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KR-20260064696-A - Composition of cannabinoid extract of CW1AS1 for the treatment of autism and related symptoms

KR20260064696AKR 20260064696 AKR20260064696 AKR 20260064696AKR-20260064696-A

Abstract

The present disclosure provides a plant-based drug composition for treating nervous system and/or mental diseases, pathological conditions, disorders and/or symptoms, and a method of using the same.

Inventors

  • 스탠리 조엘
  • 본-밀러 마르셀

Assignees

  • 디플로리아 엘엘씨

Dates

Publication Date
20260507
Application Date
20240812
Priority Date
20230811

Claims (20)

  1. As a method for treating one or more symptoms of autism spectrum disorder (ASD) or seizure disorder in subjects requiring treatment, The above method is for cannabis of the variety 'CW1AS1' lineage. The method comprises the step of administering a therapeutically effective amount of a pharmaceutical composition comprising cannabinoid and terpene extracts of Cannabis sativa L. and a carrier to the subject, A representative seed of the above variety is deposited under NCIMB No. 43291, and the carrier comprises, is composed of, or is essentially composed of mono, di, or triglycerides, or any combination thereof, and the fatty acid of the glyceride has a saturated or unsaturated carbon chain length in the range of 8 to 20 carbons.
  2. A method according to claim 1, wherein the extract is a solvent-reduced oil obtained from a process including isopropyl alcohol solvent extraction.
  3. A method according to claim 1 or 2, wherein the carbon chain length is 12 to 20.
  4. A method according to claim 1 or 2, wherein the glyceride is sesame oil, corn oil, and/or modified corn oil.
  5. In claim 1 or 3, the composition is: a. an amount of beta-caryophyllene equal to 3% to 25% of the amount of beta-caryophyllene contained in the air-dried plant material from which the extract is obtained, and/or b. an amount of α-bisabolol (α-bisabolol) equal to 3% to 20% of the amount of α-bisabolol contained in the air-dried plant material from which the extract is obtained, and/or c. an amount of α-humulene (α-humulene) equal to 3% to 30% of the amount of α-humulene contained in the air-dried plant material from which the extract is obtained, and/or d. Concentration of cannabidiol of 5 to 8% w/w in the above composition A method that includes
  6. A method according to any one of claims 1 to 5, wherein the composition comprises a ratio of cannabidiol: delta 9 tetrahydrocannabinol of 20:1 to 40:1, or about 25:1 to about 40:1.
  7. A method according to any one of claims 1 to 6, wherein the concentration of delta 9-THC is 0-0.3% w/w of the pharmaceutical composition, the concentration of cannabicromene is 0-0.5% w/w of the pharmaceutical composition, the concentration of cannabigerol is 0 to 0.3% w/w of the pharmaceutical composition, and/or the concentration of total cannabinoids is 5.6-8.4% w/w of the pharmaceutical composition.
  8. A method according to any one of claims 1 to 7, wherein the composition is not an emulsion.
  9. In any one of claims 1 to 8, the cannabis A method in which the sativa ( Cannabis sativa ) plant is a plant of the variety line 'CW1AS1', and the representative seeds of the said variety are deposited under NCIMB No. 43291.
  10. A method according to any one of claims 1 to 9, wherein the cannabinoid composition comprises a tetrahydrocannabinol concentration of 1 to 3 mg/mL.
  11. A method according to any one of claims 1 to 10, wherein the pharmaceutical composition comprises a cannabinoid extract of the Cannabis sativa plant, a carrier, and a flavoring agent, or is essentially composed thereof.
  12. A method according to any one of claims 1 to 11, wherein the carrier is a winterized oil composed of mono-, di-, and triglycerides of oleic acid and linoleic acid.
  13. A method according to any one of claims 1 to 12, wherein the method treats one or more symptoms of ASD.
  14. A method according to any one of claims 1 to 13, wherein the symptom of ASD is selected from irritability, anxiety, lethargy/social withdrawal, stereotypic behavior, hyperactivity/non-conformity, inappropriate speech, or social avoidance, or wherein the symptom is irritability.
  15. A method according to any one of claims 1 to 14, wherein the object is a human.
  16. The method of claim 15, wherein the human subject is under 18 years of age, or between 5 and 17 years of age.
  17. The method of claim 15, wherein the human subject is at least 13 years old, or between 13 and 30 years old.
  18. The method of claim 16, wherein the daily dose of the pharmaceutical composition comprises 20 mg to 400 mg of cannabinoid extract.
  19. A method according to claim 16 or 17, wherein the daily dose of the pharmaceutical composition comprises about 100 mg to about 700 mg of cannabinoid extract.
  20. A method according to claim 16 or 17, comprising the step of administering to a subject a first daily dose of a composition equivalent to about 103 mg of the extract for 4 to 7 days, administering a second daily dose of about 206 mg for 4 to 7 days after 4 to 7 days of administering the first daily dose, optionally continuing to administer the second daily dose as a maintenance dose after 4 to 7 days of administering the second daily dose, or resuming the administration of the first daily dose after 4 to 7 days of administering the second daily dose, and optionally administering the daily dose twice a day.

