Multi-component compositions for modulating age-associated biological pathways

Abstract

The present disclosure relates to compositions comprising a cannabinoid component, a mycelium-derived component, and a vitamin and / or mineral component. The cannabinoid component may comprise one or more cannabinoids, cannabinoid-like compounds, cannabinoid receptor agonists, cannabinoid acids, metabolites, or derivatives. The mycelium-derived component may comprise fungal extracts or bioactive fractions derived from one or more species, including Hericium erinaceus and Cordyceps species. The vitamin and / or mineral component may comprise one or more micronutrients in bioavailable forms. The compositions may be formulated as oral, sublingual, transdermal, or other delivery systems, including lipid-based, emulsified, or encapsulated formulations. The compositions are configured to modulate one or more biological pathways, including inflammatory signaling, oxidative stress, mitochondrial function, cellular maintenance, and neuronal signaling. Methods of making and using the compositions are also provided, including use in contexts associated with aging, cellular stress, or post-viral conditions.

Description

MULTI-COMPONENT COMPOSITIONS FOR MODULATING AGE-ASSOCIATED BIOLOGICAL PATHWAYS FIELD OF THE DISCLOSURE

[0001] The present disclosure is generally related to therapeutic formulations. More specifically, it pertains to compositions comprising cannabinoids, mycelium extracts, vitamins, and minerals designed to enhance cognitive function, reduce inflammation, and support neurological health as well as promote longevity and overall human lifespan extension through neuroprotection and systemic anti-oxidative and anti-inflammatory effects.BACKGROUND

[0002] Aging and chronic physiological stress are associated with a progressive decline in cellular and systemic function. These processes are frequently characterized by persistent low-grade inflammation, oxidative stress, mitochondrial dysfunction, impaired cellular maintenance and autophagic clearance, and reduced neuronal resilience.

[0003] These biological processes are interconnected and may contribute collectively to progressive tissue dysfunction, including cognitive decline, reduced metabolic efficiency, and increased vulnerability to stress-related and age-associated conditions. Dysregulation of key regulatory pathways, including energy-sensing pathways such as AMP-activated protein kinase (AMPK) and growth-regulating pathways such as mechanistic target of rapamycin (mTOR), has been implicated in these changes, contributing to impaired cellular maintenance and metabolic imbalance.

[0004] Existing therapeutic and nutritional approaches often target only a single aspect of this biology, such as inflammation or oxidative stress, and may not adequately address the multi-factorial nature of age-associated functional decline. Tn addition, many pharmacological antiinflammatory or neuroactive agents may be associated with limitations that reduce their suitability for long-term or preventative use.

[0005] There remains a need for compositions that can safely and simultaneously address multiple biological pathways associated with aging and cellular stress, including inflammatory signaling, oxidative injury, mitochondrial dysfunction, impaired autophagic processes, and loss of neurotrophic support.

[0006] There is further a need for compositions that provide coordinated modulation of these pathways through complementary mechanisms, rather than reliance on a single active agent, thereby potentially supporting broader or more sustained functional effects.

[0007] The present disclosure addresses these needs by providing compositions configured to modulate multiple interconnected biological pathways associated with inflammation, oxidative stress, mitochondrial function, cellular maintenance, and neuronal signaling.SUMMARY OF THE INVENTION

[0008] The present disclosure provides compositions comprising multiple component classes configured to modulate one or more biological pathways associated with inflammation, oxidative stress, mitochondrial function, cellular maintenance, and neuronal signaling.

[0009] In certain embodiments, the composition comprises: (a) a cannabinoid component comprising one or more cannabinoids, cannabinoid-like compounds, cannabinoid receptor agonists, cannabinoid acids, cannabinoid metabolites, cannabinoid derivatives, or combinations thereof; (b) a mycelium-derived component comprising one or more fungal extracts, enriched fungal fractions, isolated fungal bioactives, or combinations thereof; and (c) a vitamin and / ormineral component comprising one or more vitamins, minerals, bioavailable vitamin forms, bioavailable mineral forms, or combinations thereof.

[0010] In certain embodiments, the cannabinoid component comprises cannabidiol (CBD), cannabigerol (CBG), or a combination thereof. In certain embodiments, the mycelium-derived component comprises Hericium erinaceus. Cordyceps species, or a combination thereof. In certain embodiments, the vitamin and / or mineral component comprises one or more of vitamin D, zinc, magnesium, and one or more B vitamins.

[0011] In certain embodiments, one or more components of the composition are provided in modified or enhanced forms, including encapsulated, emulsified, liposomal, nanoparticulate, chelated, complexed, or conjugated forms, to improve one or more of stability, bioavailability, or delivery.

[0012] In certain embodiments, the composition is formulated as an oral dosage form, including capsules, tablets, softgels, powders, granules, sachets, or liquid suspensions. In certain embodiments, the composition is formulated as a sublingual, buccal, transdermal, topical, or other delivery format. In certain embodiments, the composition is formulated as a lipid-based system, microemulsion, nanoemulsion, liposomal formulation, or nanoparticle-based delivery system.

[0013] In certain embodiments, the disclosure further provides formulated delivery systems comprising a lipophilic phase including a cannabinoid component and an aqueous or polymeric phase including a mycelium-derived component and a vitamin and / or mineral component. In certain embodiments, such systems are configured to maintain separation of components prior to administration and to enable coordinated release following administration.

[0014] In certain embodiments, the disclosure further provides methods of making the compositions described herein, including methods comprising providing a cannabinoid component,a mycelium-derived component, and a vitamin and / or mineral component, and combining the components to form the composition. In certain embodiments, one or more components are extracted, processed, blended, encapsulated, emulsified, or stabilized prior to or during combination.

[0015] In certain embodiments, the disclosure further provides methods of modulating one or more biological pathways in a subject, including administering an effective amount of a composition described herein. In certain embodiments, the one or more biological pathways are selected from inflammatory signaling, oxidative stress, mitochondrial function, autophagy, mitophagy, neurotrophic signaling, synaptic plasticity, neuronal survival, and neuronal resilience.

[0016] In certain embodiments, the composition may be used to support one or more functional outcomes associated with modulation of such pathways, including cognitive function, inflammatory balance, mitochondrial energetics, cellular maintenance, or neuronal resilience.

[0017] In certain embodiments, the composition may be administered to subjects experiencing age-associated functional decline, chronic inflammatory states, oxidative stress, impaired mitochondrial function, impaired cellular maintenance processes, or combinations thereof.

[0018] In certain embodiments, the composition may be used in the context of post-viral conditions, including conditions characterized by persistent inflammation, fatigue, or cognitive impairment following viral exposure.

[0019] The foregoing summary is provided to introduce certain aspects of the disclosure and is not intended to limit the scope of the invention as defined by the appended claims.DESCRIPTIONS OF THE DRAWINGS

[0020] The foregoing and other features of the present disclosure will become more apparent from the following description of illustrative embodiments, taken in conjunction with the accompanying drawings, in which:

[0021] FIG. 1 is a schematic representation of the composition, illustrating the principal component classes including a cannabinoid component, a mycelium-derived component, a vitamin and / or mineral component, and optionally one or more auxiliary components.

[0022] FIG. 2 illustrates a representative cannabinoid component, including example cannabinoids and associated constituents that may be included in the composition.

[0023] FIG. 3 illustrates a representative mycelium-derived component, including example fungal sources and associated bioactive compounds.

[0024] FIG. 4 illustrates a representative vitamin and mineral component, including example micronutrients and their associated biological roles within the composition.

[0025] FIG. 5 is a schematic representation of an integrated multi-pathway mechanistic model of the composition, illustrating how the component classes may collectively modulate interconnected biological pathways including inflammatory signaling, oxidative stress, mitochondrial function, autophagy, and neurotrophic processes.DETAILED DESCRIPTIONOverview of the Composition

[0026] The present disclosure provides compositions comprising a combination of cannabinoids, mycelium-derived extracts, and one or more vitamins and / or minerals, which together are configured to support neurological function, reduce inflammation, and modulate biological processes associated with aging and cellular stress. As illustrated in FIG. 1, the composition may comprise a cannabinoid component,a mycelium-derived component, a vitamin and / or mineral component, and optionally one or more auxiliary components. In certain embodiments, the compositions may further include one or more pharmaceutically acceptable carriers, excipients, or delivery-enhancing components configured to improve stability, bioavailability, or user acceptability.

[0027] In certain embodiments, the composition comprises: (a) a cannabinoid component comprising one or more cannabinoids; (b) mycelium-derived component comprising one or more fungal extracts or bioactive constituents; and (c) a vitamin and / or mineral component comprising one or more micronutrients; wherein the components are combined in amounts effective to provide complementary or coordinated biological activity.

[0028] In certain embodiments, the cannabinoid component comprises cannabidiol (CBD) and / or cannabigerol (CBG), optionally in combination with one or more additional cannabinoids, cannabinoid acids, or terpenes. In certain embodiments, the mycelium-derived component comprises extracts from Hericium erinaceus (Lion’s Mane) and / or Cordyceps species, optionally enriched for bioactive constituents including, but not limited to, hericenones, erinacines, cordycepin, adenosine, and polysaccharides. In certain embodiments, the vitamin and / or mineral component comprises one or more of vitamin D, zinc, magnesium, and one or more B vitamins, including but not limited to vitamins B6, B12, and folate.

