Infant milk replacer tablet

Abstract

The present disclosure provides a compressed solid form of a nutritional composition comprising about 5 to about 35 wt% protein, about 5 to about 50 wt% fat, and about 40 to about 70 wt% sugar, wherein the compressed solid form is readily soluble in water and has a moisture content of 4 to 17%. In certain embodiments, the nutritional composition eliminates the need to scoop a powder into a narrow bottle, eliminates the need to transport loose powder for later reconstitution, and provides a more precise serving to ensure proper delivery of nutrients for each feeding, while remaining readily soluble upon contact with liquid. The present disclosure also provides a method for making a compressed solid form of a nutritional composition, comprising cooling a powdered nutritional composition, contacting the cooled powdered nutritional composition with moisture, compressing the powdered nutritional composition under pressure, and drying the nutritional composition.

Description

Technical Field

[0001] This disclosure relates to nutritional compositions in compressed solid form for use as milk substitutes for infants and children. Compressed solid nutritional compositions offer a convenient form compared to powder or liquid compositions. Furthermore, this disclosure relates to an improved method for preparing nutritional compositions in compressed solid form.

[0002] background

[0003] Nutritional compositions, such as infant formula and growing milk, are typically offered as loose powders, liquids, or liquid concentrates. While these forms are generally ready for mixing, or in the case of liquid compositions, mixing is not required, each has its disadvantages. Powder compositions are prone to spillage, difficult to measure, and may be difficult to dispense into containers with narrow openings, which is typical of many baby care bottles. Liquid compositions are less convenient to transport and generally do not have the same shelf life as powder formulations. Once a sealed container of liquid formula is opened, it must be used within a short period or refrigerated. Furthermore, oxidation of the components of the composition may occur after opening, leading to a shortened shelf life. Additionally, liquid formulations are prone to spillage during transport and may cause difficulties during air travel due to limitations on permissible liquid volumes.

[0004] Furthermore, the classic method of using pressure and adjuvants to form a compressed form from powder is unreliable for producing nutritional milk substitute tablets. Nutritional milk substitutes, such as infant formula powder, contain fat, which, due to its flow properties, may be squeezed out during compression, potentially settling on the tablet surface and limiting the tablet's solubility. If the dissolution rate is slow, this can render the compressed solid form impractical.

[0005] Therefore, there is a need for nutrient compositions in compressed solid form and methods for preparing said nutrient compositions, wherein the mobility of fat is controlled and restricted, and the compressed form is readily soluble in water. Summary of the Invention

[0006] This disclosure provides nutritional compositions in compressed solid form, such as tablets. In some embodiments, the nutritional composition comprises about 21 to about 35% by weight of protein, about 5 to about 50% by weight of fat, and about 40 to about 60% by weight of sugar. In a specific embodiment, the compressed solid form is readily soluble in water.

[0007] In some embodiments, the composition further comprises a source of long-chain polyunsaturated fatty acids, a prebiotic composition comprising polydextrose and galactooligosaccharides, nucleotides, vitamins, and minerals. In further embodiments, the nutritional composition comprises probiotics.

[0008] This disclosure also includes a method for preparing a compressed solid nutrient composition. In some embodiments, the composition can be prepared by cooling the powdered nutrient composition to a temperature below 11°C, contacting the cooled powdered nutrient composition with moisture, compressing the powdered nutrient composition under a pressure of 1-100 psi (0.07-6.89 bar), and drying the compressed powdered nutrient composition.

[0009] It should be understood that the foregoing general description and the following detailed description present embodiments of this disclosure and are intended to provide an overview or framework for understanding the nature and features of the claimed disclosure. This description is intended to explain the principles and operation of the claimed subject matter. Other and further features and advantages of this disclosure will be apparent to those skilled in the art upon reading the following disclosure.

[0010] Best mode for carrying out the invention

[0011] Reference will now be made in detail to embodiments of the present disclosure, one or more of which are set forth below. Each embodiment is provided by way of explanation of the nutritional compositions of the present disclosure and not of a limiting one. In fact, it will be apparent to those skilled in the art that various modifications and variations may be made to the teachings of the present disclosure without departing from the scope or spirit of the present disclosure. For example, features shown or described as part of one embodiment may be used with another embodiment to produce yet another embodiment.

[0012] Therefore, this disclosure is intended to cover these modifications and variations that fall within the scope of the appended claims and their equivalents. Other objects, features, and aspects of this disclosure are disclosed in or will be apparent from the following detailed description. It will be understood by those skilled in the art that this discussion is merely a description of exemplary embodiments and is not intended to limit the broader aspects of this disclosure.

[0013] "Nutritional composition" refers to a substance or preparation that meets at least a portion of the nutritional needs of a subject. The terms "nutrient," "milk substitute," "enteral nutrition," "nutritional composition," and "nutritional supplement" are used interchangeably throughout this disclosure to refer to liquid, powder, gel, paste, solid, concentrate, suspension, or ready-to-use forms of enteral milk substitutes, oral milk substitutes, infant milk substitutes, pediatric subject milk substitutes, children's milk substitutes, growing milk, and / or adult (e.g., lactating or pregnant women) milk substitutes.

[0014] The term "enteral" means via or within the gastrointestinal tract or digestive tract. "Enteral administration" includes oral feeding, gastric feeding, pyloric administration, or any other administration into the digestive tract.

[0015] "Pediatric subject" refers to a person under the age of 13 years. In some embodiments, pediatric subject refers to a human subject under the age of 8 years. In other embodiments, pediatric subject refers to a human subject between the ages of 1 and 6 years. In a further embodiment, pediatric subject refers to a human subject between the ages of 6 and 12 years.

