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WO2010057295A1 - Composition homéopathique comprenant un extrait d'hypericum perforatum et des huiles essentielles pour le traitement des douleurs neuropathiques - Google Patents

Composition homéopathique comprenant un extrait d'hypericum perforatum et des huiles essentielles pour le traitement des douleurs neuropathiques Download PDF

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Publication number
WO2010057295A1
WO2010057295A1 PCT/CA2009/001630 CA2009001630W WO2010057295A1 WO 2010057295 A1 WO2010057295 A1 WO 2010057295A1 CA 2009001630 W CA2009001630 W CA 2009001630W WO 2010057295 A1 WO2010057295 A1 WO 2010057295A1
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neuropathic pain
homeopathic
pain due
composition
base
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WO2010057295A9 (fr
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Alexander Mclellan
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Origin Biomedicinals Inc
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Origin Biomedicinals Inc
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Priority to US13/130,024 priority Critical patent/US20120128787A1/en
Priority to CA2743967A priority patent/CA2743967A1/fr
Publication of WO2010057295A1 publication Critical patent/WO2010057295A1/fr
Publication of WO2010057295A9 publication Critical patent/WO2010057295A9/fr
Anticipated expiration legal-status Critical
Priority to US14/850,054 priority patent/US20150374773A1/en
Priority to US15/480,995 priority patent/US20180055903A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/714—Aconitum (monkshood)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/42—Phosphorus; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/02—Algae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/062—Ascomycota
    • A61K36/066—Clavicipitaceae
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/11—Pteridophyta or Filicophyta (ferns)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/22—Anacardiaceae (Sumac family), e.g. smoketree, sumac or poison oak
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/38—Clusiaceae, Hypericaceae or Guttiferae (Hypericum or Mangosteen family), e.g. common St. Johnswort
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K41/00—Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
    • A61K41/0004—Homeopathy; Vitalisation; Resonance; Dynamisation, e.g. esoteric applications; Oxygenation of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K9/12—Aerosols; Foams
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin

Definitions

  • the present invention pertains to the field of homeopathic compositions and methods of use thereof to treat neuropathic pain. More particularly, the present invention pertains to the field of homeopathic compositions comprising a base for improved penetration of the homeopathic agent through the skin.
  • Neuropathic pain is pain caused by various types of nerve damage, including but not limited to diabetic peripheral neuropathy, herpes zoster, post herpetic neuralgia, trigeminal neuralgia, complex regional pain syndrome, reflex sympathetic dystrophy, phantom limb syndrome, neuropathic pain due to chronic disease (multiple sclerosis, HIV, etc), neuropathic pain due to trauma (causalgia), neuropathic pain due to impingement (i.e., sciatica, carpal tunnel, etc.), neuropathic pain due to drug exposure or toxic chemical exposure, neuropathic pain due to infection or post infection, neuropathic pain due to impaired organ function, neuropathic pain due to vascular disease, neuropathic pain due to metabolic disease, neuropathic pain due to cancer or cancer treatment, neuropathic pain due to autoimmune disease, neuropathic pain due to fibromylagia, and neuropathic pain with no know cause (idiopathic) as well as treating any pain is that is
  • This type of pain is typically associated with one or more of the characteristics below: - Allodynia: pain due to a stimulus that normally does not cause pain, for example as the light touch from air passing over skin,
  • Hyperpathia A painful syndrome characterized by increased reaction to a stimulus, especially a repetitive stimulus, as well an increased threshold.
  • Hyperalgesia An increased response to a stimulus that is normally painful.
  • Anesthesia Delorosa Pain in an area or region that is anesthetic (absence of all sensations).
  • nociceptive pain and neuropathic pain are caused by different mechanisms, and therefore respond to different treatment modalities.
  • Nociceptive pain is mediated by receptors which are located in skin, bone, connective tissue, muscle and viscera. These receptors typically respond to noxious chemical, thermal and mechanical stimuli producing pain that is typically described as sharp, aching, throbbing, or gnawing.
  • neuropathic pain is produced by damage to, or pathological changes in, the peripheral or central nervous systems, typically producing pain that is described as "burning", “electric”, 'tingling", and “shooting” in nature.
  • nociceptive pain usually responds to opioids and non-steroidal antiinflammatories (NSAIDS), whereas success treating neuropathic pain with these approaches has been limited.
