DE20310493U1 - Micronutrient combination product for dietetic treatment of inflammatory-rheumatic diseases and osteoporosis, containing specific amounts of several vitamins, minerals, trace elements and antioxidants - Google Patents

Abstract

A micronutrient combination product (I) contains specific amounts of at least 10 of the following; vitamin C, vitamin E, vitamin A, vitamin B1, vitamin B2, nicotinamide, vitamin B6, vitamin B12, pantothenic acid, vitamin D3, biotin, vitamin K1, calcium, selenium, copper, zinc, chromium, manganese, molybdenum, carotenoids, fish oil and/or omega -3 fatty acids and lecithin. A micronutrient combination product (I) contains at least 10 (preferably at least 18) of the following components (amounts given being the daily dosages): (1) 200-750 (preferably 400-600, especially 450-500) mg vitamin C; (2) 100-400 (preferably 150-300, especially 200-250) mg vitamin E; (3) 0.1-1 (preferably 0.2-0.6, especially 0.4-0.5) mg vitamin A; (4) 5-15 (preferably 7-14, especially 8-12) mg vitamin B1; (5) 5-15 (preferably 7-14, especially 8-12) mg vitamin B2; (6) 10-50 (preferably 20-40, especially 25-35) mg nicotinamide; (7) 5-15 (preferably 7-14, especially 8-12) mg vitamin B6; (8) 5-15 (preferably 7-14, especially 8-12) Microg vitamin B12; (9) 5-30 (preferably 10-25, especially 15-20) mg pantothenic acid; (10) 1-15 (preferably 2-10, especially 3-7) Microg vitamin D3; (11) 20-300 (preferably 40-250, especially 15-225) Microg biotin; (12) 100-300 (preferably 150-250, especially 175-225) Microg vitamin K1; (13) 100-400 (preferably 120-200, especially 140-180) mg calcium; (14) 40-120 (preferably 60-100, especially 70-90) Microg selenium; (15) 0.1-5 (preferably 0.5-2.5, especially 0.75-1.5) mg copper; (16) 5-25 (preferably 7.5-20, especially 10-15) mg zinc; (17) 40-120 (preferably 50-100, especially 55-70) Microg chromium; (18) 0.1-1 (preferably 0.2-0.8, especially 0.4-0.7) mg manganese; (19) 40-120 (preferably 50-100, especially 55-70) Microg molybdenum; (20) 1-10 (preferably 2-8, especially 2.5-7.5) mg carotenoids; (21) 1-3 (preferably 1.2-2, especially 1.5-1.8) mg fish oil and/or 0.5-1.5 (preferably 0.7-1.3, especially 0.8-1.2) g omega -3 fatty acids; and (22) 0.1-1 (preferably 0.2-0.8, especially 0.4-0.7) mg lecithin. ACTIVITY : Antiinflammatory; Antirheumatic; Antiarthritic; Osteopathic. MECHANISM OF ACTION : Source of vitamins, minerals, trace elements and antioxidants.

Description

Dusseldorf ■ Munich · Hamburg New York

Patent attorneys

Dr. Walter Maiwald (Munich) Dr. Volker Hamm (Hamburg) Dr. Stefan Michalski (Düsseldorf) Dr. Regina Neuefeind (Munich) Dipl.-Ing. Udo Preuss (Munich) Dipl.-Ing. Korbinian Kopf, M.A. (Munich) Dr. Norbert Hansen (Munich) Dipl.-Ing. Lutz Kietzmann LLM. (Düsseldorf) Dr. Martin Huenges (Munich) Dr. Holger Glas (Munich)

Lawyer

Stephan N. Schneller (Munich)

In cooperation with: Maiwald Inc.,

European IP Services, New York Dipl.-Ing. Korbinian Kopf, M.A. U.S. Patent Agent

Reference number Our reference

New registration OD 40054 / SAM

ORTHOMOL PHARMACEUTICAL SALES GMBH

Dusseldorf,
July 8, 2003

ORTHOMOL PHARMACEUTICAL SALES GMBH

Micronutrient combination product, suitable for nutritional supplementation in inflammatory rheumatic diseases

The present invention relates to a micronutrient combination product and its use as a dietary food for special medical purposes. The
The micronutrient combination product according to the invention (Orthomol® Rheumat) is
dietary treatment of inflammatory rheumatic diseases, especially of patients with rheumatoid arthritis. The inventive
Micronutrient combination product also provides dietary support for osteoporosis therapy.

SAM:AL

Neuer Zollhof 2 40221 Düsseldorf

Tel. +49 (0)211 669 698 40 ■ Fax +49 (0)211 669 698 60 ■ http://www.maiwqld.de _i# mgjjgrnai\yald.de.

Managing Director: Dr. Walter M3iW«l<5**ßr. VolRe« Wafam**ß>r. St^arjTviphiils.ki -JDnpegjCia N$ueS ^: ein8 ■ Dipl.-Ing. Udo Preuss ■ HRB No. 40413

Managing Director: Dr. Walter M3iW«l<5ßr. VolRe« WaramSr. St^arjTvij^

Cooperation with: Dr. Schmidt-Ffclzrj-ierin & Kozionlja ße.chijanwjirh· (HprWOfg): . : : ^j _#
Parr · Dive!· 'te litieusse^ctinsTrentJfergerRechfsanwäite flvlüncnen ■ St'arnbe'rg)

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It is known that inflammatory rheumatic diseases are characterized in particular by inflammatory processes in the joints. It is also known that, at least in inflammatory rheumatic diseases such as chronic polyarthritis, the symptoms can be influenced by the supply of nutrients. Nutrients, especially fats and fatty acids, can influence the inflammatory mediators of these inflammatory processes.

