TOPICAL PREPARATIONS

Abstract

A topical preparation for use in treating dermatological ailments is prepared from a mixture comprising salicylic acid or a salt thereof, zinc or a salt thereof, iodine or a salt thereof, and a pharmaceutically acceptable carrier vehicle. The preparation comprises any one or more of anti-inflammatory properties, keratolytic properties, anti-pruritic properties, anti-carcinogenic properties. Methods of treatment involving topical application of the preparation are also described.

Claims

1. A topical preparation for dermatological application, the preparation prepared from a mixture comprising: zinc and/or a salt thereof; salicylic acid and/or a salt thereof; and iodine and/or a salt thereof; in a pharmaceutically acceptable carrier vehicle.

2. The topical preparation according to claim 1, wherein the mixture comprises salicylic acid and/or a salt thereof in an amount of from 1 to 50% m/m based on the total weight of the preparation.

3. The topical preparation according to claim 1, wherein the mixture comprises zinc and/or a salt thereof in an amount of from 5 to 20% m/m based on the total weight of the preparation.

4. The topical preparation according to claim 3, wherein the zinc is provided as a zinc salt selected from zinc oxide, zinc hydroxide, zinc sulphate or zinc acetate.

5. The topical preparation according to claim 1, wherein the mixture comprises iodine and/or a salt thereof in an amount of from 0.001 to 10% m/m based on the total weight of the preparation.

6. The topical preparation according to claim 1, wherein the preparation includes one or more of iodine, potassium iodide, zinc iodide, a zinc salicylic acid complex, a zinc iodo-salicylate, an ethyl salicylate, a zinc ethyl salicylate, and a zinc ethyl iodo-salicylate.

7. The topical preparation according to claim 1, wherein zinc is present in molar excess with respect to salicylic acid, wherein the molar ratio of zinc to salicylic acid is at least about 1.5:1 and at most 20:1.

8. The topical preparation according to claim 1, wherein salicylic acid is present in molar excess with respect to iodine.

9. The topical preparation according to claim 1, wherein the preparation includes one or more zinc (II) iodo-salicylate.

10. The topical preparation according to claim 1, wherein the preparation includes one or more of zinc salicylate, 3-iodo salicylic acid, 5-iodo salicylic acid, 3,5-di-iodo salicylic acid and 3, 4, 5-tri-iodo salicylic acid.

11. The topical preparation according to claim 1, further comprising ethanol, wherein iodine and/or a salt thereof is provided in the mixture as a solution in ethanol.

12. The topical preparation according to claim 1, wherein the preparation is prepared from salicylic acid, iodine, and zinc oxide.

13. The topical preparation according to claim 12, wherein salicylic acid is provided at a concentration of 2% m/m, zinc oxide is provided at a concentration of 10% m/m, and iodine is provided at a concentration of 0.01% m/m.

14. The topical preparation according to claim 1, wherein the carrier vehicle comprises one or more of emulsifying ointment, aqueous cream, castor oil cream, shea butter, hydrogel, alginate hydrogel, liquid paraffin, white soft paraffin, 50/50 liquid paraffin/white soft paraffin or combinations thereof.

15. The topical preparation according to claim 1, wherein the preparation comprises from 5% m/m to 40% m/m castor oil.

16. (canceled)

17. The topical skin treatment preparation according to claim 1, which is in the form of a cream, ointment, paste, lotion, gel, wash, solution, powder or hydrogel.

18-24. (canceled)

25. The topical preparation according to claim 1, wherein the pH of the preparation is within one pH unit of the average pH of the acid mantle of the skin.

26. A method of preparing a topical preparation for dermatological application, said method comprising: preparing a mixture of salicylic acid and/or a salt thereof with zinc and/or a zinc salt; adding a pharmaceutically acceptable carrier vehicle to the salicylic acid/zinc mixture; adding iodine and/or a salt thereof to the carrier vehicle/salicylic acid/zinc mixture; optionally adding a further quantity of pharmaceutically acceptable carrier vehicle to the carrier vehicle/salicylic acid/zinc mixture; and agitating the resulting mixture to provide a homogenized preparation.

27. The method of claim 26, wherein the mixture is prepared from salicylic acid powder and zinc oxide powder, and the mixture is milled prior to adding the carrier vehicle.

28. A method of preparing a topical preparation for dermatological application, said method comprising: adding iodine to a pharmaceutically acceptable carrier vehicle at a temperature above ambient, preferably between about 40 to 60° C.; adding zinc and/or a zinc salt and salicylic acid to the iodine-containing carrier vehicle; optionally adding an emulsifier; and agitating the resulting mixture to provide a homogenized preparation.

29-32. (canceled)

33. A method of treating a dermatological condition in a subject in need thereof, the method comprising administering to the subject the topical preparation as claimed in claim 1.

34. The method according to claim 33, wherein the dermatological condition to be treated is selected from the group consisting of psoriasis, rosacea, atopic dermatitis, and or a skin wound.