  • agents employed to treat neuropathic pain such as gabapentin, have little or no effect on nociceptive pain.
  • Antiarrhythmics Certain antiarrhythmics have sodium-blocking activity. Low-dose IV lidocaine is sometimes used for temporary pain relief from peripheral nervous system injuries, including diabetic neuropathy and postherpetic neuralgia. However, IV lidocaine therapy requires constant monitoring of the patient's ECG and blood pressure to decrease the risk for seizures and arrhythmias.(l)
  • Antidepressants Both tricyclic antidepressants and serotonin reuptake inhibitors are have been used to treat neuropathic pain. Numerous clinical trials demonstrate the safety and efficacy of TCAs when used to treat either diabetic neuropathy or postherpetic neuralgia, yet response rates have been low at approximately 33%. Amitriptyline was the first tricyclic used to treat neuropathy, and it is still widely prescribed. Amitriptyline has a high incidence of anticholinergic side effects, including delirium in elderly patients. TCAs also have proarrhythmic effects which limit their use in populations with abnormal EKG.
  • Serotonin specific reuptake inhibitors have demonstrated less consistent effects on neuropathic pain, relieving neuropathic pain in only one of seven patients. Serotonin noradrenaline reuptake inhibitors have fared slightly better with a response rate of one in every 4-5 neuropathic pain sufferers.
  • Anticonvulsants Carbamazepine, phenytoin, gabapentin and lamotrigine have all been used to treat neuropathic pain. Inhibition of sodium channel blocking activity by agents such as carbamazepine, phenytoin, and lamotrigine is the proposed mechanism. Studies have shown the anticonvulsant gabapentin to be effective in painful diabetic neuropathy, mixed neuropathies, and postherpetic neuralgia. The most common adverse effects of anticonvulsants in general are sedation and cerebellar symptoms (nystagmus, tremor and incoordination). The most common side effects associated with gabapentin are asthenia, headache, dizziness and somnolence, and in some cases polyneuropathy. Lamotrigine was no better than placebo when used to treat neuropathic pain other than trigeminal neuralgia, (3)
  • NSAIDS are not generally recommended first-line agents for treating neuropathic pain. Relief of neuropathic pain with nonsteroidal anti-inflammatory drugs (NSAIDs) is variable. (4)
  • NSAIDs nonsteroidal anti-inflammatory drugs
  • Opioids Treatment of neuropathic pain has with opioids has been controversial. Opioids were thought to be ineffective for treating neuropathic pain, but may be somewhat effective for patients who have failed other modalities. Short-term studies provide only equivocal evidence regarding the efficacy of opioids in reducing the intensity of neuropathic pain, while intermediate- term studies demonstrate significant efficacy of opioids over placebo. Reported adverse events of opioids are common and long-term efficacy, safety (including addiction potential), and effects on quality of life need to be further evaluated. Overall, neuropathic pain may be less responsive to opioids than other types of pain. (5)
  • Topical agents offer the advantage of local relief without systemic toxicity.
  • a new and novel non-toxic topical preparation to treat neuropathic pain is therefore of great interest and has the potential to benefit a wide range of chronic pain sufferers.
  • such product would also not interfere or interact with oral prescription pain medications.
  • Homeopathy is widely accepted as a useful therapeutic throughout Europe, the British Commonwealth countries and India, and has been demonstrated to have characteristic and reproducible effects.
  • a critical review of more than 100 controlled and/or clinical studies of homeopathy determined that patients received positive healing benefits from homeopathy beyond the placebo effect (Kleijnen, J. et al. 1991 Brit. Med. J. 302:316-323; Linde, K., Clausius, N., Ramirez, G., Melchart, D., Eitel, F., Hedges, L. V., Jonas, W. B., 1997, Lancet, 350:834-843; Reilly, D., et al, 1994, Lancet, 344:1601 -1608).
  • One of the basic tenets of homeopathic medicine is that a cure for a disease can be evoked by using a high dilution medicine that resembles but is different from the cause of the disease.
  • a base preparation is made, either by an extract or maceration of an herbal compound or the dissolving of a selected compound in a solvent, a series of dilutions are prepared from the initial batch, called the "mother tincture".
  • Homeopathic drugs are diluted according to either the decimal "X” or centesimal "C” scales.
