Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
2001-11-19
2003-06-17
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
Reexamination Certificate
active
06579905
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates generally to the prevention or treatment of hypomagnesemia in pediatric patients and in patients with gastric tubes (G-tubes) or nasogastric tubes (NG-tubes). More particularly, the present invention relates to the administration of a powder concentrate magnesium supplement via a G-tube or NG-tube to patients in need thereof. The present invention also allows for the easy administration of a magnesium supplement to pediatric patients in need thereof.
Magnesium is essential for all living organisms and is required for over 300 different metabolic processes. For example, magnesium helps regulate the release of insulin by facilitating the activation of a tyrosine protein kinase receptor. In hypomagnesemic patients, the ability of insulin to activate the protein kinase receptor is impaired, which results in reduced peripheral glucose uptake. In addition, magnesium is a calcium antagonist and displaces calcium from cellular membrane receptors and enzymatic binding sites. One such example is the competition between calcium and magnesium for binding sites of troponin C, which is involved in muscle contractions. When magnesium binds to this receptor, it effectuates a smaller conformational change than if calcium binds to the receptor. Finally, one the mechanisms responsible for cardiac muscle contraction is the sodium/potassium pump. The driving force of this pump is a magnesium-dependant ATPase, which splits ATP. This in turn provides the energy needed for active ion transport. These are only a few of the many examples of magnesium's role in the human body.
Due to its involvement in so many cellular processes, magnesium deficiency has been shown to be associated with several disease states, including Type I and Type II diabetes, hypertension, cerebral and myocardial infarctions, atheroschlerosis, osteoporosis, PMS (headaches, fluid retention and mood changes), muscle cramps, and bipolar disorder. Furthermore, many prescription medications deplete the body of magnesium. These include, but are not limited to: loop diuretics, Thiazide diuretics, Corticosteroids, Glycosides and Estrogens and Estrogen derivatives.
Patients taking magnesium-depleting medications are often advised to supplement with oral magnesium. Magnesium supplementation is difficult because the current magnesium formulations on the market have low bioavailability and are not readily absorbed. Furthermore, these supplements often cause diarrhea.
One of the biggest problems, however, is the supplementation of pediatric patients, who are unable to swallow tablets, and patients with G-tubes or NG-tubes who are unable to take medication orally. Presently, health care providers must pulverize magnesium tablets to supplement pediatric patients and patients with G-tubes or NG-tubes. Not only is this process time consuming but it also compromises the absorption and efficacy of the product.
Therefore, a need exists for an improved composition and method for the prevention and treatment of hypomagnesemia in pediatric patients and patients with G-tubes and NG-tubes.
SUMMARY OF THE INVENTION
The present invention provides an improved method for the prophylaxis and treatment of hypomagnesemia in pediatric patients and in patients with G-tubes and NG-tubes. Particularly, the present invention provides an absorbable and bioavailable form of magnesium that can be effectively administered to pediatric patients and patients with G-tubes or NG-tubes in order to raise the blood levels of magnesium in such patients.
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Geppert Caren D
McMains Michael B.
Siegel Missy L.
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