Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
  • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
• • 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
  • A61K31/33—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 
• • 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
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
  • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
  • A61K9/1605—Excipients; Inactive ingredients
  • A61K9/1629—Organic macromolecular compounds
  • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

Definitions

• the invention pertains to veterinary compositions or dietary or feed supplements for use in the prevention or the treatment of behavioral, respectively age-related disorders or troubles in mammals, or for supporting or strengthening the immune system, the behavioral balance of mammals and for supporting the natural inflammatory response of mammals, in particular of companion animals.
• THC toxicity can be serious and prevent the pet from standing and eating , so overdosage can be counterproductive if not dangerous.
• compositions making use of hemp or cannabis oils or extracts used as the source of cannabinoids wherein the amount of active substances is easier to control.
• Such compositions are frequently provided in their liquid, in particular oily form or as capsules which, however, necessitates a very cautious administration.
• Oils or capsules do not dissolve in the pet mouth and consequently are furthermore subject to significant liver first-pass metabolism as the oral bioavailability of cannabinoids is below In certain cases, an adequate mixing to the pet diet is also of concern, especially when off flavors are too intense and then cause rejection of the diet provided to the pet.
• composition according to the invention consist in a veterinary composition or dietary supplement or complementary feed which is in the form of water soluble polysaccharide-based granules comprising as the source of cannabinoids as a standardized oil or a standardized extract of hemp (Cannabis sativa L.) essentially devoid of psychotropic substances.
• mammals define here companion animals like dogs, cats, horses, donkeys and mules and camels or zoo animals where behavioral disorders like anxiety, stress or seizures are frequently of concern.
• granules defines here edible particles in their granulated form, e.g. such as spherical or similar particles consisting essentially of a water soluble biodegradable matrix containing the selected active substances, wherein the cannabinoids providing from hemp or cannabis extract are dispersed inside or sprayed or coated on the surface.
• these granules can further comprise additives like stabilizers, binding or disintegrating agents or even flavors.
• the granules of the invention can be prepared according to the techniques conventional in the art such as extrusion, nebulization or fluid-bed granulation.
• polysaccharides defines substances commonly used in veterinary or human medicine as carriers and more particularly water-soluble polysaccharides selected among starch, soluble starch, microcrystalline cellulose, dextrin, dextrose, sucrose, isomaltose, oligosaccharides such as fructo-oligosaccharides (FOS) or gluco-oligosaccharides (GOS), mixtures of same and any other water-soluble representatives of this class of compounds. This enumeration, however, is not limitative.
• the term "essentially devoid of” defines here cannabis or hemp (Cannabis sativa L.) oils or extracts wherein the content of psychotropic substances, namely THC is significantly below the applicable regulatory provisions according to EFSA and EU regulatory bodies
• standardized oil and "standardized extract” apply to compositions of matter that are either already commercially available or manufactured on request by dedicated companies that are mastering current extraction, e.g. solvent or C02 extraction, and purification techniques and that can deliver oils or extracts with a precisely defined and characterized content in active substances, cannabinoids in the instant case.
• Standardized hemp (Cannabis sativa L.) extracts used according to the invention present furthermore a high content in non-psychotropic cannabinoids and in particular CBD, namely up to ca. 25 to 50 or even 80 % CBD and with THC less than 0.05 % (weight).
• An example of a preferred standardized hemp extract comprises 23.6 % CBD, 0.25 % of a mix of CBDV, CBDA & CBG and less than 0.05 % THC (weight).
• the selected hemp extract is defined as "full spectrum” extract, meaning that it contains a blend of other cannabinoids, terpenes, flavonoids and phytonutrients that boost its bioavailability.
• the granule composition according to the invention has been conceived to be delivered through a delivery system which maximizes the absorption and the bioavailability to optimize the benefits of the hemp oils extract, in particular the cannabinoids contained therein, essentially CBD and any additional active ingredients.
• the active ingredients are delivered through granules, which are highly soluble in saliva of the mouth and in water. While oils or capsules do not dissolve in saliva or water and have to go through the gastro-intestinal tract, the active ingredients, namely the cannabinoids, are diffused directly into the blood vessels in the mouth through buccal diffusion.
• the granule composition according to the invention absorbs straight into the pet's blood through the mucosal membrane in the mouth, allowing the hemp components, i.e. the cannabinoids, mainly CBD here, to bypass the gastrointestinal system and the first pass liver metabolism.
