Tadalafil is incorporated into the proprietary Cresaryn formulation. Its nano-sized structures pair a hydrophobic region, associated with the active ingredient, with a hydrophilic outer region that supports dispersion in an aqueous environment.

The formulation is contained in a device which delivers 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, making dissolved or dispersed tadalafil available at the site of absorption.

The buccal surface is well vascularised. Cresaryn is designed to enable tadalafil absorption across the oral mucosa into systemic circulation, eliminating reliance on gastrointestinal processing and hepatic first-pass metabolism. The bioavailability is to be established in human studies.

Through transmucosal uptake, Cresaryn is being developed to achieve earlier tadalafil exposure than a conventional swallowed tablet, with management targeting onset in approximately seven minutes. Comparative pharmacokinetics and bioavailability have not yet been demonstrated in humans.

Once systemically available, tadalafil inhibits phosphodiesterase type 5. With sexual stimulation, this established mechanism supports the physiological processes involved in achieving and maintaining an erection. Cresaryn changes the delivery format, not 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. Later registration studies have been designed following regulatory engagement.