WO2023279137A1 - A composition and application thereof - Google Patents

A composition and application thereof Download PDF

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Publication number
WO2023279137A1
WO2023279137A1 PCT/AU2022/050482 AU2022050482W WO2023279137A1 WO 2023279137 A1 WO2023279137 A1 WO 2023279137A1 AU 2022050482 W AU2022050482 W AU 2022050482W WO 2023279137 A1 WO2023279137 A1 WO 2023279137A1
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WIPO (PCT)
Prior art keywords
pharmaceutical
composition according
enteric coating
phytopharmaceutical
encapsulated
Prior art date
Application number
PCT/AU2022/050482
Other languages
French (fr)
Inventor
Ian Edward Owles
Original Assignee
Breathe Life Sciences Pty Ltd
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Filing date
Publication date
Priority claimed from AU2021902065A external-priority patent/AU2021902065A0/en
Application filed by Breathe Life Sciences Pty Ltd filed Critical Breathe Life Sciences Pty Ltd
Publication of WO2023279137A1 publication Critical patent/WO2023279137A1/en

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    • 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
    • A61K31/01—Hydrocarbons
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • 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
    • A61K31/12—Ketones
    • 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
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/127—Liposomes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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 a pharmaceutical composition adapted for use in a variety of therapeutic indications. More particularly, the present disclosure may relate to an oral pharmaceutical composition, a metered dose pump or an aerosol pharmaceutical composition for a variety of therapeutic indications. The present invention may include at least one application derived from the pharmaceutical composition.
  • Colloidal carriers such as liposomes, micelles and nanoparticles are able to modify the distribution of an associated substance. They can therefore be used to improve the therapeutic index of medicines by increasing their efficacy and/or reducing their toxicity.
  • Liposomal and micelle formulations of cannabinoids suitable for pharmaceutical and nutraceutical applications are known.
  • the two main cannabinoids are delta-9- tetrahydrocannabinol (THC) and cannabidiol (CBD).
  • THC delta-9- tetrahydrocannabinol
  • CBD cannabidiol
  • THC is the chemical that is responsible for the psychoactive effects of cannabis.
  • CBD does not have the same psychoactivity as THC.
  • Cannabinoids are lipophilic and are acid labile.
  • cannabinoids Due to their hydrophobic nature, cannabinoids are poorly absorbed from oral dosage forms due to the aqueous environment of the gastrointestinal tract. Oral formulations of cannabinoids, therefore exhibit low bioavailability. As a result of the low bioavailability, patients are required to take higher doses and several administrations. There is a long felt need for improving the oral formulation to allow for improved uptake and absorption of cannabinoids.
  • JP Patent Application No. 2020074791 describes food and beverage compositions infused with lipophilic active agents and methods of their use for the treatment of a variety of disorders.
  • Many therapeutic agents are highly lipophilic as they are readily soluble in lipids and some organic solvents but poorly soluble in water.
  • methods were tried consisting of dissolving the lipophilic compound in a water-miscible organic solvent such as ethanol or propylene glycol.
  • a water-miscible organic solvent such as ethanol or propylene glycol.
  • the lipophilic compound may usually precipitate as a solid or liquid emulsion thereby resulting in reduced bioavailability.
  • micellar formulations are capable of solubilizing a variety of lipophilic therapeutic agents, the loading capacity of conventional micellar formulations may be limited by the solubility of the therapeutic agent in the micellar surfactant.
  • US Patent No.10,052,303 describes a stable, aqueous micelle suspension of one or more cannabinoids or cannabinoid analogues with an average micelle diameter size in the range between 50 and 1000 nm and wherein the suspension of the one or more cannabinoids or cannabinoid analogues does not comprise phospholipids and cholesterol.
  • a disadvantage with this is that the size of the micelles may be too large with a smaller surface area for absorption.
  • Chinese Patent No. 101563074 describes a method for combining two or more pharmaceuticals such as the synergistic combination of ibuprofen and acetyl aminophenol and US Patent Application Publication No.
  • US2021/0023053 describes a formulation comprising of melatonin, curcumin and cannabis, specifically THC alone or with CBD. While there are formulations of combinations of pharmaceuticals, the dosage of the formulations is typically not varied over a duration of administration. There is a long felt need to combine other pharmaceuticals with cannabidiol and other phytopharmaceuticals for increasing the therapeutic benefit to the person or patient and also to be flexible with an ability to vary the dosage of the pharmaceuticals in the composition during the patient treatment regime. This present invention satisfies this need for providing flexibility and relief of many symptoms as well as supplementing the person with various vitamins, herbs and minerals for the overall wellness of the person.
  • Phytopharmaceutical medicines are defined as purified and standardized fractions with defined minimum of bio-active or phytochemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals for diagnosis, treatment, mitigation, or prevention of any disease or disorder. There is evidence of the use of medicinal plants during the Bronze Age but their use most likely precedes this period. Plants contain a variety of bioactive compounds, (also referred to as phytochemicals) the leaves, stems, flowers and fruits have differing pharmacological activity.
  • compositions with at least two pharmaceuticals for synergistically treating or providing relief to a person with at least one therapeutic condition.
  • SEDDS self-emulsifying drug delivery systems
  • DES Deep Eutectic Solvents
  • DEILs Deep Eutectic Ionic Liquids
  • LMMs Low Melting Mixtures
  • LTTMs Low Transition Temperature Mixtures
  • NADES Natural Deep Eutectic Solvents
  • compositions may be included or co administered in food products, more particularly in fatty food products, such that the fat of the food product may advantageously improve the absorption of the pharmaceuticals.
  • a first aspect of the present invention may relate to an oral composition for use in medical treatment, the oral composition comprising: a capsule containing one or more phytopharmaceuticals and one or more pharmaceuticals.
  • the first phytopharmaceutical may be encapsulated by a first colloidal carrier, wherein the first colloidal carrier may be encapsulated by a first enteric coating.
  • the second pharmaceutical may be encapsulated by a second colloidal carrier, wherein the second colloidal carrier may be encapsulated by a second enteric coating, wherein the first enteric coating may have a different disintegration rate compared to the second enteric coating at a pH range between 6 to 7.4.
  • the invention may use phospholipid complex phytopharmaceuticals to enhance bioavailablity.
  • the oral composition may be a pellet or microsphere form in capsules.
  • the first enteric coating may be coloured with a first pigment
  • the second enteric coating may be coloured with a second pigment with any number of possible phytopharmaceuticals and pharmaceuticals incorporated into the dosage form being differentiated by colour.
  • the first pigment may be a different colour to the second and subsequent pigments.
  • the phytopharmaceutical could be cannabidiol or a mixture of cannabinoids and or terpenes or a turmeric extract or any of the plant based phytochemicals with medicinal properties, such as adaptogenic herbs, essential oils, curcumin, turmeric, collagen, green coffee extract, herbal extracts, Valerian, ginger, magnesium, antioxidants, glucomannan, glucosamine, chondroitin, and wherein the pharmaceutical may be one or more selected from but not limited to the group of: melatonin, ibuprofen, ibuprofen analogues, amitriptyline, bioidentical hormones, thyroid extract, promethazine, nicotine, prochlorperazine, Ivermectin, benzodiazepines, zopiclone, nonsteroidal anti-inflammatory drugs, hydroxychloroquine, doxylamine succinate, codeine, cannabidiol, liothyronine, levothyrox
  • the therapeutic treatment is at least one selected from the group of: anxiety, stress, sleep, anti-seizure, nausea, glaucoma, irritable bowel, Crohn’s disease, ulcerative colitis neuroprotection, pain relief, cancer symptom or cancer treatment side effect relief, palliative care, autoimmune diseases, inflammatory conditions, Obstructive sleep apnea syndrome (OS AS) weight loss, smoking cessation, Alzheimer’s, Parkinson's disease, schizophrenia, diabetes, multiple sclerosis, long covid and related conditions, anorexia or cachexia syndrome, bladder dysfunction, Huntington's disease.
