HK1067017A - Ocuvite zinc - Google Patents

Abstract

A micronutrient combination product, wherein the micronutrient combination product comprises zinc and copper in the form of zinc gluconate and cupric gluconate. The micronutrient combination product, for example, can be used for nutritive supplementation in age-related macular degeneration.

Description

The present invention relates to a micronutrient combination product, which may be used, for example, for nutritional supplementation in age-related macular degeneration.

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In particular, in old age, zinc deficiency can become apparent quickly due to under-nutrition due to malnutrition or disease.The supply of the macula of the eye, which plays a central role in the visual process, is of great importance.The prevention of AMD is not taken into account by medicines tailored to it.

The disadvantage of these products is that they are not suitable for long-term therapy or for unlimited prophylaxis, as the dose of these products can lead to overdoses and adverse effects. Acute overdose of zinc sulphate can lead to nausea, vomiting or stomach cramps. If the overdose exceeds the therapeutic dose by a multiple, it can lead to symptoms such as headache, diarrhoea or constipation.

On the other hand, a reduction in dietary zinc intake can quickly lead to zinc deficiency, since there are no organs with a marked capacity to store zinc in the human body.

There is therefore a need for a product specifically designed as a food supplement to strengthen the eye and in particular to counteract a deficiency of zinc in the macula, and a product that does not cause adverse health effects as such and can be used both safely to prevent deficiency and to treat age-related macular degeneration.

The present invention is therefore intended to provide a means of overcoming the aforementioned disadvantages of the state of the art, in particular to provide a means of providing a comprehensive supply of zinc to the macula while avoiding side effects by avoiding overdose.

This task is solved by a micronutrient combination product, where the micronutrient combination product includes zinc and copper in the form of zinc gluconate and copper ((II) gluconate.

Surprisingly, zinc and copper (II) gluconate was shown to improve zinc bioavailability over zinc sulphate. Zinc gluconate is thought to improve zinc supply to the macula. It is further conceivable that the use of the well absorbable zinc gluconate may reduce the zinc required in the micronutrient combination product and thus avoid possible overdose.

The zinc gluconate used in accordance with the invention has a better absorption than the commonly used zinc sulphate. This increased bioavailability allows a much lower amount of zinc to be used as a daily or single dose, which significantly reduces the risk of side effects.

Furthermore, the use of zinc gluconate avoids the addition of large amounts of excipients, which is a major advantage of the presentation of the invention, which allows for a reduction in dosage forms, in particular tablets, and thus an easier swallowing.

The micronutrient combination product, optimized for its constituents, shall contain, as a percentage of 100 g of the micronutrient combination product, the active substances: a. 1 to 10 g, preferably 5 to 9 g, zinc; b. 100 to 300 mg, preferably 150 to 200 mg, copper.

According to the invention, zinc has been found to be very suitable for the dietary prophylaxis of macular degeneration. The targeted intake of a sufficient concentration of this trace element can therefore help to counteract a zinc deficiency. It is conceivable to protect the eye against the development of age-related macular degeneration or to slow its progression.

The micronutrient combination product of the invention is not a medicinal product and may be used as an adjunctive nutritional supplement or as a concomitant, for example, in the treatment of age-related macular degeneration.

It is also advantageous that the dosages of the product of the invention do not cause harmful side effects and can be used for prophylaxis and to compensate for existing macular deficiency, which is beneficial for nutritional and dietary treatment of age-related macular degeneration.

Preferably, the micronutrient combination product of the invention does not contain antioxidant vitamins.

The combination micronutrient product of the invention is particularly suitable for additive dietary supplementation of combination micronutrients with antioxidant ingredients. A delayed administration improves the bioavailability of zinc, which is a component of antioxidant enzymes, and it is conceivable that a synergistic effect may thus be developed.

The micronutrient combination product of the invention can, by means of the trace element zinc, support the antioxidant properties of suitable preparations and, in combination with suitable micronutrient combination products, significantly improve the properties, e.g. of vitamins and carotenoids.

Furthermore, the micronutrient combination product of the invention contains copper in the form of copper ((II) gluconate, which counteracts a possible copper deficiency that may result from the intake of zinc.

The micronutrient combination product may be in solid, liquid and/or gel form, preferably in the form of preparations selected from the group consisting of tablets, capsules, powder, granules, solutions and/or expectorant tablets of equal or different composition.

The micronutrient combination product is preferably in the form of small, easily swallowed tablets, with a diameter of less than 10 mm, preferably 7 mm, a weight of less than 200 mg, preferably 140 mg, a hardness of 20-100 N, preferably 40-60 N and/or a thickness of less than 5 mm, preferably less than 3.2 mm. The moisture content of the pressed mass is 20-40%, preferably 30.0% ± 7.5% (RF) relative humidity.

The micronutrient combination product may contain additives that improve bioavailability, solubility and/or solubility. Furthermore, the micronutrient combination product may contain fillers, deformants, decomposition accelerators, explosives, substances that enhance durability, flavor masking agents, flavor enhancers and/or coatings. Preferably, the micronutrient combination product of the invention may contain fillers, deformants and/or decomposition accelerators.

The use of common additives known to the professional is appropriate, the preferred fillers being cellulose and/or lactose, the preferred forming agents being metal soaps, especially magnesium stearate.

For masking or enhancing the flavour, substances selected from the group may include natural, natural-identical or synthetic flavourings, essences, essential oils, natural or synthetic glutamate, inosates, guanylates and/or glycine or mixtures thereof.

