Preparations containing inorganic substances and / or vitamins and polysaccharides, compositions thereof, and their use in supplementing said inorganic substances and / or vitamins.

Abstract

The present invention relates to nutrient-based solid form formulations comprising (a) a mineral or vitamin (b) a phospholipid, (c) a first agent selected from (c-i) carrageenan and (c-ii) acacia gum, and, optionally, (d) a sucrose ester and / or (e) a starch of plant origin. Furthermore, the present invention relates to compositions comprising at least one of said formulations and their use in treating deficiencies of said minerals and / or vitamins. Finally, the present invention relates to methods for preparing said formulations or compositions.

Description

Technical Field

[0001] The present invention relates to a solid - form preparation based on nutrients (such as inorganic substances and / or vitamins) comprising (a) at least one inorganic substance and / or at least one vitamin, (b) at least one phospholipid, (c) at least one polysaccharide, and optionally (d) at least one sucrose ester and / or (e) at least one starch of plant origin, or alternatively consisting of these.

Background Art

[0002]

Summary of the Invention

[0003] In a first embodiment of the preparation, the present invention relates to a solid - form preparation based on inorganic substances (referred to as cyclosome or cyclosome - inorganic substances) comprising (a) at least one inorganic substance in the form of a salt or a complex or oxide of said inorganic substance, such as magnesium, calcium, iron, zinc, iodine, selenium, chromium and / or copper, (b) at least one phospholipid, (c) at least one first agent (polysaccharide) selected from (c - i) at least one carrageenan, (c - ii) at least one gum acacia, (c - iii) at least one fucoidan and mixtures thereof, and the preparation may further comprise (d) at least one sucrose ester and / or (e) at least one starch of plant origin.

[0004] In a second embodiment of the above formulation, the present invention relates to a vitamin-based solid formulation (referred to as a cyclosome or cyclosomal vitamin) comprising or alternatively comprising (a) at least one vitamin, e.g., vitamin A, vitamin B (preferably B12), vitamin C, vitamin D (preferably D3), and / or vitamin E, (b) at least one phospholipid, (c)(ci) at least one carrageenan, (c-ii) at least one acacia gum, (c-iii) at least one fucoidan, and at least one first agent (polysaccharide) selected from mixtures thereof, wherein the formulation may further comprise (d) at least one sucrose ester and / or (e) at least one plant-derived starch.

[0005] In a third embodiment of the formulation, the present invention relates to a solid-form formulation (referred to as a cyclosome or cyclosomal inorganic-vitamin) based on at least one inorganic substance and at least one vitamin, comprising or alternatively comprising at least one first agent selected from (a) at least one inorganic substance and at least one vitamin as defined above, (b) at least one phospholipid, (c)(ci) at least one carrageenan, (c-ii) at least one acacia gum, (c-iii) at least one fucoidan and mixtures thereof, wherein the formulation may further comprise (d) at least one sucrose ester and / or (e) at least one plant-derived starch.

[0006] Furthermore, the present invention relates to compositions, preferably in solid form, comprising at least one of the solid-form formulations comprising at least one additive and at least one nutrient (i.e., at least one inorganic substance and / or at least one vitamin), and to the use of the compositions or formulations in the treatment (therapeutic or non-therapeutic) of deficiencies of the at least one nutrient, and diseases, symptoms and / or disorders relating to or arising from such deficiencies.

[0007] In a first embodiment of the composition, the present invention relates to a composition, preferably in solid form, comprising an additive and the solid-form formulation (cyclosomal inorganic) comprising at least one inorganic, and to the use of the composition or formulation in the treatment (therapeutic or non-therapeutic) of a deficiency of the at least one inorganic, and a disease, symptom or disorder relating to or arising from the deficiency.

[0008] In a second embodiment of the composition, the present invention relates to a composition, preferably in solid form, comprising an additive and the solid-form formulation (cyclosomal vitamin) containing at least one vitamin, and to the use of the composition or formulation in the treatment (therapeutic or non-therapeutic) of a deficiency of the at least one vitamin, and a disease, symptom or disorder relating to or resulting from the deficiency.

[0009] In a third embodiment of the compositions, the present invention relates to a composition, preferably in solid form, comprising at least one of the solid formulations (cyclosomal inorganics) comprising additives and inorganics and at least one of the solid formulations (cyclosomal vitamins) comprising vitamins, and to the use of the compositions in the treatment (therapeutic or non-therapeutic) of deficiencies of the inorganics and / or vitamins, and diseases, symptoms or disorders relating to or resulting from the deficiencies.

[0010] In a fourth embodiment of the composition, the present invention relates to a composition, preferably in solid form, comprising an additive and the solid-form formulation (cyclosomal inorganic-vitamin) comprising at least one inorganic substance and at least one vitamin, and to the use of the composition or formulation in the treatment (therapeutic or non-therapeutic) of deficiencies of the at least one inorganic substance and at least one vitamin, and diseases, symptoms or disorders relating to or arising from the deficiencies.

[0011] Finally, the present invention relates to a method for preparing the solid-state formulation (cyclosome or cyclosomal inorganic) comprising at least one inorganic substance, or the solid-state formulation (cyclosome or cyclosomal vitamin) comprising a vitamin, or the solid-state formulation (cyclosome or cyclosomal inorganic-vitamin) comprising at least one inorganic substance and at least one vitamin.

[0012] In addition, the present invention relates to a method for further preparing the composition comprising at least one formulation containing an inorganic substance (cyclosomal inorganic substance) and / or at least one formulation containing a vitamin (cyclosomal vitamin) (briefly, the composition method of the present invention).

[0013] Each of the inorganic substances and / or vitamins that may be present in the composition or formulation of the present invention (e.g., magnesium, calcium, iron, zinc, iodine, selenium, chromium, and copper, or vitamins A, B, C, D, and E) plays a fundamental role in the metabolism and function and homeostatic mechanisms of cells and organs in the subject, particularly in the human subject.

[0014] For example, iron is used to treat anemia in addition to iron deficiency and to increase hemoglobin and ferritin levels in subjects; magnesium is used to treat musculoskeletal disorders, cardiac metabolic disorders, emotional disorders (e.g., stress) and immune disorders (e.g., physical and mental fatigue); calcium is used to treat disorders related to pregnancy (i.e., fetal development), mood disorders, bone disorders, muscle disorders and pressure disorders; zinc is used to treat growth and development disorders, metabolic disorders, immune system disorders, visual disorders and cognitive disorders; selenium is used to treat disorders related to pregnancy (i.e., fetal development), metabolic disorders and immune system disorders; iodine is used to treat disorders related to pregnancy (i.e., fetal development), mood disorders, pressure disorders, metabolic disorders, cardiovascular disorders and energy deficiency disorders; chromium is used to treat changes in carbohydrate, lipid and energy metabolism.

[0015] In fact, chromium is an essential element in cellular energy metabolism, both for carbohydrates and lipids, and has the ability to enhance the effects of insulin by lowering blood glucose and promoting the influx of amino acids and lipids into cells.

[0016] Finally, copper is involved in redox reactions and protein synthesis, for example, for enzyme production, and plays a fundamental role in the composition of cytochrome C oxidase, a biological respiratory catalyst, in human organisms.

[0017] However, when the inorganic substances (e.g., magnesium, calcium, iron, zinc, iodine, selenium, copper and / or chromium) and / or the vitamins [e.g., vitamins A, group B (e.g., B12), C, D (e.g., D3) and / or E] are administered to a subject, preferably a human subject, via the oral route (simply put, per os), their gastrointestinal or intestinal absorption and blood bioavailability may vary from subject to subject and / or may not be particularly high, thus potentially leading to significant differences in the subject's response, along with cases of poor efficacy.

[0018] Therefore, there is a great need to provide novel formulations of the inorganic substances (e.g., magnesium, calcium, iron, zinc, iodine, selenium, copper and / or chromium) and / or the vitamins [e.g., vitamins A, group B (e.g., B12), C, D (e.g., D3) and / or E], and compositions comprising such formulations, which are highly absorbable at the gastrointestinal level, bioavailable at the blood level, and highly effective for all categories of subjects in supplementing the inorganic substances and / or vitamins, in treating deficiencies or deficits of the inorganic substances and / or vitamins, and in treating diseases, symptoms or disorders related to or resulting from such deficiencies.

[0019] For example, diseases, symptoms, or disorders relating to or resulting from deficiencies or lack thereof of the inorganic substances, such as magnesium, calcium, iron, zinc, iodine, selenium, copper, and / or chromium, may be selected from: changes in carbohydrate metabolism and / or diseases and disorders thereto, such as diabetes mellitus, hyperglycemia, insulin resistance, high carbohydrate absorption, disregard of blood glucose levels, and / or metabolic syndrome; changes in muscle energy metabolism and / or disorders thereto, such as decreased muscle mass, decreased muscle strength, decreased physical resistance to muscle tone, poor absorption of amino acids, and so on; dyslipidemia or changes in lipid metabolism and / or diseases and disorders thereto, such as high cholesterol, high triglyceride levels, and obesity or overweight; cognitive impairment; and cardiac metabolic disorders.

[0020] For example, diseases or symptoms relating to or resulting from deficiencies or lack of the aforementioned vitamins [e.g., vitamins A, group B (e.g., B12), C, D (e.g., D3), and / or E] may be selected from cognitive problems, motor problems, reduced immune defenses, and others as exemplified herein.

[0021] Finally, the novel solid-state formulations of at least one inorganic substance and / or vitamin, as well as compositions thereof, must also be stable over time, more tolerable to all categories of subjects, and easy to prepare.

[0022] Through extensive research and development activities, the applicant addresses and solves the above-mentioned need by providing novel solid-form formulations comprising at least one inorganic substance (e.g., magnesium, calcium, iron, zinc, iodine, selenium, copper and / or chromium) and / or vitamins [e.g., vitamins A, group B (e.g., B12), C, D (e.g., D3) and / or E], as well as compositions, preferably in solid form, comprising additives and the formulation comprising at least one inorganic substance and / or at least one vitamin.

[0023] The preparations and compositions based on at least one inorganic substance and / or at least one vitamin of the present invention are effective in treating partial or near-complete deficiencies of the at least one inorganic substance and / or the at least one vitamin, and in treating diseases, symptoms or disorders relating to or arising from such deficiencies.

[0024] The object of the present invention is to provide novel formulations of at least one inorganic substance (e.g., magnesium, calcium, iron, zinc, iodine, selenium, copper and / or chromium) and / or novel formulations of at least one vitamin [e.g., vitamin A, group B (e.g., B12), C, D (e.g., D3) and / or E], as well as compositions thereof, which can effectively supplement the inorganic substance administered via the oral route, for example, in accordance with increased gastrointestinal absorption and blood bioavailability of the inorganic substance.

[0025] In the context of this invention, the terms gastrointestinal absorption and intestinal absorption are used interchangeably.

[0026] A good level of efficacy and / or even a small degree of increased efficacy of at least one inorganic-based formulation and / or at least one vitamin-based formulation according to the present invention, relating to the inorganic substance (or its salt, complex, or oxide) and / or the vitamin in its pure form, in the treatment of deficiencies of the inorganic substance and / or the vitamin, or in the treatment of diseases / disorders arising from the deficiencies as shown in the present invention, results in a reduction in the effective dose to be administered to the subject in need of the inorganic substance (or its salt, complex, or oxide) and / or the vitamin in its pure form, which is therefore also cost-effective.

[0027] With regard to treatments using as-is inorganic substances (or their salts, complexes, or oxides) and / or as-is vitamins, the aforementioned good level, or even slight, of increased efficacy in the above-mentioned treatments using inorganic substances and / or vitamins or compositions thereof formulated according to the present invention may be due to increased blood bioavailability of the inorganic substances and / or vitamins when administered orally, which may then be due to increased intestinal or gastrointestinal absorption of formulations based on the inorganic substances and / or vitamin subjects of the present invention with respect to as-is inorganic substances (or their salts, complexes, or oxides) and / or as-is vitamins. However, the increased efficacy may be due to other mechanisms and reasons.

[0028] The increased intestinal absorption of formulations or compositions based on the inorganic substances and / or vitamins of the present invention, relating to inorganic substances in their pure form (or their salts, complexes, or oxides) and / or vitamins in their pure form, is thought to be due to the internal migration of the formulation into microvesicles, which enables its transport across the intestinal membrane.

[0029] With respect to inorganic substances (or their salts, complexes, or oxides) and / or vitamins, the favorable level or increased efficacy in treating inorganic substance deficiencies and / or vitamin deficiencies, or in treating diseases / disorders resulting from such deficiencies, by using formulations or compositions based on the inorganic substance and / or vitamin subject of the present invention results in achieving a greater effect than when the same amount or concentration of the inorganic substance and / or vitamin is administered to the subject requiring treatment.

[0030] In addition, the formulations and compositions of the present invention comprising the at least one inorganic substance and / or the at least one vitamin subject are stable over time from a chemical / physical and functional standpoint.

[0031] Finally, the formulations and compositions of the present invention comprising the at least one inorganic substance and / or the at least one vitamin subject exhibit no associated side effects, are well-tolerated, and can therefore be administered to all categories of subjects, including children, adolescents, pregnant or lactating women, and the elderly, even on an empty stomach.

[0032] Furthermore, the solid-form formulations containing at least one inorganic substance (e.g., magnesium, calcium, iron, zinc, iodine, selenium, copper, and / or chromium) and / or solid-form formulations containing at least one vitamin [e.g., vitamin A, group B (e.g., B12), C, D (e.g., D3), and / or E], as well as methods for preparing the compositions thereof, are easy to perform or prepare and are cost-effective in proportion to their therapeutic potential.

[0033] For example, a solid-state formulation based on at least one inorganic substance and / or at least one vitamin subject of the present invention (cyclosome or cyclosomal inorganic substance and / or vitamin) can be readily processed to provide the composition of the present invention, preferably in solid form, for oral use.

[0034] These objectives, as well as other objectives that will become apparent from the detailed description below, are achieved by the solid-state formulations of at least one inorganic substance (e.g., magnesium, calcium, iron, zinc, iodine, selenium, copper and / or chromium) and / or solid-state formulations of at least one vitamin [e.g., vitamin A, group B (e.g., B12), C, D (e.g., D3) and / or E] (cyclosomes or cyclosomal inorganic substances and / or vitamins) and compositions thereof of the present invention, thanks to the technical features claimed in the appended claims and reported herein. [Brief explanation of the drawing]

[0035] [Figure 1] A chart showing the amount of Fe3+ passing through the intestinal epithelium over time (rat isolation model). [Figure 2] A chart illustrating the kinetics of Fe3+ release from compositions of the present invention or comparable materials in a simulated stomach environment with a pH of 1.2. [Figure 3] A histogram showing the dimensions (nm) of vesicles formed by compositions according to the present invention or comparable materials.

[0036] (Summary of the invention) In the context of this invention, the term "inorganic substance" is used to refer to salts (cations and anions), oxides, complexes, cations (in a biologically active oxidized state), anions, or aggregates.

[0037] The object of the present invention is to provide a solid-form preparation of at least one inorganic substance and / or at least one vitamin, wherein, in addition to the inorganic substance and / or vitamin, the preparation comprises a phospholipid, a polysaccharide, and optionally, a sucrose ester and / or plant starch (briefly, the preparation of the present invention).

[0038] The object of the present invention is to provide a composition (briefly, a composition of the present invention), preferably in solid form, comprising at least one formulation of the present invention (based on inorganic substances and / or vitamins) and pharmaceutical or food-grade additives and / or excipients.

[0039] The object of the present invention is to provide the aforementioned formulation or composition for use as a pharmaceutical.

[0040] An object of the present invention is to provide the formulations or compositions of the present invention for use in a method of treating deficiencies of at least one inorganic substance and / or at least one vitamin for subjects requiring such treatment.

[0041] An object of the present invention is to provide a method for treating deficiencies of at least one inorganic substance and / or at least one vitamin by administering a therapeutically effective amount of the formulation or composition of the present invention to a subject requiring such an amount.

[0042] An object of the present invention is to provide non-therapeutic (or cosmetic) uses of the formulations or compositions of the present invention for supplementing healthy subjects with at least one inorganic substance and / or at least one vitamin to enhance their physical and / or mental performance.

[0043] (Detailed description of the invention) The objective of this invention is to form the following: (a) The at least one inorganic substance in the form of a salt, complex or oxide of the at least one inorganic substance, wherein the inorganic substance is selected from the group consisting of (ai) magnesium(II), (a-ii) calcium(II), (a-iii) iron(III) or iron(II), (a-iv) zinc(II), (av) iodine(V), (a-vi) selenium(IV), (a-vii) chromium(III), (a-viii) copper(II) and mixtures thereof, or alternatively; (b) at least one phospholipid, preferably a phosphoglyceride, more preferably phosphatidylcholine or lecithin; (c)(ci) at least one carrageenan, (c-ii) at least one acacia gum, (c-iii) at least one fucoidan, and at least one first agent selected from the group comprising or alternatively comprising a mixture thereof; Furthermore, as appropriate, (d) at least one fatty acid carbohydrate ester (alternatively referred to as sucrose ester) and / or (e) at least one gelatinized or pregelatinized starch of plant origin, preferably rice starch. A solid-state formulation of at least one inorganic substance comprising or substituted for (briefly, the formulation of at least one inorganic substance of the present invention or the formulation of the present invention or substituted for a cyclosome or cyclosomal inorganic substance).

[0044] An example of the solid-form formulation of at least one inorganic substance is: (a)(ai)magnesium(II), (a-ii)calcium(II), (a-iii)iron(III) or iron(II), (a-iv)zinc(II), (av)iodine(V), (a-vi)selenium(IV), (a-vii)chromium(III), or (a-viii)copper(II); (b) Lecithin, preferably sunflower, corn, or soy lecithin [preferably sunflower (E322)]; (ci) carrageenan (e.g., E407) or (c-ii) acacia gum (e.g., E414); And, as appropriate, (d) sucrose ester (e.g., sucrose ester E473); And, as appropriate, (e) gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch. It includes or consists of.

[0045] An example of the solid-form formulation of at least one inorganic substance is: (a)(ai)magnesium(II), (a-ii)calcium(II), (a-iii)iron(III) or iron(II), (a-iv)zinc(II), (av)iodine(V), (a-vi)selenium(IV), (a-vii)chromium(III), or (a-viii)copper(II); (b) Lecithin, preferably sunflower, corn, or soy lecithin [preferably sunflower (E322)]; (ci) carrageenan (e.g., E407) or (c-ii) acacia gum (e.g., E414); (d) Sucrose ester (e.g., sucrose ester E473); And, as appropriate, (e) gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch. It includes or consists of.

[0046] An example of the solid-form formulation of at least one inorganic substance is: (a)(ai)magnesium(II), (a-ii)calcium(II), (a-iii)iron(III) or iron(II), (a-iv)zinc(II), (av)iodine(V), (a-vi)selenium(IV), (a-vii)chromium(III), or (a-viii)copper(II); (b) Lecithin, preferably sunflower, corn, or soy lecithin [preferably sunflower (E322)]; (ci) carrageenan (e.g., E407) or (c-ii) acacia gum (e.g., E414); (d) Sucrose esters (e.g., sucrose ester E473); and (e) Gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0047] In the context of the present invention, the term "inorganic" is preferably used to refer to an inorganic substance consisting of a single chemical element, such as magnesium, calcium, iron, zinc, iodine, selenium, copper, or chromium.

[0048] In the context of the present invention, the term "inorganic salt" is used to refer to a salt of an inorganic substance, which is preferably an inorganic substance in the form of a cation consisting of a single chemical element, such as magnesium, calcium, iron, zinc, iodine, selenium, or chromium (inorganic cation).

[0049] In the context of the present invention, the term “inorganic cation” (or “inorganic cation”) is used to refer to a chemical form of a monovalent or polyvalent cation of an inorganic substance, which is preferably an inorganic substance consisting of a single chemical element, such as magnesium, calcium, iron, zinc, iodine, selenium, copper, or chromium.