  • OS AS Obstructive sleep apnea syndrome
  • the first enteric coating and the second enteric coating may be one selected from the group of: poly(methyl methacrylate) copolymer, cellulose acetate phthalate, cellulose acetate trimellitate, cellulose acetate succinate, hydroxypropylmethylcellulose acetate succinate, hydroxypropyl methylcellulose phthalate, polyvinyl acetate phthalate.
  • the capsule may have an external coating.
  • the external coating may be a mucoadhesive polymer. With controlled release characteristics.
  • the mucoadhesive polymer may be one selected from the group of: chitosan, polyvinyl alcohol, poly(acrylic acid), polyethylene glycol, and tocopherol polyethylene glycol succinate.
  • the colloidal carrier may include unilamellar liposomes.
  • a predetermined therapeutic dosage of the oral composition may be each stored in a pocket in a blister pack.
  • the pocket of the blister pack may further contain a third pharmaceutical.
  • each pocket of the blister pack may be sealed by a protective foil, wherein the foil may have ingredient and dosage information.
  • a second aspect of the present invention may relate to an aerosol or metered dose composition for use in therapeutic treatment, the aerosol or metered dose composition comprising: a phytopharmaceutical and a pharmaceutical mixture solubilized in a colloidal carrier in liquid; and wherein the colloidal carrier may be encapsulated by a mucoadhesive polymer.
  • these may be administered by a mechanical pump or pharmaceutically approved propellants.
  • the colloidal carrier may be a neutral or a positively charged liposomal base.
  • the average particle size of the liposomes may be in the range of: 5 nm to 50 nm with a polydispersity index of less than 0.3.
  • the mucoadhesive polymer may be one selected from the group of: chitosan, polyvinyl alcohol, poly(acrylic acid), polyethylene glycol, and tocopherol polyethylene glycol succinate.
  • the aerosol / metered dose spray composition may further comprise a non-ionic surfactant component and a phospholipid component; wherein the non-ionic surfactant component may be at least one chosen from the group of: tyloxapol, polysorbates, D-a-tocopheryl polyethylene glycol succinate, and polyethylene glycol (15)-hydroxystearate; and wherein the phospholipid component may be at least one chosen from the group of: a zwitterionic phospholipid, a saturated phospholipid, a hydrogenated phospholipid.
  • the non-ionic surfactant component may have a content between 0.01 to 5 wt%; and wherein the phospholipid component may have a content between 0.5 to 5 wt%.
  • the colloidal carrier may be a neutral or a positively charged liposomal base.
  • the phytopharmaceutical could be cannabidiol or a mixture of cannabinoids and or terpenes or a turmeric extract or any of the plant based phytochemicals with medicinal properties, such as adaptogenic herbs, essential oils, curcumin, turmeric, collagen, green coffee extract, herbal extracts, Valerian, ginger, magnesium, antioxidants, glucomannan, glucosamine, chondroitin, and wherein the pharmaceutical may be one or more selected from but not limited to the group of: melatonin, paracetamol (acetaminophen), ibuprofen, Diclofenac, indomethacin, Ketoprofen, Ketorolac, Mefenamic acid, Naproxen, Piroxicam, Sulindac, Celecoxib, Etoricoxib, eloxicam, Paracoxib and other non-steroidal anti- inflamatory drugs (NSAID), amitriptyline, ivermectin, bioidentical
  • Vitamin D Vitamin C
  • Vitamin E Vitamin B
  • Vitamin B group including active forms such as pyridoxal 5-phosphate (P5P) and riboflavin 5 phosphate.
  • P5P pyridoxal 5-phosphate
  • riboflavin 5 phosphate active forms
  • the therapeutic treatment is selected from the group of: anxiety, stress, sleep, anti-seizure, nausea, glaucoma, irritable bowel, Crohn’s disease, ulcerative colitis, neuroprotection, pain relief, cancer symptom or cancer treatment side effect relief, palliative care, autoimmune diseases, inflammatory conditions, obstructive sleep apnea syndrome (OSAS) weight loss, smoking cessation, Alzheimer’s, Parkinson's disease, schizophrenia, diabetes, multiple sclerosis, long covid and related conditions, anorexia or cachexia syndrome, bladder dysfunction, Huntington's disease.
  • OSAS obstructive sleep apnea syndrome
  • a third aspect of the present invention may relate to a method for treatment of acute injury using the oral composition, wherein the pharmaceutical is for example ibuprofen, wherein doses of one or more phytopharmaceutical and one or more pharmaceutical are adjustable for maximising effectiveness and minimising side effects.
  • the dose form of the phytopharmaceutical and the pharmaceutical may be combined and or are separate.
  • the method comprising the steps of: a) taking 400 mg of ibuprofen three times a day for a duration range between 3 to 7 days, and 50mg cannabidiol one time daily at night for a duration range between 3 to 7 days; b) taking 200 mg of ibuprofen three times a day for a duration range between 3 to 7 days, and 50mg cannabidiol two times a day for a duration range between 3 to 7 days; taking 200 mg of ibuprofen two times a day for a duration range between 3 to 7 days, and 50mg cannabidiol three times a day for a duration range between 3 to 7 days;
  • each capsule may contain 50mg cannabidiol.
  • the phytopharmaceutical ingredients and the pharmaceutical ingredients may be in the same dose form.
  • the phytopharmaceutical and the pharmaceutical may be separate dose forms.
  • the phytopharmaceutical and the pharmaceutical may be combined into one dose form.
  • the phytopharmaceutical and the pharmaceutical may be combined in one dose form and there may be either a separate dose form containing another phytopharmaceutical and a pharmaceutical combination or a phytopharmaceutical separately or a pharmaceutical separately in a separate dose form.
  • the concept is to use the lowest possible dose of the active pharmaceutical ingredient (API) with the most actual or potential side effects for individual patients.
  • API active pharmaceutical ingredient
  • Innovation is to make it very easy for customer to make these changes themselves after consultation with prescriber supported by supplied comprehensive information and disclosure of ingredients actions, dose ranges, side effects etc.
  • the invention is to be interpreted with reference to the at least one of the technical problems described or affiliated with the background art.
  • the present aims to solve or ameliorate at least one of the technical problems and this may result in one or more advantageous effects as defined by this specification and described in detail with reference to the preferred embodiments of the present invention.
  • an oral composition for use in therapeutic treatment which may be one selected the group of: anxiety, stress, sleep, anti-seizure, nausea, glaucoma, irritable bowel, Crohn’s disease, ulcerative colitis neuroprotection, pain relief, cancer symptom or cancer treatment side effect relief, palliative care, autoimmune diseases, inflammatory conditions, Obstructive sleep apnea syndrome (OSAS), weight loss, smoking cessation, Alzheimer’s, Parkinson's disease, schizophrenia, diabetes, multiple sclerosis, long covid and related conditions anorexia or cachexia syndrome, bladder dysfunction, Huntington's disease.
  • OSAS Obstructive sleep apnea syndrome
  • the oral composition may comprise a capsule containing a phytopharmaceutical and/or a pharmaceutical.
  • the capsule may be translucent or transparent such that a person can see the enteric coating colour of the phytopharmaceutical and/or the pharmaceutical contained within the capsule.
  • the first phytopharmaceutical may be a cannabis extract or a turmeric extract or a mixture of cannabis extract and turmeric extract.
  • the phytopharmaceutical may be encapsulated by a first colloidal carrier or unilamellar liposomes. The colloidal carrier may improve the uptake or absorption of the phytopharmaceutical through the cells of the targeted section of the human body.
  • the colloidal carrier may be a neutral or a positively charged liposomal base.
  • the positively charged liposomal base offer the advantage of great liposomal stability during storage, as charged particles repel each and reduce aggregation tendencies. Further advantage for positively charged liposomal base is that the cell internalisation is promoted by their electrostatic interaction of cell membranes, which are negatively charged.
  • the second pharmaceutical may be encapsulated by a second colloidal carrier, in which the second colloidal carrier may be the same or similar to the first colloidal carrier.
  • the second colloidal carrier may also be unilamellar liposomes also for the purpose of improving the uptake or absorption of the pharmaceutical through the cells of the targeted section of the human body.
