Cannibinoid formulations

Abstract

A pharmaceutically or nutraceutically acceptable formulation contains a cannabinoid which may be a full spectrum or partial spectrum cannabis extract, tetrahydrocannabinol (THC), an analog of THC, cannabidiol (CBD), an analog of CBD, ora combination thereof and at least one nootropic agent mixed in a carrier medium. A method of making the formulation mixingsaid formula and heatingthe formulation above room temperature until the mixture is homogenous. Additional supplements may be added to each formulation. The formulation may have a carrier medium suitable to be used in capsule, dissolvable tablet, vaporizer, spray, inhaler, tincture, beverage or any other suitable application.

Description

Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-HensonCANNABINOID FORMULATIONS

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to the U.S. patent provisional application Ser. No. 63,703,887, titled Cannabinoid Formulation, filed on October 4, 2024. The aforesaid application, in its entirety, is incorporated by reference herein.

[0003] FIELD OF THE INVENTION

[0005] The present invention relates to a nutritional supplement or pharmaceutical formulation comprised of at least a cannabinoid and a nootropic.

[0006] BACKGROUND OF THE INVENTION

[0007] Enhancement of self-improvement, creativity, and productivity from use of supplements or pharmaceutics such as cannabinoids and nootropics without pronounced side effects has been long sought after in an age that demands productivity and performance. Cannabinoids reportedly can elicit such effects, but not consistently and without side effects. With respect to nootropics, a recent study shows that at least for one marketed nootropic supplement at standard doses was less effective than coffee or a xanthine. Even coffee or xanthine, such as caffeine, which may also be considered a nootropic, is also known to cause anxiety, insomnia, digestive issues, atrophy, high blood pressure, rapid heart rate, and fatigue. Other studies suggest that nootropics alone may increase the likelihood of obsessive compulsive disorder and addictive behaviors.

[0008] Cannabinoids are commonly produced by the plant Cannabis sativa. It has been reported that there are over 144 naturally occurring cannabinoids, as well as a number of synthetics that are known to elicit similar effects.

[0009] A9-tetrahydrocannabinol (THC) is the major phytocannabinoid present in Cannabis sativa and has the primary psychoactive and psychomimetic effects. THC has been reported to have therapeutic effects for a variety of physical conditions and illnesses. THC may act as a strong antidepressant by releasing dopamine, causing elation, relaxation, and pain relief. Other therapeutic effects include glaucoma, appetite and weight loss associated with HI V / AIDS, Tourette syndrome, neuropathic pain,Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson spasticity in multiple sclerosis, and nausea and vomiting in people receiving chemotherapy, appetite and weight loss associated with HIV / AIDS, Tourette syndrome, post-traumatic stress di order, and schizophreni .

[0010] Some have reported that THC may provide an increase in focus and productivity, and reduced inhibitions and reduced anxiety. It has also been reported to increase creativity, improve reaction times, lower stress, and improve verbal fluency.However, such benefits have not been widely documented, and not all users of THC experience such effects.

[0011] THC has also been known to cause negative side effects such as anxiety, paranoia, memory loss, disorientation, and dizziness. In some cases, the effect on increasing one’s appetite and verbal deficit may also not be a negative. Cognitive deficits have been reported with acute exposure to THC. Such deficits are often transient. It is arguable that chronic use of cannabis is associated more with longer lasting effects such as memory loss. Chronic THC use may also lead to psychomotor impairment caused by harm to the hippocampus. THC also is known to reduce nitric oxide concentrations in the blood which is important for neurotransmission.

[0012] THC, as used herein, includes tetrahydrocannabinol precursors / prodrugs, isomers or derivatives. Such variant THCs may be chosen based on solubility, absorption, bioavailability, targeting, and / or psychoactive and psychomimetic effects. Dosaging or concentrations or percentage weights (%W / W or %W / V) may be any effective range for use in any application or processing step of manufacture of a THC containing product.

[0013] Cannabidiol (CBD) is a major phytocannabinoid produced in the Cannabis sativa plant. CBD is considered a non-psychotropic compound and may act as an agonist to the psychoactive effects of THC. CBD has a wide range of therapeutic applications ranging from treating anxiety, depression, psychosis, cognition, movement disorders, neuropathic pain, epilepsy, cancers, and anti-inflammation.

[0014] CBD, as used herein, includes cannabidiol precursors / prodrugs, isomers or derivatives. Such variant CBDs may be chosen based on solubility, absorption, bioavailability, targeting, and / or non-psychotropic effects. Dosaging and concentrations or percentage weights (%W / W or %W / V) may be any effective range for use in any application or processing step of manufacture of a CBD containing product.Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson

[0015] A nootropic may be a drug, supplement, or other substance which acts to improve cognitive function, executive function, attention, memory, learning, creativity, and / or motivation.

[0016] Nootropic, as used herein, includes nootropic precursors / prodrugs, isomers or derivatives. Such variant nootropics may be chosen based on solubility, absorption, bioavailability, targeting, and / or intended cognitive effects. Dosaging and concentrations or percentage weights (%W / W or %W / V) may be any effective range for use in any application or processing step of manufacture of a nootropic containing product.

[0017]

[0018] Racetams are a class of nootropics that share similar chemical structure, i.e. a pyrrolidone nucleus. Among the racetam family, some racetams are reported to boost memory, concentration, or attention. Some racetams are reported to relieve stress and anxiety. Others also alleviate depression and reduce exertion and raise motivation when undertaking physical tasks.

[0019] Racetam family members include piracetam, aniracetam, omberacetam (trade name: Noopept), oxiracetam, pramiracetam, phenylpiracetam (trade name: Phenotropil), and etiracetam which are considered nootropics. Levetiracetam (trade name: Keppra) and seletracetam are considered anticonvulsants. Other racetams include, but are not limited to, brivaracetam, cebaracetam, coluracetam, dimiracetam, doliracetam, dupracetam, fasoracetam, imuracetam, methylphyenylpiracetam, nebracetam, nefiracetam, phylpiracetam hydrazine, pramiracetam, rolipram, and rolziracetam.

