Dual iron containing nutritional supplement

Details Dual iron containing nutritional supplement Dual iron containing nutritional supplement

2000-03-31

2003-02-18

Page, Thurman K. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Food or edible as carrier for pharmaceutical

C424S441000, C424S451000, C424S452000, C424S457000, C424S464000, C424S465000, C424S468000, C424S489000, C426S073000, C426S074000, C514S276000, C514S251000

Reexamination Certificate

active

06521247

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a nutritional supplement and, particularly, to an oral nutritional supplement which contains two or more forms of iron. The nutritional supplement can also include vitamins, non-ferrous minerals, and other ingredients.
BACKGROUND OF THE INVENTION
Vitamin, multi-vitamin, and/or mineral preparations are commonly administered to inhibit, to prevent, or to reduce the frequency or severity of (i.e. “to alleviate”) specific medical disorders. In particular, iron-containing preparations are used to alleviate disorders related to iron deficiency (e.g. anemia). Such preparations are also used as nutritional supplements. Pregnant women, in particular, are known to require significant dietary supplementation with iron, vitamins (e.g. folic acid), and non-ferrous minerals to minimize the risk of birth deformities in the fetus, to improve the chances of a successful delivery and to improve birth weight of the fetus. Pregnant and lactating women commonly require iron to alleviate or treat iron-deficiency anemia. Indeed, various patents are directed to improving the efficacy of iron supplementation during pregnancy.
In addition to their use in pregnant and lactating women, iron supplements containing vitamins, minerals, or both are well known and are used as sources of dietary iron to treat or prevent iron deficiency in mammals. These iron supplements generally include a single form of iron, for example, an iron (II) salt (i.e. a salt containing divalent or ferrous iron), an iron (III) salt (i.e. a salt containing trivalent or ferric iron), or iron (0) powder (e.g. carbonyl iron, typically made by heating gaseous iron pentacarbonyl, Fe(CO)
5
, which deposits metallic iron as submicroscopic crystals that form microscopicspheres). The iron in known supplements has been delivered in rapid release forms and in controlled release dosage forms.
Prior art nutritional supplements containing a rapid release dosage form of iron have generally contained a rapidly dissolving iron salt, since certain iron salts are significantly more soluble in water and gastrointestinal fluids than other salts and metallic forms of iron. Administration of rapid release dosage forms can cause excessively high C
max
values (maximum concentration of iron in blood) in patients and short T
max
values (time elapsed between administration of the supplement and attainment of C
max
). These formulations can cause unpleasant, harmful, or even fatal side effects (Crosby, 1978, Arch. Intern. Med. 138:766-767). By way of example, such side effects include stomach irritation, constipation, and iron poisoning. Toxic side effects of iron can be attributed to the high solubility and the high dissolution rate of certain iron salts (e.g. ferrous sulfate) in the gastrointestinal tract. The incidence of accidental iron poisoning (e.g. by young children who ingest prenatal vitamin supplements) could be reduced by reducing the amount of highly soluble iron in iron supplements, or by removing such forms of iron from the supplement.
Prior art controlled release dosage forms of iron-containing nutritional supplements have generally used an iron (II) salt encapsulated in or mixed with a release rate modifying matrix, one of certain iron (III) salts which exhibit poor solubility, carbonyl iron or one of the other metallic forms of iron (which also exhibit poor solubility), a certain crystalline form of iron oxide, or an iron salt or carbonyl iron complexed with a protein, an amino acid, an organic acid, a natural polymer, an anionic complexing agent, or a synthetic polymer. Administration of known controlled release dosage forms generally results in temporary reductions of blood iron levels between consecutive doses. These temporary reductions can be due to the tapered delivery rate of iron from a first dose coupled with a delayed, or slow initial, delivery of iron from a second dose. At least certain supplements designed to provide sustained delivery of iron have been associated with unpleasant tastes and odors, nausea, stomach irritation, and gas formation (e.g. manifested as eructation).
Commercially available iron supplements include, for example, GERITOL™, FERROCONTIN CONTINUS™, FERRO RETARD™, FERRONICUM™, DUROFERON® DURETTER®, DUROFERON® DURULES®, TARDYFERON™, ERYFER™, FE-PM™, FERRO-GRADUMET™, FEOSPAN™ SPANSULE™, FERROGRAD™, HEMOFER™, NATALINS RX™, PRENATAL1/1™, STUARTNATAL PLUS™, PRENATE 90™, ONE-A-DAY™, PROFERDEX™, DEXFERRUM™, INFED™ and PLEXAFER™-F, among others.
U.S. Pat. No. 4,752,479 to Briggs et al. discloses a multi-vitamin and mineral dietary supplement which includes (a) one or more divalent dietary mineral components such as calcium or magnesium; (b) vitamins; and (c) a bioavailable iron component, presented in a controlled release form and adapted to be released in a controlled manner in the gastrointestinal tract.
U.S. Pat. No. 5,869,084 to Paradissis et al. discloses multi-vitamin and mineral supplements for women which are designed to meet the nutritional requirements for women at the various stages of their lives.
U.S. Pat. No. 5,494,678 to Paradissis et al. discloses multi-vitamin and mineral supplements for pregnant women which are designed to maximize fetal development and maternal health during each trimester of pregnancy.
U.S. Pat. No. 3,975,513 to Hecht et al. discloses a sustained released iron-containing supplement for prophylaxis against trace elemental deficiency diseases in animals. The iron supplement is shaped and sized so as to be retained in the stomach of the animal, and includes an acid-resistant sustained release plastic coating.
Chewable multi-vitamin tablets and powdered multi-vitamin dietary supplements are well known in the nutritional products industry. These vitamin-containing products are intended to provide a nutritious and bioavailable product while at the same time providing a product with good palatability, or organoleptic effect. Generally, however, the more vitamins and minerals a product contains the less palatable the product is.
Taste-masking technology has been developed for preparation of palatable chewable multi-vitamin tablets. This technology generally requires encapsulation of vitamins in the tablet or addition of sugars, sweeteners, acceptably flavored agents, or some combination of these, to the vitamin-containing composition before it is formulated into a tablet.
U.S. Pat. No. 4,684,534 to Valentine discloses a quick-liquefying chewable tablet which resists absorption of moisture but quickly liquefies and melts in the mouth once it has been chewed. This tablet is highly palatable and can contain vitamins.
There is a significant, continuing need for an iron supplement which can be administered to a human patient in order to safely and efficaciously deliver a nutritionally relevant amount of iron to the patient. In view of safety (e.g. accidental poisoning) and patient compliance issues (e.g. failure to consistently ingest iron supplements, owing to unpleasant side effects, unpleasant taste or odor, inconvenient tablet size, or some combination of these) which exist with regard to prior art iron supplements, a particular need remains for an iron supplement having a reduced risk of accidental poisoning, reduced side effects, and greater patient acceptance, which can lead to improved patient compliance with a dosing regimen. The present invention satisfies these needs.
SUMMARY OF THE INVENTION
The present invention relates to a nutritional supplement intended for administration to a human (although it can be administered to another animal). The supplement contains at least two iron compounds, namely a slowly dissolving pharmaceutically acceptable iron compound and a rapidly dissolving pharmaceutically acceptable iron compound. The supplement can also contain one or more vitamins, one or more non-ferrous minerals, or some combination of these. By way of example, the supplement can contain folic acid (e.g. such that a daily dose of the supplement comprises at least about 1 milligram of folate or a salt thereof).
Preferably, a daily

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