Patients suffering from inflammatory rheumatic diseases often have a disease-related deficiency in the body's vitamin and mineral supply, which has a negative impact on their general state of health and the course of the disease. The course of the disease is characterized by constant inflammation, which leads to an increased consumption of micronutrients that counteract the inflammatory process. This increased need of rheumatic patients often cannot be met by normal diet.

The state of the art provides supportive care for patients suffering from inflammatory rheumatic diseases with anti-inflammatory nutrients. However, one disadvantage of the available products is that they often contain high levels of individual antioxidant vitamins and omega-3 fatty acids, but do not take into account the patients' extensive micronutrient deficiencies.

In addition to a wide-ranging deficit in the micronutrients that counteract the inflammatory process, rheumatic patients often also suffer from an undersupply of the micronutrients that are mainly found in meat products, such as selenium, due to a diet recommendation that reduces meat consumption. A disadvantage of many of the preparations known in the state of the art is a lack of compensation for such nutritional deficiencies with the corresponding nutrients.

Other vitamin and mineral products known in the state of the art contain a wide variety of compositions of vitamins and trace elements, but no vitamins and minerals that specifically serve to provide balanced support for bone metabolism.

Patients suffering from inflammatory rheumatic diseases, especially those with chronic polyarthritis, often develop osteoporosis, which is partly caused by medication. Calcium metabolism plays a central role in osteoporosis.

A disadvantage of the products known in the state of the art is that they do not take into account the developing osteoporosis, which is a frequently developing consequence of chronic polyarthritis. The increased mineral content of these patients, particularly with regard to osteoporosis, is not sufficiently taken into account by preparations tailored to this.

A combination of osteoporosis preparations with available antioxidant multi-preparations inevitably leads to an imbalance in the dosages of the components contained and to unbalanced and sometimes overdosed supply.

A further disadvantage of the products known in the prior art is that preparations containing fish oil often cause belching in consumers, which causes an unpleasant fishy taste in consumers.

There is therefore a need for a micronutrient combination product that offers a comprehensive supply of micronutrients to patients suffering from inflammatory rheumatic diseases, especially rheumatoid arthritis. Furthermore, there is

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a need to provide a micronutrient combination product with an optimally formulated and dosed composition that reliably compensates for an existing deficiency in anti-inflammatory micronutrients and at the same time counteracts developing osteoporosis.

It is therefore the object of the present invention to provide a micronutrient combination product that overcomes the aforementioned disadvantages of the prior art. In particular, it is the object of the present invention to provide an agent that also takes the osteoporosis problem into account. A further object of the present invention is to provide a composition that prevents burping caused by fish oil.

This task is solved by a micronutrient combination product that is optimally formulated with regard to its components, suitable for nutritional supplementation in inflammatory rheumatic diseases, which, based on a daily dose, contains the following active ingredients:

a. 200 mg to 750 mg, preferably 400 mg to 600 mg, preferably 450 mg to mg vitamin C;

b. 100 mg to 400 mg, preferably 150 mg to 300 mg, preferably 200 mg to mg vitamin E;

c. 0.1 mg to 1 mg, preferably 0.2 mg to 0.6 mg, preferably 0.4 mg to 0.5 mg vitamin A;

d. 5 mg to 15 mg, preferably 7 mg to 14 mg, more preferably 8 mg to 12 mg vitamin B ₁ ;

e. 5 mg to 15 mg, preferably 7 mg to 14 mg, more preferably 8 mg to 12 mg vitamin B ₂ ;

f. 10 mg to 50 mg, preferably 20 mg to 40 mg, preferably 25 mg to 35 mg nicotinamide;

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g. 5 mg to 15 mg, preferably 7 mg to 14 mg, preferably 8 mg to 12 mg vitamin

h. 5 mg to 15 mg, preferably 7 mg to 14 mg, more preferably 8 mg to 12 mg vitamin _B12 ; i. 5 mg to 30 mg, preferably 10 mg to 25 mg, more preferably 15 mg to 20 mg pantothenic acid;

j. 1 μg to 15 μg, preferably 2 μg to 10 μg, preferably 3 μg to 7 μg vitamin D3; k. 20 μg to 300 μg, preferably 40 μg to 250 μg, preferably 150 μg to 225 μg

amino acids;
1. 100 μg to 300 μg, preferably 150 μg to 250 μg, preferably 175 μg to 225 μg

Vitamin K;
m. 100 mg to 400 mg, preferably 120 mg to 200 mg, preferably 140 mg to 180 mg calcium;

n. 40 μg to 120 μg, preferably 60 μg to 100 μg, more preferably 70 μg to 90 μg selenium; o. 0.1 mg to 5 mg, preferably 0.5 mg to 2.5 mg, more preferably 0.75 mg to 1.5 mg copper;

p. 5 mg to 25 mg, preferably 7.5 mg to 20 mg, preferably 10 mg to 15 mg zinc; q. 40 μg to 120 μg, preferably 50 μg to 100 μg, preferably 55 μg to 70 μg^

Chrome;
r. 0.1 mg to 1 mg, preferably 0.2 mg to 0.8 mg, preferably 0.4 mg to 0.7 mg

Manganese;
s. 40 μg to 120 μg, preferably 50 μg to 100 μg, preferably 55 μg to 70 μg

Molybdenum;
t. 1 mg to 10 mg, preferably 2 mg to 8 mg, preferably 2.5 mg to 7.5 mg

carotenoids;
u. Ig to 3 g, preferably 1.2 g to 2 g, more preferably 1.5 g to 1.8 g fish oil and/or 0.5 g to 1.5 g, preferably 0.7 g to 1.3 g, more preferably 0.8 g to 1.2 g omega-3 fatty acids;

vngr;. 20 mg to 60 mg, preferably 30 mg to 50 mg, preferably 35 mg to 45 mg lecithin,

wherein the micronutrient combination product comprises at least 10, preferably at least 15, preferably at least 18 and a maximum of 23, of the aforementioned substances a. to v.