[0029] In certain embodiments, the composition is formulated such that the individual components provide distinct but complementary biological functions. For example, the cannabinoid component may contribute anti-inflammatory and neuroprotective effects, the mycelium-derived component may contribute neurotrophic, metabolic, and mitochondrial-supportive effects, and the vitamin and / or mineral component may provide cofactor support for enzymatic, metabolic, and cellular maintenance processes.

[0030] In certain embodiments, the composition is configured to modulate multiple interconnected biological pathways associated with age-related decline, including inflammatory signaling, oxidative stress,mitochondrial function, autophagic processes, and neurotrophic signaling. Without being bound by theory, the inventors believe that the combined activity of the components may provide broader or more sustained biological effects (synergistic effects) than those achievable by individual components administered alone.

[0031] In certain embodiments, the components of the composition may be present in relative proportions selected to optimize functional outcomes, and such proportions may be varied depending on the intended application, target population, or delivery format. The compositions described herein may be formulated in a variety of dosage forms, including but not limited to oral, sublingual, transdermal, or other delivery systems, as described in further detail below.

[0032] In certain embodiments, the composition may be used for supporting cognitive function, reducing inflammation, promoting neuronal health, or addressing conditions associated with neuroinflammation, oxidative stress, or age-related functional decline. The compositions may be suitable for use in both therapeutic and preventative contexts

[0033] Embodiments of the present disclosure will be described more fully hereinafter with reference to the accompanying drawings in which like numerals represent like elements throughout.Component Classes and Embodiments

[0034] The compositions described herein comprise multiple classes of components that together contribute to the functional properties of the formulation. In certain embodiments, these components include a cannabinoid component, a mycelium-derived component, a vitamin and / or mineral component, and optionally one or more non-active or auxiliary components. Each component class is described in further detail below.Cannabinoid Component

[0035] As illustrated in FIG.2, the composition may comprise a cannabinoid base component. Tn certain embodiments, the composition comprises a cannabinoid component including one or more cannabinoids selected for their anti-inflammatory, neuroprotective, and homeostatic-modulating properties. In certain embodiments, the cannabinoid component comprises cannabidiol (CBD) and / or cannabigerol (CBG).

[0036] In certain embodiments, cannabidiol may constitute a majority of the cannabinoid component, for example between approximately 50% and 99% by weight of the cannabinoid fraction, while cannabigerol may constitute the remaining portion. In one non-limiting embodiment, a ratio of approximately 70:30 CBD to CBG may be used. In other embodiments, the ratio may be varied, including but not limited to 50:50, 90:10, 99:1, or other ratios selected based on desired functional outcomes.

[0037] In certain embodiments, the cannabinoid component may further comprise one or more additional cannabinoids, including but not limited to tetrahydrocannabinol (THC), cannabichromene (CBC), cannabinol (CBN), cannabidivarin (CBDV), tetrahydrocannabivarin (THCV), cannabigerolic acid (CBGA), tetrahydrocannabinolic acid (THCA), cannabidiolic acid (CBDA), cannabichromenic acid (CBCA), cannabinolic acid (CBNA), cannabicyclol (CBL), tetrahydrocannabiphorol (THCP), or combinations thereof.

[0038] In certain embodiments, the cannabinoid component may further comprise one or more terpenes, including but not limited to myrcene, limonene, pinene, linalool, caryophyllene, humulene, terpinolene, ocimene, geraniol, terpineol, valencene, eucalyptol, borneol, camphene, or bisabolol. Such terpenes may contribute to or enhance the biological effects of cannabinoids.

[0039] In certain embodiments, the cannabinoids may be obtained from plant material, including cannabis or hemp cultivars selected for high cannabinoid content. Extraction methods may includesupercritical carbon dioxide extraction, solvent extraction, or other suitable methods, followed by optional purification steps such as winterization and distillation to achieve desired purity.In certain embodiments, the cannabinoid component may be formulated in a bioavailable form, including emulsified, encapsulated, nanoparticulate, or lipid-associated forms, to enhance absorption and systemic distribution.Mycelium-Derived Component

[0040] As illustrated in FIG.3, the composition may comprise a mycelium extract component. In certain embodiments, the composition comprises a mycelium-derived component including one or more fungal extracts selected for neurotrophic, neuroprotective, metabolic, and immunomodulatory properties.

[0041] In certain embodiments, the mycelium-derived component comprises extracts from Hericium erinaceus (Lion’s Mane) and / or Cordyceps species, including Cordyceps sinensis or Cordyceps militaris. In one non-limiting embodiment, the mycelium-derived component comprises a mixture of Lion’s Mane and Cordyceps in a ratio of approximately 60:40. In other embodiments, the ratio may vary, including but not limited to 50:50, 70:30, 80:20, or other ratios selected based on desired functional outcomes.

[0042] In certain embodiments, Lion’s Mane extracts may include bioactive compounds such as hericenones and erinacines. which are associated with stimulation of nerve growth factor (NGF) synthesis and support of neuronal growth and repair. In certain embodiments, Cordyceps extracts may include bioactive compounds such as cordycepin, adenosine, and polysaccharides, which are associated with modulation of cellular energy metabolism, mitochondrial function, and immune response.

[0043] In certain embodiments, the mycelium-derived component may further comprise additional fungal species, including but not limited to Reishi (Ganoderma lucidum), Chaga (Inonotus obliquus), Shiitake (Lentinula edodes), Maitake (Grifola frondosa), Turkey Tail (Trametes versicolor), Agaricus blazei, Phellinus linteus, Tremella fuciformis, Poria cocos, Antrodia camphorata, Polyporus umbellatus, or Hericium coralloides.

[0044] In certain embodiments, the fungal materials may be derived from fruiting bodies, mycelium, or combinations thereof, and may be processed using one or more extraction methods, including hot water extraction, alcohol extraction, or dual extraction techniques, to preserve or enrich bioactive constituents.

[0045] In certain embodiments, the extracts may be standardized to contain defined levels of one or more bioactive compounds, including hericenones, erinacines, cordycepin, or polysaccharides.Vitamin and Mineral Component

[0046] In certain embodiments, the vitamin and / or mineral component comprises one or more micronutrients, cofactors, or trace elements selected to support cellular metabolism, redox homeostasis, mitochondrial function, immune regulation, and / or neurobiological signaling. Such components may function, for example, as enzymatic cofactors, antioxidant agents, or modulators of ion balance and cellular signaling pathways, thereby contributing to the overall functional profile of the composition.

[0047] The vitamin and / or mineral component may include, without limitation, one or more fatsoluble vitamins, water-soluble vitamins, essential minerals, trace minerals, or combinations thereof. In certain embodiments, the selection and relative amounts of such components may betailored to enhance bioavailability, support synergistic interactions with the cannabinoid and mycelium-derived components, and / or address specific physiological or metabolic contexts.

[0048] By way of non-limiting example, the vitamin and / or mineral component may include one or more of Vitamin D, Vitamin B 12, Vitamin C, magnesium, zinc, calcium, iron, potassium, selenium, copper, Vitamin E, folic acid, Vitamin B6, Vitamin A, manganese, or combinations thereof. It will be understood that the specific components identified are illustrative and not limiting, and that other vitamins, minerals, derivatives, salts, or bioavailable forms thereof may also be used.

[0049] As illustrated in FIG.4, the composition may comprise a vitamin and mineral component. In certain embodiments, the composition comprises a vitamin and / or mineral component including one or more micronutrients selected to support metabolic function, neurological health, immune regulation, and cellular maintenance processes.

[0050] In certain embodiments, the vitamin and / or mineral component comprises one or more of vitamin D, zinc, magnesium, and one or more B vitamins, including but not limited to vitamin B6, vitamin Bl 2, and folate.

[0051] In certain embodiments, vitamin D may contribute to immune modulation and neurological function, zinc may support synaptic activity and immune response, magnesium may function as a cofactor in enzymatic and neurological processes, and B vitamins may support energy metabolism, neurotransmitter synthesis, and maintenance of neural structures.

[0052] In certain embodiments, additional vitamins and minerals may be included, including but not limited to vitamin C, vitamin E, vitamin A, calcium, iron, potassium, selenium, copper, manganese, or combinations thereof. In certain embodiments, the vitamins and minerals may beprovided in amounts or ratios selected to complement the cannabinoid and mycelium-derived components and support overall formulation performance.Optional Non- Active and Auxiliary Components

[0053] In certain embodiments, the composition may further comprise one or more non-active or auxiliary components configured to enhance stability, bioavailability, manufacturability, or user acceptability.

[0054] Such components may include, but are not limited to, carrier oils, emulsifiers, stabilizers, fillers, binders, preservatives, flavoring agents, sweeteners, colorants, and other formulation aids.

[0055] In certain embodiments, carrier oils such as medium-chain triglyceride (MCT) oil may be used to enhance absorption of lipophilic components. Emulsifiers such as lecithin or polysorbate may be used to improve dispersion and stability. Stabilizers and antioxidants may be included to reduce degradation of active components.