35. The method according to claim 33, wherein the topical preparation is administered daily at a dose of 5g to 50g.

36. The method according to claim 33, wherein the topical preparation is administered to the skin of the subject.

37. The method according to claim 33, wherein the subject is a human or an animal.

38. The method according to claim 33, wherein the administering repels biting insects.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0063] The invention will now be further described and illustrated, by way of example only, with reference to the accompanying drawings in which;

[0064] FIGS. 1(a) to 1(d) illustrate the results of using a preparation in accordance with the invention in the treatment of psoriasis on human arms and legs;

[0065] FIGS. 2(a) to 2(e) illustrate the results of using a preparation in accordance with the invention in the treatment of wounds of the gaskin tissue;

[0066] FIGS. 3(a) to 3(g) illustrate the results of using a preparation in accordance with the invention in the treatment equine wounds arising from a road traffic accident;

[0067] FIGS. 4(a) to 4(g) illustrate the results of using a preparation in accordance with the invention in the treatment of psoriasis on the human torso;

[0068] FIGS. 5(a) to 5(h) illustrate the results of using a preparation in accordance with the invention in the treatment of rosacea;

[0069] FIGS. 6(a) to 6(c) illustrate the results of using a preparation in accordance with the invention in the treatment of a horse suffering from “sweet itch”;

[0070] FIGS. 7(a) to 7(d) illustrate the results of using a preparation in accordance with the invention in the treatment of a bacterial/fungal infection on a hand; and

[0071] FIGS. 8(a) to 8(d) illustrate the results of using a preparation in accordance with the invention in the treatment of wounds in a horse suffering from lymphangitis.

DETAILED DESCRIPTION

[0072] As hereinbefore described, the present invention provides a range of novel and improved topical preparations with low toxicity for use in treating dermatological ailments. The preparations may be used for both human and veterinary use. The present invention further provides a method of treating dermatological conditions in humans and animals through topical administration of said preparations.

[0073] The novel compositions of the topical preparations play an important part in antiseptic and healing processes and also play a role in the whole immune response process in the body.

[0074] To assist in the understanding of the invention, a number of definitions are hereinbelow set forth.

[0075] As used herein, the term “comprising” means any of the recited elements are necessarily included and other elements may optionally be included as well. “Consisting essentially of” means any recited elements are necessarily included, elements that would materially affect the basic and novel characteristics of the listed elements are excluded, and other elements may optionally be included. “Consisting of” means that all elements other than those listed are excluded. Embodiments defined by each of these terms are within the scope of this invention.

[0076] “Anti-inflammatory properties” — the ability to reduce inflammation or swelling by counteracting the effect of the cyclooxygenase (COX) enzyme which in turn affects the production of prostaglandins which are through vasodilation involved in inflammation. Prostaglandin-endoperoxide synthase (PTGS) (more commonly known as

[0077] Cyclooxygenase (COX)) is an enzyme that is associated with the formation of prostaglandins from arachidonic acid. These prostaglandins are integral in a range of both physiological and pathophysiological processes including inflammation, reproduction, nociception. Two COX isoforms have been identified; COX-1 which is constitutively expressed in most tissues and COX-2 which participates in inflammation.

[0078] “Keratolytic properties”—the ability to break down the outer layers of the skin to decrease the thickness of the psoriatic plaques.

[0079] “Anti-pruritic properties”—the ability to inhibit itching, local anesthetic action is achieved in topical agents by stabilizing the neuronal membrane and preventing the initiation and transmission of nerve impulses. (Itching may also be controlled by oral agents by blocking the effects of the endogenously released histamine.)

[0080] “Anti-carcinogenic properties”—the ability to counteract the effects of a carcinogen or inhibit the development of cancer.

[0081] “Acne vulgaris” (commonly referred to as acne) is an inflammatory skin disorder affecting the pilosebaceous unit. It can present with both inflammatory and non-inflammatory lesions. These lesions chiefly appear on the face but can also appear on the upper arms, trunk and back. Acne can be identified by open or closed comedones, and/or by erythematous papules and pustules on the face, as well as erythema on the surrounding skin. It manifests when hair follicles become clogged with oils and dead skin causing inflammation. Acne can result from a range of factors including genetics, hormonal function and bacterial growth.

[0082] “Acne Rosacea” (commonly referred to as Rosacea) is a chronic inflammatory skin condition characterized by redness, flushing and visible blood vessels. Often these symptoms can be additionally accompanied by small, red pus-filled bumps that are similar to acne and/or irritated, swollen and reddened eyelids. These symptoms predominantly affect the face. There are four subtypes of rosacea which may overlap.

[0083] While no single root cause of rosacea is known, factors including alcohol, spicy food and alcohol have been known to exacerbate the condition.

[0084] “Atopic Dermatitis” (commonly referred to as Eczema) is an inflammatory skin condition that can be characterized by dry, pruritic skin with a chronic relapsing course; it affects individuals of all ages, although diagnosis usually occurs at the infant stage typically before five years of age, as well as being a common condition in companion animals. It can accompany other atopic diseases and it can present in acute or chronic form. It most commonly affects the creases in the joints at the elbows and knees along with the wrists and neck.

