AU2016101717A4 - Formulation and method of use - Google Patents

Abstract

A formulation is provided which can treat and/or prevent dry eye syndrome. The formulation comprises omega-3 oil, vitamin D and gamma-linolenic acid, wherein 5 the omega-3 oil comprises one or more triglycerides that respectively comprise one or more polyunsaturated fatty acids.

Description

TITLE

FORMULATION AND METHOD OF USE FIELD OF THE INVENTION

[0001] The present invention relates to the field of medicaments. More particularly, the invention relates to a formulation. Most particularly, the invention relates to a formulation for treating and/or preventing dry eye syndrome.

BACKGROUND TO THE INVENTION

[0002] Any reference to background art herein is not to be construed as an admission that such art constitutes common general knowledge in Australia or elsewhere.

[0003] Irritation can occur when there is inadequate moisture in the eye. This inadequate moisture can be caused by the eye not producing sufficient tears, or due to excessive tear evaporation. This is commonly known as dry eye syndrome or keratoconjunctivitis sicca. Symptoms of dry eye syndrome include redness, discomfort, discharge and easily fatigable eyes. Additionally, scarring of the cornea can occur in severe cases of dry eye syndrome.

[0004] There can be many contributing factors to dry eye syndrome, such as the wearing of contact lenses, pollutants in the atmosphere, certain types of medication, surgery, disease, nutrient deficiencies and age. Additionally, dry eye syndrome may also be exacerbated by high temperatures and/or low humidity. Inflammation can also play a role in dry eye syndrome.

[0005] A natural reflex to dry eyes is blinking. Blinking is a semi-automatic closing of the eye, and is an essential function that assists in spreading tears across the surface of the eye. Blinking is also an automatic reaction that removes foreign matter and irritants from the surface of the eye, and prevents excess evaporation of tears and moisture. However, a person concentrating on a task may inadvertently reduce their frequency of blinking, and this may result in insufficient spreading, and excess evaporation, of tears. Many everyday tasks require close attention and so dry eye syndrome is becoming a significant problem to the population.

[0006] Significant evaporation from the eyes may lead to a higher risk of infection. In this regard, infection of the eye can lead to scarring and thinning of the cornea, and may even lead to the permanent loss of vision in an eye.

[0007] One common method of treating dry eye syndrome is to use artificial tears. However, the application of the artificial tears can be difficult due to the natural instinct of blinking when foreign matter comes into contact with the eye. As such, it would be advantageous to provide an alternative to treating and/or preventing dry eye syndrome that does not require the use of artificial tears. Additionally, artificial tears only offer a short term relief, and must be reapplied within a short period of time.

[0008] Therefore, there is a need for new methods for treating and/or preventing dry eye syndrome.

SUMMARY OF THE INVENTION

[0009] The present invention is directed to formulations and methods of treating and/or preventing dry eye syndrome. In a broad form, the invention relates to a formulation comprising omega-3 oil, vitamin D and gamma-linolenic acid for use in treating and/or preventing dry eye syndrome.

[0010] In a first aspect, the invention resides in a formulation for treating and/or preventing dry eye syndrome comprising omega-3 oil, vitamin D and gamma-linolenic acid.

[0011] Suitably, the omega-3 oil comprises one or more triglycerides. Preferably, the triglycerides comprise one or more polyunsaturated fatty acids such as eicosapentaenoic acid and docosahexaenoic acid.

[0012] In one embodiment, the omega-3 oil is selected from the group consisting of fish oil, squid oil, krill oil, algae oil, and combinations thereof. Suitably, the omega-3 oil is present in the formulation in an amount suitably between about 20% and about 90%, more suitably between about 30% and about 80%, preferably between about 40% and about 70%, more preferably between about 50% and about 70%, and most preferably about 60% by weight of the formulation.

[0013] In an embodiment, the polyunsaturated fatty acid is present in the formulation in an amount suitably between about 5% and about 50%, more suitably between about 10% to about 40%, preferably between about 20% and about 35%, and most preferably about 30% by weight of the formulation.