  • the colloidal carriers can be easily absorbed upon contact with the cell, it may be advantageous to provide an enteric coating to the colloidal carriers so that the colloidal carrier coated pharmaceuticals will not be released upon ingestion or the acidic stomach area.
  • the first colloidal carrier coated first phytopharmaceutical may be encapsulated by a first enteric coating
  • the second colloidal carrier coated second pharmaceutical may be encapsulated by a second enteric coating.
  • the enteric coating may be one selected from the group of: poly(methyl methacrylate) copolymer, cellulose acetate phthalate, cellulose acetate trimellitate, cellulose acetate succinate, hydroxypropylmethylcellulose acetate succinate, hydroxypropyl methylcellulose phthalate, polyvinyl acetate phthalate.
  • the enteric coating may be Eudragit®-coated liposomal and microsphere formulation for favourable pH-dependent release characteristics.
  • the enteric coatings may differ such the first enteric coating has a different disintegration rate compared to the second enteric coating at a pH range between 6 to 7.4. Having different disintegration rates for different pharmaceuticals at the targeted drug delivery section of the human body is important such that the cells of the same location is not oversaturated or overconcentrated with the pharmaceuticals, which may be not be optimal for cellular uptake. By having a different disintegration rate or different release characteristics, the drug is released and localised at a different area of the targeted section.
  • the phytopharmaceutical may be cannabidiol or a cannabis extract; and the pharmaceutical may be one selected from the group of: melatonin, ibuprofen, ibuprofen, amitriptyline, magnesium, adaptogenic herbs, curcumin, turmeric, S-Adenosyl methionine, 5-hydroxytryptophan, collagen, bioidentical hormones, thyroid, promethazine, nicotine, prochlorperazine, green coffee extract, Ivermectin, benzodiazepines, herbal extracts, Valerian, zopiclone, nonsteroidal anti-inflammatory drugs, hydroxychloroquine, doxylamine succinate, codeine, cannabidiol, ginger, antioxidants, liothyronine, levothyroxine, orlistat, glucomannan, glucosamine, chondroitin, Vitamin D, Vitamin C, Vitamin E, Vitamin B, pyridoxal 5’-phosphate, Zinc,
  • the first enteric coated phytopharmaceutical having a faster disintegration rate than the second enteric coated pharmaceutical so that the targeted section can absorb and therapeutically benefit from the phytopharmaceutical earlier.
  • the pharmaceutical released earlier than the phytopharmaceutical so that the person can absorb and therapeutically benefit from the pharmaceutical earlier. This may be the case when they have different sites of action or preferential absorption areas of the GI tract.
  • the person may have a deficiency in a specific vitamin (say Vitamin B12) or the need for requiring specific treatment by taking a particular pharmaceutical from the list mentioned previously.
  • the capsule may be translucent or transparent to allow a person to see the phytopharmaceutical or the pharmaceuticals have the different colour coating of the pellets. This may also aid in the placebo effect giving a higher response rate.
  • the colouring of the coating is of safe, non-toxic natural dyes for example, chlorophyll.
  • the capsule may not be see through (to protect the ingredients from light) but is adequately labelled to inform the person what the capsule contains and which of the phytopharmaceutical or the pharmaceutical will be released first relative to each other.
  • the capsule containing at least a phytopharmaceutical and a pharmaceutical having different colour enteric coatings may be able to allow the pharmacist to be able to adjust the dosage for the phytopharmaceutical and the pharmaceutical contained in one capsule depending on the prescription and regime that the healthcare professional may have recommended.
  • the capsule having an external coating, in which the external coating may be a mucoadhesive polymer.
  • the mucoadhesive polymer may be one selected from the group of: chitosan, polyvinyl alcohol, poly(acrylic acid), polyethylene glycol, and tocopherol polyethylene glycol succinate.
  • the mucoadhesive polymer may add further protection from the degradation in the acidic environment and give a controlled release action.
  • the active ingredients encapsulated in a coated capsule within the main capsule which also has active ingredients, thus giving separate active ingredients different release characteristics.
  • the capsule within a capsule may be as shown in Figure 1 with a liquid in the external capsule or the external capsule may contain a semisolid, powder, granules or pellets.
  • the internal capsule may contain a liquid, semisolid, powder, granules or pellets.
  • each capsule may be stored in a pocket of a blister pack.
  • the blister pack may contain a third pharmaceutical for a person’s convenience of having the medications in one packet when a person is taking a known combination of pharmaceuticals.
  • each pocket containing a pharmaceutical is sealed by a foil, wherein the foil has ingredient and dosage information corresponding to the pharmaceutical that is contained. This further informs the person what they will be taking prior to opening the foil.
  • the blister packs containing the oral composition may be stored in a child resistant carton and a plastic tray.
  • the tray with two protrusions should be pulled out like a drawer after pressing the push points diagonally across each side of the carton with one hand, wherein the push points are diagonally relatively far apart, while the other hand is to pull the plastic tray away from the carton.
  • Another packaging option could be using a pharmaceutical grade bottle with a child resistant cap,
  • the phytopharmaceutical ingredients and the pharmaceutical ingredients may be in the same dose form; in another preferred embodiment of the present invention, the phytopharmaceutical and the pharmaceutical may be separate dose forms; in another preferred embodiment of the present invention, the phytopharmaceutical and the pharmaceutical may be combined into one dose form; and in another preferred embodiment of the present invention, the phytopharmaceutical and the pharmaceutical may be combined in one dose form and there may be either a separate dose form containing another phytopharmaceutical and a pharmaceutical combination or a phytopharmaceutical separately or a pharmaceutical separately in a separate dose form. Preferably, there may be one or two or three or more separate dose forms in the one box or packet.
  • the composition may be co-administered or included into a food product to improve patient acceptability, ingestion and/or absorption.
  • the oral composition that may be included in the food products may be in the form of novel foods such as soothers, pills, lollies, lolly pops, chocolate, protein bars, or chocolate coated soother.
  • Food products, in particular fatty foods may be able to increase the absorption of cannabidiol as food is known to affect drug absorption by delaying gastric emptying time, altering gastrointestinal pH, stimulating bile flow or the physical interaction of drugs.
  • different foods based on factors such as nutritional composition may have distinct influences on the transit time, luminal dissolution, permeability and bioavailability of the pharmaceuticals contained in the composition.
  • An advantage of increasing the amount of cannabidiol dose being absorbed into the body can also lead to lower medication costs and/or having less of the cannabidiol component in the composition which may obtain the same effect as a higher dosage of cannabidiol but at a lower bioavailability.
  • an aerosol or a metered dose composition for use in topical or oral delivery of medicine
  • the aerosol or metered dose spray composition comprising: a phytopharmaceutical and a pharmaceutical mixture solubilized in a colloidal carrier in liquid; and wherein the colloidal carrier may be encapsulated by a mucoadhesive polymer.
  • the colloidal carrier may be unilamellar liposomes and the phyto-phospholipid complexation technique may be used for improving the pharmacokinetic profile of the active ingredient from the plant extract.
  • the making of phospholipid complex phytopharmaceuticals with Cannabis extracts and turmeric extracts may be used. It may be appreciated that other plant extracts may also be used to cater to the therapeutic use of the particular product.
  • the average particle size of the liposomes may be in the range of: 5 nm to 100 nm with a polydispersity index of less than 0.3, and wherein the mucoadhesive polymer may be one selected from the group of: chitosan, polyvinyl alcohol, poly(acrylic acid), polyethylene glycol, and tocopherol polyethylene glycol succinate.
  • the advantage of having a mucoadhesive polymer is so that once ingested, whether through the nose or the mouth, the mucoadhesive polymer readily attaches to the mucus or the cell membranes. Once adhered, the positively charged colloidal carrier or liposomal base encapsulating the phytopharmaceutical and/or pharmaceutical mixture may then be absorbed. The phytopharmaceutical and/or pharmaceutical may then provide the therapeutic benefit to the person.
