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WO2015167434A1 - Compositions pour la supplémentation nutritionnelle - Google Patents

Compositions pour la supplémentation nutritionnelle Download PDF

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Publication number
WO2015167434A1
WO2015167434A1 PCT/US2014/035727 US2014035727W WO2015167434A1 WO 2015167434 A1 WO2015167434 A1 WO 2015167434A1 US 2014035727 W US2014035727 W US 2014035727W WO 2015167434 A1 WO2015167434 A1 WO 2015167434A1
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Prior art keywords
vitamin
composition
compositions
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iron
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Eduardo Fernandez
Charles Balzer
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A23L33/155—Vitamins A or D
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16—Inorganic salts, minerals or trace elements
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • compositions and kits for nutritional supplementation Disclosed herein are various vitamin, nutrient, and mineral compositions and kits for nutritional supplementation and methods of administration of compositions and kits for nutritional supplementation.
  • Vitamins, nutrients, and minerals play integral roles in physiological mechanisms that serve to prevent, treat, and/or alleviate the occurrence or negative effects of some diseases.
  • Supplemental iron is extremely important during pregnancy due to the large increase in blood plasma volume and erythropoetic (red blood cell production) activity. Anemia is common in pregnancy, notably in the absence of supplemental iron consumption. Negative outcomes of pregnancy have been correlated with an iron-specific anemic state during pregnancy.
  • Iodine plays an important role in fetal brain and cognitive development. Studies have demonstrated moderately low systemic levels of iodine in women of childbearing age. Low iodine may be due to a general decrease in seafood secondary for fear of seaborne contaminants.
  • Vitamin D has been shown to have positive effects on the immune system, including during pregnancy.
  • epidemiologic studies have demonstrated that a large percentage of pregnant women, including those of childbearing age, possess systemically insufficient levels of vitamin D.
  • Patient compliance is a problem with conventional, commercially available nutritional supplements, including prenatal vitamins, which typically have a relatively large weights and/or volumes, e.g., weights of around 800 mg and volumes of around 0.700 cm 3 .
  • prenatal vitamins typically have a relatively large weights and/or volumes, e.g., weights of around 800 mg and volumes of around 0.700 cm 3 .
  • problems with compliance are sometimes seen when pregnant women have a condition that does not allow them to easily take current commercially available prenatal vitamins, including morning sickness or nausea and vomiting of pregnancy. Indeed, it is estimated that 50% of the population has problems swallowing such conventional dosage forms. Seger, 50 J. PHARM. PHARMACOL. 375-82 (1998).
  • compositions may be used, for example, before, during, and after pregnancy.
  • compositions and kits for nutritional supplementation and methods for providing nutritional supplementation to a patient by administering such compositions and kits may provide improved patient compliance compared to other compositions for nutritional supplementation.
  • the disclosed methods, compositions, and kits for nutritional supplementation can be used to administer one or more vitamins, minerals, or trace elements.
  • the compositions and kits for nutritional supplementation disclosed herein may be a prenatal vitamin.
  • the compositions and kits for nutritional supplementation disclosed herein may be a dietary supplement.
  • compositions for nutritional supplementation may comprise vitamin B 9 , vitamin Bi 2 , vitamin B 6 , vitamin D, iodine, and iron.
  • the compositions may comprise about 0.5 mg to about 1.5 mg vitamin B 9 , about 6 ⁇ g to about 18 ⁇ g vitamin Bi 2 , about 1.2 mg to about 3.8 mg vitamin B 6 , about 500 IU to about 1500 IU vitamin D, about 75 ⁇ g to about 225 ⁇ g iodine, and about 9 mg to about 27 mg iron.
  • the compositions may comprise about 1 mg vitamin B 9 , about 12 ⁇ g vitamin B 12 , about 2.5 mg vitamin B 6 , about 1000 IU vitamin D, about 150 ⁇ g iodine, and about 18 mg iron. In some embodiments, the compositions may comprise at least about 1 mg vitamin B 9 , at least about 12 ⁇ g vitamin Bi 2 , at least about 2.5 mg vitamin B 6 , at least about 1000 IU vitamin D, at least about 150 ⁇ g iodine, and at least about 18 mg iron.
  • the composition may comprise at least one inactive ingredient.
  • the at least one inactive ingredient may be a sweetener.
  • the composition may be a tablet. In some embodiments, the tablet may be a coated tablet. [0011] In some embodiments, the composition may have a weight of about 70 mg to about 210 mg. In some embodiments, the composition may have a weight of about 100 mg to about 180 mg. In some embodiments, the composition may have a weight of about 140 mg. In some embodiments, the composition may have a weight of about 145 mg. In some embodiments, the composition may have a volume of about 0.2 cm 3 to about 0.7 cm 3 . In some embodiments, the composition may have a volume of about 0.5 cm 3 . In some embodiments, the composition may have a volume of less than about 0.5 cm 3 .
  • the composition may have a volume of about 0.150 cm 3 to about 0.050 cm 3 . In some embodiments, the composition may have a volume of about 0.105 cm 3 . In some embodiments, the composition may have a volume of less than about 0.105 cm 3 .
  • the composition or kit disclosed herein may be administered to a patient, wherein the patient may be a pregnant woman, prenatal woman, or a woman who is breast-feeding. In some embodiments, the composition or kit disclosed herein may be administered to a patient, wherein the composition or kit disclosed herein is administered before, during, and after the patient's pregnancy. In some embodiments, the composition or kit disclosed herein may be administered to a patient once a day, twice a day, three times a day, four times a day, or five times a day. In some embodiments, the composition or kit disclosed herein may be administered to a patient once daily. In some embodiments, the composition or kit disclosed herein may be administered to a patient as directed by a physician. In some embodiments, the composition or kit disclosed herein may have improved patient compliance. In some embodiments,
  • the reduced weight and/or volume of the composition may improve patient compliance.
  • Some embodiments herein may provide for methods for providing nutritional supplementation to a patient, wherein the method may comprise administering a composition to the patient, wherein the composition may comprise vitamin Bg, vitamin Bi 2 , vitamin B 6 , vitamin D, iodine, and iron.
  • the method may comprise administering a composition to the patient, wherein the composition may comprise about 0.5 mg to about 1.5 mg vitamin Bg, about 6 ⁇ g to about 18 ⁇ g vitamin Bi 2 , about 1.2 mg to about 3.8 mg vitamin B 6 , about 500 IU to about 1500 IU vitamin D, about 75 ⁇ g to about 225 ⁇ g iodine, and about 9 mg to about 27 mg iron.
  • the method may comprise administering a composition to the patient, wherein the composition may comprise about 1 mg vitamin B 9 , about 12 ⁇ g vitamin Bi 2 , about 2.5 mg vitamin B 6 , about 1000 IU vitamin D, about 150 ⁇ g iodine, and about 18 mg iron.
  • the method may comprise administering a composition to the patient, wherein the composition may comprise at least about 1 mg vitamin Bg, at least about 12 ⁇ g vitamin Bi 2 , at least about 2.5 mg vitamin B 6 , at least about 1000 IU vitamin D, at least about 150 ⁇ g iodine, and at least about 18 mg iron.
  • the method may comprise administering a composition to the patient, wherein the composition may comprise at least one inactive ingredient.
  • the at least one inactive ingredient may be a sweetener.
  • the method may comprise administering a composition to the patient, wherein the composition may be a tablet. In some embodiments, the tablet may be a coated tablet.
