WO2019002933A1 - Veterinary granules composition containing hemp extract - Google Patents
Veterinary granules composition containing hemp extract Download PDFInfo
- Publication number
- WO2019002933A1 WO2019002933A1 PCT/IB2018/000707 IB2018000707W WO2019002933A1 WO 2019002933 A1 WO2019002933 A1 WO 2019002933A1 IB 2018000707 W IB2018000707 W IB 2018000707W WO 2019002933 A1 WO2019002933 A1 WO 2019002933A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- dietary supplement
- hemp
- veterinary composition
- cannabinoids
- mammals
- Prior art date
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- 244000025254 Cannabis sativa Species 0.000 title claims abstract description 41
- 239000000284 extract Substances 0.000 title claims abstract description 32
- 239000000203 mixture Substances 0.000 title claims abstract description 31
- 235000012766 Cannabis sativa ssp. sativa var. sativa Nutrition 0.000 title claims abstract description 28
- 235000012765 Cannabis sativa ssp. sativa var. spontanea Nutrition 0.000 title claims abstract description 28
- 235000009120 camo Nutrition 0.000 title claims abstract description 28
- 235000005607 chanvre indien Nutrition 0.000 title claims abstract description 28
- 239000008187 granular material Substances 0.000 title claims abstract description 28
- 239000011487 hemp Substances 0.000 title claims abstract description 28
- 239000003557 cannabinoid Substances 0.000 claims abstract description 25
- 229930003827 cannabinoid Natural products 0.000 claims abstract description 25
- 229940065144 cannabinoids Drugs 0.000 claims abstract description 24
- 241000124008 Mammalia Species 0.000 claims abstract description 21
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- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 6
- 229930006000 Sucrose Natural products 0.000 claims description 5
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 5
- 239000008121 dextrose Substances 0.000 claims description 5
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- 241000282832 Camelidae Species 0.000 claims description 4
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- 239000008107 starch Substances 0.000 claims description 4
- 239000002904 solvent Substances 0.000 claims description 3
- 239000004375 Dextrin Substances 0.000 claims description 2
- 229920001353 Dextrin Polymers 0.000 claims description 2
- 206010061218 Inflammation Diseases 0.000 claims description 2
- AYRXSINWFIIFAE-SCLMCMATSA-N Isomaltose Natural products OC[C@H]1O[C@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)[C@@H](O)[C@@H](O)[C@@H]1O AYRXSINWFIIFAE-SCLMCMATSA-N 0.000 claims description 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 2
- 235000019425 dextrin Nutrition 0.000 claims description 2
- 230000004054 inflammatory process Effects 0.000 claims description 2
- DLRVVLDZNNYCBX-RTPHMHGBSA-N isomaltose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)C(O)O1 DLRVVLDZNNYCBX-RTPHMHGBSA-N 0.000 claims description 2
- 239000011159 matrix material Substances 0.000 claims description 2
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 2
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 2
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 2
- 230000031990 negative regulation of inflammatory response Effects 0.000 claims description 2
- 150000002482 oligosaccharides Chemical class 0.000 claims description 2
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- 235000005911 diet Nutrition 0.000 abstract description 6
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- 239000013589 supplement Substances 0.000 abstract 1
- 239000003921 oil Substances 0.000 description 11
- 239000002775 capsule Substances 0.000 description 6
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- 241000218236 Cannabis Species 0.000 description 4
- 239000013543 active substance Substances 0.000 description 4
- 230000037213 diet Effects 0.000 description 4
- WVOLTBSCXRRQFR-SJORKVTESA-N Cannabidiolic acid Natural products OC1=C(C(O)=O)C(CCCCC)=CC(O)=C1[C@@H]1[C@@H](C(C)=C)CCC(C)=C1 WVOLTBSCXRRQFR-SJORKVTESA-N 0.000 description 3
- REOZWEGFPHTFEI-JKSUJKDBSA-N Cannabidivarin Chemical compound OC1=CC(CCC)=CC(O)=C1[C@H]1[C@H](C(C)=C)CCC(C)=C1 REOZWEGFPHTFEI-JKSUJKDBSA-N 0.000 description 3
- 241001471082 Colocasia bobone disease-associated cytorhabdovirus Species 0.000 description 3
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- WVOLTBSCXRRQFR-DLBZAZTESA-M cannabidiolate Chemical compound OC1=C(C([O-])=O)C(CCCCC)=CC(O)=C1[C@H]1[C@H](C(C)=C)CCC(C)=C1 WVOLTBSCXRRQFR-DLBZAZTESA-M 0.000 description 3
