Classifications

• • 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
  • A61K33/24—Heavy metals; Compounds thereof
  • A61K33/242—Gold; Compounds thereof
• • 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
  • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
  • A61P25/34—Tobacco-abuse
• • 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)
• • 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)
  • A61K36/34—Campanulaceae (Bellflower family)
• • 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)
  • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
• • 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)
  • A61K36/56—Loganiaceae (Logania family), e.g. trumpetflower or pinkroot
• • 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)
  • A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
• • 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
  • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Definitions

• TITLE FORMULATION FOR THE TREATMENT OF SYMPTOMS RELATED TO WITHDRAWAL
• the invention relates to the field of drugs used for the treatment of symptoms associated with smoking cessation and / or withdrawal from psychotropic drugs, and in drugs used to support people wishing to stop, or reduce, smoking and / or psychotropic drugs.
• the invention relates to a homeopathic medicine comprising a mixture obtained from 6 homeopathic strains.
• Tobacco consumption and the abuse of psychotropic substances are one of the preventable causes of serious pathologies such as cancer, cardiovascular accidents, respiratory disorders, cerebrovascular accidents and overdoses.
• pathologies such as cancer, cardiovascular accidents, respiratory disorders, cerebrovascular accidents and overdoses.
• smoking, for example is declining only very moderately.
• the consumption of tobacco and certain psychotropic substances causes a strong dependence, and this from the first intakes.
• the strong addiction caused by the consumption of these products makes it difficult to stop using it. For example, for tobacco users, and despite a declared desire to stop consumption, or even a desire to at least reduce this consumption, it is not uncommon for the dependent person not to succeed in reducing or stopping this consumption, or resumes consumption after a more or less extended period of withdrawal.
• the consumption of nicotine substitutes for example via dermal patches diffusing these derivatives through the epidermis, or by chewing chewing gum;
• Buproprion especially sold as a medicine under the trade name Zyban®;
• the mechanism of action to decrease or even eliminate the effects of smoking cessation consists of the use of nicotine molecules or nicotine analogues.
• Nicotine is a substance found in cigarettes and is involved in smoking addiction.
• nicotinic acetylcholine receptors are activated when they bind nicotine; for example, when a smoker consumes a cigarette.
• Activation of these receptors results in the release of dopamine, a hormone that provides a feeling of satisfaction.
• the brain associates tobacco consumption with immediate satisfaction.
• mood disorders including depression or sadness, anxiety, nervousness, irritability, frustration, anger, impatience, restlessness, mood swings, insomnia, difficulty concentrating, increased appetite often accompanied by significant weight gain.
• the aim of the invention is therefore to respond, at least partially, to the shortcomings of the state of the art.
• the invention aims in particular to provide a formulation reducing at least some of the symptoms that appear when a person is weaned from tobacco. Another object of the invention is to provide a formulation which reduces the intensity of at least some of the symptoms appearing with smoking cessation. Another aim of the invention is to provide a formulation which makes it possible to reduce the duration of at least part of the symptoms caused by stopping smoking.
• the invention is defined by the independent claims.
• the dependent claims define preferred embodiments of the invention.
• the invention relates to a homeopathic medicinal formulation prepared from 6 homeopathic strains.
• the homeopathic composition according to this first aspect of the invention comprises, in equal masses:
• a mother tincture of tobacco optionally diluted up to a factor of 60C;
• a mother tincture of Nux vomica optionally diluted up to a factor of 60C;
• a mother tincture of Aurum metallicum optionally diluted up to a factor
• a mother tincture of Passiflora incarnata optionally diluted up to a factor
• the homeopathic composition is formulated from 6 homeopathic strains which are diluted and added in equal masses in order to produce the composition. To this end, each of the strains can be diluted according to the following indications:
• the mother tincture of tabacum is diluted by a factor of 5D; and or
• the mother tincture of Nux Vomica is diluted by a factor of 9D; and or
• the mother tincture of Aurum metallicum is diluted by a factor of 9D; and or
• the mother tincture of Passiflora incarnata is diluted by a factor of 5D; and or
• the mother tincture of Agnus castus is diluted by a factor of 5D; and or
• the mother tincture of Lobelia inflata is diluted by a factor of 6D.
• the present formulation and in particular the formulation in homeopathic dilution, can be used to treat at least one symptom associated with smoking cessation.
