NUTRITIONAL SUPPLEMENT FORMULATION

FOR USE IN TATTOOING

The present disclosure relates to a nutritional supplement formulation containing a substance inducing, supporting and/or promoting wound healing and the use of such a formulation in connection with tattooing . Particularly, the nutritional supplement formulation contains one or more wound healing substance selected from the group consisting of hyaluronic acid, coenzyme Qio (ubiquinole and ubiquinone), panthenol and/or pantothenic acid, vitamin C, zinc, bamboo extract, acai berry extract, folic acid and biotin.

A particularly preferred use of the nutritional supplement formulation is the pre- and/or post-treatment of tattooing. The nutritional supplements ingredients of the present invention do not interact with the pigments used for tattooing and therefore the nutritional supplements can be used for maintaining and/or improving the coloring and/or the color saturation of a tattoo. The oral intake (i.e. administration) of the nutritional supplement formulations of the invention by a subject provides a better wound healing after tattooing and, therefore, can be used to obtain an improved coloring and/or color saturation of a resulting tattoo compared to a tattoo where the subject did not ingested the inventive nutritional supplement formulations before, during or after tattooing .

Description of the invention

Several nutritional supplement formulations are known in the art, but these products are not adapted to the specific requirements of the human skin before, during and/or after tattooing.

The present invention relates to a nutritional supplement for use before, during and after a tattooing process. During tattooing the skin of the individual (subject) is hurt. Already during the tattooing a wound healing process begins. During this wound healing process the human body needs many micro nutrients, enzymes and substances in order to induce, support and/or promote healing and regeneration of the dermal tissue in an optimal manner.

In the present invention such nutrients are applied to induce, support or improve the wound healing of the tattooed skin by providing substances which the body requires in the healing processes. Additionally, in the composition of the substances care is taken that there is no interaction with the color pigments which adversely influences the tattoo.

By administration of these substances the wound healing is improved and a better and/or more intense coloring of the tattoo is achieved . In addition, there are lesser infections and, therefore, reduced complications after tattooing. As a further effect, the need of re-tattooing (i.e. the need of tattooing the same tattoo again) is reduced to some extent so that further costs and pains can be avoided.

Accordingly, a nutritional supplement formulation, which contains a wound healing substance, is provided for use in the pre- and/or post-treatment of tattooing, for use in improving the coloring and/or color saturation of the tattoo and/or for use in improving the skin appearance after tattooing .

The term "tattoo" as used herein refers to the region of the skin of a subject which is tattooed by using a suitable tattooing method .

The term "wound healing substance" as used herein refers to substances promoting and/or supporting the healing of wound so that the wound is healed more rapidly and/or with lesser permanent or long lasting defects like scars or other affections of the skin. The term "administered" as used herein refers to the intake of the nutritional supplement formulation by the subject. An oral administration is most preferred .

The term "dose" as used herein refers to the amount of the nutritional supplement formulation administered to the subject.

The term "daily dose" as used herein refers to the amount of the respective substance which is administered to the subject per day.

The term "single application dose" as used herein refers to the amount of the nutritional supplement formulation administered to the subject in one administration.

The term "dosage form" as used herein refers to a product in the form in which it is marketed for use, involving a mixture of the active nutrients and excipient, along with other non-reusable material that is not considered as being an ingredient or packaging (such as a capsule shell, for example).

The term "capsule" as used herein refers to a dosage element which is used to deliver a predetermined amount of a nutritional supplement formulation to a subject, wherein the capsule comprises a shell surrounding and containing the nutritional supplement formulation.

Numeric ranges recited in the present invention may be combined in any reasonable way. Specifically, if multiple upper limits and multiple lower limits of a range (including the broadest disclosed range) are disclosed, it is intended to cover each range obtained by combining any upper limit with any lower limit. It is even desired to cover any combination of lower limits and/or upper limits.

