AU2020100994A4 - Pain Relieving Medication - Google Patents

Pain Relieving Medication Download PDF

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Publication number
AU2020100994A4
AU2020100994A4 AU2020100994A AU2020100994A AU2020100994A4 AU 2020100994 A4 AU2020100994 A4 AU 2020100994A4 AU 2020100994 A AU2020100994 A AU 2020100994A AU 2020100994 A AU2020100994 A AU 2020100994A AU 2020100994 A4 AU2020100994 A4 AU 2020100994A4
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Australia
Prior art keywords
pain
acetaminophen
formulation
cannabidiol
vitamin
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AU2020100994A
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Benjamin Jansen
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Cda Health Pty Ltd
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Cda Health Pty Ltd
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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • 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
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5146—Organic macromolecular compounds; Dendrimers obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyamines, polyanhydrides
    • 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
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5161—Polysaccharides, e.g. alginate, chitosan, cellulose derivatives; Cyclodextrin
    • 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
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Optics & Photonics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Nanotechnology (AREA)
  • Physics & Mathematics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Rheumatology (AREA)
  • Inorganic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

A pharmaceutical formulation for the treatment of pain, the formulation comprising cannabidiol, acetaminophen and Vitamin E. The preferred form is tablet, capsule or liquid. It is also preferred that the formulation comprises a tertiary analgesic.