[0085] “Psoriasis” is a chronic skin condition that speeds up the life cycle of skin cells. A build-up of cells occurs on the surface of the skin. These cells appear as thick, white, silvery or red patches of skin (known as plaques). There are five subtypes of psoriasis characterized by different plaques. These plaques most often appear on the knees, elbows scalp, hands, feet and lower back. It is not known what causes psoriasis. It is thought that T-cells travelling through the body to detect and combat invading germs begin to attach healthy skin cells by mistake causing the deepest skin layer to produce new skin cells more rapidly. However, the exact reasoning for the T-cell malfunction is not known. Psoriasis can be treated through the use of topical treatments, phototherapy and tablet and/or injectable systemic treatment.

[0086] “Cellulitis” is a bacterial infection that affects the dermis and subcutaneous tissues. The skin appears swollen and red with the individual experiencing pain and heat in the region affected. It most commonly appears on the legs but can also occur in other areas including the face, arms and neck. Cellulitis occurs when certain types of bacteria (most commonly streptococcus and staphylococcus) enter the skin through a cut or lesion. Therefore, individuals presenting with eczema or psoriasis can have a higher risk of developing cellulitis.

[0087] “Herpes simplex virus” (commonly referred to as Herpes) is a viral infection that can affect different areas of the dermis but primarily affects the external genitalia, anal region and mucosal surfaces. It is a long-term condition, and an individual does not have to present with symptoms to be infected. There are two types of herpes simplex virus: HSV-1 which typically affects the oral region and HSV-2 which typically affects the genitalia. Symptoms usually include blisters and ulceration in the infected region. Pain and itching commonly accompany such blisters. Other symptoms can include general malaise, high temperature and tender/enlarged lymph nodes. Although there is no cure for herpes, it can be treated using antiviral medications such as acyclovir. Such medications help to prevent the virus from multiplying and reduce the severity of the symptoms but cannot eradicate the virus entirely.

[0088] “Impetigo” is a highly contagious infection of the dermis. Symptoms typically include the appearance of a rash comprising blisters or sores that ooze before drying up and forming a crust, the blisters appear on the trunk, legs and arms. In addition to these blisters the individual will typically experience fever and swollen glands. The infection can be caused by either Staphylococcus aureus or Streptococcus pyogenes entering the skin. This can occur without an established site of entry and is known as primary impetigo. Alternatively, the bacteria can enter through a disruption to the skin that has been previously established known as secondary impetigo. The disruption may result from a skin condition, wound or bite. Impetigo is usually treated with antibiotics; either in topical or oral form. In very mild instances, keeping the skin clean may be sufficient to treat the infection.

[0089] “Digital dermatitis” is an infectious condition primarily affecting the skin on the heel of bovines, although it can occur in other areas. Treponeme bacteria are the primary pathogens responsible for the diseases. It is a highly contagious and can cause pain and discomfort and ultimately results in lameness. Bovines infected with the disease present with lesions. There are five different lesion categories associated with each stage of the disease. Digital dermatitis arises is unsanitary, damp conditions. Typical treatment involves topical application of Oxytetracycline.

[0090] “Wound healing” as used herein refers to a sequence of molecular and cellular events in which tissue repair and regeneration take place to restore damaged tissue after the onset of a lesion.

[0091] “Epithelialization” is used as a defining parameter of successful wound closure in wound healing. It involves both the cellular and molecular processes involved in the initiation, maintenance and completion of epithelization.

[0092] The topical preparations of the present invention have a broad spectrum of germicidal activity against bacterial, fungal and viral infections as well as fast wound healing properties, anti-inflammatory properties and anti-pruritic properties.

[0093] The preparations are prepared from a mixture of three active base ingredients, salicylic acid, iodine and zinc in different concentrations and added to different forms of topical vehicles such as creams, ointments, powders, pastes, lotions, suspensions, solutions, washes, hydrogels and mixtures thereof.

[0094] The basic preparations comprising the active ingredients salicylic acid, iodine and zinc may be used as a base for the addition of other ingredients including corticosteroids and coal tar for the treatment of other dermatological ailments. Examples of such dermatological ailments include eczema, psoriasis and various forms of skin disease.

[0095] The active ingredients are combined within a pharmaceutically acceptable carrier base, such as those hereinbefore described.

[0096] Salicylic acid is a lipophilic mono-hydroxybenzoic acid that functions as a plant hormone and is used as a key ingredient in topical preparations to treat skin related conditions such as acne and psoriasis among others. Used topically, salicylic acid works as a keratolytic, comedolytic and bacteriostatic agent. It works by lowering the pH of the skin, resulting in increased hydration and swelling of corneocytes. Desquamation is also facilitated through the solubilizing of the intercellular cement substance. Salicylic acid has anti-inflammatory, anti-pyretic and anti-pruritic properties. Salicylic acid has been shown to suppress proteins responsible for cellular damage caused by inflammation. Salicylic acid promotes apoptosis, induces exfoliation and causes shedding of the outer layer of the skin. The concentration of salicylic acid used in the preparations of the present invention is in the range of 1% to 50 m/m%. When using the preparation in relation to animals the concentration of salicylic acid may exceed 50 m/m%.