For the purposes of this application, a daily dose is understood to mean the amount of the micronutrient combination product that is administered per day.

It has surprisingly been shown that a supplementary diet with the micronutrient combination product according to the invention can have a positive effect on the development of inflammatory rheumatic processes and/or osteoporosis in existing rheumatoid arthrosis.

The advantageous properties of the micronutrient combination product according to the invention result from the special selection of the weight contents of the individual components as well as from the special properties of the individual nutritional components such as vitamins, trace elements, secondary plant substances and fish oil and/or omega-3 fatty acids.

The micronutrient combination product according to the invention comprises a selected combination of antioxidant vitamins such as vitamin C, vitamin E, vitamin A and/or carotenoids. The advantage of the antioxidant vitamins results from an inhibition of rheumatic inflammatory reactions. Without being bound to a specific theory, it is assumed that vitamin E inhibits the release of inflammatory mediators such as arachidonic acid and eicosanoids, prevents the activation of immunocompetent cells and the transmission of pro-inflammatory signals, while vitamin C plays a role in

Regeneration of used vitamin E. Vitamin E that can be used according to the invention preferably comprises tocopherols, preferably natural tocopherols.

The antioxidant properties of the micronutrient combination product are advantageously supplemented by a sufficient supply of carotenoids and vitamin A. Carotenoids that can be used according to the invention preferably include carotenoids selected from the group comprising beta-carotene, lycopene and/or lutein. Mixed carotenoids are preferably used. For the purposes of this invention, "mixed carotenoids" means a mixture of various, different carotenoids and/or carotenoid derivatives.

The beneficial effect of antioxidant vitamins is further enhanced by a sufficient supply of trace elements involved in antioxidant processes, such as selenium, copper, zinc and/or manganese.

A particular advantage of the micronutrient combination product according to the invention is achieved by the administration of oil, preferably the oil is based on fish oil and/or omega-3 fatty acids. The fish oil preferably comprises a high proportion of omega-3 fatty acids, for example the fish oil can comprise at least 50% by weight, preferably 60% by weight of omega-3 fatty acids, based on the total weight of the fish oil.

Preferably, usable omega-3 fatty acids comprise fatty acids selected from the group eicosapentaenoic acid and/or docosahexaenoic acid. Preferably, usable omega-3 fatty acids comprise a high proportion of eicosapentaenoic acid and/or docosahexaenoic acid, for example, usable omega-3 fatty acids can comprise at least 60% by weight, preferably at least 70% by weight, preferably at least 80% by weight, even more preferably at least 90% by weight, based on the total weight of the omega-3 fatty acids, of eicosapentaenoic acid and/or docosahexaenoic acid. Most preferably

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contain omega-3 fatty acids up to 100% by weight, based on the total weight of omega-3 fatty acids, eicosapentaenoic acid and/or docosahexaenoic acid.

Eicosapentaenoic acid has a positive effect due to its anti-inflammatory properties. Eicosapentaenoic acid can be converted into anti-inflammatory eicosanoids and inhibit the conversion of arachidonic acid into pro-inflammatory eicosanoids. The administration of eicosapentaenoic acid in the dosage according to the invention can therefore lead to a reduction in painful joints and morning stiffness, an improvement in working capacity, a reduction in the pain index, a reduction in the administration of pain medication, an improvement in grip strength and/or an improvement in inflammatory parameters. In an advantageous manner, the administration of eicosapentaenoic acid can also lead to a reduction in the administration of non-steroidal anti-rheumatic drugs.

The micronutrient combination product preferably contains vitamins Bi, B2, nicotinamide, Be and/or B12. The advantage of using vitamins Bi, Bö and Bn according to the invention is that they can enhance the effect of the non-steroidal anti-rheumatic drugs administered to rheumatic patients. The use of the dosage according to the invention is particularly advantageous because the diet cannot cover the necessary requirement to enhance the effect.

The micronutrient combination product preferably contains vitamin D3, vitamin Ki, calcium and/or manganese. The advantageous properties result from the combination of components designed to have a long-term effect on bone loss, which combines important substances involved in the formation and maintenance of bone. It is also advantageous that the agent according to the invention contains vitamin D3, which can cause increased absorption and incorporation of calcium into the bones. The composition of the micronutrient combination product can therefore have a significant

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Improve bone mineralization through a balanced intake of the important elements calcium, vitamin D3, vitamin Ki and manganese as well as other essential micronutrients over a longer period of time.

The micronutrient combination product according to the invention can, by administering these vitamins and trace elements involved in the process of bone formation, contribute to strengthening and thus reducing the risk of bone fracture, increase bone density, prevent degradation of the bone skeleton and thus have a positive effect on existing osteoporosis.

Surprisingly, it has been shown that the composition according to the invention and the interaction of the individual components of the micronutrient combination product according to the invention can provide comprehensive support for the organism of rheumatic patients by compensating for an existing deficiency in antioxidant nutrients as well as a supportive dietary treatment of an already existing osteoporosis.

Due to the aforementioned properties and characteristics of the vitamins and trace elements, in the context of a dietary treatment together with the normal therapeutic medication with the micronutrient combination product according to the invention, for example, a reduction in inflammatory processes, a faster onset of action of the non-steroidal anti-rheumatics, a reduction in pain, an improvement in grip strength, a reduction in morning stiffness, a general increase in performance and improved intestinal activity can be achieved.

In addition, the dosage of the micronutrient combination product according to the invention is advantageously free of harmful side effects, shows no incompatibility with medication of rheumatic patients and does not influence the effectiveness of the medication

negative. For example, the micronutrient combination product according to the invention does not negatively affect the frequency of occurrence of the symptoms nausea, vomiting, heartburn, belching, bloating, abdominal pain, diarrhea, constipation or skin rash.

