StaniPharm Co-Authors Study on Vaping Technologies for Medical THC Delivery
A new study published in the Journal of Drug Delivery Science and Technology evaluates two vaping technologies for delivering medical THC by inhalation, a CE-marked medical device (BIKY Breathe) and a commercial vape pen, with StaniPharm co-authoring the work alongside Mines Saint-Étienne / INSERM (Sainbiose laboratory)
Cannabis-based medicines using THC have demonstrated clinical benefit in the management of chronic pain, but oral and sublingual routes of administration often result in inconsistent bioavailability and a slow onset of action that is difficult to control.
Inhalation allows for rapid systemic absorption and could offer more precise dose control, provided that the combination of the delivery device and the formulation enables the delivery of a precisely controlled respirable dose. The study aimed to evaluate the respirable dose of THC and the aerosol particle size distribution of different formulations of a THC-rich cannabis distillate administered via various devices.
Using a validated protocols, a Glass Twin Impinger for respirable dose and a Next Generation Impactor for particle size distribution, the team found that all formulations produced aerosols with a submicronic mass median aerodynamic diameter (0.89–0.99 μm) consistent with deep lung deposition, and a fine particle fraction of 99.17–100%. The BIKY Breathe device delivered a consistent aerosol mass (~6 mg/puff) with low puff-to-puff variability and respirable THC doses of 50 or 95 μg/puff depending on formulation strength, while the commercial vape pen delivered higher THC doses (1.7–2.0 mg/puff) but with greater variability.
This is not just an academic characterization exercise: it maps directly onto the quality framework any inhaled medicine must satisfy under the European Pharmacopoeia. The methodology used here, aerodynamic particle size distribution by cascade impactor and determination of fine particle fraction, is precisely what Ph. Eur. 2.9.18, “Preparations for inhalation: aerodynamic assessment of fine particles,” requires for this class of products, while Ph. Eur. 0671, “Preparations for Inhalation,” sets the broader quality requirementsthat any such drug product would need to meet on the path toward a marketing authorization.
StaniPharm contributed to the study on two fronts: preparing the four THC formulations tested, drawing on its cannabinoid extraction, purification and formulation expertise, and taking part in the analytical work alongside the Mines Saint-Étienne team. BIKY PHARMA, developer of the BIKY Breathe device, supported the study.