[0097] Zinc is a chemical element belonging to the transition metal group of the periodic table. Zinc is of exceptional biological and public health importance. It is an essential trace element for humans and animals and is to be found in over 300 enzymes. Between 2 to 4 grams of zinc are distributed throughout the body with up to 20% of this found in the skin. Zinc has roles in the metabolism of RNA and DNA signal transductions and gene expressions. Zinc plays an important role in wound repair via regulation of DNA and RNA polymerases thymidine. Zinc has been used for the treatment of various dermatological disorders including acne vulgaris, eczema, psoriasis, warts, rosacea, and ulcers, it has antibacterial and antifungal activity and is used in wound treatment. All forms of zinc derivatives and salts may be used in the preparations of the present invention including but not limited to zinc oxide, zinc acetate and zinc sulphate.

[0098] Zinc complexes of simple phenolic compounds are more potent than zinc ions alone as the binding of metal ion complexes occurs at specific sites on the DNA. This induces apoptosis of cells. The process is associated with the cell cycle and is regulated by cyclin- dependent kinase (CDKs) and caspases. Cell cycle progression is regulated by the synthesis of CDKs at different phases. Cyclins are a group of regulated proteins and are among the most important core cell cycle regulators. In order to drive the cell cycle forward a cyclin must activate or inactivate many target proteins inside of the cell. Cyclins drive the events of the cell cycle by partnering with a family of enzymes called the cyclin-dependent kinases (CDK's). A lone CDK is inactive but the binding of a cyclin activates it making it a functional enzyme and allowing it to modify target proteins.

[0099] Zinc oxide in particular is a known safe and effective active sunscreen agent, with the ability to block the sun's UVA and UVB radiation from being absorbed into the dermis. The concentration range for zinc oxide used in the preparations of the present invention is preferably from 5% to 20%, more preferably from 7% to 15% and most preferably from 10% to 14%.

[0100] Zinc salicylate is a very powerful antiseptic and astringent. It is formed when zinc oxide complexes with salicylic acid in the presence of water. The ratio of the complex affects the aqueous solubility, with the 2:1 complex of salicylic acid to zinc having higher aqueous solubility than the 1:1 complex.

[0101] Iodine is a chemical element of the halogen group in the periodic table. Iodine is used as an antiseptic and is effective against bacteria, fungi, viruses and yeasts even at small concentrations. Bacteria do not develop resistance to iodine, it is effective at reducing wound size and bacterial count. The preparations of the present invention may use iodine in any form and concentration including tincture of iodine, povidone and a solution of iodine in ethanol. The concentration of iodine used in the preparations of the present invention may range from 0.001% to 10% m/m. The concentration of the iodine used will depend on the concentration of other ingredients and the condition to be treated. Some iodine will react with zinc and salicylic acid thus reducing the availability of free iodine.

[0102] Zinc iodide is used as an antiseptic and astringent for topical use. Zinc iodide is formed through the direct reaction of the zinc, typically provided as zinc oxide in powder form, with iodine in ethanol. The reaction that occurs is an exothermic redox, with the resulting product being zinc iodide once the solvent has been evaporated off. It is believed that the formation of zinc iodide and other zinc-iodo species can be observed through colour change. In particular, the reaction is known to proceed as the brown colour of the iodine solution disappears. Without wishing to be bound by theory, it is thought that the interaction between the iodine and zinc is minimal at first. However, the zinc complexes with salicylic acid in the presence of water to form either a 2:1 or 1:1 salicylic acid to zinc molar ratio complex. Once the zinc has been solubilized as the zinc salicylate then there is potential for the zinc cation to react with the iodide, resulting in zinc iodide.

[0103] Thus, it will be understood that the preparation according to the invention comprises a host of derivatives that result from the combination of salicylic acid, zinc and iodine which are believed to contribute to surprising and unexpected activity in the treatment of dermatological ailments.

[0104] Structures of the various derivatives and complexes that may arise in the preparation according to the invention are provided in Tables A to D below:

TABLE-US-00001 TABLE A Structures of 5-Iodo Salicylic acid and its complexation permutations with zinc [00001] 5-Iodo Salicylic acid [00002] 5-Iodo Zinc salicylate [00003] 5′-Iodo Zinc salicylate [00004] 5-Iodo, 3′-Iodo Zinc salicylate [00005] 5-Iodo, 3′,5′-Di-iodo Zinc salicylate [00006] 5-Iodo, 3′,4′,5′-Tri-iodo Zinc salicylate

TABLE-US-00002 TABLE B Structures of 3,5-Di-iodo Salicylic acid and its complexation permutations with zinc [00007] 3,5-Di-iodosalicylic acid [00008] 3,5-Di-iodo Zinc salicylate [00009] 3′,5′-Iodo Zinc salicylate [00010] 3,5-Di-iodo, 3′-Iodo Zinc salicylate [00011] 3,5-Di-iodo, 5′-Di-iodo Zinc salicylate [00012] 3,5-Di-iodo, 3′,4′,5′-Tri-iodo Zinc salicylate

