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  1. Article: Letter to the Editor:

    Land, M Hunter / MacNair, Laura / Thomas, Brian F / Peters, Erica N / Bonn-Miller, Marcel O

    Cannabis and cannabinoid research

    2020  Volume 5, Issue 4, Page(s) 340–343

    Language English
    Publishing date 2020-12-15
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2867624-5
    ISSN 2378-8763 ; 2578-5125
    ISSN (online) 2378-8763
    ISSN 2578-5125
    DOI 10.1089/can.2020.0054
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Enhanced Oral Bioavailability of β-Caryophyllene in Healthy Subjects Using the VESIsorb

    Mödinger, Yvonne / Knaub, Katharina / Dharsono, Tanita / Wacker, Roland / Meyrat, Remo / Land, M Hunter / Petraglia, Anthony L / Schön, Christiane

    Molecules (Basel, Switzerland)

    2022  Volume 27, Issue 9

    Abstract: β-Caryophyllene (BCP), a common constituent of many spice and food plants, is gaining increased attention due to recent research identifying numerous potential health benefits. Due to limited oral bioavailability observed in preclinical models, the ... ...

    Abstract β-Caryophyllene (BCP), a common constituent of many spice and food plants, is gaining increased attention due to recent research identifying numerous potential health benefits. Due to limited oral bioavailability observed in preclinical models, the described benefits of BCP may be maximized by using a suitable delivery system. Additionally, human pharmacokinetics (PK) remain unknown. This study evaluates the relative oral bioavailability of BCP formulated in a self-emulsifying drug delivery system (SEDDS) based on VESIsorb
    MeSH term(s) Administration, Oral ; Biological Availability ; Drug Delivery Systems/methods ; Emulsions/pharmacokinetics ; Female ; Healthy Volunteers ; Humans ; Male ; Polycyclic Sesquiterpenes ; Solubility ; Technology
    Chemical Substances Emulsions ; Polycyclic Sesquiterpenes ; caryophyllene (BHW853AU9H)
    Language English
    Publishing date 2022-04-30
    Publishing country Switzerland
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 1413402-0
    ISSN 1420-3049 ; 1431-5165 ; 1420-3049
    ISSN (online) 1420-3049
    ISSN 1431-5165 ; 1420-3049
    DOI 10.3390/molecules27092860
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Enhanced Oral Bioavailability of β-Caryophyllene in Healthy Subjects Using the VESIsorb ® Formulation Technology, a Novel Self-Emulsifying Drug Delivery System (SEDDS)

    Yvonne Mödinger / Katharina Knaub / Tanita Dharsono / Roland Wacker / Remo Meyrat / M. Hunter Land / Anthony L. Petraglia / Christiane Schön

    Molecules, Vol 27, Iss 2860, p

    2022  Volume 2860

    Abstract: β-Caryophyllene (BCP), a common constituent of many spice and food plants, is gaining increased attention due to recent research identifying numerous potential health benefits. Due to limited oral bioavailability observed in preclinical models, the ... ...

    Abstract β-Caryophyllene (BCP), a common constituent of many spice and food plants, is gaining increased attention due to recent research identifying numerous potential health benefits. Due to limited oral bioavailability observed in preclinical models, the described benefits of BCP may be maximized by using a suitable delivery system. Additionally, human pharmacokinetics (PK) remain unknown. This study evaluates the relative oral bioavailability of BCP formulated in a self-emulsifying drug delivery system (SEDDS) based on VESIsorb ® formulation technology (BCP-SEDDS) compared to BCP neat oil. Hence, a randomized, double-blind, cross-over design, single oral dose study (100 mg BCP) in 24 healthy subjects (12 men/12 women) was performed under fasting conditions. Pharmacokinetic parameters were analyzed from individual concentration-time curves. The data show that BCP-SEDDS resulted in a 2.2/2.0-fold increase in AUC 0–12h /AUC 0–24h and a 3.6-fold increase in C max compared to BCP neat oil. Moreover, BCP was absorbed faster from BCP-SEDDS (T max : 1.43 h) compared to BCP neat oil (T max : 3.07 h). Gender analysis revealed that there is no significant difference between men and women for both the investigated formulations and all investigated PK endpoints. In conclusion, BCP-SEDDS offers a well-tolerated and effective oral delivery system to significantly enhance the oral bioavailability of BCP in humans.
    Keywords beta-caryophyllene (BCP) ; bioavailability ; hemp ; Cannabis sativa L ; human ; oral drug delivery system ; Organic chemistry ; QD241-441
    Subject code 610
    Language English
    Publishing date 2022-04-01T00:00:00Z
    Publisher MDPI AG
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  4. Article ; Online: Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Red Softgels in Healthy Participants.