[0014] In one embodiment, the eicosapentaenoic acid is present in the formulation in an amount suitably between about 1% and about 50%, more suitably between about 10% and about 30%, preferably between about 15% and about 20%, and most preferably about 18% by weight of the formulation.

[0015] In another embodiment, the amount of docosahexaenoic acid present in the formulation in an amount is suitably between about 1% and about 40%, more suitably between about 7% and about 20%, preferably between about 10% and about 15%, and most preferably about 12% by weight of the formulation.

[0016] In an embodiment, the gamma-linolenic acid is present in the formulation as Borago officinalis. The Borago officinalis is present in the formulation in an amount suitably between about 10% and about 70%, more suitably between about 20% and about 50%, preferably between about 30% and about 40%, and most preferably about 34% by weight of the formulation.

[0017] In another embodiment, the gamma-linolenic acid is present in the formulation in an amount suitably between about 1% and about 20%, more suitably between about 2% and about 15%, preferably between about 5% and about 10%, and most preferably about 7% by weight of the formulation.

[0018] In an embodiment, the vitamin D is vitamin D3. Suitably, the vitamin D is present in the formulation in an amount between about 0.0001% and about 0.1%, preferably between about 0.001% and about 0.05%, and most preferably about 0.01 % by weight of the formulation.

[0019] In a further embodiment, the formulation further comprises a tocopherol concentrate. Suitably, the tocopherol concentrate is a mixed tocopherol concentrate. Suitably, the tocopherol concentrate is present in the formulation in an amount suitably between about 0.01% and about 5%, more suitably between about 0.01% and about 3%, preferably between about 0.1% and about 1%, and most preferably about 0.8% by weight of the formulation.

[0020] In another embodiment, the formulation further comprises vitamin E. Suitably, the vitamin E is present in the formulation as d-alpha tocopheryl acetate. Suitably, the vitamin E is present in the formulation in an amount between about 1% and about 10%, more suitably between about 1% and about 5%, preferably between about 2% and about 3%, and most preferably about 2.1 % by weight of the formulation.

[0021 ] In one embodiment, the formulation may be a dietary supplement.

[0022] In one particular embodiment, the formulation may be in a capsule or other orally administrable solid or semi-solid form.

[0023] In a second aspect, the invention resides in a method of treating and/or preventing dry eye syndrome in a subject, the method including a step of administering to the subject a therapeutically effective amount of a formulation comprising omega-3 oil, vitamin D and gamma-linolenic acid.

[0024] The formulation is as described in any one or more embodiments of the first aspect.

[0025] In this specification, words such as “comprises” or “includes” are intended to define a non-exclusive inclusion, such that a method or formulation that comprises a list of elements does not include only those elements but may include other elements not expressly listed, including elements that are inherent to such a method or formulation.

[0026] As used herein, the term ‘about’ means the amount is nominally the number following the term ‘about’ but the actual amount may vary from this precise number to an unimportant degree.

[0027] As used herein, the phrase ‘consisting essentially of indicates that a stated integer or group of integers are required or mandatory, but that other elements that do not interfere with or contribute to the activity or action of the stated integer or group of integers are optional.

[0028] The term “therapeutically effective amount” describes a quantity of the formulation of the first aspect sufficient to achieve a desired effect in a subject being treated. For example, this can be the amount of a formulation comprising omega-3 oil, vitamin D and gamma-linolenic acid necessary to treat and/or prevent dry eye syndrome. In some embodiments, a “therapeutically effective amount” is sufficient to reduce or eliminate a symptom of dry eye syndrome. In other embodiments, a “therapeutically effective amount” is an amount sufficient to achieve a desired biological effect. The “therapeutically effective amount” will vary, in a manner which would be understood by a person of skill in the art, with patient age, sex, weight etc.

[0029] As used herein, the amounts expressed by the ‘% by weight of the formulation’ are based on the active ingredients in the formulation. The ‘% by weight of the formulation’ is calculated using the total amount of active ingredients. In this regard, the active ingredients include the omega-3 oil, vitamin D, Borago officinalis, vitamin E and tocopherol concentrate. The active ingredients do not include substances that are inactive, such as excipients, solvents, carriers, auxiliaries, diluents, preservatives, binders, buffers, fillers, coatings and the like.

