Fat-soluble vitamin powder for food fortification

Abstract

The present invention relates to formulations that contain fat-soluble vitamins and can be used to fortify early nutritional products.

Description

Detailed Description of the Invention

[0001] The present invention relates to preparations which contain fat-soluble vitamins and which can be used to fortify foods, particularly infant formulas.

[0002] Examples of fat-soluble vitamins are vitamin A, vitamin D, vitamin K and / or their derivatives, or mixtures thereof. Vitamin A and / or its derivatives are preferred, vitamin A esters are more preferred, and here vitamin A palmitate is particularly preferred.

[0003] Vitamin A is an essential micronutrient whose deficiency remains a significant health concern in many parts of the world. Vitamin A plays essential roles in human growth and development, immunity, and vision, but it may also help prevent several other chronic diseases. The total amount of vitamin A in the human diet is often below the recommended dietary allowance (RAR) of approximately 900–1000 μg / day for healthy adults. Furthermore, a significant proportion of vitamin A is degraded during food processing, storage, and distribution, which can reduce its bioavailability. Finally, vitamin A in some foods has relatively low bioavailability, further reducing its effectiveness. The World Health Organization recommends food and beverage fortification as a safe and cost-effective means of addressing vitamin A deficiency. However, several challenges must be overcome before effective fortified foods can be developed, including the low solubility, chemical stability, and bioavailability of this fat-soluble vitamin. Consequently, strategies are needed to distribute the vitamin uniformly throughout the food matrix, inhibit its chemical degradation, avoid any adverse interactions with any other food components, ensure the food is palatable, and increase its bioavailability.

[0004] Therefore, there is a continuing need for formulations that can be used for food fortification.

[0005] Food safety is of paramount importance and there is growing concern about the presence of unnatural or harmful ingredients in foods. Particularly in the case of infant foods (early nutrition), strict regulations exist regarding which ingredients are acceptable and desirable in formulations.

[0006] Early nutrition encompasses the first 1,000 days from conception to the second birthday, as well as early childhood. As health professionals, it is essential to understand the importance of early nutrition in shaping long-term health outcomes for infants and children.

[0007] The problem with fat-soluble vitamins is that they are prone to oxidation, which means that their content decreases during storage (as well as during food manufacturing). This is a problem during the manufacturing of preparations containing these vitamins, as well as during the storage of products containing these vitamins.

[0008] The usual way to obtain and maintain a consistent amount of these ingredients in the final product is to add an excess of these vitamins.

[0009] Another way to solve the problem is to add antioxidants to vitamins. A very common and usual antioxidant is BHT (butylhydroxytoluene). Many of the vitamin A powders currently on the market (for early nutrition products) contain BHT or other important antioxidants.

[0010] BHT (butylated hydroxytoluene) is a laboratory-made chemical that is added to food as a preservative, but has a bad reputation from both a health and environmental perspective.

[0011] Therefore, it is desirable to avoid BHT in foods (or in formulations used in foods).

[0012] Also, ascorbic acid, sodium ascorbate (and any other ascorbate salt), and ascorbyl palmitate (and any other ascorbyl ester) have been excluded in many countries and are not permitted or have limited use as antioxidants in infant foods.

[0013] There are also other synthetic antioxidants such as BHA (butylated hydroxyanisole) and EMQ (ethoxyquin).

[0014] It was therefore an object of the present invention to find a formulation containing a high amount of at least one fat-soluble vitamin without containing BHT or sodium ascorbate. Such a formulation should be stable, easy to manufacture and suitable for use in a wide variety of foods, especially infant foods.

[0015] Surprisingly, a solid dosage form comprising: (i) at least one fat-soluble vitamin; (ii) at least one hydrocolloid; (iii) at least one starch hydrolysate; (iv) tocopherol and Including, However, a solid formulation that does not contain any BHT, any ascorbic acid, any sodium ascorbate (any other ascorbate), any ascorbyl palmitate (and any other ascorbyl ester), any BHA, and any EMQ is All the above advantages are shown.

[0016] Thus, the present invention provides a solid dosage form (SF), comprising: (i) at least one fat-soluble vitamin; (ii) at least one hydrocolloid; (iii) at least one starch hydrolysate; (iv) tocopherol and Including, However, the formulation relates to a solid formulation (SF) that does not contain any BHT, any ascorbic acid, any sodium ascorbate (any other ascorbate salt), any ascorbyl palmitate (and any other ascorbyl ester), any BHA, and any EMQ.

