: In recent decades, federal legislation in the U.S. has recognized a new paradigm of pharmacotherapy in which ideology and popular demand, as opposed to sound clinical evidence, drives the marketing of ostensible herbal therapeutics as 'dietary supplements'. This vogue of democratizing medicine has more recently manifested in the ongoing legalization of cannabis products at the state level, where an arbitrary variety of definitions, restrictions, and assumed therapeutic uses are applied to a family of phytochemicals with no definitive evidence of efficacy or safety. With the recent publication of clinical trials submitted to the FDA in efforts to gain approval of the cannabidiol based therapeutic Epidiolex, a rare opportunity exists to examine high-quality data for a drug which has in recent years been marketed as a greatly unregulated dietary supplement. : A critical analysis is offered of data regarding efficacy, dosing, exposure, adverse events, drug-drug interactions, and non-specific effects associated with CBD - all of which raise questions regarding the wisdom of assuming the safety and efficacy of cannabinoids in particular and dietary supplements in general. : Ongoing lack of meaningful regulation of cannabinoid supplements continues to put consumers at undue risk without clear evidence of therapeutic value.
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http://dx.doi.org/10.1080/17512433.2019.1612743 | DOI Listing |
Pharmaceutics
January 2025
Laboratory of Pharmaceutical Technology and Biopharmacy, Center for Interdisciplinary Research on Medicines (CIRM), University of Liège, 4000 Liège, Belgium.
Cannabidiol (CBD) shows interesting therapeutic properties but has yet to demonstrate its full potential in clinical trials partly due to its low solubility in physiologic media. Two different formulations of CBD (amorphous and lipid-based) have been optimized and enable an increase in bioavailability in piglets. In vivo studies are time-consuming, costly and life-threatening.
View Article and Find Full Text PDFPharmaceuticals (Basel)
January 2025
Department of Drug Form Technology, Wroclaw Medical University, Borowska 211 A, 50-556 Wroclaw, Poland.
Introduction: The official implementation of pharmaceutical-grade cannabis raw materials for medicinal use has permitted doctors to prescribe and pharmacists to prepare cannabis-based formulations. The objective of the pharmaceutical development and manufacturing process optimization work was to propose a suppository formulation containing doses of 25 mg and 50 mg of tetra-hydrocannabinol (∆-9-THC) as an alternative to existing inhalable or orally administered formulations. The formulation could be used for rectal or vaginal administration, thereby providing dosage control in the treatment of endometriosis and other conditions involving pain.
View Article and Find Full Text PDFMolecules
January 2025
Chair and Department of Pharmaceutical Chemistry, Poznan University of Medical Sciences, Rokietnicka 3, 60-806 Poznan, Poland.
Background: Intravenous nanoemulsions (NEs) are gaining attention as potential delivery systems for poorly water-soluble substances like cannabidiol (CBD). This study aimed to develop novel NEs based on CBD-enriched hemp oils and evaluate their physiochemical properties.
Methods: The stability of hemp oils enriched with various concentrations of CBD (0.
J Cannabis Res
January 2025
Anesthesiology Department, University of Michigan Medical School, Ann Arbor, MI, 48105, USA.
Introduction: Chronic pain is common among Veterans, some of whom use cannabis for pain. We conducted a feasibility pilot study of a novel coaching intervention to help Veterans optimize use of medical cannabis products for pain management (NCT06320470).
Methods: The intervention drew from scientific literature, consultation with cannabis experts, Veteran input via a Community Advisory Board, and tenets of motivational interviewing.
Epilepsy Behav
January 2025
Department of Neurosurgery, Mass General Brigham, Harvard Medical School, Boston, MA 02115, USA.
Lennox-Gastaut syndrome (LGS) is a severe, childhood-onset developmental and epileptic encephalopathy characterized by multiple drug-resistant seizure types, specific electroencephalogram (EEG) patterns, and significant cognitive and behavioral impairments. To date, eight anti-seizure medications (ASMs) have been specifically approved by the U.S.
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