Abstract
Cannabidiol (CBD) has substantial therapeutic potential, but its development as an effective drug by the pharmaceutical industry is hindered by intrinsic characteristics such as low bioavailability, low water solubility, and variable pharmacokinetic profiles. Importantly, lack of patentability of the drug substance also limits the likelihood of an expensive, full development programme in anything other than orphan indications. Potential avenues to overcome these issues with CBD include self-emulsifying drug delivery systems, improved crystal formulations and other solid-state delivery formulations, which are mostly in the pre-clinical or early clinical stages of development. This review identifies issues compromising current delivery of solid-state CBD, and how advanced pharmaceutical development strategies can enable CBD to realise the full potential as a successful therapeutic agent.
Highlights
Cannabidiol (CBD) is a phytocannabinoid used globally for a variety of indications, but with few approved medicinal applications
No studies have assessed how different crystalline forms may impact the pharmacokinetic profile of CBD, which may have implications for CBD being developed as solid-state forms
Some of hydrophilic components can diffuse into the shells of gelatine capsules causing precipitation and poor dissolution rates of the drug in the GI tract [89]
Summary
Cannabidiol (CBD) is a phytocannabinoid used globally for a variety of indications, but with few approved medicinal applications. The United States (US) Food and Drug Administration and the European Medicine Agency approved drug formulations containing CBD include Epidiolex® (a pure CBD oral solution) and Sativex® (a CBD and Delta-9-tetrahydrocannabinol (THC, 1:1) oromucosal spray), both developed by GW pharmaceuticals. Some of the most significant issues with oral CBD include poor bioavailability, variable pharmacokinetics profiles, and possible polymorphisms [6], which may have unintended consequences of less predictable efficacy, increased side effects and drug–drug interactions with higher doses. This review will outline some of the current issues with CBD pharmaceutics, the novel CBD formulations under development and under clinical investigation, and the strategies to improve CBD delivery and efficacy
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