EP2654763A1 - Utilisation de marijuana et de composés présents dans celle-ci pour traiter l'obésité - Google Patents

Utilisation de marijuana et de composés présents dans celle-ci pour traiter l'obésité

Info

Publication number
EP2654763A1
EP2654763A1 EP11850518.9A EP11850518A EP2654763A1 EP 2654763 A1 EP2654763 A1 EP 2654763A1 EP 11850518 A EP11850518 A EP 11850518A EP 2654763 A1 EP2654763 A1 EP 2654763A1
Authority
EP
European Patent Office
Prior art keywords
cannabis
cannabinoid
derivative
obesity
extract prepared
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP11850518.9A
Other languages
German (de)
English (en)
Other versions
EP2654763A4 (fr
Inventor
Yann Le Strat
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Le Foll Bernard
Original Assignee
Le Foll Bernard
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Le Foll Bernard filed Critical Le Foll Bernard
Publication of EP2654763A1 publication Critical patent/EP2654763A1/fr
Publication of EP2654763A4 publication Critical patent/EP2654763A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents

Definitions

  • the present invention relates to methods of treating or preventing obesity, or to facilitate weight loss in a subject in need thereof, as well as compositions and supplements therefor.
  • cannabis- derivatives may be a useful treatment for anorexia and weight loss associated with Human Immunodeficiency Virus infection 7 8 .
  • tobacco use and smoking cessation that have been associated with weight loss 9 and gain 10 , respectively, no study has evaluated the impact of cannabis use on weight in the general adult population.
  • the present invention accordingly relates to the prevalence of obesity as a function of cannabis use, and hence, to compositions and methods that can facilitate weight loss.
  • the invention relates at least in part to a method for the treatment or prevention of obesity.
  • the method comprises administering to a subject in need thereof a therapeutically effective amount of cannabis, at least one cannabinoid or derivative thereof, an extract prepared from at least one cannabis plant, or a combination thereof.
  • the method of facilitating weight loss comprises administering to a subject in need thereof a therapeutically effective amount of cannabis, at least one cannabinoid or derivative thereof, an extract prepared from at least one cannabis plant, or a combination thereof.
  • the above-described methods may further include, in non-limiting embodiments, additional steps of: obtaining the subject's weight or body mass index (BMI), and determining if the weight is normal or if the subject is overweight (BMI between 25 and 30) or if the subject is obese (BMI of about 30 or greater).
  • BMI body mass index
  • the cannabis, at least one cannabinoid or derivative thereof, extract prepared from at least one cannabis plant, or combination thereof is then preferentially administered if the subject is determined to be overweight or obese or have a BMI of about 25 or greater.
  • nutraceutical composition or supplement comprising an effective amount of cannabis, at least one cannabinoid or derivative thereof, an extract prepared from at least one cannabis plant, or a combination thereof.
  • the nutraceutical composition or supplement is particularly useful for regulating appetite, normalizing the need to eat and/or facilitating weight loss, or for the treatment or prevention of obesity in a subject in need thereof.
  • compositions for the treatment or prevention of obesity, regulating appetite, normalizing the need to eat and/or facilitating weight loss comprises a therapeutically effective amount of cannabis, at least one cannabinoid or derivative thereof, an extract prepared from at least one cannabis plant, or a combination thereof, in addition to one or more pharmaceutically acceptable carriers, excipients or diluents.
  • cannabis at least one cannabinoid or derivative thereof, an extract prepared from at least one cannabis plant, or a combination thereof, for the treatment or prevention of obesity, regulating appetite, normalizing the need to eat and/or facilitating weight loss in a subject in need thereof.
  • the use may also involve the manufacture of medicaments for the noted therapies or treatments.
  • nutraceutical compositions, supplements and pharmaceutical compositions can provide benefits to the subject, including regulation of appetite, normalization of the need to eat, and result in weight loss.
  • nutraceutical compositions, supplements and pharmaceutical compositions can provide benefits to the subject, including regulation of appetite, normalization of the need to eat, and result in weight loss.
  • compositions may be adapted for human or veterinary therapeutic purposes.
  • the subject may be a human or other mammal including, but not limited to horse, dog, cat, rat, or mouse.
  • the methods, uses, nutraceutical compositions, supplements and pharmaceutical compositions are particularly beneficial for humans, especially overweight and obese humans with a BMI of about 25 or greater.
  • nutraceutical compositions, supplements and pharmaceutical compositions can be incorporated into a combination therapy.
  • Such combination therapies would involve administering the cannabis, at least one cannabinoid or derivative thereof, extract prepared from at least one cannabis plant, or combinations thereof as described herein, together with one or more additional active agents effective for the treatment or prevention of obesity or for facilitating weight loss.
  • the at least one cannabinoid or derivative thereof may, in certain non-limiting embodiments, be derived from Cannabis sativa, Cannabis
  • the at least one cannabinoid or derivative thereof may be in a substantially pure or isolated form, or obtained synthetically according to methods available in the art.