    Peters, Erica N / Mosesova, Irina / MacNair, Laura / Vandrey, Ryan / Land, M Hunter / Ware, Mark A / Turcotte, Cynthia / Bonn-Miller, Marcel O

    Journal of analytical toxicology

    2021  Volume 46, Issue 5, Page(s) 528–539

    Abstract: Due to a lack of published pharmacokinetic (PK) and/or pharmacodynamic (PD) data, informed physician and patient decision-making surrounding appropriate dosing of cannabis for medical purposes is limited. This Phase 1, multiple-dose study evaluated the ... ...

    Abstract Due to a lack of published pharmacokinetic (PK) and/or pharmacodynamic (PD) data, informed physician and patient decision-making surrounding appropriate dosing of cannabis for medical purposes is limited. This Phase 1, multiple-dose study evaluated the safety, tolerability, PK and PD of Spectrum Red softgels (2.5 mg Δ9-tetrahydrocannabinol (THC) and <0.25 mg cannabidiol (CBD)). Participants (n = 41) were randomized to one of five groups: 5 mg THC and 0.06 mg CBD daily (Treatment A), 10 mg THC and 0.12 mg CBD daily (Treatment B), 15 mg THC and 0.18 mg CBD daily (Treatment C), 20 mg THC and 0.24 mg CBD daily (Treatment D) or placebo. Study medication was administered in divided doses, every 12 h, ∼60 min after a standardized meal, for 7 consecutive days. All treatment-emergent adverse events (TEAEs) (65/65) were of mild-to-moderate severity; none was serious. The highest number of TEAEs (30/65) occurred on the first day of treatment. The most common TEAEs included somnolence, lethargy and headache (reported by eight, seven and five participants, respectively). On Day 7, maximum observed plasma concentration of 11-carboxy-THC increased by 2.0- and 2.5-fold as the dose doubled between Treatments A and B and between Treatments B and D, respectively. Mean peak post-treatment ratings of self-reported subjective effects of 'feel any effect' and 'dazed' differed between Treatment D and placebo on Days 1, 3 and 7. Over a week of twice-daily dosing of Spectrum Red softgels, daily doses of THC up to 20 mg and of CBD up to 0.24 mg were generally safe and became better tolerated after the first day of treatment. A prudent approach to improve tolerability with Spectrum Red softgels might involve initial daily doses no higher than 10 mg THC and 0.12 mg CBD in divided doses, with titration upward over time as needed based on tolerability.
    MeSH term(s) Analgesics ; Cannabidiol/pharmacokinetics ; Cannabis ; Dronabinol ; Healthy Volunteers ; Humans
    Chemical Substances Analgesics ; Cannabidiol (19GBJ60SN5) ; Dronabinol (7J8897W37S)
    Language English
    Publishing date 2021-04-08
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 752391-9
    ISSN 1945-2403 ; 0146-4760
    ISSN (online) 1945-2403
    ISSN 0146-4760
    DOI 10.1093/jat/bkab035
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Safety, Pharmacokinetics and Pharmacodynamics of Spectrum Yellow Oil in Healthy Participants.

    Peters, Erica N / Mosesova, Irina / MacNair, Laura / Vandrey, Ryan / Land, M Hunter / Ware, Mark A / Turcotte, Cynthia / Bonn-Miller, Marcel O

    Journal of analytical toxicology

    2021  Volume 46, Issue 4, Page(s) 393–407

    Abstract: Due to a lack of published pharmacokinetic (PK) and/or pharmacodynamic (PD) data, decision-making surrounding appropriate dosing of cannabis used for medical purposes is limited. This multiple-dose study evaluated the safety, tolerability, PK and PD of ... ...