TABLE-US-00003 TABLE C Structures of 3,4.5-Tri-iodo Salicylic acid and its complexation permutations with zinc [00013] 3,4,5-Tri-iodosalicylic acid [00014] 3,4,5-Tri-iodo Zinc salicylate [00015] 3,4,5-Tri-iodo, 3′-Iodo Zinc salicylate [00016] 3,4,5-Tri-iodo, 5′-Iodo Zinc salicylate [00017] 3,4,5-Tri-iodo, 3′,5′-Di-iodo Zinc salicylate [00018] 3,4,5-Tri-iodo Zinc salicylate

TABLE-US-00004 TABLE D Structures of ethyl salicylate and its complexation permutations with iodine and zinc [00019] Ethyl Salicylate [00020] Di-iodo Ethyl Salicylate [00021] Zinc Ethyl Salicylate [00022] 3,5-Di-iodo Zinc Ethyl Salicylate

[0105] As will be understood, the specific concentration of active ingredients and the carrier vehicle used may be optimized depending on the specific dermatological condition being treated.

[0106] The preparations of the present invention have shown 100% germicidal activity as a result of the combined activity of iodine, salicylic acid and zinc. The preparation formed from the mixture of the three components has been shown to enhance the repair of the dermis substantially, and all microbes including bacteria, viruses and fungi including spores are eliminated. Moreover, microbes do not develop resistance to the preparations.

[0107] The preparations of the present invention accelerate the healing process of all wounds; the preparations have anti-inflammatory properties; the preparations are anti-pruritic; the preparations are anti-carcinogenic; and the preparations have keratolytic properties and inhibit dermal auto immune disorders.

[0108] The preparations of the invention may also act as a sunscreen to prevent further damage to the wound or skin while exposed to sunlight.

[0109] The preparations of the invention inhibit enzymes produced by some microbes that cause scarring of the skin. Without wishing to be bound by theory, the enzyme lysyl oxidase (LOX) has been shown to be responsible for scar formation through crosslinking in the collagen involved in the wound healing. LOX catalyzes the formation of aldehydes from lysine in collagen and elastin precursors. Due to the reactivity of the aldehydes, spontaneous cross-linking occurs. Evidence suggests that LOX inhibition is capable of altering the collagen architecture and permitting restoration of the normal appearance and pattern of the skin.

[0110] Without wishing to be bound by theory, di-iodo zinc salicylate appears to function in a similar manner to thyroxine hormones. Thyroxine hormones work intracellularly to increase base metabolic rate. In relation to dermatological application, it is postulated that due to the bio similarity of di-iodo zinc salicylate to thyroxine, healing and re-epithelialization of the affected site improves through increased metabolism and increased blood supply.

[0111] From another aspect, the invention resides in a thyroxine hormone mimetic comprising a topical preparation as hereinbefore described in accordance with the first aspect of the invention.

[0112] Many known pharmaceutical bases may be used as the carrier vehicles for the salicylic acid, zinc and iodine. Paraffin gel, emulsifying ointment, purified water or castor oil soap are among those bases that are suitable. The proportions in which the same ingredients are mixed can determine the structural forms of the resulting preparation. The tactile properties of topical preparations are important in determining product choice by consumers or for the adherence to treatment. For cosmetic preparations, odour may also be an important factor in the attractiveness of a product in the treatment of for example acne. The pH of the preparations will preferably be maintained at around 5.5 to 6 which is the pH of human skin.

[0113] There now follows some examples of topical preparations in accordance with the invention and their use for treating dermatological ailments. Unless stated otherwise, amounts in percentages are expressed as m/m.

EXAMPLE 1

[0114] A pharmaceutical composition according to the invention is prepared for topical application to the epidermis/dermis as follows:

[0115] (i) Preparation of a Base Powder

[0116] Step 1:200 grams of salicylic acid powder is mixed with 100 grams of zinc oxide powder until homogenization is achieved;

[0117] Step 2:The resultant powder is milled until a very fine consistency is achieved;

[0118] Step 3:A mixture of iodine in ethanol (5% solution) is added and the resulting composition is agitated for one hour;

[0119] Step 4:The resulting composition is placed in a microwave dryer under slight vacuum to recover the alcohol and dried at 80° C. while continuing to agitate until a dry fine powder is achieved.

[0120] Heating the mixture at 80° C. accelerates the reactions between the ingredients to achieve new derivative compounds such as di-iodo zinc salicylate.

[0121] The resultant base powder may contain any one or more of salicylic acid, zinc oxide, zinc iodide, zinc salicylate and di-iodo zinc salicylate.

[0122] The concentrations of the constituents in the base powder may be varied according to intended therapeutic use. Use of zinc oxide and salicylic acid in powder form allows for concentrations to be readily adjusted.

[0123] (ii) Preparation of Topical Formulation

[0124] The base powder is then combined with a pharmaceutically acceptable carrier vehicle, such as a combination of castor oil and aqueous cream, to produce a preparation ready for topical application, as exemplified below.

EXAMPLE 2: Preparation of Topical Paste, etc.