Further, if not stated otherwise, "%" in the present invention means "wt.- %" (% by weight). Moreover, whenever the description below states that an ingredient is contained in a certain amount (wt.-%) in a material, this means that the percentage is relative to the total (weight) of the material. For example, a statement that the nutritional supplement formulation "contains at least 20.00 wt.-% Vitamin C" means that the nutritional supplement formulation contains at least 0.2 gram (g) Vitamin C when assuming that the total weight of the formulation is 1 gram.

In the present invention, ingredients may be sometimes be referred to in accordance with the INCI/CTFA nomenclature (International Nomenclature of Cosmetic Ingredients). In any case, if an acidic or basic ingredient is disclosed below, it is desired to include the acidic or basic from, respectively, as well as pharmacologically and/or cosmetically acceptable salts thereof either individually or as a mixture. Similarly, if the description below recites a salt, it is desired to include the salt form as well as the free acid/base form thereof either individually or as a mixture.

According to a preferred embodiment of the present invention, a nutritional supplement formulation (in the following sometimes simply referred to as the "formulation") is provided, which contains one or more substances inducing, supporting and/or promoting wound healing (in the following, simply referred to as "wound healing substance(s)"). The wound healing substance(s) is/are preferably selected from the group consisting of hyaluronic acid, coenzyme Qio (ubiquinole and ubiquinone), panthenol and/or pantothenic acid, vitamin C (ascorbic acid), zinc, bamboo extract, acai berry extract, folic acid and biotin, or any suitable derivative or compound of these substances exerting the relevant biochemical action, function or effect of the respective substance. Preferably, each of the wound healing substances can be comprised in the nutritional supplement formulation alone or in combination of one or more of them.

In a preferred embodiment, the nutritional supplement formulation comprises at least one of vitamin C, zinc or biotin . In a particularly preferred embodiment, the nutritional supplement formulation comprises a combination of vitamin C, zinc and biotin.

In a particularly preferred embodiment, the nutritional supplement formulation comprises bamboo extract including high amounts of silica and/or an acai berry extract powder. In a particularly preferred embodiment, the nutritional supplement formulation comprises Qio (ubiquinole and ubiquinone), panthenol and/or pantothenic acid.

In a preferred embodiment, the total weight of the nutritional supplement formulation being administered as a single application dose, and preferably being comprised in one dosage form (i.e. in case of liquids or powders, a suitable amount of the liquid or powder), is preferably 0.1 grams to 10 grams. In a preferred embodiment, a single application dose comprises 0.1 grams to about 1.5 grams, more preferred from about 0.2 grams to about 1.0 gram of the nutritional supplement formulation.

Preferably, on the basis of the total weight of the formulation representing 100 wt.-%, the nutritional supplement formulation independently (i.e. each of these substance may be separately present in the formulation) comprises at least one wound healing substance in the following amount(s) :

> 30.00 wt.-% Ascorbic acid (Vitamin C),

2.00-15.00 wt.-%, Bamboo Extract

2.00-20.00 wt.-%, Zinc

1.00-10.00 wt.-% Acai berry extract,

0.50-10.00 wt.-% Pantothenic acid (Vitamin B ₅ ),

0.01-0.10 wt.-% Folic acid,

0.001-0.05 wt.-% D-Biotin (Vitamin H).

In addition to the above wound healing substance(s), on the basis of the total weight of the formulation representing 100 wt.-%, the nutritional supplement formulation may further comprises 5.00-20.00 wt.-% of an excipient, preferably cellulose or a cellulose derivative. In a particularly preferred embodiment, the nutritional supplement formulation comprises at least 30.00 wt. % vitamin C, preferably 30.00- 70.00 wt.-%, more preferably 40.00-60.00 wt.-% and even more preferably 50.00-55.00 wt.-% of vitamin C on the basis of the total weight of the formulation representing 100 wt.-% .

In a preferred embodiment, one or more of the wound healing substance(s) is combined with one or more additional substance selected from the group consisting of millet extract, N-acetylcysteine, vitamin D (i.e. at least one of vitamins Di _-5 ), one or more carotenoid(s) (beta- carotene, a/p/73-carotene, cryptoxanthin, zeaxanthin, lutein), green tea extract, selenium and beta- glucans.