[0056] In certain embodiments, the composition may be formulated with minimal or no non-active components, consisting essentially of the cannabinoid, mycelium-derived, and vitamin / mineral components.Variants, Derivatives and Biological Forms

[0057] In certain embodiments, the components described herein may be provided not only in their native or unmodified forms but also as derivatives, precursors, metabolites, salts, esters, complexes, conjugates, or other chemically or biologically modified forms that retain, enhance, or otherwise modulate the intended biological activity. Such forms may be selected or engineered to improve one or more properties, including but not limited to bioavailability, solubility, stability,tissue distribution, blood-brain barrier penetration, pharmacokinetic profile, or metabolic conversion to active species in vivo.Cannabinoid Variants and Derivatives

[0058] In certain embodiments, the cannabinoid component may comprise cannabinoids in one or more chemical or biological forms, including neutral cannabinoids, acidic cannabinoids, precursor forms, metabolites, and derivatives thereof.

[0059] Such forms may include, but are not limited to, cannabidiolic acid (CBDA), cannabigerolic acid (CBGA), tetrahydrocannabinolic acid (THCA), and other cannabinoid acids, which may be converted in vivo or during processing to their corresponding neutral forms.

[0060] In certain embodiments, cannabinoid metabolites, including hydroxylated or oxidized derivatives formed through enzymatic metabolism, may contribute to the biological activity of the composition and are considered within the scope of the present disclosure.

[0061] In certain embodiments, the cannabinoid component may further include synthetic or semisynthetic cannabinoid analogs, structurally modified cannabinoids designed to enhance receptor affinity, stability, or bioavailability, and / or cannabinoid-like compounds that interact with cannabinoid receptors, including CB1 and / or CB2 receptor agonists, partial agonists, inverse agonists, or modulators.

[0062] In certain embodiments, the cannabinoids may be provided in formulated forms, including encapsulated, emulsified, liposomal, nanoparticulate, or complexed forms, to improve delivery and absorption.Mycelium-Derived Variants and Bioactive Fractions

[0063] In certain embodiments, the mycelium-derived component may comprise whole extracts, enriched fractions, isolated bioactive compounds, or combinations thereof.

[0064] Such forms may include, but are not limited to, extracts enriched for hericenones, erinacines, cordycepin, adenosine, polysaccharides, sterols, or other fungal-derived metabolites.

[0065] In certain embodiments, the mycelium-derived component may comprise fermented products, cultured mycelial biomass, or bioprocessed derivatives that retain or enhance the biological activity of the original fungal material.

[0066] In certain embodiments, bioactive compounds derived from mycelium may be chemically modified, concentrated, or combined into standardized fractions to achieve consistent or enhanced functional properties.

[0067] In certain embodiments, the mycelium-derived component may include metabolites produced during fungal growth or fermentation, including secondary metabolites not present in the original substrate but generated during cultivation.Vitamin and Mineral Variants and Bioavailable Forms

[0068] In certain embodiments, vitamins and minerals may be provided in one or more bioavailable, complexed, chelated, or otherwise modified forms designed to enhance absorption, stability, or tissue-specific delivery.

[0069] For example, mineral components may be provided as organic or inorganic salts, amino acid chelates, or other complexes, including but not limited to magnesium L-threonate, magnesium glycinate, zinc picolinate, zinc citrate, or other forms known to enhance bioavailability or cellular uptake.

[0070] In certain embodiments, vitamins may be provided in active, precursor, or metabolite forms, including but not limited to methylated forms of B vitamins (e.g., methylcobalamin, methylfolate) or other biologically active derivatives.

[0071] In certain embodiments, such modified forms may enhance delivery to specific tissues, including the central nervous system, or improve participation in metabolic or enzymatic pathways relevant to the intended biological effects of the composition.Compositional and Functional Equivalents

[0072] In certain embodiments, the composition may include functional equivalents of the described components, defined as compounds or compositions that provide similar biological activities or mechanistic contributions to those described herein.

[0073] Such equivalents may include alternative cannabinoids, fungal species, micronutrients, or derived compounds that modulate one or more of the biological pathways described in the present disclosure, including inflammatory signaling, oxidative stress, mitochondrial function, autophagy, or neurotrophic signaling.

[0074] In certain embodiments, substitutions or modifications of one or more components may be made without departing from the overall functional profile of the composition, provided that the modified composition retains the ability to modulate multiple biological pathways in a coordinated manner.In Vivo Conversion and Metabolic Activation

[0075] In certain embodiments, one or more components of the composition may function as precursors or pro-compounds that are converted in vivo into active species.

[0076] Such conversion may occur through enzymatic processes, chemical transformation, or metabolic pathways within the body, resulting in the formation of active metabolites that contribute to the overall biological effect of the composition.

[0077] Accordingly, both the administered forms and their resulting metabolites are considered within the scope of the present disclosure.Formulations and Dosage Forms

[0078] In certain embodiments, the compositions described herein may be formulated into a variety of dosage forms and delivery systems configured to optimize stability, bioavailability, pharmacokinetics, user compliance, and targeted delivery of the active components. The formulation may be selected based on the intended use. target population, route of administration, and desired release profile.

[0079] In certain embodiments, the compositions may be formulated for oral, sublingual, buccal, transdermal, nasal, or other routes of administration. The formulations may be designed to provide immediate release, sustained release, delayed release, or targeted delivery of one or more components.Oral Dosage Forms

[0080] In certain embodiments, the composition may be formulated as an oral dosage form, including but not limited to capsules, tablets, softgels, powders, granules, sachets, or liquid suspensions.

[0081] In certain embodiments, capsules or tablets may include one or more binders, fillers, disintegrants, lubricants, or coatings to facilitate manufacturing and administration. Softgel formulations may be particularly suitable for delivery of lipophilic components such ascannabinoids, optionally dissolved or suspended in carrier oils such as medium-chain triglyceride (MCT) oil.

[0082] In certain embodiments, powders or granules may be provided for reconstitution or direct consumption, optionally combined with flavoring agents or sweeteners to enhance palatability.

[0083] In certain embodiments, oral liquid formulations may include emulsified or suspended forms of the active components, optionally stabilized using emulsifiers, surfactants, or viscosity modifiers.Lipid-Based and Emulsified Formulations

[0084] In certain embodiments, the composition may be formulated as a lipid-based system to enhance absorption of lipophilic components, particularly cannabinoids.

[0085] Such formulations may include oil-based carriers, self-emulsifying drug delivery systems (SEDDS), microemulsions, nanoemulsions, or other dispersion systems.

[0086] In certain embodiments, cannabinoids may be incorporated into nanoemulsions or micellar systems to increase surface area and improve bioavailability. Emulsifiers such as lecithin, polysorbates, or other amphiphilic molecules may be used to stabilize such systems.

[0087] In certain embodiments, lipid-based formulations may improve intestinal absorption, reduce variability in pharmacokinetics, and enhance systemic exposure to active compounds.Nanoparticle and Encapsulation Technologies

[0088] In certain embodiments, one or more components of the composition may be formulated using nanoparticle, microparticle, or encapsulation technologies to improve delivery, stability, or controlled release.

[0089] Such technologies may include liposomes, solid lipid nanoparticles, polymeric nanoparticles, micelles, or other encapsulation systems.

[0090] In certain embodiments, encapsulation may protect sensitive components from degradation, improve bioavailability, or enable targeted delivery to specific tissues, including the central nervous system.

[0091] In certain embodiments, nanoformulations may enhance transport across biological barriers, including the blood-brain barrier, thereby improving delivery of neuroactive compounds.Sublingual and Buccal Formulations

[0092] In certain embodiments, the composition may be formulated for sublingual or buccal administration, including drops, sprays, films, or dissolvable tablets.

[0093] Such formulations may allow for rapid absorption through mucosal tissues, potentially bypassing first-pass metabolism and providing faster onset of action.

[0094] In certain embodiments, cannabinoid components may be dissolved or dispersed in suitable earners to facilitate mucosal absorption.Transdermal and Topical Delivery Systems

[0095] In certain embodiments, the composition may be formulated for transdermal or topical delivery, including patches, gels, creams, or ointments.

[0096] Transdermal patches may be configured to provide sustained release of one or more components over an extended period. In certain embodiments, permeation enhancers may be included to facilitate transport across the skin barrier.

[0097] In certain embodiments, transdermal delivery may provide more consistent plasma levels and improved compliance for long-term administration.Controlled-Release and Sustained-Release Formulations

[0098] In certain embodiments, the composition may be formulated to provide controlled or sustained release of one or more components.

[0099] Such formulations may include matrix tablets, coated particles, osmotic systems, or other delivery technologies designed to modulate release kinetics.

[0100] In certain embodiments, sustained-release formulations may be used to maintain stable plasma concentrations of active components over extended periods, thereby improving therapeutic consistency and reducing dosing frequency.Multiple Formulation Embodiments

[0101] In certain embodiments, the composition may be provided in multiple formulation configurations, including narrow, intermediate, and broad embodiments.

[0102] In a narrow embodiment, the composition may comprise defined quantities of specific components, for example:

[0103] CBD in an amount of about 10 mg to about 50 mg, CBG in an amount of about 5 mg to about 25 mg, Lion’s Mane extract in an amount of about 100 mg to about 500 mg, Cordyceps extract in an amount of about 100 mg to about 500 mg, and one or more vitamins and / or minerals in nutritionally or therapeutically relevant amounts.