[0016] “Infant” refers to a subject no older than approximately one year of age, including infants from 0 to 12 months. The term infant includes full-term infants, preterm infants, low birth weight infants (infants weighing less than 2500g at birth), very low birth weight infants (infants weighing less than 1500g at birth), and extremely low birth weight infants (infants weighing less than 1000g at birth). “Preterm” means an infant born before the end of the 37th week of gestation, while “full-term” means an infant born after the end of the 37th week of gestation.

[0017] The term "child" refers to a subject whose age ranges from approximately 12 months to approximately 13 years. In some embodiments, a child is a subject whose age is between 1 and 12 years. In other embodiments, the term "children" or "child" refers to a subject whose age ranges are approximately 1 year to approximately 6 years, or approximately 7 years to approximately 12 years. In other embodiments, the term "children" or "child" refers to any age range between approximately 12 months and approximately 13 years.

[0018] "Children's nutritional products" refers to compositions that meet at least some of the nutritional needs of children. Growing-up milk is an example of a children's nutritional product.

[0019] "Infant formula" refers to a composition that meets at least a portion of the nutritional needs of an infant. In the United States, the content of infant formula is regulated by federal regulations as described in Chapters 100, 106, and 107 of 21 CFR.

[0020] The term "growth milk" refers to a broad range of nutritional compositions designed to be used as part of a diverse diet to support normal growth and development in children aged approximately 1 to 6 years.

[0021] "Milk-based" means containing at least one component that has been extracted or derived from the mammary glands of a mammal. In some embodiments, a milk-based nutritional composition contains milk components derived from domesticated ungulates, ruminants, or other mammals, or any combination thereof. Furthermore, in some embodiments, "milk-based" means containing bovine casein, whey, lactose, or any combination thereof. Additionally, "milk-based nutritional composition" can refer to any composition containing any milk-derived or milk-based product known in the art.

[0022] "Nutritional complete" means a composition that can be used as the sole source of nutrition, providing virtually all daily requirements for vitamins, minerals and / or trace elements, as well as proteins, carbohydrates, and lipids. In fact, "nutritional complete" describes a nutritional composition that provides sufficient amounts of carbohydrates, lipids, essential fatty acids, proteins, essential amino acids, conditionally essential amino acids, vitamins, minerals, and energy to support the normal growth and development of the subject.

[0023] Therefore, by definition, a “nutritionally complete” nutritional composition for preterm infants will provide, qualitatively and quantitatively, sufficient amounts of carbohydrates, lipids, essential fatty acids, proteins, essential amino acids, conditionally essential amino acids, vitamins, minerals, and energy required for the growth of preterm infants.

[0024] By definition, a “nutritionally complete” nutritional composition for full-term infants will provide, qualitatively and quantitatively, sufficient amounts of all sugars, lipids, essential fatty acids, proteins, essential amino acids, conditionally essential amino acids, vitamins, minerals, and energy required for the growth of full-term infants.

[0025] By definition, a “nutritionally complete” nutritional composition for children will provide, qualitatively and quantitatively, sufficient amounts of all sugars, lipids, essential fatty acids, proteins, essential amino acids, conditionally essential amino acids, vitamins, minerals, and energy required for a child’s growth.

[0026] When applied to nutrients, the term "essential" means any nutrient that cannot be synthesized by the human body, in sufficient quantities for normal growth and maintenance of health, and therefore must be supplied by diet. When applied to nutrients, the term "conditionally essential" means that the nutrient must be supplied by diet when the body does not receive sufficient amounts of precursor compounds for endogenous synthesis.

[0027] "Nutritional supplement" or "supplement" means a preparation containing at least one nutrient in a nutrient-related amount. For example, the supplements described herein can provide at least one nutrient to human subjects (such as lactating or pregnant women).

[0028] "Probiotics" refers to microorganisms with low or no pathogenicity that have a beneficial effect on the health of the host.

[0029] "Prebiotics" refers to indigestible food components that can beneficially influence the host by selectively stimulating the growth and / or activity of one or a limited number of beneficial gut bacteria in the digestive tract, selectively reducing gut pathogens, or favorablely influencing the distribution of short-chain fatty acids in the gut that can improve host health.

[0030] Unless otherwise specified, all percentages, parts and ratios used herein are based on the total weight of the formulation.

[0031] The compositions disclosed herein may be free of, substantially free of, any optional or selected ingredients described herein. In this context, and unless otherwise specified, the term “substantially free of” means that the selected composition may contain less than the functional amount of optional ingredients, typically less than 0.1% by weight, and may also include 0% by weight of such optional or selected ingredients.

[0032] Unless otherwise specified or expressly indicated by the context, all references to the singular features or limitations of this disclosure shall include the corresponding plural features or limitations, and vice versa.

[0033] As used herein, the term “about” should be interpreted as referring to two numbers specified in any range. Any reference to a range should be considered as providing support for any subset of that range.

[0034] All combinations of method steps or processing steps used herein may be performed in any order unless otherwise specified or expressly indicated by the context of the combination mentioned.

[0035] The methods and compositions disclosed herein (including their components) may comprise, consist of, or be substantially comprised of the essential elements and limitations of the embodiments described herein, as well as any additional or optional ingredients, components, or limitations described herein or otherwise used in nutritional compositions.

[0036] This disclosure provides nutritional compositions in compressed solid form, and methods for preparing them. The compressed solid form improves the usability of nutritional compositions such as infant formula and growing milk. More specifically, when combined with water, the compressed solid form provides easy delivery and reconfigurability.

