EP4577197A1 - Méthodes de traitement de troubles neurologiques pédiatriques - Google Patents

Méthodes de traitement de troubles neurologiques pédiatriques

Info

Publication number
EP4577197A1
EP4577197A1 EP23874108.6A EP23874108A EP4577197A1 EP 4577197 A1 EP4577197 A1 EP 4577197A1 EP 23874108 A EP23874108 A EP 23874108A EP 4577197 A1 EP4577197 A1 EP 4577197A1
Authority
EP
European Patent Office
Prior art keywords
composition
group
cbda
syndrome
nti164
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23874108.6A
Other languages
German (de)
English (en)
Inventor
Allan William Cripps
Esra Isikgel
Alexandra Elizabeth Marion ANDREWS
Thomas George DUTHY
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Neurotech International Ltd
Original Assignee
Neurotech International Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AU2022902914A external-priority patent/AU2022902914A0/en
Application filed by Neurotech International Ltd filed Critical Neurotech International Ltd
Publication of EP4577197A1 publication Critical patent/EP4577197A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/658—Medicinal preparations containing organic active ingredients o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/415—1,2-Diazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/66—Phosphorus compounds
    • A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Definitions

  • the present invention relates to compositions comprising cannabinoids.
  • the present invention also relates to pharmaceutical compositions, dosage forms and methods of treating paediatric neurological disorders by administering the composition to a patient in need thereof.
  • Background [0002] The following discussion of the background art is intended to facilitate an understanding of the present invention only. The discussion is not an acknowledgement or admission that any of the material referred to is or was part of the common general knowledge as at the priority date of the application.
  • A. Neuroinflammation refers to the process whereby the brain’s innate immune system is triggered following an inflammatory challenge such as those posed by injury, infection, exposure to a toxin, neurodegenerative disease, or aging.
  • Neuroinflammation is implicated in contributing to a variety of neurologic and somatic illnesses including Alzheimer’s disease (AD), Parkinson’s disease (PD), multiple sclerosis, amyotrophic lateral sclerosis, cerebral ischemia, traumatic brain injury, rheumatoid arthritis, chronic migraine, epilepsy, autism spectrum disorder (ASD), attention deficit hyperactivity disorder (ADHD), cerebral palsy and relevant subtypes, neuropathic pain, and depression.
  • AD Alzheimer’s disease
  • PD Parkinson’s disease
  • multiple sclerosis amyotrophic lateral sclerosis
  • cerebral ischemia traumatic brain injury
  • rheumatoid arthritis chronic migraine
  • epilepsy autism spectrum disorder
  • ASD autism spectrum disorder
  • ADHD attention deficit hyperactivity disorder
  • cerebral palsy and relevant subtypes neuropathic pain, and depression.
  • CNS central nervous system
  • the innate immune response plays a significant role in both physiological and pathological conditions.
  • CNS diseases including traumatic brain injury, ischemic stroke, brain tumor, and cerebrovascular and neurodegenerative diseases trigger a cascade of events broadly defined as neuroinflammation, which is characterized by the activation of the microglia and astrocyte population.
  • neuroinflammation is characterized by the activation of the microglia and astrocyte population.
  • microglial and astrocyte activation, T lymphocyte infiltration, and overproduction of inflammatory cytokines have been demonstrated in association with neuronal alteration in both animal and human tissues.
  • Neuroinflammation is therefore an important topic in contemporary neuroscience.
  • Inflammatory cytokines/markers or proinflammatory cytokines/markers are types of signaling molecules that are secreted from immune cells like helper T cells and macrophages and certain other cell types that promote the process of neuro-inflammation and general inflammatory processes.