[0050] In the context of this invention, the terms "inorganic" and "inorganic cation" (or inorganic cation) are interchangeable.

[0051] The following embodiments (FR) of the present invention of a solid-state preparation of magnesium (abbreviated as Mg) (cyclosome or cyclosomal magnesium) are included in the present invention: - FRa-Mg: Mg, (b) and (c), e.g., (ci) or (c-ii) or (c-iii); e.g., Mg, (b) and (ci) or Mg, (b) and (c-ii) or Mg, (b) and (c-iii). - FRb-Mg: Mg, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (d); e.g., Mg, (b), (ci) and (d) or Mg, (b), (c-ii) and (d) or Mg, (b), (c-iii) and (d). - FRc-Mg: Mg, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (e); e.g., Mg, (b), (ci) and (e) or Mg, (b), (c-ii) and (e) or Mg, (b), (c-iii) and (e). - FRd-Mg: Mg, (b), (c), e.g., (ci) or (c-ii) or (c-iii), (d) and (e); e.g., Mg, (b), (ci), (d) and (e) or Mg, (b), (c-ii), (d) and (e) or Mg, (b), (c-iii), (d) and (e). Here, the components referred to as (a), (b), (ci), (c-ii), (c-iii), (d), and (e) are as defined in the present invention.

[0052] In embodiments of the present invention, the solid form formulation of magnesium (referred to as cyclosome or cyclosomal magnesium) is (ai) Magnesium, preferably magnesium(II), more preferably magnesium oxide or magnesium hydroxide; (b) at least one phospholipid, preferably a phosphoglyceride, more preferably phosphatidylcholine or lecithin, even more preferably lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof; (c)(ci) at least one carrageenan, preferably carrageenan E407; (c-ii) at least one acacia gum, preferably acacia gum E414; (c-iii) at least one fucoidan; and at least one first agent selected from the group comprising or alternatively comprising mixtures thereof; Furthermore, as appropriate, (d) at least one sucrose ester, preferably sucrose ester E473; and / or (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0053] The following embodiments (FR) of the present invention of a solid-form preparation of calcium (abbreviated as Ca) (cyclosome or cyclosomal magnesium) are included in the present invention: - FRa-Ca: Ca, (b) and (c), e.g., (ci) or (c-ii) or (c-iii); e.g., Ca, (b) and (ci) or Ca, (b) and (c-ii) or Ca, (b) and (c-iii). - FRb-Ca: Ca, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (d); e.g., Ca, (b), (ci) and (d) or Ca, (b), (c-ii) and (d) or Ca, (b), (c-iii) and (d). - FRc-Ca: Ca, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (e); e.g., Ca, (b), (ci) and (e) or Ca, (b), (c-ii) and (e) or Ca, (b), (c-iii) and (e). - FRd-Ca: Ca, (b), (c), e.g., (ci) or (c-ii) or (c-iii), (d) and (e); e.g., Ca, (b), (ci), (d) and (e) or Ca, (b), (c-ii), (d) and (e) or Ca, (b), (c-iii), (d) and (e). Here, the components referred to as (a), (b), (ci), (c-ii), (c-iii), (d), and (e) are as defined in the present invention.

[0054] In embodiments of the present invention, the solid-form preparation of calcium (referred to as cyclosome or cyclosomal calcium) is (a-ii) Calcium, preferably calcium(II), more preferably calcium in the form of tricalcium phosphate, for example tricalcium phosphate E341; (b) at least one phospholipid, preferably a phosphoglyceride, more preferably phosphatidylcholine or lecithin, even more preferably lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof; (c)(ci) at least one carrageenan, preferably carrageenan E407; (c-ii) at least one acacia gum, preferably acacia gum E414; (c-iii) at least one fucoidan; and at least one first agent selected from the group comprising or alternatively comprising mixtures thereof; Furthermore, as appropriate, (d) at least one sucrose ester, preferably sucrose ester E473; and / or (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0055] According to embodiments of the formulation of the present invention, when the inorganic substance is calcium, the formulation of the present invention does not contain acacia gum.

[0056] The following embodiments (FR) of the present invention of a solid-state formulation of iron (abbreviated as Fe) (cyclosome or cyclosomal magnesium) are included in the present invention: - FRa-Fe: Fe, (b) and (c), e.g., (ci) or (c-ii) or (c-iii); e.g., Fe, (b) and (ci) or Fe, (b) and (c-ii) or Fe, (b) and (c-iii). - FRb-Fe: Fe, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (d); e.g., Fe, (b), (ci) and (d) or Fe, (b), (c-ii) and (d) or Fe, (b), (c-iii) and (d). - FRc-Fe: Fe, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (e); e.g., Fe, (b), (ci) and (e) or Fe, (b), (c-ii) and (e) or Fe, (b), (c-iii) and (e). - FRd-Fe: Fe, (b), (c), e.g., (ci) or (c-ii) or (c-iii), (d) and (e); e.g., Fe, (b), (ci), (d) and (e) or Fe, (b), (c-ii), (d) and (e) or Fe, (b), (c-iii), (d) and (e). Here, the components referred to as (a), (b), (ci), (c-ii), (c-iii), (d), and (e) are as defined in the present invention.

[0057] In embodiments of the present invention, the solid-form formulation of iron (referred to as cyclosome or cyclosomal iron) is (a-iii) iron, preferably iron(III), more preferably iron in the form of iron pyrophosphate; (b) at least one phospholipid, preferably a phosphoglyceride, more preferably phosphatidylcholine or lecithin, even more preferably lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof; (c)(ci) at least one carrageenan, preferably carrageenan E407; (c-ii) at least one acacia gum, preferably acacia gum E414; (c-iii) at least one fucoidan; and at least one first agent selected from the group comprising or alternatively comprising mixtures thereof; Furthermore, as appropriate, (d) at least one sucrose ester, preferably sucrose ester E473; and / or (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0058] The following embodiments (FR) of the present invention of a solid-state formulation of zinc (abbreviated as Zn) (cyclosome or cyclosomal magnesium) are included in the present invention: - FRa-Zn: Zn, (b) and (c), e.g., (ci) or (c-ii) or (c-iii); e.g., Zn, (b) and (ci) or Zn, (b) and (c-ii) or Zn, (b) and (c-iii). - FRb-Zn: Zn, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (d); e.g., Zn, (b), (ci) and (d) or Zn, (b), (c-ii) and (d) or Zn, (b), (c-iii) and (d). - FRc-Zn: Zn, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (e); e.g., Zn, (b), (ci) and (e) or Zn, (b), (c-ii) and (e) or Zn, (b), (c-iii) and (e). - FRd-Zn: Zn, (b), (c), e.g., (ci) or (c-ii) or (c-iii), (d) and (e); e.g., Zn, (b), (ci), (d) and (e) or Zn, (b), (c-ii), (d) and (e) or Zn, (b), (c-iii), (d) and (e). Here, the components referred to as (a), (b), (ci), (c-ii), (c-iii), (d), and (e) are as defined in the present invention.

[0059] In embodiments of the present invention, the solid-state preparation of zinc (referred to as cyclosome or cyclosomal zinc) is (a-iv) zinc, preferably zinc(IV), more preferably zinc oxide; (b) at least one phospholipid, preferably a phosphoglyceride, more preferably phosphatidylcholine or lecithin, even more preferably lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof; (c)(ci) at least one carrageenan, preferably carrageenan E407; (c-ii) at least one acacia gum, preferably acacia gum E414; (c-iii) at least one fucoidan; and at least one first agent selected from the group comprising or alternatively comprising mixtures thereof; (d) as appropriate, at least one sucrose ester, preferably sucrose ester E473; and / or (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0060] The following embodiments (FR) of the present invention of a solid-state formulation of iodine (abbreviated as I) (cyclosome or cyclosomal magnesium) are included in the present invention: - FRa-I: I, (b) and (c), e.g., (ci) or (c-ii) or (c-iii); e.g., I, (b) and (ci) or I, (b) and (c-ii) or I, (b) and (c-iii). - FRb-I: I, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (d); e.g., I, (b), (ci) and (d) or I, (b), (c-ii) and (d) or I, (b), (c-iii) and (d). - FRc-I: I, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (e); e.g., I, (b), (ci) and (e) or I, (b), (c-ii) and (e) or I, (b), (c-iii) and (e). - FRd-I: I, (b), (c), e.g., (ci) or (c-ii) or (c-iii), (d) and (e); e.g., I, (b), (ci), (d) and (e) or I, (b), (c-ii), (d) and (e) or I, (b), (c-iii), (d) and (e). Here, the components referred to as (a), (b), (ci), (c-ii), (c-iii), (d), and (e) are as defined in the present invention.

[0061] In embodiments of the present invention, the solid-state formulation of iodine (referred to as cyclosome or cyclosomal iodine) is (av) Iodine, preferably iodine(V), more preferably iodine in the form of sodium iodate; (b) at least one phospholipid, preferably a phosphoglyceride, more preferably phosphatidylcholine or lecithin, even more preferably lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof; (c)(ci) at least one carrageenan, preferably carrageenan E407; (c-ii) at least one acacia gum, preferably acacia gum E414; (c-iii) at least one fucoidan; and at least one first agent selected from the group comprising or alternatively comprising mixtures thereof; (d) as appropriate, at least one sucrose ester, preferably sucrose ester E473; and / or (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0062] The following embodiments (FR) of the present invention of a solid-state formulation of selenium (abbreviated as Se) (cyclosome or cyclosomal magnesium) are included in the present invention: - FRa-Se:Se, (b) and (c), e.g., (ci) or (c-ii) or (c-iii); e.g., Se, (b) and (ci) or Se, (b) and (c-ii) or Se, (b) and (c-iii). - FRb-Se:Se, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (d); e.g., Se, (b), (ci) and (d) or Se, (b), (c-ii) and (d) or Se, (b), (c-iii) and (d). - FRc-Se:Se, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (e); e.g., Se, (b), (ci) and (e) or Se, (b), (c-ii) and (e) or Se, (b), (c-iii) and (e). - FRd-Se:Se, (b), (c), e.g., (ci) or (c-ii) or (c-iii), (d) and (e); e.g., Se, (b), (ci), (d) and (e) or Se, (b), (c-ii), (d) and (e) or Se, (b), (c-iii), (d) and (e). Here, the components referred to as (a), (b), (ci), (c-ii), (c-iii), (d), and (e) are as defined in the present invention.

[0063] In embodiments of the present invention, the solid-form formulation of selenium (referred to as cyclosome or cyclosomal selenium) is (a-vi) Selenium, preferably selenium(IV), more preferably selenium in the form of sodium selenite; (b) at least one phospholipid, preferably a phosphoglyceride, more preferably phosphatidylcholine or lecithin, even more preferably lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof; (c)(ci) at least one carrageenan, preferably carrageenan E407; (c-ii) at least one acacia gum, preferably acacia gum E414; (c-iii) at least one fucoidan; and at least one first agent selected from the group comprising or alternatively comprising mixtures thereof; (d) as appropriate, at least one sucrose ester, preferably sucrose ester E473; and / or (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0064] The following embodiments (FR) of the chromium (abbreviated as Cr) solid formulation (cyclosome or cyclosomal magnesium) of the present invention are included in the present invention: - FRa-Cr: Cr, (b) and (c), e.g., (ci) or (c-ii) or (c-iii); e.g., Cr, (b) and (ci) or Cr, (b) and (c-ii) or Cr, (b) and (c-iii). - FRb-Cr: Cr, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (d); e.g., Cr, (b), (ci) and (d) or Cr, (b), (c-ii) and (d) or Cr, (b), (c-iii) and (d). - FRc-Cr: Cr, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (e); e.g., Cr, (b), (ci) and (e) or Cr, (b), (c-ii) and (e) or Cr, (b), (c-iii) and (e). - FRd-Cr: Cr, (b), (c), e.g., (ci) or (c-ii) or (c-iii), (d) and (e); e.g., Cr, (b), (ci), (d) and (e) or Cr, (b), (c-ii), (d) and (e) or Cr, (b), (c-iii), (d) and (e). Here, the components referred to as (a), (b), (ci), (c-ii), (c-iii), (d), and (e) are as defined in the present invention.

[0065] In embodiments of the present invention, the solid-state formulation of chromium (referred to as cyclosome or cyclosomal chromium) is (a-vii) chromium, preferably in the form of chromium(III), more preferably chromium(III) picolinate or chromium(III) nicotinic acid or polynicotinate or chromium(III) chloride, even more preferably chromium(III) picolinate; (b) at least one phospholipid, preferably a phosphoglyceride, more preferably phosphatidylcholine or lecithin, even more preferably lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof; (c)(ci) at least one carrageenan, preferably carrageenan E407; (c-ii) at least one acacia gum, preferably acacia gum E414; (c-iii) at least one fucoidan; and at least one first agent selected from the group comprising or alternatively comprising mixtures thereof; (d) as appropriate, at least one sucrose ester, preferably sucrose ester E473; and / or (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0066] The following embodiments (FR) of the present invention of a solid-state formulation of copper (abbreviated as Cu) (cyclosome or cyclosomal copper) are included in the present invention: - FRa-Cu: Cu, (b) and (c), e.g., (ci) or (c-ii) or (c-iii); e.g., Cu, (b) and (ci) or Cu, (b) and (c-ii) or Cu, (b) and (c-iii). - FRb-Cu: Cu, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (d); e.g., Cu, (b), (ci) and (d) or Cu, (b), (c-ii) and (d) or Cu, (b), (c-iii) and (d). - FRc-Cu: Cu, (b), (c), e.g., (ci) or (c-ii) or (c-iii) and (e); e.g., Cu, (b), (ci) and (e) or Cu, (b), (c-ii) and (e) or Cu, (b), (c-iii) and (e). - FRd-Cu: Cu, (b), (c), e.g., (ci) or (c-ii) or (c-iii), (d) and (e); e.g., Cu, (b), (ci), (d) and (e) or Cu, (b), (c-ii), (d) and (e) or Cu, (b), (c-iii), (d) and (e). Here, the components referred to as (a), (b), (ci), (c-ii), (c-iii), (d), and (e) are as defined in the present invention.

[0067] In embodiments of the present invention, the solid-state preparation of copper (referred to as cyclosome or cyclosomal copper) is (ai) Copper, preferably copper(II), more preferably copper gluconate [Cu(2+)] or copper sulfate [Cu(2+); CuSO4, e.g., anhydrous, pentahydrate or heptahydrate], even more preferably copper gluconate; (b) at least one phospholipid, preferably a phosphoglyceride, more preferably phosphatidylcholine or lecithin, even more preferably lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof; (c)(ci) at least one carrageenan, preferably carrageenan E407; (c-ii) at least one acacia gum, preferably acacia gum E414; (c-iii) at least one fucoidan; and at least one first agent selected from the group comprising or alternatively comprising mixtures thereof; (d) as appropriate, at least one sucrose ester, preferably sucrose ester E473; and / or (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0068] Copper gluconate: Chemical name: copper, bis(D-gluconate-O1,O2), synonym: copper D-gluconate, exemplary CAS number: 527-09-3, unmodified formula: C12H22CuO14, formula weight: 453.84.

[0069] The objective of this invention is to form the following: (a) at least one vitamin, wherein (ai) selected from the group comprising or alternatively comprising at least one vitamin of group B (e.g., B12, B9, B6, B3, or B2), preferably vitamin B12, (a-II) vitamin C, (a-III) vitamin D, preferably D3, (a-IV) vitamin E, and (aV) vitamin A; (b) at least one phospholipid, preferably a phosphoglyceride, more preferably phosphatidylcholine or lecithin; (c)(ci) at least one first agent (polysaccharide) selected from at least one carrageenan and / or (c-ii) at least one acacia gum; Furthermore, as appropriate, (d) at least one fatty acid carbohydrate ester (which may be substituted for sucrose ester); Furthermore, (e) as appropriate, at least one plant-derived starch, preferably gelatinized or pregelatinized, such as rice starch. A solid-state preparation of at least one vitamin comprising or substituted for (briefly, the preparation of at least one vitamin of the present invention or the preparation of the present invention or substituted for cyclosomes or cyclosomal vitamins).

[0070] An example of the solid-form formulation of at least one vitamin is: (a)(aI) vitamin B12, (a-II) vitamin C, (a-III) vitamin D, preferably D3, and (a-IV) vitamin E; (b) Lecithin, preferably sunflower, corn, or soy lecithin [preferably sunflower (E322)]; (ci) carrageenan (e.g., E407) or (c-ii) acacia gum (e.g., E414); And, as appropriate, (d) sucrose ester (e.g., sucrose ester E473); And, as appropriate, (e) gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch. It includes or consists of.

[0071] An example of the solid-form formulation of at least one vitamin is: (a)(aI) vitamin B12, (a-II) vitamin C, (a-III) vitamin D, preferably D3, and (a-IV) vitamin E; (b) Lecithin, preferably sunflower, corn, or soy lecithin [preferably sunflower (E322)]; (ci) carrageenan (e.g., E407) or (c-ii) acacia gum (e.g., E414); (d) Sucrose ester (e.g., sucrose ester E473); And, as appropriate, (e) gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch. It includes or consists of.

[0072] An example of the solid-form formulation of at least one vitamin is: (a)(aI) vitamin B12, (a-II) vitamin C, (a-III) vitamin D, preferably D3, and (a-IV) vitamin E; (b) Lecithin, preferably sunflower, corn, or soy lecithin [preferably sunflower (E322)]; (ci) carrageenan (e.g., E407) or (c-ii) acacia gum (e.g., E414); (d) Sucrose esters (e.g., sucrose ester E473); and (e) Gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0073] The following embodiments (FR) of the present invention of a solid-state preparation of vitamin B12 (abbreviated as vit B12) (cyclosome or cyclosomal vitamin B12) are included in the present invention: - FRa-vit B12:vit B12, (b) and (c), e.g., (ci) or (c-ii); e.g., vit B12, (b) and (ci) or vit B12, (b) and (c-ii); - FRb-vit B12:vit B12, (b), (c) [e.g., (ci) or (c-ii)] and (d); e.g., vit B12, (b), (ci) and (d) or vit B12, (b), (c-ii) and (d); - FRc-vit B12:vit B12, (b), (c) [e.g., (ci) or (c-ii)] and (e); e.g., vit B12, (b), (ci) and (e) or vit B12, (b), (c-ii) and (e); - FRd-vit B12:vit B12, (b), (c) [e.g., (ci) or (c-ii)], (d) and (e); e.g., vit B12, (b), (ci), (d) and (e) or vit B12, (b), (c-ii), (d) and (e); The components referred to here as (a), (b), (ci), (c-ii), (d), and (e) are as defined in the present invention.

[0074] In embodiments of the present invention, the solid-state preparation of vitamin B12 (referred to as a cyclosome or cyclosomal vitamin B12) is (ai) Vitamin B12 (cobalamin) (Example CAS number: 68-19-9); (b) at least one phospholipid, preferably phosphatidylcholine or lecithin, such as lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof (preferably sunflower lecithin); (c)(ci) at least one carrageenan (e.g., E407) or (c-ii) at least one acacia gum (e.g., E414) and a polysaccharide selected from a mixture thereof; In addition, (d) at least one sucrose ester (e.g., E473); as appropriate; In addition, (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0075] The following embodiments (FR) of the present invention of a solid-state formulation of vitamin C (abbreviated as vit C) (cyclosome or cyclosomal vitamin C) are included in the present invention: - FRa-vit C:vit C, (b) and (c), e.g., (ci) or (c-ii); e.g., vit C, (b) and (ci) or vit C, (b) and (c-ii); - FRb-vit C:vit C, (b), (c) [e.g., (ci) or (c-ii)] and (d); e.g., vit C, (b), (ci) and (d) or vit C, (b), (c-ii) and (d); - FRc-vit C:vit C, (b), (c) [e.g., (ci) or (c-ii)] and (e); e.g., vit C, (b), (ci) and (e) or vit C, (b), (c-ii) and (e); - FRd-vit C:vit C, (b), (c) [e.g., (ci) or (c-ii)], (d) and (e); e.g., vit C, (b), (ci), (d) and (e) or vit C, (b), (c-ii), (d) and (e); The components referred to here as (a), (b), (ci), (c-ii), (d), and (e) are as defined in the present invention.