[0020] Noopept may provide enhanced focus, reduced anxiety, increased energy, enhanced learning, and increased memory. Additionally, Noopept demonstrates a synergism with other members of the racetam family. Common dosing may be, but not limited to, 10-40 mg taken orally, once a day or in 10 mg increments throughout the day.

[0021] Noopept have neuroprotective properties. A study has shown that the introduction of Noopept assists in prompt rapid sequestration of alpha-syn oligomers into fibrils, rescues the cytoxic effect of amyloid oligomers, and reduces the level of intracellular oxidative stress in Parkinson’s disease caused by amyloid aggregates.

[0022] Another study demonstrates that Noopept has a positive impact again as a neural protectant and additionally assists in the therapy for Alzheimer’s disease. NoopeptTitle: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson demonstrates an ability to prevent ionic disbalance, excitotoxicity, reduce free radical and pro-inflammatory cytokines accumulation, and neurotrophin deficit typical in brain damage. Further to this study, Noopept affects mitochondrial function by possibly guarding against beta amyloid neurotoxicity through limiting oxidative stress, calcium dysregulation, and thus mitochondrial dysfunction through ameliorating the mitochondrial membrane potential caused by peptide mimicking the toxic effects found in Alzheimer’s disease models. Noopept has also been found to ameliorate side effects on over utilization of choline channels. Noopept’ s reported side effects include headaches, restlessness, dizziness, and irritability which typically occurs at high doses.

[0023] Pramiracetam has been reported to enhance focus and memory. In animal studies, pramiracetam may enhance high-affinity choline uptake. Pramiracetam has synergistic effects with other nootropics such as, but not limited to, adrafinil.Standard dosing of pramiracetam may be, but not limited to 400-600 mg per day. Pramiracetam has been reported to have the same benefits as Noopept and may alleviate the side effects of over utilization of choline.

[0024] Phenylpiracetam, also known as Phenotropil, has been reported to raise energy, improve learning capacity, helps the prevention of amnesia, suppresses anxiety and fear, reduces effects of sleep deprivation, increases cold tolerance, improves mood, enhances memory and cognition, and enhances athletic performance. It has also been reported that the Phenotropil may be an antidepressant and has the ability to rehabilitate stroke patients through restoring neurological functions. Unlike other racetams which focus on the adrenal system, phenylpiracetam is notable for its effect on enhancing physical focus. Standard dosing of Phenotropil may be, but not limited to, 100 to 250 mg per day.

[0025] Adrafinil is a eugeroic that promotes alertness and wakefulness and is classified as a scheduled substance. It also may increase focus, enhance learning, improve mood, and act as a neuroprotectant. Adrafinil has been reported to help treat SDAT and Parkinson’s disease. It has also demonstrated increased physical activity in animals. Adrafinil is a prodrug that is metabolized into modafinil. Direct use of modafinil exhibits the same effects as adrafinil, but with a higher potency and increase negative side effects. Adrafinil use is reported to not cause anxiety.

[0026] A variety of amino acids have been known to enhance relaxation without causing drowsiness. Examples may include L-theanine, L-pyroglutamate, and L-arginine. L-Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson arginine is an amino acid that is considered one of the 20 amino acid “building blocks” for the cell. L-arginine also may be converted to nitric oxide which is a powerful neurotransmitter that helps blood vessels relax and improves circulation. L- arginine may be consumed through diet as well as produced naturally in the body. L- arginine has also been used therapeutically and as supplement. L-arginine has been reported to enhance nootropic transmission. L-arginine powder may be formed in a crystalline form combined with L-pyroglutamate.

[0027] Kratom (Mitragyna speciose . known also as Ketum, Kratum, Thai, Meang Da , Thang, Kakuam, Thom, Ketum, and Biak. Kratom contains many alkaloids including mitragynine, mitraphylline, and 7-hydroxymitragynine. Traditionally, kratom has been used in Malaysia and Thailand by laborers and farmers to enhance productivity, but also as a substitute to opium, allegedly due to its morphine-like pharmacological effects. Kratom is a central nervous system stimulant, from which over 40 alkaloids have been isolated. In low doses it is reported to have stimulant effects used to combat fatigue, while at high doses, it can have sedative-narcotic effects.

[0028] The major alkaloid found in this plant, ‘mitragynine’, has an opioid agonistic activity and its derivative 7-hydroxymitragynine (7-OH-mitragynine) is reported to be more potent than mitragynine or morphine. Kratom shows a dose-dependent opioidlike effect providing self-reported perceived beneficial effects in alleviating pain and relieving mood disorders. Kratom was primarily used for self-treatment of pain, mood disorders, and withdrawal symptoms associated with prescription opioid use. Kratom shows a dose-dependent opioid-like effect with reported beneficial effects in alleviating pain and relieving mood disorders, and withdrawal symptoms associated with prescription opioid use. Kratom has been reportedly used with beneficial effect as an analgesic (McWhirter & Morris, 2010) and antitussive (McWhirter & Morris, 2010; Nelsen, Lapoint, Hodgman, & Aldous, 2010). It has been reportedly used with beneficial effect for the treatment of anxiety, attention deficit disorder (adult), chronic pain (Boyer et al., 2008; Rosenbaum et al., 2012), depression, diarrhea, opioid addiction, and opioid withdrawal (Boyer et al., 2008; McWhirter & Morris, 2010;Rosenbaum et al., 2012; Vicknasingam et al., 2010). Kratom has been reportedly used with beneficial effects of calming (Chittrakam et al., 2010), methadone detoxification, increases energy (Chittrakam et al., 2010; Vicknasingam et al., 2010), improved mood, and prolonged and intensified sexual performance. Well-known standardization for Mitragyna speciosa is lacking, however, dosage relies on theTitle: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson potency and form of Mitragyna speciosa used. The leaves of Mitragyna speciosa have been reportedly chewed, smoked, or made into a tea (Assanangkornchai et al., 2007; Jansen & Prast, 1988; Roche et al., 2008; Suwanlert, 1975).