[0104] In an intermediate embodiment, the composition may comprise broader ranges of the same components, allowing variation in concentration and ratio depending on formulation goals. The broader ranges include CBD in an amount of about 1 mg to about 100 mg, CBG in an amount of about 1 mg to about 100 mg, Lion’s Mane extract in an amount of about 50 mg to about 1000 mg, Cordyceps extract in an amount of about 1 mg to about 1000 mg, and one or more vitamins and / or minerals in nutritionally or therapeutically relevant amounts.

[0105] In a broadest embodiment, the composition may comprise any combination of the described component classes in amounts effective to achieve the desired functional effects, without limitationto specific ratios or quantities. The broadest ranges include CBD in an amount of about 0.1 mg to about 500 mg, CBG in an amount of about 0.1 mg to about 300 mg, Lion’s Mane extract in an amount of about 0.1 mg to about 3000 mg, Cordyceps extract in an amount of about 0.1 mg to about 3000 mg, and one or more vitamins and / or minerals in nutritionally or therapeutically relevant amounts.Cannabinoid Ratio Embodiments

[0106] In certain embodiments, the ratio of cannabinoids, including CBD and CBG, may be selected based on desired functional outcomes.

[0107] For example, higher CBD ratios may be used in embodiments emphasizing antiinflammatory and neuroprotective effects, while higher CBG ratios may be used in embodiments emphasizing metabolic modulation or additional anti-inflammatory activity.

[0108] In certain embodiments, balanced ratios may be used to provide complementary activity across multiple biological pathways.Combination and Multi-Phase Formulations

[0109] In certain embodiments, the composition may be formulated as a multi-phase or multicomponent system in which different components are delivered in distinct phases or compartments.

[0110] For example, lipophilic components such as cannabinoids may be delivered in a lipid phase, while hydrophilic components such as vitamins or polysaccharides may be delivered in an aqueous phase.

[0111] In certain embodiments, such multi-phase systems may improve stability, compatibility, or bioavailability of the individual components.Customization and Personalized Formulations

[0112] In certain embodiments, the composition may be tailored based on individual characteristics, including age, health status, or specific functional needs.

[0113] For example, formulations may be adjusted to emphasize cognitive support, antiinflammatory effects, metabolic support, or general wellness.

[0114] In certain embodiments, component ratios, dosage levels, or delivery formats may be modified accordingly.Manufacturing Embodiments

[0115] In certain embodiments, the compositions described herein may be produced using one or more manufacturing processes configured to preserve, enhance, or optimize the stability, bioavailability, and functional performance of the individual components and the overall composition.

[0116] Such processes may include extraction, purification, blending, encapsulation, emulsification, stabilization, granulation, or other processing steps, which may be performed individually or in combination, and in any suitable sequence.Extraction and Preparation of Components

[0117] In certain embodiments, cannabinoid components may be obtained from plant material using extraction techniques including supercritical carbon dioxide extraction, solvent extraction, or other suitable methods, followed by optional purification steps such as winterization, filtration, or distillation.

[0118] In certain embodiments, mycelium-derived components may be obtained using one or more extraction techniques, including hot water extraction, alcohol extraction, or dual extraction processes, to isolate or enrich bioactive constituents such as polysaccharides, hericenones, erinacines, or cordycepin.

[0119] In certain embodiments, vitamin and mineral components may be sourced as purified compounds or prepared in bioavailable forms as described herein.Blending and Co-Processing

[0120] In certain embodiments, the components may be combined using blending or co-processing techniques designed to maintain uniform distribution and compatibility of the active ingredients.

[0121] In certain embodiments, co-processing may be performed under controlled environmental conditions, including controlled temperature, humidity, or atmospheric composition.

[0122] In certain embodiments, co-processing may be conducted under an inert atmosphere, such as nitrogen or argon, to reduce oxidative degradation of sensitive components, including cannabinoids or fungal-derived bioactives.

[0123] In certain embodiments, components may be granulated, agglomerated, or otherwise processed together to improve homogeneity, flow properties, or compressibility for downstream formulations.Encapsulation and Delivery Systems

[0124] In certain embodiments, one or more components of the composition may be encapsulated or otherwise incorporated into delivery systems to enhance stability, control release, or improve bioavailability.

[0125] Such encapsulation approaches may include, but are not limited to. liposomal encapsulation, polymeric encapsulation, lipid-based encapsulation, or microencapsulation.

[0126] In certain embodiments, a dual-phase or multi-layer encapsulation system may be employed, wherein lipophilic components, including cannabinoids, are encapsulated within a lipid or liposomal phase, and hydrophilic components, including polysaccharides or certain micronutrients, are incorporated within a separate aqueous or polymeric phase.

[0127] In certain embodiments, such dual-phase encapsulation systems may be configured to maintain separation of components during storage while enabling coordinated release upon administration.Emulsification and Dispersion Techniques

[0128] In certain embodiments, emulsification techniques may be used to disperse lipophilic components within aqueous systems or to create stable multi-phase formulations.

[0129] Such techniques may include high-shear mixing, ultrasonication, homogenization, or other methods to produce microemulsions or nanoemulsions.

[0130] In certain embodiments, emulsification parameters, including droplet size, surfactant concentration, and phase composition, may be selected to enhance bioavailability, maintain component ratios during digestion, or improve absorption kinetics.

[0131] In certain embodiments, emulsified systems may be configured to reduce variability in absorption of cannabinoids and improve delivery of co-administered components.Stabilization Strategies

[0132] In certain embodiments, the composition may include stabilization strategies to reduce degradation of one or more components during manufacturing, storage, or administration.

[0133] Such strategies may include the inclusion of antioxidants, stabilizers, or protective matrices to reduce oxidation, hydrolysis, or other degradation processes.

[0134] In certain embodiments, stabilization approaches may be selected to preserve sensitive bioactive compounds, including cannabinoids, hericenones, erinacines, or cordycepin.

[0135] In certain embodiments, pH-controlled processing or formulation may be used to maintain stability of specific components or prevent undesirable interactions between components.

[0136] In certain embodiments, stabilization strategies may also include protection from light, heat, or moisture, including packaging-based approaches.Control of Component Interactions

[0137] In certain embodiments, manufacturing processes may be configured to manage or control interactions between components of the composition.

[0138] For example, in certain embodiments, processing conditions such as pH, ionic strength, or solvent composition may be selected to reduce undesirable interactions between cannabinoids and polysaccharide components, including aggregation or precipitation.

[0139] In certain embodiments, controlled processing may be used to preserve dispersion of components and maintain functional availability of active ingredients.Functional Advantages of Manufacturing Approaches

[0140] In certain embodiments, the manufacturing processes described herein may provide one or more functional advantages, including improved stability, enhanced bioavailability, reduced degradation, improved absorption kinetics, or improved consistency of delivery.

[0141] In certain embodiments, such advantages may arise from the combination of processing techniques, formulation strategies, and component selection described herein.

[0142] Without being bound by theory, the inventors believe that manufacturing approaches that preserve component integrity, optimize dispersion, and control release may contribute to the overall functional performance of the composition.Variability and Alternative Manufacturing Approaches

[0143] In certain embodiments, alternative manufacturing methods or sequences may be employed without departing from the scope of the present disclosure.

[0144] Such variations may include changes in processing order, conditions, or techniques, provided that the resulting composition retains the desired functional characteristics Mechanistic Support and Evidence Framework for the Claimed Synergistic Effects

[0145] While not being bound to theory, it is believed that the combination of cannabinoids, mushroom-derived bioactives, and selected micronutrient cofactors may provide complementary and potentially synergistic modulation of multiple biological processes associated with age-related functional decline, chronic inflammation, oxidative injury, impaired mitochondrial energetics, reduced autophagic clearance, and loss of neuronal resilience.

[0146] The mechanistic framework set forth below is not intended to assert proven clinical efficacy in humans, but rather to provide a scientifically grounded basis for enablement and for the proposition that the claimed composition may modulate multiple interrelated biological pathways in a coordinated manner.Chronic inflammatory signaling and inflammaging

[0147] Aging is frequently accompanied by a persistent, low-grade inflammatory state, sometimes referred to as inflammaging, characterized by sustained elevation of pro-inflammatory mediators and progressive dysregulation of innate and adaptive immune signaling. In certain embodiments, the claimed composition is configured to act on this inflammatory background through convergent suppression of inflammatory cytokine production, modulation of immune-cell activation, and attenuation of stress-responsive inflammatory transcription pathways.

[0148] In certain embodiments, cannabidiol (CBD) and cannabigerol (CBG) provide a first antiinflammatory layer. These cannabinoids may reduce expression of pro-inflammatory cytokines including TNF-a, IL-ip, and IL-6, while in some systems also increasing anti-inflammatory mediators such as IL- 10. Mechanistically, such effects have been associated with cannabinoidreceptor-mediated immunomodulation, adenosine signaling, and downregulation of NF-KB-linked inflammatory signaling.