  • the method may comprise administering a composition to the patient, wherein the composition may have a weight of about 70 mg to about 210 mg. In some embodiments, the method may comprise administering a composition to the patient, wherein the composition may have a weight of about 100 mg to about 180 mg. In some embodiments, the method may comprise administering a composition to the patient, wherein the composition may have a weight about 140 mg. In some embodiments, the method may comprise administering a composition to the patient, wherein the composition may have a weight about 145 mg. In some embodiments, the method may comprise administering a composition to the patient, wherein the composition may have a volume of about 0.2 cm 3 to about 0.7 cm 3 .
  • the method may comprise administering a composition to the patient, wherein the composition may have a volume of about 0.150 cm 3 to about 0.050 cm 3 . In some embodiments, method may comprise administering a composition to the patient, wherein the composition may have a volume of about 0.5 cm 3 . In some embodiments, method may comprise administering a composition to the patient, wherein the composition may have a volume of less than about 0.5 cm 3 . In some embodiments, the method may comprise administering a composition to the patient, wherein the composition may have a volume of about 0.105 cm 3 . In some embodiments, the method may comprise administering a composition to the patient, wherein the composition may have a volume of less than about 0.105 cm 3 .
  • the method may comprise administering a composition or kit disclosed herein to a patient, wherein the composition or kit administered to the patient may have improved patient compliance.
  • method may comprise administering a composition or kit disclosed herein to a patient, wherein the reduced weight and/or volume of the composition may improve patient compliance.
  • the method may comprise administering a composition or kit disclosed herein to a patient, wherein the patient may be a pregnant woman, prenatal woman, or a woman who is breast-feeding.
  • the method may comprise administering a composition or kit disclosed herein to a patient, wherein the composition or kit is administered before, during, and after the patient's pregnancy.
  • the method may comprise administering a composition or kit disclosed herein to a patient, wherein the composition or kit may be administered to a patient as directed by a physician. In some embodiments, the method may comprise administering a composition or kit disclosed herein to the patient once a day, twice a day, three times a day, four times a day, or five times a day. In some embodiments, the method may comprise administering a composition or kit disclosed herein to a patient, wherein the composition or kit may be administered to a patient once daily.
  • the term "patient” comprises any and all organisms and includes the term “subject.” “Patient” may refer to a human, a female human, or any other animal.
  • administered refers to the act of giving a composition to a patient or otherwise making such composition available to a patient or the patient taking a composition.
  • co-administration refers to administration of two or more compositions to a patient together, which includes administration at about the same time or within a certain specific or desired time.
  • drug form is the form in which the dose is to be administered to the subject or patient.
  • inactive refers to any compound that is an inactive ingredient of a described composition.
  • inactive ingredient as used herein follows that of the U.S. Food and Drug Administration, as defined in 21 C.F.R. ⁇ 201.3(b)(8), which is any component of a drug product other than the active ingredient.
  • active ingredient is meant any compound intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment and/or prevention of a condition. See 21 C.F.R. ⁇ 210.3(b)(7).
  • active ingredients include those compounds of the composition that may undergo chemical change during the manufacture of the composition and be present in the final composition in a modified form intended to furnish an activity or effect. Id. These may include the vitamins, minerals, and nutrients of the compositions disclosed herein. Indeed, the term “inactive ingredients” includes ingredients— such as, and only by way of example, dicalcium phosphate— that may be considered an active ingredient in another setting or composition, but that are intended to serve no therapeutic or nutritional purpose in the compositions disclosed herein. [0025] In some embodiments, the active ingredients, such as the vitamins, minerals, and nutrients of the disclosed invention, may be included in overages. Adding overages of these compounds may be necessary to meet the amounts claimed on the product label and product insert to ensure that those recited amounts are met throughout the shelf life of the product.
  • one or more of the vitamins, minerals, and nutrients may be included in the compositions, kits, and methods disclosed herein in overages of the recited, specific label amounts, for example, of about 100% to about 150% of the label amount, although the overages may be dependent on the stability of each ingredient.
  • overages of vitamin D and vitamin Bi 2 may be necessary due to the lack of stability of specific forms.
  • 5-methyl-tetrahydrofolate a form of vitamin Bg
  • Overages may be larger for some vitamins particularly those that are less stable and more likely to deteriorate with a long shelf life, those that have other functions (such as antioxidants) in the product itself; for minerals, excess amounts with larger overages are probably less likely because of their increased bulk and shelf life stability. Id. Accordingly, when overages are included for any specific active ingredient, at some point in time, these ingredients with overages may degrade so that they fall within the amounts provided in the specific label. Thus, there is no literal difference between the amounts for active ingredients that include overages, and those amounts listed on the specific label.
  • an active ingredient provided in overage amounts in the methods, compositions, and kits disclosed herein is an insubstantial change in comparison to the specific label amount and performs substantially the same function, in substantially the same way, and leads to substantially the same result as the same active ingredient in the amounts as provided on the specific label.
  • vitamin B 6 may be included.
  • vitamin B 6 may be included in the forms of pyridoxine, 3-hydroxy-4,5-bis(hydroxymethyl)2-methylpyridine, 5 '-deoxypyridoxal, 2- demethylpyridoxal(2-norpyridoxal), 2-propyl-2-norpyridoxal (2'-ethylpyridoxal), 6- methylpyridoxal, 2'-hydroxypyridoxal (2-hydroxymethyl-2-demethylpyridoxal or 2- hydroxymethyl-2-norpyridoxal), 4'-deoxypyridoxine 5 '-phosphate, 5'-methylpyridoxal-5'- phosphate, pyridoxal N-oxide 5 '-phosphate, Pyridoxal, Pyridoxamine, Pyridoxine-5 '-phosphate (PNP), pyridoxal-5 '-phosphate (PLP) and pyridoxamine-5 '
  • vitamin B 6 may be included in an amount ranging from about 1.2 mg to about 3.8 mg. In some embodiments, vitamin B 6 may be included in an amount ranging from about 1.5 mg to about 3.5 mg. In some embodiments, vitamin B 6 may be included in an amount ranging from about 2 mg to about 3 mg.
  • vitamin B 6 may be included in an amount of about 1.2 mg, about 1.3 mg, about 1.4 mg, about 1.5 mg, about 1.6 mg, about 1.7 mg, about 1.8 mg, about 1.9 mg, about 2 mg, about 2.1 mg, about 2.2 mg, about 2.3 mg, about 2.4 mg, about 2.5 mg, about 2.6 mg, about 2.7 mg, about 2.8 mg, about 2.9 mg, about 3 mg, about 3.1 mg, about 3.2 mg, about 3.3 mg, about 3.4 mg, about 3.5 mg, about 3.6 mg, about 3.7 mg, or about 3.8 mg.
  • vitamin B 6 may be included in an amount of at least about 1.2 mg, at least about 1.3 mg, at least about 1.4 mg, at least about 1.5 mg, at least about 1.6 mg, at least about 1.7 mg, at least about 1.8 mg, at least about 1.9 mg, at least about 2 mg, at least about 2.1 mg, at least about 2.2 mg, at least about 2.3 mg, at least about 2.4 mg, at least about 2.5 mg, at least about 2.6 mg, at least about 2.7 mg, at least about 2.8 mg, at least about 2.9 mg, at least about 3 mg, at least about 3.1 mg, at least about 3.2 mg, at least about 3.3 mg, at least about 3.4 mg, at least about 3.5 mg, at least about 3.6 mg, at least about 3.7 mg, or at least about 3.8 mg. In some embodiments of the compositions, kits, and methods disclosed herein, vitamin B 6 may be included in an overage amount of up to about 125% of the specified label amount.