- REOZWEGFPHTFEI-UHFFFAOYSA-N cannabidivarine Natural products OC1=CC(CCC)=CC(O)=C1C1C(C(C)=C)CCC(C)=C1 REOZWEGFPHTFEI-UHFFFAOYSA-N 0.000 description 3
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- 238000002156 mixing Methods 0.000 description 2
- 239000002245 particle Substances 0.000 description 2
- 238000000746 purification Methods 0.000 description 2
- LXNHXLLTXMVWPM-UHFFFAOYSA-N pyridoxine Chemical compound CC1=NC=C(CO)C(CO)=C1O LXNHXLLTXMVWPM-UHFFFAOYSA-N 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 210000003296 saliva Anatomy 0.000 description 2
- 239000003381 stabilizer Substances 0.000 description 2
- 150000003505 terpenes Chemical class 0.000 description 2
- 235000007586 terpenes Nutrition 0.000 description 2
- 230000001988 toxicity Effects 0.000 description 2
- 231100000419 toxicity Toxicity 0.000 description 2
- OSNSWKAZFASRNG-WNFIKIDCSA-N (2s,3r,4s,5s,6r)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol;hydrate Chemical compound O.OC[C@H]1O[C@H](O)[C@H](O)[C@@H](O)[C@@H]1O OSNSWKAZFASRNG-WNFIKIDCSA-N 0.000 description 1
- 244000215068 Acacia senegal Species 0.000 description 1
- 208000019901 Anxiety disease Diseases 0.000 description 1
- -1 CBD here Natural products 0.000 description 1
- 241000282836 Camelus dromedarius Species 0.000 description 1
- 208000000094 Chronic Pain Diseases 0.000 description 1
- 206010010904 Convulsion Diseases 0.000 description 1
- 206010012335 Dependence Diseases 0.000 description 1
- 241000283074 Equus asinus Species 0.000 description 1
- 241001331845 Equus asinus x caballus Species 0.000 description 1
- 229920000084 Gum arabic Polymers 0.000 description 1
- PVNIIMVLHYAWGP-UHFFFAOYSA-N Niacin Chemical compound OC(=O)C1=CC=CN=C1 PVNIIMVLHYAWGP-UHFFFAOYSA-N 0.000 description 1
- 239000000205 acacia gum Substances 0.000 description 1
- 235000010489 acacia gum Nutrition 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000036506 anxiety Effects 0.000 description 1
- 235000015895 biscuits Nutrition 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
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- 238000001125 extrusion Methods 0.000 description 1
- 238000010579 first pass effect Methods 0.000 description 1
- 229930003935 flavonoid Natural products 0.000 description 1
- 150000002215 flavonoids Chemical class 0.000 description 1
- 235000017173 flavonoids Nutrition 0.000 description 1
- 238000009477 fluid bed granulation Methods 0.000 description 1
- 210000005095 gastrointestinal system Anatomy 0.000 description 1
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- 239000008103 glucose Substances 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 239000010460 hemp oil Substances 0.000 description 1
- 230000010224 hepatic metabolism Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000011785 micronutrient Substances 0.000 description 1
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- 239000013588 oral product Substances 0.000 description 1
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- RADKZDMFGJYCBB-UHFFFAOYSA-N pyridoxal hydrochloride Natural products CC1=NC=C(CO)C(C=O)=C1O RADKZDMFGJYCBB-UHFFFAOYSA-N 0.000 description 1
- 230000002040 relaxant effect Effects 0.000 description 1
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- 235000019158 vitamin B6 Nutrition 0.000 description 1
- 239000011726 vitamin B6 Substances 0.000 description 1
- 229940011671 vitamin b6 Drugs 0.000 description 1
- YZYKBQUWMPUVEN-UHFFFAOYSA-N zafuleptine Chemical compound OC(=O)CCCCCC(C(C)C)NCC1=CC=C(F)C=C1 YZYKBQUWMPUVEN-UHFFFAOYSA-N 0.000 description 1
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)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (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)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Fodder In General (AREA)
Abstract
The veterinary compositions or dietary or feed supplements are useful in the prevention or the treatment of behavioral, respectively age-related disorders, troubles and pain in mammals. They are also for supporting or strengthening the immune system, the behavioral balance of mammals and for supporting the natural inflammatory response. These compositions or supplements are in the form of water soluble polysaccharide- based granules which comprise as the source of cannabinoids a standardized oil or extract of hemp (Cannabis sativa L.) essentially devoid of psychotropic substances.