[0030] As used herein, the term ‘subject’, includes both human and veterinary subjects. For example, administration to a subject can include administration to a human subject or a veterinary subject. Preferably, the subject is human.

[0031] As used in this specification, the indefinite articles “a” and “an” may refer to one entity or a plurality of entities and are not to be read or understood as being limited to a single entity.

[0032] The various features and embodiments of the present invention referred to in the individual sections above apply, as appropriate, to other sections, mutatis mutandis. Consequently features specified in one section may be combined with features specified in other sections as appropriate.

[0033] Further features and advantages of the present invention will become apparent from the following detailed description.

DETAILED DESCRIPTION OF THE INVENTION

[0034] Embodiments of the present invention reside primarily in a formulation for treating and/or preventing dry eye syndrome. Accordingly, the method steps and formulation have been described showing only the specific details necessary for understanding the embodiments of the present invention to not obscure the disclosure with excessive detail that will be readily apparent to those of ordinary skill in the art having the benefit of the present description.

[0035] The present inventors have formulated a formulation which, when administered to a subject, alleviates the symptoms of dry eyes syndrome and/or assists in preventing dry eyes syndrome. The symptoms of dry eyes syndrome include, but are not limited to, stinging, pain, dryness, redness, a gritty feeling, discomfort, burning, itchiness, blurred vision and light sensitivity.

[0036] In a first aspect, although it need not be the only or indeed the broadest form, the invention resides in a formulation for treating and/or preventing dry eye syndrome comprising omega-3 oil, vitamin D and gamma-linolenic acid.

[0037] Omega-3 oil is an oil that comprises at least one omega-3 triglyceride. Omega-3 triglycerides are an important building block in maintaining normal metabolism. Furthermore, the eyes and brain of mammals are extremely rich in omega-3 triglycerides. The omega-3 triglycerides present in the formulation can be derived from a number of different sources.

[0038] Suitably, the omega-3 oil comprises one or more triglycerides that respectively comprise polyunsaturated fatty acids. In some embodiments, the polyunsaturated fatty acid comprises 16-24 carbons. In some embodiments, the polyunsaturated fatty acid comprises 2-6 double bonds. In some embodiments, the polyunsaturated fatty acids are omega-3 fatty acids. Some non-limiting examples of omega-3 fatty acids are α-linolenic acid (ALA), hexadecatrienoic acid (HTA), stearidonic acid (SDA), eicosatrienoic acid (ETE), eicosatetraenoic acid (ETA), eicosapentaenoic acid (EPA), heneicosapentaenoic acid (HPA), docosapentaenoic acid (DPA; clupanodonic acid), docosahexaenoic acid (DHA), tetracosapentaenoic acid, and tetracosahexaenoic acid (nisinic acid). In one embodiment, the omega-3 oil comprises eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

[0039] It will be appreciated that the omega-3 oil may be extracted from plants and animals. As known well in the art, sources of omega-3 oil include sardines, herring, mackerel, salmon, halibut, tuna, swordfish, mussels, tilefish, tuna, Pollock, catfish, flounder, grouper, snapper, shark, hoki, gemfish, cod, oysters, snapper, eggs, broccoli, barramundi, prawn, krill oil, squid oil, algae oil, linseed, hemp, canola, raspberry, camelina, fig seed, longonberry, chia seed, kiwifruit and perilla. The person skilled in the art will appreciate that the list provided merely exemplifies some examples of the sources of omega-3 oil, and that the omega-3 oil can be obtained from numerous other sources. In one embodiment, the omega-3 oil is selected from the group consisting of fish oil, squid oil, krill oil, algae oil and combinations thereof.

[0040] The omega-3 oil may be present in the formulation in an amount suitably between about 20% and about 90%, more suitably between about 30% and about 80%, preferably between about 40% and about 70%, more preferably between about 50% and about 70%, and most preferably about 60% by weight of the formulation.

