Tadalafil is incorporated into the proprietary NanoCelle formulation. Nano-sized structures are designed with a hydrophobic region associated with the active ingredient and a hydrophilic outer region that supports dispersion in an aqueous environment.

The formulation is filled into a device intended to deliver a consistent, measured spray. At the point of use, the spray is directed toward the inner cheek, presenting the formulation directly to the buccal surface.

The fine spray spreads across the moist oral surface. The formulation is designed to maintain close contact with the buccal mucosa and make dissolved or dispersed tadalafil available at the absorption site.

The buccal surface is well vascularised. NanoCelle Virile is designed to enable tadalafil absorption across the oral mucosa and into the systemic circulation, reducing dependence on gastrointestinal processing. Buccal delivery may also reduce hepatic first-pass exposure before the active reaches the systemic circulation. The actual contribution of this pathway and its effect on bioavailability must be established in human studies.

By creating an opportunity for transmucosal uptake, NanoCelle Virile is being developed to achieve earlier tadalafil exposure than a conventional swallowed tablet. Management is targeting an onset of approximately seven minutes. Onset, comparative pharmacokinetics and bioavailability have not yet been demonstrated in humans.

Once systemically available, tadalafil inhibits phosphodiesterase type 5. In the presence of sexual stimulation, this established mechanism supports the physiological processes involved in achieving and maintaining an erection. NanoCelle changes the proposed delivery format; it does not change tadalafil's pharmacological target.

Analytical validation, local-tolerance work, manufacturing controls and a pilot human pharmacokinetic study are intended to test the formulation's quality, safety, tolerability, exposure and bioavailability profile. Later registration studies will be designed following regulatory engagement.