[0037] In one embodiment, the compressed solid nutritional composition comprises about 5 to 35% by weight of protein, about 5 to 50% by weight of fat, and about 40 to 70% by weight of sugar. In a specific embodiment, the compressed solid nutritional composition comprises about 21 to 35% by weight of protein, about 20 to 30% by weight of fat, and about 40 to 60% by weight of sugar. In a further embodiment, the compressed solid nutritional composition comprises about 10 to 15% by weight of protein, about 20 to 28% by weight of fat or lipids, and about 55 to 60% by weight of sugar. In some embodiments, the compressed solid nutritional composition is prepared from a powdered nutritional composition. Powdered nutritional compositions include, but are not limited to, children's nutritional products, such as infant formula and growing-up milk, and adult nutritional compositions. In a specific embodiment, the nutritional composition is an infant formula or growing-up milk.

[0038] In some embodiments, the powdered nutritional composition is suspended under gentle stirring or uniformly distributed over a large surface area via, but not limited to, a vibrating conveyor belt or a vessel with stirring. The powdered nutritional composition is then cooled to a temperature below 11°C. Any suitable cooling equipment or refrigeration method can be used. Cooling the powdered nutritional composition rapidly increases the solid fat content of the fat globules present in the powdered nutritional composition. The cooling temperature is determined by the solid fat content of the fat or lipids in the powdered nutritional composition.

[0039] In some embodiments, a cooled powdered nutrient composition, typically having a moisture content of less than 5%, is exposed to moisture via a fine mist to bring the moisture content of the composition to a level of up to about 17%. In some embodiments, the moisture content of the powdered nutrient composition reaches about 6% to about 17%; in other embodiments, the moisture level of the composition reaches about 8% to about 10%. The mist can be formed using, but is not limited to, ultrasound, fans, and nozzles. The particle size of the water mist can be in the range of 10-1500 nm, preferably 100-200 nm. In some embodiments, ultrasound is used to form a nanomist. The powder can be mixed or vibrated to achieve uniform adhesion of moisture to the surface of the powder particles. This adhesion results in wetting the particle surface without dissolving or disrupting the structure of the particle outer wall.

[0040] In some other embodiments, the water mist temperature is in the range of 1°C to 15°C to reduce the flow properties of fats or lipids used in powder formulations. For example, some oils that can be used as fats in powdered nutritional compositions, such as palm oil and coconut oil, have pour point temperatures (or flow temperatures) of 25°C to 35°C, while for sunflower, soybean, and algae-derived oils, the temperature is below 0°C. Using cold water as a mist reduces the mobility of the oils during the compression step and thus reduces their presence on the tablet surface. The low temperature of the water mist also reduces the formation of fat bridges, which can lead to poor tablet dispersibility.

[0041] There is an inverse relationship between tablet dissolution rate and the presence of surface fat. Spray-dried dairy powders (such as infant formula) have a higher proportion of total fat compared to fat trapped within powder particles, which is coated on the powder surface. In some embodiments, 35-40% of the fat may be located on the powder surface.

[0042] In some embodiments, the surface of the powder particles contains sugars in an amorphous form. These sugars can be, but are not limited to, lactose, maltodextrin, and corn syrup solids. When a cold water mist comes into contact with the powder surface, it hydrates some of these sugars. These hydrated sugars tend to form bridges, thereby increasing the stickiness of the powder particles.

[0043] In some embodiments, the powdered nutritional composition may undergo solid carbon dioxide treatment prior to compression. The inclusion of this step will be based on the characteristics of the powdered nutritional composition and the desired porosity. It is possible to cool the powder by introducing particles (10 μm–1 mm) of solid carbon dioxide, i.e., dry ice, during powder mixing. The dry ice sublimates and releases carbon dioxide gas, which expands and removes air trapped between the powder particles. This air removal has the benefit of reducing oxygen exposure to fatty substances on the powder surface and minimizing harmful lipid oxidation. Dry ice can also condense available moisture in contact with the powder, thereby enabling sugar-to-sugar bridge formation. It is also possible to keep the powder at a low temperature during the compression step by maintaining some small dry ice particles mixed with the powder. This results in an increase in the internal porosity of the tablets during dry ice sublimation.

[0044] In a further embodiment, the wet powdered nutrient composition is transferred to a tableting unit for compression. The size and shape of the tablets, as well as their weight, can vary depending on the serving size of the nutrient formulation and the number of tablets intended to be delivered. The tablets may have a smooth surface or indentations that allow water penetration to accelerate the dissolution rate. The powder is placed in a tableting die and rapidly compressed at a pressure of 1-100 psi; in some embodiments, the powder is compressed in a tableting die at a pressure of 1-30 psi, and preferably at 5-10 psi. In some embodiments, compression lasts for a period of at least 3 seconds; in other embodiments, compression may last for about 3 seconds to about 20 seconds. In further other embodiments, compression lasts for a period of about 3 seconds to about 10 seconds. Higher compression rates may impair tablet dissolution and may force free fats to flow to the surface of the tablet, thus reducing the wettability of the tablet. The use of a moderate pressure range maintains some powder porosity. This porosity also allows for the diffusion of carbon dioxide if dry ice is used during processing. Compression can be performed within a controlled temperature range of 1-25°C, and preferably 2-8°C. The compressed tablets can then be transferred to the drying process.

[0045] In some embodiments, the compressed tablets may be dried; in some embodiments, the tablets are dried to a moisture level of about 0.2% to about 5.0%. The drying process may include, but is not limited to, the use of hot air tunnels, vacuum drying, or freeze-drying. During the drying process, particles adhere to each other and a process known as “particle stringing” occurs due to the glass transition and molecular elasticity of hydrated molecules. Vacuum drying allows the use of lower temperatures, such as 20°C–60°C, to remove moisture entrained in the tablets. In embodiments using freeze-drying during the drying process, the tablet temperature is first lowered to about 10°C to 30°C, and then the tablet is gently heated to induce water sublimation to achieve the target tablet moisture content. When solid carbon dioxide is used prior to compression, sublimation will occur rapidly during the drying process, thereby providing the tablet with additional porosity and reducing the amount of air exposed to the formulation fats.