  • the mucoadhesive polymer may be one selected from the group of: chitosan, polyvinyl alcohol, poly(acrylic acid), polyethylene glycol, and tocopherol polyethylene glycol succinate; and the aerosol composition may further comprise a non-ionic surfactant component and a phospholipid component; wherein the non-ionic surfactant component may be at least one chosen from the group of: tyloxapol, polysorbates, D-a- tocopheryl polyethylene glycol succinate, and polyethylene glycol (15)-hydroxystearate; and wherein the phospholipid component may be at least one chosen from the group of: a zwitterionic phospholipid, a saturated phospholipid, a hydrogenated phospholipid.
  • the non-ionic surfactant component has a content between 0.01 to 5 wt% ; and wherein the phospholipid component has a content between 0.5 to 5 wt%.
  • the non-ionic surfactant component may advantageously provide a stabilising effect in the pharmaceutical emulsion.
  • an example application using a method for treatment of acute injury using the oral composition wherein the person may require a pharmaceutical such as ibuprofen, depending on the advice of a healthcare professional regarding the dosage and duration
  • the method may comprise the steps of: a) taking 400 mg of ibuprofen three times a day for a duration range between 3 to 7 days, and 50 mg cannabidiol one time daily at night for a duration range between 3 to 7 days; b) taking 200 mg of ibuprofen three times a day for a duration range between 3 to 7 days, and 50mg cannabidiol two times a day for a duration range between 3 to 7 days; c) taking 200 mg of ibuprofen two times a day for a duration range between 3 to 7 days, and 50mg cannabidiol three times a day.
  • the above method is providing an example only of the application and estimated dosage and duration. It may be appreciated that the dosage may be greater and for a longer duration than specified if the therapeutic condition is severe and may be required for the symptomatic relief. Similarly, it may also be appreciated that the dosage may be smaller and for a shorter duration than specified if the therapeutic condition is less severe or moderate as may be required for the symptomatic relief.
  • Example 1 CBD 50 mg Ibuprofen 200 mg phytopharmaceutical capsules
  • Example 2 CBD 50 mg Ibuprofen 200 mg phytopharmaceutical capsule in Capsule formula (Small Capsule)
  • a large capsule may comprise the following:
  • Example 3 CBD 50 mg Ibuprofen 200 mg phytopharmaceutical Oral mucosal in metered dose pack
  • the present invention and the described preferred embodiments specifically include at least one feature that is industrial applicable.

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Abstract

An oral composition for use in medical treatment, the composition comprising: a capsule containing a first phytopharmaceutical and a second pharmaceutical; the first phytopharmaceutical encapsulated by a first colloidal earner, wherein the first colloidal carrier is encapsulated by a first enteric coating; the second pharmaceutical encapsulated by a second colloidal carrier, wherein the second colloidal earner is encapsulated by a second enteric coating; wherein the first enteric coating has a different disintegration rate compared to the second enteric coating at a pH range between 6 to 7.4. Also disclosed is an aerosol or metered dose composition comprising a phytopharmaceutical and pharmaceutical mixture solubilised in a colloidal carrier, in turn encapsulated by a mucoadhesive polymer for topical or oral delivery. Also disclosed is the treatment of pain or inflammation associated with acute injury by administering 200 or 400 mg ibuprofen and 50 mg cannabidiol once to three times a day for 3 to 7 days.

Description

A COMPOSITION AND APPLICATION THEREOF TECHNICAL FIELD
[0001] The present invention relates to a pharmaceutical composition adapted for use in a variety of therapeutic indications. More particularly, the present disclosure may relate to an oral pharmaceutical composition, a metered dose pump or an aerosol pharmaceutical composition for a variety of therapeutic indications. The present invention may include at least one application derived from the pharmaceutical composition.
BACKGROUND
[0002] Colloidal carriers such as liposomes, micelles and nanoparticles are able to modify the distribution of an associated substance. They can therefore be used to improve the therapeutic index of medicines by increasing their efficacy and/or reducing their toxicity. Liposomal and micelle formulations of cannabinoids suitable for pharmaceutical and nutraceutical applications are known. The two main cannabinoids are delta-9- tetrahydrocannabinol (THC) and cannabidiol (CBD). The most commonly known of two is THC, which is the chemical that is responsible for the psychoactive effects of cannabis. CBD does not have the same psychoactivity as THC. Cannabinoids are lipophilic and are acid labile. Due to their hydrophobic nature, cannabinoids are poorly absorbed from oral dosage forms due to the aqueous environment of the gastrointestinal tract. Oral formulations of cannabinoids, therefore exhibit low bioavailability. As a result of the low bioavailability, patients are required to take higher doses and several administrations. There is a long felt need for improving the oral formulation to allow for improved uptake and absorption of cannabinoids.
[0003] JP Patent Application No. 2020074791 describes food and beverage compositions infused with lipophilic active agents and methods of their use for the treatment of a variety of disorders. Many therapeutic agents are highly lipophilic as they are readily soluble in lipids and some organic solvents but poorly soluble in water. To increase the bioavailability of a lipophilic compound, methods were tried consisting of dissolving the lipophilic compound in a water-miscible organic solvent such as ethanol or propylene glycol. However, when the resulting solution is mixed with gastrointestinal fluid, the lipophilic compound may usually precipitate as a solid or liquid emulsion thereby resulting in reduced bioavailability. Other methods include using a surfactant in aqueous solution, in which the surfactant micelles are used to solubilize and transport therapeutic agents. In aqueous solution, the micelles can incorporate the lipophilic therapeutic agent into the hydrocarbon core of the micelle. While micellar formulations are capable of solubilizing a variety of lipophilic therapeutic agents, the loading capacity of conventional micellar formulations may be limited by the solubility of the therapeutic agent in the micellar surfactant.
[0004] US Patent No.10,052,303 describes a stable, aqueous micelle suspension of one or more cannabinoids or cannabinoid analogues with an average micelle diameter size in the range between 50 and 1000 nm and wherein the suspension of the one or more cannabinoids or cannabinoid analogues does not comprise phospholipids and cholesterol. A disadvantage with this is that the size of the micelles may be too large with a smaller surface area for absorption. Chinese Patent No. 101563074 describes a method for combining two or more pharmaceuticals such as the synergistic combination of ibuprofen and acetyl aminophenol and US Patent Application Publication No. US2021/0023053 describes a formulation comprising of melatonin, curcumin and cannabis, specifically THC alone or with CBD. While there are formulations of combinations of pharmaceuticals, the dosage of the formulations is typically not varied over a duration of administration. There is a long felt need to combine other pharmaceuticals with cannabidiol and other phytopharmaceuticals for increasing the therapeutic benefit to the person or patient and also to be flexible with an ability to vary the dosage of the pharmaceuticals in the composition during the patient treatment regime. This present invention satisfies this need for providing flexibility and relief of many symptoms as well as supplementing the person with various vitamins, herbs and minerals for the overall wellness of the person.
Phytopharmaceutical medicines are defined as purified and standardized fractions with defined minimum of bio-active or phytochemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals for diagnosis, treatment, mitigation, or prevention of any disease or disorder. There is evidence of the use of medicinal plants during the Bronze Age but their use most likely precedes this period. Plants contain a variety of bioactive compounds, (also referred to as phytochemicals) the leaves, stems, flowers and fruits have differing pharmacological activity.
[0005] Any discussion of the prior art throughout the specification should in no way be considered as an admission that such prior art is widely known or forms part of common general knowledge in the field.
SUMMARY
[0006] PROBLEMS TO BE SOLVED
[0007] It may be an advantage to provide a pharmaceutical composition suitable for oral administration.
[0008] It may also be an advantage to provide an aerosol or metered dose pharmaceutical composition suitable for administering the medication via various routes including the nose, mouth, skin and mucosal membranes.
[0009] It may be an advantage to provide a variation in the composition of the individual pharmaceutical agents for varying the desirable dosage administered when applied. More particularly, when it is an aerosol or a metered dose composition, where a pump or a spray amounts to a measured dosage.
[0010] It may be an advantage to provide a composition with at least two pharmaceuticals for synergistically treating or providing relief to a person with at least one therapeutic condition.
