Magnesium compositions and uses thereof for neurological disorders
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Publication Number
US-9737563-B2
Publication Date
2017-08-22
Expiration Date
Abstract
A composition for administration to a subject, such as oral administration to a subject, for example, has been provided. Such a composition may comprise at least one magnesium-counter ion compound. A magnesium-counter ion composition described herein may be useful for any of a variety of applications provided herein, such as maintaining, enhancing, and/or improving health, nutrition, and/or another condition of a subject, and/or cognitive, learning, and/or memory function. A magnesium-counter ion composition provided herein may be useful for administration to a subject presenting magnesium deficiency, mild cognitive impairment, Alzheimer's disease, attention deficit hyperactivity disorder, ALS, Parkinson's disease, diabetes, migraine, anxiety disorder, mood disorder, and/or hypertension. A kit, method, and other associated technology are also provided.
Core Innovation
The document discloses magnesium threonate supplementation and magnesium-counter ion compositions for oral administration to a subject, including magnesium threonate as a magnesium-counter ion compound and magnesium-comprising components that pair magnesium with a threonate counter ion. The compositions optionally include non-acidified milk and other bioavailability enhancers, and the patent discusses compositional characteristics such as solubility and pH targets and magnesium/counter-ion specification parameters.
The document addresses magnesium deficiency and associated neurological/cognitive disorders and other conditions by formulating dosage forms that increase magnesium absorption and bioavailability under specified conditions. It emphasizes administration in connection with fasting conditions and targets physiological magnesium levels, while describing concentration targets and dosing framework elements tied to physiological magnesium and urinary magnesium excretion.
The document further reports preclinical and analytical findings intended to support magnesium-threonate-related benefits, including improvements in short-term memory and sustained learning, antidepressant-like effects, lifespan extension in Drosophila, and synaptic protection in AD mice. It also describes measurements of brain magnesium concentration, relationships between magnesium intake and blood levels and cognitive outcomes, and a calmagite-based assay approach together with a multi-compartment fasting-based model for dosage prediction and monitoring.
Claims Coverage
The provided claim set includes one independent claim focused on a topical magnesium threonate dosage form, with dependent claims refining the dosage form structure, included excipients, and dosing ranges, and with at least one dependent claim directed to treating specified subject conditions.
Topical magnesium threonate dosage form
A dosage form formulated for topical administration to a subject, wherein the dosage form comprises magnesium threonate.
Minimum magnesium threonate amount in the dosage form
The dosage form comprises at least 0.1 mg magnesium threonate.
Elemental magnesium dosing range in the dosage form
The dosage form comprises elemental magnesium administered at about 1.5 to about 9 mg/kg of body weight per day.
Transdermal patch dosage form
The dosage form is a transdermal patch.
Specific pharmaceutically acceptable excipient set
The dosage form includes a pharmaceutically acceptable excipient selected from lactose, microcrystalline cellulose, silicon dioxide, titanium dioxide, stearic acid, starch, sodium starch glycolate, povidone, pregelatinized starch, croscarmellose, ethylcellulose, calcium phosphate, talc, sucrose, calcium stearate, hydroxy propyl methylcellulose, shellac, or any combination thereof.
Treatment of specified conditions using the magnesium threonate dosage form
The method treats a subject who has one of several specified conditions, including magnesium deficiency and various neurological and psychiatric and other diseases.
Overall, the independent claim centers on a topical, including transdermal patch, dosage form comprising magnesium threonate, with dependent features specifying minimum magnesium threonate content, an elemental magnesium dosing range, named excipients, and intended treatment of subjects having magnesium deficiency and listed neurological, psychiatric, and other conditions.
Stated Advantages
Dose- and plasma/basal magnesium level-dependent improvements in short-term memory and sustained learning.
Improved magnesium absorption/bioavailability, including increased serum magnesium.
Effects are reported to last months to 15 months.
Forced swim test indicates antidepressant-like effects correlated with magnesium threonate intake.
Lifespan extension is reported across tested MgT doses in Drosophila.
Basal plasma magnesium after 12-hour fasting is described as a better indicator than post-meal magnesium peaks.
The document states that magnesium threonate better targets brain magnesium than magnesium gluconate in milk.
Synaptic protection is reported in AD mice, with magnesium threonate preserving synapses versus untreated AD.
Documented Applications
Preclinical behavioral testing in AD mice/rats, including novel object recognition and Morris/water maze assays, to support improvements in short-term memory and sustained learning.
Forced swim test use in the reported experiments to assess antidepressant-like effects correlated with magnesium threonate intake.
Drosophila lifespan studies to evaluate lifespan extension across tested MgT doses.
Human magnesium quantification guidance using a calmagite-based assay for plasma/urine and comparison of urine excretion bioavailability among magnesium gluconate (± milk) and magnesium diglycinate.
Linking dietary magnesium intake to brain magnesium concentration (ICP-OES) and correlating brain magnesium with cognitive function in AD mouse experiments.
Synaptic density assessment in AD mice via electron microscopy in the dentate gyrus to evaluate synaptic protection with magnesium threonate.
Use of a multi-compartment fasting-based model relating extracellular magnesium concentration to urine excretion and supplement requirements, including equations for dosage prediction and a proposed monitoring/feedback concept.
Addressing magnesium deficiency and neurological/cognitive disorders such as MCI and Alzheimer’s disease, including treatment contexts involving ADHD, ALS, and Parkinson’s disease.
Addressing metabolic/cardiovascular conditions including diabetes, migraine, anxiety/mood disorder/depression, and hypertension.
Topical administration applications via a dosage form comprising magnesium threonate, including a transdermal patch embodiment.
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