[0041] The one or more polyunsaturated fatty acids may be present in the formulation in a total amount suitably between about 1% and about 60%, more suitably between about 2% to about 50%, preferably between about 10% and about 40%, and more preferably about 25-35% or about 30% by weight of the formulation.

[0042] In particular embodiments, eicosapentaenoic acid may be present in the formulation in an amount suitably between about 1 % and about 50%, more suitably between about 10% and about 30%, preferably between about 15% and about 20%, and more preferably about 18% by weight of the formulation.

[0043] In particular embodiments, docosapentaenoic acid may be present in the formulation in an amount suitably between about 1% and about 40%, more suitably between about 7% and about 20%, preferably between about 10% and about 15%, and more preferably about 12% by weight of the formulation.

[0044] Gamma-linolenic acid can play a role in affecting the cellular process involved in inflammation. As such, it is postulated that gamma-linolenic acid can treat and/or prevent dry eye syndrome through its effect on inflammation. Additionally, it is believed that gamma-linolenic acid can be metabolised to antiinflammatory prostaglandin PGE-1. It will be appreciated that the gamma-linolenic acid may be extracted from natural products, or synthesized using known synthetic techniques. It is well known in the art that sources of gamma-linolenic acid include borage seed oil (Borago officinalis), primrose oil, blackcurrant seed oil, hemp seed oil, oats, barley and spirulina. The gamma-linolenic acid may be present in the formulation as Borago officinalis. The Borago officinalis may be present in the formulation in an amount suitably between about 10% and about 70%, more suitably between about 20% and about 50%, preferably between about 30% and about 40%, and most preferably about 34% by weight of the formulation. It will be appreciated that the amount of gamma-linolenic acid present in an oil may differ from oil to oil. In this regard, the formulation may have the gamma-linolenic acid in an amount suitably between about 1% and about 20%, more suitably between about 2% and about 15%, preferably between about 5% and about 10%, and most preferably about 7% by weight of the formulation.

[0045] It is proposed that there is a link between vitamin D deficiency and dry eye syndrome. As such, the vitamin D in the formulation addresses this deficiency. It will be appreciated that the vitamin D may be extracted from natural sources, or synthesized using known synthetic techniques. Non-limiting sources of vitamin D include lichen, cod liver oil, salmon, mackerel, tuna, sardines, egg yolk and beef liver. Vitamin D may be present in the formulation as cholecalciferol. Suitably, the vitamin D may be vitamin D2 or vitamin D3. Preferably, the vitamin D is vitamin D3.

[0046] The vitamin D may be present in the formulation in an amount suitably between about 0.0001% and about 0.1%, preferably between about 0.001% and about 0.05%, and most preferably about 0.01 % by weight of the formulation.

[0047] The formulation may further comprise a tocopherol concentrate. Tocopherol is a known antioxidant. The antioxidant properties of tocopherol counteract free radicals, and assists in preventing and repairing cell damage. In addition, the antioxidant properties help to stabilize cell membranes and protect the tissue of the eyes. The person skilled in the art will appreciate that there are many compounds that fall under the class of tocopherols. As such, the tocopherol concentrate may be a mixed tocopherol concentrate. In one embodiment, the tocopherol concentrate comprises gamma tocopherol.

[0048] The tocopherol may be extracted from natural products, or synthesized using known synthetic techniques. Non-limiting examples of sources of tocopherol include nuts, seeds and oils, such as wheat germ oil, sunflower oil, almond oil, sunflower seed, almond, hazelnut, walnut, peanut oil, olive oil, poppyseed oil, peanut, pollard, maize, poppy seed, asparagus, oats, chestnut, coconut, tomatoes, walnut, carrots and goat’s milk. The tocopherol concentrate is present in the formulation in an amount suitably between about 0.01% and about 5%, more suitably between about 0.01% and about 3%, preferably between about 0.1% and about 1%, and most preferably about 0.8% by weight of the formulation.