  • the at least one cannabinoid or derivative thereof may incorporate or consist of a synthetic cannabinoid ligand with similar pharmacology to the naturally derived cannabinoids described above.
  • these synthetic cannabinoid ligands may be partial agonists for the CB 1 and/or the CB2 cannabinoid receptor.
  • the extract prepared from at least one cannabis plant may be in the form of a botanical drug substance, and/or may comprise naturally occurring cannabinoids from the at least one cannabis plant.
  • nutraceutical composition or supplement described above can further comprise one or more acceptable carriers, excipients or diluents, and/or may be in the form of a dietary supplement formulated as a food, a drink, or an additive for a food or drink.
  • nutraceutical compositions for the treatment or prevention of obesity, regulating appetite, normalizing the need to eat and/or for facilitating weight loss.
  • methods, uses, nutraceutical compositions, supplements and pharmaceutical compositions involve administering to a subject in need thereof a therapeutically effective amount of cannabis, at least one cannabinoid or derivative thereof, an extract prepared from at least one cannabis plant, or a combination thereof.
  • the described nutraceutical compositions, supplements and pharmaceutical compositions may include the described active component(s) together with an acceptable carrier or excipient, or together with one or more separate active agents or drugs as part of a combination.
  • the nutraceutical compositions, supplements and pharmaceutical compositions may be administered in a treatment regime with other drugs, nutraceutical compositions, supplements or pharmaceutical compositions, either separately or in a combined formulation.
  • Such compositions will preferably be formulated with a vehicle acceptable for administration to a subject, preferably a human, in need thereof. Methods of formulation for such
  • compositions are well known in the art and taught in standard reference texts such as
  • composition may comprise a single compound, or a combination thereof.
  • Formulations expected to be useful in the present invention may include, but are not limited to, aqueous solutions (where water soluble), dispersions and powders that are stable under the conditions of manufacture and storage and will preferably be preserved against the
  • the vehicle can be a solvent or dispersion medium containing, for example, water, ethanol, polyol (for example, glycerols, mono- and di-glycerols, propylene glycol, liquid polyethylene glycol, and the like), suitable mixtures thereof, and oils (e.g., edible oils including but not limited to vegetable, fruit, nut, fish oils, and mineral oils).
  • polyol for example, glycerols, mono- and di-glycerols, propylene glycol, liquid polyethylene glycol, and the like
  • oils e.g., edible oils including but not limited to vegetable, fruit, nut, fish oils, and mineral oils.
  • the proper fluidity can be maintained, for example, by the use of a coating such as lecithin, by the maintenance of the required particle size in the case of dispersion, and by the use of surfactants.
  • Prevention of the action of microorganisms can be achieved by various antibacterial and antifungal agents, for example, parabens, chlorobutanol, phenol, ascorbic acid, thimerosal, and the like.
  • isotonic agents for example, sugars, sodium chloride, or polyalcohols such as mannitol and sorbitol, in the composition.
  • Sterile solutions can be prepared by incorporating the composition in the required amount in an appropriate solvent with one or a combination of ingredients enumerated above, as required, followed by filter sterilization.
  • dispersions are prepared by incorporating the composition into a sterile vehicle which contains a basic dispersion medium and the required other ingredients from those enumerated above.
  • a sterile vehicle which contains a basic dispersion medium and the required other ingredients from those enumerated above.
  • the preferred methods of preparation are vacuum drying and freeze-drying which yield a powder, optionally plus any additional desired ingredient from a previously sterile-filtered solution thereof.
  • Suspensions in addition to the active agent or cell extract as described herein, may contain suspending agents as, for example, ethoxylated isostearyl alcohols, polyoxyethylene sorbitol and sorbitan esters, microcrystalline cellulose, aluminum metahydroxide, bentonite, agar-agar, and tragacanth, and mixtures thereof.
  • Solid dosage forms for oral administration may include, but are not limited to, ingestible hard and soft capsules, tablets, pills, candy, chewing gum, lollipops, powders, granules, elixirs, suspensions, syrups, wafers, sublingual or buccal tablets, troches, and the like.
  • the compound is mixed with at least one inert, pharmaceutically acceptable excipient or diluent or assimilable edible carrier such as sodium citrate or dicalcium phosphate and/or a) fillers or extenders such as starches, lactose, sucrose, glucose, mannitol, and silicic acid, b) binders such as, for example, carboxymethylcellulose, alginates, gelatin, polyvinylpyrrolidone, sucrose, and acacia, c) humectants such as glycerol, d) disintegrating agents such as agar-agar, calcium carbonate, potato or tapioca starch, alginic acid, certain silicates, and sodium carbonate, e) solution retarding agents such as paraffin, f) absorption accelerators such as quaternary ammonium compounds, g) wetting agents such as, for example, cetyl alcohol and glycerol monostearate, h) absorbents such
  • the dosage form may also comprise buffering agents.
  • Solid compositions of a similar type may also be employed as fillers in soft and hard- filled gelatin capsules using such excipients as lactose or milk sugar as well as high molecular weight polyethylene glycols and the like.
