Synergistic nutritional neuroprotective compositions for ameliorating neural dysfunction
Inventors
PALKAR, Jotiram • Tongra, Rajendra Prasad
Assignees
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Publication Number
US-11285167-B2
Publication Date
2022-03-29
Expiration Date
Abstract
The present invention disclosed herein provides synergistic nutritional neuroprotective compositions for ameliorating neural dysfunction. Particularly, the invention relates to synergistic, efficient, nutritional composition for comprising specific combination of decarboxylated L-arginine called agmatine sulphate and nicotinamide riboside chloride, wherein agmatine sulphate and nicotinamide riboside chloride are present in the weight ratio of 1:0.05 to 1:2 along with pharmaceutically acceptable excipients. More particularly, the present invention offers synergistic effect for ameliorating neural dysfunction encompasses cerebrovascular diseases, neurodevelopmental disorders, mood disorders, mental health disorders and like thereof.
Core Innovation
The invention provides a nutritional neuroprotective composition that contains an exogenous synergistic blend of agmatine sulphate and nicotinamide riboside chloride. The composition is administered orally as a therapeutically effective amount using pharmaceutically acceptable excipients, and the blend is present in a weight ratio of 1:0.1 to 1:1.
The method is directed to reducing tumour necrosis factor (TNF) alpha levels in a subject in need. Through the described reduction of TNF alpha, the method thereby treats depression or autism in the subject in need thereof, and is connected to modulation of NOS/SIRT1-related pathways, including eNOS activation and nNOS/iNOS inhibition via NF-κB deacetylation.
The described neuroprotective activity is also linked to NMDAR and mTOR-related pathways and to energy metabolism, including reductions in glycolysis/Warburg-like metabolism and improved mitochondrial activity. In the documented examples, neuroinflammation markers such as TNF alpha and interleukin-6 are reduced, and additional tissue and behavioral/biochemical outcomes are reported.
Claims Coverage
The independent claim covers an oral method using a therapeutically effective amount of a nutritional neuroprotective composition with an exogenous synergistic blend of agmatine sulphate and nicotinamide riboside chloride at a defined weight ratio, including a quantified TNF alpha level reduction target and use for treating depression or autism. Dependent claims further constrain the weight percentages of each component, define excipient categories and ranges, specify an oral unit dose range, and add a quantified interleukin-6 reduction target.
Exogenous synergistic blend of agmatine sulphate and nicotinamide riboside chloride
A nutritional neuroprotective composition comprising an exogenous synergistic blend of agmatine sulphate and nicotinamide riboside chloride.
Oral administration of a therapeutically effective amount
Orally administering a therapeutically effective amount of the nutritional neuroprotective composition, along with pharmaceutically acceptable excipients.
Weight ratio for the synergistic blend
The agmatine sulphate and the nicotinamide riboside chloride are present in a weight ratio of 1:0.1 to 1:1.
Reduction of TNF alpha levels with treatment of depression or autism
Reducing tumour necrosis factor (TNF) alpha levels in a subject in need, thereby treating depression or autism in the subject in need thereof.
Agmatine sulphate weight-percentage constraint
Agmatine sulphate is present at 45% to 90% by weight of the total composition.
Nicotinamide riboside chloride weight-percentage constraint
Nicotinamide riboside chloride is present at 10% to 45% by weight of the total composition.
Excipients defined by categories and weight-percentage ranges
Pharmaceutically acceptable excipients are selected from defined categories including diluent, binder, lubricant, glidant, additive, surfactant, and stabilizer, used at specified weight-percentage ranges by weight of the total composition.
Oral unit dose range
Orally administering the composition as a unit dose of about 25 to 1000 mg.
Reduction of interleukin-6 levels
Reducing interleukin-6 levels in the subject in need.
Across the independent and dependent claim set, the coverage centers on an oral nutritional neuroprotective composition using an exogenous synergistic blend of agmatine sulphate and nicotinamide riboside chloride at a specified weight ratio, with TNF alpha reduction used to treat depression or autism. Dependent claims further narrow the formulation by specifying weight-percent ranges for each active, defining categories and ranges of pharmaceutically acceptable excipients, setting an oral unit dose range, and adding interleukin-6 reduction.
Stated Advantages
Reduces tumour necrosis factor (TNF) alpha levels in a subject in need.
Thereby treats depression or autism in a subject in need thereof.
Reduces interleukin-6 levels in the subject in need.
Documented Applications
Treating depression in a reserpine-induced depression model, with improved forced swim/open field outcomes reported.
Treating an autism-like condition in a valproic-acid model, with improved behavioral and biochemical measures reported.
Neuroprotective application in cerebral ischemia/stroke, with reduced TNF-alpha and IL-6 and improved TTC brain injury staining in ischemia-reperfusion reported.
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