Compositions and methods for nutrition supplementation

Inventors

Giordano, John A. • Balzer, Charles J.

Assignees

EXELTIS USA Inc

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Publication Number

US-7560123-B2

Patent

Publication Date

2009-07-14

Expiration Date


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.

Core Innovation

The invention relates to vitamin-and-mineral nutritional supplement compositions for subjects during physiologically stressful states. The compositions are provided in swallowable, chewable, or dissolvable dosage forms for administration to subjects, and are formulated to include specific vitamins and minerals together as a single nutritional supplement.

The compositions include vitamin A, beta carotene, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B9, vitamin B12, vitamin C, vitamin D3, vitamin E, and the minerals iron, magnesium, and zinc, together with one or more pharmaceutically acceptable carriers. The compositions can also include sweetening agents, flavorants, and excipients.

The problem addressed is nutritional supplementation during physiologically stressful states, including pregnancy, lactation, and disease state, where improvement in measured vitamin and mineral nutritional status is desired. A double-blind placebo-controlled six-month study in pregnant/lactating subjects shows statistically significant improvement in measured vitamin/mineral nutritional status following oral administration of the compositions.

Claims Coverage

The partial content provides one independent claim directed to a vitamin-and-mineral composition, with dependent claims refining quantitative nutrient details and optionally narrowing to patient administration. The inventive feature is the specific set of vitamins and minerals combined with pharmaceutically acceptable carriers.

Vitamin-and-mineral composition with specified nutrients and pharmaceutically acceptable carriers

A composition consisting of vitamin A, beta carotene, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B9, vitamin B12, vitamin C, vitamin D3, vitamin E, iron, magnesium, zinc and one or more pharmaceutically acceptable carriers.

The claim coverage is focused on a single combined vitamin-and-mineral composition containing the named vitamins and minerals, formulated with one or more pharmaceutically acceptable carriers. Dependent claims further refine the composition by specifying quantitative nutrient constraints and include embodiments that administer the claimed composition to a patient.

Stated Advantages

Statistically significant improvement in measured vitamin/mineral nutritional status in pregnant/lactating subjects following oral administration of the compositions.

Documented Applications

Nutritional supplementation for subjects during physiologically stressful states, including pregnancy and lactation.

Nutritional supplementation during disease state [procedural detail omitted for safety].

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