Cannabinoid Sol-Gel Delivery
Nose-to-Brain Delivery of Therapeutic Cannabinoids
Developing the first, sustained-release, cannabinoid-based nose-to-brain delivery system that will provide relief across a range of indications from pain, inflammation, seizures, and neurological disorders. Our proprietary nasal formulations will also be designed to be universally-patient friendly, meaning formulations that can be used in children and adults alike.
Sol-gels are taken via nasal administration and rapidly gel upon contact with mucosal tissue, which paves the way for direct nose-to-brain delivery. This effectively bypasses the stomach and intestines - eliminating first pass metabolism - and may dramatically improve bioavailability - even compared to nasal sprays and other newer delivery systems. Additionally, the gel stays in the nasal passages, slowly releasing the cannabinoid while keeping it active for up to seven days. The ease of application and its long-lasting effects may be attractive for patients when compared to other delivery systems.
How do sol-gels work?
Traditional liquid nasal sprays are not retained in the nasal cavity for any appreciable time, and are only capable of generating random spray and deposition profiles as depicted in Figure 1a and Figure 1b, respectively.
Figure 1a Liquid spray profile into adult human nasal cast from applicator device (no inhalation, cast temperature 34 °C).
Figure 1b Liquid deposition profile into adult human nasal cast from applicator device (no inhalation, cast temperature 34 °C).
In contrast, the Sol-gel spray profile from our applicator device directed the formulation high into the upper nasal cavity (Figure 2a), where it remained following rapid gelation (Figure 2b). This is an important development as the region targeted by the Sol-gel is adjacent to the olfactory epithelium (depicted by red arrows), which serves as direct passage for molecules into the brain.
Figure 2a Sol-gel spray profile into adult human nasal cast from applicator device (no inhalation, cast temperature 34 °C).
Figure 2b Sol-gel deposition profile in adult human nasal cast from applicator device (no inhalation, cast temperature 34 °C).
To exemplify the Sol-gel and applicator device further an ‘inhalation model’ was developed next; this mimics the inspiration action performed by patients when using nasal sprays, which combines an action of simultaneous spraying into a nostril accompanied by steady and deep nasal inhalation.
Once again, the liquid and Sol-gel sprays were compared for their delivery high into the nasal cavity along the olfactory epithelia, in this ‘inhalation model’. As shown in Figure 3a, the liquid spray profile shows random spray distribution with distinct large droplets generated in this inhalation model, which is undesirable for nose-to-brain delivery of therapeutics. In stark contrast, the Sol-gel formulation (Figure 3b) was drawn high into the nasal cavity rapidly gelling and coating the target olfactory epithelium region (depicted by red arrows). This encouraging and important development paves the way for the lead Cannabinoid Sol-gel and applicator device to be employed for direct nose-to-brain delivery in PreveCeutical’s Cannabinoid Sol-gel Delivery Program.
Figure 3a Liquid spray generates a
random droplet profile (inhalation model,
cast temperature 34 °C).
Figure 3b Sol-gel spray profile gels and coats olfactory epithelia (inhalation model, cast temperature 34 °C).
Link to liquid spray profile demonstration:
Link to Sol-gel spray profile demonstration:
COVID-19 CBD Sol-Gel Program
PreveCeutical elected to extend this program in July 2020 to address the current COVID-19 pandemic. Under this extension, a nasal formulation incorporating a cannabinoid extract has been created. This formulation is based on reports by independent researchers who identified this extract as having anti-inflammatory properties and the potential to reduce the ability of SARS-CoV-2 to infect mucosa tissue.
We completed this development in November 2020, and PreveCeutical has filed a provisional patent. The Company will be looking to commercialize this formulation as a nasally administered treatment for COVID- 19 caused by SARS-CoV-2 infection.
PreveCeutical has also retained Versitat, a global clinical research organization, to assist with the clinical trial process. They have developed the roadmap, and clinical trial planning is underway.
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time.
PreveCeutical now plans to begin exploratory discussions with pharmaceutical and biotechnology companies developing therapies for neurological disorders, that are seeking a targeted nose-to-brain drug delivery system in connection with same, with the intention of forming a partnership for the co-development of PreveCeutical's soluble gel.
"Sol-gel technology has certainly shown significant promise in laboratory testing at this point. eventually, I would like to see this proprietary technology be successfully applied to a drug which could be targeted for CNS delivery at the right time, we would welcome an opportunity to work with a pharmaceutical or biotechnology company to co-develop the Sol-Gel and sol-gel Applicator to be used in pharmaceutical and therapeutic products." – Chief Science Officer: Dr. Mak Jawadekar, PhD.