Preferably, by using the nutritional supplement formulation described herein, the following substances which may be comprised in the formulation are administered (separately or in combination of two or more of these substances) in the following daily dose(s) :

Vitamin C 60 to 1000 mg, preferably 500 mg Zinc 5 to 50 mg, preferably 15 to 25 mg

D-Biotin (Vitamin H) 30 to 100 pg, preferably 50 pg

Pantothenic acid (Vitamin B ₅ ) 5 to 1000 mg, preferably 400 mg

Folic acid 200 to 800 pg, preferably 400 pg

Hyaluronic acid : 10 to 100 mg, preferably 70 mg

Millet extract 300 to 800 mg, preferably 500 mg

N-Acetylcysteine 30 to 200 mg, preferably 150 mg

Coenzyme Q 10 10 to 100 mg, preferably 50 mg

Vitamin D 300 to 2000 IU, preferably 1000 IU

Carotenoid(s) 20 to 100 mg, preferably 80 mg

Green tea extract (90% catechins) 100 to 500 mg, preferably 200 mg

Selenium 20 to 150 pg, preferably 50 pg

£>efa-Glucan(s) 50 to 500 mg, preferably 150 mg . In a particularly preferred embodiment, the nutritional supplement formulation, preferably being comprised in a capsule as described herein, has the following composition :

D-Biotin (Vitamin H) 0.05 mg

Folic acid 200 pg

Calcium-D-pantothenate 5 mg

Ascorbic Acid (in the form of calcium ascorbate dihydrate) 250 mg

Zinc-D-gluconate 10 mg

Bamboo extract (comprising 50% silicon) 50 mg

Acai berry extract 20 mg

In a preferred embodiment, the nutritional supplement formulation described herein is used in connection with tattooing . In a particularly preferred embodiment, the formulation is used in the pre- and/or post- treatment of tattooing and/or for improving the skin appearance before, during and after tattooing .

In a preferred embodiment, the formulation described herein is used for the manufacturing of a pharmaceutical composition for the treatment of the skin before, during and after tattooing as described herein.

In a preferred embodiment, the nutritional supplement formulation described herein is used in a method of treatment of the skin before, during and after tattooing as described herein.

In a preferred embodiment, the nutritional supplement formulation is used in combination with a lotion, a cream or a patch or a set of patches (e.g. a dermal patch and/or a hydrogel patch) which are used for the external treatment of tattoos after tattooing .

In a particularly preferred embodiment, a kit (i.e. a set, being a combination of products) for use in the pre- and/or post-treatment of tattooing is provided, wherein the kit comprises the nutritional supplement formulation as defined above and one or more dermal patch, a set of patches, a cream and/or a lotion for the external treatment of tattoos after tattooing.

The patch may correspond to the patches or the set of patches as described in WO 2015/158841, which content is incorporated herewith by reference. In this connection, the term "patch" is used in a broad sense and generally encompasses but is not limited to a skin dressing, a wound dressing, and a patch in strict sense. For the sake of brevity, the term "patch" is used in the present application, although all definitions mentioned above equally apply

In a preferred embodiment, the patch, the cream and/or the lotion to be combined with the nutritional supplement formulation as described above may comprise bisabolol, Aloe vera/Aloe barbadensis (leaf) extract, dexpanthenol, vitamin E, Witch-hazel (Hamamelis) extract, Arnica extract, Salvia extract, Symphytum extract (fluid und alcoholic and solid), hyaluronic acid and their salts, ammonium bituminosulphonate, zinc oxide, vitamin A, cod liver (oil), blood hemolysates, essential lavender oil, tea-tree oil, olive oil, evening primrose oil, (sweet) almond oil, essential lavender oil, or oils or fat comprising omega-3 fatty acids, allantoin, propolis, medicinal honey, essential mint oil, essential eucalyptus oil, menthol, polidocanol (also known as laureth-9), lidocain, tetracain, mepivacain, benzocain, prilocain, bupivacain and their hydrochlorides and pharmaceutical/cosmetic acceptable salts.