[0017] Therefore, the present invention provides (i) at least one fat-soluble vitamin; (ii) at least one hydrocolloid; (iii) at least one starch hydrolysate; (iv) tocopherol and The present invention relates to a solid dosage form (SF') consisting essentially of:

[0018] However, the formulation according to the present invention does not contain any BHT, any ascorbic acid, any sodium ascorbate (any other ascorbate salt), any ascorbyl palmitate (and any other ascorbyl ester), any BHA, and any EMQ. This means that the solid matter is (substantially) free of any BHT, any ascorbic acid, any sodium ascorbate (any other ascorbate salt), any ascorbyl palmitate (and any other ascorbyl ester), any BHA, and any EMQ.

[0019] Trace amounts of these compounds may be present in the formulation, but they are not intentionally added. Trace amounts of such compounds may be present in components (i) to (iv) or other components, which may be part of the solid formulation according to the invention.

[0020] Surprisingly, it has been found that the formulation according to the invention provides excellent stability on its own as well as in food.

[0021] The resulting formulation is free of BHT, ascorbic acid, sodium ascorbate (or any other ascorbate), ascorbyl palmitate, BHA, and EMQ, allowing the formulation to meet early nutrition requirements, and the formulation is less complex to manufacture and the final food label is less complex due to the fewer ingredients included.

[0022] It is also advantageous that the formulation according to the invention does not contain any prebiotic and / or probiotic compounds.

[0023] Therefore, the present invention relates to a solid formulation (SF'') which is a solid formulation (SF) that does not contain any prebiotic and / or probiotic compounds.

[0024] The formulation according to the present invention comprises at least one fat-soluble vitamin, which may be vitamin A, vitamin D, vitamin K and / or a derivative thereof, or a mixture thereof. Vitamin A and / or a derivative thereof is preferred, vitamin A esters are more preferred, and vitamin A palmitate is especially preferred.

[0025] Thus, the present invention relates to a solid formulation (SF1) which is a solid formulation (SF), (SF') or (SF''), wherein the at least one fat-soluble vitamin is selected from the group consisting of vitamin A, vitamin D, vitamin K and derivatives thereof.

[0026] Therefore, the present invention relates to a solid formulation (SF1') which is a solid formulation (SF), (SF') or (SF''), wherein the at least one fat-soluble vitamin is selected from the group consisting of vitamin A and its derivatives.

[0027] Therefore, the present invention relates to a solid formulation (SF1'') which is a solid formulation (SF), (SF') or (SF''), wherein the fat-soluble vitamin is a vitamin A ester.

[0028] Therefore, the present invention relates to a solid formulation (SF1''') which is a solid formulation (SF), (SF') or (SF''), in which the fat-soluble vitamin is vitamin A palmitate.

[0029] The content of at least one fat-soluble vitamin is usually 3 to 30% by weight (wt.-%) based on the total weight of the solid preparation, preferably 5 to 25 wt.-%, more preferably 10 to 20 wt.-% based on the total weight of the solid preparation.

[0030] Therefore, the present invention relates to a solid formulation (SF2) which is a solid formulation (SF), (SF'), (SF''), (SF1), (SF1'), (SF1'') or (SF1'''), wherein the content of at least one fat-soluble vitamin is 3 to 30 wt.-% based on the total weight of the solid formulation.

[0031] The present invention therefore relates to a solid preparation (SF2') which is a solid preparation (SF), (SF'), (SF''), (SF1), (SF1'), (SF1'') or (SF1'''), and which contains 5 to 25 wt.-% of at least one fat-soluble vitamin.

[0032] Therefore, the present invention relates to a solid preparation (SF2'') which is a solid preparation (SF), (SF'), (SF''), (SF1), (SF1'), (SF1'') or (SF1'''), wherein the content of at least one fat-soluble vitamin is 10 to 20 wt.-% based on the total weight of the solid preparation.

[0033] The solid formulation according to the invention comprises at least one hydrocolloid.

[0034] In the context of the present invention, hydrocolloids are polysaccharides, low-, medium- or high-bloom gelatins of fish, porcine or bovine origin, casein / caseinates and other proteinaceous hydrocolloids.