[0029] The blue lotus flower (Nymphea caerulea) known also as Blue Lotus, Egyptian lotus, Blue Water Lily, Blue Egyptian Water Lily, Sacred Blue Lily, Blue star water lily, Star Lotus, Red and Blue water lily, and Manel Flower is an Egyptian water lily containing apomorphine and nuciferine. Blue lotus flower is used as a sleep aid and anxiety reliever but has also been described as a mild stimulant. The flower’s psychoactive effects are most often attributed to two alkaloids, apomorphine and nuciferine. Apomorphine is a nonselective dopamine receptor agonist and activates serotonin receptors and a-adrenergic receptors (LeWitt 2004; Millan et al. 2002). It has been used as a sedative-hypnotic since the late 1800s to treat insomnia, depression, or schizophrenia (Ribaric 2012). It has been used in the treatment of erectile dysfunction (Gottlieb 2000) and was sold under the trade name Upriama and Ixense. In 1951, it was reported to successfully treat Parkinson’s disease at a subcutaneous dose of 0.5 to 1.0 mg (Schwab, Amador, and Lettvin 1951). It has also been used in the treatment of alcohol and morphine addiction (Ribaric 2012). In veterinary medicine, it has been used to induce vomiting (Scherkl, Hashem, and Frey 1990). It has also been suggested that apomorphine can play a role in the treatment of Alzheimer’s disease (Okun and Foote 2010; Ribaric 2012) Nuciferine is an antagonist at 5-HT2A, 5-HT2C, and 5-HT2B, an inverse agonist at 5-HT7, a partial agonist at D2, D5 and 5-HT6, an agonist at 5-HT1A and D4 receptors, and inhibits the dopamine transporter (Farrell et al. 2016). Behavioral effects produced in rats include catalepsy, potentiation of hexobarbitone hypnosis, morphine analgesia, and anticonvulsant action (Bhattacharya et al. 1978). It has been suggested that nuciferine may have potential therapeutic applications as an anti-psychotic drug (Farrell et al. 2016) and on vascular diseases associated with aberrant vasoconstriction (Wang et al. 2015).

[0030] Coenzyme Q10 (“CoQlO”) is an essential cofactor in the electron transport chain as well as a potent antioxidant and has been shown to exhibit neuroprotective properties. In older mice with clear cognitive and psychomotor impairments, short- time (15 days) CoQlO-supplementation improved spatial learning. It has also been found to have analgesic effects.Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson

[0031] Pyrroloquinoline quinone (“PQQ”), which is found in various foods, is a redox cofactor and stimulator of mitochondria biogenesis. PQQ prevents oxidative damage in the brain and reduces the cognitive deficit caused by oxidative stress in rats during aging. PQQ has also been shown to have analgesic effects.

[0032] Reishi (Ganoderma lucidiim . also known as lingzhi,has a long history of use for promoting health and longevity in China, Japan, and other Asian countries. The mushroom was attributed with therapeutic properties, such as tonifying effects, enhancing vital energy, strengthening cardiac function, increasing memory, and antiaging effects.

[0033] Lion's mane, (Hericium erinaceus . also known as Yamabushitake and Satyr's beard, is a mushroom that grows on both living and dead broadleaf trees. It has been used for centuries as food source and herbal medicine in several Asian countries. Animal studies have found that lion’s mane confers anti-depressant, anxiolytic, and improved cognitive effects as well as prevents memory impairment.

[0034] Ginkgo biloba is a tree with leaves that have been used in traditional Chinese medicine for centuries to treat ailments of the brain, heart, and lungs. Some studies have shown that ginkgo biloba is potentially beneficial for the improvement of cognitive function, activities of daily living, and global clinical assessment in patients with mild cognitive impairment or Alzheimer's disease.

[0035] Citicoline, also known as CDP-choline and cytidine 5'-diphosphocholine, is a is an endogenous nucleotide naturally found in the body where it is an essential intermediate in the synthesis of the major phospholipid of the cell membranes, phosphatidylcholine. Citicoline has proved to be a valid treatment in patients with a cerebrovascular pathogenesis for memory disorders. Citicoline has been proposed for use in traumatic brain injuries, stroke, vascular dementia, Parkinson’s disease, and brain aging where it has the function of stabilizer of cell membranes and reduces the presence of free radicals. In particular, there is some evidence of a stimulating role of citicoline for the release of dopamine neurotransmitters in the brain.

[0036] Phosphatidylserine is a phospholipid and is a component of the cell membrane. It supports human cognitive functions, including the formation of short-term memory, the consolidation of long-term memory, the ability to create new memories, the ability to retrieve memories, the ability to learn and recall information, the ability to focus attention and concentrate, the ability to reason and solve problems, language skills,Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson and the ability to communicate. It also supports locomotor functions, especially rapid reactions and reflexes.

[0037] Huperzine A is a naturally occurring sesquiterpene alkaloid compound found in the fir moss Huperzia serrata. Huperzine A has shown cognitive improvement in clinical studies as assessed by the mini-mental state examination, clinical dementia rating, and activities of daily living scores.

[0038] Vinpocetine is a derivative of vincamine, an alkaloid of common periwinkle plant (vinca minor), which has been shown to exert a brain neuro-protective effect by a combined action on cerebral circulation, brain metabolism and rheological properties of the blood. Vinpocetine has been found to significantly improve memory and concentration.

