composition

Abstract

Composition in the form of a fixed dosage, especially as a food supplement, containing a combination of Lactobacillus reuteri, Lactobacillus salivarius, vitamin D3, vitamin B7, at least one tableting agent, at least one carrier, at least one thickener, at least one flavoring agent, at least one anti-caking agent and at least one sweetener.

Description

[0001] The invention relates to a composition in the form of a fixed dosage, in particular as a food supplement, according to the preamble of claim 1.

[0002] The term "composition" here refers to a formulation, recipe, product composition, material composition, or composition of various components. These components are selected, for example, from the following (this list is not exhaustive): chemical substances; biological substances; components of animal, plant, mineral, bio-based, synthetic, or microbial origin; components from natural raw materials, extracts, oils, waxes, resins, proteins, lipids, carbohydrates, natural or synthetic components; plant, mineral, or synthetic components; organic or inorganic components; natural or engineered components.

[0003] Dietary supplements are products intended to supplement the general diet and provide the human body with additional nutrients or other substances with nutritional or physiological effects. Typical ingredients in dietary supplements include, in particular, vitamins, minerals, trace elements, amino acids, fatty acids, dietary fiber, plant extracts, and other bioactive substances.

[0004] Such preparations are usually provided in dosed form, for example as capsules, tablets, powders, granules, liquids, or drinkable ampoules. The purpose of their use can include, among other things, supporting specific bodily functions, compensating for nutritional deficiencies, or promoting general well-being.

[0005] Modern dietary habits, such as unbalanced diets, increased physical or mental demands, environmental factors, or age-related changes, can lead to an insufficient supply of certain nutrients. Dietary supplements therefore offer a way to specifically address such nutritional gaps.

[0006] From AT 001 230 U1, a probiotic formulation is known that contains the following: microorganisms stabilized by drying and a food-grade carrier substance that enables the microorganisms stabilized by drying to pass through gastric juice in higher numbers. The microorganisms stabilized by drying are encapsulated in the carrier substance. The formulation is used as a food additive and in food products. In particular, a chocolate muesli containing this formulation is described. The described probiotic formulation serves to maintain a balanced intestinal microflora through the administration of specific microorganisms via the food route.

[0007] From AT 001 759 U1, a probiotic formulation is known that contains the following: lyophilized microorganisms and a food-grade carrier substance that allows the lyophilized microorganisms to pass through gastric juice in higher numbers. The lyophilized microorganisms are encapsulated in the carrier substance. The formulation is used as a food additive and in food products. In particular, a muesli containing this formulation is described. The described probiotic formulation serves to maintain a balanced intestinal microflora through the administration of specific microbial microorganisms via the food route.

[0008] From DE 20 2004 016 077 U1 is a pharmaceutical composition in the form of a fixed dosage, especially for the topical treatment of inflammatory diseases of the mouth and throat, containing a combination of Lichen islandicus (Icelandic moss) and / or its extract with at least one local anesthetic.

[0009] From DE 20 2007 018 403 U1, a colostrum-containing lozenge is known which contains the following in relation to the total weight: a) 20 to 60 wt% colostrum in concentrated form, with an immunoglobulin content of at least 10 g / 100 g, wherein the immunoglobulin content in the tablet is at least 6 wt%; b) 1 to 20 wt% of one or more glycans as adjuvants; c) 20 to 60 wt.% sugar alcohols as entraining agents; d) 5 to 10% by weight of usual tableting agents; and e) 0 to 10% by weight of flavoring additives.

[0010] The lozenge is used for the topical prophylaxis and treatment of colds in the throat.

[0011] Popular dietary supplements have the disadvantage that their composition is always optimized for a single purpose, such as supporting oral flora or maintaining a healthy oral mucosa in the throat. This means that users often have to take several different products for various desired effects. This frequently leads to confusion, overwhelm, and potentially even mistaking them for medications.

[0012] The invention is based on the objective of providing an improved composition that ensures high bioavailability of the active ingredients, good stability, and simple and reliable application.

[0013] This problem is solved according to the invention by a composition of the above type with the features characterized in claim 1. Advantageous embodiments of the invention are described in the further claims.

[0014] In a composition of the above type according to the invention, it is provided that it contains a combination of Lactobacillus reuteri, Lactobacillus salivarius, vitamin D3, vitamin B7, at least one tableting agent, at least one carrier, at least one thickening agent, at least one flavoring agent, at least one separating agent (anti-caking agent) and at least one sweetener.

[0015] This has the advantage that a lactose-free product is available that naturally maintains the oral mucosa, normal dental health, and a healthy oral flora, thus addressing multiple requirements for dietary supplements with a single composition or formulation, for which different dietary supplements previously had to be taken.