[0076] In embodiments of the present invention, the solid-state preparation of vitamin C (referred to as cyclosome or cyclosomal vitamin C) is (ai) Vitamin C (cobalamin) (Example CAS number: 68-19-9); (b) at least one phospholipid, preferably phosphatidylcholine or lecithin, such as lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof (preferably sunflower lecithin); (c)(ci) at least one carrageenan (e.g., E407) or (c-ii) at least one acacia gum (e.g., E414) and a polysaccharide selected from a mixture thereof; In addition, (d) at least one sucrose ester (e.g., E473); as appropriate; In addition, (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0077] The following embodiments (FR) of the present invention of a solid-state formulation of vitamin D (abbreviated as vit D) (cyclosome or cyclosomal vitamin D) are included in the present invention: - FRa-vit D:vit D, (b) and (c), e.g., (ci) or (c-ii); e.g., vit D, (b) and (ci) or vit D, (b) and (c-ii); - FRb-vit D:vit D, (b), (c) [e.g., (ci) or (c-ii)] and (d); e.g., vit D, (b), (ci) and (d) or vit D, (b), (c-ii) and (d); - FRc-vit D:vit D, (b), (c) [e.g., (ci) or (c-ii)] and (e); e.g., vit D, (b), (ci) and (e) or vit D, (b), (c-ii) and (e); - FRd-vit D:vit D, (b), (c) [e.g., (ci) or (c-ii)], (d) and (e); e.g., vit D, (b), (ci), (d) and (e) or vit D, (b), (c-ii), (d) and (e); The components referred to here as (a), (b), (ci), (c-ii), (d), and (e) are as defined in the present invention.

[0078] In embodiments of the present invention, the solid-state preparation of vitamin D (referred to as cyclosome or cyclosomal vitamin D) is (ai) Vitamin D (cobalamin) (Example CAS number: 68-19-9); (b) at least one phospholipid, preferably phosphatidylcholine or lecithin, such as lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof (preferably sunflower lecithin); (c)(ci) at least one carrageenan (e.g., E407) or (c-ii) at least one acacia gum (e.g., E414) and a polysaccharide selected from a mixture thereof; In addition, (d) at least one sucrose ester (e.g., E473); as appropriate; In addition, (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0079] The following embodiments (FR) of the present invention of a solid-state preparation of vitamin E (abbreviated as vit E) (cyclosome or cyclosomal vitamin E) are included in the present invention: - FRa-vit E:vit E, (b) and (c), e.g., (ci) or (c-ii); e.g., vit E, (b) and (ci) or vit E, (b) and (c-ii); - FRb-vit E:vit E, (b), (c) [e.g., (ci) or (c-ii)] and (d); e.g., vit E, (b), (ci) and (d) or vit E, (b), (c-ii) and (d); - FRc-vit E:vit E, (b), (c) [e.g., (ci) or (c-ii)] and (e); e.g., vit E, (b), (ci) and (e) or vit E, (b), (c-ii) and (e); - FRd-vit E:vit E, (b), (c) [e.g., (ci) or (c-ii)], (d) and (e); e.g., vit E, (b), (ci), (d) and (e) or vit E, (b), (c-ii), (d) and (e); The components referred to here as (a), (b), (ci), (c-ii), (d), and (e) are as defined in the present invention.

[0080] In embodiments of the present invention, vitamin E or the solid-form preparation (referred to as cyclosome or cyclosomal vitamin E) is (ai) Vitamin E (cobalamin) (Example CAS number: 68-19-9); (b) at least one phospholipid, preferably phosphatidylcholine or lecithin, such as lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof (preferably sunflower lecithin); (c)(ci) at least one carrageenan (e.g., E407) or (c-ii) at least one acacia gum (e.g., E414) and a polysaccharide selected from a mixture thereof; In addition, (d) at least one sucrose ester (e.g., E473); as appropriate; In addition, (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0081] Phospholipids are phosphate-containing lipids. This class of organic compounds has a phosphate-based water-soluble polar head (i.e., insoluble in water-soluble and nonpolar solvents) and a hydrophobic, water-insoluble, nonpolar tail (i.e., insoluble in water and soluble in nonpolar solvents), and for this reason they are called amphiphilic molecules.

[0082] Phosphoglycerides (also called glycerophospholipids) are the most important class of phospholipids.

[0083] Glycerophospholipids (or phosphoglycerides) all originate from sn-glycerol-3-phosphate, where glycerol (CH2OH-CHOH-CH2OH) is esterified with orthophosphate (H3PO4) at the 3-position. In glycerophospholipids, glycerol is esterified with a fatty acid at the 2-position, and different classes of compounds can be attached at the 1-position; since carbon 2 is asymmetric, two possible stereoisomers exist: L and D. In nature, all glycerophospholipids belong to the L series.

[0084] Depending on the nature of the molecule attached to the 1-position of glycerol, three subclasses of phosphoglycerides can be distinguished: 1,2-diacyl-phospholipids, 1-alkyl-2-acyl-phospholipids, and 1-alkenyl-2-acyl-phospholipids.

[0085] Diacyl phospholipids (phosphoglycerides) derive their structure from triglycerides, where the fatty acid is replaced by a phosphate group, which gives the molecule a negative charge and therefore polarity; these molecules have the common name phosphatide. More complex organic molecules, generally serine, choline, ethanolamine, inositol, or a single hydrogen atom, are bonded to a phosphate group via an ester bond, producing phospholipids called phosphatidylserine, phosphatidylcholine (or lecithin), phosphatidylethanolamine, phosphatidylinositol, or phosphatidic acid, respectively.

[0086] Diacyl phospholipids are characterized by a water-soluble polar head that dissolves well in water, while the two saturated fatty acids represent two non-polar tails that are lipophilic rather than water-soluble.

[0087] The term lecithin is used to refer to a class of chemical compounds found in animal and plant tissues (particularly egg yolks). Chemically, lecithin is phosphatidylcholine [(R)-1-oleoyl-2-palmitoyl-phosphatidylcholine], or alternatively, lecithin contains phosphatidylcholine as its primary component.

[0088] Phosphatidylcholine is a phosphoglyceride obtained by esterifying phosphatidic acid with choline. Phosphatidic acid is the simplest phosphoglyceride and is formally produced by esterification of glycerol with fatty acids at positions 1 and 2, and with orthophosphate at position 3.

[0089] Lecithin is a natural emulsifier due to its chemical / physical properties and, considering its richness in natural antioxidants, possesses secondary antioxidant functions.

[0090] Lecithin E322 is a food additive (emulsifier). The term "E322" indicates that lecithin is a food additive approved under European law and regulated by Italian ministerial decree N° DM 1996.

[0091] Directive 2008 / 84 / EC of 27 August 2008 (published in Official Journal of the European Union, No. L253) sets forth purity standards that lecithin must meet in order to be considered to meet the food quality standard (lecithin E322): insoluble in acetone (basically the active portion of lecithin): minimum 60%; water: maximum 2%; acidity: maximum 35; peroxide count: maximum 10; insoluble in toluene (basically impurities): maximum 0.3%.

[0092] Advantageously, the (b) phospholipids of the present invention, which are included in at least one inorganic formulation and / or at least one vitamin formulation of the present invention together with (a), (c), for example (ci) or (c-ii) or (c-iii), and optionally together with (d) and / or (e), are phosphoglycerides selected from 1,2-diacyl-phospholipids, 1-alkyl-2-acylphospholipids, 1-alkenyl-2-acylphospholipids, preferably diacyl-phospholipids.

[0093] In embodiments of the present invention, the at least one phospholipid (b) contained in the at least one inorganic preparation and / or at least one vitamin preparation of the present invention together with (a), (c), for example (ci) or (c-ii) or (c-iii), and optionally together with (d) and / or (e), is selected from the group of diacyl phospholipids comprising or alternatively comprising phosphoglycerides, preferably diacyl phospholipids, more preferably phosphatidylcholine or lecithin, phosphatidylserine, phosphatidylethanolamine, phosphatidylinositol, phosphatidic acid and mixtures thereof; preferably phosphatidylcholine or lecithin (E322); more preferably sunflower lecithin (E322), corn lecithin (E322), or soybean lecithin (E322); even more preferably allergen-free lecithin (E322), for example allergen-free sunflower lecithin (E322).

[0094] Advantageously, the lecithin (E322) is powdered or granular lecithin (E322), preferably powdered or granular sunflower lecithin (E322), corn lecithin (E322), or soy lecithin (E322), more preferably powdered or granular allergen-free sunflower lecithin (E322), corn lecithin (E322), or soy lecithin (E322). The term "allergen-free" means that it does not contain any allergen residues.

[0095] If (b) phosphatidylcholine or lecithin (E322) is in powder or granular form, the lecithin may have a water content in the range of 1.5% to 4.5%, preferably 2% to 4%, and more preferably 2.5% to 3.5% by weight relative to the weight of the lecithin.

[0096] If the (b) phosphatidylcholine or lecithin is sunflower lecithin E322, preferably in powdered or granular form, the lecithin may have a glucose content in weight % that is, for example, in the range of 20% to 60%, preferably 30% to 50%, for example about 45% relative to the weight of the lecithin. The (b) sunflower lecithin E322, preferably in powder or granular form, which can be used in the context of the present invention, may have the following composition in weight % (chemical / physical analysis): 40% to 50% sunflower lecithin, 40% to 50% (e.g. about 42%) carbohydrates, 6% to 10% protein, 3% to 8% ash, 2% to 5% moisture, and 0.5% to 1.5% another fluidizing agent.

[0097] In embodiments of the present invention, the (b) lecithin contained in at least one inorganic preparation and / or at least one vitamin preparation of the present invention together with (a), (c), for example (ci) or (c-ii) or (c-iii), and optionally together with (d) and / or (e), is not composed of or without decomposed or hydrolyzed lecithin, nor is it composed of or without enzymatically decomposed or hydrolyzed lecithin.

[0098] In other words, the (b) lecithin contained in the preparation of at least one inorganic substance and / or at least one vitamin of the present invention together with (a), (c), for example (ci) or (c-ii) or (c-iii), and optionally (d) and / or (e), is undegraded or enzymatically hydrolyzed lecithin (E322).

[0099] Preferably, in the formulation according to the present invention [(a) inorganic substances and / or vitamins, (b), (c), e.g., (ci) or (c-ii), and optionally (d) and / or (e)], the weight ratio of (c) + (d)]:(b) [i.e., the total weight of polysaccharides (i.e., carrageenan or acacia gum) and sucrose esters:phospholipids (preferably lecithin, more preferably sunflower lecithin)] is contained in a ratio of 50:1 to 10:1 (e.g., 45:1, 40:1, 35:1, 30:1, 25:1, 20:1, or 15:1), preferably 40:1 to 10:1, more preferably 30:1 to 15:1 (e.g., about 17:1 or 17:0.6 to 0.5).

[0100] The weight ratio [(c)+(d)]:(b) described above may not be obtainable for the preparation according to the present invention that contains calcium.

[0101] Preferably, in a solid-form preparation of an inorganic substance or a solid-form preparation of a vitamin according to the present invention, components (a), (b), (c), for example (ci) or (c-ii), and optionally (d) and / or (e), are included in the preparation in the following amounts, expressed as a weight percentage with respect to the total weight of the preparation as 100: - The (b) phospholipid, preferably lecithin or sunflower lecithin (E322), is present in an amount of 0.05% to 15%, preferably 0.1% to 5%, more preferably 0.1% to 2%, for example, about 0.5% to 1.0%; - (c) the total of the first agent [polysaccharide, e.g., (ci) carrageenan or (c-ii) acacia gum] and (d) sucrose ester (sucrose ester which may be present in the formulation) is contained in an amount of 1% to 50% (e.g., 10%, 20%, 30%, or 40%), preferably 5% to 35%, more preferably 10% to 25%, e.g., 15% to 20% (e.g., 16%, 17%, or 18%); - The (a) at least one inorganic substance (in the form of a salt, oxide, or complex) and / or at least one vitamin varies with the variation in its weight; - The appropriate amount of starch in (e) above varies with the variation in the percentage of inorganic substances and / or vitamins.

[0102] In a preferred example, the inorganic solid formulation and / or vitamin solid formulation of the present invention, comprising (a), (b), (c), e.g., (ci) or (c-ii), and optionally (d) and / or (e), contains the following amounts, expressed as a weight percentage with respect to the total weight of the formulation as 100: - Approximately 0.5-1.0% of the aforementioned (b) phospholipid, preferably lecithin or sunflower lecithin (E322); - 15% to 20% (e.g., 16%, 17%, or 18%) of the total of (c) the first agent [polysaccharide, e.g., (ci) carrageenan or (c-ii) acacia gum] and (d) sucrose ester (sucrose ester may be present); and - The (a) at least one inorganic substance (in the form of a salt, oxide, or complex) and / or at least one vitamin varies with its weight; - The appropriate amount of starch in (e) above varies with the variation in the percentage of inorganic substances and / or vitamins.

[0103] (c) In 100 parts by weight of the total of the first agent [polysaccharide, e.g., (ci) carrageenan (c-ii) acacia gum] and (d) sucrose ester (may be present), the first agent (c) is present in a weight percentage of 1% to 100% (e.g., 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95%), and the sucrose ester (d) is present in a weight percentage of 0% (absent) to 99% (e.g., 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, or 7. The amounts vary between 5%, 80%, 85%, 90%, or 95%; preferably 50% to 95% of the (c) first agent and 5% to 50% of the (d) sucrose ester [e.g., about 50% of (c) and about 50% of (d)], or 70% to 95% of the (c) first agent and 5% to 30% of the (d) sucrose ester [e.g., 70% to 80% and 20% to 30%, or about 75% of (c) and about 25% of (d)], or 5% to 30% of the (c) first agent and 70% to 95% of the (d) sucrose ester [e.g., 20% to 30% and 70% to 80%, or about 25% of (c) and about 75% of (d)].

[0104] Advantageously, in the formulation of at least one inorganic substance and / or at least one vitamin according to the present invention, of 100 parts by weight of the total of (c) a first agent [polysaccharide, e.g., (ci) carrageenan or (c-ii) acacia gum] and (d) a sucrose ester, the first agent (c) is about 75% and the sucrose ester (d) is about 25%.

[0105] In the embodiments of the solid formulation of at least one inorganic substance of the present invention, components (a), (b), (c), for example (ci) or (c-ii) or (c-iii), and optionally (d) and / or (e), are present in the formulation in the following amounts, expressed as a weight % of the total weight of the formulation of at least one inorganic substance: - The inorganic elements (cations of inorganic substances) mentioned above (a) vary according to the inorganic substance as follows: - Mg(II) or magnesium metal is present in an amount of 5% to 80%, preferably 10% to 60%, more preferably 30% to 40%; for example, about 53 to 54% magnesium oxide, corresponding to about 32 to 38% Mg(II) element; - Ca(II) or calcium metal is present in the range of 5% to 80%, preferably 10% to 60%, more preferably 30% to 40%; for example, about 97% tricalcium phosphate corresponding to about 31% to 37% Ca(II) element; - Fe(III) or iron metal is present in an amount of 1% to 40%, preferably 1% to 30%, more preferably 5% to 20%; for example, about 44 to 45% iron(III) pyrophosphate, corresponding to about 10 to 12% Fe(III) element; - Zn(II) or zinc metal is included in the range of 10% to 80%, preferably 20% to 70%, more preferably 30% to 60%; for example, about 53 to 54% zinc oxide, corresponding to about 40 to 50% Zn(II) element; - I(V) or iodine metal is included in an amount of 0.01% to 15%, preferably 0.05% to 10%, more preferably 0.1% to 3%; for example, about 1 to 2% sodium iodate, corresponding to about 0.9 to 1.1% of element I(V); - Se(IV) or selenium metal is included in an amount of 0.01% to 15%, preferably 0.05% to 10%, more preferably 0.1% to 3%; for example, about 2.0% to 2.5% sodium selenite, corresponding to about 0.9% to 1.2% of Se(IV) element; - Cr(III) or chromium metal is included in an amount of 1% to 40%, preferably 3% to 20%, more preferably 5% to 15%; for example, about 9+1% diCr(III) given by chromium(III) picolinate; - Cu(II) or metallic copper is included in an amount of 1% to 30%, preferably 1% to 20%, more preferably 1% to 10%; for example, about 6+1% Cu(II) given by copper(II) gluconate; - The (b) phospholipids, preferably phosphoglycerides, more preferably phosphatidylcholine or lecithin, even more preferably solid lecithin (E322) or solid sunflower lecithin (E322), are included in an amount of 0.05% to 15%, preferably 0.1% to 5%, more preferably 0.1% to 2%, for example, within the range of about 0.6 ± 0.5% or 1.0 ± 0.5%: - The (c) first agent, in the form of (ci) carrageenan or (c-ii) acacia gum or (c-iii) fucoidan or a mixture thereof, is contained in an amount of 1% to 50% (e.g., 3%, 5%, 7%, 10%, 12%, 15%, 17%, 20%, 25%, 30%, or 40%), preferably 1% to 35%, more preferably 1% to 20%, or 1% to 10%, or 10% to 20%, for example, in the range of about 4% to 5% or 12% to 13% or 17% to 18%; - If present, the (d) sucrose ester (E473) is present in an amount of 1% to 50% (e.g., 3%, 5%, 7%, 10%, 12%, 15%, 17%, 20%, 25%, 30%, or 40%), preferably 1% to 35%, more preferably 1% to 20%, or 1% to 10%, or 10% to 20%, for example, in the range of about 4% to 5% or 12% to 13% or 17% to 18%; or alternatively, absent (0%); - If present, the starch(e), preferably pregelatinized rice starch, is included in an amount of 10% to 85%, preferably 15% to 60%, more preferably 25% to 50%, for example, in the range of about 37% to 38%+1%.

[0106] In embodiments of the present invention concerning solid-form formulations of vitamins (vitamins C, B12, or E), components (a), (b), (c) [e.g., (ci) or (c-ii)], and optionally (d) and / or (e), are present in the formulation in the following amounts, expressed as a weight percentage of the total weight of the formulation: - The above (a) vitamin C, vitamin B12, or vitamin E is included in an amount of 20% to 80% (e.g., 25%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, or 75%), preferably 45% to 60% (e.g., about 50% to 55%); - The (b) phospholipids, preferably phosphoglycerides, more preferably phosphatidylcholine or lecithin, even more preferably solid lecithin (E322) or solid sunflower lecithin (E322), are included in amounts of 0.05% to 10% (e.g., 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, or 8%), preferably in amounts of about 0.1% to 2% (e.g., about 1.0 ± 0.1%); - The (c) first agent (polysaccharide), for example (ci) carrageenan or (c-ii) acacia gum, or alternatively, the total of the first agent (c) and the (d) sucrose ester (E473) is included in an amount of 1% to 50% (e.g., 3%, 5%, 7%, 10%, 12%, 14%, 16%, 18%, 20%, 25%, 30%, or 40%), preferably about 10% to 25% (e.g., about 15±1 to 20±1%); - If present, the (e) starch, preferably pregelatinized rice starch, is present in an amount of 5% to 60% (e.g., 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, or 55%), preferably about 20% to 40% (e.g., about 30 ± 0.1%).