[0046] In some embodiments, the solubility properties of the compressed solid tablets can be enhanced by applying a coating to the tablets. This coating can use ingredients already present in the formulation or other materials approved for use in nutritional milk substitutes, particularly infant formulas. These materials can be, but are not limited to, organic acids, fatty acids, phospholipids, salts, sugars, and proteins. Furthermore, organic acids and bicarbonates can combine in such a way that, upon hydration, they interact to generate microbubbles, which have an additional effect on the surface and within the tablet to increase the solubility rate without significantly affecting the final pH of the reconstituted milk substitute. The coating can be applied by any method known in the art, and in some embodiments, the thickness is at least 1 mm; alternatively, the coating thickness is from about 1 mm to about 5 mm.

[0047] The porosity of compressed solids can be adjusted according to the desired properties of the final product. For example, a compressed solid composition with higher porosity can dissolve faster than a compressed solid with lower porosity, but may not have sufficient hardness. Conversely, a compressed solid with lower porosity is harder, but dissolves more slowly. In some embodiments, it is preferred that the compressed solid formulation has sufficient hardness to avoid breakage during packaging and transportation, while still maintaining a sufficiently fast dissolution profile for user convenience. Therefore, in some embodiments, the compressed solid composition has a porosity greater than about 60%, for example, about 60% to 80%, or about 65% to about 70%. In alternative embodiments, the porosity is less than about 30%, for example, about 10% to about 30%, or about 15% to about 25%.

[0048] The compressed solid form can be provided in any desired shape, such as cubes, tablets, spheres, or discs, and can be of any desired size. In one embodiment, the compressed solid form is about 5 to about 20 grams, or about 5 to about 15 grams. However, larger tablets can also be prepared. For example, in one embodiment, the compressed solid form is provided in a single serving of about 8 to 9 grams. An 8 to 9-gram compressed solid can be readily reconstituted in about 45 to about 55 mL of water to provide a single serving of liquid nutrient composition.

[0049] The compressed solid composition provides sufficient rigidity to prevent breakage during transport by the end user. For example, particularly in the case of infant formula or growing milk, it may be convenient to carry one or more compressed solid compositions for feeding pediatric subjects during travel. Unwanted breakage or fragmentation of the solid could cause a portion of the serving to spill out. Therefore, in some embodiments, the compressed solids provided herein are rigid enough to prevent breakage during travel, while advantageously being readily dispersed or dissolved upon exposure to water. For example, a single serving of compressed solid can dissolve in water at 22°C–40°C within 30–80 seconds with the aid of gentle shaking.

[0050] An exemplary embodiment of a method for preparing a compressed solid nutritional composition includes the following steps: A powdered nutritional composition, such as infant formula or growing milk, is uniformly distributed onto a large surface area by stirring. The powder is then cooled to a temperature below 11°C using refrigeration. The powder is then contacted with a nanoparticle mist having a particle size range of 100-200 nm via ultrasonic technology. The wet powder is then transferred to a tableting unit for compression at a pressure range of 5-8 psi. The compressed tablets are immediately transferred to a drying process. The drying process is carried out in a hot air tunnel and produces final tablets with a moisture content of 0.5-5%. Finally, the dried tablets may be coated with an organic acid, etc.

[0051] In some embodiments, this disclosure provides fortified milk-based growth milk designed for children aged 1-3 years and / or 4-6 years, wherein the growth milk supports growth and development as well as lifelong health. In some embodiments, this disclosure provides infant formula suitable for infants aged 0-12 months, or 0-3 months, 0-6 months, or 6-12 months.

[0052] Suitable sources of fats or lipids for use in the nutritional compositions of this disclosure may be any source of fats or lipids known or used in the art, including but not limited to animal sources such as milk fat, milk fat fractions and derivatives, beef tallow, lard, egg yolk lipids and derivatives; marine sources (such as fish oil and derivatives, single-cell oil); vegetable and plant oils (such as corn oil, rapeseed oil, sunflower oil, soybean oil, palm oil, coconut oil, high-oleic sunflower oil, evening primrose oil, rapeseed oil, olive oil, flaxseed oil, cottonseed oil, high-oleic safflower oil, palm stearin, palm kernel oil, wheat germ oil); medium-chain triglyceride oils and emulsions and esters of fatty acids; and any combination thereof.

[0053] The sugar source can be any substance used in this field, such as lactose, glucose, fructose, corn syrup solids, maltodextrin, sucrose, starch, rice syrup solids, etc. The amount of sugar in a nutritional composition can typically vary between about 5g and about 25g / 100kcal.

[0054] One or more nutritional compositions disclosed herein may also contain a protein source. In some embodiments, the nutritional composition contains about 1 g to about 7 g of protein source per 100 kcal. The protein source can be any substance used in the art, such as skim milk, whey protein, casein, soy protein, hydrolyzed protein, amino acids, etc. Bovine milk protein sources that can be used to implement this disclosure include, but are not limited to, milk protein powder, milk protein concentrate, milk protein isolate, skim milk solids, skim milk, skim dried milk, whey protein, whey protein isolate, whey protein concentrate, sweet whey, acid whey, casein, acid casein, caseinates (e.g., sodium caseinate, sodium calcium caseinate, calcium caseinate), and any combination thereof.

[0055] In one embodiment, the protein in the nutritional composition is provided as a complete protein. In other embodiments, the protein is provided as a combination of both complete and partially hydrolyzed proteins. For example, in some embodiments, the partially hydrolyzed protein has a degree of hydrolysis of about 4% to about 10%. In some other embodiments, the protein is more completely hydrolyzed, such as reaching about 55%. In further embodiments, the protein source comprises amino acids. In yet another embodiment, the protein source may be supplemented with glutamine-containing peptides. In a specific embodiment, the nutritional composition does not contain exogenous lysine.