A particular advantage of the micronutrient combination product according to the invention is that the frequency of occurrence of the symptom of burping is positively influenced. Surprisingly, it has been shown that burping can be completely or almost completely avoided by the composition of the micronutrient combination product. This is a great advantage, since burping is often caused by the fish oils contained and causes the consumer to have an unpleasant fishy taste. Surprisingly, it has been found that lecithin can prevent or at least significantly reduce burping. The micronutrient combination product according to the invention avoids or at least significantly reduces the frequency of this unpleasant "fishy" burping and thus leads to improved tolerability of the micronutrient combination product. The micronutrient combination product according to the invention preferably comprises lecithin, with a preferred lecithin being, for example, soy lecithin.

Advantageously, the micronutrient combination product comprises, based on 100 g of the micronutrient combination product, the weight contents of the individual components being selected such that the total weight of the components does not exceed 100 g, the substances as active ingredients:

a. 7.5 g to 12.5 g, preferably 9.8 g vitamin C;

b. 3.0 g to 6.0 g, preferably 4.5 g vitamin E;

c. 6.5 mg to 13 mg, preferably 9.2 mg vitamin A;

d. 175 mg to 230 mg, preferably 205 mg vitamin B12;

e. 175 mg to 230 mg, preferably 205 mg vitamin B2;

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f. 450 mg to 800 mg, preferably 616 mg nicotinamide;

g. 175 mg to 230 mg, preferably 205 mg vitamin B12; h. 165 μg to 220 μg, preferably 185 μg vitamin _B22 ;

i. 260 mg to 470 mg, preferably 370 mg pantothenic acid;

j. 75 μg to 130 μg, preferably 103 μg vitamin D3;

k. 3.0 mg to 5.2 mg, preferably 4.1 mg biotin;

1. 3.0 mg to 5.2 mg, preferably 4.1 mg vitamin Ki;

m. 2.5 g to 4.5 g, preferably 3.3 g calcium;

n. 1.2 mg to 2.0 mg, preferably 1.6 mg selenium;

o. 17.5 mg to 23.0 mg, preferably 20.5 mg copper;

p. 190 mg to 320 mg, preferably 257 mg zinc;

q. 0.9 mg to 1.5 mg, preferably 1.2 mg chromium;

r. 7.5 mg to 13.0 mg, preferably 10.3 mg manganese;

s. 0.9 mg to 1.5 mg, preferably 1.2 mg molybdenum;

t. 7.5 mg to 130 mg, preferably 103 mg carotenoids;

u. 24.0 g to 45.0 g, preferably 34.3 g fish oil and/or 11 g to 20 g, preferably 15.4 g omega-3 fatty acids;

v. 575 mg to 1066 mg, preferably 821 mg lecithin,

wherein the micronutrient combination product comprises at least 10, preferably at least 15, more preferably at least 18 and a maximum of 23 of the aforementioned substances a. to v.

The micronutrient combination product can be in solid, liquid and/or gel form. The micronutrient combination product is preferably in preparation forms selected from the group comprising tablets, capsules, powder, granules, solutions and/or effervescent tablets.

Advantageously, the micronutrient combination product can comprise one and/or more tablets, capsules and/or granules with the same and/or different contents of micronutrients or vital substances.

Advantageously, the micronutrient combination product is in the form of at least two separate preparation forms, preferably in the form of at least three separate preparation forms and particularly preferably in the form of at least four separate preparation forms, wherein the preparation forms can have the same or different compositions of active ingredients and/or active ingredient weight contents.

It has been shown that due to the poor miscibility of some of the components, homogeneous distribution is not possible or only possible with increased effort, possibly by adding excipients. When administered orally, individual components can settle in the mouth/throat area and/or are poorly absorbed in the gastrointestinal tract and/or reach the bloodstream with a significant delay. The aforementioned effects can lead to the individual components being absorbed in different or too low concentrations, which has a particularly detrimental effect on the effect.

In order to overcome the aforementioned disadvantages, the contents and substances of the individual components were selected such that after oral administration of the micronutrient combination product according to the invention, an optimal blood plasma level for the respective nutritional substances is established with regard to the desired effect.

The micronutrient combination product is particularly preferably in the form of tablets and/or capsules. In preferred embodiments, the micronutrient combination product comprises at least two preparation forms with different compositions of active ingredients and/or active ingredient weight contents in the form of 1 to

Tablets, preferably 2 to 5 tablets and/or 1 to 10 capsules, preferably 2 to 5 capsules.

In preferred embodiments of the micronutrient combination product, lecithin is preferably contained in oil-containing capsule(s). This advantageously results in lecithin being taken together with fish oil and/or omega-3 fatty acids. Fish oils or fatty acids often lead to burping, which causes an unpleasant fishy taste in consumers. By administering lecithin preferably in oil-containing capsules together with fish oil and/or omega-3 fatty acids, lecithin can exert its effect without delay and burping can be avoided more effectively than if the administration of the lecithin takes place with a time delay after the administration of the fish oil or omega-3 fatty acids.

In further preferred embodiments of the micronutrient combination product, vitamin K] and calcium are preferably contained in at least one tablet.

Advantageously, the micronutrient combination product comprises:

- at least one multivitamin/trace element capsule containing vitamin A, vitamin B1, vitamin B2, nicotinamide, vitamin B2, vitamin B12, pantothenic acid, vitamin _D3 , vitamin E, biotin, selenium, copper, zinc, chromium, manganese, molybdenum and/or carotenoids, wherein the carotenoids are preferably selected from the group comprising beta-carotene, lycopene and/or lutein;

- at least one tablet containing vitamin C;

at least one calcium tablet containing vitamin Ki and/or calcium, and/or

- at least three oil-containing capsules containing fish oil and/or omega-3 fatty acids and/or lecithin.