[0049] The formulation may further comprise vitamin E. Vitamin E is an antioxidant, and it is believed that vitamin E can protect certain parts of the eye. In this regard, it is believed that vitamin E can protect the parts of the eye that are particularly susceptible to oxidative damage. Additionally, a combination of vitamin E with other antioxidants may be able to alleviate the problem of age-related macular degeneration. The vitamin E may be present in the formulation in an amount suitably between about 1% and about 10%, more suitably between about 1% and about 5%, preferably between about 2% and about 4%, and most preferably about 2.1% by weight of the formulation. The vitamin E may be present as d-alpha tocopherol.

[0050] The amount of vitamin E and vitamin D in the formulation may be based on their biological activity. It will be appreciated that different substances have different biological activities and so the amount of each substance will vary. In this regard, the international units (IU) may be used to define the amount of these vitamins in the formulation. The international unit is a unit of measurement for the amount of a substance, and this amount varies based on the biological activity of the substance. International units are used to quantify vitamins, hormones, some medications, vaccines and blood products. The international unit is typically used for determine the amount of a substance in a dose or capsule.

[0051] It will be appreciated that vitamin E can be present in the formulation as a number of different compounds. Non-limiting examples of these compounds include d-alpha-Tocopherol, dl-alpha-Tocopherol, d-alpha-Tocopheryl acetate, dl-alpha-Tocopheryl acetate, d-alpha-Tocopheryl acid succinate and dl-alpha-Tocopheryl acid succinate. In one embodiment, the vitamin E is present in the formulation as d-alpha tocopherol.

[0052] In one embodiment, the amount of vitamin E may be suitably between about 5 IU and about 200 IU, more suitably between about 10 IU and about 100 IU, preferably between about 30 IU and about 50 IU, and most preferably about 40 IU. In another embodiment, the amount of vitamin D may be suitably between about 100 IU and about 1000 IU, more suitably between about 150 IU and about 500 IU, preferably between about 150 IU and about 300 IU, and most preferably about 200 IU.

[0053] The formulation alleviates the symptoms associated with dry eye syndrome, and alleviates the need for artificial tears. As previously mentioned, this is a significant advantage because subjects may face difficulties in using artificial tears.

[0054] The formulation is believed to be more beneficial than other products, such as artificial tears, because it provides longer term relief. It is believed that the artificial tears only rehydrate the eye and prevent further evaporation to provide short term relief to dry eye syndrome. It is believed that the present invention is able to provide longer term relief by addressing the problem systemically.

[0055] It will be appreciated that the formulation may be provided in any suitable formulation. In this regard, the formulation may be in a solid form, a liquid form, a gel form, a powder form, a paste form, and the like. In this regard, the formulation may be in the form of a tablet, a capsule and the like. Suitably, the formulation is in the form of a capsule, or a liquid. Preferably, the formulation is in the form of a capsule. The formulation may be in liquid form and combined with other pharmaceutically acceptable excipients such as emulsifiers, rheology modifiers, dispersants and the like. The formulation may include other food grade products such as starch, sugars, colouring agents, flavouring agents, fillers and the like.

[0056] Any carrier or diluent, or other excipients, will depend on the route of administration, and again the person skilled in the art will readily be able to determine the most suitable formulation for each particular case.

[0057] Frequently used carriers or auxiliaries include but are not limited to other oils, sugars, talc, milk protein, gelatin, starch, vitamins, cellulose and its derivatives, animal and vegetable oils, polyethylene glycols and solvents, such as sterile water, alcohols, glycerol and polyhydric alcohols. Preservatives include antimicrobials, anti-oxidants, and chelating agents. Other pharmaceutically acceptable carriers include aqueous solutions, non-toxic excipients, including salts, preservatives, buffers and the like, as described, for instance, in Remington's Pharmaceutical Sciences, 20th ed. Williams & Wilkins (2000) and The British National Formulary 43rd ed. (British Medical Association and Royal Pharmaceutical Society of Great Britain, 2002; http://bnf.rhn.net), the contents of which are hereby incorporated by reference. The pH and exact concentration of the various components of the pharmaceutical composition are adjusted according to routine skills in the art. See Goodman and Gilman's The Pharmacological Basis for Therapeutics (7th ed., 1985).