[0039] Wormwood (Artemisia absinthium L.) has a high content of nutrients and phytochemicals such as total phenolic compounds and total flavonoids. Wormwood has been shown to have antioxidative activity and play a role in reduction of neurotoxicological damage.

[0040] Prior art references suggested that nootropics could enhance the effects of cannabis. However, this prior art suggested higher doses of cannabis to achieve the desirable “high”, i.e. the euphoric feeling associated with THC. In another prior art reference, a full extract from Cannabis sativa in combination with high doses of piracetam, i.e. 150 mg / kg, once a day, was used on mice to evaluate the negative effects of the extract as related to oxidative stress on the brain and liver. Both prior art teachings focused on how piracetam would reduce the negative effects of a cannabis full extract. The prior art references fails to evaluate a range of concentrations of nootropics as well as recognize the use of a variety of nootropics that may be used to both reduce the negative effects of THC while enhancing the THC’s positive effects on improving focus, mental and physical productivity, creativity, reduction of inhibitions and anxiety.

[0041] INVENTION SUMMARY

[0042] The present invention is a formulation, a process of manufacturing the formulation, and method of using the formulation comprising a cannabis extract or THC in combination with nootropics such as at least one racetam as well as other supplements or pharmaceuticals. Effective nootropic concentrations are much lower than the individually administered standard doses of nootropics. The addition of the nootropics at these modulated concentrations effectively reduces the negative effects associated byTitle: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-HensonTHC while enhancing the positive desired effects of THC.

[0043] DETAILED DESCRIPTION OF THE INVENTION

[0044] The present invention combines cannabinoids with one or more nootropics, and in particular, cannabis extract, THC or an analog of THC, CBD or an analog of CBD, combined with at least one nootropic into one formulation. The combined administration of the nootropic is designed to reduce or mute certain non-desirable effects from cannabinoids or enhance neurologic function while still under the effects of cannabinoids.

[0045] The added nootropic may counteract the cannabinoid’s effect on anxiety, paranoia, memory loss, disorientation, and dizziness. The nootropic may also lower cannabinoid-associated increase in appetite and verbal deficit. Furthermore, the nootropic may lower any cannabinoid-associated harm to neural tissue such as the hippocampus. By muting such effects, the nootropic allows the cannabinoid effects to improve focus, creativity, reaction times, verbal fluency, and productivity, while reducing inhibitions and reducing anxiety. Varying the concentrations of the cannabinoids and nootropics, as well as the types of nootropics, may modulate the types of positive effects elicited from the cannabinoids.

[0046] In one embodiment, the formulation may comprise 4-8 g of full spectrum cannabis oil (FSCO; also known as Full Extract Cannabis Oil). FSCOs contain the complete range of cannabinoids and range of terpenes. In one preferred embodiment, the FSCO contains 75% W / WT (THC / Total Weight). The nootropic concentration of this embodiment may be from 0.001 to 50% W / WT.

[0047] In an alternate embodiment, the formulation may include partial spectrum cannabis extract such as nitrogen extracted THC oil. Some nitrogen extract oils contain an 83% W / W THC concentration.

[0048] In the following examples below, formulations (or mixtures) may contain THC, an analog of THC analogs, CBD, an analog of CBD, a range cannabinoids or combinations thereof.

[0049] Example 1 provides one exemplary formulation.

[0050] Example 1 Formulation a. 75% W / WT Cannabinoid / THC

[0051] 4-8 gOILTitle: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson

[0052] 10-100 mg a. Racetam

[0053] In the above Example 1 formulation, one or more racetams may be dissolved under stirring and heated using a hot plate set to a low to moderate temperature setting, room temperature to 65° Celsius (° C), in a volume containing approximately 4-8 g of THC / CBD / FSCO amount and an approximately equivalent amount of 40-60 %%W7WT Medium-Chain Transglycerides (MCT) oil. An exemplary final concentration of THC may be approximately 37.5% W / WT. An exemplary final concentration of nootropic may be 0.001 to 50% W / WT. The formulation is stirred and heat until it has been completely dissolved.

[0054] The racetam may be any of the nootropics exhibiting effects associated with improved cognitive function and neuroprotective properties. In one exemplary embodiment, the racetam may be Noopept having an initial purity of greater than 98%. In this exemplary embodiment, the formulation may mute the negative side effects of a cannabinoid related to a lack of focus, increased anxiety, psychomotor impairment, and increased appetite thereby having a counteracting sobering effect while not affecting the cannabinoid’s effect on euphoria, relaxation, and pain relief. The formulation may also improve the ability to sleep while not causing a lack of focus, paranoia, memory loss, disorientation, and dizziness.

[0055] The formulation may be delivered in the form of vaporizer, tincture, inhaler, oral or nasal spray, beverage, or any other means of administration. The mixture may also be delivered in the form of soft-shell, liquid-filled, or oleogel-based capsules, or a molded tablet having a chewable, lozenge, or gummy-like form. The formulation may be a pharmaceutically or nutraceutically acceptable composition / mixture suitable for administration via oral, nasal, sublingual, or other mucosal or systemic delivery routes. Doses of the formulation may be taken in multiple “micro” doses throughout the day such as when using a vaporizer or an inhaler or any other suitable means for administration.

[0056] With respect to a tincture, a droplet of the formulation may be added to a glass of water, and the effectiveness may last longer than using other means. It has been reported that the effects of a tincture may last for a few hours. The small or “micro” dosing of the formulation demonstrates the nootropic concentration is on the order of 3 to 4 mg or less. The standard dosing of nootropics is of the order of 10 to 1000 mgTitle: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson depending on the type of nootropic. In some embodiments, especially for wholistic purposes, the dosing may even be lower.