[0035] Preferred hydrocolloids according to the present invention are polysaccharides.

[0036] In the context of the present invention, the term polysaccharides as used herein includes xanthan gum, gum acacia, pectin, guar gum, carob gum, alginates, cellulose, cellulose derivatives, starch and starch derivatives. Preferred polysaccharides according to the invention are gum acacia, starch and starch derivatives, more preferred are gelling starches and modified food starches, with modified food starches being especially preferred.

[0037] In the context of the present invention, the term "modified food starch" as used herein relates to modified starch made from starch substituted with hydrophobic moieties by known chemical methods, for example, starch can be treated with cyclic dicarboxylic acid anhydrides, such as succinic anhydride and / or glutaric anhydride, substituted with alkyl or alkenyl hydrocarbon groups.

[0038] A very common and preferred modified starch is starch sodium octenyl succinate (OSA starch). As used herein, OSA starch refers to any starch (derived from any natural source, such as corn, wheat, tapioca, potato, etc., or synthetically) that has been treated with octenyl succinic anhydride. The degree of substitution, i.e., the number of esterified hydroxyl groups relative to the total number of hydroxyl groups, typically varies between 0.1% and 10%, preferably between 0.5% and 5%, and more preferably between 2% and 4%.

[0039] OSA starches are commercially available, for example, from Ingredion under the trade names HiCap 100, Capsul HF, Capsul HS, Purity Gum 2000, UNI-PURE, HYLON VII, from Rockete Freres, from Cargill under the trade name C*EmCap, or from Tate and Lyle.

[0040] The content of at least one hydrocolloid is usually 20 to 85 wt.-% based on the total weight of the solid preparation, preferably 25 to 80 wt.-% based on the total weight of the solid preparation, and more preferably 25 to 70 wt.-%.

[0041] The present invention therefore relates to a solid formulation (SF3) which is a solid formulation (SF), (SF'), (SF''), (SF1), (SF1'), (SF1''), (SF1'''), (SF2), (SF2') or (SF2''), wherein the at least one hydrocolloid is selected from the group consisting of polysaccharides, low bloom, medium bloom or high bloom gelatin of fish, porcine or bovine origin, casein / caseinates and other proteinaceous hydrocolloids.

[0042] Thus, the present invention relates to a solid formulation (SF3') which is a solid formulation (SF), (SF'), (SF''), (SF1), (SF1'), (SF1''), (SF1'''), (SF2), (SF2') or (SF2''), wherein the at least one hydrocolloid is selected from the group consisting of xanthan gum, acacia gum, pectin, guar gum, carob gum, alginate, cellulose, cellulose derivatives such as starch and starch derivatives.

[0043] Thus, the present invention relates to a solid formulation (SF3") which is a solid formulation (SF), (SF'), (SF"), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2') or (SF2"), wherein the hydrocolloid is a modified food starch.

[0044] Thus, the present invention relates to a solid formulation (SF3''') which is a solid formulation (SF3''), wherein the modified food starch is starch sodium octenyl succinate.

[0045] The present invention therefore relates to a solid formulation (SF4) which is a solid formulation (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3") or (SF3'"), wherein the content of at least one hydrocolloid is 20 to 85 wt.-% based on the total weight of the solid formulation.

[0046] The present invention therefore relates to a solid formulation (SF4') which is a solid formulation (SF), (SF'), (SF''), (SF1), (SF1'), (SF1''), (SF1'''), (SF2), (SF2'), (SF2''), (SF3), (SF3'), (SF3'') or (SF3'''), wherein the content of at least one hydrocolloid is 25 to 80 wt.-% based on the total weight of the solid formulation.

[0047] The present invention therefore relates to a solid formulation (SF4") which is a solid formulation (SF), (SF'), (SF"), (SF"), (SF1), (SF1'), (SF1"), (SF1""), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3") or (SF3'"), wherein the content of at least one hydrocolloid is 25 to 70 wt.-% based on the total weight of the solid formulation.

[0048] The solid formulation according to the invention comprises at least one starch hydrolysate.

[0049] Hydrolyzed starch is a dry product or aqueous dispersion of sugars (hydrolysate) obtained by hydrolysis of native starch by using suitable acids or enzymes.

[0050] Starch hydrolysates means dextrins, maltodextrins and glucose syrups.