  • vitamin B 6 may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • vitamin B 6 may be in the form of pyridoxine hydrochloride and may be included in the amount of about 2.5 mg. Accordingly, in this example, "pyridoxine hydrochloride in the amount of about 2.5 mg" would include 2.5 mg of pyridoxine hydrochloride and/or its equivalents and would, for example, include a product having 2.5 mg pyridoxamine instead of pyridoxine hydrochloride, as well as intended overages of vitamin B 6 , in any form.
  • vitamin Bg may be included.
  • Vitamin Bg is a generic name of a B-vitamin that includes multiple compounds with a general structure.
  • vitamin Bg encompasses the term folate, which itself is the generic name for many different forms of this water-soluble vitamins.
  • folate encompasses numerous compounds that, for example, are based on a pteridine ring, an aminobenzoic acid and one or more glutamic acid residues.
  • Folic acid pteroglutamic acid or PGA is a synthetic form of folate, and the first folate synthesized and used as a supplement.
  • folates may also be used in the generic sense to designate any members of the family of pteroylglutamates, or mixtures of them, having various levels of reduction of the pteridine ring, one-carbon substitutions and numbers of glutamate residues. Accordingly, vitamin Bg is not exclusively defined by its structure, but also by its various functions, which include DNA synthesis, cell division, and as a coenzyme in one-carbon transfer reactions.
  • vitamin Bg may include numerous forms. In a specific embodiment,
  • vitamin Bg may be included in the form of folic acid.
  • vitamin Bg may be folic acid USP (i.e., folic acid that conforms to the applicable specifications of United States Pharmacopeia ("USP")).
  • vitamin Bg may be included one or more of the forms of folic acid, folacin, Metafolin® (Merck KGaA, Darmstadt, Germany) (also known as the calcium salt of L-5-methyl-tetrahydro folic acid), folate and/or one or more natural isomers of folate including (6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-methyl-(6S)-tetrahydrofolic acid or a polyglutamyl derivative thereof, 5-formyl-(6S)- tetrahydro folic acid or a polyglutamyl derivative thereof, 10-formyl-(6R)-tetrahydro folic acid or a polyglutamyl
  • vitamin B 9 may be in the form of a folate or folate derivative thereof that is eventually converted to 5-methyl-tetrahydrofolic acid in the body and/or is absorbed into the bloodstream as 5-methyl-tetrahydrofolic acid. Folates, such as folic acid and folate, are eventually absorbed in the body and converted to L-5-methyl-tetrahydro folic acid.
  • vitamin Bg may be in the form of a folate or folate derivative thereof that increases blood folate levels, thereby reducing homocysteine levels.
  • vitamin B9 may be in the form of folate or reduced folates with various salts.
  • the folate and reduced folate are selected from the group consisting of D-glucosamine-folate, D-galactosamine- folate, D-glucosamine (6R, S) - tetrahydrofolate, D-glucosamine (6S) -tetrahydrofolate, D-glucosamine (6R) -tetrahydrofolate; D-galactosamine (6R, S) -tetrahydrofolate, D-galactosamine (6S) -tetrahydrofolate, D- galactosamine (6R) -tetrahydrofolate; D-glucosamine 5-methyl- (6R, S) -tetrahydrofolate, D- glucosamine 5-methyl- (6S) -tetrahydrofolate, D-glucosamine 5-methyl- (6R) -
  • vitamin B9 may folic acid, a calcium salt of L-5-methyl-tetrahydro folic acid, or a combination thereof. In some embodiments, vitamin B9 may be a combination of folic acid and a calcium salt of L-5-methyl-tetrahydro folic acid. In some embodiments, the ratio of the amount of folic acid to the amount of calcium salt of L-5-methyl-tetrahydro folic acid may be about 1 : 1 , about 2:3, or about 3 :7.
  • vitamin B 9 may be included in an amount ranging from about 0.5 mg to about 1.5 mg. In some embodiments, vitamin B 9 may be included in an amount ranging from about 0.8 mg to about 1.2 mg. In some embodiments, vitamin B9 may be included in an amount ranging from about 0.9 mg to about 1.1 mg. In certain specific embodiments, vitamin B9 may be included in an amount of about 0.5 mg, about 0.6 mg, about 0.7 mg, about 0.8 mg, about 0.9 mg, about 1.0 mg, about 1.1 mg, about 1.2 mg, about 1.3 mg, about 1.4 mg, or about 1.5 mg. In certain specific specific
  • vitamin B9 may be included in an amount of at least about 0.5 mg, at least about 0.6 mg, at least about 0.7 mg, at least about 0.8 mg, at least about 0.9 mg, at least about 1.0 mg, at least about 1.1 mg, at least about 1.2 mg, at least about 1.3 mg, at least about 1.4 mg, or at least about 1.5 mg.
  • vitamin B9 may be included in an overage amount of up to about 140% of the specified label amount.
  • vitamin Bg may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • vitamin B9 may be in the form folic acid and may be included in the amount of about 1 mg. Accordingly, in this example, "folic acid in the amount of about 1 mg" would include 1 mg of folic acid and/or its equivalents and would, for example, include a product having 1 mg 5-methyl-(6S)-tetrahydrofolic acid instead of folic acid, as well as intended overages of vitamin B9, in any form.
  • vitamin B 12 may be included.
  • Vitamin Bi 2 can be converted to the active coenzymes methylcobalamin and 5 '-deoxyadenosylcobalamin.
  • vitamin Bi 2 may be in one or more of the forms of cobalamin, methylcobalamin, 5'-deoxyadenosylcobalamin (adenosylcobalamin or cobamamide), cyanocobalamin, hydroxycobalamin and mecobalamin.
  • vitamin Bi 2 may be cyanocobalamin.
  • vitamin Bi 2 may be cobalamin.
  • vitamin B 12 may be included in an amount ranging from about 6 ⁇ g to about 18 ⁇ g. In some embodiments of the compositions, kits, and methods disclosed herein, vitamin B 12 may be included in an amount ranging from about 6 ⁇ g to about 18 ⁇ g. In some embodiments of the compositions, kits, and methods disclosed herein, vitamin B 12 may be included in an amount ranging from about 6 ⁇ g to about 18 ⁇ g. In some embodiments of the compositions, kits, and methods disclosed herein, vitamin B 12 may be included in an amount ranging from about 6 ⁇ g to about 18 ⁇ g. In some embodiments of the compositions, kits, and methods disclosed herein, vitamin B 12 may be included in an amount ranging from about 6 ⁇ g to about 18 ⁇ g. In some embodiments of the compositions, kits, and methods disclosed herein, vitamin B 12 may be included in an amount ranging from about 6 ⁇ g to about 18 ⁇ g. In some embodiments of the compositions, kits, and methods disclosed herein, vitamin B 12 may be included in an
  • vitamin Bi 2 may be included in an amount ranging from about 9 ⁇ g to about 15 ⁇ g. In some embodiments, vitamin Bi 2 may be included in an amount ranging from about 1 1 ⁇ g to about 13 ⁇ g. In certain specific embodiments, vitamin Bi 2 may be included in an amount of about 6 ⁇ g, about 7 ⁇ g, about 8 ⁇ g, about 9 ⁇ g, about 10 ⁇ g, about 1 1 ⁇ g, about 12 ⁇ g, about 13 ⁇ g, about 14 ⁇ g, about 15 ⁇ g, about 16 ⁇ g, about 17 ⁇ g, or about 18 ⁇ g.