  • the percentage of the compound of the invention in the compositions and preparations may, of course, be varied.
  • the amount of active agent in such compositions is such that a suitable dosage will be obtained.
  • the solid dosage forms of tablets, dragees, capsules, pills, and granules can be prepared with coatings and shells such as enteric coatings and other coatings well known in the
  • compositions may optionally contain opacifying agents and can also be of a composition that they release the compound(s) of the invention only, or preferentially, in a certain part of the intestinal tract, optionally, in a delayed manner.
  • embedding compositions which can be used include polymeric substances and waxes.
  • the compositions can also be in microencapsulated form, if appropriate, with one or more of the above-mentioned excipients.
  • Liquid dosage forms for oral administration include pharmaceutically acceptable emulsions, solutions, suspensions, syrups and elixirs.
  • the liquid dosage forms may contain inert diluents commonly used in the art such as, for example, water or other solvents, solubilizing agents and emulsifiers such as ethyl alcohol, isopropyl alcohol, ethyl carbonate, ethyl acetate, benzyl alcohol, benzyl benzoate, propylene glycol, 1 ,3- butylene glycol, dimethyl formamide, oils (in particular, cottonseed, ground nut corn, germ olive, castor, and sesame oils), glycerol, tetrahydrofurfuryl alcohol, polyethylene glycols and fatty acid esters of sorbitan, and mixtures thereof.
  • inert diluents commonly used in the art such as, for example, water or other solvents, solubilizing agents and emulsifiers
  • compositions can also include adjuvants such as wetting agents, emulsifying and suspending agents, sweetening, flavoring, and perfuming agents.
  • adjuvants such as wetting agents, emulsifying and suspending agents, sweetening, flavoring, and perfuming agents.
  • Suspensions in addition to the composition or extract as described herein, may contain suspending agents such as, for example, ethoxylated isostearyl alcohols, polyoxyethylene sorbitol and sorbitan esters, microcrystalline cellulose, aluminum metahydroxide, bentonite, agar-agar, and tragacanth, and mixtures thereof.
  • suspending agents such as, for example, ethoxylated isostearyl alcohols, polyoxyethylene sorbitol and sorbitan esters, microcrystalline cellulose, aluminum metahydroxide, bentonite, agar-agar, and tragacanth, and mixtures thereof.
  • nutraceutical compositions, supplements or pharmaceutical compositions can be administered to a subject, preferably a mammal, more preferably a human, to treat and/or prevent obesity, or for facilitating weight loss, regulating appetite, and/or normalizing the need to eat.
  • the nutraceutical compositions, supplements or pharmaceutical compositions may be administered by various routes including, but not limited to, orally, through bucall sprays, intravenously, intramuscularly, intraperitoneally,
  • Extracts as described herein may be prepared, in certain non-limiting embodiments, using one or more liquid extraction steps.
  • the source material may be extracted using solvents including alcohol(s) such as methanol (MeOH), ethanol (EtOH), isopropanol, or combinations thereof.
  • the source material is extracted in a solvent system of about 5 to about 100 % alcohol such as EtOH.
  • Liquid extraction steps may be carried out according to a variety of methods, which methods may include without limitation steps of mixing followed by separation.
  • the source material may be mixed by vortexing followed by filtration or centrifugation to remove solid material.
  • the source material may be mixed by vortexing for up to about 2 minutes, followed by separation of the mixture by filtration or centrifugation.
  • this/these step(s) may be carried out at sufficient time and speed to remove substantially all of the solid material from solution.
  • a centrifugation step may be carried out at about 5,000 x g to about 20,000 x g, including any centrifugation speed within this range, preferably between about 10,000 x g to about 15,000 x g.
  • the time required for the centrifugation step will typically be dependent upon the speed, and in certain non-limiting embodiments may be up to 1 hour or even more.
  • the centrifugation time will typically be between about 5 minutes to about 30 minutes, more preferably about 15 minutes.
  • the centrifugation steps as well as any of the additional separation steps may be carried out at room temperature or lower, preferably at about 4°C. Concentration of supernatant fractions may also be carried out in a variety of ways, including by lyophilization (freeze-drying), spray-drying, rota-evaporating or other evaporating technologies, and other non-limiting concentrating methods.
  • the extraction process may also include chromatographic separation steps, for instance but not limited to separation by high-pressure liquid chromatography (HPLC), to further separate bioactive components of the extracted materials.
  • HPLC high-pressure liquid chromatography
  • the extraction process may also include one or more quantification and identification steps to measure the content of the extract, including the content of cannabinoids as described herein.
  • an effective amount means that amount of a drug or pharmaceutical agent that will elicit the biological or medical response of a tissue, system, animal, or human that is being sought, for instance, by a researcher or clinician.
  • therapeutically effective amount means any amount which, as compared to a corresponding subject who has not received such amount, results in improved treatment, healing, prevention, or amelioration of a disease, disorder, or side effect, or a decrease in the rate of advancement of a disease or disorder.