[0051] Starch hydrolysates with a DE value of 10-30 are preferred, hydrolysates with a DE value of 15-25 are more preferred, and hydrolysates with a DE value of 17-20 are most preferred.

[0052] The DE value characterizes the reducing power based on the reducing power of anhydrous dextrose and is determined by the DIN 10 308 method of the Deutsche Normenausschuss Lebensmittel und landwirtschaftliche Produkte, edition 5.71.

[0053] Thus, the present invention relates to a solid formulation (SF5) which is a solid formulation (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3'"), (SF4), (SF4') or (SF4"), wherein the at least one starch hydrolysate is selected from the group consisting of dextrin, maltodextrin and glucose syrup.

[0054] The present invention therefore relates to a solid formulation (SF5') which is a solid formulation (SF), (SF'), (SF''), (SF1), (SF1'), (SF1''), (SF1'''), (SF2), (SF2'), (SF2''), (SF3), (SF3'), (SF3''), (SF3'''), (SF4), (SF4') or (SF4''), wherein at least one starch hydrolysate has a DE value of 10 to 30.

[0055] Thus, the present invention relates to a solid formulation (SF5") which is a solid formulation (SF), (SF'), (SF"), (SF"), (SF1), (SF1'), (SF1"), (SF1""), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3""), (SF4), (SF4') or (SF4"), wherein at least one starch hydrolysate has a DE value of 15 to 25.

[0056] The present invention therefore relates to a solid formulation (SF5''') which is a solid formulation (SF), (SF'), (SF''), (SF1), (SF1'), (SF1''), (SF1'''), (SF2), (SF2'), (SF2''), (SF3), (SF3'), (SF3''), (SF3'''), (SF4), (SF4') or (SF4''), wherein at least one starch hydrolysate has a DE value of 17 to 20.

[0057] The solid formulation according to the invention comprises 10 to 60 wt.-% of at least one starch hydrolysate, based on the total weight of the solid formulation.

[0058] Preferably, it is 15 to 55 wt.-% based on the total weight of the solid preparation, and more preferably 18 to 55 wt.-%.

[0059] The present invention therefore relates to a solid formulation (SF6) which is a solid formulation (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3'"), (SF3'"), (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5") or (SF5'"), wherein the content of at least one starch hydrolysate is 10 to 60 wt.-% based on the total weight of the solid formulation.

[0060] The present invention therefore relates to a solid formulation (SF6') which is a solid formulation (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3'"), (SF3'"), (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5") or (SF5'"), wherein the content of at least one starch hydrolysate is 15 to 55 wt.-% based on the total weight of the solid formulation.

[0061] The present invention therefore relates to a solid formulation (SF6") which is a solid formulation (SF), (SF'), (SF"), (SF"), (SF1), (SF1'), (SF1"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3'"), (SF3'", (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5") or (SF5'"), wherein the content of at least one starch hydrolysate is 18 to 55 wt.-% based on the total weight of the solid formulation.

[0062] The solid formulation according to the present invention comprises tocopherol.

[0063] In the context of the present invention, the term "tocopherol" encompasses DL-α-tocopherol, γ-tocopherol, δ-tocopherol and mixed tocopherols.

[0064] The tocopherol content is 0.1 to 5 wt.-% based on the total weight of the solid preparation, preferably 0.2 to 4 wt.-% based on the total weight of the solid preparation, and more preferably 0.5 to 3 wt.-%.

[0065] Accordingly, the present invention relates to a solid formulation (SF7) which is a solid formulation (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3'"), (SF3'", (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5"), (SF5'"), (SF6), (SF6') or (SF6"), wherein the tocopherol content is 0.1 to 5 wt.-% based on the total weight of the solid formulation.

[0066] Accordingly, the present invention relates to a solid formulation (SF7') which is a solid formulation (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3'"), (SF3'"), (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5"), (SF5'"), (SF6), (SF6') or (SF6"), wherein the tocopherol content is 0.2 to 4 wt.-% based on the total weight of the solid formulation.

[0067] Accordingly, the present invention relates to a solid formulation (SF7") which is a solid formulation (SF), (SF'), (SF"), (SF"), (SF1), (SF1'), (SF1"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3'"), (SF3'", SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5"), (SF5'"), (SF6), (SF6') or (SF6"), and wherein the tocopherol content is 0.5 to 3 wt.-% based on the total weight of the solid formulation.

