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Compositions and methods for nutrition supplementation

a technology applied in the field of compositions and methods for nutrition supplementation, can solve the problems of poor or even non-compliance with dosing regimens, negative impact on treatment efficiency, and 50% of the population's problems with whole tablet swallowing, etc., to promote administration and compliance. , the effect of improving the effect of complian

Inactive Publication Date: 2006-02-16
EVERETT LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0005] The present invention provides compositions and methods of using these compositions for both prophylactic and therapeutic nutritional supplementation. Specifically, for example, the present invention relates to novel compositions of vitamins and minerals that can be used to supplement the nutritional deficiencies observed in patients undergoing physiologically stressful states such as, for example and without limitation, pregnancy, lactation, and any disease state. The compositions of the present invention may be in a swallowable, chewable or dissolvable form according to an individual patient's preference. Choice in dosage form promotes ease of administration and compliance with dosing regimens.
[0009] In another specific embodiment, the compositions of the present invention may be substantially free of added vitamin A; substantially free of added beta carotene; substantially free of added vitamin B1; substantially free of added vitamin B2; substantially free of added vitamin B3; substantially free of added vitamin B6; substantially free of added vitamin B9; substantially free of added vitamin B12; substantially free of added vitamin C; substantially free of added vitamin D3; substantially free of added vitamin E; substantially free of added iron; substantially free of added magnesium; and / or substantially free of added zinc.
[0018] In another embodiment of the present invention, the compositions may be suitable for administration to subjects in physiologically stressful states, such as those resulting from pregnancy, lactation or disease states. Such compositions may be suitable for treating nutritional deficiencies resulting from such physiologically stressful states, which may result from, for example and without limitation, elevated metabolic demand, increased plasma volume, or decreased concentrations of nutrient-binding proteins such as, for example and without limitation, serum-ferritin, maltose-binding protein, lactoferrin, calmodulin, tocopheryl binding protein, riboflavin binding protein, retinol binding protein, transthyretin, high density lipoprotein-apolipoprotein A1, folic acid binding protein and 25-hydroxyvitamin D binding protein.
[0032] In another embodiment of the present invention, the methods may utilize compositions suitable for administration to subjects in physiologically stressful states, such as those resulting from, for example and without limitation, pregnancy, lactation or disease states. Such compositions may be suitable for treating nutritional deficiencies resulting from such physiologically stressful states, which may result from, for example and without limitation, elevated metabolic demand, increased plasma volume, or decreased concentrations of nutrient-binding proteins such as serum-ferritin, maltose-binding protein, lactoferrin, calmodulin, tocopheryl binding protein, riboflavin binding protein, retinol binding protein, transthyretin, high density lipoprotein-apolipoprotein A1, folic acid binding protein and 25-hydroxyvitamin D binding protein.

Problems solved by technology

Further, while some patients may prefer swallowable dosage forms, it is estimated that 50% of the population has problems swallowing whole tablets.
These problems can lead to poor, or even noncompliance, with dosing regimens and thus have negative impacts on treatment efficiency.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

A composition of the Following Formulation Was Prepared in Chewable Form

[0089]

Vitamin A (acetate)1100IUBeta Carotene600IUVitamin B1 (thiamine mononitrate)1.6mgVitamin B2 (riboflavin)1.8mgVitamin B3 (niacinamide)15mgVitamin B6 (pyridoxine hydrochloride)2.5mgVitamin B9 (folic acid)1000μgVitamin B12 (cyanocobalamin)5μgVitamin C (ascorbic acid)60mgVitamin D (cholecalciferol)400IUVitamin E (d-alpha-tocopheryl acetate)30IUIron (polysaccharide complex)29mgMagnesium (magnesium oxide)25mgZinc (zinc oxide)15mg

example 2

[0090] A study is undertaken to evaluate the effectiveness of the compositions of the present invention 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.

[0091] 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 A, beta carotene and vitamin B6 are measured using high performance liquid chromatography. Erythrocyte transketolase activity is used to measure vitamin B1 levels. Vitamin B2 levels are determined by assessment of erythrocyte glutathione reductase activity. Vitamin B3 levels are assessed by measu...

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Abstract

The present invention relates to compositions that may be swallowable, chewable or dissolvable, comprising various vitamins and minerals, and in a specific embodiment comprising vitamin A, beta carotene, B-complex vitamins, vitamin C, vitamin D3, vitamin E, iron, magnesium and zinc, and methods for using these compositions for nutritional supplementation in subjects undergoing physiologically stressful events, such as, for example and without limitation, pregnancy, lactation or any disease state.

Description

FIELD OF THE INVENTION [0001] The present invention relates to compositions, that may be swallowable, chewable and / or dissolvable, comprising various vitamins and minerals, and methods for using these compositions for nutritional supplementation in, for example, subjects in physiologically stressful states. BACKGROUND OF THE INVENTION [0002] Nutrition plays a critical role in maintaining good health. Proper nutrition prevents dietary deficiencies, and also protects against the development of disease. When the body faces physiological stress, proper nutrition plays an increasingly important role. For example, pregnancy and lactation are among the most nutritionally volatile and physiologically stressful periods and processes in the lifetimes of women. Vitamin and mineral needs are almost universally increased during these natural processes. Increased vitamin and mineral needs during these times are almost always due to elevated metabolic demand, increased plasma volume, increased lev...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/525A61K31/51A61K31/4415A61K31/455A61K31/375A61K31/355A61K31/714A61K31/015A23L27/12A23L27/30A23L33/155
CPCA61K33/30A61K31/715A61K31/4406A61K31/07A61K45/06Y10S514/904A61K33/26A61K33/08A61K33/06A61K31/714A61K31/593A61K31/525A61K31/519A61K31/51A61K9/0056A61K31/015A61K31/355A61K31/375A61K31/4415A61K31/455A61K2300/00A61P3/02A61K9/20A61K9/0053A61K47/34
Inventor GIORDANO, JOHN A.BALZER, CHARLES J.
Owner EVERETT LAB
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