  • the term also includes within its scope amounts effective to enhance normal physiological function.
  • a “pharmaceutical agent” or “drug” refers to a chemical compound or composition capable of inducing a desired therapeutic or prophylactic effect when properly administered to a subject.
  • the NESARC is a survey of 43,093 respondents (response rate, 81%) conducted by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) from 2001-2002.
  • the NCS-R is an independent survey of 9,282 respondents (response rate, 73.0%) conducted by the
  • the frequency of cannabis use in the preceding 12 months among users was assessed with the question: "on average, how often in the past 12 months have you used marijuana or hashish", with the following possible answers: (i) daily, (ii) almost daily (3 to 6 times a week), (iii) 1 or 2 days a week, (iv) several times a month (25 to 51 days a year), (v) 1 to 2 times a month (12 to 24 days a year), (vi) every other month or so (6 to 1 1 days a year), (vii) 3 to 5 days in past 12 months, or (viii) 1 or 2 days in past 12 months.
  • BMI Body Mass Index
  • Past 12-month cigarette use was coded into 3 categories in both samples: (i) current smoker, defining someone who currently smokes cigarettes daily or occasionally, (ii) ex-smoker, defining a non-user who previously was a daily or occasional smoker, and (iii) never smoked, defining a non-user who has never used any tobacco.
  • Other measures We also considered sociodemographic characteristics, including race, age, educational level and marital status, as well as the use of other drugs in the past 12 months. We did not include household income, since this data was available only in a sub-sample of the NCS-R dataset.
  • age at interview was categorized into: (i) 18-29, (ii) 30-44, (iii) 45-64 and (iv) >65 years.
  • Marital status was classified into: (i) married or common-law, (ii) widowed, divorced or separated, and (iii) never married.
  • Educational level was classified into: (i) less than high school, (ii) high school graduate, and (iii) some college or higher.
  • Region of residence was classified into: (i) Northeast, (ii) Midwest, (iii) South, and (iv) West. Race/ethnicity coding was different between the two samples.
  • race/ethnicity was categorized into: (i) white, (ii) black, (iii) Asian/Native Hawaiian Pacific Islander, (iv) Hispanic/Latino, and (5) American Indian/ Alaska Native.
  • race/ethnicity was categorized into: (i) white, (ii) black, (iii) Asian, (iv) Hispanic/Latino, and (v) other (including American Indian/Pacific Islander).
  • participants were asked whether they had used sedatives, tranquilizers, opiates, heroin, amphetamine, cocaine/crack, hallucinogens or inhaler in the past 12 months.
  • Cannabis use No use in the past More than once a Once a month to 2 3 days a week to frequency 12 months year, less than days a week everyday once a month n % (SE) n % (SE) n % (SE) n % (SE)
  • Asian/Native 1.244 4.4 (0.5) 20 4.0(1.2) 11 3.0(1.0) 7 2.8(1.2) Hawaiian /
  • Sample sizes are unweighted values, percentages are weighted values. All analyses are weighted to reflect national population estimates. ⁇ 2 statistics are used to compare respondent characteristics among the 4 sub-groups defined by cannabis use. All P values ⁇ 0.001. Column total may not add to 100 due to rounding.
  • Cannabis use No use in the More than once a Once a month 3 days a week to frequency past 12 months year, less than to 2 days a everyday once a month week n c >/o (SE) n % (SE) n % n %
  • Asian 175 2. 1 5 2.4 3 2.0 3 1.9
  • Sample sizes are unweighted values, percentages are weighted values. All analyses are weighted to reflect national population estimates. ⁇ 2 statistics are used to compare respondent characteristics among the 4 sub-groups defined by cannabis use. All P values ⁇ 0.001. Column total may not add to 100 due to rounding.
  • the proportion of obese participants decreased with the frequency of cannabis use (Cochran- Mantel-Haenszel ⁇ 2 test, PO.001 in both samples, Figure 1 ).
  • the prevalence of obesity in participants of the NESARC who reported no cannabis use in the past 12 months was 22.0%, but was only 14.3% in participants who "used cannabis 3 days a week or more" (percentages are weighted and adjusted for survey design).
  • the prevalence of obesity in participants of the NCS-R who reported no cannabis use in the past 12 months was 25.3%, but was only 17.2% in participants who "used cannabis 3 days a week or more".
  • Table 4 presents the data on tobacco smoking status by the frequency of cannabis use in the last 12 months in both samples. Frequent cannabis users were more likely to be current or ex-smokers ( ⁇ 2 test for heterogeneity, PO.001 in both samples).
  • Sample sizes are unweighted and unadjusted values, percentages are weighted values. All analyses are weighted to reflect national population estimates. ⁇ 2 statistics are used to compare respondent characteristics among the 4 subgroups defined by cannabis use. All P values ⁇ 0.001. Column total may not add to 100 due to rounding.
  • the relationship between the frequency of cannabis use and BMI showed that smoking cannabis once a year or more was associated with a significantly lower BMI in the NESARC (Table 5). In the NCS-R this association was significant only in the subgroups using cannabis "at least once a year, less than 1 a month" and "more than 3 times a week.”
  • Dhaliwal SS Howat P, Bejoy T, Welborn TA. Self-reported weight and height for evaluating obesity control programs. Am J Health Behav 2010;34:489-99. 16. Stommel M, Schoenborn CA. Accuracy and usefulness of BMI measures based on self- reported weight and height: findings from the NHANES & NHIS 2001-2006. BMC Public Health 2009;9:421.