  • the mother tincture is diluted with nine parts of the desired diluent, in either liquid or powder form.
  • the resultant mixture is then diluted a second time, in a ratio of one part mixture to ten parts solvent and the resulting mixture is diluted a third time in a ration of one to ten. Therefore, the 3X drug is actually at 10 "3 potency of the mother tincture.
  • United States Patent 7,229,648 entitled “Homeopathic formulations useful for treating pain and/or inflammation” teaches the use of homeopathic active drug ingredients for the treatment of pain.
  • the homeopathic ingredients chosen and claimed focus on the treatment of nociceptive pain rather than neuropathic pain conditions.
  • Current medical science recognizes a clear distinction between nociceptive and neuropathic pain.
  • Dreyer teaches the use of water based homeopathics only, which are not suited for topical delivery of the active drug to the nerves that are the source of the pain signals.
  • Application #20030161867 Lu teaches the use of essential oil components such as terpenes, terpenoids, fatty alcohols and derivatives thereof as skin permeation enhancers for the delivery of a selective COX-2 inhibitory drug to a site of pain and/or inflammation, by application to an overlying or adjacent position to the site of pain/ and or inflammation.
  • United States Patent #6,132,760 describes a topical transdermal patch for the delivery of testosterone containing terpenes as a delivery enhancing adjuvant.
  • McClung teaches the use of a topical composition for the relief of pain containing a variety of compounds, including an analgesic, an antioxidant, an anti-neuralgic, an anti-inflammatory, an antidepressant and a blood circulation enhancer.
  • the active analgesic is chosen from a laundry list of substances not prepared in traditional homeopathic method but crude herbal forms.
  • McClung does not reference treatment of neuropathic pain, and includes no mention of that condition or specific manifestations of neuropathy.
  • Zupan teaches the use of eucalyptol for its effect on enhancing the skin permeation of cosmetic and therapeutic agents.
  • Tusik teaches the use of menthol for the enhancement of transdermal drug delivery across mammalian skin.
  • Zupan teaches enhancement of the delivery of non-steroidal anti-inflammatory agents selected from the group consisting of indomethacin, naproxen, fenoprofen, ibuprofen, sulindac and desoxysulindac.
  • Tusik teaches enhancement of the delivery of the drugs propranolol, conjugated estrogens, etodalac, and 17 ⁇ -estradiol.
  • United States Patent #6,638,981 describes an oil-in-water emulsion comprising an antidepressant, an NMDA-receptor antagonists, a lipophilic component, water; and a surfactant, which is applied topically to the skin for the treatment of neuropathic pain.
  • United States Patent #5,976,547 teaches the use of a combination of an herbal extract (arnica tnontana) with menthol crystal, camphor, oil of mint, eucalyptus oil, guaifenesin, non- steroidal anti-inflammatory medications, topical analgesics, or transdermal opioid analgesics.
  • United States Patent #5,260,313 presents a method of diagnosing and treating neuropathic pain syndromes with a composition of the essential oil extract of pelarooniiim graveolens Air.
  • An object of the present invention is to provide a homeopathic composition and method for the treatment of neuropathic pain.
  • a method for the treatment of neuropathic pain comprising topical administration of a composition comprising one or more homeopathic active ingredients combined with a base of one or more physiologically acceptable ingredients that enhances penetration of the homeopathic drug through the skin.
  • composition comprising one or more homeopathic active ingredients combined with a base of one or more physiologically acceptable ingredients that enhances penetration of the homeopathic drug through the skin.
  • the current invention differs from known compositions and methods in a number of ways. Specifically, the use of homeopathic medication in a pharmaceutical product containing essential oils has been previously untested, in part, since traditional homeopathic practitioners consider essential oils to be contraindicated for concurrent use with homeopathic medications. Further, traditional homeopathics are prepared in an alcohol/water base which is not soluble in essential oil mixtures and not useful for effective topical administration of the homeopathic agents. Finally, the present inventors have now surprisingly found the use of homeopathic medications in combination with essential oils is effective for the treatment of neuropathic pain.
  • Figure 1 graphically depicts the effect of the topical application on pain reduction following the procedure of Example 1 .
  • Figure 2 graphically depicts the effect of a composition according to one embodiment of the invention (A) in comparison to a placebo (B).
