US-20260124218-A1 - Comprehensive Cannabinoid Compositions and Methods for the Management of Anxiety Disorders

Abstract

This disclosure introduces an advanced cannabinoid-based nanoplatform formulation for oral drop administration, designed for fast-acting anxiety control via the sublingual route to maximize bioavailability. The formulation incorporates broad-spectrum CBD, including cannabinoids such as CBD, CBG, and CBC, alongside terpenes, flavonoids, selected herbal extracts, and essential vitamins to enhance therapeutic efficacy. This formulation targets multiple therapeutic endpoints relevant to a range of anxiety disorders, including Panic Disorder, Specific Phobias, Social Anxiety Disorder, Generalized Anxiety Disorder (GAD), and others. Symptoms addressed span from restlessness, nervousness, and fatigue to concentration difficulties, irritability, muscle tension, sleep disturbances, palpitations, excessive sweating, tremors, nausea, and gastrointestinal discomfort. The active compounds act centrally by modulating 5HT1-A serotonin receptors, dopaminergic pathways, and CB1 and CB2 cannabinoid receptors, aiming to reduce neuroinflammation and rebalance neurotransmitters. Together, cannabinoids, herbal extracts, and vitamins synergistically reduce oxidative stress, fostering mental well-being and delivering a comprehensive approach to anxiety management.

Inventors

• Dante Picazo
• Nancy Paola Duarte Delgado
• Nancy Rodrigues Das Fontes
• Stephanie Dona Hartmann
• Ana Maria Maldonado Vacca
• Maria Angelica Clavijo Romero
• Rosangel del Valle Andrades Fuentes

Assignees

• Dante Picazo
• Nancy Paola Duarte Delgado
• Nancy Rodrigues Das Fontes
• Stephanie Dona Hartmann
• Ana Maria Maldonado Vacca
• Maria Angelica Clavijo Romero
• Rosangel del Valle Andrades Fuentes

Dates

Publication Date

20260507

Application Date

20241101

Claims (20)

1. 1 . A composition for the treatment of anxiety, comprising: a) an active principle that includes Broad-spectrum CBD oil comprising a blend of cannabinoids; b) a second active principle comprising an herbal extract; c) a third active principle comprising a vitamin; d) at least two emulsifying agents; wherein the composition is suitable for oral administration.
2. 2 . The composition according to claim 1 , wherein the Broad-spectrum CBD oil comprises one or more of the following: cannabidiol (CBD), cannabigerol (CBG), cannabichromene (CBC), terpenes, or combinations thereof.
3. 3 . The composition according to claim 2 , wherein the Broad-spectrum CBD oil is present in a concentration in the range of 6.25% to 25%.
4. 4 . The composition according to claim 1 , wherein herbal extracts are in a concentration in the range of 45% to 50%, and vitamins in the range of 0.01% to 0.02%.
5. 5 . The composition according to claim 1 , wherein the emulsifying agents are Egg Lecithin, Sorbitan, or combinations thereof and are present in a concentration in the range of 7.0% to 9.0%.
6. 6 . The composition described in claim 1 , wherein the nanoplatform has an average particle size of less than 200 nm and is formulated to ensure the controlled release of cannabinoids and other active ingredients over a sustained period.
7. 7 . The composition of claim 1 , wherein the formulation is provided as an oral nanoemulsion dosage in drop form.
8. 8 . The composition according to claim 1 , wherein the herbal extract is Ashwagandha extract, and the vitamin is Vitamin D.
9. 9 . A method for treating anxiety in a human individual, comprising: administering an effective concentration of the composition of claim 1 , wherein the active principle comprises at least two cannabinoids, at least one herbal extract enriched with Vitamins, and at least two emulsifying agents.
10. 10 . The method of claim 9 , wherein the human subject is selected for treatment based on the diagnosis of anxiety.
11. 11 . The method of claim 10 , wherein the individual is selected for treatment of anxiety disorders, including Panic Disorder, Specific Phobias, Social Anxiety Disorder, and Generalized Anxiety Disorder (GAD).
12. 12 . The method of claim 9 wherein further comprises identifying individuals using: medical history, physical examination, symptom diary, psychiatric and psychological symptoms, and additional psychiatric tests.
13. 13 . The method of claim 1 , wherein the individual is identified by having alterations in restlessness or nervousness, difficulty concentrating, irritability, muscle tension, sleep problems, palpitations, excessive sweating, tremors, nausea, or stomach discomfort.
14. 14 . The method according to claim 9 , wherein the effective concentration is administered as 6 to 8 drops, every 12 hours for 15 days (2 weeks), then increases to 12 to 16 drops daily, every 12 hours for 3 to 6 months.
15. 15 . The method according to claim 9 , wherein the administration of the effective concentration of the composition acts as a monotherapy for treating anxiety.
16. 16 . The method of claim 9 , wherein the treatment composition alleviates: restlessness or nervousness, difficulty concentrating, irritability, muscle tension, sleep problems, palpitations, excessive sweating, tremors, nausea, or stomach discomfort.
17. 17 . A process for manufacturing the composition for treating anxiety of claim 1 , wherein the process comprises: a. Combining broad-spectrum cannabidiol (CBD) oil which contains additional cannabinoids including cannabigerol (CBG) and cannabichromene (CBC), terpenes, and flavonoids to form an active cannabinoid mixture; b. Incorporating herbal extract into the active cannabinoid mixture to support the neural axis; c. Utilizing at least two emulsifying agent to enhance the bioavailability and stability of the composition for oral administration; d. Subjecting the mixture to ultrasonic cavitation or high-pressure homogenization to create a nanoemulsion, wherein the nanoemulsion provides consistent dispersion of cannabinoids and herbal extract within the composition; and e. Formulating the resulting nanoemulsion into an oral solution for oral administration, wherein the solution composition is effective in modulating neurotransmitter levels and reducing neuroinflammation associated with anxiety symptoms.
18. 18 . A therapeutic composition for treating anxiety of claim 1 , comprising: a. Broad-spectrum CBD in a concentration ranging from 6.25% to 25%; b. Herbal extract in a concentration ranging from 45% to 50%; c. Vitamin D in a concentration ranging from 0.01% to 0.02%; and d. Emulsifying agents in a concentration ranging from 7.0% to 9.0%.
19. 19 . A therapeutic composition for treating anxiety, comprising: a. Broad-spectrum cannabidiol (CBD) at a concentration of 25%; b. Herbal extract at a concentration of 47%; c. Vitamin D at a concentration of 0.01%; d. Egg Lecithin at a concentration of 6.0%; and e. Sorbitan at a concentration of 1.0%, wherein the composition is formulated for oral administration.
20. 20 . The composition according to claim 2 , wherein the terpene are selected from myrcene, limonene, caryophyllene, linalool, pinene or combinations thereof.