[0057] In another preferred embodiment, the formulation may contain a cannabinoid and two or more nootropics. The formulation may further comprise supplements and flavor additives.

[0058] Example 2 provides an exemplary formulation with one or more nootropic and other additives such as supplements and flavor additives.Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson

[0060] Example 2 Formulation. . . . .. , .

[0061] 4-8 g a. Cannabinoid Oil Mixture1 J°. • ..t

[0062] 10-1000 mg a. Nootropic Mixture °Tr

[0063] ~0.16g a. L-Argmine (Optional) °

[0064] In the Example 2 formulation, a nootropic mixture and supplements may be dissolved under constant stirring and heated using a hot plate set to a low to moderate temperature setting, room temperature to 65° Celsius (° C), in a volume containing the desired cannabinoid oil mixture amount and an approximately equivalent amount of 40-60 %% W / WT MCT oil. The formulation may be heated and stirred till the nootropic mixture is completely dissolved.

[0065] The cannabinoid oil mixture may comprise a full spectrum cannabis oil and / or nitrogen extract THC oil. In one exemplary embodiment, a 75% W / WT FSCO may be used in combination with 83% W / WT nitrogen extracted THC oil. In another exemplary embodiment, higher amounts of the nitrogen extracted THC may be used relative to the amounts of FSCO. An exemplary final concentration of nootropic may be 0.001 to 50% % W / WT.

[0066] The nootropic mixture of example 2 may contain at least one racetam. The nootropic mixture may also contain other types of nootropics such as a eugeric. In one exemplary embodiment, a formulation may contain Noopept, pramiracetam, phenylpiracetam, and adrafinil. The formulation may also contain CoQlO, PQQ, reishi, lionsmane, gingko, citocholine, phosphatidylserene, huperzine A, vinpocetine and / or wormwood. Racetam powders may have a greater than 98% purity. An example supplement may also include L-arginine in the form of L-arginine-L- pyroglutamate crystalline mixture. Flavor additives known in the art may be added which may include natural flavor additives such as shavings from ginseng and / or turmeric. Further to this exemplary embodiment, the phenylpiracetam may be at higher concentration relative to the other nootropics while the adrafinil may be at a lower concentration relative to the other nootropics. Further to this embodiment, in addition to or in place of adrafinil, gingko, lion’s mane, and / or vinopectine may be added. Overall, the concentrations of the nootropics are substantially lower than aTitle: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson nootropic’s individual standard dosing as well as the dosing in Example 1. Furthermore, the formulation may be administered in small or micro doses which further reduces the nootropic dose and dramatically increases its safety.

[0067] In an exemplary formulation based on Example 2, the combination of the cannabinoid oil and nootropics provides a multifaced and layered effect. The nootropics may negate the “high” and euphoric effect. Without being bound to any theory, the racetams may have a neural protective / repair effect that may guard against the harmful side effects caused by THC. The nootropics also increase physical abilities, stabilize and enhance mood, enhance observational abilities, and improve focus and learning.

[0068] In one case using the exemplary formulation based on Example 2, the user reports that after a night of heavy alcohol consumption combined with the simultaneous micro dosing through use of a vaporizer, the user experienced no negative effects from the alcohol consumption the next morning as well as increased physical activity during a boxing session. In another case using the exemplary formulation, the user reports increased focus and decreased levels of ADHD.

[0069] An exemplary formulation, as shown in Example 3, may have a lower overall nootropic concentration and a higher THC concentration with respect to the formulation of Example 2.

[0070] Example 3 Formulation a.fCannabinoid Oi il M Mixt .ure

[10071] J4-8 g °. • ..t

[0072] 10-1000 mg a. Nootropic Mixture ° a.TL-Argmine ( rOptional)

[0073] ~0.05g °

[0074] In the Example 3 formulation, a nootropic mixture and optionally one or more supplements may be dissolved under constant stirring and heated using a hot plate that is set to a low to moderate temperature setting, room temperature to 65° Celsius (° C), in a volume containing the desired cannabinoid oil mixture amount and approximately 3.7 g of MCT oil. The formulation may be heated and stirred till the nootropic mixture is completely dissolved.Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson

[0075] The cannabinoid oil mixture may comprise an FSCO and / or nitrogen extract THC oil. In one exemplary embodiment, a 75% W / WT FSCO may be used in combination with 83% W / WT nitrogen extracted THC in oil. In another exemplary embodiment, higher amounts of the nitrogen extracted THC may be used relative to the FSCO. An exemplary final concentration of nootropic may be 0.001 to 50% W / WT.

[0076] In an exemplary formulation of Example 3, the nootropic mixture may contain one or more nootropics. For example, the nootropic mixture may include Noopept, pramiracetam, phenylpiracetam, and adrafinil. The formulation may also contain CoQlO, PQQ, reishi, lion’s mane, gingko, citocholine, phosphatidylserene, huperzine A, vinpocetine and / or wormwood. In one preferred embodiment based on Example 3, the adrafinil may be at a relatively higher concentration than the other nootropics to assist with mood stabilization and to ease tiredness. Further to this embodiment, in addition to or in place of adrafinil, gingko, lion’s mane, and / or vinopectine may be added. Further to this embodiment, the Noopept concentration may be higher than other racetams. The higher amounts are designed to counter the side effects of the relatively higher concentrations of THC.

[0077] In some exemplary embodiments, supplements and flavoring may be added. L- arginine may be added in the form of L-arginine-L-pyroglutamate crystalline mixture. The flavoring may be added before, during, or after the nootropics and supplements are dissolved in MCT oil prior to adding to the other components of the formulation.

[0078] In one exemplary embodiment, the formulation may contain a cannabinoid and one or more nootropics, including a sleep aid.

