Synergistic nutritional compositions for pain management
Inventors
Dhamane, Dhiraj • Tongra, Rajendra Prasad
Assignees
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Publication Number
US-10653737-B1
Publication Date
2020-05-19
Expiration Date
Abstract
The present invention discloses a synergistic nutritional composition(s) for pain management. Particularly, the invention relates to synergistic nutritional composition comprising specific combination of palmitoylethanolamide (PEA) and standardized red spinach extract enriched with nitrate content, present in the ratio of 1:0.1 to 1:5 along with pharmaceutically acceptable carriers/excipients. More particularly the invention discloses synergistic nutritional composition comprising combination of PEA and nitrate of the red spinach extract, which are present in the ratio of 1:0.01 to 1:0.5. Further the instant synergistic composition is useful for treating neuropathic pain, particularly in the treatment of subject suffering with diabetic peripheral neuropathy and/or small fiber neuropathy.
Core Innovation
The invention relates to a synergistic nutritional composition(s) for treating neuropathic pain. The composition comprises a therapeutic exogenous blend of palmitoylethanolamide (PEA) and a standardized red spinach extract with enriched nitrate content, together with pharmaceutically acceptable excipients. The therapeutic blend is defined by specific ratios between PEA and the nitrate-enriched standardized red spinach extract and between PEA and the nitrate derived from the standardized red spinach extract.
The standardized red spinach extract is defined as being enriched in nitrate content, with nitrate present in the extract and in a defined relationship to the overall composition. The ratio ranges specify that PEA and the standardized red spinach extract with enriched nitrate content are present at 1:0.1 to 1:5, and that PEA and nitrate of the standardized red spinach extract are present at 1:0.01 to 1:0.5. Additional parameters described in the dependents define nitrate content levels and include characterization of nitrate as inorganic nitrate and/or organic nitrate.
The invention also describes a method of treatment involving oral administration of a therapeutically effective amount of the nutritional composition. The method is directed to neuropathic pain and includes embodiments focused on diabetic peripheral neuropathy and/or small fiber neuropathy. The document further describes measurable biological and functional outcomes for the combination, including improved analgesic activity versus a control and increased endothelial nitric oxide synthase (eNOS) expression associated with the composition.
Claims Coverage
The document provides two independent claims. Both claims center on a PEA and standardized red spinach extract with enriched nitrate content composition defined by specific component ratios, and the method claim further specifies oral administration for neuropathic pain.
Exogenous synergistic PEA and nitrate-enriched standardized red spinach blend
A synergistic nutritional composition(s) for treating neuropathic pain comprising a therapeutic exogenous blend of palmitoylethanolamide (PEA) and standardized red spinach extract with enriched nitrate content, along with pharmaceutically acceptable excipients.
Defined PEA-to-extract and PEA-to-nitrate ratios
The PEA and the standardized red spinach extract with enriched nitrate content are present in the ratio of 1:0.1 to 1:5; and PEA and nitrate of the standardized red spinach extract are present in the ratio of 1:0.01 to 1:0.5.
Oral administration method for neuropathic pain
A method of treatment of neuropathic pain in a subject in need thereof, the method comprising oral administration of therapeutically effective amount of a nutritional composition comprising an exogenous synergistic blend of palmitoylethanolamide (PEA) and standardized red spinach extract enriched with nitrate content, along with pharmaceutically acceptable excipients.
Defined ratios in the treatment method
The PEA and the standardized red spinach extract enriched with nitrate content are present in the ratio of 1:0.2 to 1:2; and PEA and nitrate of standardized red spinach extract are present in the ratio of 1:0.02 to 1:0.2.
Across the independent claims, the core inventive coverage is the use of an exogenous synergistic nutritional composition combining PEA with a nitrate-enriched standardized red spinach extract, where specific PEA-to-extract and PEA-to-nitrate ratios define the composition. The second independent claim further covers treating neuropathic pain by orally administering a therapeutically effective amount of that composition, with additional dependent claim limitations directed to specific neuropathic pain indications and biological readouts.
Stated Advantages
Improves analgesic activity versus a control (as recited in dependent claim performance thresholds).
Increases eNOS expression versus a control (as recited in dependent claim biological readouts).
Documented Applications
Treating neuropathic pain in a subject in need thereof, including embodiments for diabetic peripheral neuropathy and/or small fiber neuropathy.
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