Description
Veterinary granules composition containing hemp extract
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.
Background of the invention
There exist already a few veterinary products comprising cannabinoids and which have been proposed for preventing or treating behavioral troubles affecting pets or companion animals, mainly dogs, cats and horses.
They are provided in various forms like treats, croquettes or biscuits comprising hemp or cannabis plant material intimately mixed with a suitable carrier. Although the relevant plant material can be controlled more or less efficiently in terms of concentration of active substances, i.e. the cannabinoids, administration of same can be problematic if dosage is not duly monitored.
This is particularly true if minor quantities of psychotropic substances like e.g. THC or are still present: THC toxicity can be serious and prevent the pet from standing and eating , so overdosage can be counterproductive if not dangerous.
There also exist veterinary 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.
For instance, a few more drops only per body weight, can lead to undesired effects due to their high concentration of cannabinoids and namely psychotropic THC even when the latter is only present as traces. In that context too, THC toxicity can be serious and prevent the pet from standing and eating.
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.
There is today an imperious need to obviate and to overcome efficiently all the above-mentioned drawbacks when providing to the pets in need thereof new and easily absorbed veterinary compositions comprising hemp extracts. This goal is achieved by means of the invention defined below.
The invention
The 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.
The latter is designed for a wide scope of uses and in particular in:
- the prevention or the treatment of behavioral disorders or troubles in mammals
- the prevention or the treatment of age related disorders or troubles in mammals
- supporting or strengthening the behavioral balance of mammals
- the prevention or the treatment of pain or inflammation in mammals
- supporting and strengthening the immune system and the natural anti-inflammatory response in mammals
and even more, in fact almost any troubles and disorders that can be therapeutically addressed in animals by means of the administration of cannabis- or hemp derived extracts with non-psychotropic cannabinoids and terpenes.
Definitions
The term "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.
The term "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. In certain cases, 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. The term "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
recommendation to be equal to or lower than 10 ppm (mg per kg), usually below 0.2 % if not below 0.05 % (weight). Some of such oils or extracts are commercially available whereas others can be obtained when subjecting the adequate raw plant material i.e. buds, leaves, flowers, etc. or their oils or their extracts to specific extraction and purification techniques.
The terms "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).
According to an optional embodiment of the invention 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.
Embodiments of the invention
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.
Within the frame of the invention, it was observed that such a buccal diffusion allows 3 to 4 times higher bioavailability that comparable oral products delivered in an oil or in a capsule.
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.
Eventually, besides being better absorbed, fast and reliable, 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.
For preventing or treating the various troubles or disorders which are addressed within the frame of the invention the dosage of CBD, i.e. the main active cannabinoid, 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;
for horses or camels or zoo animals, pouches or bags or capsules containing 16 g of granules comprising 320 mg of the hemp (Cannabis sativa L.) extract mentioned here above or, expressed differently 80 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. Alternatively, 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.
Adding the said portions to the daily diet of the horses at stake, nevertheless, is also possible. It was observed that treatments ranging for or even over 20 days did not reveal any negative side effects.
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.
Examples
Example 1
Predefined portions of sucrose (41 % weight), dextrose (D-glucose monohydrate 58 %) and glucose syrup (1.4 % weight) were intimately mixed with minute amounts of a commercially available, standardized hemp extract** and eventually processed according to a standard granulation technique to afford dried spherical granules containing 0.23 g of the said hemp extract** per lOOg granules.