[0079] The exemplary formulation, as shown in Example 4, may include a sleep aid having one or more nootropics, and a cannabinoid oil mixture.Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson

[0081] Example 4 Formulation a. Cannabinoid Oil Mixture

[0083] 10-1000 mg a. Nootropic

[0084] -0.05 g a. L-Arginine (Optional)

[0085] -1.5 g a. Blue Lotus Extract

[0086] One exemplary formulation may include the sleep aid, blue lotus extract, additional nootropics, including Noopept, L-Arginine LPyrogultamate, coluracetam, casoracetam, phenibut, CoQlO, PQQ, reishi, lion’s mane, gingko, citocholine, phosphatidyl serene, huperzine A, vinpocetine, wormwood, and / or THC, an analog of THC, CBD, an analog of CBD, any cannibinoids, or combinations thereof.

[0087] In another embodiment, the formulation may contain a cannabinoid and one or more nootropics, including a pain aid or pain-relieving analgesic.

[0088] The exemplary formulation, as shown in Example 5, may include a cannabinoid oil mixture and a pain aid concentration and one or more nootropics. An exemplary final concentration of nootropic may be 0.001 to 50% W / WT.

[0089] Example 5 Formulation a. Cannabinoid Oil Mixture

[0091] 10-1000 mg a. Nootropic

[0092] -0.05 g a. L-Arginine (Optional)

[0093] -4.1 g a. Kratom Extract

[0094] One exemplary formulation may include a pain aid, such as Kratom, additional nootropics, including Noopept, phenylpiracetam, aniracetam, DL phenylalanine, L- arginine. L-pyrogultamate, and THC. In addition to, or in place of kratom, the formulation may include CoQlO and / or PQQ. Without being bound by theory, regenerative properties of CoQlO and / or PQQ may permanently alleviate pain.Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson

[0095] Extraction. In the example 4 and 5 formulations, the sleep and / or pain aid, may be extracted to achieve miscibility in a solution with the additional one or more nootropic.

[0096] The sleep and / or pain aid may be extracted using a conventional heating extraction procedure or using rotary evaporation, ultrasound assisted extraction (UAE), microwave-assisted extraction (MAE), supercritical carbon dioxide extraction SFE-CO2, using methanol, ethanol, water and binary mixtures.

[0097] In one exemplary extraction process, powdered Mitragyna speciosa leaves, whole, milled, ground, or pulverized into powdered form are dissolved into an alcohol solvent, including but not limited to absinthe. The solution may be mixed for 1-2 weeks. The solution may be mixed in equal parts with a hydrophobic carrier medium such as hazelnut oil. The mixture is stirred and heated to a temperature ranging from 50 to 63° Celsius until the scent of alcohol no longer remains. Once the alcohol has evaporated, the mixture is cooled down and filtered on filter paper. The solvent is removed under vacuum.

[0098] The mixture is then added in equal parts to a cannabinoid oil mixture comprising a 78% W / WT FSCO and / or nitrogen extract cannabinoid oil (THC, an analog of THC, CBD, an analog of CBD, any cannabinoid, or combinations thereof). The solution is stirred and gradually heated to ~77°C.

[0099] Additional nootropics may be added to the solution. Some nootropics, including but not limited to adrafinil, may only dissolve in specific hydrophobic solutions. In one exemplary process, adrafinil is not completely miscible when added to a carrier medium such as macadamia nut oil or MCT oil, but will dissolve efficiently in THC oil.

[0100] The extraction process for plant extracts mentioned in Examples 4 and 5 requires a soaking of plant material in grain alcohol before blending with 40-60 % W / WT MCT oil to form kratom oil and blue lotus oil, respectively. This traditional maceration method is both labor-intensive and time-consuming, and yields can vary depending on environmental conditions and manual intervention.

[0101] The use of a rotary evaporator (rotovap) introduces a significant advancement in both efficiency and quality control. A rotovap enables the rapid removal of grain alcohol under reduced pressure and controlled temperature, concentrating the plant extract without compromising the bioactive compounds. The use of a rotovap may reduce the processing timeline from weeks to hours while minimizing the loss ofTitle: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson delicate alkaloids and active constituents that may degrade during prolonged maceration or exposure to solvent.

[0102] Rotary evaporated extract may be more concentrated and substantially free of residual solvents. This enables precise measurements for the desired potency and dosage formulation. The production is scalable from benchtop to industrial units for commercial production. The overall extraction time is shortened dramatically, increasing throughput and improving cost-effectiveness without compromising quality.

[0103] Example 6 Extraction Method

[0104] In one exemplary method of producing a botanical-infused mixture, the method may include (a) completely submerging a plant material in a first solvent such as grain alcohol to extract active compounds, the plant material being between zero and 12 g of powder which may be selected from the group consisting of Mitragyna speciosa (kratom) and / or Nymphaea caerulea (blue lotus) added to a sufficient volume of first solvent; (b) stirring the plant material (duration may be as long as 2 weeks); (c) subjecting the resulting mixture to rotary evaporation under reduced pressure and controlled temperature conditions. The pressure and controlled temperature may be selected to conditions that ideally minimize degradation of the active ingredients in the plant material and / or reducing the time of evaporation of a first solvent. The process will remove at least a portion of the first solvent in order to obtain a concentrated extract measuring the resulting alcohol content in the extract and adding equal parts of a second solvent or carrier medium, comprising a hydrocarbon based solvent such as oils (MCT oil); (d) stirring mixture and heating at a high enough temperature to further evaporation (in the case of grain alcohol, a temperature from 50 to 63° C ) until further amounts of first solvent are evaporated from the mixture to produce a standardized botanical solution suitable for formulation for use in an vaporizer, tincture, inhaler, oral or nasal spray, beverage, or any other means of administration. The solution may also be delivered in the form of soft-shell, liquid- filled, or oleogel-based capsule, or a molded tablet having a chewable, lozenge, or gummy-like form. With respect to tinctures, the standardized botanical solution mayTitle: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson refer to a botanical oil having a viscosity low enough to permit proper application such as use with a dropper, other application devices or beverage.