  • vitamin Bi 2 may be included in an amount of at least about 6 ⁇ g, at least about 7 ⁇ g, at least about 8 ⁇ g, at least about 9 ⁇ g, at least about 10 ⁇ g, at least about 1 1 ⁇ g, at least about 12 ⁇ g, at least about 13 ⁇ g, at least about 14 ⁇ g, at least about 15 ⁇ g, at least about 16 ⁇ g, at least about 17 ⁇ g, or at least about 18 ⁇ g.
  • vitamin Bi 2 may be included in an overage amount of up to about 140% of the specified label amount.
  • vitamin Bi 2 may be included in specific ranges or amounts for each specific form. When provided in their specific forms, the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • vitamin Bi 2 may be in the form cyanocobalamin and may be included in the amount of about 12 ⁇ g. Accordingly, in this example, "cyanocobalamin in the amount of about 12 ⁇ g" would include about 12 ⁇ g of cyanocobalamin and/or its equivalents and would, for example, include a product having about 12 ⁇ g methylcobalamin instead of cyanocobalamin, as well as intended overages of vitamin Bi 2 , in any form.
  • vitamin D may be included.
  • vitamin D may be in one or more of the forms of vitamin D 3 (also known as calciol or cholecalciferol or colecalciferol), vitamin D 2 (also known as calciferol, ergocalciol, ergocalciferol, ercalciol, Deltalin or Viosterol), previtamin D2, ergosterol, calcitriol (also known as 1,25-dihydroxycholecalciferol), 7-dehydrocholesterol, vitamin D ls vitamin D 4 (also known as 22-dihydroergocalciferol, 22,23-dihydroercalciol or (24S)-methylcalciol), vitamin D5 (also known as (24S)-Ethylcalciol or sitocalciferol), 7- dehydrositosterol, Lumisterol, 25-hydroxyvita D 3 (also known as calciol or cholecalciferol or colecalc
  • vitamin D may be included in an amount ranging from about 500 IU to about 1500 IU. In some embodiments, vitamin D may be included in an amount ranging from about 800 IU to about 1200 IU. In some embodiments, vitamin D may be included in an amount ranging from about 900 IU to about 1100 IU.
  • vitamin D may be included in an amount of about 900 IU, about 910 IU, about 920 IU, about 930 IU, about 940 IU, about 950 IU, about 960 IU, about 970 IU, about 980 IU, about 990 IU, about 1000 IU, about 1010 IU, about 1020 IU, about 1030 IU, about 1040 IU, about 1050 IU, about 1060 IU, about 1070 IU, about 1080 IU, about 1090 IU, about 1000 IU, or about 1100 IU.
  • vitamin D may be included in an amount of at least about 900 IU, at least about 910 IU, at least about 920 IU, at least about 930 IU, at least about 940 IU, at least about 950 IU, at least about 960 IU, at least about 970 IU, at least about 980 IU, at least about 990 IU, at least about 1000 IU, at least about 1010 IU, at least about 1020 IU, at least about 1030 IU, at least about 1040 IU, at least about 1050 IU, at least about 1060 IU, at least about 1070 IU, at least about 1080 IU, at least about 1090 IU, at least about 1000 IU, or at least about 1100 IU.
  • vitamin D may be included in an overage amount of up to about 140% of the specified label amount.
  • vitamin D may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • vitamin D may be in the form vitamin D 3 and may be included in the amount of about 1000 IU.
  • vitamin D 3 in the amount of about 1000 IU would include 1000 IU of vitamin D 3 and/or its equivalents and would, for example, include a product having 1000 IU vitamin D 2 instead of vitamin D 3 , as well as intended overages of vitamin D, in any form.
  • vitamin D may be present in an amount determined by a measure of mass, as opposed to International Units.
  • One International Unit (IU) of vitamin D is defined as the biological equivalent of about 0.025 ⁇ g of vitamin D 3 .
  • iron may be included.
  • iron may be included in one or more of the forms of elemental iron, in the form of a salt, chelated form, non-chelated form, chelated to an amino acid, carbonyl iron, ferrous gluconate, ferrous fumarate, polysaccharide iron complex, elemental polysaccharide iron, polysaccharide iron, ferrous (Il)-bis-glycinate chelate, ferrous asparto glycinate, ferrous bisglycinate, ferrous bisglycinate hydrochloride, ferrous bisglycinate, elemental ferrous bisglycinate, ferrous sulfate, ferronyl (micronized), as Iron Aid, iron protein succinylate, carbonyl iron, Sumalate iron, Heme iron complex, as Ferrochel amino acid chelate, heme iron polypeptide as Proferrin-bovine source, as hem
  • iron may be included in an amount ranging from about 9 mg to about 27 mg. In some embodiments, iron may be included in an amount ranging from about 12 mg to about 24 mg. In some embodiments, iron may be included in an amount ranging from about 15 mg to about 21 mg. In certain specific embodiments, iron may be included in an amount of about 9 mg, about 10 mg, about 1 1 mg, about 12 mg, about 13 mg, about 14 mg, about 15 mg, about 16 mg, about 17 mg, about 18 mg, about 19 mg, about 20 mg, about 21 mg, about 22 mg, about 23 mg, about 24 mg, about 25 mg, about 26 mg, or about 27 mg.
  • iron may be included in an amount of at least about 9 mg, at least about 10 mg, at least about 11 mg, at least about 12 mg, at least about 13 mg, at least about 14 mg, at least about 15 mg, at least about 16 mg, at least about 17 mg, at least about 18 mg, at least about 19 mg, at least about 20 mg, at least about 21 mg, at least about 22 mg, at least about 23 mg, at least about 24 mg, at least about 25 mg, at least about 26 mg, or at least about 27 mg.
  • iron may be included in an overage amount of up to about 105% of the specified label amount.
  • iron may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • iron may be in the form iron hydroxide polysaccharide complex and may be included in the amount to provide about 18 mg of elemental iron.
  • iron hydroxide polysaccharide complex in the amount to provide about 18 mg of elemental iron would include the amount of iron hydroxide polysaccharide complex in the amount to provide about 18 mg of elemental iron and/or its equivalents and would, for example, include a product having ferrous fumarate instead of iron hydroxide polysaccharide complex, as well as intended overages of iron, in any form.
  • iodine may be included.
  • iodine may be included in one or more of the forms of elemental iodine, iodized salt, Lugol's iodine, sodium iodide, potassium iodide, potassium iodate, nascent iodine, and Nano-Colloidal Detoxified Iodine.
  • iodine may be potassium iodide.