**containing 23.6 % weight CBD; 0.25 % weight (CBDV + CBDA + CBG) and less that 0.05 % weight THC
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.
These portions are designed for small mammals like dogs and cats and provide the recommended daily serving for an animal subject to behavioral disorders. Depending on the animal or the severity of the disorder, one observes first signs of relaxing within 30 minutes to 2 hours already.
Example 2
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.
♦♦containing 23.6 % weight CBD; 0.25 % weight (CBDV + CBDA + CBG) and less that 0.05 % weight THC.
Example 3
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.
Example 4
Referring to the recipe disclosed in Example 1 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.
The same applies concerning sucrose the proportions of which can vary from 10 to 70 % weight whereas those of GOS/FOS are kept between 10 and 20 % weight.
Claims
1. A veterinary composition or dietary supplement for use in the prevention or the treatment of behavioral disorders or troubles in mammals which is in the form of water soluble polysaccharide-based granules comprising as the source of
cannabinoids an oil or an extract of hemp (Cannabis sativa L.) essentially devoid of psychotropic substances.
2. A veterinary composition or dietary supplement for use in the prevention or the treatment of age related disorders or troubles in mammals which is in the form of water soluble polysaccharide-based granules comprising as the source of
cannabinoids an oil or an extract of hemp (Cannabis sativa L.) essentially devoid of psychotropic substances.
3. A veterinary composition or dietary supplement for use in supporting or
strengthening the behavioral balance of mammals which is in the form of water soluble polysaccharide-based granules comprising as source of cannabinoids an oil or an extract of hemp (Cannabis sativa L.) essentially devoid of psychotropic substances.
4. A veterinary composition or dietary supplement for use in the prevention or the treatment of pain or inflammation or nauseas in mammals which is in the form of water soluble polysaccharide-based granules comprising as source of cannabinoids an oil or an extract of hemp (Cannabis sativa L.) essentially devoid of psychotropic substances.
5. A veterinary composition or dietary supplement for use in supporting and
strengthening the immune system and the natural anti-inflammatory response in mammals which is in the form of water soluble polysaccharide-based granules comprising as source of cannabinoids an oil or an extract of hemp (Cannabis sativa L.) essentially devoid of psychotropic substances.
6. A veterinary composition or dietary supplement according to any of the preceding claims wherein the granules consist of a matrix of water soluble polysaccharides selected among starch, soluble starch, microcrystalline cellulose, dextrin, dextrose, sucrose, isomaltose, oligosaccharides such as fructo-oligosaccharides (FOS) or gluco- oligosaccharides (GOS) and mixtures of same.
7. A veterinary composition or dietary supplement according to any of the preceding claims wherein the source of cannabinoids is a C02 or solvent extract of hemp (cannabis sativa L.) essentially devoid of psychotropic substances and namely devoid of THC.
8. A veterinary composition or dietary supplement according to any of the preceding claims wherein the source of cannabinoids is a standardized solvent extract of hemp (cannabis sativa L.) comprising ca. 25 % (weight) of CBD.
9. A veterinary composition or dietary supplement according to any of the preceding claims wherein the granules comprise ca. 0.01 to 0.25 %, preferably 0.05 to 0.15 % (weight) of CBD.
10. A veterinary composition or dietary supplement according to any of the preceding claims wherein the mammals are zoo animals or companion animals and in particular dogs, cats, horses and camels.
11. A veterinary composition or dietary supplement according to any of the preceding claims which is administered in such a way to provide to the mammals in need thereof a daily dose of ca. 0.1 to 10 mg, preferably ca. 0.5 to 5.0 mg CBD per kg body weight.