Description

FIELD OF THE DISCLOSURE The technical field of the disclosure relates to medicinal, therapeutic, and pharmaceutical uses of cannabinoids for managing anxiety disorders. This disclosure introduces therapeutic compositions featuring broad-spectrum CBD enhanced by a blend of cannabinoids, including cannabigerol (CBG) and cannabichromene (CBC), a plant-based herbal extract and essential vitamins designed to support neurotransmitter balance and reduce neuroinflammation. Key ingredients include Ashwagandha root extract and vitamin D to enhance stress management and promote mental well-being. This composition targets GABAergic and serotoninergic neurotransmitter systems while providing a natural, comprehensive strategy for anxiety management. Through the synergistic effects of these bioactive compounds, the formulation aims to support mood regulation, reduce reliance on traditional anxiolytics, and improve quality of life by offering a balanced, plant-based approach to anxiety relief. BACKGROUND INFORMATION The American Psychiatric Association (APA) defines anxiety disorders as conditions marked by excessive fear and anxiety with accompanying behavioral disturbances. Fear typically responds to immediate threats, triggering autonomic defenses and flight behaviors, whereas anxiety anticipates future threats, manifesting muscle tension, vigilance, and avoidant behaviors. Unlike normal, developmentally appropriate fear or transient anxiety, anxiety disorders are excessive and persistent, lasting at least six months in adults and often less in children. These disorders usually develop in childhood and tend to persist without treatment and require a clinician's evaluation of whether the fear or anxiety is disproportionate, considering cultural factors. Recent studies underscore the significant roles of the amygdala and hippocampus in the pathophysiology of anxiety disorders. The amygdala is central to processing fear-related stimuli, and its hyperactivity is associated with increased vigilance and emotional dysregulation. Meanwhile, the hippocampus is crucial in contextualizing emotional memories and modulating stress responses via its interaction with the hypothalamic-pituitary-adrenal (HPA) axis (van de Poll et al., 2023). Additionally, the bed nucleus of the stria terminalis (BNST), a part of extended amygdala, is essential for sustained threat responses. Understanding the connectivity between these structures, including the medial prefrontal cortex, is vital for deciphering emotional regulation and anxiety experiences (Duval et al., 2015). Disruptions in these neural circuits may contribute to various anxiety disorders, indicating the potential for targeted therapies. Anxiety appears to result from dysregulation in key neurotransmitter systems coupled with increased sympathetic nervous system arousal. Imbalances in the serotonergic and noradrenergic systems, particularly underactivity in serotonin and overactivity in norepinephrine, are strongly linked to anxiety symptoms, supporting the use of SSRIs and SNRIs as primary treatments (Adwas et al., 2019). Additionally, the GABAergic system remains central to anxiety treatments like benzodiazepines, with recent studies identifying the α2 GABA receptor subtype as a promising target for reducing anxiety with fewer sedative effects. Corticosteroids and cholecystokinin (CCK) also play roles in modulating neural circuits tied to stress and fear processing, suggesting that these systems may be valuable therapeutic targets for anxiety management (Nuss, 2015). Medications like Selective Serotonin Reuptake Inhibitors (SSRIs), Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs), and benzodiazepines are effective in managing anxiety, but they can also lead to adverse effects. Benzodiazepines, which enhance GABA's calming effects, may cause drowsiness, muscle relaxation, memory issues, and motor skill impairment, with paradoxical effects like irritability in some cases. They may cause tolerance with long-term use, requiring higher doses for the same effect due to receptor adaptations. This tolerance can increase anxiety over time, as symptoms may worsen or persist due to withdrawal-like effects even with ongoing medication. Acute benzodiazepine intoxication is another risk, typically impacting the central nervous system (CNS) with symptoms like decreased consciousness, hypotonia, and hyporeflexia. In severe cases, intoxication can lead to respiratory depression, hypotension, and the risk of broncho-aspiration, particularly when combined with other CNS depressants (Osés, 2003). Considering the limitations of current anti-anxiety medications, particularly their side effects and the risk of tolerance with long-term use, there is a significant need for alternative approaches that address both the neurochemical and physiological roots of anxiety. Formulations incorporating broad-spectrum CBD are enhanced by phytotherapeutic compounds such as flavonoids and terpenoids, includ