  • IL-1 interleukin-1
  • IL-12 interleukin-12
  • IL- 18 tumor necrosis factor alpha
  • IFN ⁇ interferon gamma
  • GM-CSF granulocyte- macrophage colony stimulating factor
  • Neurological Disorders and Paediatric Neurological Disorders Examples of neurological disorders that are “neuro-inflammatory based” include: Alzheimer’s disease (Alzheimer’s disease is the most prevalent chronic, progressive neurodegenerative disease, and cause of dementia); Parkinson’s disease; multiple sclerosis; amyotrophic lateral sclerosis; cerebral ischemia; traumatic brain injury; rheumatoid arthritis; chronic migraine; epilepsy; autism spectrum disorder; attention deficit hyperactivity disorder (ADHD); cerebral palsy and relevant subtypes; neuropathic pain; and depression.
  • Alzheimer’s disease Alzheimer’s disease is the most prevalent chronic, progressive neurodegenerative disease, and cause of dementia
  • Parkinson’s disease multiple sclerosis; amyotrophic lateral sclerosis; cerebral ischemia; traumatic brain injury; rheumatoid arthritis; chronic migraine; epilepsy; autism spectrum disorder; attention deficit hyperactivity disorder (ADHD); cerebral palsy and relevant subtypes; neuropathic pain; and depression.
  • paediatric neurological disorders that are “neuro-inflammatory based” include: Paediatric Autoimmune Neuropsychiatric Syndrome (PANS), and subsets of PANS, including Paediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS) and Paediatric Infection Triggered Neuropsychiatric Disorder (PITAND).
  • PANS Paediatric Autoimmune Neuropsychiatric Syndrome
  • PANDAS Paediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections
  • PITAND Paediatric Infection Triggered Neuropsychiatric Disorder
  • OCD obsessive-compulsive disorder
  • Tourette syndrome tics
  • OCD and Tourette syndrome symptoms in these cases of PANS and PANDAS have been hypothesized to arise from the development of autoantibodies that cross-react with proteins normally expressed in the brain; this mechanism is known as molecular mimicry.
  • the association of immune dysregulation with OCD and Tourette syndrome symptoms in this subset of paediatric patients is increasingly clear.
  • a TSPO/PK PET imaging study of microglial activation examined both noninfectious Tourette syndrome and PANDAS (Kurlan R. Tourette's syndrome. New England Journal of Medicine.2010;363(24):2332–2338; Leckman J. F. Tourette's syndrome. The Lancet.2002;360(9345):1577–1586.
  • Microglia sculpt postnatal neural circuits in an activity and complement-dependent manner. Neuron.2012;74(4):691–705). This is complemented by studies in the Hdc-KO mouse model of Tourette syndrome.
  • Neurodegeneration Microglia cells are the unique residential macrophages of the central nervous system (CNS). They play an important role during CNS development and adult homeostasis. They have a major contribution to adult neurogenesis and neuroinflammation (Zhan Y., Paolicelli R. C., Sforazzini F., et al. Deficient neuron-microglia signaling results in impaired functional brain connectivity and social behavior.
  • Microglia are consequently the key cell population linking the nervous and the immune system (Xiong XY, Liu L, Yang QW. Functions and mechanisms of microglia/macrophages in neuroinflammation and neurogenesis after stroke. Prog Neurobiol.2016;142:23–44). [0014] Under physiological conditions, ramified, resting microglia provides a neuroprotective environment (David S, Greenhalgh AD, Kroner A. Macrophage and microglial plasticity in the injured spinal cord. Neuroscience.2015;307:311–18; Bieber K, Autenrieth SE.
  • Activated microglia driving chronic neuroinflammation have also been shown to substantially contribute to aging of the CNS (Loane DJ, Kumar A. Microglia in the TBI brain: the good, the bad, and the dysregulated. Exp Neurol.2016;275:316–27), chronic neuropathic pain (Orihuela R, McPherson CA, Harry GJ. Microglial M1/M2 polarization and metabolic states.
  • the metabolic disorder is selected from the group consisting of: Hurler syndrome, Niemann-Pick disease, Tay-Sachs disease, Gaucher disease, Fabry disease and Krabbe disease, Galactosemia, Maple syrup urine disease, Phenylketonuria, glycogen storage disease, mitochondrial disorders, Friedreich ataxia, Peroxisomal disorder, metal metabolism disorder, organic acidemias and urea cycle disorders.