• the inventor has discovered that the present formulation, especially in very diluted form, for example in the form of a homeopathic medicine, decreases symptoms associated with smoking cessation or psychotropic drugs and can help in stopping smoking.
• the invention relates to a homeopathic composition for its use in the treatment of at least one symptom associated with smoking cessation and / or withdrawal from psychotropic drugs.
• the invention also relates to a homeopathic composition for an accompanying treatment of a person in a situation of smoking cessation and / or withdrawal from psychotropic drugs.
• the invention relates to a process for the preparation of a homeopathic medicinal composition.
• the method comprises the following steps:
• a homeopathic medicine is defined according to Directive 2001/83 / EC; a homeopathic medicinal product thus relates to any medicinal product obtained from products, substances or compositions called homeopathic strains according to a manufacturing process described by the European Pharmacopoeia, or failing this, by the French Pharmacopoeia.
• compositions, formulation, medicinal composition, medicinal formulation may refer to a drug.
• the compositions, formulations and medicaments according to the invention can be presented in a variety of different dosage forms, such as but not limited to a granule, a globule, an oral solution such as a syrup, an injectable solution, a suppository, a eye drops, a powder to be consumed orally or for skin application, a cream, an ointment, a tablet, a cachet, a capsule, a capsule, a chewing gum, a pill, a lozenge, an oral emulsion.
• the preparations can also be administered by means of a medical device, such as a transdermal system such as a patch or patch, an inhalation device such as a powder inhaler or a pressurized inhaler or nebulizer.
• Homeopathic strains can be of plant, animal, or chemical, mineral or organic origin.
• Homeopathic medicines are obtained by the so-called method of successive deconcentrations of homeopathic strains or homeopathic mother tinctures.
• This deconcentration is carried out by successive operations of division of the strain or mother tincture in a vehicle (dilution or trituration) at 1/100 (centesimal; 1 part of strain or mother tincture and 99 parts of vehicle, commonly referred to as “C” or “CH”, the term CH referring to “Hahnemannian centesimal”) or to 1/10 (decimals; 1 part of strain or mother tincture and 9 parts of vehicle, commonly designated “D”, “DH” or “X”, the term DH corresponding to “Hahnemannian decimal”), and by successive dynamization operations (dilution followed by a succussion).
• the number of operations thus carried out defines the height of dilution (or the degree of dilution).
• D3 or 3DH or 3X
• C3 or 3CH or 3C
• dilution used in the present description may thus also be understood to mean that dynamization is carried out, or that the dilution is carried out by trituration.
• part refers to parts by mass.
• the invention relates to a formulation, composition or homeopathic medicine comprising 6 homeopathic mother tinctures, optionally diluted.
• a formulation, composition or homeopathic medicine comprising, in equal mass:
• a mother tincture of tobacco optionally diluted up to a factor of 60C;
• a mother tincture of Nux vomica optionally diluted up to a factor of 60C;
• a mother tincture of Aurum metallicum optionally diluted up to a factor of
• a mother tincture of Passiflora incarnata optionally diluted up to a factor of 60C;
• a mother tincture of Agnus castus optionally diluted up to a factor of 60C;
• a mother tincture of Lobelia inflata optionally diluted up to a factor of 60C.
• a mother tincture is made from a strain.
• a mother tincture can be prepared by methods known to those skilled in the art.
• the final extraction ratio (ratio) of the mother tincture is 1: 10, i.e. 10 grams of the mother tincture are prepared from 1 gram of the drug which serves as the strain (for example a plant powder dries up when the strain is a plant).
• a method of making any mother tincture may include the following steps: maceration followed by an expression step.
• Maceration can include a step of mixing the raw materials in a maceration vessel.
• the raw materials are usually purified water, ethanol, such as 96% ethanol, and the split drug, which is the strain from which the mother tincture will be derived.
• Each of the raw materials is weighed according to the mother tincture manufacturing protocol.
• Mother tincture manufacturing protocols can be found in the reference books of the European or French Pharmacopoeia.
• the French Pharmacopoeia for example, contains a homeopathic section, which indicates the characteristics of the mother tinctures (weight of dry residues, chromatography).
• the container can be closed and the mixture can macerate for a period of between 10 days and 8 weeks. During this period, the mixture can be stirred regularly, but usually at least 3 times during the maceration period.