Abstract

L'invention concerne un procédé pour le traitement ou la prévention de l'obésité ou pour faciliter une perte de poids, en particulier chez des individus en surpoids ayant un indice de masse corporelle (IMC) d'environ 25 ou plus ou chez des individus obèses ayant un IMC d'environ 25 ou plus. L'invention concerne également des compositions nutraceutiques ou pharmaceutiques et des suppléments pour celles-ci. Les procédés mettent en jeu l'administration à un sujet en ayant besoin d'une quantité thérapeutiquement efficace de cannabis, d'au moins un cannabinoïde ou d'un dérivé de celui-ci, d'un extrait préparé à partir d'au moins une plante de cannabis ou d'une combinaison de ceux-ci.
EP11850518.9A 2010-12-20 2011-10-11 Utilisation de marijuana et de composés présents dans celle-ci pour traiter l'obésité Withdrawn EP2654763A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CA2726085A CA2726085A1 (fr) 2010-12-20 2010-12-20 Utilisateur de cannabis et autres composes contenus pour le traitement de l'obesite
PCT/CA2011/001131 WO2012083414A1 (fr) 2010-12-20 2011-10-11 Utilisation de marijuana et de composés présents dans celle-ci pour traiter l'obésité

Publications (2)

Publication Number Publication Date
EP2654763A1 true EP2654763A1 (fr) 2013-10-30
EP2654763A4 EP2654763A4 (fr) 2014-05-21

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EP11850518.9A Withdrawn EP2654763A4 (fr) 2010-12-20 2011-10-11 Utilisation de marijuana et de composés présents dans celle-ci pour traiter l'obésité

Country Status (3)

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EP (1) EP2654763A4 (fr)
CA (1) CA2726085A1 (fr)
WO (1) WO2012083414A1 (fr)

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KR102269820B1 (ko) * 2021-01-18 2021-06-28 주식회사 네이처센스 대마 추출물을 포함하는 비만 예방 및 치료용 조성물
KR102269823B1 (ko) * 2021-01-18 2021-06-28 주식회사 네이처센스 대마 추출물을 포함하는 대사성 질환의 예방 및 치료용 조성물

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Publication number Publication date
CA2726085A1 (fr) 2012-06-20
WO2012083414A1 (fr) 2012-06-28
EP2654763A4 (fr) 2014-05-21

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