  • the glycosylation disorder is selected from the group consisting of: disorders of N-glycosylation, disorders of O-glycosylation, disorders of glycosylphosphatidylinositol (GPI) anchor and glycolipid anchor and disorders of glycosylation pathways.
  • a typical dosage may range from about 0.1 ⁇ g/kg to up to about 100 mg/kg or more, depending on the factors mentioned above. In other embodiments, the dosage may range from 0.1 ⁇ g/kg up to about 100 mg/kg; or 1 ⁇ g/kg up to about 100 mg/kg; or 5 ⁇ g/kg up to about 100 mg/kg. [00135] The frequency of dosing will depend upon the pharmacokinetic parameters of the active agent and the formulation used. Typically, a clinician will administer the composition until a dosage is reached that achieves the desired effect. The composition may therefore be administered as a single dose, or as two or more doses (which may or may not contain the same amount of the desired molecule) over time, or as a continuous infusion via an implantation device or catheter.
  • pharmaceutically acceptable carrier includes any and all solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents, and the like that are physiologically compatible.
  • subject generally includes mammals such as: humans; farm animals such as sheep, goats, pigs, cows, horses, llamas; companion animals such as dogs and cats; primates; birds, such as chickens, geese and ducks; fish; and reptiles.
  • the subject is preferably human.
  • the human subject is an infant, child, or adolescent.
  • the human subject is a paediatric patient and aged 21 or younger at the time of their diagnosis or treatment.
  • the present invention provides a composition comprising the following cannabinoids: about 50 w/w% of CBDA; and wherein all other cannabinoids come to about 15 w/w%.
  • the invention provides a composition comprising the following cannabinoids: w/w % about 50% of CBDA; and about 2% CBD.
  • the invention provides a composition comprising the following cannabinoids: w/w % about 50% of CBDA; and about 5% CBG.
  • the invention provides a composition comprising the following cannabinoids: w/w % CBDA 49%; CBD 2%; CBG 5%; CBDP 2%; CBDB 2%; CBGA 5%; CBN 2%; and THC ⁇ 0.3%.
  • the invention provides a composition comprising the following cannabinoids: w/w % CBDA 48.78%; CBD 1.89%; CBG 4.88%; CBDP 1.68%; CBDB 1.76%; CBGA 4.76%; CBN 1%; and THC ⁇ 0.18%.
  • the invention provides a composition wherein the cannabinoids are present in amounts selected from the group consisting of: Composition 1 comprising w/w % CBDA 50%; CBD 2%; CBG 5%; CBDP 2%; CBDB 2%; CBGA 5%; CBN 3%; and THC ⁇ 0.3%; and Composition 2 comprising w/w % CBDA 45%; CBD 1%; CBG 4%; CBDP 1%; CBDB 2%; CBGA 4%; CBN 2%; and THC ⁇ 0.2%.
  • Composition 1 comprising w/w % CBDA 50%; CBD 2%; CBG 5%; CBDP 2%; CBDB 2%; CBGA 5%; CBN 3%; and THC ⁇ 0.3%
  • Composition 2 comprising w/w % CBDA 45%; CBD 1%; CBG 4%; CBDP 1%; CBDB 2%; CBGA 4%; CBN 2%; and THC ⁇ 0.2%.
  • the invention provides a composition, wherein the quantity of the cannabinoids is determined by a method selected from the group consisting of: high performance chromatography (HPLC), proton nuclear magnetic resonance spectroscopy (H 1 NMR); and mass spectrometry.
  • HPLC high performance chromatography
  • H 1 NMR proton nuclear magnetic resonance spectroscopy
  • mass spectrometry mass spectrometry.
  • the invention provides a composition derived from cannabis plant material.
  • the invention provides a composition wherein the said listed cannabinoids are synthetic.