Priority Applications (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| BR112019026635-6A BR112019026635A2 (en) | 2017-06-30 | 2018-06-25 | veterinary composition or dietary supplement |
| EP18746743.6A EP3645119A1 (en) | 2017-06-30 | 2018-06-25 | Veterinary granules composition containing hemp extract |
| MX2019015673A MX2019015673A (en) | 2017-06-30 | 2018-06-25 | Veterinary granules composition containing hemp extract. |
| CONC2020/0000111A CO2020000111A2 (en) | 2017-06-30 | 2020-01-07 | Composition of veterinary granules containing hemp extract |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762527463P | 2017-06-30 | 2017-06-30 | |
| US62/527,463 | 2017-06-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2019002933A1 true WO2019002933A1 (en) | 2019-01-03 |
Family
ID=63042061
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IB2018/000707 WO2019002933A1 (en) | 2017-06-30 | 2018-06-25 | Veterinary granules composition containing hemp extract |
Country Status (5)
| Country | Link |
|---|---|
| EP (1) | EP3645119A1 (en) |
| BR (1) | BR112019026635A2 (en) |
| CO (1) | CO2020000111A2 (en) |
| MX (1) | MX2019015673A (en) |
| WO (1) | WO2019002933A1 (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2020010454A1 (en) * | 2018-07-10 | 2020-01-16 | Beleave Inc. | Formulation of cannabinoid compounds |
| CN111978417A (en) * | 2019-09-06 | 2020-11-24 | 云南汉盟制药有限公司 | Extraction method of hemp polysaccharide, product and application thereof |
| US11040932B2 (en) | 2018-10-10 | 2021-06-22 | Treehouse Biotech, Inc. | Synthesis of cannabigerol |
| US11084770B2 (en) | 2016-12-07 | 2021-08-10 | Treehouse Biotech, Inc. | Cannabis extracts |
| US11202771B2 (en) | 2018-01-31 | 2021-12-21 | Treehouse Biotech, Inc. | Hemp powder |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009039843A2 (en) * | 2007-09-26 | 2009-04-02 | Letzel Heinz | Plant extract from low-thc cannabis for the treatment of disease |
| WO2016094810A2 (en) * | 2014-12-12 | 2016-06-16 | Ojai Energetics Pbc | Microencapsulated cannabinoid compositions |
-
2018
- 2018-06-25 WO PCT/IB2018/000707 patent/WO2019002933A1/en active Application Filing
- 2018-06-25 EP EP18746743.6A patent/EP3645119A1/en not_active Withdrawn
- 2018-06-25 MX MX2019015673A patent/MX2019015673A/en unknown
- 2018-06-25 BR BR112019026635-6A patent/BR112019026635A2/en not_active Application Discontinuation
-
2020
- 2020-01-07 CO CONC2020/0000111A patent/CO2020000111A2/en unknown
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009039843A2 (en) * | 2007-09-26 | 2009-04-02 | Letzel Heinz | Plant extract from low-thc cannabis for the treatment of disease |
| US20100216872A1 (en) * | 2007-09-26 | 2010-08-26 | Heinz Letzel | Plant extract from low-thc cannabis for the treatment of disease |
| WO2016094810A2 (en) * | 2014-12-12 | 2016-06-16 | Ojai Energetics Pbc | Microencapsulated cannabinoid compositions |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11084770B2 (en) | 2016-12-07 | 2021-08-10 | Treehouse Biotech, Inc. | Cannabis extracts |
| US11202771B2 (en) | 2018-01-31 | 2021-12-21 | Treehouse Biotech, Inc. | Hemp powder |
| WO2020010454A1 (en) * | 2018-07-10 | 2020-01-16 | Beleave Inc. | Formulation of cannabinoid compounds |
| US11040932B2 (en) | 2018-10-10 | 2021-06-22 | Treehouse Biotech, Inc. | Synthesis of cannabigerol |
| CN111978417A (en) * | 2019-09-06 | 2020-11-24 | 云南汉盟制药有限公司 | Extraction method of hemp polysaccharide, product and application thereof |
| CN111978417B (en) * | 2019-09-06 | 2021-08-06 | 云南汉盟制药有限公司 | Extraction method of hemp polysaccharide, product and application thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| MX2019015673A (en) | 2020-02-26 |
| EP3645119A1 (en) | 2020-05-06 |
| CO2020000111A2 (en) | 2020-01-17 |
| BR112019026635A2 (en) | 2020-06-30 |
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