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Sol-Gel Delivery Platform for Nose-to-Brain Delivery of Therapeutic Compounds

Developing the first, sustained-release, CANNABIS and CBD-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 CBD 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 Sol-gel and applicator device to be employed for direct nose-to-brain delivery in PreveCeutical’s Sol-gel 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:

 

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