[0011] It may be an advantage to provide an oral composition having a phytopharmaceutical encapsulated by a first colloidal carrier and a pharmaceutical encapsulated by a second colloidal carrier, in which the colloidal carriers improve drug absorption into or onto the cell membrane of a targeted section of the human body.
[0012] It may be an advantage to provide a first enteric coating encapsulating the first colloidal carrier so it prevents the phytopharmaceutical from being released in the acidic conditions of the stomach before reaching the intestine.
[0013] It may be an advantage to provide a second enteric coating encapsulating the second colloidal carrier so it prevents the pharmaceutical from also being released in the acidic conditions of the stomach before reaching the intestine.
[0014] It may be an advantage to use a self-emulsifying drug delivery systems (SEDDS) are lipid-based formulations that encompass isotropic mixtures of natural or synthetic oils, solid or liquid surfactants and co-surfactants
[0015] It may be an advantage to use solid dispersion systems, using available surface- active and self-emulsifying carriers and technologies to encapsulate solid dispersions directly into hard gelatin capsules as melts or form them into pellets.
It may be an advantage to use Deep Eutectic Solvents (DESs), also known in the literature as Deep Eutectic Ionic Liquids (DEILs), Low Melting Mixtures (LMMs), Low Transition Temperature Mixtures (LTTMs), or Natural Deep Eutectic Solvents (NADES),
[0016] It may be an advantage to provide the first enteric coating having a different disintegration rate compared to the second enteric coating at a pH range between 6 to 7.4 so as to allow for a good therapeutic exposure of an amount of the phytopharmaceutical or pharmaceutical at different cellular locations of the targeted section of the body.
[0017] It may be an advantage to provide a non-toxic colouring to the first enteric coating and a different non-toxic colouring to the second enteric coating, in which the colour provides an indication to a person regarding the disintegration rate of the enteric coating. [0018] It may be an advantage to provide a translucent or transparent capsule to allow a person to see the colour of the enteric coating of the phytopharmaceutical or the pharmaceutical when it is contained in the capsule.
[0019] It may be an advantage to coat the entire capsule with an enteric coating so as to allow for a good therapeutic exposure of an amount of the phytopharmaceutical or pharmaceutical at different cellular locations of the targeted section of the body. This may be time release or pH range sensitive.
[0020] It may be an advantage to provide a composition that may be included or co administered in food products, more particularly in fatty food products, such that the fat of the food product may advantageously improve the absorption of the pharmaceuticals.
[0021] It may be an advantage to provide other modes of application such as creams/ointments/gels, aerosols, viscous oral mixture, suppositories, pessaries, nasal spray, Troche, Gummies, chocolate bars, for example.
[0022] It may be an advantage to store the composition in a blister pack, in which the blister pack is secured in a packaging that may be easy for adults to open but may be difficult for children to open to prevent children from assessing the contents.
[0023] It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative.
[0024] MEANS FOR SOLVING THE PROBLEM
[0025] A first aspect of the present invention may relate to an oral composition for use in medical treatment, the oral composition comprising: a capsule containing one or more phytopharmaceuticals and one or more pharmaceuticals. The first phytopharmaceutical may be encapsulated by a first colloidal carrier, wherein the first colloidal carrier may be encapsulated by a first enteric coating. The second pharmaceutical may be encapsulated by a second colloidal carrier, wherein the second colloidal carrier may be encapsulated by a second enteric coating, wherein the first enteric coating may have a different disintegration rate compared to the second enteric coating at a pH range between 6 to 7.4.
[0026] Preferably, the invention may use phospholipid complex phytopharmaceuticals to enhance bioavailablity..
[0027] Preferably, the oral composition may be a pellet or microsphere form in capsules.
[0028] Preferably, the first enteric coating may be coloured with a first pigment, and wherein the second enteric coating may be coloured with a second pigment with any number of possible phytopharmaceuticals and pharmaceuticals incorporated into the dosage form being differentiated by colour.
[0029] Preferably, the first pigment may be a different colour to the second and subsequent pigments.
[0030] Preferably, the phytopharmaceutical could be cannabidiol or a mixture of cannabinoids and or terpenes or a turmeric extract or any of the plant based phytochemicals with medicinal properties, such as adaptogenic herbs, essential oils, curcumin, turmeric, collagen, green coffee extract, herbal extracts, Valerian, ginger, magnesium, antioxidants, glucomannan, glucosamine, chondroitin, and wherein the pharmaceutical may be one or more selected from but not limited to the group of: melatonin, ibuprofen, ibuprofen analogues, amitriptyline, bioidentical hormones, thyroid extract, promethazine, nicotine, prochlorperazine, Ivermectin, benzodiazepines, zopiclone, nonsteroidal anti-inflammatory drugs, hydroxychloroquine, doxylamine succinate, codeine, cannabidiol, liothyronine, levothyroxine, orlistat, bupropion, S- Adenosyl methionine, 5-hydroxytryptophan, Vitamin D, Vitamin C, Vitamin E, Vitamin B, pyridoxal 5 ’-phosphate, Zinc, multivitamins and minerals. [0031] Preferably, the therapeutic treatment is at least one selected from the group of: anxiety, stress, sleep, anti-seizure, nausea, glaucoma, irritable bowel, Crohn’s disease, ulcerative colitis neuroprotection, pain relief, cancer symptom or cancer treatment side effect relief, palliative care, autoimmune diseases, inflammatory conditions, Obstructive sleep apnea syndrome (OS AS) weight loss, smoking cessation, Alzheimer’s, Parkinson's disease, schizophrenia, diabetes, multiple sclerosis, long covid and related conditions, anorexia or cachexia syndrome, bladder dysfunction, Huntington's disease.
[0032] Preferably, the first enteric coating and the second enteric coating may be one selected from the group of: poly(methyl methacrylate) copolymer, cellulose acetate phthalate, cellulose acetate trimellitate, cellulose acetate succinate, hydroxypropylmethylcellulose acetate succinate, hydroxypropyl methylcellulose phthalate, polyvinyl acetate phthalate.
[0033] Preferably, the capsule may have an external coating.
[0034] Preferably, the external coating may be a mucoadhesive polymer. With controlled release characteristics.
[0035] Preferably, the mucoadhesive polymer may be one selected from the group of: chitosan, polyvinyl alcohol, poly(acrylic acid), polyethylene glycol, and tocopherol polyethylene glycol succinate.
[0036] Preferably, the colloidal carrier may include unilamellar liposomes.
[0037] Preferably, a predetermined therapeutic dosage of the oral composition may be each stored in a pocket in a blister pack.
[0038] Preferably, the pocket of the blister pack may further contain a third pharmaceutical. [0039] Preferably, each pocket of the blister pack may be sealed by a protective foil, wherein the foil may have ingredient and dosage information.
[0040] A second aspect of the present invention may relate to an aerosol or metered dose composition for use in therapeutic treatment, the aerosol or metered dose composition comprising: a phytopharmaceutical and a pharmaceutical mixture solubilized in a colloidal carrier in liquid; and wherein the colloidal carrier may be encapsulated by a mucoadhesive polymer.
[0041] Preferably, these may be administered by a mechanical pump or pharmaceutically approved propellants.
[0042] Preferably, the colloidal carrier may be a neutral or a positively charged liposomal base.
[0043] Preferably, the average particle size of the liposomes may be in the range of: 5 nm to 50 nm with a polydispersity index of less than 0.3.
[0044] Preferably, the mucoadhesive polymer may be one selected from the group of: chitosan, polyvinyl alcohol, poly(acrylic acid), polyethylene glycol, and tocopherol polyethylene glycol succinate.
[0045] Preferably, the aerosol / metered dose spray composition may further comprise a non-ionic surfactant component and a phospholipid component; wherein the non-ionic surfactant component may be at least one chosen from the group of: tyloxapol, polysorbates, D-a-tocopheryl polyethylene glycol succinate, and polyethylene glycol (15)-hydroxystearate; and wherein the phospholipid component may be at least one chosen from the group of: a zwitterionic phospholipid, a saturated phospholipid, a hydrogenated phospholipid. [0046] Preferably, the non-ionic surfactant component may have a content between 0.01 to 5 wt%; and wherein the phospholipid component may have a content between 0.5 to 5 wt%.