[0056] In one specific embodiment of the nutritional composition, the whey-to-casein ratio of the protein source is similar to that found in human breast milk. In one embodiment, the protein source comprises about 40% to about 80% whey protein and about 20% to about 60% casein.

[0057] In one embodiment, the nutritional composition may contain one or more probiotics. Any probiotic known in the art may be acceptable in this embodiment. In a specific embodiment, the probiotic may be selected from any Lactobacillus (…). Lactobacillus ) species, Lactobacillus rhamnosus ( Lactobacillus rhamnosus GG (e.g., ATCC number 53103), Bifidobacterium ( Bifidobacterium ) species, Bifidobacterium longum ( Bifidobacterium longum (e.g., AH1205 or AH1206) and Bifidobacterium animalis subsp. lactis ( Bifidobacterium animalis subsp. lactis BB-12 (DSM No. 10140), Bifidobacterium infantis ( Bifidobacterium infantis (e.g., 35624), spore-forming bacteria such as Bacillus coagulans ( Bacillus coagulans (e.g., ATCC PTA-6086, 6085, 6087, 11748) or any combination thereof.

[0058] If included in the composition, the amount of probiotics can range from approximately 1 × 10⁻⁶ per gram of nutritional composition. 4 To approximately 1×10 12 The colony-forming units (CFU) can vary. In another embodiment, the amount of probiotics can range from approximately 1 × 10⁻⁶ per gram of nutrient composition. 6 To approximately 1×10 12 CFU variation. In yet another embodiment, the amount of probiotics can be increased from approximately 1 × 10⁻⁶ per gram of nutrient composition. 6 To approximately 1×10 9 CFU or approximately 1×10 per gram of nutritional composition 9 To approximately 1×10 12 CFU variation. In yet another embodiment, the amount of probiotics may be at least about 1 × 10⁻⁶ per gram of nutrient composition. 6 CFU.

[0059] In one embodiment, the one or more probiotics may be viable or non-viable. As used herein, the term "viable" means a living microorganism. The term "non-viable" or "non-viable probiotic" means a non-living probiotic microorganism, its cellular components, and / or its metabolites. Such non-viable probiotics may have been heat-killed or otherwise inactivated, but they retain the ability to advantageously affect the health of the host. Probiotics that can be used in this disclosure may be naturally occurring, synthetic, or developed through genetic manipulation of an organism, regardless of whether such a novel source is now known or subsequently developed.

[0060] In some embodiments, the nutritional composition may also contain one or more prebiotics. Such prebiotics may be naturally occurring, synthetic, or developed through genetic manipulation of an organism and / or plant, regardless of whether such a new source is now known or later developed. Prebiotics used in this disclosure may include oligosaccharides, polysaccharides, and other prebiotics containing glucose, fructose, galactose, mannose, and xylose.

[0061] More specifically, the prebiotics used in this disclosure may include polydextrose (PDX), polydextrose powder, lactulose, lactose, raffinose, oligodextrose, dextran, inulin, fructooligosaccharide, isomaltooligosaccharide, soybean oligosaccharide, lactose, xylooligosaccharide, chitosan oligosaccharide, mannose oligosaccharide, arabinose oligosaccharide, sialyl-oligosaccharide, fucoidan oligosaccharide, galactooligosaccharide (GOS), and gentiosaccharide oligosaccharide.

[0062] In one embodiment, the total amount of prebiotics present in the nutritional composition can be from about 1.0 g / L to about 10.0 g / L of the composition (based on ready-to-use feed). For example, in some embodiments, PDX can be included in the nutritional composition in an amount of about 1.0 to 10.0 g / L. In another embodiment, the amount of PDX is from about 2.0 to about 8.0 g / L.

[0063] In some embodiments, at least 20% of the prebiotic may comprise GOS, PDX, or a mixture thereof. In one embodiment, PDX and GOS have a PDX:GOS ratio of about 9:1 to 1:9. In another embodiment, the PDX:GOS ratio may be about 5:1 to 1:5. In yet another embodiment, the PDX:GOS ratio may be about 1:3 to 1:3. In a further, more specific embodiment, the ratio may be about 1:1 or 4:1. In another embodiment, the amount of the PDX:GOS combination may be between about 2.0 g / L and 8.0 g / L. In one specific embodiment, the amount of the PDX:GOS combination may be about 2 g / L of PDX and 2 g / L of GOS. At least 20% of the prebiotic may comprise GOS, PDX, or a mixture thereof. In one embodiment, the amount of each of GOS and / or PDX in the nutritional composition may be in the range of about 1.0 g / L to about 4.0 g / L. In other embodiments, the amount of GOS and / or PDX is about 1 to about 10 g / 100 kcal, about 2 to about 10 g / 100 kcal, or about 4 to about 8 g / 100 kcal in a powder formulation.

[0064] The nutritional compositions disclosed herein may contain a source of long-chain polyunsaturated fatty acids (LCPUFAs) containing docosahexaenoic acid (DHA). Other suitable LCPUFAs include, but are not limited to, α-linolenic acid, γ-linolenic acid, linoleic acid, linolenic acid, eicosapentaenoic acid (EPA), and arachidonic acid (ARA).

[0065] In one embodiment, particularly if the nutritional composition is an infant formula, the nutritional composition is supplemented with both DHA and ARA. In this embodiment, the ARA:DHA weight ratio can be between about 1:3 and about 9:1. In a specific embodiment, the ARA:DHA ratio is from about 1:2 to about 4:1.

[0066] Nutritional compositions can be supplemented with oils containing DHA and / or ARA using standard techniques known in the art. For example, DHA and ARA can be added to the composition by replacing an equal amount of an oil typically present in the composition (such as high-oleic sunflower oil). As another example, oils containing DHA and ARA can be added to the composition by replacing an equal amount of the remainder of a total fat blend typically present in compositions without DHA and ARA.