Preferably, the patch(es) (i.e. the dermal patch and/or the hydrogel patch), the cream and/or the lotion comprise at least (dex)panthenol, more preferably at least a combination of (dex)panthenol and aloe barbadensis (leaf) extract, and even more preferably at least a combination of (dex)panthenol, aloe barbadensis leaf extract and polidocanol. In a further preferred embodiment, the patch(es) (i.e. the dermal patch and/or the hydrogel patch) of the present invention comprises one of the following combinations: (dex)panthenol and aloe barbadensis (leaf) extract; (dex)panthenol and polidocanol; aloe barbadensis (leaf) extract and polidocanol; and (dex)panthenol, aloe barbadensis (leaf) extract and polidocanol . Preferably, the patch(es), the cream and/or the lotion comprises vitamin E.

In further preferred embodiments, the nutritional supplement formulation of the present invention, preferably in combination with a cream, a lotion, a patch, patches or a set of patches in a kit as specified above, may be alternatively or additionally used for treating :

1. Skin irritations due to allergic reactions (especially in case of redness, itching and for cooling the skin) or skin irritations due to contact with skin- irritating substances (especially acids, bases, substances causing irritations when coming into contact with the skin or hazardous substances);

2. Skin injuries (especially superficial burns; sunburn etc.) and radiation affections or injuries of the skin (especially after laser treatment, e.g. when removing tattoos by laser light), or due to radiation or exposure (e.g . ionizing radiation for treating cancer) UV radiation (during dermatologic treatments etc.);

3. All kinds of wounds and lesions (especially abrasion wounds, cuts or wounds resulting from operations).

The nutritional supplement formulation may be in any suitable dosage form to be orally administered to a subject. In a preferred embodiment, the formulation is provided in a dosage element like a capsule, is compressed into a tablet, is formulated as a liquid or is in the form of a powdery composition which can be administered as it is or can be used to prepare a liquid solution and/or dispersion of the ingredients. The dosage form is prepared by using processes known to the person skilled in the art. The nutritional supplement formulation can be combined with suitable foods and/or beverages which do not interact with the formulation in an adverse manner. In a preferred embodiment, the nutritional supplement formulation is filled into a capsule by using an appropriate method known to those skilled in the art.

In order to prepare such a dosage form, the formulation may preferably be combined with one ore more further component (excipient(s)) for providing the dosage form but which do not adversely affect the function and/or stability of the above active ingredients. Typical components for preparing such finished dosage forms are fillers, lubricants, carriers, disintegration agents, formulation aids, flavoring substances, pH-adjusting substances and other components known and usually applied in the present technical field . These components can be each taken alone or in combination with one or more of them. In a preferred embodiment, cellulose is contained in the formulation as an excipient.

Non-limiting examples of formulations include the nutritional supplement formulations contained in dosage elements intended for oral consumption. Suitable dosage elements include tablets, hard gelatin capsules, starch capsules, cellulose-based capsules, softgel capsules, and elixirs.

In a preferred embodiment, the dosage element to be used for the administration of the nutritional supplement formulation is a capsule. Capsules comprise a shell surrounding containing the nutritional supplement formulation. The capsule shell dissolves and/or disintegrates in the digestive tract after the capsule is ingested, thereby releasing the nutritional supplement formulation to be absorbed by the body of the subject ingesting the capsule. Capsule shells are typically made of gelatin, starch, cellulose, and/or other components that readily dissolve or disintegrate after ingestion, and the composition, manufacture, and use of capsule shells are well known in the present technical field . In a particularly preferred embodiment, the dosage element is a softgel capsule. Softgel capsules are particularly suitable for containing liquid-based ingredients, such as nutrients dissolved, dispersed or suspended in a carrier liquid . The shell of a softgel capsule is typically made of gelatin plasticized with glycerin and water, although vegetarian softgel capsules made from starch or carrageenan are also available. Softgel capsule shells are typically made and filled with nutritional supplement formulations in continuous processes that are known in the art.