    Abstract Due to a lack of published pharmacokinetic (PK) and/or pharmacodynamic (PD) data, decision-making surrounding appropriate dosing of cannabis used for medical purposes is limited. This multiple-dose study evaluated the safety, tolerability, PK and PD of Spectrum Yellow oil [20 mg/mL cannabidiol (CBD)/<1 mg/mL ∆9-tetrahydrocannabinol (THC)]. Participants (n = 43) were randomized to one of five groups: 120 mg CBD and 5.4 mg THC daily, 240 mg CBD and 10.8 mg THC daily, 360 mg CBD and 16.2 mg THC daily, 480 mg CBD and 21.6 mg THC daily or placebo. Study medication was administered every 12 h for 7 consecutive days. Treatment-emergent adverse events (TEAEs); plasma and urine concentrations of THC, CBD and metabolites; and self-reported subjective effects were collected. Nearly all TEAEs (44/45) were of mild or moderate severity; none was serious. The highest incidence of TEAEs (67%) was in the two higher-dose treatment groups. The highest number of TEAEs (17/45) occurred on the first treatment day. Steady-state plasma CBD concentrations were reached by Day 7. On Day 7, CBD exposure showed dose proportionality (AUC0-t slope = 1.03 [0.70, 1.36], Cmax slope = 0.92 [0.53, 1.31]). Most plasma THC concentrations were below the limit of quantification. Across Days 1 and 7, there were no consistent differences in subjective effects between placebo and active study medication. A prudent approach to improve tolerability with Spectrum Yellow oil might involve initial doses no higher than 240 mg total CBD and 10.8 mg total THC daily in divided doses, with titration upward over time as needed based on tolerability.
    MeSH term(s) Analgesics ; Cannabidiol/pharmacokinetics ; Cannabis ; Dronabinol/pharmacokinetics ; Healthy Volunteers ; Humans
    Chemical Substances Analgesics ; Cannabidiol (19GBJ60SN5) ; Dronabinol (7J8897W37S)
    Language English
    Publishing date 2021-03-12
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 752391-9
    ISSN 1945-2403 ; 0146-4760
    ISSN (online) 1945-2403
    ISSN 0146-4760
    DOI 10.1093/jat/bkab026
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Effect of Cannabidiol on the Long-Term Toxicity and Lifespan in the Preclinical Model

    Land, M Hunter / Toth, Marton L / MacNair, Laura / Vanapalli, Siva A / Lefever, Timothy W / Peters, Erica N / Bonn-Miller, Marcel O

    Cannabis and cannabinoid research

    2020  Volume 6, Issue 6, Page(s) 522–527

    Abstract: Introduction: ...

    Abstract Introduction:
    MeSH term(s) Animals ; Caenorhabditis elegans ; Cannabidiol/toxicity ; Humans ; Longevity ; Thermotolerance
    Chemical Substances Cannabidiol (19GBJ60SN5)
    Language English
    Publishing date 2020-11-20
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2867624-5
    ISSN 2378-8763 ; 2578-5125
    ISSN (online) 2378-8763
    ISSN 2578-5125
    DOI 10.1089/can.2020.0103
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: In Vitro

    Anderson, Lyndsey L / Etchart, Maia G / MacNair, Laura / Land, M Hunter / Mosesova, Irina A / Bonn-Miller, Marcel O / Arnold, Jonathon C

    Cannabis and cannabinoid research

    2020  Volume 7, Issue 3, Page(s) 304–317

    Abstract: Introduction: ...