  • iodine may be included in an amount ranging from about 75 ⁇ g to about 225 ⁇ g. In some embodiments of the compositions, kits, and methods disclosed herein, iodine may be included in an amount ranging from about 75 ⁇ g to about 225 ⁇ g. In some embodiments of the compositions, kits, and methods disclosed herein, iodine may be included in an amount ranging from about 75 ⁇ g to about 225 ⁇ g. In some embodiments of the compositions, kits, and methods disclosed herein, iodine may be included in an amount ranging from about 75 ⁇ g to about 225 ⁇ g. In some embodiments of the compositions, kits, and methods disclosed herein, iodine may be included in an amount ranging from about 75 ⁇ g to about 225 ⁇ g. In some embodiments of the compositions, kits, and methods disclosed herein, iodine may be included in an amount ranging from about 75 ⁇ g to about 225 ⁇ g. In some embodiments of the composition
  • iodide may be included in an amount ranging from about 120 ⁇ g to about 180 ⁇ g. In some embodiments, iodide may be included in an amount ranging from about 135 ⁇ g to about 165 ⁇ g. In certain specific embodiments, iodine may be included in an amount of about 75 ⁇ g, about 80 ⁇ g, about 90 ⁇ g, about 100 ⁇ g, about 110 ⁇ g, about 120 ⁇ g, about 130 ⁇ g, about 140 ⁇ g, about 150 ⁇ g, about 160 ⁇ g, about 170 ⁇ g, about 180 ⁇ g, about 190 ⁇ g, about 200 ⁇ g, about 210 ⁇ g, about 220 ⁇ g, or about 225 ⁇ g.
  • iodine may be included in an amount of at least about 75 ⁇ g, at least about 80 ⁇ g, at least about 90 ⁇ g, at least about 100 ⁇ g, at least about 110 ⁇ g, at least about 120 ⁇ g, at least about 130 ⁇ g, at least about 140 ⁇ g, at least about 150 ⁇ g, at least about 160 ⁇ g, at least about 170 ⁇ g, at least about 180 ⁇ g, at least about 190 ⁇ g, at least about 200 ⁇ g, at least about 210 ⁇ g, at least about 220 ⁇ g, or at least about 225 ⁇ g.
  • iodine may be included in an overage amount of up to about 125% of the specified label amount.
  • iodine may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • iodine may be in the form potassium iodide and may be included in the amount to provide about 150 ⁇ g of iodine.
  • potassium iodide in the amount to provide about 150 ⁇ g of iodine would include potassium iodide in the amount to provide about 150 ⁇ g of iodine and/or its equivalents and would, for example, include a product having Nano-Colloidal Detoxified instead of potassium iodide, as well as intended overages of iodide, in any form.
  • compositions, kits, and methods disclosed herein may be used as a dietary supplement.
  • the composition, kits and methods disclosed herein may be used as a prenatal vitamin.
  • the compositions, kits and methods disclosed herein may be administered to a patient, such as a pregnant woman, prenatal woman, or a woman who is breast-feeding.
  • the compositions, kits and methods disclosed herein may be administered to a patient before, during, and after the patient's pregnancy.
  • the methods disclosed herein may comprise administering compositions and kits disclosed herein once a day, twice a day, three times a day, four times a day, or five times a day.
  • the methods disclosed herein may comprise administering compositions and kits disclosed herein once daily. In some embodiments, the methods disclosed herein may comprise administering compositions and kits disclosed herein as directed by a physician. In some embodiments, the compositions and kits may be utilized or administered in a single dosage form, or in multiple dosage forms, once a day, twice a day, three times a day, four times a day, or five times a day. In some embodiments, the compositions and kits may be utilized or administered once daily. In some embodiments, the compositions and kits may be utilized or administered as directed by a physician. In some embodiments, multiple compositions or kits disclosed herein may be administered at the same time or administered separately. In some embodiments, when multiple compositions are provided in a kit, the compositions may be administered at the same time or administered separately. In a specific embodiment, the compositions and kits of the present invention are administered once daily in a single tablet dosage form.
  • compositions for nutritional supplementation disclosed herein may comprise any necessary inactive ingredients for formulating the active ingredients.
  • the compositions may comprise one or more inactive ingredients.
  • These inactive ingredients may include, but are not limited to: water; anticaking agents (including, by way of example and without limitation, silica (e.g., Sipernat® 50 S, manufactured by Evonik Industries®,
  • binders including, by way of example and without limitation, hydroxypropyl cellulose, microcrystalline cellulose, starch (e.g., modified food starch), sugars (e.g., sucrose, glucose, etc.), natural and synthetic gums, polyethylene glycol, alcohol, and others known to those of ordinary skill in the art); disintegrants (including, by way of example and without limitation, hydroxypropyl cellulose, croscarmellose sodium, corn starch, potato starch, crospovidone, methylcellulose, agar, and others known to those of ordinary skill in the art); lubricants
  • buffers including, by way of example, and without limitation, phosphate buffers (e.g., dibasic calcium phosphate), citrate buffers, lactic acid, and others known to those of ordinary skill in the art); stabilizing agents (including, by way of example and without limitation, antioxidants (e.g., ascorbic acid (or sodium ascorbate), propionic acid, sodium bisulfite, sodium sulfite, dl-alpha- tocopherol, and the like)); chelating agents (e.g., fumaric acid, sodium edetate, and the like), and others known to those of ordinary skill in the art); surfactants (including, by way of example and without limitation, wetting agents (e.g., sorbitan monolaurate, etc.), antifoaming agents (e.g.,
  • caramel ferric oxide, red, pigments, dyes, tints, titanium dioxide, natural coloring agents, such as grape skin extract, beet red powder, beta carotene, annato, carmine, tumeric, paprika, black carrot juice, and others known to those of ordinary skill in the art); sweeteners or sweetening agents (including, by way of example and without limitation, sucrose, fructose, fructose, high fructose com syrup, dextrose, saccharin sodium, maltodextrin, aspartame, potassium acesulfame, neohesperidin
  • dihydrochalcone sucralose, monoammonium glycyrrhizinate, and others known to those of ordinary skill in the art
  • perfuming agents including, by way of example and without limitation, natural flavor oil, a synthetic flavor oil, and others known to those of ordinary skill in the art
  • glazing agents including, by way of example and without limitation, vegetable oil, beeswax, camauba wax, and others known to those of ordinary skill in the art
  • flavoring agents or flavorant including, by way of example and without limitation, natural flavor oil, synthetic flavor oil, and other masking flavors known to those of ordinary skill in the art
  • excipients i.e., medium chain tiglycerides, etc.
  • At least one inactive ingredient may be included.
  • the at least one inactive ingredient may be a sweetener or sweetening agent.
  • the sweetener or sweetening agent may be one or more selected from the group consisting of sucrose, fructose, fructose, high fructose com syrup, dextrose, saccharin sodium, maltodextrin, aspartame, potassium acesulfame, neohesperidin dihydrochalcone, sucralose, monoammonium
  • the sweetener or sweetening agent may be sucralose.
  • compositions which may be in the form of a solid powder, caplets, tablets, lozenges, pills, capsules, or a liquid, and which may be administered alone or in suitable combination with other components.
  • the compositions disclosed herein may be administered in one or more caplets, tablets, or lozenges as practical for ease of administration.
  • Each of the vitamins and minerals is preferably commercially available, and can be blended to form a single composition or can form multiple compositions, which may be co-administered.
  • each of the active ingredients may be combined in intimate admixture with a suitable carrier according to conventional compounding techniques.
  • the carrier may take a wide variety of forms depending upon the form of the preparation desired for administration, e.g., oral, sublingual, nasal, topical patch, or parenteral.
  • the composition may be in an oral dosage form.
  • a composition may consist of one to three tablets, caplets or lozenges, the composition of each being identical to each other caplet or lozenge.
  • any of the usual media may be utilized.