[0125] The appropriate quantities of salicylic acid powder and zinc salt are milled together until a fine powder is obtained. The powder is triturated with a portion of the carrier vehicle until a smooth paste results. The carrier vehicle may be castor oil, however any suitable carrier vehicle may be used. These include white soft paraffin, liquid paraffin, emulsifying ointment, aqueous cream, castor oil cream BP, and various creams, ointments, lotions, shampoos, or gels. The appropriate quantity of iodine is added with further mixing until the desired consistency is achieved. The iodine may be in the form of iodine in ethanol, tincture of iodine or povidone or any other suitable iodine salt including zinc iodide. The frictional heat generated through the milling and mixing process aids the formation of associated compounds such as zinc iodide and zinc salicylates. The balance of the carrier vehicle is then added to the smooth paste while mixing and the final product is mixed until homogenized.

[0126] The following examples show the range of products using different concentrations and salts of the active ingredients, and various vehicles:

[0127] A Topical Cream

TABLE-US-00005 Rx Zinc Oxide 100 g Salicylic Acid  20 g Tincture of Iodine 100 g Emollient 780 g

[0128] A Topical Ointment

TABLE-US-00006 Rx Zinc Oxide 100 g Salicylic Acid  20 g Tincture of Iodine 100 g Paraffin Gel 780 g

[0129] A Topical Paste

TABLE-US-00007 Rx Zinc Oxide 100 g Salicylic Acid  10 g Tincture of Iodine  50 g Emulsifying Ointment 240 g

[0130] A Topical Lotion

TABLE-US-00008 Rx Zinc Oxide 100 g Salicylic Acid  20 g Tincture of Iodine 100 g Sodium Alginate  20 g Purified Water 760 g

[0131] A Topical Wash

TABLE-US-00009 Rx Zinc Oxide 100 g Salicylic Acid  20 g Tincture of Iodine 100 g Castor Oil Soap BP 780 g

[0132] A Topical Cream

TABLE-US-00010 Rx Zinc Sulphate 100 g Salicylic Acid  20 g Povidone-iodine 8% 100 g Emollient 780 g

[0133] The preparations according to the present invention may include additional pharmaceutically acceptable carriers, adjuvants, and/or biologically active substances.

EXAMPLE 3: Preparation for Topical Application

[0134] A preparation for topical application was prepared comprising:

[0135] 5% m/m Zinc Oxide

[0136] 3% m/m Salicylic Acid

[0137] 0.5% m/m Iodine

[0138] 4% m/m Ethanol

[0139] Ad to 100% Carrier (oil and water emulsion)

[0140] The above preparation was analyzed for bacteria regeneration using preservative efficacy testing (PET) method. The strains of bacteria tested for were; Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Aspergillus brasiliensis, Candida albicans. The product was sampled at day 0, day 14 and day 28. As shown in Table D below, the tests run with a higher concentration of product show a lower percentage recovery overall. In the case of Aspergillus brasilensis 0% recovery was observed with a 1:10 product dilution as opposed to 100% recovery with a 1:100 product dilution.

TABLE-US-00011 TABLE D Reference Strains Product Control Sample % Bacteria Dilution (cfu/ml) (cfu/ml) Recovery Pass/Fail Pseudomonas 1:10  22 1 *5 Fail aeruginosa 1:100 9 *41  Fail E. coli 1:10  63 1 *2 Fail 1:100 29 *46  Fail Staphylococcus 1:10  70 21 *30  Fail aureus 1:100 78 111  Pass Aspergillus 1:10  14 <1 *0 Fail brasiliensis 1:100 14 100  Pass Candida 1:10  41 2 *5 Fail albicans 1:100 25 85 Pass Sterility <1 <1 <1 Pass Inactivation Broth & Product No Spike

EXAMPLE 4: Preparation for Topical Application

[0141] A preparation according to the invention was prepared from the following ingredients, the concentrations being the initial concentrations as added:

TABLE-US-00012 TABLE E Preparation Ingredient concentration Molar ratio in Composition (% m/m) preparation Salicylic Acid — 2 0.118 Tincture of Iodine — 6 — KI 2.5 0.007 I.sub.2 2.5 0.005 EtOH 95 0.132 Zinc Oxide — 10 1 Castor oil — 6 0.052 Aqueous cream 76 Not determined Emulsifying Wax — — Cetostearyl — — alcohol Sodium — — laurilsulfate Purified water — — White Soft — — Paraffin

[0142] Samples were prepared in accordance with the above preparation, but in which the primary components, namely salicylic acid, zinc and iodine, were included or excluded in different combinations as follows:

[0143] Sample 1: Salicylic acid +ZnO

[0144] Sample 2: Salicylic acid +(tincture of iodine)

[0145] Sample 3: ZnO +(tincture of iodine)

[0146] Sample 4: Salicylic acid +ZnO +(tincture of iodine)

[0147] Testing of the samples was conducted using nuclear magnetic resonance (NMR), scanning electron microscope (SEM/EDX) and infra-red spectroscopy (FT-IR), together with a simple visual inspection. These tests indicated that there was some interaction between the salicylic acid and the iodine, but that there was a strong interaction between the salicylic acid and zinc. Moreover, from the visual inspection it was observed that Samples 1, 2 and 4 all resulted in a colourless solution, indicating that iodine was consumed. Overall, the results suggested that there is complexation between elemental zinc and salicylic acid to form zinc salicylates, and that iodine does not react strongly with zinc, but reacts with the salicylic acid to form iodo-salicylic acid (which can be mono-, di- and/or tri-iodo salicylic acid) and these iodo-salicylic acid species react with the zinc to form zinc iodo-salicylate complexes.