The dosage forms of the invention may continue to contain excipients which are commonly used in Galenic, are pharmacologically safe and are compatible with gluconate.

In a particularly preferred embodiment, the micronutrient combination product contains zinc gluconate, copper (II) gluconate, cellulose, lactose, polyvinyl polypyrrolidone and/or magnesium stearate.

In a preferred embodiment, the micronutrient combination product shall comprise, in terms of 100 g of the micronutrient combination product, the active substances: a. 7,1 g of zinc; b. 179 mg of copper.

In a further preferred embodiment, the micronutrient combination product shall have less than 1 g protein, less than 1 g fat and/or 14,3 g carbohydrates per 100 g of the micronutrient combination product, and further preferred, the micronutrient combination product shall have 1,2 loaf units and/or 204 kcal or 875 kJ per 100 g of the micronutrient combination product.

In another preferred embodiment, the micronutrient combination product, in terms of a single dose, comprises the active substances: "Software" specially designed or modified for the "development" or "production" of equipment specified in 1C002.a.

For the purposes of this application, a single dose means a unit of administration of the micronutrient combination product, whereby a single dose of the micronutrient combination product corresponds, for example, to a tablet, a capsule or a single unit of administration of another formulation, such as a powder or granules.

In a preferred embodiment, the micronutrient combination product shall, in relation to a single dose, contain less than 0,01 g of protein, less than 0,01 g of fat and/or 0,02 g of carbohydrates; furthermore, in relation to a single dose, the micronutrient combination product shall, in relation to a single dose, contain 0,002 loafing units and/or 0,3 kcal or 1,2 kJ.

The micronutrient preparation may also contain additives, co-formulants and/or raw materials which are heavier than the actual active substances, so that the amounts indicated may be lower or higher depending on the daily dose or single dose.

The daily dose and/or single dose should preferably be distributed over several forms of the same or different active substance and/or active substance weight, which may be the same or different.

The micronutrient combination product can be used to manufacture a product for the dietary prevention and treatment of eye diseases, preferably in age-related macular degeneration.

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The beneficial active substances of the micronutrient combination product allow it to be used as a food, in particular as a food supplement, in the context of dietary nutrition advice. Preferably, the micronutrient combination product can be used as a nutritional supplement for concomitant or supportive administration. It has been shown to compensate for the threat of zinc deficiency in the elderly in particular.

In its function as a food supplement, the micronutrient combination product of the invention contains the trace element zinc, which, by providing a balanced supply of macular material, may contribute positively to the improvement of vision in old age.

Examples of micronutrient combination products are given below:

It is understood that the formulations selected from the group comprising tablets, capsules, powder, granules, solutions and/or excipients contain the usual excipients used to formulate the respective formulations, so that only the active substances contained can be listed in the examples.

Example 1

Micronutrient combination product containing 1 tablet containing the following active substances: 10 mg of zinc; 250 μg of copper.

Example 2

Prescription for 1 tablet of 140 mg, including: 73,17 mg zinc gluconate, granules;1,87 mg copper (II) gluconate, powder;40,04 mg cellulose, microcrystalline;20,02 mg lactose;3,5 mg polyplasdone XL;1,4 mg magnesium stearate, the information for zinc gluconate and copper (II) gluconate being supplemented by 5%. The information refers to the dried substance.

Example 3

The formula is 210 kg or 1,500,000 tablets, including 1,500,000 tablets: The total value of all the materials used does not exceed 20% of the ex-works price of the product

The moisture content of the pressed mass was measured with a rotronic hygroscope and was 30.0% ± 7.5% (RF) relative humidity. The following shall be indicated in the column for the following categories of products:

The machinery was set up in accordance with SOP P-001.

Claims (10)

1. Micronutrient combination product, characterised by the inclusion of zinc and copper in the form of zinc gluconate and copper ((II) gluconate.
2. Micronutrient combination product as claimed by claim 1, characterised by the fact that the micronutrient combination product contains, per 100 g of micronutrient combination product, the active substances: Other

   a. 1 to 10 g, preferably 5 to 9 g, of zinc;

   b. 100 to 300 mg, preferably 150 to 200 mg, of copper.
3. Micronutrient combination product as claimed by claim 1 or 2, characterised by the presence of the micronutrient combination product in solid, liquid and/or gel form, preferably in form of preparations selected from the group comprising tablets, capsules, powder, granules, solutions and/or spray tablets.
4. Micronutrient combination product with one of the above claims, characterised by the presence of fillers, deformants and/or decomposition accelerators.
5. Micronutrient combination product according to one of the previous claims, characterised by the presence of zinc gluconate, copper ((II) gluconate, cellulose, lactose, polyvinyl polypyrrolidone and/or magnesium stearate in the micronutrient combination product.
6. Micronutrient combination product with one of the above claims, characterised by the fact that the micronutrient combination product contains active substances, expressed as per 100 g of the micronutrient combination product: Other

   a. 7,1 g of zinc;

   b. 179 mg of copper.
7. Micronutrient combination product with one of the above claims, characterised by the fact that the micronutrient combination product, in relation to a single dose, contains active substances: Other

   a. 10 mg of zinc;

   b. 250 μg of copper.
8. Use of a micronutrient combination product according to one of the previous claims for the manufacture of a product for the dietary prevention and treatment of eye diseases, preferably in age-related macular degeneration.
9. Use of a micronutrient combination product with one of the previous claims as a food supplement.
10. Food, in particular food supplements, containing active substances as defined in one of the foregoing claims.