Fat-soluble vitamin powder for fortifying food products

Abstract

The present invention relates to a formulation comprising a fat-soluble vitamin, useful for fortifying early life nutritional products.

Description

[0001] The present invention relates to a formulation comprising fat-soluble vitamins which can be used to fortify food products, especially infant formulations.

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

[0003] Vitamin A is an essential micronutrient, and deficiency remains a major health concern in many parts of the world. It plays an important role in human growth and development, immunity, and vision, and also helps prevent several other chronic diseases. The total amount of vitamin A in the human diet is often below the recommended dietary intake for healthy adults, which is about 900-1000 micrograms per day. In addition, a large portion of vitamin A may be degraded during food processing, storage, and distribution, which reduces its biological activity. Finally, the bioavailability of vitamin A in some foods is relatively low, which further reduces its efficacy. The World Health Organization recommends that the addition of nutritional fortification to foods and beverages is a safe and cost-effective way to address vitamin A deficiency. However, several factors must be overcome before effective fortified foods can be developed, including the low solubility, chemical stability, and bioavailability of this oil-soluble vitamin. Therefore, strategies need to be developed to evenly disperse the vitamin in the food matrix, inhibit its chemical degradation, avoid any adverse interactions with any other food components, ensure food palatability, and improve its bioavailability.

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

[0005] Food safety is of paramount importance and the inclusion of unnatural or non-beneficial ingredients in food is a growing concern. Especially for baby food (early life nutrition), there are strict regulations governing what ingredients are allowed and required in the formula.

[0006] Early life nutrition covers the first 1,000 days of a child’s life, from conception to the second birthday, and into early childhood. As healthcare professionals, it is critical to understand the importance of early life nutrition in shaping long-term health outcomes for infants and children.

[0007] The problem with fat-soluble vitamins is that they oxidize easily. This means that during storage (and during the production of food products) the content of these vitamins decreases. This is a problem both when producing preparations containing these vitamins and when storing products containing these vitamins.

[0008] In order to obtain and maintain a certain amount of these components in the final product, it is common practice to add these vitamins in excess.

[0009] Another way to solve this problem is to add antioxidants to the vitamin. A very common and commonly used antioxidant is BHT (Butylated Hydroxytoluene). Many vitamin A powders on the market today contain BHT or other key antioxidants (used in early life nutrition products).

[0010] BHT (butylated hydroxytoluene) is a lab-made chemical that is added to foods as a preservative, but it has a somewhat negative reputation from both a health and environmental perspective.

[0011] Therefore, it is desirable to avoid the use of BHT in food products (or in formulations for use in food products).

[0012] Furthermore, ascorbic acid, sodium ascorbate (and other ascorbate salts) and ascorbyl palmitate (and other ascorbyl esters) are not permitted or are restricted for use as antioxidants in infant foods in many countries.

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

[0014] Therefore, the object of the present invention is to find a formulation containing high amounts of at least one fat-soluble vitamin, which formulation does not contain BHT or sodium ascorbate. Such a formulation needs to be stable, easy to produce, and can be used in a large number of different types of food products (especially baby food).

[0015] Surprisingly, a solid dosage form has been discovered, comprising:

[0016] (i) at least one fat-soluble vitamin, and

[0017] (ii) at least one hydrogel, and

[0018] (iii) at least one starch hydrolysate, and

[0019] (iv) tocopherol,

[0020] Provided, however, that the formulation does not contain any BHT, any ascorbic acid, any sodium ascorbate (and any other salts of ascorbic acid), any ascorbyl palmitate (and any other esters of ascorbic acid), any BHA, and any EMQ.

[0021] The formulation has all the advantages listed above.

[0022] Therefore, the present invention relates to a solid dosage form (SF) comprising:

[0023] (i) at least one fat-soluble vitamin, and

[0024] (ii) at least one hydrogel, and

[0025] (iii) at least one starch hydrolysate, and

[0026] (iv) tocopherol,

[0027] Provided, however, that the formulation does not contain any BHT, any ascorbic acid, any sodium ascorbate (and any other salts of ascorbic acid), any ascorbyl palmitate (and any other esters of ascorbic acid), any BHA, and any EMQ.