[0067] If included, the source of DHA and / or ARA can be any source known in the art, such as marine oil, fish oil, single-cell oil, egg yolk lipids, and brain lipids. In some embodiments, DHA and ARA are derived from single-cell Martek oil, DHASCO... ® and ARASCO ® Or its variants. DHA and ARA may be in their natural form, provided that the remainder of the LCPUFA source does not cause any materially harmful effects on the subject. Alternatively, DHA and ARA may be used in their purified form.

[0068] In one embodiment, the source of DHA and ARA is single-cell oil, as taught in U.S. Patent Nos. 5,374,657; 5,550,156; and 5,397,591, the disclosure of which is incorporated herein by reference in its entirety. However, this disclosure is not limited to such oil.

[0069] Nutritional compositions may also include sources of β-glucan. Glucans are polysaccharides, specifically polymers of glucose, that are naturally occurring and found in the cell walls of bacteria, yeast, fungi, and plants. β-glucan itself is a diverse subset of glucose polymers, consisting of chains of glucose monomers linked together via β-glycosidic bonds to form complex sugars. Sources of β-glucan can be distinguished by the presence of branched bonds. Cereal-derived β-glucan has a linear moiety formed by β-1,3 bonds and a branched moiety formed by β-1-4 bonds. Yeast, mushroom, and bacterial-derived β-glucan has a linear moiety formed by β-1,3 bonds and a branched moiety formed by β-1-6 bonds. These differences in branched structure can have significant implications for the bioactivity of β-glucan.

[0070] Derived from baking yeast and brewing yeast Saccharomyces cerevisiae β-glucan is composed of D-glucose molecular chains linked at positions 1 and 3, with glucose side chains linked at positions 1 and 6. Yeast-derived β-glucan is an insoluble, fibrous complex sugar with a general structure of straight-chain glucose units with β-1,3 main chains dispersed with β-1,6 side chains, typically 6-8 glucose units in length. More specifically, β-glucan derived from baking yeast is poly-(1,6)-β-D-glucopyranosyl-(1,3)-β-D-glucopyranose.

[0071] Furthermore, β-glucan is well-tolerated and does not produce or cause excessive gas, bloating, distension, or diarrhea in pediatric subjects. Adding β-glucan to nutritional compositions intended for pediatric subjects, such as infant formula, growing milk, or other children's nutritional products, will improve the immune response of subjects by increasing resistance to invading pathogens and thus maintaining or improving overall health.

[0072] In some embodiments, one or more nutritional compositions disclosed herein may further comprise nucleotides, including but not limited to cytidine 5'-monophosphate, uridine 5'-monophosphate, adenosine 5'-monophosphate, guanosine 5'-monophosphate, and mixtures thereof.

[0073] In one embodiment, one or more nutritional compositions of this disclosure comprise choline. Choline is an essential nutrient for normal cellular function. It is a precursor to membrane phospholipids and accelerates the synthesis and release of acetylcholine, a neurotransmitter involved in memory storage. Furthermore, while not wishing to be bound by this or any other theory, it is believed that dietary choline and docosahexaenoic acid (DHA) synergistically promote the biosynthesis of phosphatidylcholine and thus help promote synapsis in human subjects. Additionally, choline and DHA can exhibit a synergistic effect in promoting dendritic spine formation, which is important for maintaining established synaptic connections. In some embodiments, the one or more nutritional compositions of this disclosure comprise from about 40 mg of choline per serving to about 100 mg per 8 ounce serving.

[0074] In one embodiment, the nutritional composition comprises an iron source. In one embodiment, the iron source is ferric pyrophosphate, ferric orthophosphate, ferrous fumarate, or a mixture thereof, and in some embodiments, the iron source may be encapsulated.

[0075] One or more vitamins and / or minerals may also be added to the nutritional composition in amounts sufficient to meet the subject's daily nutritional requirements. Those skilled in the art will understand that vitamin and mineral requirements will vary, for example, based on a child's age. For instance, an infant may have different vitamin and mineral requirements than a child aged one to thirteen. Therefore, the embodiments are not intended to limit the nutritional composition to a specific age group, but rather to provide a range of acceptable vitamin and mineral components.

[0076] In some embodiments, the composition may optionally include one or more of the following vitamins or derivatives thereof: vitamin B1 (thiamine, thiamine pyrophosphate, thiamine triphosphate, thiamine hydrochloride, thiamine mononitrate), vitamin B2 (riboflavin, flavin mononucleotide, flavin adenine dinucleotide, lactoflavin, riboflavin), vitamin B3 (niacin, nicotinic acid, nicotinamide, niacinamide, nicotinamide adenine dinucleotide, nicotinic acid mononucleotide, pyridine-3-carboxylic acid), vitamin B3 precursor tryptophan, vitamin B6 (pyridoxine, pyridoxal, pyridoxine, pyridoxine hydrochloride), pantothenic acid (pantothenate, panthenol), folate (folic acid, folacin, pteroylglutamic acid), vitamin B1, thiamine ... 12(Cobalamin, Methylcobalamin, Deoxyadenosylcobalamin, Cyanocobalamin, Hydroxycobalamin, Adenosylcobalamin), Biotin, Vitamin C (Ascorbic Acid), Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate, Retinyl Esters with Other Long-Chain Fatty Acids, Retinaldehyde, Retinic Acid, Retinyl Esters), Vitamin D (Calciferol, Cholecalciferol, Vitamin D3, 1,25-Dihydroxyvitamin D), Vitamin E (α-Tocopherol, α-Tocopheryl Acetate, α-Tocopherol ... α-Tocopherol succinate, α-Tocopherol nicotinate, α-Tocopherol), vitamin K (vitamin K1, phylloquinone, naphthoquinone, vitamin K2, methylnaphthoquinone-7, vitamin K3, methylnaphthoquinone-4, methylnaphthoquinone, methylnaphthoquinone-8, methylnaphthoquinone-8H, methylnaphthoquinone-9, methylnaphthoquinone-9H, methylnaphthoquinone-10, methylnaphthoquinone-11, methylnaphthoquinone-12, methylnaphthoquinone-13), choline, inositol, β-carotene and any combination thereof.