  • the present invention provides a solution to a number of unique and previously unsolved problems.
  • Current pharmaceutical treatments are often ineffective or result in unacceptable side effects at the doses necessary for symptom relief.
  • the only approved over-the-counter drug, capsaicin results in increased pain and burning at the site of application and is therefore not widely tolerated.
  • homeopathic medicine utilizes a unique materia medica based on compounds found in the natural world.
  • Homeopathic medications are prepared, by one skilled in the art, using the traditional techniques of dilution and succession, to various potencies.
  • traditional textbooks of homeopathic medicine make no mention of "neuropathic pain” per se, homeopathic remedies can be chosen based on the unique symptoms of the neuropathic pain condition.
  • Traditional homeopathic remedies are prepared in an alcohol and water base and administered orally.
  • the current invention is unique in that, for the purpose of relieving neuropathic pain, the formula which is the subject of the invention is applied topically to the area of pain and contains skin permeation enhancers.
  • the current invention utilizes traditionally prepared homeopathic medicines, but in a hydrophobic base comprising essential oils as skin permeation enhancers.
  • a hydrophobic base comprising essential oils as skin permeation enhancers.
  • the final dilution of the homeopathic medicines takes place in an alcohol environment (80-100% alcohol by volume).
  • the exclusion of water enables the resultant homeopathic formulation to be soluble in an essential oil mixture or any individual essential oil compounds.
  • This type of fo ⁇ nulation is unique since those skilled in the art of homeopathy consider essential oils to be contraindicated for use combined with, or even concurrently with, homeopathics.
  • essential oil refers to a concentrated, hydrophobic liquid containing volatile aroma plant compounds isolated from a plant or derived synthetically.
  • the essential oil comprises a variety of hydrophobic constituents (e.g., various terpenes, alcohol esters, aldehydes, ketones, phenols etc., typically soluble in water less than 10 wt %).
  • essential oils are prepared by steam distillation, maceration, expression, and/or solvent extraction of plant materials, for example leaves and/or petals. Synthetic oil blends can also be utilized. Individual synthetic compounds, or natural compounds purified to homogeneity (e.g., synthetic or isolated terpenes, terpenoids, alcohol esters, ketones, phenols etc.) may also be utilized in the composition of the present invention. Similarly, one or more essential oils may be supplemented with one or more of the volatile compounds commonly found in plants or prepared synthetically.
  • the essential oil is from pelargonium, melaleuca (tea tree), bergamot , eucalyptus, lavender or a combination thereof.
  • Suitable essential oils are prepared from plant material of one or more plant species using isolation methods well know to those skilled in the art, or prepared synthetically by one skilled in the art.
  • Essential oils are highly complex mixtures of often hundreds of individual compounds. A typical plant essential oil chromatogram may contain in the order of 200 or more distinct peaks. Plant essential oils are a complex mixture of terpenes, sesquiterpenes, esters, alcohols, phenols, aldehydes, ketones, organic acids, and various miscellaneous molecular structures. Furthermore, each class of compound above contains many subclasses. For example, the terpene classification includes hem ⁇ terpenes, monoterpenes, diterpenes, sesquiterpenes, triterpenes, tetraterpenes, and associated terpenoids formed by the modification or oxidation of the carbon skeleton. Essential oils often have an odour and are therefore used in food flavouring and perfumery. Essential oils are typically distinguished as a group by their minimal solubility Sn water, and this criteria makes them suitable for use in this invention.
  • essential oils that would be suitable for use in this invention are; Agar (Aquilaria malaccensis), Ajwain (Carum copficum), Angelica root oil (Angelica archangelica), Anise (Pimpinella anisum), Asafoetida, Balsam (Myroxylon pereirae), Basil Bergamot, Black Pepper (Piper nigrum), Buchu, Cannabis, Caraway, Cardamom, Carrot seed, Cedarwood, Chamomile, Calamus, Cinnamon, Cistus species, Citronella, Clary Sage, Coffee, Coriander, Costmary, Costus, Cranberry, Cubeb, Cumin, Cypress, Cypriol, Curry Leaf, (Artemisia pollens), Dill, Elecampane, Eucalyptus, F ⁇ ennell, Fenugreek, Fir, Frankincense, Galbanum, Geranium (and/or Pelargonium), Ginger, Goldenrod, Grapefruit, Henna, Helich
  • the essential oils include pelargonium oil, bergamot oil, eucalyptus oil, lavender oil, and/or melaleuca oil.