[0068] Furthermore, the solid dosage form according to the invention may also contain some residual water, the content of which depends on the drying process used to dry the solid dosage form.

[0069] The water content of the solid preparation according to the present invention is usually preferably less than 5 wt-% based on the total weight of the solid preparation, more preferably less than 4 wt-% based on the total weight of the solid preparation.

[0070] Accordingly, the present invention relates to a solid formulation (SF8) which is a solid formulation (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3'"), (SF3'", (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5"), (SF5'"), (SF6), (SF6'), (SF6"), (SF7), (SF7') or (SF7"), wherein the water content of the solid formulation is less than 5 wt-% based on the total weight of the solid formulation.

[0071] Accordingly, the present invention relates to a solid formulation (SF8′) which is a solid formulation (SF), (SF′), (SF″), (SF1), (SF1′), (SF1″), (SF1′″), (SF2), (SF2′), (SF2″), (SF3), (SF3′), (SF3″), (SF3′″), (SF4), (SF4′), (SF4″), (SF5), (SF5′), (SF5″), (SF5′′), (SF6), (SF6′), (SF6″), (SF7), (SF7′) or (SF7″), wherein the water content of the solid formulation is less than 4 wt-% based on the total weight of the solid formulation.

[0072] The solid formulation according to the invention may further contain additional ingredients such as powdering agents, oils, anti-caking agents such as tricalcium phosphate, silicon dioxide, flavors and colorants.

[0073] Such additional ingredients may be present in the present invention in an amount of up to 10 wt-%, based on the total weight of the solid dosage form.

[0074] Accordingly, the present invention relates to a solid formulation (SF9) which is a solid formulation (SF), (SF1), (SF"), (SF1'), (SF1"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3'"), (SF3'"), (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5"), (SF5'"), (SF6), (SF6'), (SF6"), (SF7), (SF7'), (SF7"), (SF8) or (SF8'), wherein the solid formulation comprises at least one additional ingredient selected from the group consisting of powdering agents, oils, anti-caking agents such as tricalcium phosphate, and silicates such as silicon dioxide or sodium aluminum silicate, flavors, and colorants.

[0075] Thus, the present invention relates to a solid formulation (SF9') which is a solid formulation (SF9), wherein the content of at least one additional ingredient is up to 10 wt-% based on the total weight of the solid formulation.

[0076] Components (i) to (v) and the remaining water and additional ingredients (e.g., powdering agents, anti-caking agents such as tricalcium phosphate, silicon dioxide, flavors and colorants) are in the form of particles that form a solid formulation according to the present invention.

[0077] Preferably, the solid formulation according to the present invention does not contain sucrose (such as sucrose, lactose, trehalose, cellobiose and chitobiose (preferably sucrose)).

[0078] Accordingly, the present invention relates to a solid formulation (SF10) which is a solid formulation (SF), (SF1), (SF"), (SF1'), (SF1"), (SF1'"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3'"), (SF3'"), (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5"), (SF5'"), (SF6), (SF6'), (SF6"), (SF7), (SF7'), (SF7"), (SF8), (SF8'), (SF9) or (SF9') which does not contain a disaccharide selected from the group consisting of sucrose, lactose, trehalose, cellobiose and chitobiose.

[0079] Preferably, the solid formulation according to the invention is silicate-free.

[0080] Optionally, the particles forming the solid dosage form according to the invention may also be coated, meaning that the particles may have a coating layer.

[0081] The coating layer can be any commonly known coating layer. It can also be a powder coating layer. Such powder coatings can be made from starch (such as corn starch).

[0082] The coating layer may be up to 45 wt-% of the coated solid dosage form, based on the total weight of the coated solid dosage form, which means that at least 55 wt-% of the coated solid dosage form is at least one solid dosage form as defined above.

[0083] Thus, the present invention relates to a coated solid formulation (CSF1), which is a solid formulation (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3'"), (SF3'", (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5"), (SF5'"), (SF6), (SF6'), (SF6"), (SF7), (SF7'), (SF7"), (SF8), (SF8'), (SF9), (SF9') or (SF10) coated with a coating layer.

[0084] Thus, the present invention relates to a solid formulation (CSF1') which is a coated solid formulation (CSF1), wherein the coating layer is up to 45 wt-% of the coated solid formulation, based on the total weight of the coated solid formulation.