Description

I PAIN RELIEVING MEDICATION TECHNICAL FIELD
[0001] The present invention is generally directed to pain relieving medications and methods of their use.
BACKGROUND
[0002] Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Pain is the most common reason for patient consultation with a doctor and a symptom in many medical conditions. Pain can interfere with a person's general functioning and quality of life.
[0003] Pain signals are sent through multiple signalling pathways. Pain signals are modulated both peripherally and centrally inside the body. Pain signalling pathways are not entirely understood.
[0004] Different pain-relieving medications can act on different signalling pathways. It is common for increasingly high doses of those medications to be used for increasingly high levels of pain. However, high doses of any one medication can result in adverse side effects. For example, opioid drugs are used to treat intense pain, but their long-term use in high doses leads to addiction, toxicity and organ failure. Use of acetylsalicylic acid is high doses can result in excessive bleeding and lack of clotting. Use of non-steroidal-anti-inflammatory drugs in high doses results in organ toxicity and bleeding. High doses of acetaminophen results in liver failure and death in a short period of time.
[0005] The object of the present invention is to provide a medication for pain which is not addictive, has minimal side effects and is effective.
SUMMARY OF THE INVENTION
[0006] According to the present invention, there is provided a pharmaceutical formulation for the treatment of pain, the formulation comprising a cannabidiol, acetaminophen and Vitamin E. The inventor has found through experimentation that Vitamin E makes a substantial contribution to the absorption of the cannabinoid by the body.
[0007] The formulation may be delivered orally by dry tablet, capsule, or liquid.
[0008] Preferably, the capsule and liquid forms comprise a lipophilic base or bases (e.g., alcohols, ethanol, propylene glycol, polyethylene glycol, oils, lipids, triglycerides, fatty acids, fatty acid esters, glycerol).
[0009] The formulation preferably comprises pain killers such as acetylsalicylic acid, ibuprofen or codeine.
[0010] Preferably, the pharmaceutical formulation has pH which is close to neutral and more preferably in the range of 5 to 8.
[0011] In another aspect of the present invention, there is provided a method for treating pain, comprising administering a formulation of cannabinoid and acetaminophen into a patient. The combination has the advantage of patient compliance and clinical effect. It also enables the medication to comprise a lower dosage of any one of its integers.
[0012] Any of the features described herein can be combined in any combination with any one or more of the other features described herein within the scope of the invention.
DETAILED DESCRIPTION
[0013] Whilst treating patients for various conditions, the inventor discovered that patients treated with cannabinoids and acetaminophen at the same time provided significant pain relief, which was not obtained from the use of any one of the integers independently. The first patient was a 46-year-old female patient with fibromyalgia. She was initially treated with acetaminophen but only experienced mild pain relief. She was also treated separately with cannabidiol, but once again, only received mild pain relief. However, when she was simultaneously treated with a combination both cannabidiol and acetaminophen, she experienced significant pain relief. The combination of cannabidiol and acetaminophen had a synergistic effect which dramatically improved the results.
[0014] Different medications interact with different pain signalling pathways. Some medications have a particular effect on a particular pathway. However, it has been observed that the treatment of multiple pathways simultaneously has an additive effect, which could not be delivered by any one medication independently. More particularly, it appears that acetaminophen modulates the endocannabinoid receptor signalling system, which increases the pain relief gained by the cannabidiol.
[0015] Accordingly, further experiments were conducted with the following patients:
[0016] In a 36-year-old male patient with severe neuropathic pain resulting from an
-Y
ischaemic brain injury we found the addition of cannabidiol, vitamin E, delta-9 tetrahydrocannabinol, and acetaminophen was an ideal mixture to resolve the patient's symptoms. Combining therapy at one time was found to provide the greatest benefit.
[0017] In a 77-year-old male patient with peripheral neuropathic pain due to ischaemic injury we used a combination of cannabidiol, vitamin E, acetylsalicylic acid and acetaminophen to achieve symptom relief.
[0018] In a 57-year-old male patient with chronic spinal pain due to degenerative spinal disease we used a combination of cannabidiol, ibuprofen, acetylsalicylic acid and acetaminophen to achieve significant pain relief.
[0019] In a 33-year-old female patient with chronic lumbar radiculopathy pain due to degenerative disc disease we used a combination of cannabidiol, tramadol (a synthetic opioid), and acetaminophen to achieve pain relief. The combination of these ingredients enabled a reduced dose of the opioid to be used, thereby reducing its addictive effects and its direct toxicity on organs.
[0020] Furthermore, the inventor found it surprising that patients remarked that their pain relief was more pronounced and effective when the formulation included Vitamin E. The inventor therefore concluded that Vitamin E makes a substantial contribution to the absorption of the cannabinoid by the body.
[0021] The medication made by the inventor comprised:
a cannabinoid or combination of cannabinoids;
acetaminophen;
Vitamin E; and
a lipophilic base (e.g., alcohols, ethanol, propylene glycol, polyethylene glycol, oils, lipids, triglycerides, fatty acids, fatty acid esters, glycerol); and
wherein the formulation has a pH of from about 5 to about 8.
[0022] The capsule form of the medication comprised:
from 25mg to 50mg of a cannabidiol;
250mg to 500mg acetaminophen;
formulated by dissolving in propylene glycol;
500 International Units (IU) of Vitamin E (alpha tocopherol); and
injected in soft gelatine capsule by an encapsulation machine.
[0023] The tablet form of the medication comprised:
from 25mg to 50mg of a cannabidiol in crystalline powder form; and
250mg to 500mg acetaminophen in powder form;
formulated by mixing with 36mg maize starch and 25mg sodium starch glycollate;
pressed into tablets by a tableting machine; and
coated with hydroxypropylmethyl cellulose 7mg, titanium dioxide 0.2mg, and polyethylene glycol 6000 0.8mg.
[0024] The ratio of 1:10 of cannabidiol to acetaminophen can be altered for effects in stability, cannabinoid solubility and administration to children, other special populations or animals.
[0025] The invention can also be used for other administration routes, e.g. rectal, buccal, transdermal and injectable routes.
[0026] Any of the features described herein can be combined in any combination with any one or more of the other features described herein within the scope of the invention.
Concluding Remarks
[0027] In the present specification and claims (if any), the word 'comprising' and its derivatives including 'comprises' and 'comprise' include each of the stated integers but does not exclude the inclusion of one or more further integers.
[0028] Reference throughout this specification to 'one embodiment' or 'an embodiment' means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearance of the phrases 'in one embodiment' or 'in an embodiment' in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more combinations.
[0029] In compliance with the statute, the invention has been described in language more or less specific to structural or methodical features. It is to be understood that the invention is not limited to specific features shown or described since the means herein described comprises preferred forms of putting the invention into effect. The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims (if any) appropriately interpreted by those skilled in the art.

Claims (5)

1. A pharmaceutical formulation for the treatment of pain, the formulation comprising a cannabidiol, acetaminophen and Vitamin E.
2. The pharmaceutical formulation of claim 1, wherein the Vitamin E is alpha tocopherol.
3. The pharmaceutical formulation of claim 1, wherein pharmaceutical formulation also comprises ibuprofen.
4. The pharmaceutical formulation of any one of the preceding claims, wherein pharmaceutical formulation also comprises an opioid.
5. A method for treating pain, the method comprising administering a formulation of cannabinoid, acetaminophen and Vitamin E simultaneously into a patient.
AU2020100994A 2019-07-11 2020-06-11 Pain Relieving Medication Active AU2020100994A4 (en)

Applications Claiming Priority (2)

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AU2019902462A AU2019902462A0 (en) 2019-07-11 Pain Relieving Medication
AU2019902462 2019-07-11

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023279137A1 (en) * 2021-07-07 2023-01-12 Breathe Life Sciences Pty Ltd A composition and application thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023279137A1 (en) * 2021-07-07 2023-01-12 Breathe Life Sciences Pty Ltd A composition and application thereof

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