[0149] In certain embodiments, the anti-inflammatory contribution of CBD and / or CBG may further include modulation of immune-cell behavior, including reduced migration and inflammatory output of macrophages, T-cells, and neutrophils, thereby providing a broader immunomodulatory effect beyond cytokine reduction alone. In certain embodiments, this activity may further involve p38 MAPK- associated signaling in addition to CB2- and adenosine-linked mechanisms.

[0150] In certain embodiments, Hericium erinaceus extracts, including extracts enriched in erinacines and / or hericenones, provide a second anti-inflammatory layer by modulating inflammatory pathways such as NF-KB and COX-2 and by reducing the production of inflammatory mediators in neural and non-neural tissues.

[0151] In certain embodiments, cordycepin, as a principal bioactive associated with Cordyceps-derived material, provides a third anti-inflammatory layer. The literature supports that cordycepin can reduce inflammatory cytokines and inflammatory effector molecules, including IL-ip, IL-6, IL-8, nitric oxide, and prostaglandin-related signaling, and that these effects are commonly associated with inhibition of ERK and suppression of PI3K / AKT / mTOR signaling together with activation of AMPK.

[0152] In certain embodiments, the anti-inflammatory effects of cordycepin may also be associated with reduced production of inflammatory mediators such as nitric oxide and prostaglandin E2 in stress-responsive cellular systems, thereby complementing cannabinoid-mediated cytokine control through partially distinct upstream signaling mechanisms.T1

[0153] In certain embodiments, vitamin D, zinc, B vitamins, and magnesium function as antiinflammatory cofactors that reinforce the principal actives rather than replace them. Vitamin D may reduce pro-inflammatory cytokine signaling and modulate NF-KB-related transcription; zinc may reduce inflammatory signaling; certain B vitamins may lower homocysteine and inflammatory burden; and magnesium may help dampen inflammatory activation associated with calcium dysregulation and cellular stress.

[0154] Accordingly, in certain embodiments, the claimed composition may reduce inflammatory tone not through a single target but through a layered, multi-node anti-inflammatory mechanism in which cannabinoids, cordycepin-bearing mushroom material, Lion’s Mane bioactives, and micronutrient cofactors influence overlapping but non-identical inflammatory pathways.Oxidative stress and redox homeostasis

[0155] In certain embodiments, the claimed composition may further act by reducing oxidative stress and improving redox homeostasis. Oxidative stress has long been implicated as a contributing factor in aging and age-associated functional decline, including through the accumulation of reactive oxygen species and oxidative damage to cellular components. While the role of oxidative stress in aging is multifactorial and interconnected with other biological processes, maintenance of redox homeostasis is widely recognized as an important aspect of cellular health.

[0156] CBD and CBG may contribute to redox regulation through more than one route. In certain embodiments, these cannabinoids may directly or indirectly reduce oxidative stress by scavenging reactive species, reducing inducible inflammatory oxidant formation, supporting glutathione homeostasis, and promoting antioxidant-response pathways including Nrf2-linked transcription. CBG may additionally reduce iNOS-linked oxidative injury and has been described in the literature as having antioxidant and neuroprotective properties.

[0157] In certain embodiments, cannabinoid-mediated redox support may include direct free-radical scavenging, maintenance of glutathione pools, increased activity or expression of endogenous antioxidant enzymes including superoxide dismutase and glutathione peroxidase, and reduction of transition-metal-mediated reactive oxygen species formation.

[0158] Hericium erinaceus-derived material may contribute a second redox-protective layer. In certain embodiments. Lion’s Mane extracts may reduce ROS burden, increase endogenous antioxidant enzymes such as SOD, catalase, and glutathione peroxidase, and reduce lipid peroxidation.

[0159] Cordycepin-bearing Cordyceps material may contribute a third redox-protective layer. In certain embodiments, cordycepin may reduce oxidative burden by preserving mitochondrial membrane potential, increasing antioxidant enzyme activity, and reducing signaling states associated with oxidative stress and inflammatory amplification.

[0160] In certain embodiments, vitamin D, zinc, magnesium, and selected B vitamins may further support redox homeostasis by functioning as enzymatic cofactors, maintaining antioxidant-defense systems, or reducing pro-oxidant metabolic states.

[0161] Taken together, the antioxidant rationale of the claimed composition is not simply that each ingredient is “an antioxidant.” Rather, in certain embodiments, different components may act at different levels of the redox cascade, including free-radical limitation, suppression of oxidantgenerating inflammatory pathways, activation of endogenous defense systems, and preservation of mitochondrial integrity.

[0162] In certain embodiments, this redox architecture may be particularly relevant to aging-associated cellular decline because mitigation of mitochondrially generated reactive oxygenspecies may help limit senescence-associated dysfunction while preserving adaptive responses to metabolic stress.Mitochondrial energetics and quality control

[0163] In certain embodiments, the claimed composition may support mitochondrial energetics, mitochondrial quality control, and ATP-preserving cellular adaptation.

[0164] CBD may contribute to mitochondrial support through several routes. In certain embodiments, CBD may influence mitochondrial calcium handling, mitochondrial stress responses, and quality-control pathways including PINKl / Parkin-associated mitophagy or related mitochondrial maintenance mechanisms.

[0165] In certain embodiments, cannabinoid-mediated mitochondrial support may further include regulation of mitochondrial membrane potential, mitochondrial biogenesis, mitochondrial DNA-associated stress responses, electron transport chain activity, and mitochondrial network dynamics, thereby supporting maintenance of a functionally healthy mitochondrial pool under stress conditions.

[0166] Cordycepin may contribute a particularly important energetic mechanism. In certain embodiments, cordycepin or its intracellular phosphorylated forms may act as AMP-mimetic or AMP-like stress signals that favor AMPK activation, with downstream suppression of mTOR signaling and increased prioritization of ATP-generating and organelle-quality-control pathways.

[0167] In certain embodiments, cordycepin may function as an AMP-mimetic or AMP-like metabolic stress signal following intracellular phosphorylation, thereby shifting cellular signaling toward catabolic ATP-generating pathways and away from energy-intensive anabolic signaling.

[0168] Vitamin D, zinc, magnesium, and B vitamins may serve as supportive mitochondrial cofactors. In certain embodiments, vitamin D signaling may support mitochondrial oxidativephosphorylation capacity; zinc may influence mitochondrial homeostasis and stress signaling; magnesium may support ATP handling and ATP-dependent enzymology; and B vitamins may support TCA-cycle and electron-transfer metabolism.

[0169] Accordingly, in certain embodiments, the claimed composition may address mitochondrial decline at multiple levels, including stress sensing, ATP preservation, mitochondrial turnover, and preservation of oxidative metabolism. The claimed composition is not limited to symptomatic antiinflammatory action, but instead may also support upstream energetic homeostasis relevant to aging and neurodegenerative vulnerability.Autophagy, mitophagy, and senescence-related cellular housekeeping

[0170] In certain embodiments, the claimed composition may promote autophagic and mitophagic housekeeping, thereby facilitating removal of damaged proteins, dysfunctional organelles, and senescence-associated cellular debris.

[0171] CBD may contribute to this housekeeping function. In certain embodiments, CBD may promote autophagy through cannabinoid receptor-associated signaling, TRPV-linked signaling, ERK / AKT modulation, and SIRTl-associated stress responses, with downstream effects that favor clearance of damaged cellular components.

[0172] Cordycepin may provide a second and particularly strong autophagy-enabling mechanism. In certain embodiments, cordycepin may activate AMPK, suppress mTOR signaling, and facilitate autophagy or autophagic flux in stressed cells.

[0173] In certain embodiments, cordycepin-mediated autophagic support may include restoration of lysosomal function and enhanced clearance of damaged intracellular components in aged or stressed cells, thereby reinforcing the proposed housekeeping role of the composition in senescence-associated cellular states.

[0174] Vitamin D and zinc may further reinforce autophagic housekeeping. In certain embodiments, vitamin D may promote autophagy through VDR-linked signaling associated with AMPK / mTOR regulation, intracellular calcium, and Beclin-1 -related autophagic initiation, while zinc may promote autophagic flux and lysosomal function through stress-responsive signaling that can intersect with AMPK and ERK pathways.

[0175] Selected B vitamins and magnesium may also contribute. In certain embodiments, folate and vitamin B12 may reduce homocysteine-associated protein damage that can interfere with cellular housekeeping, while magnesium may support AMPK / mTOR-related homeostatic responses.

[0176] In certain embodiments, folate and vitamin B12 may contribute to autophagic competence by reducing homocysteinylation-associated interference with protein quality-control pathways, while vitamin B3 may, in certain systems, further support autophagy-related signaling through mTOR-associated regulation.

[0177] Thus, in certain embodiments, the formulation may facilitate cellular housekeeping through coordinated control of energy sensing, nutrient sensing, and stress signaling, rather than by relying on a single autophagy trigger.Neurotrophic signaling, neuronal survival, and repair

[0178] In certain embodiments, the claimed composition may support neuronal survival, neurotrophic signaling, synaptic plasticity, neurite extension, and related repair-associated processes.

[0179] CBD may contribute through anti-neuroinflammatory, antioxidant, anti-excitotoxic, and neuroplasticity-linked mechanisms. In certain embodiments, CBD may reduce microglial inflammatory output, limit ROS-linked neuronal stress, reduce glutamate- associated excitotoxicburden, and influence signaling cascades associated with BDNF expression and synaptic remodeling, including ERK / CREB and P 13 K / A KT- related pathways.