  • media containing, for example, water, oils, alcohols, flavoring agents, preservatives, coloring agents and the like may be used.
  • Carriers such as starches, sugars, diluents, granulating agents, lubricants, binders, disintegrating agents and the like may be used to prepare oral solids ⁇ e.g., powders, caplets, pills, tablets, capsules, and lozenges). Controlled release forms may also be used.
  • caplets, tablets, pills, and capsules may be an advantageous oral dosage unit form, in which case solid carriers are employed.
  • the compositions may be any known type of tablet, including but not limited to, compressed tablets (such as sugar-coated tablets, film-coated tablets, enteric-coated tablets, multiple compressed tablets, controlled-release tablets, tablets for solution, effervescent tablets, buccal and sublingual tablets, and the like) and molded tablets or tablet triturates.
  • the composition may be a coated tablet.
  • Opadry II® manufactured by Colorcon®, HarleysviUe, PA
  • the nutritional supplements described herein may include multiple vitamins, nutrients and minerals in a composition.
  • Providing a single composition multivitamin and multinutrient supplement may be an appealing feature because it may improve patient compliance. Patients, and specifically for example, pregnant patients, often have nausea, and may have difficulties taking multiple pills.
  • a single composition for nutritional supplement that includes the beneficial vitamins, nutrients and minerals in appropriate dosage amounts may thus be beneficial for improving patient compliance in, for example, pregnant women.
  • the reduced weight and/or volume of the compositions disclosed herein, as compared to the weight and/or volume of other compositions for nutritional supplementation, including prenatal vitamin compositions may improve patient compliance as compared to these compositions. In some embodiments, the reduced weight and/or volume of the compositions disclosed herein, as compared to the weight and/or volume of other compositions for nutritional supplementation, including prenatal vitamin compositions, may help a patient be able to swallow the composition. In some embodiments, the composition may be swallowed by a patient without the need for chewing the composition.
  • the composition may have a weight of about 70 mg to about 210 mg. In some embodiments, the composition may have a weight of about 100 mg to about 180 mg. In some embodiments, the composition may have a weight of about 70 mg, about 75 mg, about 80 mg, about 85 mg, about 90 mg, about 95 mg, about 100 mg, about 105 mg, about 110 mg, about 115 mg, about 120 mg, about 125 mg, about 130 mg, about 135 mg, about 140 mg, about 145 mg, about 150 mg, about 155 mg, about 160 mg, about 165 mg, about 170 mg, about 175 mg, about 180 mg, about 185 mg, about 190 mg, about 195 mg, about 200 mg, about 205 mg, or about 210 mg.
  • the composition may have a weight of at least about 70 mg, at least about 75 mg, at least about 80 mg, at least about 85 mg, at least about 90 mg, at least about 95 mg, at least about 100 mg, at least about 105 mg, at least about 110 mg, at least about 115 mg, at least about 120 mg, at least about 125 mg, at least about 130 mg, at least about 135 mg, at least about 140 mg, at least about 145 mg, at least about 150 mg, at least about 155 mg, at least about 160 mg, at least about 165 mg, at least about 170 mg, at least about 175 mg, at least about 180 mg, at least about 185 mg, at least about 190 mg, at least about 195 mg, at least about 200 mg, at least about 205 mg, or at least about 210 mg.
  • the composition may have a weight of less than about 210 mg, less than about 205 mg, less than about 200 mg, less than about 195 mg, less than about 190 mg, less than about 185 mg, less than about 180 mg, less than about 175 mg, less than about 170 mg, less than about 165 mg, less than about 160 mg, less than about 155 mg, less than about 150 mg, less than about 145 mg, less than about 140 mg, less than about 135 mg, less than about 130 mg, less than about 125 mg, less than about 115 mg, less than about 105 mg, less than about 110 mg, less than about 105 mg, or less than about 100 mg.
  • the volume of the composition may be about 1.5 cm 3 to about
  • the volume of the composition may be about 1.5 cm 3 , about 1.4 cm 3 , about 1.3 cm 3 , about 1.2 cm 3 , about 1.1 cm 3 , about 1.0 cm 3 , about 0.9 cm 3 , about 0.8 cm 3 , about 0.7 cm 3 , about 0.6 cm 3 , about 0.5 cm 3 , about 0.45 cm 3 , about 0.4 cm 3 , about 0.35 cm 3 , about 0.3 cm 3 , about 0.25 cm 3 , about 0.2 cm 3 , about 0.15 cm 3 , about 0.145 cm 3 , about 0.14 cm 3 , about 0.135 cm 3 , about 0.13 cm 3 , about 0.125 cm 3 , about 0.12 cm 3 , about 0.115 cm 3 , about 0.11 cm 3 , about 0.109 cm 3 , about 0.108 cm 3 , about 0.107 cm 3 , about 0.106 cm 3 , about
  • the volume of the composition may be at least about 1.5 cm 3 , at least about 1.4 cm 3 , at least about 1.3 cm 3 , at least about 1.2 cm 3 , at least about 1.1 cm 3 , at least about 1.0 cm 3 , at least about 0.9 cm 3 , at least about 0.8 cm 3 , at least about 0.7 cm 3 , at least about 0.6 cm 3 , at least about 0.5 cm 3 , at least about 0.45 cm 3 , at least about 0.4 cm 3 , at least about 0.35 cm 3 , at least about 0.3 cm 3 , at least about 0.25 cm 3 , at least about 0.2 cm 3 , at least about 0.15 cm 3 , at least about 0.145 cm 3 , at least about 0.14 cm 3 , at least about 0.135 cm 3 , at least about 0.13 cm 3 , at least about 0.125 cm 3 , at least about 0.12 cm 3 , at least about 0.115 cm 3 , at least about 0.11 cm 3 , at least about 0.109 cm 3 ,
  • the volume of the composition may be less than about 1.5 cm 3 , less than about 1.4 cm 3 , less than about 1.3 cm 3 , less than about 1.2 cm 3 , less than about 1.1 cm 3 , less than about 1 cm 3 , less than about 0.9 cm 3 , less than about 0.8 cm 3 , less than about 0.7 cm 3 , less than about 0.6 cm 3 , less than about 0.5 cm 3 , less than about 0.45 cm 3 , less than about 0.4 cm 3 , less than about 0.35 cm 3 , less than about 0.3 cm 3 , less than about 0.25 cm 3 , less than about 0.2 cm 3 , less than about 0.15 cm 3 , less than about 0.145 cm 3 , less than about 0.14 cm 3 , less than about 0.135 cm 3 , less than about 0.13 cm 3 , less than about 0.125 cm 3 , less than about 0.12 cm 3 , less than about 0.115 cm 3 , less than about 0.11 cm 3 , less than about 0.109 cm 3 , less than about 1.5 cm
  • the nutritional supplements described herein may include multiple vitamins, nutrients and minerals in more than one composition.
  • the nutritional supplements described herein may include multiple vitamins, nutrients and minerals in more than one composition.
  • various active ingredients may be incorporated into multiple compositions as a kit.
  • the multiple compositions may be separated due to size or large dosage amounts of specific ingredients.
  • the nutritional supplementation of a multivitamin may not be adequate in one composition. Accordingly, all the active ingredients may be divided into a total of two compositions, three compositions, four compositions and five compositions.
  • each composition may have equal amounts of each active ingredient.
  • compositions may have unequal amounts of various active ingredients, or merely supplemental amounts of specific active ingredients.
