of sorbitan esters, ethoxilated alcohols, or fatty acids, and mono-and-di-glycerides. O

16. A method of ameliorating at least one skin disorder condition such as C 5 eczema or dermatitis that includes, applying a natural cream emulsion, Scomprising about 15-30 weight per cent of a suspension of active ingredient of coconut oil, to skin suffering from said disorder, and leaving said cream o emulsion on said skin until at least substantially all of the coconut oil has been C absorbed by the skin and said disorder has been ameliorated through such application.

17. The method of claim 16 wherein the application of the cream emulsion to the skin are administered 3 to 5 times per day.

18. A natural leave on cream emulsion including an oil phase, water phase and a third Phase, said oil phase including stearic acid, cetyl stearyl acid and coconut oil, said water phase including water and borax and said phase three including glycerine, benzoin tincture and comfrey.

19. A method of producing the cream emulsion of claim 18 wherein the water and oil phases are heated separately to at least 65-70 degrees C and thereafter combined and cooled to 50 degrees C. COMS ID No: SBMI-05987235 Received by IP Australia: Time 17:02 Date 2007-01-19