  • the invention provides a composition wherein the said listed cannabinoids are a mixture of plant derived and synthetic cannabinoids.
  • the invention provides a composition further comprising an oil selected from the group consisting of: a synthetic oil; plant based oil; mineral oil; canola oil; and olive oil.
  • the composition comprises less than 5% w/w terpenes.
  • the composition comprises less than 2% w/w organic plant material.
  • the composition comprises less than 2% w/w of plant phenols.
  • the composition comprises components selected from the group consisting of: flavonoids, proteins, sterols and esters.
  • the composition is substantially pure.
  • the purity is determined by a method selected from the group consisting of: high performance chromatography (HPLC), proton nuclear magnetic resonance spectroscopy (H 1 NMR); and mass spectrometry.
  • the purity is selected from the group consisting of: greater than 75% purity; greater than 80% purity; greater than 85% purity; greater than 90% purity; greater than 95% purity; greater than 96% purity; greater than 97% purity; greater than 98% purity; greater than 99% purity; greater than 99.5% purity; greater than 99.6% purity; greater than 99.7% purity; greater than 99.8% purity; greater than 99.9% purity; greater than 99.95% purity; greater than 99.96% purity; greater than 99.97% purity; greater than 99.98% purity and greater than 99.99% purity.
  • the composition comprises less than 0.1 wt% organic impurities as measured a method selected from the group consisting of: high performance chromatography (HPLC), proton nuclear magnetic resonance spectroscopy (H 1 NMR); and mass spectrometry.
  • HPLC high performance chromatography
  • H 1 NMR proton nuclear magnetic resonance spectroscopy
  • mass spectrometry mass spectrometry.
  • the composition is substantially free of atmospheric oxygen.
  • the composition is sterile. In an alternative preferred embodiment, the composition is not sterile.
  • the invention provides a composition wherein the cannabinoid component of the composition is selected from the group consisting of: between 1 and 500mg/ml; between 10 and 100mg/ml; be at a concentration of 50mg/ml.
  • the invention provides a composition wherein the CBDA component of the composition is selected from the group consisting of: between 1 and 500mg/ml; between 10 and 100mg/ml; be at a concentration of 50mg/ml.
  • the composition is a liquid.
  • the composition is an oil.
  • the composition demonstrates no cannabinoid degradation or decarboxylation when measured at a time point selected from the group consisting of: at 1 day; at 2 days; at 7 days; at 14 days; at 28 days; at 5 weeks; at 6 weeks; and 32 weeks.
  • the composition demonstrates cannabinoid stability when measured at a time point selected from the group consisting of: at 1 day; at 2 days; at 7 days; at 14 days; at 28 days; at 5 weeks; at 6 weeks; and at 32 weeks.
  • the composition demonstrates no mutagenicity, carcinogenicity or genotoxicity when delivered at a concentration that delivers 120mg/ml of CBDA.
  • the composition is adapted to suppress the activity of any one of the following biomarkers: COX-2; iNOS; TNF-alpha; IL-2; IL-12 and GS-MCF.
  • the composition is adapted to suppress neuroinflammation. More preferably, the composition is adapted for the treatment of a neurological disorder. More preferably, the composition is adapted for the treatment of a paediatric neurological disorder.
  • the invention provides a composition having a UPLC mass chromatogram corresponding to Figure 3 utilising the conditions described in Example 1.
  • the composition comprises an additional active ingredient.
  • the additional active ingredient is selected from the group consisting of: a polypeptide; an antibody; a NSAID; a neuro-regulator; and a neurotransmitter, steroids – all relevant classes (corticosteroids), analgesics, anti-psychotics, anti-depressants, immuno-therapy.
  • the NSAID is selected from the group consisting of: aspirin, ibuprofen, naproxen, diclofenac, celecoxib, ketorolac, meloxicam, esomeprazole, naproxen, diclofenac, misoprostol, nabumetone, indomethacin, mefenamic acid, etodolac, piroxicam, ketoprofen, diflunisal, oxaprozin, flurbiprofen, sulindac, tolmetin, prednisolone and fenoprofen.