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In a preferred embodiment, the micronutrient combination product comprises, based on 100 g of the micronutrient combination product, the weight contents of the individual components being selected such that the total weight of the components does not exceed 100 g, the substances as active ingredients:

a. 9.8 g vitamin C;

b. 4.5 g vitamin E;

c. 9.2 mg vitamin A;

d. 205 mg vitamin B12;

e. 205 mg vitamin B ₂ ;

f. 616 mg nicotinamide;

G. 205 mg vitamin B^, h. 185 /ig vitamin Bi ₂ ;

i. 370 mg pantothenic acid;

103 mg vitamin D3;

k. 4.1 mg biotin;

1. 4.1 mg vitamin K;

m. 3.3 g calcium;

n. 1.6 mg selenium;

o. 20.5 mg copper;

p. 257 mg zinc;

q. 1.2 mg chromium;

r. 10.3 mg manganese;

see 1.2 mg molybdenum;

t. 103 mg carotenoids;

and 34.3 g fish oil and/or 20.5 g omega-3 fatty acids;

v. 821 mg lecithin,

wherein the micronutrient combination product comprises at least 10, preferably at least 15, more preferably at least 18 and a maximum of 23 of the aforementioned substances a. to v.

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Preferably, 20.5 g of omega-3 fatty acids comprise 15.4 g of eicosapentaenoic acid and 5.1 g of docosahexaenoic acid.

9.2 mg of vitamin A corresponds to 30801 IU (International Units) of vitamin A.

In a preferred embodiment, the micronutrient combination product contains, based on 100 g, 12.3 g protein, 39 g fat and/or 2.1 g carbohydrates. The micronutrient combination product also preferably contains, based on a daily dose, 0.2 bread units and/or 452 kcal or 1898 kJ.

In a further preferred embodiment, the micronutrient combination product comprises, based on a daily dose, the following active ingredients:

a. 475 mg vitamin C;

b. 217 mg vitamin E;

c. 450 mg vitamin A;

d. 10 mg vitamin B12;

e. 10 mg vitamin B ₂ ;

f. 30 mg nicotinamide;

G. 10 mg vitamin B^, h. 9 /xg vitamin B^;

i. 18 mg pantothenic acid;

j. 5/g vitamin D3;

k. 200 ßg biotin;

1. 200mg Vitamin K;

m. 160 mg calcium;

n. 80 /Ag selenium;

o. 1 mg copper;

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p. 12.5 mg zinc;

q. 60 μg chromium;

r. 500 μg manganese;

s. 60 μg molybdenum;

t. 5 mg carotenoids;

and 1.67 g fish oil and/or 1.0 g omega-3 fatty acids;

v. 40 mg lecithin,

wherein the micronutrient combination product comprises at least 10, preferably at least 15, more preferably at least 18 and a maximum of 23 of the aforementioned substances a. to v.

Preferably, 1.0 g of omega-3 fatty acids contains 750 mg of eicosapentaenoic acid and 250 mg of docosahexaenoic acid.

450 μg of vitamin A corresponds to 1500 IU (International Units).

In a preferred embodiment, the micronutrient combination product has, based on a daily dose, 0.6 g protein, 1.9 g fat and/or 0.1 g carbohydrates. The micronutrient combination product also preferably has, based on a daily dose, 0.01 bread units and/or 22 kcal or 92 kJ.

In a particularly preferred embodiment, the micronutrient combination product comprises, based on a daily dose:

at least one multivitamin/trace element capsule comprising: 450 μg vitamin A, 10 mg vitamin Bj, 10 mg vitamin B2, 30 mg nicotinamide, 10 mg vitamin B^, 9 μg vitamin Bi ₂ , 18 mg pantothenic acid, 5 μg vitamin D3, 217 mg vitamin E, 200 μg biotin, 80 μg selenium, 1 mg copper, 12.5 mg zinc, 60 μg chromium, 500 μg manganese, 60 μg molybdenum and/or 5 mg carotenoids, wherein the carotenoids are preferably selected from the group comprising beta-carotene, lycopene and/or lutein;

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- at least one vitamin C-containing tablet containing 475 mg vitamin C;

- at least one calcium tablet containing 200 /ng vitamin Ki and/or 160 mg calcium, and/or

- at least three oil-containing capsules containing a total of 1.67 g fish oil and/or 40 mg lecithin.

In a further particularly preferred embodiment, the micronutrient combination product comprises, based on a daily dose:

- at least one multivitamin/trace element capsule comprising: 450 μg vitamin A, 10 mg vitamin B1, 10 mg vitamin _B2 , 30 mg nicotinamide, 10 mg vitamin B6, ₉ μg vitamin B2, 18 mg pantothenic acid, 5 μg vitamin D3, 217 mg vitamin E, 200 μg biotin, 80 μg selenium, 1 mg copper _, 12.5 mg zinc, 60 μg chromium, 500 μg manganese, 60 μg molybdenum and/or 5 mg carotenoids, wherein the carotenoids are preferably selected from the group comprising beta-carotene, lycopene and/or lutein;

- at least one vitamin C-containing tablet containing 475 mg vitamin C; at least one calcium tablet containing 200 ßg vitamin Ki and/or 160 mg calcium, and/or

- at least three oil-containing capsules containing a total of 1.0 g of omega-3 fatty acids, preferably comprising 750 mg of eicosapentaenoic acid and 250 mg of docosahexaenoic acid, and/or 40 mg of lecithin.

The quantities given above are merely examples, as the micronutrient combination product may also contain additives, accompanying substances and/or raw materials that are heavier than the actual active ingredient(s), so that the quantities given in relation to a daily dose and/or 100 g may be lower or higher.