[0085] The solid formulations (SF), (SF'), (SF''), (SF1), (SF1'), (SF1''), (SF1'''), (SF2), (SF2'), (SF2''), (SF3), (SF3'), (SF3''), (SF3'''), (SF4), (SF4'), (SF4''), (SF5), (SF5'), (SF5''), (SF5'''), (SF6), (SF6'), (SF6''), (SF7), (SF7'), (SF7''), (SF8), (SF8'), (SF9), (SF9') or (SF10) and the coated solid formulations (CSF1) or (CSF1') can be manufactured by commonly known methods such as spray drying, powder catch method, freeze drying, granulation, agglomeration or extrusion.

[0086] The particle size of the solid formulations and coated solid formulations according to the present invention may vary depending on the process used to produce the (coated) solid formulations. Typical size ranges for particle distribution (Dv(10)) are 10 μm to 500 μm, preferably 10 μm to 250 μm.

[0087] Therefore, the particle size distribution (Dv(10)) of the (coated) solid preparations (SF), (SF'), (SF1), (SF"), (SF1'), (SF1"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3'"), (SF3'"), (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5"), (SF5'"), (SF6), (SF6'), (SF6"), (SF7), (SF7'), (SF7"), (SF8), (SF8'), (SF9), (SF9'), (SF10), (CSF1) and (CSF1') is in the range of 10 μm to 500 μm, preferably in the range of 10 μm to 250 μm.

[0088] The formulations according to the invention are used to fortify food products, especially infant formulas (early nutritional products).

[0089] The formulation can be incorporated into food products, especially infant formulas (early nutritional products).

[0090] It is also possible to mix the formulations according to the invention into premix formulations (containing other ingredients for the desired use (vitamins, trace minerals, etc.)) which can then be mixed into food, in particular infant formulas (early nutritional products).

[0091] The (coated) solid dosage forms (SF), (SF'), (SF''), (SF1), (SF1'), (SF1''), (SF1'''), (SF2), (SF2'), (SF2''), (SF3), (SF3'), (SF3''), (SF3'''), (SF4), (SF4'), (SF4''), (SF5), (SF5'), (SF5''), (SF5'''), (SF6), (SF6'), (SF6''), (SF7), (SF7'), (SF7''), (SF8), (SF8'), (SF9), (SF9'), (SF10), (CSF1) and / or (CSF1') are used to fortify food.

[0092] The solid dosage forms (SF), (SF'), (SF''), (SF1), (SF1'), (SF1''), (SF1'''), (SF2), (SF2'), (SF2''), (SF3), (SF3'), (SF3''), (SF3'''), (SF4), (SF4'), (SF4''), (SF5), (SF5'), (SF5''), (SF5'''), (SF6), (SF6'), (SF6''), (SF7), (SF7'), (SF7''), (SF8), (SF8'), (SF9), (SF9'), (SF10), (CSF1) and / or (CSF1') are used to fortify early nutritional foods.

[0093] Furthermore, the present invention relates to food products enriched with solid formulations (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3'"), (SF3'", (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5"), (SF5'"), (SF6), (SF6'), (SF6"), (SF7), (SF7'), (SF7"), (SF8), (SF8'), (SF9), (SF9'), (SF10), (CSF1) and / or (CSF1').

[0094] Furthermore, the present invention relates to an early nutritional food product fortified with (coated) solid formulations (SF), (SF'), (SF1), (SF"), (SF1'), (SF1"), (SF1'"), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3'"), (SF3'"), (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5"), (SF5'"), (SF6), (SF6'), (SF6"), (SF7), (SF7'), (SF7"), (SF8), (SF8'), (SF9), (SF9'), (SF10), (CSF1) and / or (CSF1').

[0095] The following examples illustrate the present invention.

[0096] All parts and percentages in the examples relate to weight (unless otherwise stated) and temperatures are given in degrees Celsius (unless otherwise stated).

[0097] [Example] [Example 1] A matrix solution was prepared by dissolving 180 g of Hicap 100, 56 g of acacia gum, and 97 g of Glucidex 19D in 222 g of water with stirring at 65°C. The pH of the solution was adjusted to 5.0 by adding 13.6 g of 2 M sodium acetate solution. 66 g of vitamin A palmitate (1.7 million IU / g) and 4.2 g of mixed tocopherols (70 IP) were mixed at 60°C for 10 minutes, and 68.3 g of this mixture was added to the matrix solution. The mixture was emulsified until the particle size, D(0.5), was less than 1 μm as measured with a Malvern Mastersizer 2000. The viscosity was adjusted by adding water, and the emulsion was spray-dried to yield 199 g of dry powder with an LOD of 2.01%. The final dry powder had the composition of Example 1.