[0180] In certain embodiments, cannabinoid-mediated neuroprotection may also involve suppression of microglial inflammatory activation together with reduction of oxidative and excitotoxic stress, thereby helping preserve neuronal survival pathways under conditions relevant to neurodegenerative injury or age-associated neuronal vulnerability.

[0181] Hericium erinaceus provides a distinct neurotrophic mechanism that materially strengthens the composition. In certain embodiments, Lion’s Mane extracts may increase NGF expression, stimulate neurite outgrowth, and support regenerative neuronal signaling.

[0182] Cordycepin may contribute additional neuroprotective and neuroregenerative support. In certain embodiments, cordycepin may reduce neuroinflammatory signaling, improve stress resilience, and support neurite-associated recovery processes in preclinical systems. Because the cordycepin literature is broader and more heterogeneous than the Lion’s Mane NGF literature, I would keep these statements slightly more moderate in tone unless your colleague supplies specific papers he wants anchored here.

[0183] Vitamin D may contribute a supportive neurotrophic transcriptional environment. In certain embodiments, vitamin D signaling through VDR-RXR complexes may regulate transcriptional programs associated with neuronal survival and may support expression of neurotrophic factors such as BDNF. GDNF, and CNTF.

[0184] Zinc, B vitamins, and magnesium may further support neuronal resilience by influencing neurotransmission, myelin integrity, homocysteine balance, and synaptic plasticity. The workbook’s mapping of zinc to neurotransmitter regulation, B vitamins to myelin andhomocysteine-related protection, and magnesium to ERK / CREB, cognition, and synaptic plasticity is conceptually coherent.

[0185] Accordingly, in certain embodiments, the claimed composition may create a more favorable neuronal environment by combining anti-inflammatory protection, oxidative-stress reduction, energy support, and neurotrophin-associated signaling.

[0186] In certain embodiments, the combined presence of anti-inflammatory, antioxidant, mitochondrial-supporting, autophagy-supporting, and neurotrophin-associated components may provide a mechanistic basis for supporting both neuronal protection and neuronal recovery-related processes within the same composition.Integrated synergy model of the composition

[0187] Without being bound by theory, the inventors believe that the claimed synergistic effects arise not because each ingredient performs the same function, but because the ingredients occupy different and reinforcing positions within a connected biological network associated with inflammaging, oxidative injury, mitochondrial decline, impaired autophagy, and neuronal vulnerability.

[0188] As illustrated in FIG. 5, the composition may modulate multiple interconnected biological pathways through complementary contributions of the cannabinoid, mycelium-derived, and micronutrient components, resulting in integrated effects across inflammatory, redox, metabolic, autophagic, and neurotrophic signaling networks.

[0189] In certain embodiments, the claimed composition is expected to provide at least additive, and in some systems potentially synergistic, modulation of selected pathway nodes including NF-KB, Nrf2, AMPK, mTOR, BDNF, NGF, and mitochondrial quality-control markers, by virtue of the complementary but non-identical mechanistic roles of the constituent ingredients.Convergent inflammatory-pathway synergy

[0190] In certain embodiments, CBD / CBG, Lion’s Mane constituents, cordycepin, and selected cofactors converge on overlapping inflammatory nodes, including TNF-a, IL-10, IL-6, NF-KB, and related inflammatory signaling. Because these agents act through partially distinct upstream mechanisms, the combination may provide broader modulation of inflammatory tone than any one constituent alone.Redox-mitochondrial synergy

[0191] In certain embodiments, the composition addresses both oxidative injury and the metabolic consequences of oxidative injury. Cannabinoids may limit oxidant-generating inflammatory states and activate antioxidant response programs; Lion’s Mane and cordycepin-bearing material may contribute further redox buffering and preservation of cellular stress resilience; and micronutrient cofactors may support the enzymatic systems and ATP-dependent processes needed to maintain mitochondrial function. Thus, the combination may provide a complementary redox-mitochondrial effect that is more comprehensive than direct radical scavenging alone.AMPK-mTOR-autophagy synergy

[0192] In certain embodiments, one of the strongest synergy models resides in coordinated control of AMPK, mTOR, and associated autophagy pathways. CBD may contribute through SIRT1-linked and receptor-associated autophagic signaling; cordycepin may provide a strong AMPK-activating and mTOR-suppressing input; zinc and vitamin D may further support autophagic flux and pathway regulation; and magnesium and selected B vitamins may support the metabolic conditions under which productive cellular housekeeping can proceed.

[0193] In certain embodiments, this coordinated AMPK-mTOR-autophagy profile may be particularly relevant to aging-related decline because it addresses both impaired energy sensingand impaired cellular cleanup, two processes that frequently coexist in senescent or metabolically stressed cells.Neurotrophic-repair synergy

[0194] In certain embodiments, CBD provides a BDNF-associated, anti-excitotoxic, and anti-neuroinflammatory component, while Lion’s Mane provides a distinct NGF- and neurite-growth-associated component. Cordycepin may add further stress-resilience and neuronal-support signaling, and vitamin D, zinc, B vitamins, and magnesium may support transcriptional, synaptic, metabolic, and structural conditions favorable to neuronal maintenance and repair. Accordingly, the composition may support a trophic and repair-favorable neuronal environment through complementary mechanisms rather than through a single neurotrophic pathway.

[0195] Table 1 shows the representative mechanistic pathways, biomarkers, and functional roles of the claimed components.Table 1:Ingredient Principal Mechanistic Representative Conclusion Pathway Biomarkers / NodesCBD CB2-associated TNF-a, IL-ip, IL-6, IL- Core antiimmunomodulation, 10, NF-KB, Nrf2, inflammatory, redoxNF-KB suppression, BDNF, PINKl / Parkin regulating,Nrf2-linked antioxidant neuroprotective response, ERK / CREB ingredientand PI3K / AKT-relatedneuroplasticity,mitophagy / mitochondrial stressresponsesCBG Anti-inflammatory and NF-KB, Nrf2, iNOS, Complements CBD antioxidant signaling, ROS, IL-6possible PPARy-relatedcontribution, iNOSreduction, support ofneuronal stressresistanceLion’s Mane NGF induction, neurite NGF, neurite Distinct neurotrophic / outgrowth, JNK-linked outgrowth, JNK, NF- repair-oriented neurotrophic signaling, KB, COX -2 contributor possible antiinflammatory andantioxidant supportCordycepin / AMPK activation, AMPK, mTOR, AKT, Central energetic and Cordyceps PI3K / AKT / mT0R ERK, IL-6, IL-8, NO autophagic synergy suppression, ERK driver modulation,inflammatorysuppression, autophagysupportVitamin D VDR-mediated VDR, NF-KB, Beclin-1, Supportive cofactor immunomodulation, mTOR, BDNF, GDNF, that reinforces autophagy support, CNTF inflammatory, mitochondrial support, autophagic, and neurotrophin-related neurotrophic transcriptional support mechanisms Zinc NF-KB modulation, NF-KB, Nrf2, AMPK, Supportive cofactor for antioxidant defense, lysosomal flux, IL-6 redox, inflammatory, Nrf2 -related signaling, and autophagic stability autophagic flux / lysosomal support,neurotransmitterregulationB Vitamins Homocysteine Homocysteine, myelin- Supportive cofactor reduction, related endpoints, NGF layer, especially for neurotransmitter support, neuronal neuroprotection and synthesis, myelin metabolism metabolic integrity support, metabolic andmethylation supportMagnesium ATP-associated ATP handling, Supportive cofactor for enzymology, calcium ERK / CREB, synaptic energetics and neuronal regulation, synaptic plasticity, inflammatory resilience plasticity, ERK / CREB- markerslinked neuronalsupport, autophagysupportExample Embodiments

[0196] In certain embodiments, the compositions described herein may be evaluated using one or more experimental models, assays, or analytical techniques to assess biological activity, functional effects, and mechanistic contributions of the individual components and combinations thereof.

[0197] The following examples are provided for illustrative purposes and are not intended to limit the scope of the present disclosure.In Vitro Inflammatory Response Assays

[0198] In certain embodiments, the composition may be evaluated using in vitro models of inflammatory response.

[0199] For example, immune or neural cell lines, including microglial or macrophage-derived cells, may be exposed to inflammatory stimuli, including lipopolysaccharide (LPS), followed by treatment with the composition or individual components thereof.

[0200] In certain embodiments, levels of inflammatory mediators, including but not limited to tumor necrosis factor alpha (TNF-a), interleukin- 1 beta (IL-ip), interleukin-6 (IL-6), or nitric oxide, may be measured using appropriate analytical methods.

[0201] In certain embodiments, treatment with the composition may result in a reduction in one or more inflammatory markers relative to untreated or control samples.Oxidative Stress and Redox Assays

[0202] In certain embodiments, the composition may be evaluated for its ability to modulate oxidative stress in cellular systems.

[0203] Cells may be subjected to oxidative stress conditions, including exposure to reactive oxygen species or oxidative agents, followed by treatment with the composition.

[0204] In certain embodiments, intracellular reactive oxygen species (ROS) levels, lipid peroxidation, or antioxidant enzyme activity, including superoxide dismutase or glutathione peroxidase, may be measured.