EXAMPLE 5: Preparation for Treatment of Psoriasis

[0148] A composition according to the invention (zinc oxide 10%, salicylic acid 2%, iodine 0.01%, aqueous cream 100%) was used to treat psoriasis on the arms and legs of an individual. FIGS. 1(a) and 1(b) show the arm and leg of the individual on day one of treatment. Throughout the following days of treatments (days two to four) the individual reported a decrease in the propensity to scratch the areas where the composition had been applied, the areas also appeared less inflamed and red to the individual, on day four a decrease in the amount of scaling on the affected areas was evident. FIGS. 1(c) and 1(d) show the individual's leg and arm on day 7 of treatment. The reduction in inflammation and scaling is apparent.

EXAMPLE 6: Preparation for Veterinary Treatment of Wounds

[0149] A composition according to the invention (zinc oxide 10%, salicylic acid 2%, iodine 0.01%, aqueous cream to 100%) was used to treat the gaskin tissue of an equine. The gaskin tissue was fully open to the tibia. When the equine walked, the tissue moved relative to the tibia. FIGS. 2(a) to 2(e) show the different stages of healing with application of the composition. FIG. 2(a) shows the open wound on Day 1, FIG. 2(b) shows the open wound on day 21 after application of the cream on a daily basis (10g per application), scabs have started to form, and the wound is red in colour indicating that inflammation is occurring as part of the repair process. FIG. 2(c) shows the wound on day 39 of treatment with the composition, the surface area of the wound has significantly decreased, the presence of coagulated blood/scabbing has also decreased. On day 57 the wound size has reduced so significantly it cannot be considered more than a minor cut, see FIG. 2(d). The healing is neat and there are no irregularities in the periphery of wound. By day 84 the wound has completely healed as shown in FIG. 2(e), it is important to note the hair regeneration that accompanied the wound healing and the complete absence of scarring and granulation tissue. The rapid nature of the healing properties of the cream accelerates post-injury time and consequently for equines competing at a high level, such a composition can reduce time out of competition for the wounded horse and thus is also economically beneficial.

EXAMPLE 7: Preparation for Veterinary Treatment of Wounds

[0150] A composition according to the invention (zinc oxide 10%, salicylic acid 2%, iodine 0.01%, aqueous cream to 100%) was used to treat a very large deep open wound on the shoulder/arm of an equine that occurred as a result of the equine being struck by a lorry. The open wound of FIG. 3(a) shows stiches (in blue) at the top of the wound however the surface area of the rest of the wound is too great to permit the application of any further stitches. The veterinary surgeon treating the equine recommended euthanizing as it was not envisaged that the equine would make a recovery whereby the wound would heal to a point where it would not inhibit the equine's normal function. The owner of the equine began treatment with the composition, 10g of the composition was applied twice daily for forty-five days after which the dosage was reduced to 10 g once daily for twenty-five days. FIG. 3(b) shows the wound on day 9 of topical application of the composition. The narrower parts of the wound have already diminished in size leaving only the lower part of the wound open, the strong red colour visible indicates inflammation as such it can be inferred that wound healing is occurring. FIG. 3(c) shows day 22 of the use of the composition, the wound has drastically diminished in size and the wound appears to have completely dried up. Day 39 of topical application as show in in the FIG. 3(d) shows that the wound has completely healed over, with only minor scabbing remaining and hair regeneration has started to occur. FIG. 3(e) shows the wound on day 52 of use of the composition, the wound is barely visible and significant hair regeneration has occurred. FIGS. 3(f) and (g) show complete hair regeneration and the equine is restored to full health. FIG. 3(h) shows a small untreated wound that occurred at the same time, the hair remains grey and elements of proud flesh are present. Overall, the time period for wound healing is sixty days.

EXAMPLE 8: Preparation for Treatment of Psoriasis

[0151] A composition according to the invention (zinc oxide 10%, salicylic acid 2%, iodine 0.01%, aqueous cream to 100%) was used to treat the torso and back of an individual with a severe case of psoriasis for which NSAIDS were ineffective. FIGS. 4(a) and 4(c) show the individual prior to commencing treatments. The affected area is large, particularly on the back and the affected scaly patches of skin are dark red in colour indicating severe inflammation. The individual commenced a treatment regimen utilizing the composition according to the invention. The regimen involved the topical application of 20g of the composition twice daily to the affected area over the course of 70 days. FIGS. 4(d), 4(e) and 4(f) show the improvement of the affected areas throughout the treatment. The aforementioned figures show a significant reduction in the size of the affected scaly areas. The colour of the affected area has also improved which indicates a reduction in the level of inflammation. FIGS. 4(b) and 4(g) show the torso and back of the individual after treatment has finished, the affected areas have decreased significantly in size and there is no evidence of scarring.