    Abstract Introduction:
    MeSH term(s) Adenosine Triphosphate ; Cannabinoid Receptor Agonists ; Cannabis/chemistry ; Dronabinol/pharmacokinetics ; HEK293 Cells ; Hallucinogens/pharmacology ; Humans ; Liver-Specific Organic Anion Transporter 1 ; Membrane Transport Proteins/metabolism
    Chemical Substances Cannabinoid Receptor Agonists ; Hallucinogens ; Liver-Specific Organic Anion Transporter 1 ; Membrane Transport Proteins ; SLCO1B1 protein, human ; Dronabinol (7J8897W37S) ; Adenosine Triphosphate (8L70Q75FXE)
    Language English
    Publishing date 2020-09-22
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2867624-5
    ISSN 2378-8763 ; 2578-5125
    ISSN (online) 2378-8763
    ISSN 2578-5125
    DOI 10.1089/can.2020.0053
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article: Letter to the Editor: Possible Drug–Drug Interactions Between Cannabinoids and Candidate COVID-19 Drugs

    Land, M. Hunter / MacNair, Laura / Thomas, Brian F. / Peters, Erica N. / Bonn-Miller, Marcel O.

    Cannabis and Cannabinoid Research

    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #733428
    Database COVID19

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  9. Article ; Online: Letter to the Editor

    Land, M. Hunter / MacNair, Laura / Thomas, Brian F. / Peters, Erica N. / Bonn-Miller, Marcel O.

    Cannabis and Cannabinoid Research ; ISSN 2578-5125 2378-8763

    Possible Drug–Drug Interactions Between Cannabinoids and Candidate COVID-19 Drugs

    2020  

    Keywords covid19
    Language English
    Publisher Mary Ann Liebert Inc
    Publishing country us
    Document type Article ; Online
    DOI 10.1089/can.2020.0054
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  10. Article ; Online: Pharmacokinetics of cannabichromene in a medical cannabis product also containing cannabidiol and Δ

    Peters, Erica N / MacNair, Laura / Mosesova, Irina / Christians, Uwe / Sempio, Cristina / Klawitter, Jost / Land, M Hunter / Ware, Mark A / Turcotte, Cynthia / Bonn-Miller, Marcel O

    European journal of clinical pharmacology

    2021  Volume 78, Issue 2, Page(s) 259–265

    Abstract: Purpose: Cannabichromene (CBC) is a phytocannabinoid commonly found in cannabis, yet its acute post-dose pharmacokinetics (PK) have not been examined in humans. This is a secondary data analysis from a trial investigating Spectrum Yellow oil, an oral ... ...

    Abstract Purpose: Cannabichromene (CBC) is a phytocannabinoid commonly found in cannabis, yet its acute post-dose pharmacokinetics (PK) have not been examined in humans. This is a secondary data analysis from a trial investigating Spectrum Yellow oil, an oral cannabis product used for medical purposes that contained 20 mg cannabidiol (CBD), 0.9 mg Δ
    Methods: Participants (N = 43) were randomized to one of 5 groups: 120 mg CBD, 5.4 mg THC, and 6.6 mg CBC daily; 240 mg CBD, 10.8 mg THC, and 13.2 mg CBC daily; 360 mg CBD, 16.2 mg THC, and 19.8 mg CBC daily; 480 mg CBD, 21.6 mg THC, and 26.4 mg CBC daily; or placebo. Study medication was administered every 12 h for 7 days. Plasma CBC concentrations were analyzed by a validated two-dimensional high-performance liquid chromatography-tandem mass spectrometry assay.
    Results: After a single dose and after the final dose, the C
    Conclusions: CBC may have preferential absorption over CBD and THC when administered together.
    Trial registration: Australian New Zealand Clinical Trials Registry #ACTRN12619001450101, registered 18 October 2019.
    MeSH term(s) Area Under Curve ; Cannabidiol/pharmacokinetics ; Cannabinoids/pharmacokinetics ; Dose-Response Relationship, Drug ; Double-Blind Method ; Dronabinol/pharmacokinetics ; Humans ; Medical Marijuana/pharmacokinetics ; Pilot Projects
    Chemical Substances Cannabinoids ; Medical Marijuana ; Cannabidiol (19GBJ60SN5) ; Dronabinol (7J8897W37S) ; cannabichromene (K4497H250W)
    Language English
    Publishing date 2021-10-18
    Publishing country Germany
    Document type Clinical Trial, Phase I ; Journal Article ; Randomized Controlled Trial
    ZDB-ID 121960-1
    ISSN 1432-1041 ; 0031-6970
    ISSN (online) 1432-1041
    ISSN 0031-6970
    DOI 10.1007/s00228-021-03232-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

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