[0028] Therefore, the present invention relates to a solid preparation (SF') which (essentially) consists of the following ingredients:

[0029] (i) at least one fat-soluble vitamin, and

[0030] (ii) at least one hydrogel, and

[0031] (iii) at least one starch hydrolysate, and

[0032] (iv) Tocopherol.

[0033] The solid formulation according to the present invention does not contain any BHT, any ascorbic acid, any sodium ascorbate (and any other ascorbate salt), any ascorbyl palmitate (and any other ascorbate ester), any BHA and any EMQ. This means that the solid formulation does not (substantially) contain any BHT, any ascorbic acid, any sodium ascorbate (and any other ascorbate salt), any ascorbyl palmitate (and any other ascorbate ester), any BHA and any EMQ.

[0034] Trace amounts of these compounds may be present in the formulation, but they are not intentionally added. Trace amounts of these compounds may be present in components (i) to (iv) or other components that may be part of the solid formulation according to the invention.

[0035] Surprisingly, it was found that the preparations according to the invention have excellent stability both per se and in food products.

[0036] Since the formulation does not contain BHT, ascorbic acid, sodium ascorbate (and any other ascorbate salts), ascorbyl palmitate, BHA and EMQ, the formulation of the present invention meets the requirements of early life nutrition. In addition, the production process of the formulation is relatively simple, and the labeling of the final food product becomes less complicated because it contains fewer ingredients.

[0037] It is also advantageous if the preparation according to the invention does not contain any prebiotic and / or probiotic compounds.

[0038] Therefore, the present invention relates to a solid dosage form (SF") which is (SF) and does not contain any prebiotic and / or probiotic compounds.

[0039] The preparation according to the invention comprises at least one fat-soluble vitamin. The fat-soluble vitamin is vitamin A, vitamin D, vitamin K and / or its derivatives or a mixture of these substances. Vitamin A and / or its derivatives are preferred, and esters of vitamin A, especially vitamin A palmitate, are more preferred.

[0040] Therefore, the present invention relates to a solid preparation (SF1) which is (SF), (SF') or (SF"), wherein at least one fat-soluble vitamin is selected from the group consisting of vitamin A, vitamin D, vitamin K and derivatives thereof.

[0041] Therefore, the present invention relates to a solid formulation (SF1′) which is (SF), (SF′) or (SF″), wherein at least one fat-soluble vitamin is selected from the group consisting of vitamin A and its derivatives.

[0042] Therefore, the present invention relates to a solid preparation (SF1") which is (SF), (SF') or (SF"), wherein the fat-soluble vitamin is an ester of vitamin A.

[0043] Therefore, the present invention relates to a solid preparation (SF1''"), which is (SF), (SF') or (SF"), wherein the fat-soluble vitamin is vitamin A palmitate.

[0044] The at least one fat-soluble vitamin is generally present in an amount of 3 to 30 weight percent (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.

[0045] Therefore, the present invention relates to a solid preparation (SF2), which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1") or (SF1"'), 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.

[0046] Therefore, the present invention relates to a solid formulation (SF2') which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1") or (SF1"'), wherein the content of the at least one fat-soluble vitamin is 5 to 25 wt.%.

[0047] Therefore, the present invention relates to a solid preparation (SF2"), which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1") or (SF1"'), wherein the content of the at least one fat-soluble vitamin is 10 to 20 wt.%, based on the total weight of the solid preparation.

[0048] The solid preparation according to the invention comprises at least one hydrogel.

[0049] In the context of the present invention, hydrogels refer to polysaccharides, low-, medium- or high-bloom gelatin from fish, pork or cattle, casein / caseinate and other proteinaceous hydrogels.

[0050] According to the present invention, preferred hydrogels are polysaccharides.