  • Homeopathics are prepared in the manner practiced by one skilled in the art according to the Homeopathic Pharmacopoeia of the United States (HPUS), Good Manufacturing Practice (GMP), and applicable Over the Counter (OTC) regulations.
  • Homeopathics chosen can be any of those based on traditional rubrics (symptom lists) from traditional textbooks of homeopathic medicine by one skilled in the art.
  • Examples of homeopathics traditionally used to treat the symptoms of neuropathic pain include Hypericum perforatum, Acoratum napellus, Secale cornutum, Rhus toxicodendron, Lycopodium, Phosphorus, Sulphur, Pulsatilla, Arsenicum, Nux vomica, Thuja occidentalis, Causticum, Kali carbonicum, Sepia, Silica, Conium maculatum, Apis Mel ⁇ fica, Belladonna, Agaricus, Platina, Calcarea Phosphorica, Chininum, Coccus cacti,
  • Rhododendron chrysanthum OR Rhodium metallicum, Graphites, Colocynthis, Mercurius, Stannum metallicum, Phosphoricum acidum, Lachesis, Capsicum, Staphylococcinum, Natrum mur, Colchicinum, Bryonia, Ferrumphos, Allium cepa, Agrentum metallicum, Baryta-carb, Zincum, Chamomilla, Mezereum, Ranunculus bulbases, Ammonium muriaticum, Euphrasia, Sabad ⁇ la officinalis, Asafoetida, Secale comutum, Carbo-veg,
  • the potency of the homeopathic ingredients may vary from mother tincture (undiluted) to IM, however the preferred embodiment recommends a homeopathic OTC potency of 3X to 3OC, with 12C ideal.
  • the homeopathic ingredients may be added to the essential oils in an amount varying from 0.1 % by volume to 50% by volume, with 1 % to 10% by volume preferred.
  • the composition described herein can be delivered to the skin overlying the area of aberrant nerve function or neuropathic pain in a number of ways.
  • the composition can be applied topically directly to the area using the finger or other instrument of application.
  • the composition can also be delivered via a container suitable for topical applications to the skin, such as a container with the ability to spray, roll or otherwise apply the composition to the skin.
  • the composition can also be added to a suitable material containing a reservoir and adhesive for application to the skin.
  • the composition consists only of an essential oil or mixture of essential oils as a base and one or more homeopathic active agents.
  • the composition additionally comprises a pharmaceutically acceptable diluent or excipient suitable for use in a topical composition. Selection of such additional diluents or excipients is within the abilities of a person of ordinary skill in the field and is made based on the intended use of the product. The additional diluents or excipients do not affect the therapeutic efficacy of the composition.
  • the composition is or can be incorporated into a device containing a reservoir for the sustained release of medication to be absorbed topically through the skin.
  • the medication within the reservoir migrates over time from within the reservoir to the site of action.
  • the reservoir is supported by a backing structure and is attached to the skin via a suitable adhesive.
  • the composition and adhesive are comingled in the reservoir. Treatment involves placing the device on the skin for a prescribed duration.
  • the composition is prepared using a suitable gelling agent.
  • a suitable gelling agent for example, a combination of bees wax and sorbitan monopalmitate can be used as a gelling agent. Selection of a suitable gelling agent is made to ensure proper consistency and absorption without negatively affecting therapeutic activity or being an irritant.
  • compositions of the present invention are useful in treating neuropathic pain.
  • Neuropathic pain can be caused by a disorder selected from, but not limited to, diabetic peripheral neuropathy, herpes zoster, post herpetic neuralgia, trigeminal neuralgia, complex regional pain syndrome, reflex sympathetic dystrophy, phantom limb syndrome, neuropathic pain due to chronic disease (multiple sclerosis, HIV, etc), neuropathic pain due to trauma (causalgia), neuropathic pain due to impingement (ie.