[0107] In embodiments of the solid-form formulation of vitamin D3 of the present invention, components (a), (b), (c) [e.g., (ci) or (c-ii)], and optionally (d) and / or (e), are present in the formulation in the following amounts, expressed as a weight percentage of the total weight of the formulation: - The (a) vitamin D3 (commercial) is present in an amount of 50% to 95% (e.g., 60%, 70%, 75%, 80%, 85%, or 90%), preferably about 80% to 90% (e.g., 85%), and the amount of pure vitamin D3 (or unprocessed vitamin D3) is about 0.10% to 0.25% (e.g., 0.12%, 0.14%, 0.16%, 0.18%, 0.20%, 0.22%, or 0.24%), preferably about 0.20±1%; - The (b) phospholipids, preferably phosphoglycerides, more preferably phosphatidylcholine or lecithin, even more preferably solid lecithin (E322) or solid sunflower lecithin (E322), are included in amounts ranging from 0.05% to 10% (e.g., 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, or 8%), preferably in amounts ranging from about 0.1% to 2% (e.g., about 0.5±0.1% to 1.0±0.1%); - The (c) first agent (polysaccharide), for example (ci) carrageenan or (c-ii) acacia gum, or alternatively, the total of the first agent (c) and the (d) sucrose ester (E473) is included in an amount of 1% to 50% (e.g., 3%, 5%, 7%, 10%, 12%, 14%, 16%, 18%, 20%, 25%, 30%, or 40%), preferably about 5% to 20% (e.g., about 10±1 to 15±1%); - If present, the (e) starch, preferably pregelatinized rice starch, is included in an amount of 0.05% to 10% (e.g., 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1%, 2%, 3%, 4%, 5%, or 8%), preferably in an amount of about 0.1% to 2% (e.g., about 1.0 ± 0.1%).

[0108] In the solid-form formulation of vitamin D3 according to the present invention, it is clear that the amount of commercial vitamin D3 may vary depending on the amount of pure vitamin D3 (or unprocessed vitamin D3) contained in the commercial vitamin D3, such that the formulation of the present invention has a weight percentage of pure vitamin D3 of about 0.10% to 0.25%, preferably about 0.20 ± 1%, relative to the weight of the formulation.

[0109] In Embodiment A of the present invention, where (c) is (ci) carrageenan, the solid-form formulation of at least one inorganic substance is (a) The at least one inorganic substance in the form of a salt or complex of at least one inorganic substance, wherein the inorganic substance is selected from the group comprising or alternatively comprising (ai) magnesium(II), (a-ii) calcium(II), (a-iii) iron(III) or iron(II), (a-iv) zinc(II), (av) iodine(V), (a-vi) selenium(IV), (a-vii) chromium(III), (a-viii) copper(II) and mixtures thereof; (b) at least one phospholipid, preferably a phosphoglyceride, more preferably phosphatidylcholine or lecithin, even more preferably lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof; (ci) at least one carrageenan, preferably carrageenan E407; In addition, (d) at least one sucrose ester, preferably sucrose ester E473; and / or (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0110] A preferred example of the above embodiment A is: (a)(ai)magnesium(II), (a-ii)calcium(II), (a-iii)iron(III) or iron(II), (a-iv)zinc(II), (av)iodine(V), (a-vi)selenium(IV), (a-vii)chromium(III), or (a-viii)copper(II); (b) Lecithin, preferably sunflower, corn, or soy lecithin [preferably sunflower (E322)]; (ci) carrageenan, preferably carrageenan E407; (d) Sucrose ester (e.g., sucrose ester E473); And, as appropriate, (e) gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch. It includes or consists of.

[0111] In a preferred embodiment A of the present invention, wherein (c) is (ci) carrageenan, the solid-form preparation of at least one inorganic substance and / or at least one vitamin comprises or alternatively comprises (a), (b), (ci), (d), and (e) as defined in Embodiment A.

[0112] In a further preferred embodiment A of the present invention, wherein (c) is (ci) carrageenan, the solid-state preparation of at least one inorganic substance and / or at least one vitamin comprises or alternatively comprises (a), (b), (ci), and (e) as defined in Embodiment A.

[0113] Carrageenan is a food additive (thickener, stabilizer, gelling agent, emulsifier) ​​approved under European and Italian law, and is classified as food additive "E407" according to European law.

[0114] Carrageenan, or carrageenan [INCI name: Carrageenan, EU INCI name: Chrondrus Chrispus powder], derives its name from Carragheen in Ireland. Carrageenan is a product derived from carrageheen. Extracted from red algae, carrageenan is a linear polysaccharide complex, often sulfate. They are high molecular weight compounds, i.e., very large molecules, characterized by repeating units of galactose and 3,6-anhydrogalactose (3,6-AG), both sulfated and non-sulfate. The units have alternating alpha-1-3 and beta-1-4 glycosidic bonds. Due to their structure, carrageenan behaves like a highly flexible molecule, curling to form helical structures. The spatial configuration of the molecules generally confers upon them the ability to form a variety of different gels at room temperature. There are three main commercial classes of carrageenan: lambda, kappa, and iota.

[0115] Carrageenan essentially consists of calcium, potassium, sodium, and magnesium salts and sulfated polysaccharides, which, upon hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan is never hydrolyzed or otherwise chemically broken down. It is in the form of a coarse to fine consistency powder, yellow to colorless in color, and essentially odorless.

[0116] Carrageenan is a gelatin widely used for food, medicine, and industrial purposes, particularly in Ireland and Great Britain (used for the manufacture of honey, beer clarification, paper, starch, and other products); it is obtained by boiling two red algae [Giganteus spp. and Gigartina mamitiosa] found on the rocky coasts of the North Atlantic, known by the names Irish moss or Tochaka.

[0117] An example of (ci)carrageenan that may be used in the present invention is standardized CSW-2 type carrageenan containing sucrose [Genuvisco®, registered trademark, CP Kelco]; CAS 9000-07-1, 57-50-1; according to European standard E407; pH (0.5% solution) 7.0-10.0; loss on drying <= 12.0; instantaneous viscosity - high salt <= 12; instantaneous viscosity - low salt >= 50.

[0118] The (ci) carrageenan can be obtained by methods known to those skilled in the art, for example, by extraction from seaweed with water and Ca(OH)2 at high temperatures (e.g., slightly >100°C), neutralization, and precipitation with ethanol or isopropanol.

[0119] In a preferred embodiment of the solid formulation of the at least one inorganic substance of the present invention, wherein (c) is (ci) carrageenan, components (a), (b), (cI), and optionally (d) and / or (e) are present in the formulation in the following amounts, expressed as a weight % of the total weight of the at least one inorganic substance formulation: - The inorganic elements (cations of inorganic substances) mentioned above (a) vary according to the inorganic substance as follows: - Mg(II) or magnesium metal is present in an amount of 5% to 80%, preferably 10% to 60%, more preferably 30% to 40%; for example, about 53 to 54% magnesium oxide, corresponding to about 32 to 38% Mg(II) element; - Ca(II) or calcium metal is present in the range of 5% to 80%, preferably 10% to 60%, more preferably 30% to 40%; for example, about 97% tricalcium phosphate corresponding to about 31% to 37% Ca(II) element; - Fe(III) or iron metal is present in an amount of 1% to 40%, preferably 1% to 30%, more preferably 5% to 20%; for example, about 44 to 45% iron(III) pyrophosphate, corresponding to about 10 to 12% Fe(III) element; - Zn(II) or zinc metal is included in the range of 10% to 80%, preferably 20% to 70%, more preferably 30% to 60%; for example, about 53 to 54% zinc oxide, corresponding to about 40 to 50% Zn(II) element; - I(V) or iodine metal is included in an amount of 0.01% to 15%, preferably 0.05% to 10%, more preferably 0.1% to 3%; for example, about 1 to 2% sodium iodate, corresponding to about 0.9 to 1.1% of element I(V); - Se(IV) or selenium metal is included in an amount of 0.01% to 15%, preferably 0.05% to 10%, more preferably 0.1% to 3%; for example, about 2.0% to 2.5% sodium selenite, corresponding to about 0.9% to 1.2% of Se(IV) element; - Cr(III) or chromium metal is included in an amount of 1% to 40%, preferably 3% to 20%, more preferably 5% to 15%; for example, about 9+1% diCr(III) given by chromium(III) picolinate; - Cu(II) or metallic copper is included in an amount of 1% to 30%, preferably 1% to 20%, more preferably 1% to 10%; for example, about 6+1% Cu(II) given by copper(II) gluconate; - The (b) phospholipids, preferably phosphoglycerides, more preferably phosphatidylcholine or lecithin, even more preferably solid lecithin (E322) or solid sunflower lecithin (E322), are included in an amount of 0.05% to 15%, preferably 0.1% to 5%, more preferably 0.1% to 2%, for example, in the range of about 0.6 + 0.5%; - (ci) Carrageenan is included in an amount of 1% to 50% (e.g., 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, or 45%), preferably 1% to 35%, more preferably 1% to 10% (e.g., about 4% to 5% or 1%) or 10% to 20% (e.g., about 12% to 13% or 17% to 18% or 1%); - If present, the (d) sucrose ester (E473) is included in an amount of 1% to 50% (e.g., 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, or 45%), preferably 1% to 35%, more preferably 10% to 20% (e.g., about 12% to 13+1% or 17% to 18+1%) or 1% to 10% (e.g., about 4% to 5+1%); - If present, the starch(e), preferably pregelatinized rice starch, is included in an amount of 10% to 85%, preferably 15% to 60%, more preferably 25% to 50%, for example, in the range of about 37% to 38%+1%.

[0120] In Embodiment B of the present invention, where (c) is (c-ii) acacia gum, the solid formulation of at least one inorganic substance is (a) The at least one inorganic substance in the form of a salt or complex of at least one inorganic substance, wherein the inorganic substance is selected from the group consisting of (ai) magnesium(II), (a-ii) calcium(II), (a-iii) iron(III), (a-iv) zinc(II), (av) iodine(V), (a-vi) selenium(IV), (a-vii) chromium(III), (a-viii) copper(II) and mixtures thereof, or alternatively; (b) at least one phospholipid, preferably a phosphoglyceride, more preferably phosphatidylcholine or lecithin, even more preferably lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof; (c-ii) at least one acacia gum, preferably acacia gum E414; more preferably acacia gum E414 having an average molecular weight in the range of 250,000 to 400,000, more preferably an average molecular weight of about 350,000; In addition, (d) at least one sucrose ester, preferably sucrose ester E473; and / or (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0121] A preferred example of the above embodiment A is: (a) an inorganic substance selected from (ai) magnesium(II), (a-ii) calcium(II), (a-iii) iron(III) or iron(II), (a-iv) zinc(II), (av) iodine(V), (a-vi) selenium(IV), (a-vii) chromium(III), or (a-viii) copper(II); (b) Lecithin, preferably sunflower, corn, or soy lecithin [preferably sunflower (E322)]; (ci) Acacia gum, preferably acacia gum E414; (d) Sucrose ester (e.g., sucrose ester E473); And, as appropriate, (e) gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch. It includes or consists of.

[0122] In a preferred embodiment B of the present invention, wherein (c) is (c-ii) acacia gum, the solid-form formulation of at least one inorganic substance and / or at least one vitamin comprises or alternatively comprises (a), (b), (c-ii), (d), and (e) as defined in embodiment B.

[0123] In a further preferred embodiment B of the present invention, wherein (c) is (c-ii) acacia gum, the solid-form formulation of at least one inorganic substance and / or at least one vitamin comprises or alternatively comprises (a), (b), (c-ii) and (e) as defined in Embodiment B.

[0124] Acacia gum, or gum arabic, is a food additive (thickener, stabilizer, emulsifier) ​​approved under European and Italian law, and is classified as food additive "E414" according to European law.

[0125] Acacia gum is a natural gum of plant origin, and is so named because it is extracted from two species of sub-Saharan acacia: Acacia senegal (L) and Acacia seyal. Specifically, acacia gum is a dried exudate obtained from the trunks and branches of natural species such as the Acacia genus.

[0126] Gum arabic is a complex mixture of high molecular weight polysaccharides (Mw 250,000-400,000), their calcium, magnesium, and potassium salts, and glycoproteins, the glycoproteins which give them one of their most important properties: the fact that they are completely edible. It consists of various components: arabinose, D-galactopyranose, rhamnopyranose, D-glucuronic acid, calcium, magnesium, potassium, sodium, and mucilage.

[0127] Like almost all plant-derived gums and resins, it is produced by plants through a natural process of "gummosis," which spontaneously activates to heal damage (wounds) toward surface integrity. It is primarily used as an excipient, a "stabilizer," in the food industry, but also has viscosity-controlling properties in certain inks.

[0128] An example of acacia gum that may be used in the present invention is acacia gum having CAS number 232-519-5, EINECS 232-519-5, conforming to E414, with a purity of at least 99.9%, a loss in drying of at most 10%, a total ash of at most 4%, a viscosity (at 20°C) of at least 60 cps., and a specific rotation of 30-60° (commercial example: 386° gum arabic produced by Chimab, cod. 306045).

[0129] Acacia gum is obtained by methods known to those skilled in the art, including the steps of centrifugation, filtration, heating, and drying.

[0130] In Embodiment C of the present invention, wherein (c) is (c-iii) fucoidan, the solid-form formulation of at least one inorganic substance is (a) The at least one inorganic substance in the form of a salt or complex of at least one inorganic substance, wherein the inorganic substance is selected from the group consisting of (ai) magnesium(II), (a-ii) calcium(II), (a-iii) iron(III), (a-iv) zinc(II), (av) iodine(V), (a-vi) selenium(IV), (a-vii) chromium(III), (a-viii) copper(II) and mixtures thereof, or alternatively; (b) at least one phospholipid, preferably a phosphoglyceride, more preferably phosphatidylcholine or lecithin, even more preferably lecithin (E322) selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof; (c-iii) at least one fucoidan; preferably a fucoidan having an average molecular weight in the range of 20,000 to about 30,000; In addition, (d) at least one sucrose ester, preferably sucrose ester E473; and / or (e) at least one gelatinized or pregelatinized starch of plant origin, preferably pregelatinized rice starch It includes or consists of.

[0131] In a preferred embodiment C of the present invention, wherein (c) is (c-iii) fucoidan, the solid-state preparation of at least one inorganic substance and / or at least one vitamin comprises or alternatively comprises (a), (b), (c-iii), (d), and (e) as defined in embodiment C.

[0132] In a further preferred embodiment C of the present invention, wherein (c) is (c-iii) fucoidan, the solid-form preparation of at least one inorganic substance and / or at least one vitamin comprises or alternatively comprises (a), (b), (c-ii) and (e) as defined in Embodiment C.

[0133] Fucoidan is a sulfated polysaccharide (average molecular weight approximately 20,000-30,000) mainly found in various brown algae species, such as mozuku, kelp, rovina vescica, wakame, and hijiki. It can be extracted from these brown algae species by methods known to those skilled in the art, preferably by a low-temperature extraction method using water followed by precipitation using ethanol.

[0134] An example of (c-iii) fucoidan that may be used in the present invention is CAS number 9072-19-9, solubility in H2O > 95, specific gravity (H2O=1) 0.45~0.65 g / cm³. 3 This is fucoidan (supplied by Zhejiang Sanhe Biotech Co., Ltd.) that contains [the specified ingredient].

[0135] Further examples of (c-iii) fucoidan that can be used in the present invention are obtained by extraction from the brown algae species Laminaria japonica by low-temperature extraction using water, and have the following chemical composition: fucoidan minimum 85% (UV), organic SO4 2- Minimum 20% (GBT16484.12-2006), carbohydrates minimum 60%, L-fucose minimum 23%, alginate maximum 31%; and the following physical characteristics: density (bulk density) 40-60g / 100ml, total ash maximum 3.0% (USP <281> ), loss during drying up to 5.0% (USP <731> It is a fucoidan that possesses the properties of ).

[0136] In a preferred embodiment of the solid formulation of the at least one inorganic substance of the present invention, wherein (c) is (c-ii) acacia gum or (c-iii) fucoidan, components (a), (b), (c), for example (c-ii) or (c-iii), and optionally (d) and / or (e) are present in the formulation in the following amounts, expressed as a weight % of the total weight of the at least one inorganic substance formulation: - The inorganic elements (cations of inorganic substances) mentioned above (a) vary according to the inorganic substance as follows: - Mg(II) or magnesium metal is present in an amount of 5% to 80%, preferably 10% to 60%, more preferably 30% to 40%; for example, about 53 to 54% magnesium oxide, corresponding to about 32 to 38% Mg(II) element; - Ca(II) or calcium metal is present in the range of 5% to 80%, preferably 10% to 60%, more preferably 30% to 40%; for example, about 97% tricalcium phosphate corresponding to about 31% to 37% Ca(II) element; - Fe(III) or iron metal is present in an amount of 1% to 40%, preferably 1% to 30%, more preferably 5% to 20%; for example, about 44 to 45% iron(III) pyrophosphate, corresponding to about 10 to 12% Fe(III) element; - Zn(II) or zinc metal is included in the range of 10% to 80%, preferably 20% to 70%, more preferably 30% to 60%; for example, about 53 to 54% zinc oxide, corresponding to about 40 to 50% Zn(II) element; - I(V) or iodine metal is included in an amount of 0.01% to 15%, preferably 0.05% to 10%, more preferably 0.1% to 3%; for example, about 1 to 2% sodium iodate, corresponding to about 0.9 to 1.1% of element I(V); - Se(IV) or selenium metal is included in an amount of 0.01% to 15%, preferably 0.05% to 10%, more preferably 0.1% to 3%; for example, about 2.0% to 2.5% sodium selenite, corresponding to about 0.9% to 1.2% of Se(IV) element; - Cr(III) or chromium metal is included in an amount of 1% to 40%, preferably 3% to 20%, more preferably 5% to 15%; for example, about 9+1% diCr(III) given by chromium(III) picolinate; - Cu(II) or metallic copper is included in an amount of 1% to 30%, preferably 1% to 20%, more preferably 1% to 10%; for example, about 6+1% Cu(II) given by copper(II) gluconate; - The (b) phospholipids, preferably phosphoglycerides, more preferably phosphatidylcholine or lecithin, even more preferably solid lecithin (E322) or solid sunflower lecithin (E322), are included in an amount of 0.05% to 15%, preferably 0.1% to 5%, more preferably 0.1% to 2%, for example, in the range of about 0.6 + 0.5%; - The first agent (c), in the form of (c-ii) acacia gum or (c-iii) fucoidan (e.g., 80-85% by weight of fucoidan) or a mixture thereof, is contained in an amount of 1%-50% (e.g., 3%, 5%, 7%, 10%, 12%, 15%, 20%, 17%, 25%, 30%, or 40%), preferably 1%-35%, more preferably 10%-20%, for example, in the range of about 12-13+1% or 17-18+1%; - If present, the (d) sucrose ester (E473) is present in an amount of 1% to 50% (e.g., 3%, 5%, 7%, 10%, 12%, 15%, 17%, 20%, 25%, 30%, or 40%), preferably 1% to 35%, more preferably 1% to 10%, for example, in an amount of about 4% to 5% or 1%, or is not present; - If present, the starch(e), preferably pregelatinized rice starch, is included in an amount of 10% to 85%, preferably 15% to 60%, more preferably 25% to 50%, for example, in the range of about 37% to 38%+1%.

[0137] In embodiments of the present invention, the preparation comprising at least one inorganic substance and / or at least one vitamin comprises or alternatively comprises (a), (b), (c), for example (ci) or (c-ii) or (c-iii), (d), and, as appropriate, (e).

[0138] In the embodiments of the present invention, the (d) sucrose ester or fatty acid carbohydrate ester contained in the preparation of at least one inorganic substance or at least one vitamin of the present invention together with (a), (b), (c), for example (ci) or (c-ii) or (c-iii) and optionally (e) is sucrose ester E473, preferably sucrose ester E473 comprising a monoester obtained by esterification of sucrose using one or more fatty acids of plant origin in an amount of at least 50% by weight, preferably 70% to 90% by weight, relative to the total weight of the sucrose ester, wherein the fatty acid is preferably selected from stearic acid and / or palmitic acid.

[0139] The abbreviation "E473" is used to indicate that sucrose ester or sucrose fatty acid ester is a food additive (emulsifier) ​​approved under European law and regulated by Italian ministerial decree DM 1996.