In a preferred embodiment, the nutritional supplement formulation is in a vegan capsule made of hydroxypropyl methylcellulose (HPMC), which contains no (animal) gelatin or colorants.

Capsules are available in a wide range of sizes, and the capsule size should be chosen to contain an appropriate volume or weight of the nutritional supplement formulation and, hence, an appropriate dosage of the nutrient(s). The capsule size can be chosen to contain at least about 0.1 grams of nutritional supplement formulation, including from about 0.1 grams to about 1.5 grams or from about 0.2 grams to about 1.0 grams of nutritional supplement formulation, as these capsule sizes are easy to swallow. For any ingesting subject, preferred capsule sizes should be chosen both to contain an effective amount of the nutrient(s) and also be easily swallowed by the subject.

In a preferred embodiment, one or more dose(s) or dosage form(s) of the nutritional supplement formulation is administered once, twice or thrice daily. Preferably, the nutritional supplement formulation is administered twice a day.

In a preferred embodiment, the nutritional supplement formulation or one or more dose(s) or dosage form(s) of the nutritional supplement formulation is/are administered to the subject 7 days before and/or 21 days after tattooing, wherein formulation is preferably administered at least 30 days in total. In a particularly preferred embodiment, two dosage forms of the nutritional supplement formulation are daily administered 7 days before tattooing and at least 21 days after tattooing, or two dosage forms of the nutritional supplement formulation are daily administered at least 28 days after tattooing, so that the whole treatment last about one month.

In a preferred embodiment, the nutritional supplement formulation is administered daily for at least one month, preferably at least two months.

The above described embodiments of the invention, in particular the described ingredients, the dosage regimens and the dosage forms of the nutritional supplement formulation, may be freely combined in any suitable combination with each other. The present invention is described by the following items and the subsequent detailed description :

1. A nutritional supplement formulation containing a wound healing substance for use in the pre- and/or post-treatment of tattooing, for use in improving the coloring and/or the color saturation of the tattoo and/or for use in improving the skin appearance after tattooing .

2. The nutritional supplement formulation for the use according to item 1, wherein the wound healing substance is one or more selected from the group consisting of hyaluronic acid, coenzyme Qio (ubiquinole and ubiquinone), panthenol and/or pantothenic acid, vitamin C, zinc, bamboo extract, acai berry extract, folic acid and biotin.

3. The nutritional supplement formulation for the use according to item 1 or 2, which comprises a combination of vitamin C, zinc, and biotin.

4. The nutritional supplement formulation for the use according to any one of items 1 to 3, wherein formulation is administered in a dose of 0.1 grams to 1.5 grams per administration. 5. The nutritional supplement formulation for the use to any one of items 1 to 4, wherein, on the basis of the total weight of the formulation representing 100 wt.-%, the formulation independently comprises at least one wound healing substance in the following amount(s) :

> 30.00 wt.-% Ascorbic acid (Vitamin C),

2.00-15.00 wt.-%, Bamboo Extract

2.00-20.00 wt.-%, Zinc

1.00-10.00 wt.-% Acai berry extract,

0.50-10.00 wt.-% Pantothenic acid (Vitamin B ₅ ),

0.01-0.10 wt.-% Folic acid,

0.001-0.05 wt.-% D-Biotin (Vitamin H).

6. The nutritional supplement formulation for the use according to any one of items 1 to 5, wherein the formulation comprises at least 30.00 wt. % vitamin C, preferably 30.00-70.00 wt.-%, more preferably 40.00-60.00 wt- % and even more preferably 50.00-55.00 wt.-% of vitamin C on the basis of the total weight of the formulation representing 100 wt.-%.

