Controlling neuropathic pain
Inventors
SINGH, Ankit Shyam • MISHRA, Vedprakash • TONGRA, Neelima
Assignees
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Publication Number
US-12138242-B1
Publication Date
2024-11-12
Expiration Date
Abstract
The present application describes a method of treating neuropathic pain in a patient. The method includes a step of administering a pharmaceutical composition to the patient. The pharmaceutical composition consists of one or more pharmaceutically acceptable excipients, Palmitoylethanolamide (PEA) ranging from 35 to 80% by weight, one or more naturally occurring Fatty Acid Amide Hydrolase (FAAH) Inhibitors ranging from 0.5 to 40% by weight, and optionally a vitamin and/or a co-enzyme. The combination of PEA and the one or more naturally occurring FAAH inhibitors in the administered pharmaceutical composition act synergistically to reduce neuropathic pain in the patient.
Core Innovation
The invention relates to a pharmaceutical composition for treating neuropathic pain. The composition comprises palmitoylethanolamide (PEA) and naturally occurring fatty acid amide hydrolase (FAAH) inhibitors, with the combination of the components acting synergistically to reduce neuropathic pain.
A described embodiment provides an oral pharmaceutical composition containing micronized or non-micronized PEA in a defined amount range together with a defined amount range of one or more naturally occurring FAAH inhibitors. The naturally occurring FAAH inhibitors include genistein/daidzein and other listed compounds, and the combination of PEA with the natural FAAH inhibitor(s) is described as synergistically reducing neuropathic pain.
The document also describes optional formulation components such as vitamins and/or coenzymes, and provides formulation options including oral dosage forms such as tablets, capsules, granules, sachets, and modified release formulations. It further describes stability and dissolution outcomes for example compositions and a peripheral neuropathy study in which PEA combined with daidzein and genistein is reported to improve neuropathy-related outcomes compared with single components and to be comparable to pregabalin.
Claims Coverage
The partial content contains one independent claim (clm-00001). It covers a specific synergistic neuropathic-pain-reducing pharmaceutical composition defined by weight percentages of micronized PEA, daidzein, and genistein, together with one or more pharmaceutically acceptable excipients; dependent claims further refine excipient selection, excipient ranges, and dosage forms.
Synergistic neuropathic-pain-reducing composition with micronized PEA, daidzein, and genistein
A pharmaceutical composition comprising micronized palmitoylethanolamide (PEA), daidzein, genistein, and one or more pharmaceutically acceptable excipients, wherein the combination of PEA, genistein, and daidzein acts synergistically to reduce neuropathic pain.
Excipient selection from specified formulation excipient types
The composition of the synergistic neuropathic-pain-reducing composition including pharmaceutically acceptable excipients selected from specified formulation excipient types.
Weight-percentage ranges for multiple excipients (or quantity-sufficient solvent)
The composition of the synergistic neuropathic-pain-reducing composition defined with specified weight-percentage ranges for excipients including diluent, disintegrant, binder, solubilizing agent, lubricant, and glidant, or alternatively defined with a quantity-sufficient solvent.
Dosage forms including tablets, capsules, sachets, powders/granules, suspensions, and modified release
The composition of the synergistic neuropathic-pain-reducing composition formulated in one of specified dosage forms including solid and modified-release formulations.
Overall, claim coverage centers on a defined-weight synergistic combination of micronized PEA with daidzein and genistein for reducing neuropathic pain, with dependent claim refinements directed to pharmaceutically acceptable excipient types, excipient weight-percentage ranges (or quantity-sufficient solvent), and selected dosage forms including modified-release.
Stated Advantages
Synergistically reduces neuropathic pain.
Improves neuropathy-related outcomes in a described oxaliplatin-induced peripheral neuropathy rat study versus single components and is reported as comparable to pregabalin.
Documented Applications
Treatment of neuropathic pain using an oral pharmaceutical composition comprising PEA and naturally occurring FAAH inhibitors that act synergistically to reduce neuropathic pain.
A described oxaliplatin-induced peripheral neuropathy rat study evaluating outcomes related to cold hyperalgesia (tail immersion test).
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