  • the additional active ingredient is selected from the group consisting of: diclofenac, prednisone, celecoxib and psylocibin.
  • the ratio of cannabinoid component and the additional active ingredient is selected from the group consisting of: 1 unit w/w of cannabinoid : 1 unit w/w/ of the additional active ingredient; 2:1; 3:1; 4:1; 5:1; between 10,000:1 and 1:1; between 1,000:1 and 1:1; between 500:1 and 1:1; between 100:1 and 1:1; between 50:1 and 1:1; and between 10:1 and 1:1.
  • the ratio of the additional active ingredient and cannabinoid is selected from the group consisting of: 1 unit w/w of the additional active ingredient and 1 unit w/w/ of the cannabinoid; 2:1; 3:1; 4:1; 5:1; between 10,000:1 and 1:1; between 1,000:1 and 1:1; between 500:1 and 1:1; between 100:1 and 1:1; between 50:1 and 1:1; and between 10:1 and 1:1.
  • the ratio of CBDA and the additional active ingredient is selected from the group consisting of: 1 unit w/w of CBDA : 1 unit w/w/ of the additional active ingredient; 2:1; 3:1; 4:1; 5:1; between 10,000:1 and 1:1; between 1,000:1 and 1:1; between 500:1 and 1:1; between 100:1 and 1:1; between 50:1 and 1:1; and between 10:1 and 1:1.
  • the ratio of the additional active ingredient and CBDA is selected from the group consisting of: 1 unit w/w of the additional active ingredient and 1 unit w/w/ of the CBDA; 2:1; 3:1; 4:1; 5:1; between 10,000:1 and 1:1; between 1,000:1 and 1:1; between 500:1 and 1:1; between 100:1 and 1:1; between 50:1 and 1:1; and between 10:1 and 1:1.
  • the neuroregulator is a psychedelic substance.
  • the neuroregulator is selected from the group consisting of: 3,4- methylenedioxymethamphetamine; lysergic acid diethylamide; and psilocybin.
  • the biological activity is selected from the group consisting of: suppressing inflammation; suppressing neuroinflammation; treating a neurological disorder; suppressing the activity of COX-2; suppressing the activity of iNOS; suppressing the activity of TNF-alpha; suppressing the activity of IL-2; suppressing the activity of IL-12 and suppressing the activity of GS-MCF.
  • the composition is selected from the group consisting of: a therapeutic composition; a pharmaceutical composition; a cosmetic composition; and a veterinary composition.
  • Pharmaceutical Compositions [00196] The present invention also provides a pharmaceutical composition comprising the composition of the invention together with a pharmaceutically acceptable carrier. [00197] Therapeutic compositions are within the scope of the present invention.
  • compositions are combined with a pharmaceutically acceptable carrier or diluent to produce a pharmaceutical composition (which may be for human or animal use).
  • Suitable carriers and diluents include isotonic saline solutions, for example phosphate- buffered saline.
  • pharmaceutically acceptable carrier includes any and all solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents and the like. The use of such media and agents for pharmaceutically active substances is well known in the art. Except insofar as any conventional media or agent is incompatible with the active ingredient, its use in the therapeutic compositions is contemplated. Supplementary active ingredients can also be incorporated into the compositions.
  • the pharmaceutical composition can contain formulation materials for modifying, maintaining or preserving, for example, the pH, osmolarity, viscosity, clarity, colour, isotonicity, odour, sterility, stability, rate of dissolution or release, adsorption or penetration of the composition.