[0077] In other embodiments, the composition may optionally include, but is not limited to, one or more of the following minerals or derivatives thereof: boron, calcium, calcium acetate, calcium gluconate, calcium chloride, calcium lactate, calcium phosphate, calcium sulfate, chloride, chromium, chromium chloride, chromium picolonate, copper, copper sulfate, copper gluconate, copper sulfate, fluoride, iron, carbonyl iron, ferric ions, ferrous fumarate, ferric orthophosphate, iron trituration, polysaccharide iron, iodide, iodine, magnesium, magnesium carbonate, magnesium hydroxide, magnesium oxide, magnesium stearate, magnesium sulfate, manganese, molybdenum, phosphorus, potassium, potassium phosphate, potassium iodide, potassium chloride, potassium acetate, selenium, sulfur, sodium, sodium docusate, sodium chloride, sodium selenate, molybdate, zinc, zinc oxide, zinc sulfate, and mixtures thereof. Non-limiting exemplary derivatives of the mineral compound include salts, alkali salts, esters, and chelates of any mineral compound. However, in specific embodiments, the composition does not contain manganese gluconate, copper carbonate, or zinc oxide.

[0078] Minerals can be added to growing milk or other children's nutritional compositions in the form of salts such as calcium phosphate, glycerophosphate, sodium citrate, potassium chloride, potassium phosphate, magnesium phosphate, ferrous sulfate, zinc sulfate, copper sulfate, manganese sulfate, and sodium selenite. Additional vitamins and minerals may be added, as is known in the art.

[0079] The amounts of vitamins and minerals in a children's nutritional composition may vary by country. In one embodiment, for any given country, the children's nutritional composition may contain about 10% to about 50% of the maximum dietary recommendations per serving of vitamins A, C, and E, zinc, iron, iodine, selenium, and choline, or for a group of countries, about 10% to about 50% of that average dietary recommendation. In another embodiment, for any given country, the children's nutritional composition may supply about 10-30% of the maximum dietary recommendations per serving of B vitamins, or for a group of countries, about 10-30% of that average dietary recommendation. In yet another embodiment, the levels of vitamin D, calcium, magnesium, phosphorus, and potassium in the children's nutritional product may correspond to the average levels found in milk. In other embodiments, for any given country, other nutrients in the children's nutritional composition may be present at about 20% of the maximum dietary recommendations per serving, or for a group of countries, at about 20% of that average dietary recommendation.

[0080] The pediatric nutritional compositions disclosed herein may optionally include one or more of the following flavoring agents, including but not limited to flavoring extracts, volatile oils, cocoa or chocolate flavorings, peanut butter flavorings, biscuit crumbs, vanilla, or any commercially available flavoring agent. Examples of useful flavoring agents include, but are not limited to: pure fennel extract, imitation banana extract, imitation cherry extract, chocolate extract, pure lemon extract, pure orange extract, pure peppermint extract, honey, imitation pineapple extract, imitation rum extract, imitation strawberry extract, or vanilla extract; or volatile oils such as balsam oil, laurel oil, bergamot oil, cedarwood oil, cherry oil, cinnamon oil, clove oil, or peppermint oil; peanut butter, chocolate flavorings, vanilla cookie crumbs, caramel, toffee, and mixtures thereof. The amount of flavoring agent can vary considerably depending on the flavoring agent used. As is known in the art, the type and amount of flavoring agent can be selected.

[0081] The nutritional compositions disclosed herein may optionally contain one or more emulsifiers that may be added for the stability of the final product. Examples of suitable emulsifiers include, but are not limited to, lecithin (e.g., from eggs or soybeans), alpha-lactalbumin, and / or monoglycerides and diglycerides, and mixtures thereof. Other emulsifiers will be apparent to those skilled in the art, and the selection of one or more suitable emulsifiers will depend in part on the formulation and the final product.

[0082] The nutritional compositions disclosed herein may optionally contain one or more preservatives, which may also be added to extend the product's shelf life. Suitable preservatives include, but are not limited to, potassium sorbate, sodium sorbate, potassium benzoate, sodium benzoate, calcium disodium EDTA, and mixtures thereof.

[0083] The nutritional compositions disclosed herein may optionally contain one or more stabilizers. Suitable stabilizers for implementing the nutritional compositions disclosed herein include, but are not limited to, gum arabic, gum ghatti, ebony gum, tragacanth gum, agar, furceliaran, guar gum, gellan gum, locust bean gum, pectin, low-methoxyl pectin, gelatin, microcrystalline cellulose, CMC (sodium carboxymethyl cellulose), methylcellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, DATEM (diacetyl tartrate of monoglycerides and diglycerides), dextran, carrageenan, and mixtures thereof.

[0084] The nutritional compositions disclosed herein can provide minimal, partial, or complete nutritional support. The composition may be a nutritional supplement or a meal replacement. The composition may, but need not, be nutritionally complete. In one embodiment, the nutritional compositions disclosed herein are nutritionally complete and contain suitable types and amounts of lipids, carbohydrates, proteins, vitamins, and minerals. The amount of lipids or fats typically varies from about 2 to about 7 g / 100 kcal. The amount of protein typically varies from about 1 to about 5 g / 100 kcal. The amount of carbohydrates typically varies from about 8 to about 14 g / 100 kcal.