In preferred embodiments, the micronutrient combination product comprises additives that improve the bioavailability, solubility and/or dissolution rate and/or

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Additives selected from the group comprising disintegrants, substances that improve shelf life, taste-masking and/or taste-enhancing substances, substances to increase or reduce viscosity, colorants, fillers, mold release agents and/or disintegration accelerators.

Customary additives and/or auxiliaries known to the person skilled in the art are suitable. Particularly preferred are additives selected from the group comprising gelatin, L-ascorbic acid, humectants such as glycerin, sorbitol, microcrystalline cellulose, HP cellulose, HPM cellulose, vegetable triglycerides, natural flavors such as natural orange flavor, lactose, soybean oil, corn starch, release agents such as vegetable magnesium stearate, sweeteners such as sodium cyclamate and/or aspartame, calcium glycerophosphate dihydrate, acidifiers such as citric acid, colorants such as titanium dioxide and/or iron oxide, silicon dioxide and/or talc.

In a particularly preferred embodiment, the micronutrient combination product comprises fish oil, gelatin, L-ascorbic acid, calcium carbonate, glycerin, sorbitol, microcrystalline cellulose, tocopherols, preferably natural tocopherols, vegetable triglycerides, sodium L-ascorbate, calcium glycerophosphate dihydrate, lactose, soya lecithin, hydrogenated soya bean oil, selenium yeast or sodium selenate, zinc sulfate monohydrate, nicotinamide, calcium D-pantothenate, corn starch, natural orange flavor, vegetable magnesium stearate, sodium cyclamate, vitamin B i mononitrate, vitamin B 0 hydrochloride, HPM cellulose, vitamin B2, titanium dioxide, copper gluconate, iron oxide, manganese gluconate, silicon dioxide, beta-carotene, talc, HP cellulose, vitamin A palmitate, lutein, chromium (III) chloride hexahydrate, lycopene, D-biotin, vitamin Ki, sodium molybdate dihydrate, aspartame, vitamin D3 and/or vitamin B12.

The micronutrient combination product can be used to produce a product for the dietary treatment of inflammatory rheumatic diseases, preferably rheumatic

&bull;t ····

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Arthritis, and/or osteoporosis. The micronutrient combination product according to the invention is also suitable as a means of supplementing the diet of rheumatic patients.

The term "dietetic treatment" is explained in more detail in the EU Directive 1999/21/EC, which has been implemented into German law since January 1, 2002 as the 10th Regulation amending the Diet Regulation.

Due to the beneficial active ingredients of the micronutrient combination product, it can also be used as a food, particularly a food supplement, as part of dietary nutritional advice. The food, particularly a food supplement, preferably contains the aforementioned active ingredients. The micronutrient combination product can preferably be used as a nutritional supplement for accompanying or supportive administration. It has been shown that osteoporosis in patients with rheumatoid arthritis in particular can also be accompanied by diet.

Examples of micronutrient combination products are given below:

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

example 1

Micronutrient combination product comprising 1 capsule and 2 tablets of different composition as well as 3 oil-containing capsules of the same composition as follows:

&bull; ft * » · f f &diams;

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1 capsule containing:

450 μg vitamin A, 10 mg vitamin Bi, 10 mg vitamin B2, 30 mg nicotinamide, 10 mg vitamin B ₆ , 9 μg vitamin Bi ₂ , 18 mg pantothenic acid, 5 /xg vitamin D ₃ , 217 mg vitamin E, 200 /ig biotin, 80 /ig selenium, 1 mg copper, 12.5 mg zinc, 60 /ig chromium, 500 /ig manganese, 60 /ig molybdenum, 5 mg carotenoids selected from the group comprising beta-carotene, lycopene, lutein;

3 oil-containing capsules containing in total:
1.67 g fish oil and 40 mg lecithin;

1 tablet containing:
475 mg vitamin C;

1 tablet containing:

200 mg vitamin _K1 , 160 mg calcium.

The weight information, unless otherwise stated, refers to a daily dose. Example 2

Micronutrient combination product comprising 1 capsule and 2 tablets of different composition as well as 3 oil-containing capsules of the same composition as follows:

1 capsule containing:

450 mg of vitamin A, 10 mg of vitamin Bi, 10 mg of vitamin _B2 , 30 mg of nicotinamide, 10 mg of vitamin _B6 , 9 mg of vitamin _Bi2 , 18 mg of pantothenic acid, 5 mg of vitamin D3, 217 mg of vitamin E, 200 /ig

&bull; t ···

·· ti· · il ·

Biotin, 80 μg selenium, 1 mg copper, 12.5 mg zinc, 60 μg chromium, 500 μ% manganese, 60 μg molybdenum, 5 mg carotenoids selected from the group comprising beta-carotene, lycopene, lutein;

3 oil-containing capsules containing in total: 1.0 g omega-3 fatty acids and 40 mg lecithin;

1 tablet containing:
475 mg vitamin C;

1 tablet containing:

200 mg vitamin Ki, 160 mg calcium.

Unless otherwise stated, the weights refer to a daily dose. Table I

ingredients Inflammatory rheumatism
tic complaints Osteoporosis-
complaints (A) Vitamin E, Omega-3 fatty acids + - (B) Vitamins D ₃ , K ₁ , C, B ₆ , calcium,
Copper, manganese, zinc ++ (C) Vitamin E, Omega-3 fatty acids
Vitamins D3, Ki, C, Be, calcium,
Copper, manganese, zinc
Vitamins B ₂ , Bn, A +++ +++

(A) - (B): State of the art comparative preparations:

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(A) Epamax available from Merck, Darmstadt.