EXAMPLE 9: Preparation for Topical Treatment

[0152] A composition according to the invention is prepared for topical application to the epidermis/dermis as follows:

TABLE-US-00013 Zinc Oxide 6% Salicylic Acid 3% Tincture of Iodine 3% Glyceryl Stearate 1% Cetyl Alcohol 1% Xanthan Gum 0.5%.sup.  Sucrose Stearate HLB 11 1.5%.sup.  Sucrose Stearate HLB 15 4% Castor Oil 20%  Purified water 60% 

[0153] The preparation was prepared according to the following steps:

[0154] Castor oil was heated to about 55° C. and glyceryl stearate, cetyl alcohol and xanthan gum were added to the heated oil while stirring and the stirring was continued for five minutes.

[0155] The purified water was heated to about 45° C. and the iodine tincture then added to the heated water. The solution of iodine in water was then added to the castor oil mix. Zinc oxide and salicylic acid were then added to the mixture while stirring and continued for five minutes. Finally, sucrose stearate HLB 11 and sucrose stearate HLB 15 were added and mixed in a blender for fifteen minutes.

[0156] The resulting preparation in the form of a cream displayed excellent stability.

EXAMPLE 10: Preparation for Treatment of Rosacea

[0157] The preparation according to Example 9 was used to treat an individual suffering from rosacea. The preparation in the form of a cream was applied to the face and neck of the individual once daily for the first week, then reduced to one application on each of five days in the second week, and further reduced to one application on two days in the third week.

[0158] FIGS. 5(a) to 5(h) are photographs showing the improvement in the appearance of the skin on the face and neck of the treated individual over the aforementioned three-week period.

EXAMPLE 11: Preparation for Treatment of “Sweet Itch”

[0159] The preparation according to Example 9 was used in late summer to treat several horses suffering from sweet itch. The preparation was applied daily to the horses in the affected areas, especially at the base of the tail, where the constant irritation had resulted in loss of tail hair and open wounds where the flesh had torn. It was observed that all horses treated with the preparation ceased rubbing and scratching from the first day of application, and wound healing was observed from the third day. While it would be usual for horses suffering from sweet itch to have little or no tail hair left at this time in the season, hair regrowth was also observed from as early as the fifth day of treatment. After about one month of treatment, complete hair regrowth was evident even in what would have been considered hopeless cases.

[0160] FIGS. 6(a) to 6(c) are photographs showing the condition of a horse's tail that had been suffering from sweet itch as treatment progressed. As will be seen, after ten days of treatment (FIG. 6(b)), the open wounds had substantially healed, and the affected area had almost been completely recovered in tail hair. As evident from FIG. 6(c) taken on day 42, the appearance of the tail and tail hair had been completely restored and no visible signs of the condition remained.

EXAMPLE 12: Preparation for Treatment of Bacterial/Funqal Infection

[0161] The preparation according to Example 9 was used to treat an individual suffering from a bacterial/fungal infection across the palm of the hand. The preparation was applied as a cream once daily over a period of two weeks by which time the infection had cleared and the skin had returned to a normal appearance.

[0162] FIGS. 7(a) and 7(b) show the appearance of the hand before treatment commenced and FIGS. 7(c) and 7(d) show the transformation following two weeks of treatment.

EXAMPLE 13: Preparation for Treatment of Infected Equine Wounds

[0163] The preparation according to Example 9 was used to treat a horse suffering from lymphangitis that resulted in a severely swollen right hind leg with accompanying pain and elevated temperature. Lymphangitis frequently results in significant permanent scarring of the flesh, and in the present case the leg displayed significant wound swelling as well as a build-up of proud flesh. The horse was initially treated with antibiotics, and subsequently the affected leg area was treated with the preparation which was applied once daily for a period of several weeks.

[0164] Recovery visibly commenced within three days from the first application. The preparation eliminated oozing of fluids from the exposed wound and normalized hot spots across the affected area. Further, it was observed that use of the preparation not only accelerated wound healing, but also the existing proud flesh was reduced and indeed substantially eliminated over a three-week period. Regrowth of hair across the affected area was also apparent and ultimately the appearance of the affected leg restored. The horse was able to be returned to its paddock within five weeks of commencing treatment.

[0165] FIGS. 8(a) to 8(d) show the appearance of the affected hind leg prior to commencement of treatment and the progressive recovery over the five-week treatment period.

[0166] Although particular embodiments of the invention have been disclosed herein in detail, this has been done by way of example and for the purposes of illustration only. The aforementioned embodiments and examples are not intended to be limiting with respect to the scope of the appended claims, which follow. It is contemplated by the inventors that various substitutions, alterations, and modifications may be made to the invention without departing from the spirit and scope of the invention as defined by the claims. In addition, the above-described embodiments may be used in combination unless otherwise indicated.