[0140] Sucrose esters are generally obtained from the esterification of fatty acids or the trans-esterification of fatty acid methyl esters using carbohydrates (also called saccharides). Sucrose (monosaccharide) and polysaccharides are commonly used carbohydrates. This is why sucrose esters are also called "sucrose fatty acid esters." The chemical / physical properties of these compounds depend on the number and type of fatty acids being esterified.

[0141] These are essentially emulsifiers and are added to the composition to determine greater stabilization of the aqueous phase with the fatty phase.

[0142] For example, (d) sucrose ester (E473) that can be used in the context of the present invention may be a sucrose ester having an HLB (hydrophilic-lipophilic balance) value in the range of 14 to 18, preferably an HLB value of about 15 or 16.

[0143] (d) Sucrose ester (E473) that can be used in the context of the present invention may have the following composition by weight: at least 90% total ester content, of which at least 70% by weight is monoester obtained by esterification of sucrose using one or more fatty acids of plant origin, preferably stearic acid and / or palmitic acid, relative to the total weight of the sucrose ester; free fatty acid content not exceeding 3% (e.g., oleic acid); free sucrose content not exceeding 2%; humidity not exceeding 4%; acid value not exceeding 5. An example of a commercial sucrose ester (d) that can be used in the context of the present invention is sucrose ester SP70 from Chimab SpA-Italia.

[0144] In embodiments of the present invention, the (d) sucrose ester contained in the preparation of at least one inorganic substance or at least one vitamin of the present invention together with (a), (b), (c), for example (ci) or (c-ii) or (c-iii), and optionally (e), does not contain or consist of a polyglycerol fatty acid ester.

[0145] In embodiments of the present invention, the formulation of at least one inorganic substance or the formulation of at least one vitamin comprises or alternatively comprises (a), (b), (c), for example (ci) or (c-ii) or (c-iii), (e), and (d) as appropriate.

[0146] In the embodiments of the present invention, the preparation of at least one inorganic substance or at least one vitamin of the present invention further comprises (a), (b), (c), for example (ci) or (c-ii) or (c-iii), and optionally (d), and (e) a plant-derived starch, preferably gelatinized or pregelatinized; preferably the plant-derived starch is selected from rice starch and / or corn starch; preferably the plant-derived starch is rice starch [rice (Oryza sativa)] or native rice starch, preferably gelatinized or pregelatinized; more preferably the plant-derived starch is pregelatinized rice starch.

[0147] Pregelatinized rice starch (E) used in the context of the present invention may have, for example, the following chemical / physical characteristics: humidity not exceeding 7%; protein content not exceeding 1%; ash content not exceeding 1%; pH in 5.5-7.5 (10% solution), 0.40-0.48 g / cm³ 3 Density; minimum starch content of 97% and fat content not exceeding 0.1%. An example of commercially available pregelatinized rice starch is AX-FG-P, manufactured by Reire Srl - Italia.

[0148] In alternative embodiments of the present invention, the preparation of at least one inorganic substance or at least one vitamin of the present invention further comprises (a), (b), (c), for example (ci), or (c-ii), or (c-iii), and optionally (d) and / or (e), at least one second preparation (f) comprising (fi) at least one cyclodextrin, preferably α-cyclodextrin; (f-ii) at least one fatty acid having a number of carbon atoms in the range of C6-C18, preferably C12-C18; (f-iii) at least one chitosan derivative, preferably carboxymethyl chitosan; and a mixture thereof.

[0149] The object of the present invention is formed by any one of the embodiments described herein, (a), (b), (c), for example (ci) or (c-ii) or (c-iii), and optionally (d) and / or (e) [for example, FR-Mg of (a)~(d), FR-Ca of (a)~(d), FR-Fe of (a)~(d), FR-Zn of (a)~(d), FR-I of (a)~(d), FR-Se of (a)~(d), FR-Cr of (a)~(d), FR-vit B12 of (a)~(d), FR-vit C of (a)~(d), FR-vit D of (a)~(d), FR-vit of (a)~(d) A composition (briefly, the composition of the present invention), preferably in solid form, comprising or substituted for at least one solid-form formulation of an inorganic substance (the at least one inorganic formulation of the present invention) and / or at least one solid-form formulation of a vitamin (the vitamin formulation of the present invention), wherein the composition optionally comprises at least one acceptable pharmaceutical or food-grade additive and / or excipient.

[0150] The at least one acceptable pharmaceutical or food-grade additive and / or excipient may be selected from all substances known to those skilled in the art of pharmaceutical or food preparations, which include, for example, preservatives, emulsifiers and / or thickeners, such as hydroxymethylcellulose; sweeteners, colorants, such as colorant E171; natural and artificial flavors; antioxidants, stabilizers, fillers, anti-caking agents, such as vegetable magnesium stearate, magnesium salts of fatty acids and silicon dioxide; fillers, such as microcrystalline cellulose; and mixtures thereof.

[0151] In a first embodiment, the composition of the present invention may comprise a single solid-form formulation of an inorganic substance (e.g., Mg, Ca, Fe, Zn, I, Se, Cr, or Cu).

[0152] In a second embodiment, the composition of the present invention may comprise a single solid-form preparation of a vitamin (e.g., vitamin B12, C, D3, or E).

[0153] In a third embodiment, the composition of the present invention may comprise two, three, or four solid-form formulations of the inorganic substances (e.g., Mg, Ca, Fe, Zn, I, SE, Cr, and / or Cu).

[0154] In a fourth embodiment, the composition of the present invention may comprise two, three, or four solid-form formulations of the vitamins (e.g., vitamins B12, C, D3, and / or E).

[0155] In a fifth embodiment, the composition of the present invention may comprise a single solid-form preparation of an inorganic substance (e.g., Mg, Ca, Fe, Zn, I, Se, Cr, or Cu) and a single solid-form preparation of a vitamin (e.g., vitamin B12, C, D3, or E).

[0156] In a sixth embodiment, the composition of the present invention may comprise two, three, or four solid-form formulations of the inorganic substances (e.g., Mg, Ca, Fe, Zn, I, Se, Cr, and / or Cu) and a single solid-form formulation of a vitamin (e.g., vitamin B12, C, D3, or E).

[0157] In a seventh embodiment, the composition of the present invention may comprise a single solid-form formulation of an inorganic substance (e.g., Mg, Ca, Fe, Zn, I, Se, Cr, or Cu) and two, three, or four solid-form formulations of the vitamins (e.g., vitamins B12, C, D3, and / or E).

[0158] In the eighth embodiment, the composition of the present invention may comprise two, three, or four solid-form formulations of the inorganic substance (e.g., Mg, Ca, Fe, Zn, I, Se, Cr, and / or Cu) and two, three, or four solid-form formulations of the vitamin (e.g., vitamin B12, C, D3, and / or E).

[0159] Examples of compositions according to the present invention comprising at least one cyclosomal inorganic and / or at least one cyclosomal vitamin, or alternatively, multiple cyclosomal inorganics, or alternatively, multiple cyclosomal vitamins, are as follows: Iron + at least one vitamin selected from vitamins C, D3, B12, E and mixtures thereof; Iron + vitamin C; Iron + vitamin D3; Iron + vitamin C + vitamin D3; Iron + vitamin C + vitamin B12; Iron + vitamin D3 + vitamin B12; Iron + vitamin C + vitamin D3 + vitamin B12; Iron + chromium + at least one inorganic substance selected from Mg, Ca, Zn, I, Se, Cr, Cu and mixtures thereof; iron + chromium + vitamin D3 + vitamin B12; iron + chromium + vitamin D3 + vitamin B12 + vitamin C; iron + chromium + vitamin C + vitamin B12; iron + chromium + vitamin C + vitamin D3; Calcium + at least one vitamin selected from vitamins C, D3, B12, E, and mixtures thereof; Calcium + vitamin D3; Calcium + vitamin D3 + at least one vitamin selected from vitamins C, B12, E, and mixtures thereof; Calcium + Magnesium + at least one vitamin selected from vitamins C, D3, B12, E and mixtures thereof; Magnesium + Calcium + Vitamin D3; Magnesium + Calcium + Vitamin C; Magnesium + Calcium + Vitamin C + Vitamin D3; Magnesium + Calcium + Vitamin D3 + at least one vitamin selected from vitamins C, B12, E and mixtures thereof; Magnesium + at least one vitamin selected from vitamins C, D3, B12, E, and mixtures thereof; Zinc + at least one vitamin selected from vitamins C, D3, B12, E and mixtures thereof; Zinc + vitamin C + vitamin D; Zinc + vitamin C + vitamin D3 + vitamin B12 and / or vitamin E; Selenium + at least one vitamin selected from vitamins C, D3, B12, E and mixtures thereof; Selenium + vitamin E; Selenium + vitamin E + at least one vitamin selected from vitamins C, D3, B12 and mixtures thereof; Selenium + iodine + at least one vitamin selected from vitamins C, D3, B12, E and mixtures thereof; selenium + iodine + vitamin E; selenium + iodine + vitamin E + at least one vitamin selected from vitamins C, D3, B12 and mixtures thereof; Iodine + at least one vitamin selected from vitamins C, D3, B12, E, and mixtures thereof; Chromium + at least one vitamin selected from vitamins C, D3, B12, E, and mixtures thereof; Copper + at least one vitamin selected from vitamins C, D3, B12, E, and mixtures thereof; Chromium + copper + zinc; chromium + copper; chromium + zinc; copper + zinc; chromium + copper + zinc + at least one vitamin selected from vitamins C, D3, B12, E and mixtures thereof Vitamin C + at least one vitamin selected from vitamins D3, B12, E, and mixtures thereof (e.g., D3+B12, D3+E, B12+E, D3+B12+E).

[0160] Preferred examples of compositions according to the present invention comprising at least one cyclosomal inorganic and at least one cyclosomal vitamin, or alternatively, multiple cyclosomal inorganics, are as follows: Iron + Vitamin C; Iron + Vitamin D; Iron + Vitamin C + Vitamin D; Iron + Vitamin C + Vitamin B12; Iron + Chromium + Vitamin D + Vitamin B12; Calcium + Vitamin D; Magnesium + Calcium + Vitamin D; Zinc + Vitamin C + Vitamin D; Selenium + Vitamin E; Selenium + Iodine + Vitamin E, Chromium + Copper + Zinc.

[0161] In compositions according to the present invention that contain multiple inorganic substances and / or vitamins, each inorganic substance and each vitamin is preferably formulated independently (i.e., as separate and independent cyclosomal formulations for each inorganic substance or vitamin) in accordance with the present invention, together with (b), (c), and optionally (d) and / or (e).

[0162] Advantageously, a composition of the present invention comprising at least one formulation of the inorganic and / or vitamin of the present invention [comprising (a), (b), (c), e.g., (ci) or (c-ii) or (c-iii) according to any one of the embodiments described, and optionally (d) and / or (e)] further comprises at least one or more further active ingredients selected from the group comprising or alternatively: (g)(gi) Vitamin C, (g-ii) Vitamin E, (g-iii) Vitamin B, preferably vitamin B6 and / or B9 and / or B12, (g-iv) Vitamin D, preferably vitamin D3, and mixtures thereof, or at least one vitamin selected from the group of vitamins; preferably (gi) Vitamin C (L-ascorbic acid and / or sodium L-ascorbate); - (h)(hi) magnesium glycinate, (h-ii) selenium methionine, (h-iii) zinc gluconate, and mixtures thereof, preferably at least one organic or inorganic salt selected from the group comprising these or alternatively; - At least one antioxidant preferably selected from the group comprising or alternatively comprising (l)(li)N-acetylcysteine ​​(NAC), (l-ii)coenzyme Q10 (CoQ10), (g-iii)acetyl-L-carnitine (ALC) and mixtures thereof; and - (m)folic acid; - (n) Amino acids, such as phenylalanine, isoleucine, histidine, leucine, lysine, methionine, threonine, tryptophan, valine, arginine, cysteine, and tyrosine.

[0163] Preferably, each of the vitamins (e.g., vitamins B12, C, D3 and / or E) is present in the composition of the present invention in the form of a formulation according to the present invention, the formulation comprising (a) at least one of the vitamins, (b) phospholipids (preferably lecithin), (c) a first agent [preferably (ci) carrageenan or (c-ii) acacia gum], and optionally (d) sucrose ester and / or (e) starch.

[0164] Advantageously, if present, each individual vitamin (g) and / or salt (h) is present in the composition of the present invention in an amount equal to 100% of the Recommended Dietary Allowance (RDA).

[0165] Advantageously, if present, each single antioxidant (I) is present in the composition of the present invention in an amount equal to 100 mg / day.

[0166] In a preferred embodiment of the present invention, the composition of the present invention is in solid form, for example, as a solid, or in an orally soluble solid (or in an orally dispersible solid that dissolves in the oral cavity), or in a water-dispersible solid.

[0167] Alternatively, the composition of the present invention may be in liquid form, for example, in the form of a solution, dispersion or suspension of a solid in a liquid, or in semi-solid form, for example, in the form of a cream, gel or soft gel.

[0168] In a preferred embodiment of the present invention, the composition of the present invention is formulated for oral administration (simply put, per os).

[0169] Advantageously, the compositions of the present invention may be in as-is or orally soluble or water-dispersible solid form for oral administration, such as powder, granules, microgranules, flakes, tablets, or capsules.

[0170] When the composition of the present invention is in tablet form, the tablet may have a weight within the range of 200 mg to 2000 mg, and may be, for example, a hard tablet of 800 mg to 1000 mg.

[0171] The tablet may be coated or film-treated with one or more coating layers or films having the ability to pass through the gastric barrier. The coating may include beeswax or a sugar-based solution.

[0172] When the composition of the present invention is in capsule form, the capsule may be a hard gelatin or soft gelatin or soft gel capsule; preferably the gelatin capsule may have a weight within the range of 100 mg to 1500 mg, more preferably about 800 mg.

[0173] The composition of the present invention containing the solid form preparation of at least one inorganic substance of the present invention according to any one of the embodiments described in the present invention may be a pharmaceutical composition, a medical device composition, a dietary supplement, a food or a novel food or functional food composition.

[0174] In the context of the present invention, the expression "medical device" is used in the meaning according to Italian Decree n° 46 of 24 February 1997 or the new Medical Device Regulation (EU) 2017 / 745 (MDR).

[0175] The object of the present invention is the use as a medicine, both as a primary medicine and as a medicine (adjuvant) to support other medicines, of the solid form preparation of at least one inorganic substance of the present invention according to any one of the embodiments described (a), (b), (c), for example (c-i) or (c-ii) or (c-iii) and, optionally, (d) and / or (e) and / or alternatively consisting of, and the composition of the present invention containing the solid form preparation of at least one inorganic substance and / or at least one vitamin of the present invention according to any one of the embodiments described.

[0176] Furthermore, the formation of the object of the present invention is a composition and preparation of at least one inorganic substance (e.g., magnesium, calcium, iron, zinc, iodine, selenium, copper, or chromium) and / or at least one vitamin [e.g., vitamin A, group B (e.g., B12), C, D (e.g., D3), and / or E] of the present invention, according to any one of the embodiments described, for use in methods of preventive and / or therapeutic and / or adjuvant treatment of deficiencies or lack thereof of the at least one inorganic substance and / or the at least one vitamin in a subject requiring such treatment, or for use in supplementation of the at least one inorganic substance and / or the at least one vitamin.

[0177] Diseases, symptoms, and / or disorders relating to deficiencies or deficits of inorganic substances (e.g., magnesium, calcium, iron, zinc, iodine, selenium, copper, or chromium) and / or at least one vitamin [e.g., vitamins A, group B (e.g., B12), C, D (e.g., D3), and / or E], which can be treated in a prophylactic and / or therapeutic and / or adjuvant manner by administering the composition or formulation of at least one inorganic substance and / or at least one vitamin of the present invention to the subject, may be selected from the following in the subject requiring treatment: - Changes in carbohydrate metabolism and / or diseases and disorders related thereto, such as diabetes, preferably type 2 diabetes, hyperglycemia, insulin resistance, high carbohydrate absorption, disregard for blood glucose levels and / or metabolic syndrome; - Changes in and / or impairments in muscle energy metabolism, such as a decrease in muscle mass, a decrease in muscle strength, a decrease in physical resistance to muscle tension, and poor absorption of amino acids; - Dyslipidemia or changes in lipid metabolism and / or related diseases and disorders, such as high cholesterol, high triglyceride levels, and obesity or overweight; - Cognitive impairment or changes in the cognitive-affective domain; - Cardiac metabolic disorders: - Changes in the immune system; - Stress, fatigue, chronic fatigue, and / or asthenia related to anxiety and depression.

[0178] Compositions and formulations comprising at least one inorganic substance and / or at least one vitamin of the present invention may be administered to any category of subjects, including children, the elderly, sports-loving men / women, pregnant women, preferably post-pregnancy women, and women both before, during, and after their menstrual cycle.

[0179] In addition, the formation of the object of the present invention is the composition and formulation of at least one inorganic substance (e.g., magnesium, calcium, iron, zinc, iodine, selenium, copper, or chromium) and / or at least one vitamin [e.g., vitamin A, group B (e.g., B12), C, D (e.g., D3), and / or E] of the present invention, according to any one of the embodiments described, for use in methods of prophylactic and / or therapeutic and / or adjuvant treatment (e.g., for use in subjects requiring or healthy subjects) to increase muscle energy metabolism (for both therapeutic and non-therapeutic purposes) and, therefore, to increase muscle mass, increase muscle strength, increase physical resistance to muscle tension, and reduce the time to energy recovery after physical exertion; and / or for use in methods of prophylactic and / or therapeutic and / or adjuvant treatment (for both therapeutic and non-therapeutic purposes) to increase the physical or mental performance of subjects, preferably healthy subjects, e.g., subjects performing physical activity and / or research.

[0180] Advantageously, a composition or formulation based on iron [preferably iron(III) pyrophosphate] according to any one of the embodiments described in the present invention may be used to prevent, reduce or treat iron deficiency, anemia, and increase hemoglobin and ferritin levels in individuals who require it, such as women before, during, and after pregnancy, during lactation, or during their menstrual cycle, or in the elderly or in sports-loving men / women. The formulation is referred to as “cyclosome or cyclosomal iron”.

[0181] Advantageously, compositions or formulations based on magnesium (preferably magnesium oxide or magnesium hydroxide) according to any one of the embodiments described in the present invention can be used to prevent, reduce, or treat musculoskeletal, cardiac metabolism, emotional domain (e.g., stress), and immune system disorders (e.g., physical and mental fatigue) in the target area where needed. The formulations are referred to as “magnesium cyclosomes or cyclosomes.”

[0182] Advantageously, a composition or formulation based on calcium (preferably tricalcium phosphate) according to any one of the embodiments described in the present invention may be used to prevent, reduce, or treat disorders relating to pregnancy (i.e., fetal development), mood, bone, muscle, and pressure in the subjects in need. The formulation is referred to as “cyclosome or cyclosomal calcium.”

[0183] Advantageously, a composition or formulation based on zinc (preferably zinc oxide) according to any one of the embodiments described in the present invention may be used to prevent, reduce, or treat disorders relating to growth and development, metabolism (intermediate metabolism, DNA metabolism), the immune system, vision, and cognitive behavior in the target population. The formulation is referred to as “cyclosome or cyclosomal zinc.”

[0184] Advantageously, a composition or formulation based on selenium [preferably sodium selenite (IV)] according to any one of the embodiments described in the present invention may be used to prevent, reduce, or treat pregnancy (i.e., fetal development), metabolic disorders, and immune system disorders in subjects requiring such treatment. The formulation is referred to as "cyclosome or cyclosomal selenium."

[0185] Advantageously, a composition or formulation based on iodine [preferably sodium iodate (V)] according to any one of the embodiments described in the present invention may be used to prevent, reduce, or treat, in the target population, disorders related to pregnancy (i.e., fetal development), mood, pressure, metabolism, cardiovascular disorders, and energy deficiency disorders. The formulation shall be referred to as “cyclosome or cyclosomal iodine.”