• an expression step is implemented.
• a canvas can be placed on a plate of a press, and the macerated preparation can be poured onto this canvas.
• the preparation is then pressed, preferably in stages, until the end of the flow of the macerated preparation through the canvas.
• the liquid thus collected is the expressed liquid, and can be left to stand for a period of 48 hours.
• a formulation according to the invention thus corresponds to the mixture of 6 different homeopathic strains, of which the height of dilution of each of the strains is between the initial dilution of the strain within the mother tincture up to a maximum dilution corresponding to 60 CH , preferably 30 CH, and more preferably 60 DH.
• Each strain can be incorporated within the formulation of equivalent mass of the other strains.
• the formulation can comprise 1 mass or the same mass, which can be arbitrarily determined, of each of the 6 homeopathic strains, diluted or not.
• the first homeopathic strain present in a formulation according to the invention is the homeopathic strain tabacum, also called Nicotiana tabacum.
• the drug tabacum consists of fresh leaves of Nicotiana tabacum, harvested at the end of flowering.
• the mother tincture tabacum (or the strain of tabacum) complies with the TABACUM monograph for homeopathic preparations of the French pharmacopoeia, Xth edition (January 1989 - January 1992). It is prepared at 1/10 at an ethanol content of 45% V / V from freshly harvested Nicotiana tabacum leaves.
• the formulation according to the invention can thus comprise 1 mass of the homeopathic strain tabacum, of an undeconcentrated mother tincture at a dilution, or deconcentration, of a maximum equivalent to 60 CH.
• 1 mass of the tabacum strain is present at a dilution height of between 0 (i.e. mother tincture) at a dilution height of at most 60 DH.
• 1 mass of the tabacum strain is present within the formulation at a dilution height of between 0 (i.e. the mother tincture) at a dilution height of at most 10 DH.
• 1 mass of the tabacum strain is present within the formulation at a dilution level of 5 DH.
• the height of dilution relates to the number of dilutions of the tabacum strain (i.e. the mother tincture).
• the Hahnemannian method can be used with ethanol as deconcentration vehicle, preferably at 30% V / V.
• ethanol can for example be obtained by mixing purified water with 96% ethanol corresponding respectively to the monographs purified water (No. 0008) and 96 percent ethanol (No. 1317) of the European Pharmacopoeia.
• tabacum in the formulation allows it to exert a physiological action on headaches, dizziness, paleness of the face, cold sweats, obscured sensitivity with awareness of anxiety, nausea and vomiting.
• the second homeopathic strain present in the formulation according to the invention is the homeopathic strain Nux vomica.
• the drug Nux vomica is prepared by macerating the dried seed of Strychnos Nux vomica.
• the homeopathic strain Nux vomica can consist of the mother tincture of Nux vomica corresponding to the NUX VOMICA monograph for homeopathic preparations of the French Pharmacopoeia Xth edition (2002). It is prepared at 1/10 with an ethanol content of 65% V / V, from the dried seed of Strychnos Nux vomica, in accordance with the NUX VOMICA monograph for homeopathic preparations of the French Pharmacopoeia Xth edition (January 1989 - January 1992 ).
• the formulation according to the invention can thus comprise 1 mass of the homeopathic strain Nux vomica, of an undeconcentrated mother tincture at a dilution, or deconcentration, of a maximum equivalent to 60 CH.
• 1 mass of the Nux vomica strain is present at a dilution height of between 0 (i.e. mother tincture) at a dilution height of at most DH 60.
• 1 mass of the Nux vomica strain is present within the formulation at a dilution height of between 0 (i.e. the mother tincture) at a dilution height of at most 10 DH.
• 1 mass of the Nux vomica strain is present within the formulation at a dilution level of 9 DH.
• the height of dilution refers to the number of dilutions of the Nux vomica strain (i.e. the mother tincture).
• the Hahnemannian method can be used with 60% V / V ethanol as the deconcentration vehicle for the 1 st dilution, and 50% V / V ethanol for the deconcentration vehicle. the second dilution, and 30% V / V ethanol for all subsequent dilutions.
• Such an ethanol can for example be obtained by mixing purified water with 96% ethanol corresponding respectively to the monographs purified water (n ° 0008) and 96% ethanol (n ° 1317) of the European Pharmacopoeia 4th edition .