[0016] A stable filler with the function of a binder for the components of the solid dosage and simultaneously accelerating the disintegration of the components of the solid dosage in the mouth for rapid and efficient drug release with good machine processability through improved flow properties is achieved by using at least one tableting agent that is perlitol-flash-mannitol (mannitol-corn starch mixture) and is contained in an amount of 59 g to 60 g, in particular 59.801 g, per 100 g of the solid dosage.

[0017] Excellent flow properties for particularly good processability are achieved by the fact that the Perlitol Flash Mannitol contains 78 wt.% to 82 wt.% mannitol and 15 wt.% to 19 wt.% corn starch.

[0018] A naturally biodegradable, hypoallergenic, non-toxic carrier substance with improved stability and shelf life of the solid dosage is achieved by using at least one carrier substance that is microcrystalline cellulose (MCC) and is contained in an amount of 19 g to 20 g, in particular 19.565 g, per 100 g of the solid dosage.

[0019] A thickening agent that is easily soluble in water, has a low sweetening power compared to sugar, and simultaneously functions as a filler and stabilizer, and does not significantly raise blood sugar levels, is achieved by using at least one thickening agent that is maltodextrin, modified starch, or starch hydrolysate, and is present in an amount of 7g to 8g, in particular 7.3912g, per 100g of the solid dosage.

[0020] Particularly natural support for the oral flora is achieved by using Lactobacillus reuteri strain BIO5454 with a colony-forming unit (CFU) of 5.0*10 9 CFU is contained in an amount of 6 g to 7 g, in particular 6.5224 g, per 100 g of the fixed dosage.

[0021] Further support for the oral flora is achieved by using Lactobacillus salivarius strain BIO6313 with a colony-forming unit (CFU) number of 3.5*10 9 CFU is contained in an amount of 4 g to 5 g, in particular 4.5644 g, per 100 g of the fixed dosage.

[0022] A pleasant, sweet taste for the user is achieved by including at least one peppermint flavoring agent, which is present in an amount of 1 g to 2 g, in particular 1.087 g, per 100 g of the fixed dosage.

[0023] An advantageous, water-repellent layer against ambient humidity with only a low dosage and thermal stability, and further improvement of flowability for machine processing, is achieved by including at least one separating agent (anti-caking agent) magnesium fatty alcohol salts (magnesium salts of fatty acids) in an amount of 0.1 g to 1 g, in particular 0.565 g, per 100 g of the solid dosage.

[0024] A very precise dosage of the smallest amounts with particularly fast and efficient absorption, bypassing the first-pass effect of the liver, is achieved by the fact that the vitamin D3 cholecalciferol is 100,000 IU / g and is contained in a quantity of 0.1 g to 1 g, in particular 0.435 g, per 100 g of the fixed dosage.

[0025] Particularly good sweetening even in small quantities and at the same time without the risk of dental diseases due to the absence of calories is achieved by using at least one sweetener, sucralose (artificial sweetener E 955), which is contained in an amount of 0.1 g to 1 g, in particular 0.065 g, per 100 g of the fixed dosage.

[0026] Good absorption into the oral mucosa with rapid effectiveness and high tolerability is achieved because the vitamin B7 is D-Biotin and is contained in an amount of 0.1 g to 1 g, in particular 0.003 g, per 100 g of the fixed dosage.

[0027] Particularly simple application without the need for additional means, such as water, is achieved by using a fixed dosage in the form of a chewable tablet, lozenge or melt-in-the-mouth tablet.

[0028] A particularly convenient application is achieved by using a fixed dosage with a total weight of 400 mg to 500 mg, especially 460 mg.

[0029] The invention is explained in more detail below.

[0030] In a preferred embodiment, the composition according to the invention contains mannitol, microcrystalline cellulose, and corn starch as fillers. Maltodextrin is used as a carrier or thickening agent. Active ingredients include Lactobacillus reuteri, Lactobacillus salivarius, cholecalciferol (vitamin D3), and D-biotin. Magnesium salts of fatty acids serve as an anti-caking agent.

[0031] Sucralose is used as a sweetener. The composition preferably contains a specific flavoring or flavor carrier, such as peppermint flavoring.

[0032] Vitamin D contributes to the maintenance of normal teeth. Biotin contributes to the maintenance of normal mucous membranes.

[0033] The composition according to the invention is a dietary supplement that, in addition to vitamins (for teeth and oral mucosa), also contains bacteria of the natural oral flora. The composition according to the invention is specifically designed for use in the oral cavity and is therefore not a classic intestinal probiotic. A lozenge dosage form is therefore particularly preferred.