  • kits comprising the disclosed compositions may be packaged in blister packs.
  • Blister packs as packaging for compositions are well known to those of ordinary skill in the art. Blister packs may be made of a transparent plastic sheet which has been formed to carry a matrix of depression or blisters. One or more compositions are received in each depression or blister. A foil or plastic backing is then adhered across the plane of the sheet sealing the compositions in their respective blisters.
  • Examples of materials used for the blister packs include, but are not limited to, aluminum, paper, polyester, PVC, and polypropylene. Alternative materials are known to those of ordinary skill in the art.
  • To remove a composition the depression material is pressed in and the composition is pushed through the backing material.
  • Multiple blister packs may be placed in an outer package, often a box or carton for sale and distribution.
  • compositions may be packaged in bottles.
  • the bottle may be glass or plastic in form with a pop or screw top cap.
  • Bottle packaging for compositions as disclosed herein are well known to those of ordinary skill in the art.
  • the disclosed compositions may be individually wrapped, packaged as multiple units on paper strips or in vials of any size, without limitation.
  • the compositions of the invention may be packaged in unit dose, rolls, bulk bottles, blister packs and combinations thereof, without limitation.
  • Omega-3 fatty acids such as docosahexaenoic acid (or docahexaenoic acid, DHA), also play integral roles in physiological mechanisms that serve to prevent, treat and/or alleviate the occurrence or negative effects of some diseases.
  • at least one omega-3 fatty acid may be co-administered with the compositions and kits disclosed herein.
  • the methods disclosed herein further may comprise the co-administration of at least one omega-3 fatty acid with the compositions and kits disclosed herein.
  • a composition that may comprise at least one omega-3 fatty acid may be coadministered with the compositions and kits disclosed herein.
  • the methods disclosed herein further may comprise the co-administration of a composition that may comprise at least one omega-3 fatty acid with the compositions and kits disclosed herein.
  • a kit wherein at least one omega-3 acid may be packaged along with at least one composition as described herein for co-administration to a patient.
  • the kit may include a first composition that may comprise at least one omega-3 acid and may be packaged along with one or more of the compositions for nutritional supplementation as described herein for co-administration to a patient.
  • the at least one omega-3 fatty acid may comprise one or more of docahexaenoic acid (or docosahexaenoic acid, DHA), eicosapentaenoic acid (EPA), and a- linolenic acid (ALA).
  • DHA may be obtained in solid form, such as in a whole-cell microbial product, or in liquid form, such as an oil.
  • a non- limiting example of DHA in oil form is DHASCO®-T vegetable oil from micro-algae (Martek Biosciences Corporation, Columbia, MD).
  • the DHA may be DHAgold® (Martek Biosciences, Columbia, MD), life'sDHATM (DSM Nutritional Products, Parsippany, NJ) (DHASCO®, Martek
  • the source of DHA may be from one or more of animal, fish, plants, algae or microorganism production.
  • DHA may be derived from algae.
  • the source of DHA may be from algae oil.
  • the source of algae oil may be one or more of microalgae Schizochytrium sp., microalgae Crypthecodinium cohnii, microalgae Ulkenia sp. SAM2179, microalgae
  • the source of DHA may be Martek Oil C53-O100 (Martek Biosciences Corporation, Columbia, MD).
  • the at least one omega-3 fatty acid may be enclosed in a gel-cap, as, for example, in a kit with the compositions of the present invention, or may be in liquid form.
  • the at least one omega-3 fatty acid may be present in the amount of about 25 mg to about 250 mg, about 50 mg to about 200 mg, about 50 mg to about 150 mg, about 75 mg to about 125 mg, or about 90 mg to about 110 mg.
  • the at least one omega-3 fatty acid may be present in in the amount of about 25 mg, about 30 mg, about 35 mg, about 40 mg, about 45 mg, about 50 mg, about 55 mg, about 60 mg, about 65 mg, about 70 mg, about 75 mg, about 80 mg, about 85 mg, about 90 mg, about 95 mg, about 100 mg, about 105 mg, about 110 mg, about 115 mg, about 120 mg, about 125 mg, about 130 mg, about 135 mg, about 140 mg, about 145 mg, about 150 mg, about 155 mg, about 160 mg, about 165 mg, about 170 mg, about 175 mg, about 180 mg, about 185 mg, about 190 mg, about 195 mg, about 200 mg, about 205 mg, about 210 mg, about 215 mg, about 220 mg, about 225 mg, about 230 mg, about 235 mg, about 240 mg, about 245 mg, or about 250 mg.
  • the at least one omega-3 fatty acid may be present in in the amount of at least about 25 mg, at least about 30 mg, at least about 35 mg, at least about 40 mg, at least about 45 mg, at least about 50 mg, at least about 55 mg, at least about 60 mg, at least about 65 mg, at least about 70 mg, at least about 75 mg, at least about 80 mg, at least about 85 mg, at least about 90 mg, at least about 95 mg, at least about 100 mg, at least about 105 mg, at least about 110 mg, at least about 115 mg, at least about 120 mg, at least about 125 mg, at least about 130 mg, at least about 135 mg, at least about 140 mg, at least about 145 mg, at least about 150 mg, at least about 155 mg, at least about 160 mg, at least about 165 mg, at least about 170 mg, at least about 175 mg, at least about 180 mg, at least about 185 mg, at least about 190 mg, at least about 195 mg, at least about 200 mg, at least about 205
  • omega-3 fatty acids may be included in specific ranges or amounts for each specific form.
  • the provided numerical range or amount includes the amounts of the specific form and/or compounds that are equivalent to the specific form.
  • omega-3 fatty acids may be in the form of DHA and may be included in the amount of about 75 mg. Accordingly, in this example, "DHA in the amount of about 75 mg" would include 75 mg of DHA and/or its equivalents and would, for example, include a product having 75 mg EPA instead of DHA, as well as intended overages of the omega-3 fatty acid , in any form.
  • any vitamins, nutrients and/or minerals may be explicitly excluded from the compositions disclosed herein.
  • the compositions disclosed herein may be substantially free of added alpha carotene; substantially free of added lutein; substantially free of added lycopene; substantially free of added zeaxanthin; substantially free of added vitamin B 4 ; substantially free of added vitamin B 5 ; substantially free of added vitamin B 7 ; substantially free of added vitamin B 8 ;
  • substantially free of added vitamin Bi 0 substantially free of added vitamin Bn; substantially free of added calcium; substantially free of added chromium; substantially free of added copper; substantially free of added manganese; substantially free of added selenium; substantially free of added boron; substantially free of added odorless garlic; substantially free of added coenzyme Q- 10; substantially free of added 1-carnitine; substantially free of added grape seed extract;
  • compositions may be substantially free of other added vitamins and minerals.
  • substantially free of added means free from therapeutically effective amounts of compounds when administered in suggested doses, but may include trace amounts of compounds in non-therapeutically effective amounts.
  • a composition of the present disclosure that includes an inactive ingredient that is a salt or compound including a mineral would still be substantially free of added minerals.
  • trace amounts of titanium dioxide may be provided. Titanium dioxide which is an effective opacifier in powder form, where it is employed as a pigment to provide whiteness and opacity to numerous pharmaceutical products.
  • Example 1 A representative composition. Such composition was prepared according to standard methods known to those of ordinary skill in the art.
  • Inactive Ingredients Sipernat® 50 S, croscarmellose sodium, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, Opadry II®, water, sucralose.
