A Novel, Modified Release Drug Delivery Technology Containing Amphetamine-Ion Exchange Complexes

The proprietary immediate+extended drug delivery technology LiquiXR™ utilizes an ion-exchange resin that complexes with any protonated, water-soluble active moiety. The active drug complexes with ion-exchange polymers in the resin, which is then formed into micron-sized particles. Some particles are coated with an aqueous, pH-independent polymer for immediate or sustained release. The coating applied to the ion-exchange resin particles is of varying thickness for programmed, extended release. Solid, coating-free particles provide for immediate release. The micron-sized particles are formulated into solid or chewable tablet, suspension, orally disintegrating tablet, film, or capsules. Active drug is subsequently released in millions of particles, driven by ion exchange and diffusion. After release, the ion-exchange resin is excreted. LiquiXR™ technology allows for customized, sustained release of active drug for ~24 hours. Mechanistically, drug particles enter the gastrointestinal (GI) tract. As positively-charged ions from GI fluids diffuse across the coating, ionically-charged drug diffuses through the coating, into the GI fluids. As the coating is of variable thickness, some drug takes longer to diffuse+absorb, providing for programmable delayed release. The LiquiXR™ drug delivery technology is utilized in Dyanavel® XR (amphetamine extended-release oral suspension; AMPH EROS), indicated for ADHD. It comprises 2.5 mg/mL amphetamine base complexed with the technology for immediate release followed by an extended release, with onset of effect demonstrated at < 1 hour after dosing and efficacy observed through 13 hours. The efficacy reported for AMPH EROS provides an example of the clinical application for other active drug products requiring an immediate release and extended release profile.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.