[0051] In the context of the present invention, the term "polysaccharide" used includes xanthan gum, gum arabic, pectin, guar gum, carob gum, alginates, cellulose, cellulose derivatives, starch and starch derivatives. According to the present invention, preferred polysaccharides are gum arabic, starch, starch derivatives, more preferably gelatinized starch and modified edible starch, and particularly preferably modified edible starch.

[0052] In the context of the present invention, the term "modified edible starch" as used relates to modified starches made by known chemical methods by substituting starch with hydrophobic groups. For example, starch may be treated with cyclic dicarboxylic anhydrides such as succinic anhydride and / or glutaric anhydride and substituted with alkyl or alkenyl hydrocarbon groups.

[0053] A very common and preferred modified starch is sodium starch octenyl succinate (OSA-starch). OSA-starch as used in the present invention refers to any starch (from any natural source, such as corn, wheat, cassava, potato or synthetic) treated with octenyl succinic anhydride. The degree of substitution, i.e. the ratio of the number of esterified hydroxyl groups to the total number of hydroxyl groups, is generally in the range of 0.1% to 10%, preferably in the range of 0.5% to 5%, more preferably in the range of 2% to 4%.

[0054] OSA-starch is commercially available, for example, from Ingredion under the trade names HiCap 100, Capsul HF, Capsul HS, Purity Gum 2000, UNI-PURE, HYLON VII; from Roquette Freres; from Cargill under the trade name C*EmCap; or from Tate & Lyle.

[0055] Based on the total weight of the solid formulation, the at least one hydrogel is generally present in an amount of 20 to 85 weight percent (wt.%), preferably 25 to 80 wt.%, more preferably 25 to 70 wt.% of the total weight of the solid formulation.

[0056] Therefore, the present invention relates to a solid formulation (SF3), which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2') or (SF2"), wherein the at least one hydrogel is selected from the group consisting of polysaccharides, low bloom, medium bloom or high bloom gelatin from fish, pork or cattle, casein / caseinate and other protein hydrogels.

[0057] Therefore, the present invention relates to a solid formulation (SF3') which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2') or (SF2"), wherein the at least one hydrogel is selected from the group consisting of xanthan gum, gum arabic, pectin, guar gum, carob gum, alginates, cellulose, cellulose derivatives such as starch and starch derivatives.

[0058] Therefore, the present invention relates to a solid formulation (SF3"), which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2') or (SF2"), wherein the hydrogel is a modified edible starch.

[0059] Therefore, the present invention relates to a solid formulation (SF3'"), which is (SF3"), wherein the modified edible starch is sodium starch octenylsuccinate.

[0060] Therefore, the present invention relates to a solid formulation (SF4), which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3") or (SF3"'), wherein the content of the at least one hydrogel is 20 to 85 wt.-%, based on the total weight of the solid formulation.

[0061] Therefore, the present invention relates to a solid formulation (SF4') which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3") or (SF3"'), wherein the content of the at least one hydrogel is 25 to 80 wt.-%, based on the total weight of the solid formulation.

[0062] Therefore, the present invention relates to a solid formulation (SF4") which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3") or (SF3"'), wherein the content of the at least one hydrogel is 25 to 70 wt.-%, based on the total weight of the solid formulation.

[0063] The solid preparation according to the invention comprises at least one starch hydrolyzate.

[0064] Hydrolyzed starch is a dry product or aqueous suspension of sugars (hydrolysate) obtained by hydrolyzing native starch using an appropriate acid or enzyme.

[0065] Starch hydrolysates refer to dextrin, maltodextrin and glucose syrup.

[0066] Preferred starch hydrolysates have a DE value of 10 to 30, more preferably a hydrolysate having a DE value of 15 to 25, and most preferably a hydrolysate having a DE value of 17 to 20.

[0067] The DE value characterizes the reducing power based on the reducing power of anhydrous glucose and is determined by the DIN 10 308 method version 5.71 of the German Standards Committee for Food and Agricultural Products (Deutsche Normenausschuss für Lebensmittel und landwirtschaftliche Produkte).