[0105] In addition to rotary evaporation, the sleep and / or pain aid may be extracted using ultrasound assisted extraction (UAE), microwave-assisted extraction (MAE), supercritical carbon dioxide extraction SFE-CO2, using methanol, ethanol, water and binary mixtures.

[0106] The rotary evaporation reduces processing time and improves purity. In this exemplary method, the processing may be reduced from approximately two weeks to less than 24 hours. This method produces a more purified extract that may be substantially free of residual solvents, wherein the concentrated extract exhibits improved consistency in alkaloid or active constituent content relative to traditional maceration methods. The process is scalable, such that a benchtop rotary evaporator (such as IKA RV 10 Auto Pro V-C, Marshall Scientific) is used for laboratory-scale production and an industrial-scale rotary evaporator is used for commercial production. Additionally, the use of rotary evaporation method ensures substantial removal of alcohol from the extract while providing precise control over concentration levels, thereby allowing accurate formulation of measured dosages in the final product.

[0107] Although the present invention has been described above by referring to particular embodiments, it should be understood that modifications and variations could be made to the formulations or methods without departing from the intended scope of invention.

[0108] Clauses:

[0109] Clause 1. A pharmaceutically or nutraceutically acceptable formulation comprising:(a) a cannabinoid comprising a cannabis extract, tetrahydrocannabinol (THC), an analog of THC, cannabidiol (CBD), an analog of CBD or a combination thereof; and(b) at least one nootropic agent other than a xanthine; and(b) a carrier medium.

[0110] Clause 2. The formulation of claim 1, wherein the one or more nootropic agents is a racetam such as aniracetam, omberacetam (Noopept), pramiracetam, phenylpiracetam (Phenotropil), coluracetam, casoracetam or a combination of two or more thereof.Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson

[0111] Clause 3. The formulation of claim 2 wherein the racetam is dosed at 10-100 mg.

[0112] Clause 4. The formulation of claim 1, wherein the one or more nootropic agents is adrafinil, reishi (lingzhi), blue lotus, lion’s mane, ginkgo biloba, citicoline, phosphatidylserine, huperzine A, vinpocetine, wormwood, phenibut, kratom, Coenzyne Q10, pyrroloquinoline quinone, vinpocetine or a combination two or more thereof.

[0113] Clause 5. The formulation of claim 4, wherein the one or more nootropic is dosed at 10-1000 mg.

[0114] Clause 6. The formulation of claim 1, wherein the cannabinoid is dosed at 4-8 g-

[0115] Clause 7. The formulation of claim 1 further comprising at least one of an additional supplement or flavoring.

[0116] Clause 8. The formulation of claim 7 wherein the additional supplement or flavoring is ginseng and / or turmeric.

[0117] Clause 9. The formulation of claim 7, where the additional supplement or flavoring is an amino acid comprising of L-arginine, Phenylalanine, L-pyroglutamate or a combination of two or more thereof.

[0118] Clause 10. The formulation of claim 1, wherein the nootropic concentration ranges from 0.001 to 50% weight to total weight (% W / WT).

[0119] Clause I L A method of formulating a cannabinoid-containing extract a pharmaceutically or nutraceutically acceptable formulation comprising:

[0120] combining a nootropic with a cannabinoid wherein the cannabinoid comprising a cannabis extract, tetrahydrocannabinol (THC), an analog of THC, cannabidiol (CBD), an analog of CBD or a combination thereof;

[0121] adding an approximately equivalent amount of a carrier medium; and

[0122] heating the formulation above room temperature until the mixture is homogeneous.

[0123] Clause 12. The method of claim 11 wherein the formulation may be heated for use in a tablet, capsule, vaporizer, tincture, inhaler, oral or nasal spray, or beverage.

[0124] Clause 13. The method of claim 11 wherein a supplement or flavor additive is added to the formulation before or after heating the formulation.

[0125] Clause 14. The method of claim 11 wherein the carrier medium is a mediumchain transglyceride (MCT Oil).Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson

[0126] Clause 15. The method of claim 14 wherein about 40-60 %% W / WT MCT Oil is added to the formulation.

[0127] Clause 16. The formulation of claim 11, wherein the one or more nootropic is a racetam such as aniracetam, omberacetam (Noopept), pramiracetam, phenylpiracetam (Phenotropil), coluracetam, casoracetam or a combination of two or more thereof.

[0128] Clause 17. The formulation of claim 11, wherein the one or more nootropic is adrafinil, reishi (lingzhi), blue lotus, lion’s mane, ginkgo biloba, citicoline, phosphatidylserine, huperzine A, vinpocetine, wormwood, phenibut, kratom, Coenzyme Q10, pyrroloquinoline quinone, vinpocetine or a combination two or more thereof.

[0129] Clause 18. The formulation of claim 11, wherein the cannabinoid is dosed at 4-8 g.

[0130] Clause 19. A method of preparing a pharmaceutically or nutraceutically acceptable mixture or composition comprising:

[0131] Dissolving a plant-based material having a nootropic agent into an alcoholic solvent;

[0132] Extracting the nootropic agent using a conventional heating extraction procedure ;

[0133] Adding an amount of hydrophobic solvent approximately equal in parts;

[0134] Stirring the mixture at within a temperature range that increases alcohol is substantially evaporated;

[0135] Cooling and filtering the mixture to expose excess solvent;

[0136] Removing excess solvent by vacuum;

[0137] Adding the mixture in equal parts to a cannabinoid oil carrier medium and stirring, gradually heating the mixture to homogeneity; and

[0138] Combining resulting solution with additional nootropics.