• the effect is likely as high as 30 % versus 4 to 6 % of that observed when cannabinoids are administered by means of oils.
• buccal absorption provides a more precise dosing.
• Veterinary compositions or dietary supplements according to the invention are conveniently used by simple addition or mixing with the regular diet of the selected mammal, e.g. the selected companion animal (pet).
• the administration follows usually the same feeding pattern as that applied for healthy pets, e.g. once or twice a day. Although this way of administration is preferred, pouring directly granules according to the invention into the pet's mouth is also accepted and even common practice.
• the dosage of CBD i.e. the main active cannabinoid
• the dosage of CBD extends conveniently from ca. 0.2 to 10, preferably from 0.2 to 5 mg per day per kg body weight.
• the prevention of said troubles or disorders requires low 0.2 to 0.5 mg CBD per day per kg body weight.
• the advice is to start low and increase slowly. Due to the lack of THC negative side effects or even drug addiction are definitely avoided.
• Severe troubles may require significantly higher dosages over a shortened period, e.g. ca. 10 to 25 mg CBD per day per kg body weight or even more. But even at these doses no negative side effects are predicted as well as any addiction.
• the veterinary composition or dietary supplement according to the invention can be provided in the form of unit doses each corresponding to one serving as follows: for dogs, sachets, pouches or bags or capsules containing 5 g of granules comprising 10 mg of the hemp (Cannabis sativa L.) extract mentioned here above or, expressed differently 2.0 to 3.0 mg CBD;
• dogs weighing from 5 to 20 kg are conveniently treated by means of one portion of 5 g granules per day whereas dogs with body weight over that 20 kg are conveniently treated with 3 portions of 5 g per day or even more if ever necessary.
• sachets containing granules providing up to 8 mg CBD par dose can be used within that frame.
• horses weighing less than 500 kg are usually provided with one 16 g portion of granules per day which is most frequently administered directly into the mouth, whereas horses weighing more than 500 kg are usually provided with two 16 g doses of granules per day or even more if ever necessary.
• Camels or zoo animals can be subject to similar dosages as long as the above ratio CBD per day per kg body weight is duly monitored.
• sucrose 41 % weight
• dextrose D-glucose monohydrate 58 %
• glucose syrup 1.4 % weight
• Micronutrients like Vitamin B6, Niacin and zinc acetate dihydrate can be added to the above formulation if ever desired; the latter can further comprise a stabilizer like gum Arabic or similar. Portions of 5 g granules were then packed individually to afford dose units providing each ca. 10.5 mg hemp extract** corresponding to ca. 2.5 mg CBD per 5 g portion.
• Portions of 16 granules each manufactured according to the method of Example 1 have been prepared in such a way to comprise 360 to 370 mg of the above hemp extract** or, expressed differently ca. 80 mg CBD per 16 portions.
• the latter are designed for large mammals like horses, camel and zoo animals.
• CBD 0.25 % weight (CBDV + CBDA + CBG) and less that 0.05 % weight THC.
• a sugar-free granule composition was prepared according to Example 1 when substituting the 41 % weight of sucrose by 20 % weight of GOS/FOS and the necessary increase of weight % of dextrose to balance.
• Such a granule formulation has the advantage to be less caloric and consequently better suited to dogs suffering from age related disorders or diseases like diabetes.
• This granule formulation is also better suited for treating chronic pain over an extended period.
• the proportions of dextrose can vary from 30 to 90 % of weight without affecting substantially the delivery of the cannabinoids provided by the hemp extract.
• sucrose the proportions of which can vary from 10 to 70 % weight whereas those of GOS/FOS are kept between 10 and 20 % weight.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Pharmacology & Pharmacy (AREA)
• Medicinal Chemistry (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Chemical & Material Sciences (AREA)
• Epidemiology (AREA)
• Engineering & Computer Science (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Natural Medicines & Medicinal Plants (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Biotechnology (AREA)
• General Chemical & Material Sciences (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Organic Chemistry (AREA)
• Hospice & Palliative Care (AREA)
• Alternative & Traditional Medicine (AREA)
• Otolaryngology (AREA)
• Botany (AREA)
• Medical Informatics (AREA)
• Microbiology (AREA)
• Mycology (AREA)
• Medicines Containing Plant Substances (AREA)
• Fodder In General (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

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• 2018
  • 2018-06-25 EP EP18746743.6A patent/EP3645119A1/de not_active Withdrawn
  • 2018-06-25 MX MX2019015673A patent/MX2019015673A/es unknown
  • 2018-06-25 WO PCT/IB2018/000707 patent/WO2019002933A1/en active Application Filing
  • 2018-06-25 BR BR112019026635-6A patent/BR112019026635A2/pt not_active Application Discontinuation
• 2020
  • 2020-01-07 CO CONC2020/0000111A patent/CO2020000111A2/es unknown

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