[0058] Diluents may include one or more of microcrystalline cellulose, lactose, mannitol, calcium phosphate, calcium sulfate, kaolin, dry starch, powdered sugar, and the like. Binders may include one or more of povidone, starch, stearic acid, gums, hydroxypropylmethyl cellulose and the like. Solvents may include one or more of ethanol, methanol, isopropanol, chloroform, acetone, methylethyl ketone, methylene chloride, water and the like. Buffers may include phosphate buffers, borate buffers and carbonate buffers, although without limitation thereto. Fillers may include one or more gels inclusive of gelatin, starch and synthetic polymer gels, although without limitation thereto. Coatings may comprise one or more of film formers, solvents, plasticizers and the like. Suitable film formers may be one or more of hydroxypropyl methyl cellulose, methyl hydroxyethyl cellulose, ethyl cellulose, hydroxypropyl cellulose, povidone, sodium carboxymethyl cellulose, polyethylene glycol, acrylates and the like. Plasticizers may be one or more of propylene glycol, castor oil, glycerin, polyethylene glycol, polysorbates, and the like.

[0059] Reference is made to the Handbook of Excipients 6th Edition, Eds. Rowe, Sheskey & Quinn (Pharmaceutical Press), which provides non-limiting examples of excipients which may be useful according to the invention.

[0060] The formulation may further comprise flavour oil. Flavour oil is an oil that generally includes volatile compounds having a pleasant aroma, fragrance or smell. Typically, flavour oils or components thereof are obtained from suitable plants, fruit, vegetables, herbs or spices. The flavour oil may be, for example, an essential oil, cold pressed oil, an infused oil or any other lipid-containing extract, fraction or infusion that comprises one or more therapeutically effective elements of the source material from which it is derived. In particular embodiments, the flavour oil is an essential oil.

[0061 ] Flavour oil typically contains the characteristic fragrance of the source material from which it has been derived. It would be apparent to the person skilled in the art that the constituents of a flavour oil may vary depending upon, for example, the production and/or extraction methods used as well as the source material (i.e., fruit, vegetables, plants, herbs, spices etc), from which the oil has been derived. Preferably, the flavour oil of the present invention is suitable for human consumption.

[0062] Non-limiting examples of flavour oils include orange oil, eucalyptus oil, geranium oil, lemongrass oil, petitgrain oil, rosemary oil, thyme oil (white and red), lavender oil, tea tree oil, Tagete minuta oil, lovage oil, Lippia javanica oil, lemon oil, peppermint oil, grapefruit oil, oil of bergamot, galbanun oil, pennyroyal oil, pomegranate oil, apple peel oil, cinnamon oil, raspberry oil, strawberry oil, black pepper oil and citrus peel oils. Examples of components or derivatives of flavour oils include, but are not limited to, acetophenone, allyl caprate, a-amylcinnamic aldehyde, amyl salicylate, trans-anethole, anisaldehyde, benzyl alcohol, benzyl acetate, benzyl propionate, bomeol, β-caryophyllene, caryophyllene, cinnamyl acetate, cinnamaldehyde, cinnamic alcohol, cinnamyl alcohol, carvacrol, carved, citral, citronellal, citronellol, cumin aldehyde, cyclamen aldehyde, decanol, dimethyl salicylate, ethyl butyrate, ethyl caprate, ethyl cinnamate, eucalyptol (cineole), eugenol, iso-eugenol, galaxolide, geranial, geraniol, germacrene D, guaiacol, hexenol, α-hexylcinnamic aldehyde, hydroxycitrolnellal, ionone, ipsdienone, isopropenyl acetophenone, linalol, linalyl acetate, menthol, p-methylacetophenone, methyl anthranilate, methyl dihydrojasmonate, methyl eugenol, methyl ionone, methyl salicylate, neral, a-phellandrene, perillaldehyde, 1- or 2-phenyl ethyl alcohol, 1- or 2-phenyl ethyl propionate, piperine, piperonal, piperitenone, piperonyl acetate, piperonyl alcohol, o-isopropenyl anisole, D-pulegone, terpinen-4-ol, terpinyl acetate, A-tert-butylcyclohexyl acetate, α-terpineol, thymol, trans-tagetenone, myrcenone, linalool, carvone, ipsenone, α-phellandrene, piperitenone, gamma-undecalactone, undecenal, vanillin, and ethyl vanillin. In one embodiment, the flavour oil is orange oil. The flavour oil advantageously masks the flavour of the omega-3 oil to provide a more pleasurable experience to the consumer.