[0139] Clause 20. The method of claim 19 wherein other conventional extraction procedures comprising of rotary evaporation, ultrasound assisted extraction (UAE), microwave-assisted extraction (MAE), supercritical carbon dioxide extraction SFE- CO2, using methanol, ethanol, and binary mixtures.

[0140] Clause 21. The method of claim 19 wherein the alcoholic solvent includes but is not limited to absinthe.Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-Henson

[0141] Clause 22. The method of claim 19 wherein the hydrophobic carrier medium is hazelnut oil or MCT oil.

[0142] Clause 23. The method of claim 19 wherein the temperature range at which the mixture is heated is from 50 to 63° Celsius.

[0143] Clause 24. The method of claim 19 wherein the excess solvent is removed under vacuum.

Claims

Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-HensenK&L Ref. No. 670014.39946CLAIMSWe claim:

1. A pharmaceutically or nutraceutically acceptable formulation comprising:(a) a cannabinoid comprising a cannabis extract, tetrahydrocannabinol (THC), an analog of THC, cannabidiol (CBD), an analog of CBD or a combination thereof; and(b) at least one nootropic agent other than a xanthine; and(c) a carrier medium.

2. The formulation of claim 1 , wherein the one or more nootropic agents is a racetam such as aniracetam, omberacetam (Noopept), pramiracetam, phenylpiracetam (Phenotropil), coluracetam, casoracetam or a combination of two or more thereof.

3. The formulation of claim 2 wherein the racetam is dosed at 10-100mg.

4. The formulation of claim 1 , wherein the one or more nootropic agents is adrafinil, reishi (lingzhi), blue lotus, lion’s mane, ginkgo biloba, citicoline, phosphatidylserine, huperzine A, vinpocetine, wormwood, phenibut, kratom, Coenzyne Q10, pyrroloquinoline quinone, vinpocetine or a combination two or more thereof.

5. The formulation of claim 4, wherein the one or more nootropic is dosed at 10-1000 mg.

6. The formulation of claim 1 , wherein the cannabinoid is dosed at 4-8 g.

7. The formulation of claim 1 further comprising at least one of an additional supplement orflavoring.

8. The formulation of claim 7 wherein the additional supplement or flavoring is ginseng and / or turmeric.Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-HensenK&L Ref. No. 670014.399469. The formulation of claim 7, where the additional supplement or flavoring is an amino acid comprising of L-arginine, Phenylalanine, L-pyroglutamate or a combination of two or more thereof.11 . The formulation of claim 1 , wherein the nootropic concentration ranges from 0.0001 to 50% weight to total weight of the formulation (%W / WT).

12. A method of formulating a cannabinoid-containing extract a pharmaceutically or nutraceutically acceptable formulation comprising:(a) combining a nootropic with a cannabinoid wherein the cannabinoid comprising a cannabis extract, tetrahydrocannabinol (THC), an analog of THC, cannabidiol (CBD), an analog of CBD or a combination thereof;(b) adding an approximately equivalent amount of a carrier medium; and(c) heating the formulation above room temperature until the mixture is homogeneous.

13. The method of claim 12 wherein the formulation may be heated for use in a pill, vaporizer, tincture, inhaler, oral or nasal spray, or beverage.

14. The method of claim 12 wherein a supplement or flavor additive is added to the formulation before or after heatingthe formulation.

15. The method of claim 12 wherein the carrier medium is a medium-chain transglyceride (MCT Oil).

16. The method of claim 15 wherein about 40-60 %W / WTMCT Oil is added to the formulation.Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-HensenK&L Ref. No. 670014.3994617. The formulation of claim 12, wherein the one or more nootropic is a racetam such as aniracetam, omberacetam (Noopept), pramiracetam, phenylpiracetam (Phenotropil), coluracetam, casoracetam or a combination of two or more thereof.

18. The formulation of claim 12, wherein the one or more nootropic is adrafinil, reishi (lingzhi), blue lotus, lion’s mane, ginkgo biloba, citicoline, phosphatidylserine, huperzine A, vinpocetine, wormwood, phenibut, kratom, Coenzyme Q10, pyrroloquinoline quinone, vinpocetine or a combination two or more thereof.

19. The formulation of claim 12, wherein the cannabinoid is dosed at 4-8 g.

20. A method of preparing a pharmaceutically or nutraceutically acceptable mixture or composition comprising:(a) Dissolving a plant-based material having a nootropic agent into an alcoholic solvent;(b) Extracting the nootropic agent using a conventional heating extraction procedure ;(c) Adding an amount of hydrophobic solvent approximately equal in parts;(d) Stirring the mixture at within a temperature range that increases alcohol is substantially evaporated;(e) Cooling and filtering the mixture to expose excess solvent;(f) Removing excess solvent by vacuum;(g) Addingthe mixture in equal parts to a cannabinoid oil mixture and stirring, gradually heating the mixture to homogeneity; and(h) Combining resulting solution with additional nootropics.21 . The method of claim 20 wherein other conventional extraction procedures comprising of rotary evaporation, ultrasound assisted extraction (UAE), microwave- assisted extraction (MAE), supercritical carbon dioxide extraction SFE-CO2, using methanol, ethanol, and binary mixtures.Title: Cannabinoid FormulationsFirst Named Inventor: Lisa Liu-HensenK&L Ref. No. 670014.3994622. The method of claim 20 wherein the alcoholic solvent includes but is not limited to absinthe.

23. The method of claim 20 wherein the hydrophobic solvent is hazelnut oil or MCT oil.

24. The method of claim 20 wherein the temperature range at which the mixture is heated is from 50 to 63° Celsius.

25. The method of claim 20 wherein the excess solvent is removed under vacuum.

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