7. The nutritional supplement formulation for the use according to any one of items 1 to 6, wherein the formulation further comprises one or more substance selected from the group consisting of millet extract, N- acetylcysteine, vitamin D, one or more carotenoid (/^eta-carotene, alpha- carotene, cryptoxanthin, zeaxanthin, lutein), green tea extract, selenium and befa-glucans.

8. The nutritional supplement formulation for the use according to any one of items 1 to 7, wherein at least one of the following substances is administered alone or in combination of two or more of these substances in the following daily dose(s) :

- Ascorbic acid (Vitamin C) 60 to 1000 mg, preferably 500 mg

- Zinc 5 to 50 mg, preferably 15 to 25 mg

- Biotin (Vitamin H) 30 to 100 pg, preferably 50 pg - Pantothenic acid (Vitamin B ₅ ) 5 to 1000 mg, preferably 400 mg

- Folic acid 200 to 800 pg, preferably 400 pg

- Hyaluronic acid : 10 to 100 mg, preferably 70 mg

- Millet extract 300 to 800 mg, preferably 500 mg

- N-Acetylcysteine 30 to 200 mg, preferably 150 mg

- Coenzyme Qio 10 to 100 mg, preferably 50 mg

- Vitamin D 300 to 2000 IU, preferably 1000 IU

- Carotenoid(s) 20 to 100 mg, preferably 80 mg

- Green tea extract (90% catech 100 to 500 mg, preferably 200 mg

- Selenium 20 to 150 pg, preferably 50 pg

- £>efa-Glucan(s) 50 to 500 mg, preferably 150 mg .

9. The nutritional supplement formulation for the use according to any one of items 1 to 8, wherein formulation is administered once, twice or thrice daily.

10. The nutritional supplement formulation for the use according to any one of items 1 to 9, wherein formulation is administered for at least 28 days in total.

11. The nutritional supplement formulation for the use according to any one of items 1 to 10, wherein formulation is administered at least 7 days before tattooing.

12. The nutritional supplement formulation for the use according to any one of items 1 to 11, wherein formulation is administered 7 days before and/or 21 days after tattooing, and/or wherein the formulation is administered 28 days after tattooing.

13. The nutritional supplement formulation for the use according to any one of items 1 to 12, wherein the formulation is provided in a capsule, preferably a vegetarian or vegan capsule. 14. Kit comprising the nutritional supplement formulation as defined in any one of items 1 to 13 and one or more of a dermal patch, a set of patches, a cream and/or a lotion for externally treating tattoos.

Example

Capsules were prepared for orally administering a nutritional supplement formulation.

A single application dose of the nutritional supplement formulation formed by simply mixing the ingredients in the indicated amounts had the following composition :

Calcium ascorbate dihydrate 0.3030g (83% ascorbic acid; 0.2515g ascorbic acid; 0.0282g calcium)

Bamboo shoots extract, powder 75%

0.0500g

(0.0375g silicate)

Zinc-D-gluconate hydrate 11.8%, powder 0.0848g

(0.0109g zinc)

(0.0712g gluconate)

Acai extract 4: 1 (manufactured by Koisser) 0.0200g Vitamin B5 - calcium-D-pantothenat 9 0.0055g

(0.0051g Vitamin B ₅ (pantonthenic acid))

(0.0004g Calcium)

Folic acid, powder 0.2000mg

(0.1970mg folic acid)

D-Biotin (Vitamin H), powder 0.0500mg Celullose powder Type 101 O. lOOOg

The above formulation was filled in a vegetarian gelatin capsule, representing a dosage form comprising a single application dose of the nutritional supplement formulation. Tests

The above capsules were given to persons with freshly formed tattoos. For comparison, persons with freshly formed tattoo to which no nutritional supplement formulation was were examined as a comparison group.

After 30 days of the treatment, the tattoos were visually inspected. Besides improved healing of the skin from the persons who have taken the above nutritional supplement formulation, the color saturation was better.

Best results regarding the color saturation could be achieved when the nutritional supplement formulation was given one week before tattooing, while at least good results were achieved when people start taking the nutritional supplement formulation after the tattooing process.