High-loading, controlled-release magnesium oral dosage forms and methods of making and using same

Abstract

Disclosed are high-loading, controlled-release dosage forms for oral administration of magnesium salts. For example, an oral dosage form can comprise from about 80% to about 95% magnesium lactate and one or more components. As another example, an oral dosage form can comprise at least about 50% magnesium salt and exhibit a controlled release dissolution profile. Also disclosed are methods for making controlled release dosage forms for oral administration of a therapeutically effective amount of magnesium salt to a mammal. Also disclosed are methods for treating a disorder characterized by magnesium deficiency and methods for preventing or alleviating low magnesium levels. This abstract is intended as a scanning tool for purposes of searching in the particular art and is not intended to be limiting of the present invention.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Patent Application Serial No. 61 / 054,305, filed May 19, 2008, which is hereby incorporated by reference in its entirety. Background technique [0003] Magnesium is the fourth most abundant in the human body - the second most abundant - cation in the intercellular environment, and participates in more than three hundred enzymatic reactions. Magnesium is also important for the proper function of many body organs, including the heart and kidneys. Magnesium deficiency has been linked to a wide range of diseases and conditions, including heart disease, irregular heartbeats, diabetes, migraines and osteoporosis. These symptoms affect a large number of people in the United States alone. [0004] Unfortunately, many of the magnesium salts currently used orally for the treatment of magnesium deficiency, such as magnesium oxide, magnesium chloride, magnesium sulfate, magnesium gluconate, or...

AI Technical Summary

Problems solved by technology

Unfortunately, traditional oral formulations of magnesium do not provide satisfactory control of the targeted release of magnesium to these parts of the digestive tract; therefore, optimal absorption is not achieved in magnesium-deficient patients using traditional formulations

[0008] Because the traditional magnesium salt preparation process cannot provide high bioavailability, high drug loading and controlled release characteristics in a single preparation, there is still a need for a high-load, high bioavailability controlled-release oral drug formulation of magnesium salt and its Method of preparation and use

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