• Nux vomica in the formulation allows it to exert a physiological action on the cerebrospinal system and on the gastrohepato-intestinal system, causing a general hyper reflectivity, that is to say motor, psychic, visceral sensory. , in association with hyperesthesia to pain.
• the third homeopathic strain present in the formulation according to the invention is the homeopathic strain Aurum metallicum.
• the Aurum metallicum strain responds to the AURUM METALLICUM monograph for homeopathic preparations of the French Pharmacopoeia, Xth edition (January 1993).
• the strain is gold (Au).
• the strain contains a minimum of 98% gold, and a maximum of the equivalent of 101% gold.
• the formulation according to the invention can thus comprise 1 mass of the homeopathic strain Aurum metallicum, of an undeconcentrated mother tincture at a dilution, or deconcentration, of at most equivalent to 60 CH.
• 1 mass of the Aurum metallicum strain is present at a dilution height of between 0 (ie mother tincture) to maximum dilution height of 60 DH.
• 1 mass of the Aurum metallicum strain is present within the formulation at a dilution height of between 0 (ie the mother tincture) at a dilution height of at most 10 DH.
• 1 mass of the Aurum metallicum strain is present within the formulation at a dilution level of 9 DH.
• the height of dilution relates to the number of dilutions of the Aurum metallicum strain (ie the mother tincture).
• the vehicle is lactose when the deconcentrations are intended for oral powders.
• the deconcentrations of the Aurum metallicum strain are as follows:
• Centesimal deconcentrations dissolution of the third 3C centesimal trituration, in equal volumes of water and 60% V / V alcohol, added successively; the following deconcentrations are carried out using 30% V / V ethanol, prepared from purified water and 96% V / V ethanol.
• Lactose, purified water and 96% ethanol meet the specifications of the monographs lactose monohydrate, purified water and 96% ethanol of the European Pharmacopoeia Nie Edition, respectively.
• Aurum metallicum within the formulation allows it to exert a physiological action on depression, cardiovascular erethism, for example with cephalic congestion, hypertensive tendency and cardiomegaly.
• the fourth homeopathic strain present in the formulation according to the invention is the homeopathic strain Passiflora incarnata.
• the homeopathic strain Passiflora incarnata is made up of the mother tincture of Passiflora incarnata responding to the monograph Passiflora incarnata for homeopathic preparations of the French Pharmacopoeia Xth edition (1989). It is prepared at 1/10 with an ethanol content of 65% V / V, from the aerial part of Passiflora incarnata.
• the formulation according to the invention can thus comprise 1 mass of the homeopathic strain Passiflora incarnata, of an undeconcentrated mother tincture at a dilution, or deconcentration, of at most equivalent to 60 CH.
• 1 mass of the Passiflora incarnata strain is present at a dilution height of between 0 (ie mother tincture) at a dilution height of at most 60 DH.
• 1 mass of the Passiflora incarnata strain is present within the formulation at a dilution level of between 0 (ie the mother tincture) at a dilution level of at most 10 DH.
• 1 mass of the Passiflora incarnata strain is present at within the formulation at a dilution height of 5 DH.
• the height of dilution refers to the number of dilutions of the Passiflora incarnata strain (ie the mother tincture).
• the Hahnemannian method can be used with as deconcentration vehicle 60% V / V ethanol for the 1st dilution, 50% V / V ethanol for the second dilution, and 30% V / V ethanol for all subsequent dilutions.
• Such an ethanol can for example be obtained by mixing purified water with 96% ethanol corresponding respectively to the monographs purified water (n ° 0008) and 96% ethanol (n ° 1317) of the European Pharmacopoeia 4th edition .
• Passiflora incarnata in the formulation according to the invention enables it to exert a physiological action on the cerebrospinal nervous system and to treat problems of insomnia.
• the fifth homeopathic strain present in the formulation according to the invention is the homeopathic strain Agnus castus.
• the homeopathic strain Agnus castus consists of the mother tincture of Agnus castus responding to the monograph Agnus castus for homeopathic preparations (1998) of the French Pharmacopoeia Xth edition. It is prepared at 1/10 with an ethanol content of 65% V / V, from the dried fruit of Vitex angus-castus.