Description

Composition of cannabinoid extract of CW1AS1 for the treatment of autism and related symptoms Integration by reference This application claims priority to U.S. Provisional Application No. 63/519,006, the entirety of which is incorporated herein by reference. Field of invention The present disclosure relates to cannabis for treating autism, epilepsy, and/or symptoms. This relates to a composition derived from Cannabis sativa L. ( Cannabis sativa L.) and a method of using the same. Plant cannabinoid extracts containing cannabidiol (CBD) as a major cannabinoid may be effective in treating nervous system and psychiatric diseases, conditions, disorders, and/or symptoms, including those of the central nervous system (CNS). Examples of CNS-related disorders include, but are not limited to, autism spectrum disorder (ASD). It is estimated that 1 in 68 children may have ASD (CDC 2014). ASD is characterized by deficits in social communication, irritability, repetitive behaviors, impulsivity, temper tantrums, and a high caregiving burden (Lecavalier et al 2006). There has long been a need for effective CBD-based herbal medicines that can be used to treat one or more symptoms of autism and epilepsy. Summary of the present disclosure This disclosure concerns cannabis The present invention provides a pharmaceutical composition comprising a cannabinoid extract of Cannabis sativa L., having a concentration of beta-caryophyllene in an amount of 3% to 25% of the amount of beta-caryophyllene contained in the air-dried plant material from which the extract is obtained, and/or an amount of α-bisabolol in an amount of 3% to 20% of the amount of α-bisabolol contained in the air-dried plant material from which the extract is obtained, and/or an amount of α-humulene in an amount of 3% to 30% of the amount of α-humulene contained in the air-dried plant material from which the extract is obtained. Another aspect of the present disclosure is a pharmaceutical composition comprising a cannabinoid extract of the hemp variety 'CW1AS1', and representative seeds of said variety are deposited at NCIMB No. 43291. In some embodiments, said extract is a cannabinoid and terpenoid extract of the hemp variety 'CW1AS1'. In some embodiments, the pharmaceutical composition of the present disclosure comprises a cannabinoid extract and a glyceryl monolinoleate, such as unsaturated glycerol monolinoleate, and optionally a flavoring agent, or is composed of or essentially composed of the same. In some embodiments, the composition is not an emulsion. Another aspect of the present disclosure is a method for treating autism, epilepsy, or one or more of the symptoms thereof by administering an effective amount of the pharmaceutical composition of the present disclosure. In some embodiments, the treatment method disclosed herein is intended to treat primary indications of disease, disorder, pathological condition or symptom. In some embodiments, the treatment method disclosed herein is intended to treat secondary indications of a disease, disorder, pathological condition or symptom. In some embodiments, the treatment method disclosed herein is intended to treat anxiety and/or irritability associated with autism. The present disclosure provides a method for treating a disease, disorder, pathology and/or symptoms, including symptoms associated with autism spectrum disorder, by administering a pharmaceutical composition containing a cannabinoid extract of CW1AS1, wherein the daily dose of the cannabinoid extract of CW1AS1 for patients under 14 years of age is about 25 mg to about 650 mg, and the daily dose for adults is about 50 mg to about 650 mg. Current treatments for autism spectrum disorder (ASD) have limited efficacy and are accompanied by serious side effects. The botanical drug product of the present disclosure has the potential to be effective in treating irritability, repetitive behaviors, improved cognitive function, social skills, and quality of life in patients with ASD. FIG. 1 provides an exemplary study design for a clinical protocol of the present disclosure. Detailed description of the present disclosure I. Definition Unless otherwise specified, all technical and scientific terms used herein have the same meaning as generally understood by those skilled in the art to which this disclosure pertains. Although the following terms are believed to be well understood by those skilled in the art, the following definitions are provided to facilitate the explanation of the claims disclosed herein. Any method and material similar or equivalent to the method and material described herein may be used for the practice or testing of this disclosure, but preferred methods and materials are described. The following terms are defined below. These definitions are provided for illustrative purposes only and are not intended to limit the general meaning of the defined terms in the relevant field. The terms "a" or "an" refer to one or more of the entity, that is, the