[0068] Therefore, the present invention relates to a solid formulation (SF5), which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3"'), (SF4), (SF4') or (SF4"), wherein the at least one starch hydrolyzate is selected from the group consisting of dextrin, maltodextrin and glucose syrup.

[0069] Therefore, the present invention relates to a solid formulation (SF5') which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3"'), (SF4), (SF4') or (SF4"), wherein the at least one starch hydrolyzate has a DE value of 10 to 30.

[0070] Therefore, the present invention relates to a solid formulation (SF5") which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3"'), (SF4), (SF4') or (SF4"), wherein the at least one starch hydrolyzate has a DE value of 15 to 25.

[0071] Therefore, the present invention relates to a solid formulation (SF5"'), which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3"'), (SF4), (SF4') or (SF4"), wherein the at least one starch hydrolyzate has a DE value of 17 to 20.

[0072] The solid preparation according to the present invention comprises 10 to 60 wt.% of the at least one starch hydrolysate based on the total weight of the solid preparation, preferably 15 to 55 wt.%, more preferably 18 to 55 wt.% based on the total weight of the solid preparation.

[0073] Therefore, the present invention relates to a solid preparation (SF6), which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3"'), (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5") or (SF5"'), wherein the content of the at least one starch hydrolysate is 10 to 60 wt.% based on the total weight of the solid preparation.

[0074] Therefore, the present invention relates to a solid preparation (SF6'), which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3"'), (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5") or (SF5"'), wherein, based on the total weight of the solid preparation, the content of the at least one starch hydrolysate is 15 to 55 wt.%.

[0075] Therefore, the present invention relates to a solid preparation (SF6"), which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3"'), (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5") or (SF5"'), wherein, based on the total weight of the solid preparation, the content of the at least one starch hydrolysate is 18 to 55 wt.%.

[0076] The solid preparation according to the present invention comprises tocopherol.

[0077] In the context of the present invention, the term "tocopherol" includes DL-α-tocopherol, γ-tocopherol, δ-tocopherol and mixed tocopherols.

[0078] The content of tocopherol is 0.1 to 5 wt.%, preferably 0.2 to 4 wt.%, more preferably 0.5 to 3 wt.%, based on the total weight of the solid preparation.

[0079] Therefore, the present invention relates to a solid preparation (SF7), which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2'), (SF2"), (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 preparation.

[0080] Therefore, the present invention relates to a solid preparation (SF7'), which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2'), (SF2"), (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 preparation.

[0081] Therefore, the present invention relates to a solid preparation (SF7"), which is (SF), (SF'), (SF"), (SF1), (SF1'), (SF1"), (SF1"'), (SF2), (SF2'), (SF2"), (SF3), (SF3'), (SF3"), (SF3"'), (SF4), (SF4'), (SF4"), (SF5), (SF5'), (SF5"), (SF5"'), (SF6), (SF6') or (SF6"), wherein the tocopherol content is 0.5 to 3 wt.% based on the total weight of the solid preparation.

[0082] Furthermore, the solid preparations according to the invention may also contain some residual moisture. The content depends on the drying process used to dry the solid preparation.

[0083] The moisture content of the solid preparation according to the present invention is usually and preferably less than 5 wt.% of the total weight of the solid preparation. More preferably, the moisture content is less than 4 wt.% of the total weight of the solid preparation.

[0084] Therefore, the present invention relates to a solid formulation (SF8), which is (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 moisture content of the solid formulation is less than 5 wt.% based on the total weight of the solid formulation.

[0085] Therefore, the present invention relates to a solid formulation (SF8'), which is (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 moisture content of the solid formulation is less than 4 wt.% based on the total weight of the solid formulation.

[0086] The solid preparation according to the present invention may further comprise other additional ingredients, such as powders, oils, anti-caking agents (eg tricalcium phosphate, silicon dioxide), flavors and pigments.