  • neuropathic pain due to drug exposure or toxic chemical exposure neuropathic pain due to infection or post infection
  • neuropathic pain due to impaired organ function neuropathic pain due to vascular disease
  • neuropathic pain due to metabolic disease neuropathic pain due to cancer or cancer treatment
  • neuropathic pain due to autoimmune disease neuropathic pain due to fibre mylagia
  • neuropathic pain with no known cause idiopathic
  • any pain is that is characterized by burning sensations, shooting pain, numbness, tingling, allodynia or a combination thereof
  • the treatment group received external application of a composition containing the homeopathic ingredient hypericum perforatum combined with an essential oil mixture of lavender, pelargonium, bergamot, eucalyptus and tea tree oil. Before each application pain level was monitored on a 0-10 visual scale.
  • Pain level associated with the feet was self-monitored on a 0 — 10 scale (10 being most severe) three times every session. Participants recorded their pain level immediately upon arrival (PRE), five minutes following composition application in the treatment group (or five minutes of quiet sitting in no treatment group) (5MIN), and immediately following one hour of exercise (POST).
  • the pain relieving composition was applied with a spray top applicator for a total of five pumps per foot, with one pump over (1) the dorsal aspect of the toes, (2) the dorsal foot roughly half way between the toes and the ankle, (3) the inside of the foot midway along the longitudinal arch, (4) the outside of the foot midway between the toes and ankle, and (5) the plantar surface of the foot half way between the heel and toes. Total volume of composition applied was approximately 0.75 ml to each foot.
  • a composition containing the homeopathic ingredient Hypericum perforatum combined with an essential oil mixture of lavender, pelargonium, bergamot, eucalyptus and tea tree was tested in a double blind placebo controlled fashion. Sixty subjects with plantar cutaneous (foot sole) pain due to all cause neuropathy were recruited from the community. Each subject was assessed for inclusion/exclusion based on standard criteria for neuropathic pain studies. Subjects found suitable were given the opportunity to participate once they signed a consent form. Each subject was also be provided with an adverse events report form, and instructed in its use.
  • the pain relieving composition was applied with a spray top applicator for a total of five pumps per foot, with one pump over (1 ) the dorsal aspect of the toes, (2) the dorsal foot roughly halfway between the toes and the ankle, (3) the inside of the foot midway along the longitudinal arch, (4) the outside of the foot midway between the toes and ankle, and (5) the plantar surface of the foot halfway between the heel and toes.
  • Total volume of composition applied was approximately 0.75 ml to each foot,
  • homeopathic ingredients equal parts Hypericum perforatum, Aconitum napellus, Secale cornutum, Rhus toxicodendron, Lycopodium, and Phosphorus all at 12C potency
  • Her right foot was treated with a thin film of the same 1% homeopathic ingredients (Hypericum perforatum, Aconitum napellus, Secale cornutum, Rhus toxicodendron, Lycopodium, and Phosphorus all at 12C potency) prepared in a base consisting of an essential oil mixture of 28.29% v/v lavender, 28.29% v/v pelargonium graveolens, 14.14% v/v citrus hergamia, 14, 14% v/v eucalyptus globulus and 14.14 % v/v Melaleuca alternifolia. After 5 minutes of quiet sitting she reported a pain level of 6/10 in the left foot and 2/10 in the right foot. After one hour she reported that her left foot was still painful and she asked to use the essential oil formula on the left foot. She proceeded to do so and received the same degree of pain relief as experienced in the right foot.
  • homeopathic ingredients Hypericum perforatum, Aconitum napellus,
  • Table 1 provides a list of the components within the essential oil blend used as the base in this Example.
  • ⁇ -terpinene neiyl form ate trans-linalool oxide (for.) lavandulyl ac etate terpinolene geranyl formate cis-linalool oxide (fur.) citronellyl acetate linaiool ⁇ eryl acetate cis-rose oxide ⁇ -copae ⁇ e phenyiethyl alcohol ⁇ -bourb onene trans-rose oxide geranyl acetate dihydrolinalool longifolen ⁇ camphor ⁇ -caryophyllene raenthone decyl acetate isoborneol trans ⁇ jxbergarnote ⁇ e isomenthone ⁇ -guaiene borneol 6,9-guaiadiene lavandulol muurola-3,5-diene terpin-1 -en-4-ol citronellyl propionate isomenthol ⁇ -humulene ⁇ -terpineo
  • R.M. a 58 year old male with post shingles pain (post herpetic neuralgia) of the left lateral trunk region of 6 months duration. He reported almost constant pain, with pricking and burning sensations, worse from touch. He was taking 20mg Lipitor per day for cholesterol management and no other medications.