[0034] The purpose of the composition according to the invention is to provide, for example, a lozenge which, when dissolved in the oral cavity, releases a combination of vitamin D, biotin and two strains of lactic acid bacteria (L. salivarius, L. reuteri) which naturally occur in the human oral flora.

[0035] By combining the micronutrients vitamin D and biotin, which are known to support normal teeth and the maintenance of normal mucous membranes respectively, with selected strains of lactic acid bacteria that occur physiologically in the mouth and function as part of the natural oral flora, the composition according to the invention is intended to enable a combined, functionally coordinated approach for teeth, oral mucosa and the oral microbiota.

[0036] The chosen lozenge dosage form is particularly advantageous in making the active ingredients available locally in the oral cavity rather than in the gastrointestinal tract. This involves the lozenge dissolving and the spatial distribution of the ingredients within the mouth. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] AT 001 230 U1

[0006] AT 001 759 U1

[0007] DE 20 2004 016 077 U1

[0008] DE 20 2007 018 403 U1

[0009]

Claims

[1] Composition in the form of a fixed dosage, especially as a food supplement, containing a combination of Lactobacillus reuteri, Lactobacillus salivarius, vitamin D3, vitamin B7, at least one tableting agent, at least one carrier, at least one thickener, at least one flavouring, at least one anti-caking agent and at least one sweetener. [2] Composition according to claim 1, characterized by , that at least one tableting agent is perlitol flash mannitol (mannitol maize starch mixture) and is contained in an amount of 59 g to 60 g, in particular 59.801 g, per 100 g of the fixed dosage. [3] Composition according to claim 2, characterized by , that the Perlitol Flash Mannitol contains the following, (a) 78% to 82% w / w mannitol and (b) 15% to 19% wt. of maize starch. [4] Composition according to at least one of the preceding claims, characterized by , that the at least one carrier substance is microcrystalline cellulose (MCC) and is contained in an amount of 19 g to 20 g, in particular 19.565 g, per 100 g of the solid dosage. [5] Composition according to at least one of the preceding claims, characterized by that at least one thickening agent is maltodextrin, modified starch or starch hydrolysate and is contained in an amount of 7 g to 8 g, in particular 7.3912 g, per 100 g of the solid dosage. [6] Composition according to at least one of the preceding claims, characterized by , that the Lactobacillus reuteri strain BIO5454 with a number of colony-forming units (CFU) of 5.0*10 9 CFU is. [7] Composition according to claim 1 or 6, characterized by, that the Lactobacillus reuteri is contained in an amount of 6 g to 7 g, in particular 6.5224 g, per 100 g of the fixed dosage. [8] Composition according to at least one of the preceding claims, characterized by , that the Lactobacillus salivarius strain BIO6313 has a number of colony-forming units (CFU) of 3.5*10 9 CFU is. [9] Composition according to claim 1 or 8, characterized by , that the Lactobacillus salivarius is contained in an amount of 4 g to 5 g, in particular 4.5644 g, per 100 g of the fixed dosage. [10] Composition according to at least one of the preceding claims, characterized by , that at least one flavoring agent is peppermint flavoring agent and is contained in an amount of 1 g to 2 g, in particular 1.087 g, per 100 g of the fixed dosage. [11] Composition according to at least one of the preceding claims, characterized bythat it contains at least one separating agent (anti-caking agent) magnesium fatty alcohol salts (magnesium salts of fatty acids) and is present in an amount of 0.1 g to 1 g, in particular 0.565 g, per 100 g of the solid dosage. [12] Composition according to at least one of the preceding claims, characterized by , that the vitamin D3 cholecalciferol is 100,000 IU / g and is contained in a quantity of 0.1 g to 1 g, in particular 0.435 g, per 100 g of the fixed dosage. [13] Composition according to at least one of the preceding claims, characterized by , that it contains at least one sweetener sucralose (artificial sweetener E 955) and is present in an amount of 0.1 g to 1 g, in particular 0.065 g, per 100 g of the fixed dosage. [14] Composition according to at least one of the preceding claims, characterized by, that the vitamin B7 is D-Biotin and is contained in an amount of 0.1 g to 1 g, in particular 0.003 g, per 100 g of the fixed dosage. [15] Composition according to at least one of the preceding claims, characterized by that the fixed dosage is a chewable tablet, lozenge or melt-in-the-mouth tablet. [16] Composition according to at least one of the preceding claims, characterized by , that the fixed dosage has a total weight of 400 mg to 500 mg, in particular 460 mg.