• the formulation according to the invention can thus comprise 1 mass of the homeopathic strain Agnus castus, of an undeconcentrated mother tincture at a dilution, or deconcentration, of a maximum equivalent to 60 CH.
• 1 mass of the Agnus castus strain is present at a dilution height of between 0 (i.e. mother tincture) at a maximum dilution height of 60 DH.
• 1 mass of the Agnus castus strain is present in the formulation at a dilution level of between 0 (i.e. the mother tincture) at a dilution level of at most 10 DH.
• 1 mass of the Agnus castus strain is present within the formulation at a dilution level of 5 DH.
• the height of dilution relates to the number of dilutions of the Agnus castus strain (i.e. the mother tincture).
• the Hahnemannian method can be used with as deconcentration vehicle 60% V / V ethanol for the 1st dilution, 50% V / V ethanol for the second dilution, and 30% V / V ethanol for all subsequent dilutions.
• Such an ethanol can for example be obtained by mixing purified water with 96% ethanol corresponding respectively to the monographs purified water (no. 0008) and 96 percent ethanol (no. 1317) of the European Pharmacopoeia 4th edition. .
• the presence of the Agnus castus strain within the formulation enables it to exert a physiological action on sexual neurasthenia, nervous headaches, and the prevention of tachycardias.
• the sixth homeopathic strain present in the formulation according to the invention is the homeopathic strain Lobelia inflata.
• the homeopathic strain Lobelia inflata responds as to its method of manufacture and its specifications to the monograph lobelia swollen for homeopathic preparations of the French Pharmacopoeia. It can also be made, using a maceration method, at 1/10 at an ethanol content of 65% V / V from the freshly flowered aerial part of Lobelia inflata, according to method 4c of the European Pharmacopoeia (no. 2371). It contains a minimum of 0.01% m / m and a maximum of 0.05% m / m of total alkaloids expressed as lobeline (C22H27N02; Mr 337.5) (adjusted content).
• the formulation according to the invention can thus comprise 1 mass of the homeopathic strain Lobelia inflata, of an undeconcentrated mother tincture at a dilution, or deconcentration, of a maximum equivalent to 60 CH.
• 1 mass of Lobelia inflata is present at a dilution height of between 0 (i.e. mother tincture) at a maximum dilution height of 60 DH.
• 1 mass of the Lobelia inflata strain is present within the formulation at a dilution height of between 0 (i.e. the mother tincture) at a dilution height of at most 10 DH.
• 1 mass of the Lobelia inflata strain is present within the formulation at a dilution level of 6 DH.
• the height of dilution refers to the number of dilutions of the Lobelia inflata strain (i.e. the mother tincture).
• the Hahnemannian method can be used with ethanol as deconcentration vehicle, preferably at 30% V / V.
• ethanol can for example be obtained by mixing purified water with 96% ethanol corresponding respectively to the monographs purified water (No. 0008) and 96 percent ethanol (No. 1317) of the European Pharmacopoeia.
• the presence of the Lobelia inflata strain in the formulation allows it to exert a physiological action on the symptoms of smoking cessation, in particular by reducing violent nausea and asthmatic dyspnea with vagotonic syndrome.
• the homeopathic formulation comprises, for equal mass:
• a mother tincture of tobacco optionally diluted up to a factor of 60D;
• a mother tincture of Nux vomica optionally diluted up to a factor of 60D;
• a mother tincture of Aurum metallicum optionally diluted up to a factor
• a mother tincture of Passiflora incarnata optionally diluted up to a factor 60D;
• the homeopathic formulation comprises, for equal mass:
• a mother tincture of tobacco optionally diluted up to a factor of 10D;
• a mother tincture of Nux vomica optionally diluted up to a factor of 10D;
• a mother tincture of Aurum metallicum optionally diluted up to a factor
• a mother tincture of Passiflora incarnata optionally diluted up to a factor
• the homeopathic formulation comprises, for equal mass:
• the homeopathic formulation comprises, for equal mass:
• compositions, formulations and medicaments according to the invention can be defined as pharmaceutical compositions, pharmaceutical formulations or medicaments, able to be administered to a person or a patient, such as a human being.
• these compositions, formulations or medicaments are sterile, and do not include any compound capable of causing an undesirable response within the subject to which the invention is administered.