  • Example 2 A representative composition. Such composition was prepared according to standard methods known to those of ordinary skill in the art. INGREDIENT AMOUNT
  • Vitamin Bg (as a combination of folic acid and the calcium 1 mg
  • Vitamin Bi 2 (as cyanocobalamin) 12 ⁇ ⁇
  • Iodine (as potassium iodide) 150 ⁇ ⁇
  • Vitamin B 6 (as pyridoxine hydrochloride) 2.5 mg
  • Vitamin D (as cholecalciferol) 1000 IU
  • Inactive Ingredients microcrystalline cellulose, hydroxypropyl cellulose, modified food starch, croscarmellose sodium, magnesium stearate, sucrose, silicon dioxide, dibasic calcium phosphate, sodium ascorbate, medium chain triglycerides, dl-alpha-tocopherol, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, sucralose, FD&C Blue #2/Indigo Carmine Aluminum Lake.
  • Example 3 Clinical Trial of Representative Compositions disclosed herein
  • a study is undertaken to evaluate the effectiveness of the compositions of the present disclosure in the treatment of patients.
  • the objective of the study is to determine whether oral intake of the compositions results in an improvement of the nutritional status of patients with regard to the specific vitamins and minerals contained in the administered compositions, particularly through improved patient compliance.
  • Vitamin B 6 is measured using high performance liquid chromatography.
  • Vitamin B9 is measured by radioimrmmoas say (RIA), specifically The Solid Phase No Biol Folic Acid Kit (Diagnostic Products, Los Angeles, Calif.).
  • Vitamin B12 is measured by RIA using human intrinsic factor as a binder.
  • Vitamin D is measured using an extraction double-antibody RIA (Dia Sori , Inc., Stillwater, Minn.). Iron levels are measured using standard spectrophotometry. Iodine levels are measured by PLC.
  • total serum homocysteine levels are determined by extraction on the Multi-Prep® gravity series GVSA-100 column, a strong anion exchange gravity flow column, and measurement by gas chromatography/mass spectrometry. Biochemical Diagnostics, Austin, Tex.
  • the 120 subjects are separated into four separate groups of 30 women.
  • each subject is administered one dosage form of the composition as described in Example 2 and having a weight of about 145 rag once a day.
  • each subject is administered one placebo dosage form once a day, the placebo dosage form having a weight of about 800 mg, a typical weight as other commercial!' available prenatal vitamins (i.e., having a greater weight as compared to the compositions disclosed herein).
  • dosage form administration occurs every 24 hours. No other nutritional supplements are taken by the subjects during the assessment period.
  • Detection of the temporal onset of effects is done sequentially by testing for the presence of significant treatment effects at I, 2, 3, 4, 5, and 6 months, proceeding to the earlier time in sequence only when significant effects have been identified at each later time period. Changes from the baseline within each group are evaluated using paired t-tests. In addition, analysis of variance is performed on all. baseline measurements and measurable subject characteristics to assess homogeneity between groups. All statistical procedures are conducted using the Statistical Analysis System (SAS Institute Inc., Gary, N.C.). An alpha level of 0.05 is used in all statistical tests.
  • a study is undertaken to evaluate the effectiveness of the compositions of the present disclosure in the treatment of patients.
  • the objecti ve of the study is to determine whether oral intake of the compositions results in an improvement of the nutritional status of patients with regard to the specific vitamins and minerals contained in the administered compositions, particularly through improved patient compliance.
  • a double-blind, placebo controlled study is conducted over a six-month period.
  • a total of 120 subjects 60 pregnant women entering the second trimester of pregnancy and 60 lactating women), aged 20-35 years, are chosen for the study.
  • An initial assessment of the nutritional status of each woman is conducted.
  • Vitamin B 6 is measured using high performance liquid chromatography.
  • Vitamin B9 is measured by radioimmunoas say (RIA), specifically The Solid Phase No Biol Folic Acid Kit (Diagnostic Products, Los Angeles, Calif.).
  • Vitamin B12 is measured by RIA using human intrinsic factor as a binder.
  • Vitamin D is measured using an extraction double-antibody RIA. (Dia Sorin, Inc., Stillwater, Minn.). Iron levels are measured using standard spectrophotometry. Iodine levels are measured by HPLC.
  • total serum homocysteine levels are determined by extraction on the Multi-Prep® gravity series GVSA-100 column, a strong anion exchange gravity flow column, and measurement by gas chromatography/mass spectrometry. Biochemical Diagnostics, Austin, Tex.
  • the 120 subjects are separated into four separate groups of 30 women.
  • each subject is administered one dosage form of the composition as described in Example 2 and having a volume of about 0.105 cm 3 once a day.
  • each subject is administered one placebo dosage form once a day, the placebo dosage form having a volume of 0.68 cm 3 , a typical volume as other commercially available prenatal vitamins (i.e., having a greater volume as compared to the compositions disclosed herein).
  • dosage form administration occurs every 24 hours. No other nutritional supplements are taken by the subjects during the assessment period.
  • Detection of the temporal onset of effects is done sequentially by testing for the presence of significant treatment effects at 1, 2, 3, 4, 5, and 6 months, proceeding to the earlier time in sequence only when significant effects have been identified at each later time period. Changes from the baseline within each group are evaluated using paired t-tests. In addition, analysis of variance is performed on all baseline measurements and measurable subject characteristics to assess homogeneity between groups. All statistical procedures are conducted using the Statistical Analysis System (SAS Institute Inc., Gary, N.C.). An alpha level of 0.05 is used in all statistical tests.

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  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne des compositions pour la supplémentation nutritionnelle et des procédés d'administration de telles compositions. Ces compositions permettent d'obtenir une plus grande observance de la part des patients. Ces compositions peuvent être utilisées pour administrer une ou plusieurs vitamines et/ou un ou plusieurs minéraux et/ou oligo-éléments.
PCT/US2014/035727 2014-04-28 2014-04-28 Compositions pour la supplémentation nutritionnelle Ceased WO2015167434A1 (fr)

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WO2023084177A1 (fr) * 2021-11-11 2023-05-19 Nutri-Genetix Limited Compositions nutritionnelles

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WO2004091317A1 (fr) * 2003-04-17 2004-10-28 Boehringer Ingelheim International Gmbh Supplement multivitamines/mineraux pour femmes enceintes
US20050037065A1 (en) * 1999-05-27 2005-02-17 Drugtech Corporation Nutritional formulations
WO2006031420A2 (fr) * 2004-08-27 2006-03-23 Spherics, Inc. Comprimes multicouche et formes posologiques bioadhesives
US20140010914A1 (en) * 2003-08-21 2014-01-09 Duchesnay Inc. Micronutrient supplement

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US20050037065A1 (en) * 1999-05-27 2005-02-17 Drugtech Corporation Nutritional formulations
WO2004091317A1 (fr) * 2003-04-17 2004-10-28 Boehringer Ingelheim International Gmbh Supplement multivitamines/mineraux pour femmes enceintes
US20140010914A1 (en) * 2003-08-21 2014-01-09 Duchesnay Inc. Micronutrient supplement
WO2006031420A2 (fr) * 2004-08-27 2006-03-23 Spherics, Inc. Comprimes multicouche et formes posologiques bioadhesives

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023084177A1 (fr) * 2021-11-11 2023-05-19 Nutri-Genetix Limited Compositions nutritionnelles

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