[0063] In the embodiment where the formulation is provided in capsule form, the capsule will typically have a soft gelatin shell. The soft gelatin shell will typically be made from a combination of gelatin, glycerol and purified water. However, it will be appreciated by the person skilled in the art that other shells can be used with the formulation.

[0064] The composition may additionally be combined with other compositions or compounds to provide an operative combination or cotreatment. It is intended to include any chemically compatible combination of pharmaceutically-active agents, as long as the combination does not negatively impact upon the activity of the metals of this invention.

[0065] In one embodiment, the formulation comprises omega-3 oil, vitamin D, gamma-linolenic acid, vitamin E and tocopherol concentrate, wherein the omega-3 oil comprises one or more omega-3 triglycerides that comprise eicosapentaenoic acid and docosahexaenoic acid.

[0066] In another embodiment, the formulation consists essentially of omega-3 oil, vitamin D, gamma-linolenic acid, vitamin E and tocopherol concentrate, wherein the omega-3 oil comprises one or more omega-3 triglycerides that comprise eicosapentaenoic acid and docosahexaenoic acid.

[0067] In one embodiment, a capsule comprising the formulation may have the formulation with the following ranges of each active ingredient: - an omega-3 oil that comprises one or more omega-3 triglyceride that comprises: o eicosapentaenoic acid in an amount between about 100 mg and about 400 mg, and o docosahexaenoic acid in an amount between about 50 mg and about 250 mg; a gamma-linolenic acid in an amount between about 20 mg and about 150 mg; vitamin D3 in an amount between about 40 IU and 400 IU; vitamin E in an amount between about 5 IU and 100 IU; and gamma-tocopherol in an amount between about 1 mg and about 30 mg.

[0068] Suitably, the amount of eicosapentaenoic acid in the capsule may be between about 150 mg and about 350 mg, more suitably between about 200 mg and about 300 mg, and preferably about 240 mg.

[0069] Suitably, the amount of docosahexaenoic acid in the capsule may be between about 100 mg and about 200 mg, more suitably between about 150 mg and about 180 mg, and preferably about 160 mg.

[0070] Suitably, the amount of gamma-linolenic acid in the capsule may be between about 30 mg and about 130 mg, more suitably between about 50 mg and about 120 mg, preferably between about 80 mg and about 120 mg, and most preferably about 100 mg.

[0071] Suitably, the amount of vitamin D3 in the capsule may be between about 50 IU and about 350 IU, more suitably between 100 IU and 300 IU, preferably between about 150 IU and about 250 IU, and most preferably about 200 IU.

[0072] Suitably, the amount of vitamin E in the capsule may be between about 10 IU and about 90 IU, more suitably between 20 IU and 50 IU, preferably between about 30 IU and about 50 IU, and most preferably about 40 IU.

[0073] Suitably, the amount of gamma-tocopherol in the capsule may be between about 1 mg and about 20 mg, more suitably between 1 mg and 10 mg, preferably between about 1 mg and 5 mg, and preferably about 4.38 mg.

[0074] In a further embodiment, a capsule comprising the formulation may have the formulation with one or more omega-3 triglyceride that comprises 240 mg of eicosapentaenoic acid and 160 mg of docosahexaenoic acid; 100 mg of gamma-linolenic acid, 200 IU of vitamin D3, 40 IU of vitamin E, and 10 IU of mixed tocopherol. The mixed tocopherol has about 4.38 mg of gamma-tocopherol. Suitably, these capsules can be administered with a daily dose of between 1 and 4 capsules.

[0075] In one embodiment, the formulation may be a dietary supplement.