  • homeopathic ingredients unequal parts Hypericum perforatum, Aconitum napellus, Secale cornutum, Rhus toxicodendron, Lycopodium, and Phosphorus all at 12C potency
  • a non-medicinal cream base consisting of water, glycerin, distearyldirnonium chloride, petrolatum, isopropyl palmitate, cetyl alcohol

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Abstract

La présente invention porte sur un procédé consistant à traiter les douleurs neuropathiques par administration d'une composition homéopathique topique à un sujet mammifère. La formulation homéopathique contient des ingrédients homéopathiques actifs comprenant Hypericum perforatum dans une base d'huiles essentielles qui facilite l'administration de l'ingrédient homéopathique à travers la peau.
PCT/CA2009/001630 2008-11-18 2009-11-18 Composition homéopathique comprenant un extrait d'hypericum perforatum et des huiles essentielles pour le traitement des douleurs neuropathiques Ceased WO2010057295A1 (fr)

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US13/130,024 US20120128787A1 (en) 2008-11-18 2009-11-18 Homeopathic Composition Comprising Hypericum Perforatum Extract And Essential Oils For The Treatment Of Neuropathic Pain
CA2743967A CA2743967A1 (fr) 2008-11-18 2009-11-18 Composition homeopathique comprenant un extrait d'hypericum perforatum et des huiles essentielles pour le traitement des douleurs neuropathiques
US14/850,054 US20150374773A1 (en) 2008-11-18 2015-09-10 Homeopathic Composition Comprising Hypericum Perforatum Extract And Essential Oils For The Treatment Of Neuropathic Pain
US15/480,995 US20180055903A1 (en) 2008-11-18 2017-04-06 Homeopathic composition comprising hypericum perforatum extract and essential oils for the treatment of neuropathic pain

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US20120171316A1 (en) * 2012-03-14 2012-07-05 Forces Of Nature, Inc. Method for manufacturing homeopathic mixtures
CN102579611A (zh) * 2012-03-15 2012-07-18 张志华 一种治疗坐骨神经痛的中药草乌散
US20120183624A1 (en) * 2012-03-23 2012-07-19 Forces Of Nature, Inc. Method for manufacturing homeopathic personal care products
WO2012175379A1 (fr) 2011-06-23 2012-12-27 Jean-Pierre Mageren Compositions homeopathiques pour le traitement des douleurs du dos, des sciatiques et lombaires
CN103304518A (zh) * 2013-06-14 2013-09-18 中国科学院昆明植物研究所 倍半萜类化合物及其药物组合物与其在制药中的应用
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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9415023B2 (en) 2008-08-13 2016-08-16 Neuroquest Inc. Compositions comprising terpene compounds for treating negative sensory phenomena
WO2012034232A1 (fr) * 2010-09-14 2012-03-22 Neuroquest Inc. Analogues des terpénoïdes et leurs utilisations pour le traitement de troubles neurologiques
CN103153297A (zh) * 2010-09-14 2013-06-12 安元有限公司 类萜类似物及其用于治疗神经病症的用途
JP2013538218A (ja) * 2010-09-14 2013-10-10 ニューロクエスト インク 神経疾患を治療するためのテルペノイド類似体およびその使用
WO2012175379A1 (fr) 2011-06-23 2012-12-27 Jean-Pierre Mageren Compositions homeopathiques pour le traitement des douleurs du dos, des sciatiques et lombaires
US20120171316A1 (en) * 2012-03-14 2012-07-05 Forces Of Nature, Inc. Method for manufacturing homeopathic mixtures
CN102579611A (zh) * 2012-03-15 2012-07-18 张志华 一种治疗坐骨神经痛的中药草乌散
US20120183624A1 (en) * 2012-03-23 2012-07-19 Forces Of Nature, Inc. Method for manufacturing homeopathic personal care products
CN103304518A (zh) * 2013-06-14 2013-09-18 中国科学院昆明植物研究所 倍半萜类化合物及其药物组合物与其在制药中的应用
CN103304518B (zh) * 2013-06-14 2014-12-31 中国科学院昆明植物研究所 倍半萜类化合物及其药物组合物与其在制药中的应用

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CA2743967A1 (fr) 2010-05-27

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