[0186] Advantageously, a chromium-based composition or formulation according to any one of the embodiments described in the present invention [preferably chromium(III) picolinate] can be used to prevent, reduce, or treat changes in carbohydrate, lipid, and energy metabolism in the target area where desired. The formulation is referred to as “cyclosome or cyclosomal chromium”.

[0187] For chromium deficiency (for both therapeutic and non-therapeutic or cosmetic purposes), and for treating diseases or symptoms related to said deficiency, a daily oral dose of a therapeutically effective amount of the chromium preparation (cyclosomal chromium) or its composition known to those skilled in the art is recommended, which is, for example, 10 μg to 500 μg (e.g., 50 μg, 100 μg, 150 μg, 200 μg, 250 μg, 300 μg, 350 μg, 400 μg, or 450 μg), preferably 50 μg to 250 μg, more preferably 150 μg to 250 μg, for example, an amount of elemental chromium [chromium(III) or chromium metal] contained in the range of about 200 to 250 μg.

[0188] Advantageously, a composition or formulation based on copper (preferably copper gluconate) according to any one of the embodiments described in the present invention may be used to prevent, reduce, or treat physical fatigue, anemia and decreased white blood cell count, osteoporosis, nerve damage, tingling and loss of sensitivity in the feet and hands, muscle weakness, connective tissue diseases (a group of autoimmune diseases characterized by inflammation of connective tissue), or disorders related to oxidative stress (oxidative stress is a mechanism involved in the pathogenesis of many neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease, and multiple sclerosis). The formulation shall be referred to as “cyclosome or cyclosomal copper”.

[0189] For copper deficiency (for both therapeutic and non-therapeutic or cosmetic purposes), and for treating diseases or symptoms related to said deficiency, a daily oral dose of the copper preparation (cyclosomal copper) or composition of the present invention in a therapeutically effective amount known to those skilled in the art is recommended, which is, for example, 0.1 mg to 10 mg (e.g., 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg, 3 mg, 3.5 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, or 9 mg), preferably 1 mg to 4 mg, for example, in the range of about 2 mg of copper element [copper(II) or copper metal].

[0190] Advantageously, compositions or formulations containing vitamin B12 (according to any one of the embodiments described herein) are used to prevent, reduce, or treat vitamin B12 deficiency. Diseases or symptoms associated with vitamin B12 deficiency include, for example, weakness and physical fatigue, shortness of breath, tingling in the extremities, memory loss or cognitive impairment, difficulty walking due to balance problems, hallucinations, anemia, and pallor. The formulations are referred to as “cyclosomes or cyclosomal vitamin B12.”

[0191] Advantageously, a composition or formulation comprising vitamin C (according to any one of the embodiments described in the present invention) is used to prevent, reduce or treat vitamin C deficiency. Diseases or symptoms related to vitamin C deficiency are, for example, fatigue, depression, connective tissue disorders (such as collagen, gingivitis, petechiae, skin rash, internal bleeding and delayed wound healing), inflammation or the fragility of nails, skin and hair after medical treatment, as well as changes in bone growth in children, changes in the immune system, oxidative stress, and decreased iron absorption. Said formulation is referred to as "cyclosome or cyclosome vitamin C".

[0192] Advantageously, a composition or formulation comprising vitamin D (according to any one of the embodiments described in the present invention) is used to prevent, reduce or treat vitamin D deficiency. Diseases or symptoms related to vitamin D deficiency are, for example, rickets in children and osteomalacia in adults (due to changes in bone mineralization), osteoporosis, as well as hyperparathyroidism, changes in the immune system. Said formulation is referred to as "cyclosome or cyclosome vitamin D".

[0193] Advantageously, a composition or formulation comprising vitamin E (according to any one of the embodiments described in the present invention) is used to prevent, reduce or treat vitamin E deficiency. Diseases or symptoms related to vitamin E deficiency (especially in pediatric subjects) are, for example, lack of reflex and coordination, difficulty walking, muscle weakness, anemia in the form of red blood cells being destroyed (hemolytic anemia), hair loss, skin diseases, weak immune system, fatigue, difficulty concentrating, visual problems, as well as loss of muscle tension, oxidative stress. Said formulation is referred to as "cyclosome or cyclosome vitamin E".

[0194] For vitamin C deficiency (for both therapeutic and non-therapeutic or cosmetic purposes), and for treating diseases or symptoms related to said deficiency, a daily oral dose of the vitamin C preparation (cyclosomal vitamin C) or composition of the present invention in a therapeutically effective amount known to those skilled in the art is recommended, which is, for example, 100 mg to 1500 mg (e.g., 200 mg, 400 mg, 600 mg, 800 mg, 1000 mg, or 1200 mg), preferably 500 mg to 1000 mg, for example, the amount of pure vitamin C (or as-is vitamin C) contained in a range of about 1000 mg (currently, the maximum permissible daily dose is 1000 mg).

[0195] For vitamin B12 deficiency (for both therapeutic and non-therapeutic or cosmetic purposes), and for treating diseases or symptoms related to said deficiency, a daily oral dose of a therapeutically effective amount of the vitamin B12 preparation (cyclosomal vitamin B12) or composition of the present invention, known to those skilled in the art, is recommended, which is, for example, 0.5 μg to 1000 μg (e.g., 1 μg, 1.5 μg, 2 μg, 2.5 μg, 5 μg, 10 μg, 50 μg, 100 μg, 200 μg, 300 μg, 400 μg, 500 μg, 600 μg, 700 μg, 800 μg, or 900 μg), preferably 1 μg to 5 μg, for example, in the range of about 2 to 2.5 μg of pure vitamin B12 (or unprocessed vitamin B12) (currently, the maximum permissible daily dose is 1000 μg).

[0196] For vitamin E deficiency (for both therapeutic and non-therapeutic or cosmetic purposes), and for treating diseases or symptoms related to said deficiency, a daily oral dose of the vitamin E preparation (cyclosomal vitamin E) or its composition known to those skilled in the art is recommended, which is, for example, 0.5 mg to 80 mg (e.g., 1 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, or 70 mg), preferably 5 mg to 15 mg, for example, the amount of pure vitamin E (or unprocessed vitamin E) contained in a range of about 10 mg (currently, the maximum permissible daily dose is 60 mg).

[0197] For vitamin D3 deficiency (for both therapeutic and non-therapeutic or cosmetic purposes), and for treating diseases or symptoms related to said deficiency, a daily oral dose of a therapeutically effective amount of the vitamin D3 preparation (cyclosomal vitamin D3) or composition of the present invention, known to those skilled in the art, is recommended, which is, for example, 1 μg to 100 μg (e.g., 5 μg, 10 μg, 15 μg, 20 μg, 25 μg, 30 μg, 50 μg, 100 μg, 150 μg, 200 μg, 250 μg, 300 μg, 350 μg, 400 μg, or 450 μg), preferably 10 μg to 100 μg, for example, in the range of about 25 to 50 μg of pure vitamin D3 (or as-is vitamin D3).

[0198] Ingestion of a composition or formulation of the present invention comprising the at least one inorganic substance and / or the at least one vitamin results in a significant change (efficacy) in the subject after ingestion. In particular, continuous ingestion of the composition or formulation of the present invention in the above doses significantly increases the relative levels of inorganic substances and / or vitamins in both the blood and organs of the treated individual (symptomatic or healthy individual), for example, in the liver, which is an organ that stores excess iron in the form of Fe(III) and transports the iron portion through the blood to tissues that need it (iron transport).

[0199] Furthermore, continuous intake of the compositions or formulations of the present invention in the described doses is without side effects and can be taken by all types of subjects, including pregnant women, both on a full or empty stomach.

[0200] Finally, the compositions or formulations of the present invention, particularly in solid form, are easy to ingest and do not have the undesirable problem of taste.

[0201] Additionally, the compositions or formulations of the present invention exhibit chemical / physical and functional stability over time.

[0202] In the context of the present invention, the term "subject" is used to refer to a human or animal subject, preferably a mammal (e.g., a pet, e.g., a dog, cat, horse, sheep, or cow). Preferably, the formulations and compositions of the present invention are for use in methods of treatment of human subjects.

[0203] The compositions of the present invention or the preparations of at least one inorganic substance and / or at least one vitamin of the present invention (cyclosomes or cyclosomal inorganic substances and / or vitamins) may be administered over a period of time ranging from 3 to 60 or 90 days.

[0204] The object of the present invention is a method for the prophylactic and / or therapeutic and / or adjuvant treatment of deficiencies or deficits of inorganic substances (e.g., magnesium, calcium, iron, zinc, iodine, selenium, copper and / or chromium) and / or at least one vitamin [e.g., vitamin A, group B (e.g., B12), C, D (e.g., D3) and / or E] or diseases, symptoms and / or disorders related to such deficiencies, the method providing an effective amount (therapeutic effective amount) of the composition of the present invention or a formulation of at least one inorganic substance and / or at least one vitamin of the present invention to the subject in need.

[0205] The term "therapeutic dose" is used to refer to the amount of a formulation or compound that elicits a biological or medical response in a tissue, system, or subject, as determined and defined by those skilled in the art.

[0206] Furthermore, the achievement of the object of the present invention is the use (non-therapeutic) of at least one inorganic substance (e.g., magnesium, calcium, iron, zinc, iodine, selenium, copper and / or chromium) and / or at least one vitamin [e.g., vitamin A, group B (e.g., B12), C, D (e.g., D3) and / or E] compositions and formulations of the present invention, according to any one of the described embodiments, for the purpose of increasing muscle energy metabolism in healthy subjects, and therefore increasing muscle mass, increasing muscle strength, increasing physical resistance to muscle tension and reducing the time to energy recovery after physical exertion; and / or increasing the physical or mental performance of healthy subjects; and / or supporting or enhancing immune defense in healthy subjects.

[0207] The objective of the present invention is the preparation of a solid-state formulation (cyclosome or cyclosomal inorganic) of at least one inorganic substance (e.g., magnesium, calcium, iron, zinc, iodine, selenium, copper, or chromium) and / or a method (briefly, the method of the present invention) for the preparation of a solid-state formulation (cyclosome or cyclosomal vitamin) of at least one vitamin [e.g., vitamin A, group B (e.g., B12), C, D (e.g., D3), and / or E].

[0208] In a first embodiment of the present invention, the method of the present invention (briefly, the first method of the present invention) is described in page 7, line 1 to page 8, line 20 of the International Patent Publication No. 2014 / 009806(A1) (incorporated by reference in this application).

[0209] In a second embodiment of the present invention, the method of the present invention (abbreviatedly, the second method of the present invention) is described in page 8, line 22 to page 10, line 21 of the International Patent Publication No. 2014 / 009806(A1) (incorporated by reference in this application).

[0210] According to the present invention, the first method and the second method of the present invention are applied as described in Patent Document International Publication No. 2014 / 009806(A1), taking into consideration that (ci), (c-ii), and (c-iii) may be used as a substitution or addition to (d) and in amounts suitable for obtaining the formulation of the present invention, and that (b) the term lecithin should be read as representative of the phospholipid class [where (ci) is carrageenan, (c-ii) is acacia gum, (c-iii) is fucoidan, and (d) is a sucrose ester].

[0211] Therefore, in the context of the present invention, the term “cyclosome or cyclosomal inorganic” refers to a formulation of at least one inorganic substance that can be obtained by processing an inorganic salt or complex or oxide (a) together with a phospholipid or phosphatidylcholine or lecithin (b), a first agent (c), such as carrageenan (ci) or acacia gum (c-ii) or fucoidan (c-iii), and optionally a sucrose ester (d) and / or starch (e), according to the first or second method described in International Publication No. 2014 / 009806(A1), or as described in the present invention.

[0212] In the context of the present invention, the term “cyclosome or cyclosomal vitamin” refers to a preparation of at least one vitamin that can be obtained by processing vitamin (a) together with phospholipids or phosphatidylcholine or lecithin (b), a first agent (c) [e.g., carrageenan (ci) or acacia gum (c-ii)], and optionally sucrose ester (d) and / or starch (e), according to the first or second method described in International Publication No. 2014 / 009806(A1) or as described herein.

[0213] The method according to the present invention is carried out by mixing components (a), (b), (c), and optionally (d) and / or (e) in weight percentages as defined in the context of the present invention, to obtain a formulation according to the present invention comprising at least one inorganic substance and / or at least one vitamin, preferably a formulation according to the present invention comprising an inorganic substance or a vitamin.

[0214] Preferably, the method of the present invention for preparing a formulation according to the present invention, comprising inorganic substances and / or vitamins (preferably inorganic substances only or vitamins only), as described in embodiments such as those in International Publication No. 2014 / 009806(A1), comprises the following steps: - Step 1: Prepare inorganic substances (salts, oxides, or complexes of inorganic substances) or vitamins (preferably either inorganic substances only or vitamins only) in the form of powder or granules; Step 2: Mix the inorganic substance or vitamin with phospholipid (b), preferably lecithin (e.g., sunflower lecithin) to obtain the mixture of Step 2; advantageously, the lecithin is not hydrolyzed or enzymatically hydrolyzed lecithin; - Step 3: Mix the mixture from Step 2 with a polysaccharide (c) [e.g., (ci) carrageenan or acacia gum] and, optionally, a sucrose ester (d) to obtain the mixture from Step 3; - Step 4 (optional): Mix the mixture from Step 3 with a gelatinized or pregelatinized starch (e) of plant origin, preferably pregelatinized, such as pregelatinized rice starch; - Step 5 (as appropriate after Step 3 and / or after Step 4): Sieve using at least one sieve having a size (or nominal sieve mesh) within the range of 150 μm to 1400 μm (e.g., 180 μm, 212 μm, 250 μm, 300 μm, 355 μm, 425 μm, 500 μm, 600 μm, 710 μm, 850 μm, 1000 μm, or 1180 μm), preferably within the range of 600 μm to 850 μm, for example, 710 μm (25 US mesh).

[0215] Advantageously, the mixing steps 2, 3 and / or 4 are carried out over a period of time including 10 to 120 minutes, preferably 15 to 60 minutes, for example, about 30 minutes, at room temperature (15°C to 30°C, preferably about 25°C).

[0216] Advantageously, the mixing steps 2, 3 and / or 4 are carried out in the absence of a solvent (dry mixing).

[0217] In embodiments in which the sucrose ester (d) is present in the formulation of the present invention, step 3 of the method of the present invention may provide mixing the mixture of step 2 first with the polysaccharide and then with the sucrose ester, or alternatively, mixing the mixture of step 2 first with the sucrose ester and then with the polysaccharide, or alternatively and preferably, mixing the mixture of step 2 simultaneously with the sucrose ester and the polysaccharide.

[0218] The preparation method for the formulation (based on inorganic substances or vitamins) of the present invention may also provide that steps 2 and 3 are performed simultaneously, i.e., the inorganic substance or vitamin is mixed with phospholipids, polysaccharides, and optionally sucrose esters in a single step (steps 2+3).

[0219] According to an example of the present invention for the preparation of a formulation containing inorganic substances or vitamins, the method does not include a spray-drying step.

[0220] The objective of the present invention is to provide a method for further preparing a composition comprising at least one formulation containing an inorganic substance according to the present invention (e.g., magnesium, calcium, iron, zinc, iodine, selenium, copper, or chromium) (cyclosomal inorganic substance) and / or at least one formulation containing a vitamin according to the present invention (cyclosomal vitamin) (e.g., vitamin A, vitamin group B (e.g., B12), C, D (e.g., D3), and / or E).

[0221] The composition method of the present invention includes the following steps: - Step (i) [briefly, step (i)] of preparing (or producing) at least one solid-state formulation (cyclosomal inorganic) of an inorganic substance (e.g., magnesium, calcium, iron, zinc, iodine, selenium, copper, or chromium) according to the present invention, and / or preparing (or producing) at least one solid-state formulation (cyclosomal vitamin) of a vitamin [e.g., vitamin A, group B (e.g., B12), C, D (e.g., D3), and / or E] according to the present invention, to obtain at least one formulation based on an inorganic substance and / or at least one formulation based on a vitamin; - A suitable step (ii) to obtain the mixture of step (ii) by mixing the at least one (or two or three) formulations containing the inorganic substance according to the present invention [obtained from step (i)] with the at least one (or two or three) formulations containing the vitamin according to the present invention [obtained from step (i)], or alternatively, mixing at least two (or three or four) formulations each containing the inorganic substance according to the present invention, or alternatively, mixing at least two (or three or four) formulations each containing the vitamin according to the present invention; - Step (iii) of mixing the at least one formulation of step (i) or the mixture of step (ii) with at least one additive and / or excipient to obtain a composition according to the present invention comprising at least one inorganic substance and / or at least one vitamin (each in cyclosomal form) and at least one additive / excipient; and - A suitable sieving step (iv) after step (ii) and / or after step (iii), preferably using at least one sieve having a size (or nominal sieve mesh) within the range of 150 μm to 1400 μm (e.g., 180 μm, 212 μm, 250 μm, 300 μm, 355 μm, 425 μm, 500 μm, 600 μm, 710 μm, 850 μm, 1000 μm, or 1180 μm), preferably 600 μm to 850 μm, for example 710 μm (25 US mesh).

[0222] Advantageously, the mixing step (ii) and / or step (iii) are carried out at room temperature (15°C to 30°C, preferably about 25°C) over a period of time including 10 to 120 minutes, preferably 15 to 60 minutes, for example, about 30 minutes.

[0223] The mixing step (ii) may provide mixing at least one inorganic substance and at least one vitamin, or mixing several inorganic substances (e.g., 2, 3, 4, or 5 inorganic substances) without vitamins, or mixing several vitamins (e.g., 2, 3, 4, or 5 vitamins) without inorganic substances. Thus, compositions that can be obtained according to the composition method of the present invention may include inorganic substances and vitamins, or inorganic substances and several vitamins (e.g., 2, 3, 4, or 5 vitamins), or several inorganic substances (e.g., 2, 3, 4, or 5 inorganic substances) and vitamins, or several inorganic substances (e.g., 2, 3, 4, or 5 inorganic substances) and several vitamins (e.g., 2, 3, 4, or 5 vitamins), or several inorganic substances (e.g., 2, 3, 4, or 5 inorganic substances) without vitamins, or several vitamins (e.g., 2, 3, 4, or 5 vitamins) without inorganic substances.

[0224] Unless otherwise specified, the term "composition or other" containing an ingredient in an amount "within the range of x~y" is used to indicate that the ingredient may be present in the composition or formulation or other in all amounts that are within the range, and includes limits to the range, even if not expressly stated.

[0225] Unless otherwise specified, the content of an ingredient in a composition or formulation refers to the weight percentage of that ingredient based on the total weight of the composition or formulation.

[0226] Unless otherwise specified, the statement that a composition "contains" one or more components means that other components may be present in addition to the one or more specifically indicated, and the statement that a composition "consists of" determined components means that the presence of other components is excluded.

[0227] Examples of embodiments of the present invention (FRa-nr) are reported below:

[0228] FRa-1. A formulation in solid form, - (a) The at least one inorganic substance in the form of a salt or complex of at least one inorganic substance, selected from the group comprising or alternatively comprising (ai) magnesium, (a-ii) calcium, (a-iii) iron, (a-iv) zinc, (av) iodine, (a-vi) selenium, (a-vii) chromium, (a-viii) copper(II) and mixtures thereof; - (b) at least one phospholipid; - (c)(ci) at least one carrageenan, (c-ii) at least one acacia gum, (c-iii) at least one fucoidan and a mixture thereof at least one first agent selected from the group consisting of or alternatively comprising The formulation comprising or otherwise comprising

[0229] FRa-2. The formulation according to FRa-1, wherein (c) at least one first agent comprises (ci) at least one carrageenan; preferably carrageenan E407.

[0230] FRa-3. The formulation according to FRa-1, wherein (c) at least one first agent comprises (c-ii) at least one acacia gum; preferably acacia gum E414; more preferably an acacia gum E414 having an average molecular weight in the range of 250,000 to 400,000, more preferably an average molecular weight of 350,000.