[0205] In certain embodiments, treatment with the composition may result in reduced oxidative stress markers or enhanced antioxidant capacity relative to controls.Mitochondrial Function and Bioenergetics

[0206] In certain embodiments, the composition may be evaluated for effects on mitochondrial function and cellular bioenergetics.

[0207] Such evaluations may include measurement of mitochondrial membrane potential, ATP production, oxygen consumption rate (OCR), extracellular acidification rate (ECAR), or other indicators of mitochondrial activity.

[0208] In certain embodiments, treatment with the composition may result in improved mitochondrial function or energy metabolism under stress conditions.Autophagy and Cellular Maintenance Assays

[0209] In certain embodiments, the composition may be evaluated for its ability to influence autophagic or cellular maintenance pathways.

[0210] Markers of autophagy, including LC3, Beclin-I, or p62, may be assessed using biochemical or imaging techniques.

[0211] In certain embodiments, signaling pathways associated with autophagy, including AMPK or mTOR, may be evaluated.

[0212] In certain embodiments, treatment with the composition may result in modulation of autophagic markers or pathways associated with cellular housekeeping.Neurotrophic and Neuronal Function Assays

[0213] In certain embodiments, the composition may be evaluated using neuronal or neuron-like cell models.

[0214] Such models may include primary neurons, induced pluripotent stem cell-derived neurons, or neuronal cell lines.

[0215] In certain embodiments, expression of neurotrophic factors, including nerve growth factor (NGF) or brain-derived neurotrophic factor (BDNF), may be assessed.

[0216] In certain embodiments, neurite outgrowth, synaptic markers, or neuronal survival may be evaluated.

[0217] In certain embodiments, treatment with the composition may result in increased expression of neurotrophic factors or improved neuronal morphology or viability.Combined or Synergistic Effects

[0218] In certain embodiments, the composition may be evaluated for combined or synergistic effects of multiple components. Such evaluation may include comparison of: individual components; partial combinations; and the full composition.

[0219] In certain embodiments, the combined composition may demonstrate greater modulation of one or more biological markers than individual components alone.In Vivo and Translational Models

[0220] In certain embodiments, the composition may be evaluated in models relevant to post-viral inflammatory or neurological conditions, including models of persistent inflammation, fatigue, or cognitive impairment following viral exposure.

[0221] In certain embodiments, the composition may be evaluated in in vivo models relevant to inflammation, oxidative stress, neurological function, or aging.

[0222] Such models may include animal models of neuroinflammation, cognitive impairment, or metabolic dysfunction.

[0223] In certain embodiments, biomarkers including inflammatory cytokines, oxidative stress markers, mitochondrial function indicators, or behavioral outcomes may be assessed.

[0224] In certain embodiments, administration of the composition may result in improvement in one or more measured parameters.Biomarker and Analytical Endpoints

[0225] In certain embodiments, evaluation of the composition may include measurement of one or more biomarkers associated with the biological pathways described herein. Such biomarkers may include, but are not limited to: inflammatory markers (e.g., TNF-a, IL-6); oxidative stress markers (e.g., ROS, lipid peroxidation); mitochondrial markers (e.g., ATP levels, membrane potential); autophagy markers (e.g., LC3, p62); neurotrophic markers (e.g., NGF, BDNF).

[0226] In certain embodiments, such biomarkers may be used to assess the functional effects of the composition in experimental or clinical contexts.Dosage and Administration in Experimental Contexts

[0227] In certain embodiments, the composition may be administered in experimental settings using dosing regimens appropriate for the selected model.

[0228] Dosing may vary depending on factors including formulation, route of administration, and desired exposure levels.

[0229] In certain embodiments, repeated administration over time may be used to assess sustained or cumulative effects.Functional Use Statements

[0230] In certain embodiments, the compositions described herein may be used to modulate one or more biological pathways associated with inflammation, oxidative stress, mitochondrial function, cellular maintenance, and neuronal signaling.

[0231] In certain embodiments, the compositions may be used to reduce or modulate inflammatory signaling, including chronic low-grade inflammation associated with aging or stress-related conditions.

[0232] In certain embodiments, the compositions may be used to reduce oxidative stress or enhance antioxidant capacity within cells or tissues.

[0233] In certain embodiments, the compositions may be used to support mitochondrial function, energy metabolism, or cellular bioenergetics.

[0234] In certain embodiments, the compositions may be used to support autophagic processes, cellular maintenance, or clearance of damaged cellular components.

[0235] In certain embodiments, the compositions may be used to support neurotrophic signaling, neuronal function, synaptic activity, or neuronal resilience.

[0236] In certain embodiments, the compositions may be used to support cognitive function, including memory, focus, or mental clarity.

[0237] In certain embodiments, the compositions may be used in the context of aging or age-associated functional decline to support one or more aspects of health span or physiological resilience.

[0238] In certain embodiments, the compositions may be administered to a subject in need thereof to modulate one or more of the biological pathways described herein.

[0239] In certain embodiments, the compositions may be used alone or in combination with other interventions, including nutritional, lifestyle, or pharmacological approaches.

[0240] In certain embodiments, the compositions described herein may be used to support individuals experiencing persistent or post-acute conditions associated with prior viral infection, including conditions characterized by sustained inflammation, fatigue, cognitive impairment, or neurological dysfunction. In certain embodiments, such conditions may include post-viral syndromes or post-acute sequelae of viral infection.

[0241] In certain embodiments, such post-viral conditions may include those associated with coronavirus infection, including post-acute sequelae of SARS-CoV-2 infection (PASC).

Claims

CLAIMSWhat is claimed is:

1. A composition comprising:a. a cannabinoid component comprising one or more cannabinoids, cannabinoid- like compounds, cannabinoid receptor agonists, cannabinoid acids, cannabinoid metabolites, cannabinoid derivatives, or combinations thereof;b. a mycelium-derived component comprising one or more fungal extracts, enriched fungal fractions, isolated fungal bioactives, or combinations thereof; andc. a vitamin and / or mineral component comprising one or more vitamins, minerals, bioavailable vitamin forms, bioavailable mineral forms, or combinations thereof.

2. The composition of claim 1, wherein the cannabinoid component comprises cannabidiol (CBD), cannabigerol (CBG), or a combination thereof.

3. The composition of claim 2, wherein the cannabinoid component further comprises one or more additional cannabinoids selected from tetrahydrocannabinol (THC), cannabichromene (CBC), cannabinol (CBN), cannabidivarin (CBDV), tetrahydrocannabivarin (THCV), cannabigerolic acid (CBGA), tetrahydrocannabinolic acid (THCA), cannabidiolic acid (CBDA), cannabichromenic acid (CBCA), cannabinolic acid (CBNA), cannabicyclol (CBL), tetrahydrocannabiphorol (THCP), and combinations thereof.

4. The composition of any one of claims 1 to 3, wherein the cannabinoid component further comprises one or more terpenes selected from myrcene, limonene, pinene, linalool,caryophyllene, humulene, terpinolene, ocimene, geraniol, terpineol, valencene, eucalyptol, borneol, camphene, bisabolol, and combinations thereof.

5. The composition of any one of claims 1 to 4, wherein the mycelium-derived component comprises Hericium erinaceus, Cordyceps species, or a combination thereof.

6. The composition of claim 5, wherein the Cordyceps species comprises Cordyceps sinensis, Cordyceps militaris, or both.

7. The composition of any one of claims 1 to 6, wherein the mycelium-derived component comprises one or more bioactives selected from hericenones, erinacines, cordycepin, adenosine, polysaccharides, sterols, and combinations thereof.

8. The composition of any one of claims 1 to 7, wherein the vitamin and / or mineral component comprises one or more of vitamin D, zinc, magnesium, vitamin B6, vitamin B12, folate, vitamin B3, vitamin C, vitamin E, vitamin A, calcium, iron, potassium, selenium, copper, manganese, and combinations thereof.

9. The composition of any one of claims 1 to 8, wherein the vitamin and / or mineral component comprises one or more bioavailable or modified forms selected from magnesium L-threonate, magnesium glycinate, zinc picolinate, zinc citrate, methylcobalamin, methylfolate, and combinations thereof.

10. The composition of any one of claims 1 to 9, further comprising one or more auxiliary components selected from carrier oils, emulsifiers, stabilizers, fillers, binders, preservatives, flavoring agents, sweeteners, colorants, and combinations thereof.

11. The composition of claim 10, wherein the one or more auxiliary components comprise medium-chain triglyceride oil, lecithin, polysorbate, or a combination thereof.

12. The composition of any one of claims 1 to 11, wherein the cannabinoid component comprises CBD and CBG in a weight ratio from about 99:1 to about 50:50.

13. The composition of claim 12, wherein the CBD and CBG are present in a weight ratio of about 70:30.

14. The composition of any one of claims 1 to 13, wherein the mycelium-derived component comprises Hericium erinaceus and Cordyceps species in a weight ratio from about 80:20 to about 50:50.

15. The composition of claim 14, wherein the Hericium erinaceus and Cordyceps species are present in a weight ratio of about 60:40.