(B) Orthomol ® Osteo, available from Orthomol GmbH in Langenfeld. (C): Micronutrient preparation according to the invention:

corresponds to example 2 according to the invention; Orthomol ® Rheumat, available from Orthomol GmbH in Langenfeld.

Table I shows a comparison of the effect of micronutrient products of various compositions known in the art on inflammatory rheumatic and osteoporotic complaints. Table I shows that a combination of vitamins and trace elements according to the invention shows an improved effect with regard to both the inflammatory rheumatic and the osteoporotic complaints that characterize the clinical picture of rheumatoid arthritis with developed osteoporosis.

Furthermore, it was found in the context of an application observation that the tolerability of the micronutrient preparation according to the invention was significantly improved compared to preparations known in the prior art. For example, taking the micronutrient preparation according to the invention led to an increase in performance, an improvement in intestinal activity, an improved general condition and an increase in well-being.

Claims (13)

1. Micronutrient combination product, suitable for nutritional supplementation in inflammatory rheumatic diseases, characterized in that the micronutrient combination product, based on a daily dose, contains as active ingredients the substances: a) 200 mg to 750 mg, preferably 400 mg to 600 mg, preferably 450 mg to 500 mg vitamin C; b) 100 mg to 400 mg, preferably 150 mg to 300 mg, preferably 200 mg to 250 mg vitamin E; c) 0.1 mg to 1 mg, preferably 0.2 mg to 0.6 mg, preferably 0.4 mg to 0.5 mg vitamin A; d) 5 mg to 15 mg, preferably 7 mg to 14 mg, preferably 8 mg to 12 mg vitamin B ₁ ; e) 5 mg to 15 mg, preferably 7 mg to 14 mg, preferably 8 mg to 12 mg vitamin B ₂ ; f) 10 mg to 50 mg, preferably 20 mg to 40 mg, preferably 25 mg to 35 mg nicotinamide; g) 5 mg to 15 mg, preferably 7 mg to 14 mg, preferably 8 mg to 12 mg vitamin B ₆ ; h) 5 µg to 15 µg, preferably 7 µg to 14 µg, preferably 8 µg to 12 µg vitamin B ₁₂ ; i) 5 mg to 30 mg, preferably 10 mg to 25 mg, preferably 15 mg to 20 mg pantothenic acid; j) 1 µg to 15 µg, preferably 2 µg to 10 µg, preferably 3 µg to 7 µg vitamin D ₃ ; k) 20 µg to 300 µg, preferably 40 µg to 250 µg, preferably 150 µg to 225 µg biotin; l) 100 µg to 300 µg, preferably 150 µg to 250 µg, preferably 175 µg to 225 µg vitamin K ₁ ; m) 100 mg to 400 mg, preferably 120 mg to 200 mg, preferably 140 mg to 180 mg calcium; n) 40 µg to 120 µg, preferably 60 µg to 100 µg, preferably 70 µg to 90 µg selenium; o) 0.1 mg to 5 mg, preferably 0.5 mg to 2.5 mg, preferably 0.75 mg to 1.5 mg copper; p) 5 mg to 25 mg, preferably 7.5 mg to 20 mg, preferably 10 mg to 15 mg zinc; q) 40 µg to 120 µg, preferably 50 µg to 100 µg, preferably 55 µg to 70 µg chromium; r) 0.1 mg to 1 mg, preferably 0.2 mg to 0.8 mg, preferably 0.4 mg to 0.7 mg manganese; s) 40 µg to 120 µg, preferably 50 µg to 100 µg, preferably 55 µg to 70 µg molybdenum; t) 1 mg to 10 mg, preferably 2 mg to 8 mg, preferably 2.5 mg to 7.5 mg carotenoids; u) 1 g to 3 g, preferably 1.2 g to 2 g, preferably 1.5 g to 1.8 g of fish oil and/or 0.5 g to 1.5 g, preferably 0.7 g to 1.3 g, preferably 0.8 g to 1.2 g of omega-3 fatty acids; v) 20 mg to 60 mg, preferably 30 mg to 50 mg, preferably 35 mg to 45 mg lecithin, wherein the micronutrient combination product comprises at least 10, preferably at least 15, preferably at least 18 and a maximum of 23, of the aforementioned substances a. to v. 1. Micronutrient combination product according to claim 1, characterized in that the micronutrient combination product, based on 100 g of the micronutrient combination product, wherein the weight contents of the individual components are selected such that the total weight of the components does not exceed 100 g, comprises the substances as active ingredients: 2. 7.5 g to 12.5 g, preferably 9.8 g vitamin C; 3. 3.0 g to 6.0 g, preferably 4.5 g vitamin E; 4. 6.5 mg to 13.0 mg, preferably 9.2 mg vitamin A; 5. 17.5 mg to 230 mg, preferably 205 mg vitamin B ₁ ; 6. 175 mg to 230 mg, preferably 205 mg vitamin B ₂ ; 7. 450 mg to 800 mg, preferably 616 mg nicotinamide; 8. 175 mg to 230 mg, preferably 205 mg vitamin B ₆ ; 9. 165 µg to 220 µg, preferably 185 µg vitamin B ₁₂ ; 10. 260 mg to 470 mg, preferably 370 mg pantothenic acid; 11. 75 µg to 130 µg, preferably 103 µg vitamin D ₃ ; 12. 3.0 mg to 5.2 mg, preferably 4.1 mg biotin; 13. 3.0 mg to 5.2 mg, preferably 4.1 mg vitamin K ₁ ; 14. 2.5 g to 4.5 g, preferably 3.3 g calcium; 15. 1.2 mg to 2.0 mg, preferably 1.6 mg selenium; 16. 17.5 mg to 23.0 mg, preferably 20.5 mg copper; 17. 190 mg to 320 mg, preferably 257 mg zinc; 18. 0.9 mg to 1.5 mg, preferably 1.2 mg chromium; 19. 7.5 mg to 13.0 mg, preferably 10.3 mg manganese; 20. 0.9 mg to 1.5 mg, preferably 1.2 mg molybdenum; 21. 7.5 mg to 130 mg, preferably 103 mg carotenoids; 22. 24.0 g to 45.0 g, preferably 34.3 g of fish oil and/or 11 g to 20 g, preferably 15.4 g of omega-3 fatty acids; 23. 