  • Suitable formulation materials include, but are not limited to, amino acids (such as glycine, glutamine, asparagine, arginine or lysine); antimicrobials; antioxidants (such as ascorbic acid, sodium sulphite or sodium hydrogen-sulphite, Vitamin E, Vitamin E phosphate – lipid soluble vitamins, nano emulsions); buffers (such as borate, bicarbonate, tris-HCl, citrates, phosphates or other organic acids); bulking agents (such as mannitol or glycine); chelating agents (such as ethylenediamine tetraacetic acid (EDTA)); complexing agents (such as caffeine, polyvinylpyrrolidone, beta-cyclodextrin or hydroxypropyl-beta- cyclodextrin), fillers; monosaccharides, disaccharides; and other carbohydrates (such as glucose, mannose, or dextrins); proteins (such as serum albumin, gelatin or immuno
  • Sustained-release compositions may also include liposomes, which can be prepared by any of several methods known in the art.
  • the pharmaceutical composition to be used for in vivo administration typically must be sterile. This may be accomplished by filtration through sterile filtration membranes. In addition, the compositions generally are placed into a container having a sterile access port. Once the pharmaceutical composition has been formulated, it may be stored in sterile vials as a solution.
  • the composition retains its effective biological activity for a period selected from the group consisting of; greater than 24 hours; greater than 36 hours; and greater than 48 hours. Preferably, the composition is stable for periods selected from the group consisting of: 6 months, 1 year and 2 years.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne des compositions contenant des cannabinoïdes. La présente invention concerne également des compositions pharmaceutiques, des formes pharmaceutiques et des méthodes de traitement de troubles neurologiques pédiatriques par l'administration de la composition à un patient en ayant besoin.
EP23874108.6A 2022-10-06 2023-10-05 Méthodes de traitement de troubles neurologiques pédiatriques Pending EP4577197A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2022902914A AU2022902914A0 (en) 2022-10-06 Methods for treating paediatric neurological disorders
PCT/AU2023/050969 WO2024073812A1 (fr) 2022-10-06 2023-10-05 Méthodes de traitement de troubles neurologiques pédiatriques

Publications (1)

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EP4577197A1 true EP4577197A1 (fr) 2025-07-02

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EP (1) EP4577197A1 (fr)
JP (1) JP2025532803A (fr)
KR (1) KR20250079154A (fr)
CN (1) CN120322226A (fr)
AU (1) AU2023356549A1 (fr)
CA (1) CA3267884A1 (fr)
IL (1) IL320087A (fr)
WO (1) WO2024073812A1 (fr)

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160000843A1 (en) * 2014-07-01 2016-01-07 MJAR Holdings, LLC High cannabidiol cannabis strains
GB2541191A (en) * 2015-08-10 2017-02-15 Gw Pharma Ltd Use of cannabinoids in the treatment of epilepsy
GB2549277B (en) * 2016-04-11 2021-02-17 Gw Res Ltd Cannabidiolic Acid for use in the Treatment of Autism Spectrum Disorder
GB2572125B (en) * 2018-01-03 2021-01-13 Gw Res Ltd Pharmaceutical
WO2021003341A1 (fr) * 2019-07-02 2021-01-07 Ellevet Sciences Extrait de chanvre pour le traitement de la douleur, du cancer et de l'epilepsie chez les animaux
WO2023060302A1 (fr) * 2021-10-11 2023-04-20 Neurotech International Ltd Compositions et méthodes pour traiter des troubles neurologiques avec des produits combinés
JP2024536075A (ja) * 2021-10-11 2024-10-04 ニューロテック インターナショナル リミテッド 神経障害を処置するための組成物および方法
WO2023130160A1 (fr) * 2022-01-10 2023-07-13 Dolce Cann Global Pty Ltd Compositions et méthodes permettant le traitement de troubles non neurologiques à l'aide de produits combinés comprenant un mélange de cannabinoïdes riche en acide cannabidiolique (cbda).
WO2023130161A1 (fr) * 2022-01-10 2023-07-13 Dolce Cann Global Pty Ltd Compositions et procédés de traitement de troubles non neurologiques avec des produits mixtes comprenant un mélange cannabinoïde riche en acide cannabidiolique (cbda) conjointement avec un principe actif supplémentaire

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CN120322226A (zh) 2025-07-15
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