16. The composition of any one of claims 1 to 15, wherein the composition is formulated as a capsule, tablet, softgel, powder, granule, sachet, liquid suspension, sublingual drop, spray, film, dissolvable tablet, transdermal patch, gel, cream, ointment, microemulsion, nanoemulsion, liposome, micelle, nanoparticle dispersion, or sustained-release matrix tablet.

17. The composition of claim 16, wherein the composition is formulated as a lipid-based formulation, self-emulsifying drug delivery system, microemulsion, nanoemulsion, liposome, solid lipid nanoparticle, polymeric nanoparticle, or micellar formulation.

18. The composition of any one of claims 1 to 17, wherein one or more components of the composition are present in encapsulated, emulsified, liposomal, nanoparticulate, lipid- associated, chelated, complexed, or conjugated form.

19. The composition of any one of claims 1 to 18, wherein the composition comprises: a. CBD in an amount of about 0.1 mg to about 500 mg;b. CBG in an amount of about 0.1 mg to about 300 mg;c. Hericium erinaceus extract in an amount of about 0.1 mg to about 3000 mg; d. Cordyceps extract in an amount of about 0.1 mg to about 3000 mg; and e. one or more vitamins and / or minerals in nutritionally or therapeutically relevant amounts.

20. The composition of any one of claims 1 to 19, wherein the composition comprises: a. CBD in an amount of about 1 mg to about 150 mg;b. CBG in an amount of about 1 mg to about 100 mg;c. Hericium erinaceus extract in an amount of about 50 mg to about 1000 mg; d. Cordyceps extract in an amount of about 50 mg to about 1000 mg; and e. one or more vitamins and / or minerals in nutritionally or therapeutically relevant amounts.

21. The composition of any one of claims 1 to 20, wherein the composition comprises: a. CBD in an amount of about 10 mg to about 50 mg;b. CBG in an amount of about 5 mg to about 25 mg;c. Hericium erinaceus extract in an amount of about 100 mg to about 500 mg; d. Cordyceps extract in an amount of about 100 mg to about 500 mg; and e. one or more vitamins and / or minerals in nutritionally or therapeutically relevant amounts.

22. The composition of any one of claims 1 to 21, wherein the composition is configured for coordinated modulation of two or more biological pathways selected from inflammatory signaling, oxidative stress, mitochondrial function, autophagy, mitophagy, neurotrophic signaling, synaptic plasticity, and neuronal resilience.

23. A composition comprising:a. cannabidiol (CBD);b. cannabigerol (CBG);c. a Hericium erinaceus extract comprising one or more of hericenones and erinacines;d. a Cordyceps extract comprising cordycepin; ande. one or more micronutrients selected from vitamin D, zinc, magnesium, vitamin B6, vitamin B12, folate, and combinations thereof.

24. The composition of claim 23, wherein the magnesium comprises magnesium L- threonate or magnesium glycinate.

25. The composition of claim 22 or claim 23, wherein the folate comprises methylfolate and the vitamin B12 comprises methylcobalamin.

26. The composition of any one of claims 22 to 25, wherein the composition comprises:a. CBD in an amount of about 0.1 mg to about 500 mg;b. CBG in an amount of about 0.1 mg to about 300 mg;c. Hericium erinaceus extract in an amount of about 0.1 mg to about 3000 mg; d. Cordyceps extract in an amount of about 0.1 mg to about 3000 mg; and e. one or more vitamins and / or minerals in nutritionally or therapeutically relevant amounts.

27. The composition of any one of claims 22 to 26, wherein the composition comprises:a. CBD in an amount of about 1 mg to about 150 mg;b. CBG in an amount of about 1 mg to about 100 mg;c. Hericium erinaceus extract in an amount of about 50 mg to about 1000 mg; d. Cordyceps extract in an amount of about 50 mg to about 1000 mg; ande. one or more vitamins and / or minerals in nutritionally or therapeutically relevant amounts.

28. The composition of any one of claims 1 to 20, wherein the composition comprises: a. CBD in an amount of about 10 mg to about 50 mg;b. CBG in an amount of about 5 mg to about 25 mg;c. Hericium erinaceus extract in an amount of about 100 mg to about 500 mg; d. Cordyceps extract in an amount of about 100 mg to about 500 mg; and e. one or more vitamins and / or minerals in nutritionally or therapeutically relevant amounts.

29. A method of making a composition, the method comprising:a. providing a cannabinoid component;b. providing a mycelium-derived component;c. providing a vitamin and / or mineral component; andd. combining the cannabinoid component, the mycelium-derived component, and the vitamin and / or mineral component to form the composition.

30. The method of claim 29, wherein the method results in a composition comprises: a. CBD in an amount of about 0.1 mg to about 500 mg;b. CBG in an amount of about 0.1 mg to about 300 mg;c. Hericium erinaceus extract in an amount of about 0.1 mg to about 3000 mg; d. Cordyceps extract in an amount of about 0.1 mg to about 3000 mg; and e. one or more vitamins and / or minerals in nutritionally or therapeutically relevant amounts.

31. The method of claims 29 or 30, wherein the method results in a composition comprises:a. CBD in an amount of about 1 mg to about 150 mg;b. CBG in an amount of about 1 mg to about 100 mg;c. Hericium erinaceus extract in an amount of about 50 mg to about 1000 mg; d. Cordyceps extract in an amount of about 50 mg to about 1000 mg; and e. one or more vitamins and / or minerals in nutritionally or therapeutically relevant amounts.

32. The method of claims 29 to 31, wherein the method results in a composition comprises:a. CBD in an amount of about 10 mg to about 50 mg;b. CBG in an amount of about 5 mg to about 25 mg;c. Hericium erinaceus extract in an amount of about 100 mg to about 500 mg; d. Cordyceps extract in an amount of about 100 mg to about 500 mg; and e. one or more vitamins and / or minerals in nutritionally or therapeutically relevant amounts.

33. The method of claims 29 to 32, further comprising extracting the cannabinoid component from plant material by supercritical carbon dioxide extraction, solvent extraction, or both.

34. The method of claims 29 to 33, further comprising obtaining the mycelium-derived component by hot water extraction, alcohol extraction, dual extraction, or a combination thereof.

35. The method of any one of claims 29 to 34, wherein combining comprises blending or co-processing the cannabinoid component, the mycelium-derived component, and the vitamin and / or mineral component under controlled temperature, humidity, atmospheric composition, or a combination thereof.

36. The method of claim 29, wherein the blending or co-processing is conducted under an inert atmosphere.

37. The method of any one of claims 29 to 36, further comprising encapsulating one or more of the cannabinoid component, the mycelium-derived component, and the vitamin and / or mineral component in a liposomal, lipid-based, polymeric, or microencapsulated delivery system.

38. The method of claim 37, wherein the encapsulating comprises a dual-phase or multilayer encapsulation system in which a lipophilic component is incorporated into a lipid or liposomal phase and a hydrophilic component is incorporated into an aqueous or polymeric phase.

39. The method of any one of claims 29 to 38, further comprising emulsifying one or more lipophilic components using high-shear mixing, ultrasonication, homogenization, or a combination thereof to form a microemulsion or nanoemulsion.

40. The method of any one of claims 29 to 39, further comprising stabilizing the composition by pH-controlled processing, incorporation of one or more antioxidants or stabilizers, protection from light, heat, or moisture, or a combination thereof.

41. The method of any one of claims 29 to 40, wherein the method reduces degradation of cannabinoids, hericenones, erinacines, cordycepin, or combinations thereof.

42. A method of modulating one or more biological pathways in a subject, the method comprising administering to the subject an effective amount of the composition of any one of claims 1 to 27.

43. The method of claim 42, wherein the one or more biological pathways are selected from inflammatory signaling, oxidative stress, mitochondrial function, autophagy,mitophagy, neurotrophic signaling, synaptic plasticity, neuronal survival, and neuronal resilience.

44. The method of claim 42 or claim 43, wherein administering the composition modulates one or more biomarkers selected from TNF-a, IL-ip, IL-6, IL- 10, NF-KB, Nrf2, AMPK, mTOR, AKT, ERK, BDNF, NGF, PINKl / Parkin, Beclin-1, ROS, nitric oxide, and combinations thereof.

45. The method of any one of claims 42 to 44, wherein the subject is experiencing age- associated functional decline, chronic low-grade inflammation, oxidative stress, impaired mitochondrial function, impaired autophagic processes, reduced neurotrophic support, or a combination thereof.

46. The method of any one of claims 42 to 45, wherein the subject is experiencing a post- viral inflammatory or neurological condition.

47. The method of claim 46, wherein the post-viral inflammatory or neurological condition comprises persistent inflammation, fatigue, cognitive impairment, or combinations thereof following viral exposure.

48. The method of any one of claims 34 to 47, wherein the composition is administered orally, sublingually, buccally, transdermally, nasally, or topically.

49. Use of the composition of any one of claims 1 to 27 for supporting cognitive function, reducing inflammation, supporting mitochondrial function, supporting autophagic processes, supporting neurotrophic signaling, or combinations thereof.

50. Use of the composition of any one of claims 1 to 27 for modulating one or more pathways associated with aging, cellular stress, or post-viral inflammatory or neurological conditions.for supporting one or more of cognitive function, inflammatory balance, oxidative stress regulation, mitochondrial energetics, cellular maintenance, and neuronal resilience.

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