[0087] The content of these additional ingredients in the invention may be up to 10 wt. %, based on the total weight of the solid preparation.

[0088] Therefore, the present invention relates to a solid formulation (SF9), which is (SF), (SF1), (SF"), (SF1'), (SF1"), (SF1"'), (SF2), (SF2'), (SF2"), (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 powders, oils, anti-caking agents (e.g. tricalcium phosphate and silicates, such as silicon dioxide or sodium aluminum silicate), flavors and pigments.

[0089] Therefore, the present invention relates to a solid formulation (SF9') which is (SF9), wherein the content of the at least one additional ingredient does not exceed 10 wt.% of the total weight of the solid formulation.

[0090] Components (i) to (iv) as well as residual moisture and additional ingredients such as powders, anti-caking agents, for example tricalcium phosphate, silicon dioxide, flavors and pigments are present in granular form to form a solid preparation according to the invention.

[0091] Preferably, the solid preparation according to the present invention does not contain any sucrose (such as sucrose, lactose, trehalose, cellobiose and chitobiose (preferably sucrose)).

[0092] Therefore, the present invention relates to a solid preparation (SF10), which is (SF), (SF1), (SF"), (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) or (SF9'), which does not contain any disaccharide selected from the group consisting of sucrose, lactose, trehalose, cellobiose and chitobiose (preferably sucrose).

[0093] Preferably, the solid formulation according to the present invention does not contain any silicates.

[0094] Optionally, the particles forming the solid formulation according to the invention may also be coated, which means that they may have a coating layer.

[0095] The coating layer can be any commonly known coating layer. It can also be a powder coating layer. Such a powder coating layer can be made of starch (such as corn starch).

[0096] Based on the total weight of the coated solid preparation, the coating layer may account for no more than 45 wt.% of the coated solid preparation. This means that at least 55 wt.% of the coated solid preparation is at least one solid preparation as defined above.

[0097] Therefore, the present invention relates to a coated solid preparation (CSF1), which is a solid preparation coated with a coating layer (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).

[0098] Therefore, the present invention relates to a solid preparation (CSF1'), which is a coated solid preparation (CSF1), wherein the coating layer accounts for no more than 45 wt.% of the coated solid preparation, based on the total weight of the coated solid preparation.

[0099] Solid preparations (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') and (SF10) and coated solid preparations (CSF1) or (CSF1') can be produced by common methods such as spray drying, powder capture, freeze drying, granulation, agglomeration or extrusion.

[0100] The particle size of the solid preparation and the coated solid preparation according to the present invention can vary depending on the process used to produce the (coated) solid preparation. The usual size range of the particle distribution (Dv(10)) is 10 microns to 500 microns, preferably 10 microns to 250 microns.

[0101] Therefore, the particle size distribution (Dv(10)) of the (coated) solid preparations (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 (CSF1') is in the range of 10 μm to 500 μm, preferably in the range of 10 μm to 250 μm.

[0102] The preparations according to the invention are used for fortifying food products, in particular infant formulas (early life nutritional products).

[0103] The formulation may be incorporated into food products, in particular infant formula (early life nutritional products).

[0104] The preparation according to the invention can also be mixed with premixed preparations (comprising other ingredients such as vitamins, trace elements etc. for the desired use) and then incorporated into food products, in particular infant formulas (early life nutritional products).

[0105] (Coated) 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'), (SF10), (CSF1) and / or (CSF1') are used to fortify food products.

[0106] (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 early life nutrition products.

[0107] In addition, the present invention also relates to food products fortified by 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').

[0108] In addition, the present invention also relates to early life nutrition products fortified by solid formulations (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').

[0109] The following examples illustrate the invention.

