Food effect on pharmacokinetics of cannabidiol oral capsules in adult patients with refractory epilepsy

Angela K Birnbaum, Ashwin Karanam, Susan E Marino, Christopher M Barkley, Rory P Remmel, Michaela Roslawski, Mary Gramling-Aden, Ilo E Leppik

Research output: Contribution to journalArticle

13 Scopus citations

Abstract

Objective: To evaluate the pharmacokinetics of a purified oral cannabidiol (CBD) capsule administered with and without food in adults with refractory epilepsy. Methods: Adult patients who were prescribed CBD for seizures, had localization-related intractable epilepsy with ≥4 seizures per month, and qualified for Minnesota cannabis were enrolled. A single dose of 99% pure CBD capsules was taken under both fasting (no breakfast) and fed (high fat 840-860 calorie) conditions. Blood sampling for CBD plasma concentrations was performed under each condition between 0 and 72 hours post-dose and measured by a validated liquid chormatography-mass spectometry assay. CBD pharmacokinetic profiles including maximum concentration (Cmax), area-under-the-curve from zero to infinity (AUC0-∞), and time-to-maximum concentration (Tmax) were calculated. The confidence intervals (CIs) for log-transformed Cmax and AUC0-∞ ratios between fed and fasting states were calculated. Seizure and adverse events information was collected. Results: Eight patients completed the study. On average Cmax was 14 times and AUC0-∞ 4 times higher in the fed state. The 90% CI for the ratio of fed versus fast conditions for Cmax and AUC0-∞ were 7.47-31.86 and 3.42-7.82, respectively. No sequence or period effect for Cmax and AUC0-∞ was observed. No adverse events were reported. Significance: Administering CBD as a capsule rather than a liquid allows for more precise determination of pharmacokinetics parameters and is more representative of CBD swallowed products. The fat content of a meal can lead to significant increases in Cmax and AUC0-∞ and can account for variability in bioavailability and overall drug exposure within patients with oral products.

Original languageEnglish (US)
Pages (from-to)1586-1592
Number of pages7
JournalEpilepsia
Volume60
Issue number8
DOIs
StatePublished - Jan 1 2019

Keywords

  • CBD
  • cannabidiol
  • epilepsy
  • food-effect
  • pharmacokinetics

PubMed: MeSH publication types

  • Journal Article
  • Research Support, Non-U.S. Gov't
  • Randomized Controlled Trial

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