[0076] In a second aspect, the invention resides in a method of treating and/or preventing dry eye symptoms in a subject, the method including step of administering to the subject a therapeutically effective amount of a formulation comprising omega-3 oil, vitamin D and gamma-linolenic acid, wherein the omega-3 oil comprises one or more triglycerides that respectively comprise one or more polyunsaturated fatty acids.

[0077] The formulation is as described for the first aspect.

[0078] The term ‘administering’ or ‘administration’, as used herein, is defined as the introduction of an orally administrable formulation (e.g. comprising omega-3 oil, vitamin D and gamma-linolenic acid) into a subject by a chosen route, and in particular by the oral route.

[0079] The amount of the formulation prescribed to a subject may vary depending on manner of administration, nature and severity of the symptoms, age and body weight of the subject. Under certain circumstances, however, higher or lower daily amounts of the formulation may be appropriate. The administration of the formulation can be carried out both by single administration in the form of an individual administration or by several smaller administrations by multiple administrations at specific intervals. Alternatively, the administration of the formulation may be given in an extended, depot or slow release format.

[0080] It is postulated that the initial administration of the formulation will be greater to restore tear balance and reduce inflammation. The initial administration of the formulation may suitably be 3 capsules per day for about 4-6 weeks. The administration may then be reduced to maintain the tear balance at an appropriate level. The latter administration may suitably be reduced to 1 or 2 capsules per day.

[0081] So that the present invention may be readily understood and put into practical effect, the person skilled in the art is referred to the following nonlimiting examples.

EXAMPLES

Example 1 - Sample formulation [0082] A formulation capable of treating and/or preventing dry eye symptoms was prepared containing the relative amounts of the ingredients shown in Table 1 below. The formulation was prepared by the process described in Example 2.

Table 1 - Sample formulation Example 2 - Example Manufacturing Process [0083] The following working steps were taken to produce a formulation with the relative amounts as set out in Table 1: a. adding the omega-3 triglyceride, vitamin D3, vitamin E, mixed tocopherol and Borago officinalis to a suitably sized vessel; b. mixing the omega-3 triglyceride, vitamin D3, vitamin E, mixed tocopherol and Borago officinalis to ensure uniformity of the formulation; and c. forming the formulation as a capsule.

[0084] The above description of various embodiments of the present invention is provided for purposes of description to one of ordinary skill in the related art. It is not intended to be exhaustive or to limit the invention to a single disclosed embodiment. As mentioned above, numerous alternatives and variations to the present invention will be apparent to those skilled in the art of the above teaching. Accordingly, while some alternative embodiments have been discussed specifically, other embodiments will be apparent or relatively easily developed by those of ordinary skill in the art. Accordingly, this invention is intended to embrace all alternatives, modifications and variations of the present invention that have been discussed herein, and other embodiments that fall within the spirit and scope of the above described invention.

Claims (5)

1. A formulation for treating and/or preventing dry eye syndrome comprising omega-3 oil, vitamin D and gamma-linolenic acid, wherein the omega-3 oil comprises one or more triglycerides that respectively comprise one or more polyunsaturated fatty acids.

2. The formulation of claim 1 further comprising vitamin E.

3. The formulation of claim 1 or claim 2, further comprising a tocopherol concentrate.

4. A capsule comprising a formulation for treating and/or preventing dry eye syndrome that comprises: - an omega-3 oil comprising one or more triglycerides that comprise: o eicosapentaenoic acid in an amount between about 100 mg and about 400 mg, and o docosahexaenoic acid in an amount between about 50 mg and about 250 mg; - gamma-linolenic acid in an amount between about 20 mg and about 150 mg; - vitamin D3 in an amount between about 40 IU and 400 IU; - vitamin E in an amount between about 5 IU and 100 IU; and - gamma-tocopherol in an amount between about 1 mg and about 30 mg.

5. A method of treating and/or preventing dry eye syndrome in a subject, the method including step of administering to the subject a therapeutically effective amount of a formulation comprising omega-3 oil, vitamin D and gamma-linolenic acid, wherein the omega-3 oil comprises one or more triglycerides that respectively comprise one or more polyunsaturated fatty acids.