[0047] Preferably, the colloidal carrier may be a neutral or a positively charged liposomal base.
[0048] Preferably, the phytopharmaceutical could be cannabidiol or a mixture of cannabinoids and or terpenes or a turmeric extract or any of the plant based phytochemicals with medicinal properties, such as adaptogenic herbs, essential oils, curcumin, turmeric, collagen, green coffee extract, herbal extracts, Valerian, ginger, magnesium, antioxidants, glucomannan, glucosamine, chondroitin, and wherein the pharmaceutical may be one or more selected from but not limited to the group of: melatonin, paracetamol (acetaminophen), ibuprofen, Diclofenac, indomethacin, Ketoprofen, Ketorolac, Mefenamic acid, Naproxen, Piroxicam, Sulindac, Celecoxib, Etoricoxib, eloxicam, Paracoxib and other non-steroidal anti- inflamatory drugs (NSAID), amitriptyline, ivermectin, bioidentical hormones, thyroid extract, promethazine, nicotine, prochlorperazine, hydroxychloroquine, benzodiazepines, zopiclone, doxylamine succinate, codeine, cannabidiol, liothyronine, levothyroxine, orlistat, bupropion S-Adenosyl, methionine, 5-hydroxytryptophan,
Vitamin D, Vitamin C, Vitamin E, Vitamin B and Vitamin B group including active forms such as pyridoxal 5-phosphate (P5P) and riboflavin 5 phosphate.
[0049] Preferably, the therapeutic treatment is selected from the group of: anxiety, stress, sleep, anti-seizure, nausea, glaucoma, irritable bowel, Crohn’s disease, ulcerative colitis, neuroprotection, pain relief, cancer symptom or cancer treatment side effect relief, palliative care, autoimmune diseases, inflammatory conditions, obstructive sleep apnea syndrome (OSAS) weight loss, smoking cessation, Alzheimer’s, Parkinson's disease, schizophrenia, diabetes, multiple sclerosis, long covid and related conditions, anorexia or cachexia syndrome, bladder dysfunction, Huntington's disease. [0050] A third aspect of the present invention may relate to a method for treatment of acute injury using the oral composition, wherein the pharmaceutical is for example ibuprofen, wherein doses of one or more phytopharmaceutical and one or more pharmaceutical are adjustable for maximising effectiveness and minimising side effects. In this iteration the dose form of the phytopharmaceutical and the pharmaceutical may be combined and or are separate.
[0051] Preferably, the method comprising the steps of: a) taking 400 mg of ibuprofen three times a day for a duration range between 3 to 7 days, and 50mg cannabidiol one time daily at night for a duration range between 3 to 7 days; b) taking 200 mg of ibuprofen three times a day for a duration range between 3 to 7 days, and 50mg cannabidiol two times a day for a duration range between 3 to 7 days; taking 200 mg of ibuprofen two times a day for a duration range between 3 to 7 days, and 50mg cannabidiol three times a day for a duration range between 3 to 7 days;
[0052] Preferably, each capsule may contain 50mg cannabidiol.
[0053] Preferably, the pharmaceutical contained in the same blister pack as the capsule or contained in a different blister pack, wherein the pharmaceutical may contain 200 mg ibuprofen.
[0054] In another iteration of the invention, the phytopharmaceutical ingredients and the pharmaceutical ingredients may be in the same dose form.
[0055] In another iteration of the invention, the phytopharmaceutical and the pharmaceutical may be separate dose forms.
[0056] In another iteration of the invention, the phytopharmaceutical and the pharmaceutical may be combined into one dose form.
[0057] In another iteration of the invention, the phytopharmaceutical and the pharmaceutical may be combined in one dose form and there may be either a separate dose form containing another phytopharmaceutical and a pharmaceutical combination or a phytopharmaceutical separately or a pharmaceutical separately in a separate dose form.
[0058] Preferably, there may be one or two or three or more separate dose forms in the one box or packet.
[0059] Preferably, the concept is to use the lowest possible dose of the active pharmaceutical ingredient (API) with the most actual or potential side effects for individual patients. Innovation is to make it very easy for customer to make these changes themselves after consultation with prescriber supported by supplied comprehensive information and disclosure of ingredients actions, dose ranges, side effects etc.
[0060] In the context of the present invention, the words “comprise”, “comprising” and the like are to be construed in their inclusive, as opposed to their exclusive, sense, that is in the sense of “including, but not limited to”.
[0061] The invention is to be interpreted with reference to the at least one of the technical problems described or affiliated with the background art. The present aims to solve or ameliorate at least one of the technical problems and this may result in one or more advantageous effects as defined by this specification and described in detail with reference to the preferred embodiments of the present invention.
DESCRIPTION OF THE INVENTION
[0062] Preferred embodiments of the invention will now be described with reference to the accompanying figures and non-limiting examples.
[0063] In a first preferred embodiment of the present invention, there may be provided an oral composition for use in therapeutic treatment which may be one selected the group of: anxiety, stress, sleep, anti-seizure, nausea, glaucoma, irritable bowel, Crohn’s disease, ulcerative colitis neuroprotection, pain relief, cancer symptom or cancer treatment side effect relief, palliative care, autoimmune diseases, inflammatory conditions, Obstructive sleep apnea syndrome (OSAS), weight loss, smoking cessation, Alzheimer’s, Parkinson's disease, schizophrenia, diabetes, multiple sclerosis, long covid and related conditions anorexia or cachexia syndrome, bladder dysfunction, Huntington's disease.
[0064] The oral composition may comprise a capsule containing a phytopharmaceutical and/or a pharmaceutical. The capsule may be translucent or transparent such that a person can see the enteric coating colour of the phytopharmaceutical and/or the pharmaceutical contained within the capsule. The first phytopharmaceutical may be a cannabis extract or a turmeric extract or a mixture of cannabis extract and turmeric extract. The phytopharmaceutical may be encapsulated by a first colloidal carrier or unilamellar liposomes. The colloidal carrier may improve the uptake or absorption of the phytopharmaceutical through the cells of the targeted section of the human body.
[0065] The colloidal carrier may be a neutral or a positively charged liposomal base. The positively charged liposomal base offer the advantage of great liposomal stability during storage, as charged particles repel each and reduce aggregation tendencies. Further advantage for positively charged liposomal base is that the cell internalisation is promoted by their electrostatic interaction of cell membranes, which are negatively charged.
[0066] The second pharmaceutical may be encapsulated by a second colloidal carrier, in which the second colloidal carrier may be the same or similar to the first colloidal carrier. The second colloidal carrier may also be unilamellar liposomes also for the purpose of improving the uptake or absorption of the pharmaceutical through the cells of the targeted section of the human body. As the colloidal carriers can be easily absorbed upon contact with the cell, it may be advantageous to provide an enteric coating to the colloidal carriers so that the colloidal carrier coated pharmaceuticals will not be released upon ingestion or the acidic stomach area. The first colloidal carrier coated first phytopharmaceutical may be encapsulated by a first enteric coating, and the second colloidal carrier coated second pharmaceutical may be encapsulated by a second enteric coating. The enteric coating may be one selected from the group of: poly(methyl methacrylate) copolymer, cellulose acetate phthalate, cellulose acetate trimellitate, cellulose acetate succinate, hydroxypropylmethylcellulose acetate succinate, hydroxypropyl methylcellulose phthalate, polyvinyl acetate phthalate. Preferably, the enteric coating may be Eudragit®-coated liposomal and microsphere formulation for favourable pH-dependent release characteristics.
[0067] The enteric coatings may differ such the first enteric coating has a different disintegration rate compared to the second enteric coating at a pH range between 6 to 7.4. Having different disintegration rates for different pharmaceuticals at the targeted drug delivery section of the human body is important such that the cells of the same location is not oversaturated or overconcentrated with the pharmaceuticals, which may be not be optimal for cellular uptake. By having a different disintegration rate or different release characteristics, the drug is released and localised at a different area of the targeted section.