[0231] FRa-4. The formulation according to FRa-1, wherein (c) at least one first agent comprises (c-iii) at least one fucoidan; preferably a fucoidan having an average molecular weight in the range of 20,000 to 30,000.

[0232] FRa-5. The formulation according to any one of Fra-1 to Fra-4, wherein the formulation further comprises (d) at least one sucrose ester or fatty acid carbohydrate ester; preferably sucrose ester E473; more preferably a monoester obtained by esterification of sucrose using one or more fatty acids of plant origin in an amount of 70% to 90% by weight relative to the total weight of the sucrose ester, wherein the fatty acid is preferably selected from stearic acid and / or palmitic acid.

[0233] FRa-6. The formulation according to any one of FRa-1 to FRa-5, wherein the formulation further comprises (e) at least one gelatinized or pregelatinized starch of plant origin; preferably, the (e) at least one starch of plant origin is selected from rice starch and / or corn starch; preferably, the (e) is pregelatinized rice starch.

[0234] FRa-7. The formulation according to any one of Fra-1 to Fra-6, wherein the (b) phospholipid is a phosphoglyceride; preferably phosphatidylcholine or lecithin; more preferably, the (b) phospholipid is lecithin E322 selected from sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof.

[0235] FRa-8.- The above (b) phospholipid, preferably lecithin E322, more preferably solid sunflower lecithin E322, is included in an amount of 0.05% to 15%, preferably 0.1% to 5%, more preferably 0.1% to 2%; - The (c) first agent, selected from the group comprising or alternatively comprising (ci) carrageenan, (c-ii) acacia gum, (c-iii) fucoidan and mixtures thereof, is included in a percentage within the range of 1% to 50%, preferably 1% to 35%, more preferably 1% to 20%; as appropriate, - The (d) sucrose ester, preferably sucrose ester E473, is included in a percentage within the range of 1% to 50%, preferably 1% to 35%, and more preferably 1% to 20%; The aforementioned percentage is a weight percentage relative to the total weight of the preparation. A preparation described in any one of Fra-1 to Fra-7.

[0236] A composition comprising, as appropriate, at least one inorganic solid formulation as described in any one of FRa-9, FRa-1 to FRa-8, and at least one acceptable pharmaceutical or food-grade additive and / or excipient.

[0237] FRa-10. The composition according to FRa-9 for use in methods of prophylactic and / or therapeutic and / or adjuvant treatment of (a) deficiencies of at least one inorganic substance, and diseases, symptoms or disorders relating to or arising from such deficiencies, in subjects requiring such treatment.

[0238] Further examples of embodiments of the present invention (FRb-nr) are reported below:

[0239] FRb-1. A formulation in solid form, - (a) Nutrients that are inorganic substances or vitamins, The inorganic substance is selected from the group comprising or alternatively comprising (ai) magnesium, (a-ii) calcium, (a-iii) iron, (a-iv) zinc, (av) iodine, (a-vi) selenium, (a-vii) chromium, and (a-viii) copper(II), and the inorganic substance is in the form of a salt, complex, or oxide of the inorganic substance; The aforementioned vitamin is selected from the group consisting of or alternatively comprising vitamin B12, vitamin C, vitamin D3, and vitamin E. The aforementioned nutrients; - (b) Phospholipids; - (c)(ci) carrageenan or (c-ii) acacia gum - a first agent selected from these two. The formulation comprising or otherwise comprising

[0240] FRb-2. The formulation comprises (d) at least one sucrose ester or fatty acid carbohydrate ester; Preferably, the sucrose ester E473; more preferably, the sucrose ester (E473) further comprises a monoester obtained by esterification of sucrose using one or more plant-derived fatty acids in an amount of 70% to 90% by weight relative to the total weight of the sucrose ester, preferably the fatty acid being selected from stearic acid and / or palmitic acid. The formulation described in FRb-1.

[0241] FRb-3. The formulation according to FRb-1 or FRb-2, wherein the (c) first agent comprises the (ci) carrageenan; preferably carrageenan E407.

[0242] FRb-4. The first agent (c) is (c-ii) acacia gum; Preferably acacia gum E414; more preferably acacia gum E414 having an average molecular weight in the range of 250,000 to 400,000. A formulation according to FRb-1 or FRb-2, comprising the above.

[0243] FRb-5. The preparation further comprises (e) gelatinized or pregelatinized starch of plant origin; Preferably, the (e) starch is selected from rice starch or corn starch; preferably, the starch is pregelatinized rice starch. A formulation described in any one of FRb-1 to FRb-4.

[0244] FRb-6. The formulation according to any one of FRb-1 to FRb-5, wherein the (b) phospholipid is phosphatidylcholine or lecithin; preferably, the (b) phospholipid is lecithin (E322) selected from the group comprising or alternatively comprising sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof.

[0245] FRb-7. The weight ratio between the first agent (c) and the phospholipid (b) [(c):(b)], or alternatively, the weight ratio between the total weight of the first agent (c) and the sucrose ester (d), and the weight of the phospholipid [[(c)+(d)]:(b)], is 50:1 to 10:1, preferably 40:1 to 10:1, more preferably 30:1 to 15:1; Preferably, the phospholipid in (b) is lecithin. A formulation described in any one of FRb-1 to FRb-6.

[0246] FRb-8. With a total of 100 parts by weight of the first agent (c) and the sucrose ester (d), the first agent (c) is present in an amount of 1% to 100% by weight, and the sucrose ester (d) is present in an amount of 0% (absent) to 99%; Preferably, the composition is 50% to 95% of (c) the first agent and 5% to 50% of (d) the sucrose ester; More preferably, the mixture consists of 70% to 80% of the (c) first agent and 20% to 30% of the (d) sucrose ester. A formulation described in any one of FRb-2 to FRb-7.

[0247] A solid formulation of at least one of the nutrients described in FRb-9 - FRb-1 to FRb-8; and - At least one acceptable pharmaceutical or food-grade additive and / or excipient A composition containing the following:

[0248] FRb-10. The composition according to FRb-9, wherein the nutrient is an inorganic substance.

[0249] FRb-11. The composition according to FRb-9, wherein the nutrient is a vitamin.

[0250] FRb-12.- At least one solid-form formulation of an inorganic substance described in any one of FRb-1 to FRb-8; - At least one solid-form preparation of a vitamin listed in any one of FRb-1 to FRb-8; and at least one acceptable pharmaceutical or food-grade additive and / or excipient. A composition according to FRb-9, comprising [the specified element].

[0251] FRb-13. A formulation or composition described in any one of FRb-1 to FRb-12, for use as a pharmaceutical.

[0252] FRb-14. Formulations or compositions according to any one of FRb-1 to FRb-13 for use in a subject requiring (a) inorganic and / or vitamin deficiencies, and in methods of prophylactic and / or therapeutic and / or adjuvant treatment of diseases, symptoms or disorders relating to or arising from such deficiencies.

[0253] FRb-15. The disease or symptoms relating to or arising from the deficiency, - Iron deficiency, anemia, poor iron absorption, hemolytic anemia; - Changes in carbohydrate metabolism and related diseases and disorders, diabetes, type 2 diabetes, hyperglycemia, insulin resistance, high carbohydrate absorption, disregard for blood glucose levels, metabolic syndrome; - Changes in and / or impairments in muscle energy metabolism, decrease in muscle mass, decrease in muscle strength, decrease in physical resistance to muscle tension, poor absorption of amino acids; - Dyslipidemia or changes in lipid metabolism and related diseases and disorders, high cholesterol, high triglyceride levels, and obesity or overweight; - Cognitive impairment or changes in the cognitive-affective domain; - Cardiac metabolic disorders: - Changes in the immune system; - Stress related to anxiety and depression, fatigue, chronic fatigue, asthenia, lack of reflexes and coordination; - Rickets or delayed bone growth in children, osteomalacia, osteoporosis, and hyperparathyroidism in adults. - Gingivitis; fragility of nails, hair, and / or skin after inflammation or medical treatment. Selected from the group which includes or alternatively includes, A formulation or composition for use as described in FRB-14.

[0254] FRb-16. Non-therapeutic use of any one of the formulations or compositions described in FRb-1 to FRb-12 for the supplementation of (a) inorganic substances and / or vitamins in healthy subjects.

[0255] FRb-17. Non-therapeutic use as described in FRb-16, wherein the use is selected from increasing muscle mass, increasing muscle strength, increasing physical resistance to muscular exertion, reducing the time to energy recovery after physical exertion, increasing mental efficiency, and strengthening nails and hair.

[0256] A method for preparing a pharmaceutical product as described in any one of FRb-18, FRb-1 to FRb-8, - (1) A step of obtaining the inorganic substance or vitamin (a) of step 1 by providing an inorganic substance or vitamin (a) in the form of a powder or granules, wherein the inorganic substance is in the form of a salt, oxide or complex of the inorganic substance; - (2) In the absence of a solvent, the inorganic substance or vitamin from step 1 is mixed with phospholipid (b), preferably lecithin, to obtain the mixture from step 2; - (3) In the absence of a solvent, the mixture from step 2 is mixed with a polysaccharide (c) selected from (ci) carrageenan or (c-ii) acacia gum, and optionally with a sucrose ester (d) to obtain the mixture from step 3 or the above formulation; - (4) A step of mixing the mixture from step 3 with a plant-derived gelatinized or pregelatinized starch (e), preferably pregelatinized rice starch, to obtain the above-mentioned formulation. The above method, including.

[0257] FRb-19. A method for preparing the composition according to claim 12, - (i) a step of preparing at least one solid formulation of an inorganic substance and at least one solid formulation of a vitamin according to any one of claims 1 to 8, or alternatively, producing at least one solid formulation of an inorganic substance and at least one solid formulation of a vitamin in accordance with FRb-18 to obtain the at least one solid formulation of an inorganic substance and the at least one solid formulation of a vitamin; - (ii) A step of mixing the at least one solid-form preparation of an inorganic substance and the at least one solid-form preparation of a vitamin to obtain the mixture of step (ii), - (iii) A step of mixing the mixture from step (ii) with at least one additive and / or excipient to obtain the composition. The above method, including. [Examples]

[0258] Examples of the formulation according to the present invention

[0259] [Example 1] A solid formulation (approximately 100 mg) based on iron according to the present invention, comprising approximately 40 mg to 50 mg of iron pyrophosphate [Fe(3+) approximately 10 to 12 mg], 0.3 mg to 2 mg of lecithin (e.g., unhydrolyzed sunflower lecithin), 15 mg to 20 mg of carrageenan or acacia gum, and 30 mg to 45 mg of pregelatinized rice starch (sucrose esters are absent).

[0260] [Example 2] A solid formulation (approximately 100 mg) based on iron according to the present invention, comprising approximately 40 mg to 50 mg of iron pyrophosphate [Fe(3+) approximately 10 to 12 mg], 0.3 mg to 2 mg of lecithin (e.g., unhydrolyzed sunflower lecithin), 2.5 mg to 5 mg of carrageenan or acacia gum, 10 mg to 20 mg of sucrose ester, and 30 mg to 45 mg of pregelatinized rice starch (polysaccharide:sucrose ester weight ratio approximately 25:75).

[0261] [Example 3] A solid formulation (approximately 100 mg) based on iron according to the present invention, comprising approximately 40 mg to 50 mg of iron pyrophosphate [Fe(3+) approximately 10 to 12 mg], 0.3 mg to 2 mg of lecithin (e.g., unhydrolyzed sunflower lecithin), 10 mg to 20 mg of carrageenan or acacia gum, 2.5 mg to 5 mg of sucrose ester, and 30 mg to 45 mg of pregelatinized rice starch (polysaccharide:sucrose ester weight ratio approximately 75:25).

[0262] [Example 4] A magnesium-based solid formulation (approximately 100 mg) according to the present invention, comprising approximately 45 mg to 60 mg of magnesium oxide [approximately 32 to 38 mg of Mg(2+)], 0.5 mg to 2 mg of lecithin (e.g., unhydrolyzed sunflower lecithin), 15 mg to 20 mg of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (polysaccharide:sucrose ester weight ratio approximately 75:25 or 50:50 or 25:75), and 20 mg to 35 mg of pregelatinized rice starch.

[0263] [Example 5] A zinc-based solid formulation (approximately 100 mg) according to the present invention, comprising approximately 45 mg to 60 mg of zinc oxide (approximately 40 to 50 mg of elemental zinc), 0.5 mg to 2 mg of lecithin (e.g., unhydrolyzed sunflower lecithin), 15 mg to 20 mg of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (polysaccharide:sucrose ester weight ratio is approximately 75:25 or 50:50 or 25:75), and 20 mg to 35 mg of pregelatinized rice starch.

[0264] [Example 6] A solid formulation (approximately 100 mg) according to the present invention, based on iodine, comprising approximately 1 mg to 3 mg of sodium iodate (approximately 0.5 to 1.5 mg of elemental iodine), 0.5 mg to 2 mg of lecithin (e.g., unhydrolyzed sunflower lecithin), 15 mg to 20 mg of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (polysaccharide:sucrose ester weight ratio is approximately 75:25 or 50:50 or 25:75), and 75 mg to 85 mg of pregelatinized rice starch.

[0265] [Example 7] A calcium-based solid formulation (approximately 100 mg) according to the present invention, comprising approximately 90 mg to 99 mg of tricalcium phosphate [approximately 31 to 37 mg of Ca(2+)], 0.5 mg to 2 mg of lecithin (e.g., unhydrolyzed sunflower lecithin), 1 mg to 4 mg of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (polysaccharide:sucrose ester weight ratio approximately 75:25 or 50:50 or 25:75), and starch present in the absence or at a low percentage (e.g., 0.5 to 5% w / w).

[0266] [Example 8] A selenium-based solid formulation according to the present invention (approximately 100 mg) comprising approximately 1 mg to 4 mg of sodium selenite (approximately 0.5 to 2 mg of elemental selenium, e.g., approximately 1 mg), 0.5 mg to 2 mg of lecithin (e.g., unhydrolyzed sunflower lecithin), 15 mg to 20 mg of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (weight ratio of polysaccharide:sucrose ester approximately 75:25 or 50:50 or 25:75), and 75 mg to 85 mg of pregelatinized rice starch.

[0267] [Example 9] A solid formulation (approximately 100 mg) according to the present invention, comprising approximately 70 mg to 80 mg of chromium picolinate [Cr(3+) approximately 8 to 10 mg], 0.3 mg to 1 mg of lecithin (e.g., unhydrolyzed sunflower lecithin), 15 mg to 20 mg of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (polysaccharide:sucrose ester weight ratio approximately 75:25 or 50:50 or 25:75), and 5 mg to 15 mg of pregelatinized rice starch.

[0268] [Example 10] A solid formulation according to the present invention (approximately 30-40 mg) based on approximately 13.5 mg to 18 mg of copper gluconate [Cu(2+) approximately 2 to 2.5 mg], 0.17 mg to 0.23 mg of lecithin (e.g., unhydrolyzed sunflower lecithin), 5 mg to 7 mg of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (weight ratio of polysaccharide:sucrose ester approximately 75:25 or 50:50 or 25:75), and 11 mg to 15 mg of pregelatinized rice starch.

[0269] [Example 11] (A) A solid formulation according to the present invention based on iron (approximately 250-300 mg, for example, approximately 270 mg) comprising approximately 110 mg-135 mg of iron pyrophosphate [Fe(3+) 27-33 mg, e.g., approximately 30 mg], 1.5 mg-1.8 mg (e.g., approximately 1.6 mg) of lecithin (e.g., unhydrolyzed sunflower lecithin), 40 mg-50 mg (e.g., approximately 45 mg) of polysaccharide (carrageenan or acacia gum) and sucrose ester (weight ratio of polysaccharide:sucrose ester approximately 75:25 or 50:50 or 25:75), and 95 mg-115 mg (e.g., approximately 100 mg) of pregelatinized rice starch; and (B) A solid formulation according to the present invention based on vitamin D3 (10-15 mg, e.g., about 12 mg) comprising approximately 8.5 mg to 12.5 mg of commercial vitamin D3 [20 μg to 30 μg (approximately 0.20%) of pure vitamin D3 intake], 0.7 mg to 0.10 mg of lecithin (e.g., unhydrolyzed sunflower lecithin), 1.8 mg to 2 mg of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (polysaccharide:sucrose ester weight ratio approximately 75:25 or 50:50 or 25:75), and 0.05 mg to 0.25 mg of pregelatinized rice starch. A composition according to the present invention, comprising:

[0270] [Example 12] (A) A zinc-based solid formulation according to the present invention consisting of approximately 15 mg to 22 mg of zinc oxide [Zn(2+) approximately 12 to 18 mg, e.g., 15 mg], 0.3 mg to 0.4 mg (e.g., approximately 0.35 mg) of lecithin (e.g., unhydrolyzed sunflower lecithin), 5 mg to 8 mg (e.g., approximately 6 mg) of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (polysaccharide:sucrose ester weight ratio approximately 75:25 or 50:50 or 25:75), and 8.5 mg to 12 mg (e.g., approximately 10 mg) of pregelatinized rice starch (30 to 40 mg, e.g., approximately 35 mg); and (B) A solid formulation according to the present invention based on vitamin D3 (20-30 mg, e.g., about 24 mg) consisting of approximately 17 mg-25 mg of commercial vitamin D3 [40 μg-60 μg (e.g., about 50 μg) of pure vitamin D3 intake], 0.14 mg-0.20 mg (e.g., about 0.17 mg) of lecithin (e.g., unhydrolyzed sunflower lecithin), 2.5 mg-4 mg (e.g., about 3 mg) of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (polysaccharide:sucrose ester weight ratio of about 75:25 or 50:50 or 25:75), and 0.1 mg-0.5 mg of pregelatinized rice starch; and (C) A solid formulation according to the present invention based on vitamin C, comprising 0.5g to 2g (e.g., about 1g) of vitamin C, 0.01g to 0.03g of lecithin (e.g., unhydrolyzed sunflower lecithin), 0.15g to 0.3g of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (polysaccharide:sucrose ester weight ratio is about 75:25 or 50:50 or 25:75), and 0.3g to 0.6g of pregelatinized rice starch (1 to 3g, e.g., about 2g). A composition according to the present invention, comprising:

[0271] [Example 13] (A) A solid formulation according to the present invention based on chromium (approximately 2.2 mg) comprising approximately 1 mg to 2 mg (e.g., approximately 1.65 mg) of chromium picolinate [0.12 to 0.24 mg of Cr(3+); equivalent to, for example, 0.20 mg], 0.01 mg to 0.02 mg (e.g., 0.013 mg) of lecithin (e.g., unhydrolyzed sunflower lecithin), 0.3 mg to 0.45 mg (e.g., approximately 0.38 mg) of carrageenan or acacia gum and sucrose ester (polysaccharide:sucrose ester weight ratio approximately 75:25 or 50:50 or 25:75), and 0.1 mg to 0.25 mg (e.g., approximately 0.18 mg) of pregelatinized rice starch; and (B) A solid formulation (5 μg) according to the present invention based on vitamin B12, comprising 2 μg to 3 μg (e.g., about 2.5 μg) of vitamin B12, 0.025 μg to 0.075 μg of lecithin (e.g., unhydrolyzed sunflower lecithin), 0.70 μg to 1 μg of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (weight ratio of polysaccharide:sucrose ester is about 75:25 or 50:50 or 25:75), and 1.5 μg to 2 μg of pregelatinized rice starch. A composition according to the present invention, comprising:

[0272] [Example 14] A solid formulation (1-3g, e.g., about 2g) according to the present invention based on vitamin C [sucrosomial® vitamin C], comprising 0.5g-2g (e.g., about 1g) of vitamin C, 0.01g-0.03g of lecithin (e.g., unhydrolyzed sunflower lecithin), 0.15g-0.3g of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (polysaccharide:sucrose ester weight ratio is about 75:25 or 50:50 or 25:75), and 0.3g-0.6g of pregelatinized rice starch.