575 mg to 1066 mg, preferably 821 mg lecithin, wherein the micronutrient combination product comprises at least 10, preferably at least 15, preferably at least 18 and a maximum of 23, of the aforementioned substances a. to v. 3. Micronutrient combination product according to claim 1 or 2, characterized in that the micronutrient combination product is in solid, liquid and/or gel form, preferably the micronutrient combination product is in preparation forms selected from the group comprising tablets, capsules, powders, granules, solutions and/or effervescent tablets. 4. Micronutrient combination product according to one of the preceding claims, characterized in that the micronutrient combination product is in the form of at least two separate preparation forms, preferably in the form of at least three separate preparation forms and particularly preferably in the form of at least four separate preparation forms, wherein the preparation forms can have the same or different compositions of active ingredients and/or active ingredient weight contents. 5. Micronutrient combination product according to one of the preceding claims, characterized in that the micronutrient combination product comprises at least two preparation forms with different compositions of active ingredients and/or active ingredient weight contents in the form of 1 to 10 tablets, preferably 2 to 5 tablets and/or 1 to 10 capsules, preferably 2 to 5 capsules. 6. Micronutrient combination product according to one of the preceding claims, characterized in that lecithin is preferably contained in oil-containing capsule(s). 7. Micronutrient combination product according to one of the preceding claims, characterized in that vitamin K ₁ and calcium are preferably contained in at least one tablet. 8. Micronutrient combination product according to one of the preceding claims, characterized in that the micronutrient combination product comprises: - at least one multivitamin/trace element capsule containing vitamin A, vitamin B ₁ , vitamin B ₂ , nicotinamide, vitamin B ₆ , vitamin B ₁₂ , pantothenic acid, vitamin D ₃ , vitamin E, biotin, selenium, copper, zinc, chromium, manganese, molybdenum and/or carotenoids, wherein the carotenoids are preferably selected from the group comprising beta-carotene, lycopene and/or lutein; - at least one tablet containing vitamin C; - at least one calcium tablet containing vitamin K ₁ and/or calcium, and/or - at least three oil-containing capsules containing fish oil and/or omega-3 fatty acids and/or lecithin. 9. Micronutrient combination product according to one of the preceding claims, characterized in that the micronutrient combination product, based on 100 g of the micronutrient combination product, wherein the weight contents of the individual components are selected so that the total weight of the components does not exceed 100 g, contains as active ingredients the substances: a) 9.8 g vitamin C; b) 4.5 g vitamin E; c) 9.2 mg vitamin A; d) 205 mg vitamin B ₁ ; e) 205 mg vitamin B ₂ ; f) 616 mg nicotinamide; g) 205 mg vitamin B ₆ ; h) 185 µg vitamin B ₁₂ ; i) 370 mg pantothenic acid; j) 103 µg vitamin D3; k) 4.1 mg biotin; l) 4.1 mg vitamin K1; m) 3.3 g calcium; n) 1.6 mg selenium; o) 20.5 mg copper; p) 257 mg zinc; q) 1.2 mg chromium; r) 10.3 mg manganese; s) 1.2 mg molybdenum; t) 103 mg carotenoids; u) 34.3 g fish oil and/or 20.5 g omega-3 fatty acids; v) 821 mg lecithin, wherein the micronutrient combination product comprises at least 10, preferably at least 15, preferably at least 18 and a maximum of 23, of the aforementioned substances a. to v. 10. Micronutrient combination product according to one of the preceding claims, characterized in that the micronutrient combination product, based on a daily dose, contains as active ingredients the substances: a) 475 mg vitamin C; b) 217 mg vitamin E; c) 450 µg vitamin A; d) 10 mg vitamin B ₁ ; e) 10 mg vitamin B ₂ ; f) 30 mg nicotinamide; g) 10 mg vitamin B ₆ ; h) 9 µg vitamin B ₁₂ ; i) 18 mg pantothenic acid; j) 5 µg vitamin D ₃ ; k) 200 µg biotin; l) 200 µg vitamin K ₁ ; m) 160 mg calcium; n) 80 µg selenium; o) 1 mg copper; p) 12.5 mg zinc; q) 60 µg chromium; r) 500 µg manganese; s) 60 µg molybdenum; t) 5 mg carotenoids; u) 1.67 g fish oil and/or 1.0 g omega-3 fatty acids; v) 40 mg lecithin, wherein the micronutrient combination product comprises at least 10, preferably at least 15, preferably at least 18 and a maximum of 23, of the aforementioned substances a. to v. 11. Micronutrient combination product according to one of the preceding claims, characterized in that the micronutrient combination product contains additives which improve the bioavailability, solubility and/or dissolution rate and/or additives selected from the group comprising disintegrants, substances which improve the shelf life, taste-masking and/or taste-improving substances, substances for increasing or reducing the viscosity, colorants, fillers, mold release agents and/or disintegration accelerators. 12. Use of a micronutrient combination product according to one of the preceding claims for producing an agent for the dietary treatment of inflammatory rheumatic diseases, preferably rheumatoid arthritis, and/or osteoporosis. 13. Use of a micronutrient combination product according to one of the preceding claims as a food supplement. 14. Foodstuffs, in particular food supplements, comprising active ingredients according to one of the preceding claims.