[0068] The phytopharmaceutical may be cannabidiol or a cannabis extract; and the pharmaceutical may be one selected from the group of: melatonin, ibuprofen, ibuprofen, amitriptyline, magnesium, adaptogenic herbs, curcumin, turmeric, S-Adenosyl methionine, 5-hydroxytryptophan, collagen, bioidentical hormones, thyroid, promethazine, nicotine, prochlorperazine, green coffee extract, Ivermectin, benzodiazepines, herbal extracts, Valerian, zopiclone, nonsteroidal anti-inflammatory drugs, hydroxychloroquine, doxylamine succinate, codeine, cannabidiol, ginger, antioxidants, liothyronine, levothyroxine, orlistat, glucomannan, glucosamine, chondroitin, Vitamin D, Vitamin C, Vitamin E, Vitamin B, pyridoxal 5’-phosphate, Zinc, multivitamins, minerals, and bupropion.
[0069] It may be preferable to have the first enteric coated phytopharmaceutical having a faster disintegration rate than the second enteric coated pharmaceutical so that the targeted section can absorb and therapeutically benefit from the phytopharmaceutical earlier. Alternatively, depending on the medical needs of the person, it may also be preferable to have the pharmaceutical released earlier than the phytopharmaceutical so that the person can absorb and therapeutically benefit from the pharmaceutical earlier. This may be the case when they have different sites of action or preferential absorption areas of the GI tract. For example, the person may have a deficiency in a specific vitamin (say Vitamin B12) or the need for requiring specific treatment by taking a particular pharmaceutical from the list mentioned previously.
[0070] The capsule may be translucent or transparent to allow a person to see the phytopharmaceutical or the pharmaceuticals have the different colour coating of the pellets. This may also aid in the placebo effect giving a higher response rate. Preferably, the colouring of the coating is of safe, non-toxic natural dyes for example, chlorophyll. Alternatively, in another preferred embodiment, the capsule may not be see through (to protect the ingredients from light) but is adequately labelled to inform the person what the capsule contains and which of the phytopharmaceutical or the pharmaceutical will be released first relative to each other. The capsule containing at least a phytopharmaceutical and a pharmaceutical having different colour enteric coatings may be able to allow the pharmacist to be able to adjust the dosage for the phytopharmaceutical and the pharmaceutical contained in one capsule depending on the prescription and regime that the healthcare professional may have recommended.
[0071] It may be preferable to have the capsule having an external coating, in which the external coating may be a mucoadhesive polymer. The mucoadhesive polymer may be one selected from the group of: chitosan, polyvinyl alcohol, poly(acrylic acid), polyethylene glycol, and tocopherol polyethylene glycol succinate. The mucoadhesive polymer may add further protection from the degradation in the acidic environment and give a controlled release action.
[0072] It may be preferable to have one or more of the active ingredients encapsulated in a coated capsule within the main capsule which also has active ingredients, thus giving separate active ingredients different release characteristics.
[0073] The capsule within a capsule may be as shown in Figure 1 with a liquid in the external capsule or the external capsule may contain a semisolid, powder, granules or pellets. The internal capsule may contain a liquid, semisolid, powder, granules or pellets. [0074] It may be preferable to have one or more of the active ingredients as an enteric coated “mini tablet” in which one or more of these can be inserted into a capsule, as shown in Figure 2, which may also have active ingredients, thus giving separate active ingredients different release characteristics.
[0075] For the oral composition, each capsule may be stored in a pocket of a blister pack. The blister pack may contain a third pharmaceutical for a person’s convenience of having the medications in one packet when a person is taking a known combination of pharmaceuticals. Preferably, each pocket containing a pharmaceutical is sealed by a foil, wherein the foil has ingredient and dosage information corresponding to the pharmaceutical that is contained. This further informs the person what they will be taking prior to opening the foil. For improved safety in reducing the exposure of the oral composition from young children, the blister packs containing the oral composition may be stored in a child resistant carton and a plastic tray. For accessing the product, the tray with two protrusions should be pulled out like a drawer after pressing the push points diagonally across each side of the carton with one hand, wherein the push points are diagonally relatively far apart, while the other hand is to pull the plastic tray away from the carton. Another packaging option could be using a pharmaceutical grade bottle with a child resistant cap,
[0076] In another preferred embodiment of the present invention, the phytopharmaceutical ingredients and the pharmaceutical ingredients may be in the same dose form; in another preferred embodiment of the present invention, the phytopharmaceutical and the pharmaceutical may be separate dose forms; in another preferred embodiment of the present invention, the phytopharmaceutical and the pharmaceutical may be combined into one dose form; and in another preferred embodiment of the present invention, the phytopharmaceutical and the pharmaceutical may be combined in one dose form and there may be either a separate dose form containing another phytopharmaceutical and a pharmaceutical combination or a phytopharmaceutical separately or a pharmaceutical separately in a separate dose form. Preferably, there may be one or two or three or more separate dose forms in the one box or packet.
[0077] It may be appreciated that the composition may be co-administered or included into a food product to improve patient acceptability, ingestion and/or absorption. The oral composition that may be included in the food products may be in the form of novel foods such as soothers, pills, lollies, lolly pops, chocolate, protein bars, or chocolate coated soother. Food products, in particular fatty foods, may be able to increase the absorption of cannabidiol as food is known to affect drug absorption by delaying gastric emptying time, altering gastrointestinal pH, stimulating bile flow or the physical interaction of drugs. Furthermore, different foods, based on factors such as nutritional composition may have distinct influences on the transit time, luminal dissolution, permeability and bioavailability of the pharmaceuticals contained in the composition.
An advantage of increasing the amount of cannabidiol dose being absorbed into the body can also lead to lower medication costs and/or having less of the cannabidiol component in the composition which may obtain the same effect as a higher dosage of cannabidiol but at a lower bioavailability.
[0078] In another preferred embodiment of the present invention, there may be an aerosol or a metered dose composition for use in topical or oral delivery of medicine, the aerosol or metered dose spray composition comprising: a phytopharmaceutical and a pharmaceutical mixture solubilized in a colloidal carrier in liquid; and wherein the colloidal carrier may be encapsulated by a mucoadhesive polymer. The colloidal carrier may be unilamellar liposomes and the phyto-phospholipid complexation technique may be used for improving the pharmacokinetic profile of the active ingredient from the plant extract. Preferably, the making of phospholipid complex phytopharmaceuticals with Cannabis extracts and turmeric extracts may be used. It may be appreciated that other plant extracts may also be used to cater to the therapeutic use of the particular product.
[0079] The average particle size of the liposomes may be in the range of: 5 nm to 100 nm with a polydispersity index of less than 0.3, and wherein the mucoadhesive polymer may be one selected from the group of: chitosan, polyvinyl alcohol, poly(acrylic acid), polyethylene glycol, and tocopherol polyethylene glycol succinate. The advantage of having a mucoadhesive polymer is so that once ingested, whether through the nose or the mouth, the mucoadhesive polymer readily attaches to the mucus or the cell membranes. Once adhered, the positively charged colloidal carrier or liposomal base encapsulating the phytopharmaceutical and/or pharmaceutical mixture may then be absorbed. The phytopharmaceutical and/or pharmaceutical may then provide the therapeutic benefit to the person.
[0080] The mucoadhesive polymer may be one selected from the group of: chitosan, polyvinyl alcohol, poly(acrylic acid), polyethylene glycol, and tocopherol polyethylene glycol succinate; and the aerosol composition may further comprise a non-ionic surfactant component and a phospholipid component; wherein the non-ionic surfactant component may be at least one chosen from the group of: tyloxapol, polysorbates, D-a- tocopheryl polyethylene glycol succinate, and polyethylene glycol (15)-hydroxystearate; and wherein the phospholipid component may be at least one chosen from the group of: a zwitterionic phospholipid, a saturated phospholipid, a hydrogenated phospholipid. The non-ionic surfactant component has a content between 0.01 to 5 wt% ; and wherein the phospholipid component has a content between 0.5 to 5 wt%. The non-ionic surfactant component may advantageously provide a stabilising effect in the pharmaceutical emulsion.