[0273] [Example 15] A solid formulation according to the present invention (2-6 mg, e.g., about 4 mg) based on vitamin B12 [sucrosomial® vitamin B12], comprising 1 mg to 3 mg (e.g., about 2 mg) of vitamin B12, 0.02 g to 0.06 g of lecithin (e.g., unhydrolyzed sunflower lecithin), 0.3 g to 0.6 g of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (polysaccharide:sucrose ester weight ratio is about 75:25 or 50:50 or 25:75), and 0.6 g to 1.2 g of pregelatinized rice starch.

[0274] [Example 16] A solid formulation according to the present invention (10-30 mg, e.g., about 20 mg) based on vitamin E [sucrosomial® vitamin E], comprising 5 mg-15 mg (e.g., about 10 mg) of vitamin E, 0.1 mg-0.3 mg of lecithin (e.g., unhydrolyzed sunflower lecithin), 1.7 g-5 mg of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (polysaccharide:sucrose ester weight ratio is about 75:25 or 50:50 or 25:75), and 3 mg-9 mg of pregelatinized rice starch.

[0275] [Example 17] A solid formulation according to the present invention (20-30 mg, e.g., about 24 mg) based on vitamin D3 [sucrosomial® vitamin D3] comprising approximately 17 mg-25 mg of commercial vitamin D3 [40 μg-60 μg (e.g., about 50 μg) of pure vitamin D3 intake], 0.14 mg-0.20 mg (e.g., about 0.17 mg) of lecithin (e.g., unhydrolyzed sunflower lecithin), 2.5 mg-4 mg (e.g., about 3 mg) of polysaccharide (i.e., carrageenan or acacia gum) and sucrose ester (polysaccharide:sucrose ester weight ratio of about 75:25 or 50:50 or 25:75), and 0.1 mg-0.5 mg of pregelatinized rice starch.

[0276] Experiment Part I. Fe through isolated rat intestines 3+ Research on transmission I.1. Method For transcatheter studies, intestinal mucosa was isolated from male Wistar rats weighing 250-300 g. After the rats were sacrificed, the first 20 cm of the jejunum was immediately removed. The isolated intestine was cut into 1.5 cm strips, the luminal contents were gently removed, and the Ussing-type cells (0.78 cm) were extracted without removing the underlying muscle layer. 2The samples were mounted in the exposed surface. 1 ml of phosphate buffer, pH 6.8, 0.13 M, was added to the apical side, and 3 ml of pH 7.4, 0.13 M isotonic buffer (PB 7.4) was added to the bottom side (acceptor medium). A mixture of 95% O2 and 5% CO2 was bubbling in each compartment to ensure oxygenation and agitation. The Ussing chamber was placed in a 37°C water bath.

[0277] After equilibration for 20 minutes, the culture medium in each donor compartment was replaced with a 1 ml suspension of the previously processed composition to be tested to simulate its passage through the stomach. Gastric digestion was simulated by solubilizing 0.2 g of pepsin in 5 ml of aqueous solution of 0.1 M HCl. 2.5 g of Chelex-100 resin was added thereto, and they were stirred for 30 minutes. The suspension was then transferred to a column, the eluate was collected once, and an additional 5 ml of 0.1 M HCl was added to the column. The final volume of eluate was 8 ml. A predetermined amount of sample was placed in a container with a screw cap, then 10 ml of aqueous solution containing NaCl (140 mM) and KCl (5 mM) was added, the suspension was pH 2 using 5 M HCl, and 0.5 ml of pepsin solution was added thereto. The suspension was then degassed using carboxicarb to create anaerobic conditions similar to those found in the gastrointestinal tract, and the tightly sealed container was placed in a 37°C shaker bath for 60 minutes. As a control, an experiment similar to the one described was performed in a donor compartment while maintaining PBS pH 6.8.

[0278] 1 ml of sample was collected from the receiving compartment at 30-minute intervals for a total of 240 minutes, and replaced with the same volume of fresh culture medium. Permeated Fe 3+ The amount was determined according to the analytical method.

[0279] I.2. Composition under analysis All compositions analyzed contained the same iron concentration (1.34 mg / mL): - Iron(III) pyrophosphate in its raw form (an embodiment not according to the present invention). - Fe-Suc-V 000 : Containing ferric pyrophosphate, sunflower lecithin, sucrose esters and pre-gelatinized starch; not containing carrageenan, gum arabic and fucoidan (embodiment not according to the present invention, reference composition). - Fe-Car25-V 001 (Table 1): Containing ferric pyrophosphate, sunflower lecithin, carrageenan (25% w / w) and sucrose esters (75% w / w), and pre-gelatinized starch (embodiment according to the present invention). - Fe-Car75-V 001 (Table 2): Containing ferric pyrophosphate, sunflower lecithin, carrageenan (75% w / w) and sucrose esters (25% w / w), and pre-gelatinized starch (embodiment according to the present invention). - Fe-GA75-V 001 (Table 3): Containing ferric pyrophosphate, sunflower lecithin, gum arabic (75% w / w) and sucrose esters (25% w / w), and pre-gelatinized starch (embodiment according to the present invention). - Fe-GA95-V 001 : Containing ferric pyrophosphate, sunflower lecithin, gum arabic (95% w / w) and sucrose esters (5% w / w), and pre-gelatinized starch (embodiment according to the present invention). - Fe-GA100-V 001 (Table 5): Containing ferric pyrophosphate, sunflower lecithin, gum arabic (100% w / w), and pre-gelatinized starch (embodiment according to the present invention, sucrose esters are absent). Note: "% w / w" means the weight percentage relative to the total weight of the polysaccharide (carrageenan or gum arabic) and sucrose esters. - Sideral RM V 000 -M: Containing ferric pyrophosphate, sunflower lecithin, sucrose esters and pre-gelatinized starch; not containing carrageenan, gum arabic and fucoidan (embodiment not according to the present invention).

[0280] Each composition under analysis was subjected to at least three tests in two consecutive cycles in different animals.

[0281] I.3. Results Studies on isolated rat intestines have shown that Fe 3+ This allows for the evaluation of the permeability of the intestinal epithelium to Fe. Figure 1 shows Fe passing through isolated rat intestines. 3+ The permeation data is shown. Fe at neutral pH in the intestine. 3+ Since it forms insoluble Fe(OH)3, this type of ion found in the receiving phase across the membrane can only be transported by being encapsulated in a nanosystem that has the ability to be internally transported by intestinal epithelial cells.

[0282] Figure 1, and Fe 3+ Table 8 reports the coefficient of transmission enhancement (enhancement ratio) for Fe 3+ The transparency is Fe-GA100V 001 Fe-Car25V 001 As a result, and to a lesser extent, composition Fe-GA95-V 001 It is observed that this effectively enhances the effect.

[0283] Formulation e-GA100V 001 and Fe-Car25V 001 Fe-Suc-V 000 and Sideral RM V 000 - Not significantly different from M.

[0284] Composition Fe-GA100-V 001 Fe-Car25V 001 and Fe-GA95-V 001 In this case, the cumulative percentage of permeation at the end of the experiment (4h) is also the composition Fe-Suc-V 000 and Sideral RM V 000 -This is equivalent to the cumulative percentage of transmission in the case of M.

[0285] In particular, the carrageenan-based prototype (Fe-Car25-V 001and Fe-Car75V 001 In the case of ), by increasing the percentage of carrageenan, Fe 3+ A reduction in transparency may be observed.

[0286] On the other hand, acacia gum composition (Fe-GA25-V 001 and Fe-Car75V 001 ) behaves in the opposite way compared to carrageenan-based. In fact, by increasing the percentage of acacia gum, Fe 3+ The transparency increases.

[0287] Acacia gum is Fe 3+ These data indicate that it has the ability to form vesicles that are capable of transporting it intact through the intestinal epithelium.

[0288] As reported above, Fe 3+ Since it forms Fe(OH)3, which is substantially insoluble, this type of ion found in the receptor phase can only be transported by being encapsulated within a nanosystem that has the ability to be internally transported by intestinal epithelial cells.

[0289] The compositions under analysis, particularly Sideral RM V 000 -M, Fe-Car25-V 001 and Fe-GA100V 001 This was also tested in Caco-2, because the differences between the various compositions can be amplified to a greater extent using this substrate than in experiments using isolated rat intestine models.

[0290] [Table 1] Table 8

[0291] II. Fe from the composition or comparative composition according to the present invention 3+ Research on the kinetics of emission II.1 Method Fe from the composition under analysis 3+ The apparatus used to determine the kinetics of the release consisted of an external circulating thermostat regulated to a temperature of 37°C, a beaker (inner diameter, 95 mm; height, 100 mm) provided with a thermostat jacket placed on a lift, and a 120 rpm synchronous motor driving a paddle stirrer (length 49 mm, height 15 mm), into which 500 mg of the composition to be tested was introduced.

[0292] At time t=0, a stirrer was immersed in a beaker containing 100 ml of the receiving phase, which had been preheated to 37°C by a thermostat. The described apparatus allows for control of the hydrodynamics around the matrix.

[0293] After centrifugation at 13400 rpm for 5 minutes, Fe 3+ The concentration of the substance was analyzed under UV light, and the receptor phase of the measured volume (1 ml) was collected at 30-minute intervals.

[0294] Unless otherwise specified, the elution method was a simulated gastrointestinal fluid consisting of the following solutions: • Simulated gastric juice (SGF) consisting of 0.04 M HCl, pH 1.2 (40 g of 1 N HCl and 1 g of NaCl per 500 ml), isotonicized with NaCl.

[0295] II.2. Compositions under analysis All compositions analyzed contained the same iron concentration (1.34 mg / mL): - Fe-Suc-V 000 : Contains Fe(III) pyrophosphate, sunflower lecithin, sucrose ester, and pregelatinized rice starch; does not contain carrageenan, acacia gum, or fucoidan (non-inventive embodiments, reference composition). - Fe-Car25-V 001 (Table 1): Contains Fe(III) pyrophosphate, sunflower lecithin, carrageenan (25% w / w), sucrose ester (75% w / w), and pregelatinized rice starch (embodiment according to the present invention). - Fe-Car75-V 001 (Table 2): Contains Fe(III) pyrophosphate, sunflower lecithin, carrageenan (75% w / w), sucrose ester (25% w / w), and pregelatinized rice starch (embodiment according to the present invention). - Fe-GA25-V 001 (Table 3): Contains Fe(III) pyrophosphate, sunflower lecithin, gum arabic (25% w / w), sucrose ester (75% w / w), and pregelatinized rice starch (embodiment according to the present invention). - Fe-GA75-V 001 (Table 4): Contains Fe(III) pyrophosphate, sunflower lecithin, gum arabic (75% w / w), sucrose ester (25% w / w), and pregelatinized rice starch (embodiment according to the present invention). - Fe-GA100-V 001 (Table 5): Contains Fe(III) pyrophosphate, sunflower lecithin, gum arabic (100% w / w), and pregelatinized rice starch (embodiment according to the present invention, without sucrose esters). - Fe-FU25-V 001 (Table 6): Contains Fe(III) pyrophosphate, sunflower lecithin, fucoidan (25% w / w), sucrose ester (75% w / w), and pregelatinized rice starch (embodiment according to the present invention). - Fe-FU75-V 001 (Table 7): Contains Fe(III) pyrophosphate, sunflower lecithin, fucoidan (75% w / w), sucrose ester (25% w / w), and pregelatinized rice starch (embodiment according to the present invention).

[0296] Each composition under analysis was subjected to at least three tests in two consecutive cycles.

[0297] II.3. Results Figure 2 shows carrageenan (Fe-Car25-V 001 Fe-Car75-V 001 ), acacia gum (Fe-GA25-V 001 Fe-GA75-V 001 Fe-GA100-V001 ) and fucoidan (Fe-FU25-V 001 Fe-FU75-V 001 The composition according to the present invention based on ) and the reference composition (not according to the present invention) Fe-Suc-V 000 Fe in a simulated stomach environment (pH 1.2) at 2-hour intervals. 3+ This shows the emission profile.

[0298] The composition includes Fe to the stomach. 3+ The data reported in Figure 2 shows that the release can be controlled. Such release tests measure the ability of the composition according to the present invention to encapsulate iron.

[0299] Therefore, if the composition of the present invention causes the immediate formation of vesicles or vesicular structures, the iron remains encapsulated or bound to the vesicular structures.

[0300] III. Determination of the presence of particles smaller than a micron in the composition under analysis and determination of micelle size. III. Method One g of each composition under analysis was dispersed in water. The dispersion was centrifuged at 2000 rpm for 10 minutes. Particles larger than microns that settle can be separated from smaller particles at this rate. The presence of powder residue was observed in both cases. The supernatant was collected for light scattering analysis (Coulter N4 plus).

[0301] III.2. Composition under analysis: Same as in paragraph II.2.

[0302] III. Results Figure 3 shows carrageenan (Fe-Car25-V 001 Fe-Car75-V 001 ), acacia gum (Fe-GA25-V 001 Fe-GA75-V 001 Fe-GA100-V 001 ) and fucoidan (Fe-FU25-V 001 Fe-FU75-V 001The composition according to the present invention based on ) and the reference composition (not according to the present invention) Fe-Suc-V 000 The results of the light scattering analysis are shown. 。

[0303] Composition based on carrageenan according to the present invention (Fe-Car25-V 001 Fe-Car75-V 001 In this case, the data in Figure 3 shows that the average size of vesicles increases significantly as the presence of carrageenan increases.

[0304] This proportional relationship can be attributed to the fact that the polymer (carrageenan) is adsorbed onto the surface of the vesicles.

[0305] Composition based on acacia gum according to the present invention (Fe-GA25-V 001 Fe-GA75-V 001 Fe-GA100-V 001 ) and compositions based on fucoidan according to the present invention (Fe-FU25-V 001 Fe-FU75-V 001 In this case, the data in Figure 3 shows that the average vesicle size decreases as the presence of both fucoidan and acacia gum increases.

[0306] This inverse relationship can be attributed to the fact that both fucoidan and acacia gum act as emulsifiers and stabilizers.

[0307] In fact, the composition Fe-GA100-V according to the present invention 001 Regarding the dimensions of the vesicles, the reference composition (Fe-Suc-V 000 ) does not differ significantly.

[0308] However, not all compositions according to the present invention have uniform dimensions relative to the average, and in any case they are not reference compositions Fe-Suc-V 000 The multivariance index (ranging from 0.8 to 1.5, not reported) indicates that there is no significant difference.

[0309] Table 2 Table 1

[0310] Table 3 Table 2

[0311] Table 4 Table 3

[0312] Table 5 Table 4

[0313] Table 6 Table 5

[0314] Table 7 Table 6

[0315] Table 8 Table 7

Claims

1. A solid-form formulation for oral administration, (a) a nutrient, wherein the nutrient is iron pyrophosphate as an inorganic substance; (b) a phospholipid, wherein the phospholipid is lecithin; (c) A first agent selected from (c-ii) acacia gum, wherein the (c-ii) acacia gum is present in an amount of 15% to 20% by weight; (e) Pregelatinized starch of plant origin The formulation comprising or otherwise comprising

2. The preparation further comprises (d) at least one sucrose ester or fatty acid carbohydrate ester; Here, the sucrose ester is sucrose ester E473, or a monoester obtained by esterifying sucrose with one or more plant-derived fatty acids in an amount of 70% to 90% by weight relative to the total weight of the sucrose ester, wherein the fatty acid is selected from stearic acid and / or palmitic acid. The formulation according to claim 1.

3. The formulation according to claim 1 or 2, wherein the (c) first agent comprises the (cii) acacia gum or acacia gum E414.

4. The formulation according to claim 3, wherein the (c) first agent comprises acacia gum E414 having an average molecular weight in the range of 250,000 to 400,000.

5. The formulation according to any one of claims 1 to 4, wherein the (e) starch is selected from rice starch or corn starch.

6. The formulation according to claim 5, wherein the starch is pregelatinized rice starch.

7. The formulation according to any one of claims 1 to 6, wherein the (b) phospholipid is lecithin (E322) selected from the group comprising or alternatively comprising sunflower lecithin, corn lecithin, soybean lecithin and mixtures thereof.

8. The weight ratio between the first agent (c) and the phospholipid (b) [(c):(b)], or alternatively, the weight ratio between the total weight of the first agent (c) and the sucrose ester (d), and the weight of the phospholipid [[(c) + (d)]:(b)], is between 50:1 and 10:

1. The preparation according to any one of claims 2 to 7.

9. The weight ratio between the first agent (c) and the phospholipid (b) [(c):(b)], or alternatively, the weight ratio between the total weight of the first agent (c) and the sucrose ester (d), and the weight of the phospholipid [[(c) + (d)]:(b)], is between 30:1 and 15:

1. The formulation according to claim 8.

10. The total amount of the first agent (c) and the sucrose ester (d) is 100 parts by weight, wherein the first agent (c) is present in an amount of 1% to 100% by weight, and the sucrose ester (d) is present in an amount of 0% (absent) to 99%. The preparation according to any one of claims 3 to 9.

11. The formulation according to claim 10, wherein the first agent (c) is contained in an amount of 50% to 95% by weight, and the sucrose ester (d) is contained in an amount of 5% to 50%.

12. The formulation according to any one of claims 10 or 11, wherein the first agent (c) is contained in an amount of 70% to 80% by weight, and the sucrose ester (d) is contained in an amount of 20% to 30%.

13. (a) A solid formulation of a nutrient, wherein the nutrient is iron pyrophosphate as an inorganic substance; (b) a phospholipid, wherein the phospholipid is lecithin; (c) A first agent selected from (c-ii) acacia gum, wherein the (c-ii) acacia gum is present in an amount of 15% to 20% by weight; (e) Pregelatinized starch of plant origin; and At least one acceptable pharmaceutical or food-grade additive and / or excipient, A composition containing the following:

14. A preparation or composition according to any one of claims 1 to 13, for use as a pharmaceutical.

15. A formulation or composition according to any one of claims 1 to 14 for use in a subject requiring it, in a method of prophylactic and / or therapeutic and / or adjuvant treatment for (a) inorganic deficiencies and diseases, symptoms or disorders relating to or arising from such deficiencies, The inorganic substance is iron pyrophosphate. The preparation or composition.

16. The disease or symptoms relating to or arising from the aforementioned deficiency, Iron deficiency, anemia, poor iron absorption, hemolytic anemia; A formulation or composition for use according to claim 15, comprising or alternatively selected from the group comprising.

17. A method for preparing a pharmaceutical preparation according to any one of claims 1 to 12, (1) A step of providing an inorganic substance in the form of a powder or granules, wherein the inorganic substance is iron pyrophosphate, and providing the inorganic substance to obtain the inorganic substance of step 1; (2) A step of mixing the inorganic substance from step 1 with lecithin, which is a phospholipid (b), in the absence of a solvent to obtain the mixture from step 2; (3) A step of mixing the mixture from step 2 with a polysaccharide (c) selected from (c-ii) acacia gum in the absence of a solvent to obtain the mixture from step 3 or the formulation; and, (4) A step of mixing the mixture from step 3 with pregelatinized rice starch, which is a plant-derived pregelatinized starch (e), to obtain the formulation. The method, including the method described above.

18. The method according to claim 17, wherein in step 3, the mixture from step 2 is mixed with a polysaccharide (c) selected from (c-ii) acacia gum and a sucrose ester (d) in the absence of a solvent.

19. A method for preparing the composition according to claim 13, (i) A step of obtaining the at least one solid-form formulation of the inorganic substance by providing the at least one solid-form formulation of the inorganic substance, or alternatively, by producing the at least one solid-form formulation of the inorganic substance in accordance with claim 17; (ii) A step of mixing at least one of the inorganic solid formulations to obtain the mixture of step (ii), and (iii) A step of mixing the mixture from step (iii) with at least one additive and / or excipient to obtain the composition. The method, including the method described above.

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