• a composition according to the invention can thus also comprise pharmaceutical excipients, such as water and / or sodium chloride, diluents, adjuvants, and / or pharmaceutical salts.
• the formulation according to the invention is particularly suitable for the treatment of symptoms associated with smoking cessation and / or withdrawal from psychotropic drugs.
• the formulation according to the invention is particularly suitable for the accompanying treatment of people stopping their consumption of tobacco and / or psychotropic drugs.
• the formulation according to the invention is particularly suitable for an accompanying treatment for smoking cessation therapy, in addition to another treatment such as another drug treatment or consumption of nicotine derivatives.
• the invention also relates to a process for the preparation of a homeopathic medicinal composition. This process comprises the following steps:
• the dilution of at least one of the 6 mother tinctures can be carried out up to a factor of 60D, the dilution of each mother tincture being carried out individually.
• each mother tincture is diluted up to a factor of 60C maximum, more preferably up to a factor of 60D.
• the mother tincture of tabacum is diluted by a factor of 5D; the mother tincture of Nux vomica is diluted by a factor of 9D; the mother tincture of Aurum metallicum is diluted by a factor of 9D; the mother tincture of Passiflora incarnata is diluted by a factor of 5D; the mother tincture of Agnus castus is diluted by a factor of 5D; and the mother tincture of Lobelia inflata is diluted by a factor of 6D.
• the method further comprises a step of final dilution of the formulation with a sodium chloride solution, in order to ultimately obtain a 0.9% isotonic solution.
• a step of sterilizing the formulation can be implemented.
• the composition according to the invention is in a form acceptable for injection, more particularly in a form acceptable for transdermal or subcutaneous injection.
• the composition can thus be administered, for example by means of a syringe to a patient.
• the composition is administered only once to a patient.
• This single administration can comprise the taking, in particular by oral route, or the injection, of a sample of the composition or of a plurality of samples of the composition, in particular according to the supposed dependence of the patient on nicotine or on psychotropic drug whose treatment seeks to eliminate or reduce the effects during withdrawal.
• the composition in another embodiment, in particular when the patients maintain a troublesome dependence during the treatment or when the dependence is considered to be important, the composition can be administered several times, over a period of time which may vary depending on different clinical elements, such as the suspected dependence of the patient, the effects of withdrawal, and the urge to use tobacco or a psychotropic drug again.
• the assumed dependence can be assessed by known methods; for example, the Fagerstrom test can be used to determine a patient's level of addiction.
• Figure 1 illustrates the socio-professional data associated with the patient cohort.
• Figure 1A illustrates the age distribution of patients in the study, and
• Figure 1B illustrates the distribution within the cohort of socio-professional categories of patients.
• FIG. 2 illustrates the success rate by sex of smoking cessation in patients who received a composition according to the invention. By success, it should be understood that the patients declared abstinence from tobacco consumption after administration of the composition according to the invention.
• FIG. 3 is a graph representing, as a function of the declared motivation to stop smoking, the proportion of patients who have stopped smoking and those who have consumed tobacco after administration of the formulation.
• FIG. 4 is a graph relating the declared abstinence duration of patients after having been treated with a composition according to the invention and the duration of this abstinence.
• FIG. 5 is a graph illustrating the abstinence rate of patients as a function of their estimated dependence according to the Fagerstrom test.
• FIG. 6 is a graphical representation showing the time within which the effects of the composition on smoking cessation are felt by the patients.
• the effects are for example the phenomenon known as "craving", sleep or eating disorders, emotional instability.
• the age and socio-professional category of the subjects were noted.
• the graphs in Figure 1A and Figure 1B illustrate these two data for the entire cohort.
• varenicline marketed under the trademark champix® in Europe
• Varenicline causes serious adverse effects and is the subject of reinforced surveillance by the National Agency for the Safety of Medicines and Health Products in France, while the patients in the present study pointed out the absence of drug-related side effects.

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• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

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• 2019
  • 2019-01-17 FR FR1900425A patent/FR3091818B1/fr active Active
• 2020
  • 2020-01-17 CN CN202080017050.4A patent/CN113543850A/zh active Pending
  • 2020-01-17 WO PCT/EP2020/051168 patent/WO2020148443A1/fr unknown
  • 2020-01-17 EP EP20700613.1A patent/EP3911412A1/de not_active Withdrawn
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