[0098] The powder designated as Example 2 is produced according to Example 1.

[0099] [Table 1]

[0100] The powder designated as Example 3 is prepared according to Example 1. This is a comparative example. This formulation contains sodium ascorbate.

[0101] [Table 2]

[0102] [Application test] The stability of example vitamin A forms was evaluated in a typical infant formula vitamin premix with a final composition containing 3% vitamin A product form, 46% lactose, 16% inositol, 16% taurine, 7% vitamin E, 3% vitamin D3, 2% vitamin K1, and 7% other ingredients (vitamin B3, calcium, vitamin B12, vitamin B7, vitamin B9, vitamin B2, vitamin B1, and vitamin B6). Note that concentrations are given for the product form.

[0103] To prepare the blend, 485 g of the premix was filled into a 1-liter glass bottle with 15 g of vitamin A product. The contents of the bottle were then mixed for 10 minutes at 22 rpm in an orbital mixer (Turbula®, Type T2 C Shaker Mixer). The resulting mixture was aliquoted into aluminum bags, and stability testing of vitamin A palmitate was performed at 30°C for up to 3 months. Initial determinations of vitamin A content were performed twice in duplicate using three different bags, while the following time points were based on duplicate measurements of two different bags.

[0104] [Table 3]

[0105] It can be seen that the formulations according to the invention exhibit improved stability.

Claims

1. A solid dosage form comprising: (i) at least one fat-soluble vitamin; (ii) at least one hydrocolloid; (iii) at least one starch hydrolysate; (iv) tocopherol and Including, However, the formulation is a solid formulation that does not contain any BHT, any ascorbic acid, any sodium ascorbate (any other ascorbate salt), any ascorbyl palmitate (and any other ascorbyl ester), any BHA, and any EMQ.

2. 2. The solid formulation according to claim 1, wherein the at least one fat-soluble vitamin is selected from the group consisting of vitamin A, vitamin D, vitamin K, and derivatives thereof.

3. 2. The solid formulation according to claim 1, wherein the at least one fat-soluble vitamin is selected from the group consisting of vitamin A and its derivatives.

4. 4. The solid preparation according to claim 1, wherein the content of the at least one fat-soluble vitamin is 3 to 30 wt. % based on the total weight of the solid preparation.

5. 4. The solid formulation according to claim 1, wherein the content of the at least one fat-soluble vitamin is 5 to 25 wt. % based on the total weight of the solid formulation.

6. 6. The solid formulation according to any one of claims 1 to 5, wherein the at least one hydrocolloid is selected from the group consisting of polysaccharides, low-, medium- or high-bloom gelatins of fish, porcine or bovine origin, casein / caseinates and other proteinaceous hydrocolloids.

7. 6. The solid formulation according to any one of claims 1 to 5, wherein the at least one hydrocolloid is selected from the group consisting of xanthan gum, gum acacia, pectin, guar gum, carob gum, alginate, cellulose, cellulose derivatives such as starch and starch derivatives.

8. 8. The solid formulation according to claim 1, wherein the content of the at least one hydrocolloid is 20 to 85 wt. % based on the total weight of the solid formulation.

9. The solid formulation according to any one of claims 1 to 8, wherein the at least one starch hydrolysate is selected from the group consisting of dextrin, maltodextrin and glucose syrup.

10. 10. The solid formulation according to claim 1, wherein the content of the at least one starch hydrolysate is 10 to 60 wt.-% based on the total weight of the solid formulation.

11. 11. The solid formulation according to claim 1, wherein the content of the tocopherol is 0.1 to 5 wt. % based on the total weight of the solid formulation.

12. The solid preparation according to any one of claims 1 to 11, wherein the water content of the solid preparation is less than 5 wt-% based on the total weight of the solid preparation.

13. Use of the solid formulation according to any one of claims 1 to 12 for fortifying early life nutrition (ELN) products.

14. A fast-food nutritional product enriched with the solid formulation according to any one of claims 1 to 12.

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