[0110] All parts and percentages in the examples are by weight (unless otherwise specified) and temperatures are in ° C. (unless otherwise specified). Example

[0111] Embodiment 1:

[0112] Under stirring, 180 grams of Hicap 100, 56 grams of gum arabic and 97 grams of Glucidex 19D were dissolved in 222 grams of water at 65 degrees Celsius to prepare a base solution. 13.6 grams of 2M sodium acetate solution were added and the pH value of the solution was adjusted to 5.0. 66 grams of vitamin A palmitate (1,7 MioIU / gram) and 4.2 grams of mixed tocopherols (70IP) were mixed at 60 degrees Celsius for 10 minutes, and then 68.3 grams of them were added to the base solution. The mixture was emulsified to a particle size D (0,5) of less than 1 micron (measured with Malvern Mastersizer 2000). Water was added to adjust the viscosity and the emulsion was spray dried to obtain 199 grams of dry powder with an LOD of 2.01%. The final dry powder had the composition of Example 1.

[0113] The Example 2 powder shown in the table was produced according to Example 1.

[0114] Table 1:

[0115]

[0116] The Example 3 powder shown in the table was produced according to Example 1. This is a comparative example. The formulation contains sodium ascorbate.

[0117] Table 2:

[0118]

[0119] Application Testing

[0120] The stability of the vitamin A form in each example was evaluated in a typical infant formula vitamin premix, the 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). Please note that the concentrations given are for the product form.

[0121] During the mixing preparation, 485 grams of premix were placed in a 1-liter glass bottle and 15 grams of the vitamin A product were added. The mixture was then mixed in an orbital mixer ( The contents of the bottle were mixed for 10 minutes at 22 rpm in a T2 C-type oscillating mixer. The resulting mixture was then divided into aluminum bags and subjected to a stability study of vitamin A palmitate at 30°C for 3 months. The initial determination of the vitamin A content was repeated in duplicate measurements in three different bags, while subsequent time points were based on duplicate measurements in two different bags.

[0122] Table 3: Stability data

[0123] Element 1 month 3 months Preparation of Example 1 100 81 Preparation of Example 2 100 98.5 Preparation of Example 3 100 58

[0124] It can be seen that the formulations according to the invention show improved stability.

Claims

1. A solid preparation comprising: (i) at least one fat-soluble vitamin, and (ii) at least one hydrogel, and (iii) at least one starch hydrolysate, and (iv) tocopherol, And the formulation does not contain any BHT, any ascorbic acid, any sodium ascorbate (and any other ascorbate salts), any ascorbyl palmitate (and any other ascorbyl esters), any BHA and any EMQ.

2. The solid preparation 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. The solid preparation 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. A solid dosage form according to any preceding claim, wherein The at least one fat-soluble vitamin is present in an amount of 3 to 30 wt. % based on the total weight of the solid preparation.

5. A solid preparation according to any one of claims 1 to 3, wherein The at least one fat-soluble vitamin is present in an amount of 5 to 25 wt. % based on the total weight of the solid preparation.

6. A solid dosage form according to any preceding claim, wherein the at least one hydrogel is selected from the group consisting of polysaccharides, low-, medium- or high-bloom gelatin from fish, pork or cattle, casein / caseinate and other protein hydrogels.

7. The solid formulation according to any one of the preceding claims 1 to 5, wherein the at least one hydrogel is selected from the group consisting of xanthan gum, gum arabic, pectin, guar gum, locust bean gum, alginates, cellulose, cellulose derivatives such as starch and starch derivatives.

8. A solid dosage form according to any preceding claim, wherein The at least one hydrogel is present in an amount of 20 to 85 wt. % based on the total weight of the solid preparation.

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

10. A solid dosage form according to any preceding claim, wherein The at least one starch hydrolysate may be present in an amount of 10 to 60 wt. %, based on the total weight of the solid preparation.

11. A solid dosage form according to any preceding claim, wherein The tocopherol is included in an amount of 0.1 to 5 wt. % based on the total weight of the solid preparation.

12. A solid dosage form according to any preceding claim, 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 a solid formulation according to any preceding claim for fortifying an early life nutrition (ELN) product.

14. An early life nutritional product fortified by a solid dosage form according to any one of claims 1 to 12.

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