[0081] In another preferred embodiment of the present invention, an example application using a method for treatment of acute injury using the oral composition, wherein the person may require a pharmaceutical such as ibuprofen, depending on the advice of a healthcare professional regarding the dosage and duration, the method may comprise the steps of: a) taking 400 mg of ibuprofen three times a day for a duration range between 3 to 7 days, and 50 mg cannabidiol one time daily at night for a duration range between 3 to 7 days; b) taking 200 mg of ibuprofen three times a day for a duration range between 3 to 7 days, and 50mg cannabidiol two times a day for a duration range between 3 to 7 days; c) taking 200 mg of ibuprofen two times a day for a duration range between 3 to 7 days, and 50mg cannabidiol three times a day. for a duration range between 3 to 7 days; [0082] It may be appreciated that the above method is providing an example only of the application and estimated dosage and duration. It may be appreciated that the dosage may be greater and for a longer duration than specified if the therapeutic condition is severe and may be required for the symptomatic relief. Similarly, it may also be appreciated that the dosage may be smaller and for a shorter duration than specified if the therapeutic condition is less severe or moderate as may be required for the symptomatic relief.
[0083] Some simple formula examples are described in the following tables:
[0084] Example 1 , CBD 50 mg Ibuprofen 200 mg phytopharmaceutical capsules
Figure imgf000019_0001
Figure imgf000020_0001
[0085] Example 2, CBD 50 mg Ibuprofen 200 mg phytopharmaceutical capsule in Capsule formula (Small Capsule)
Figure imgf000020_0002
[0086] Continuing from Example 2, a large capsule may comprise the following:
Figure imgf000021_0001
[0087] Example 3, CBD 50 mg Ibuprofen 200 mg phytopharmaceutical Oral mucosal in metered dose pack
Figure imgf000021_0002
Figure imgf000022_0001
[0088] Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms, in keeping with the broad principles and the spirit of the invention described herein.
[0089] The present invention and the described preferred embodiments specifically include at least one feature that is industrial applicable.

Claims

l lll CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:
1. An oral composition for use in medical treatment, the oral composition comprising: a capsule containing a first phytopharmaceutical and a second pharmaceutical; the first phytopharmaceutical encapsulated by a first colloidal carrier, wherein the first colloidal carrier is encapsulated by a first enteric coating; the second pharmaceutical encapsulated by a second colloidal carrier, wherein the second colloidal carrier is encapsulated by a second enteric coating; wherein the first enteric coating has a different disintegration rate compared to the second enteric coating at a pH range between 6 to 7.4.
2. The oral composition according to claim 1, wherein the first enteric coating is coloured with a first pigment, and wherein the second enteric coating is coloured with a second pigment.
3. The oral composition according to claim 2, wherein the first pigment is a different colour to the second pigment.
4. The oral composition according to any one of claims 1 to 3, wherein the first enteric coating and the second enteric coating are one selected from the group of: poly(methyl methacrylate) copolymer, cellulose acetate phthalate, cellulose acetate trimellitate, cellulose acetate succinate, hydroxypropylmethylcellulose acetate succinate, hydroxypropyl methylcellulose phthalate, polyvinyl acetate phthalate.
5. The oral composition according to any one of claims 1 to 4, wherein the capsule has an external coating.
6. The oral composition according to claim 5, wherein the external coating is a mucoadhesive polymer.
7. The oral composition according to any one of claims 1 to 6, wherein a predetermined therapeutic dosage of the oral composition is each stored in a pocket in a blister pack.
8. The blister pack according to claim 7, wherein the pocket further contains a third pharmaceutical.
9. The blister pack according to any one of claims 7 to 8, wherein each pocket is sealed by a foil, wherein the foil has ingredient and dosage information.
10. An aerosol or a metered dose composition for use in topical or oral delivery of medicine, the aerosol or metered dose composition comprising: a phytopharmaceutical and a pharmaceutical mixture solubilized in a colloidal carrier in liquid; and wherein the colloidal carrier is encapsulated by a mucoadhesive polymer.
11. The aerosol or metered dose composition according to claim 10, wherein the colloidal carrier is unilamellar liposomes.
12. The aerosol or metered dose composition according to claim 11, wherein the average particle size of the liposomes is in the range of: 5 nm to 50 nm with a polydispersity index of less than 0.3.
13. The aerosol or metered dose composition according to any one of claims 10 to 12, wherein the mucoadhesive polymer is one selected from the group of: chitosan, polyvinyl alcohol, poly(acrylic acid), polyethylene glycol, and tocopherol polyethylene glycol succinate.
14. The aerosol or metered dose composition according to any one of claims 10 to 13, further comprising a non-ionic surfactant component and a phospholipid component; wherein the non-ionic surfactant component is at least one chosen from the group of: tyloxapol, polysorbates, D-a-tocopheryl polyethylene glycol succinate, and polyethylene glycol (15)-hydroxystearate; or any other suitable surfactant or suspending agent and wherein the phospholipid component is at least one chosen from the group of: a zwitterionic phospholipid, a saturated phospholipid, a hydrogenated phospholipid. Ideally derived from natural food sources.
15. The aerosol or metered dose composition according to claim 14, wherein the non ionic surfactant component has a content between 0.01 to 5 wt%; and wherein the phospholipid component has a content between 0.5 to 5 wt% and the suspending agent has a content between 0.5 to 8 wt%.
16. The composition according to any one of claims 1 to 15, wherein the colloidal carrier is a neutral or a positively charged liposomal base.
17. The composition according to any one of claims 1 to 16, wherein the phytopharmaceutical is cannabidiol or a mixture of cannabinoid and or terpenes or a turmeric extract or any of the plant based phytochemicals with medicinal properties, such as adaptogenic herbs, essential oils, curcumin, turmeric, collagen, green coffee extract, herbal extracts, Valerian, ginger, magnesium, antioxidants, glucomannan, glucosamine, chondroitin, and wherein the pharmaceutical may be one or more selected from but not limited to the group of: melatonin, ibuprofen, ibuprofen, amitriptyline, Ivermectin, bioidentical hormones, thyroid extract, promethazine, nicotine, prochlorperazine, benzodiazepines, hydroxychloroquine, zopiclone, nonsteroidal anti-inflammatory drugs, doxylamine succinate, codeine, cannabidiol, liothyronine, levothyroxine, orlistat, bupropion S-Adenosyl methionine, 5-hydroxytryptophan, Vitamin D, Vitamin C, Vitamin E, Vitamin B, pyridoxal 5 ’-phosphate, Zinc, multivitamins and minerals.
18. The composition according to any one of claims 1 to 17, wherein the therapeutic treatment is one selected from the group of: anxiety, stress, sleep, anti-seizure, nausea, glaucoma, irritable bowel, Crohn’s disease, ulcerativecolitis neuroprotection, pain relief, cancer symptom or cancer treatment side effect relief, palliative care, autoimmune diseases, inflammatory conditions, Obstructive sleep apnea syndrome (OS AS), weight loss, smoking cessation, Alzheimer’s, Parkinson's disease, schizophrenia, diabetes, multiple sclerosis, Long covid and related conditions anorexia or cachexia syndrome, bladder dysfunction, and Huntington's disease.
19. A method for treatment of acute injury using the oral composition according to claim 8, wherein the third pharmaceutical is ibuprofen, the method comprising the steps of: a) taking 400 mg of ibuprofen three times a day for a duration range between 3 to 7 days, and 50 mg cannabidiol one time daily at night for a duration range between 3 to 7 days; b) taking 200 mg of ibuprofen three times a day for a duration range between 3 to 7 days, and 50 mg cannabidiol two times a day for a duration range between 3 to 7 days; c) taking 200 mg of ibuprofen two times a day for a duration range between 3 to 7 days, and 50 mg cannabidiol three times daily for a duration range between 3 to 7 days.
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