[0085] In some embodiments, the nutritional compositions disclosed herein are growing milk. Growing milk is a fortified milk-based beverage designed for use in children over 1 year of age (typically 1 to 6 years of age). They are not medical foods and are not intended to be used as meal replacements or supplements to address specific nutritional deficiencies. Rather, growing milk is designed to be used as a supplement to a diverse diet to provide additional assurance that children receive a continuous, daily intake of all essential vitamins and minerals, macronutrients, and other functional dietary components, such as non-essential nutrients that claim to have health-promoting properties.

[0086] The exact composition of infant formula, growing milk, or other nutritional compositions according to this disclosure may vary by country, depending on local regulations and dietary intake information of the population of interest. In some embodiments, the nutritional compositions according to this disclosure consist of a milk protein source (such as whole or skim milk) plus added sugars and sweeteners to achieve desired sensory properties, as well as added vitamins and minerals. The fat composition is typically derived from milk raw materials. The target for total protein may be to match the total protein content of human milk, cow's milk, or lower. The target for total sugar is typically to provide as little added sugar, such as sucrose or fructose, as possible to achieve an acceptable taste. Typically, the levels of added vitamin A, calcium, and vitamin D depend on the nutritional contribution of the milk in the region. Alternatively, in some embodiments, vitamins and minerals may be added at a level that provides approximately 20% of the Dietary Reference Intake (DRI) or 20% of the Daily Value (DV) per serving. Furthermore, nutritional values ​​may vary between different markets, depending on the identified nutritional needs of the target population, the contribution of raw materials, and regional regulations.

[0087] Examples are provided to illustrate some embodiments of the nutritional compositions of this disclosure, but should not be construed as limiting them in any way. Other embodiments within the scope of the claims will be apparent to those skilled in the art from considerations of the description or practice of the nutritional compositions or methods disclosed herein. It is intended that the specification, together with the examples, be considered exemplary only, and the scope and spirit of this disclosure are indicated by the claims following the examples. Example

[0088] Preparation of infant formula tablets

[0089] A powdered nutritional formulation containing approximately 11% protein, 27% fat, 57% sugar, and 2% moisture was suspended in a fluidized bed under gentle stirring and cooled to 8°C. The suspended powder was then contacted with a 150 nm water mist generated by ultrasonication at a temperature between 8 and 10°C. The wet powder composition was transferred to a tableting unit for compression. The tableting die was cylindrical with a diameter of 2.5 cm. The die was loaded with 8 g of wet powder and compressed at approximately 8 psi for 5 seconds at 5°C. The compressed tablets were then transferred to a drying belt oven with circulating air at 60°C, where they were dried to approximately 3% moisture content.

[0090] Therefore, this disclosure provides a nutrient composition in compressed solid form and a method for preparing the same, which provides a practical nutrient solid tablet that is easily soluble in water. Furthermore, the disclosed compressed solid form can reduce the oxidation rate of some components of the composition, such as LCPUFA, thus potentially providing a longer shelf life for the tablet.

[0091] All references cited in this specification (including but not limited to all papers, publications, patents, patent applications, presentations, textbooks, reports, manuscripts, brochures, books, online publications, journal articles, journals, etc.) are incorporated herein in their entirety. The discussion of references herein is solely for summarizing the authors' claims and does not constitute prior art for any reference. The applicant reserves the right to challenge the accuracy and relevance of any cited references.

[0092] Although specific terms, apparatus, and methods have been used to describe embodiments of this disclosure, such description is for illustrative purposes only. The language used is descriptive and not restrictive. It should be understood that changes and variations can be made by those skilled in the art without departing from the spirit or scope of this disclosure as set forth in the following claims. Furthermore, it should be understood that aspects of the various embodiments can be interchanged in whole or in part. Therefore, the spirit and scope of the appended claims should not be limited to the descriptions contained herein.

Claims

1. A method for preparing a nutritional composition in compressed solid form, comprising: Provide powdered nutritional compositions, The powdered nutrient composition is cooled to a temperature below 11°C. A cooled powdered nutrient composition is brought into contact with moisture by spraying a fine mist, wherein the temperature of the fine mist is between 1°C and 15°C. The powdered nutrient composition was compressed under pressures ranging from 1 to 100 psi, and Dry and compressed powdered nutritional compositions, The nutritional composition comprises: 5 to 35% by weight of protein, 5 to 50% by weight of fat, and 40 to 70 percent sugar by weight.

2. The method of claim 1, wherein the fine mist has a particle size of 10 to 1500 nm.

3. The method of claim 1, wherein the powdered nutrient composition is contacted with water to achieve a moisture content of 4% to 17%.

4. The method of claim 3, wherein the powdered nutrient composition is contacted with water to achieve a moisture content of 8 to 10%.

5. The method of claim 1, wherein the nutritional composition is an infant formula or growing milk.

6. The method of claim 1, wherein the powdered nutrient composition is compressed under a pressure of 5 to 8 psi.

7. The method of claim 1, wherein the compressed solid form is provided in a single serving of 8 to 9 grams.

8. The method of claim 6, wherein the compressed solid form readily dissolves in water at 22°C to 40°C within 30 to 80 seconds.

9. The method of claim 1, wherein the nutritional composition further comprises a source of long-chain polyunsaturated fatty acids of 5 to 200 mg / 100 kcal.

10. The method of claim 9, wherein the source of the long-chain polyunsaturated fatty acids comprises docosahexaenoic acid and arachidonic acid in a ratio of 1:3 to 1:

9.

11. The method of claim 1, wherein the nutritional composition comprises 1 to 10 g / 100 kcal of a prebiotic composition, wherein the prebiotic composition comprises polydextrose and galactooligosaccharides.

12. The method of claim 1, wherein the nutritional composition further comprises at least one probiotic.