- We are continuing to investigate the use of our proprietary extended-release drug delivery technology platform in an XR-ODT formulation of methylphenidate and an XR oral suspension formulation of amphetamine. We have developed these investigational products by utilizing the following attributes in each of our product candidates:
- An extended-release profile, which may allow for once daily dosing
- An ODT or oral suspension dosage form, which may be taken without water
- Taste-masking of bitter ADHD medications, with flavoring options
- Portable single-unit blister-packaging.
Our Proprietary Technology Platform
We are able to apply the XR-ODT and XR oral suspension technologies to other active pharmaceutical ingredients, or APIs. We have the ability to produce drug-loaded micro-particles with complex release profiles, which allows us to develop ODT or oral suspension formulations that can mimic various release profiles not otherwise available in XR-ODT or XR oral suspension form.
Our proprietary extended-release drug delivery technology platform, as illustrated below in Figure 7, allows us to produce drug-loaded micro-particles through an ion exchange process that creates new salt forms of certain existing marketing drugs.
Our XR-ODT Technology: Rapidly Disintegrating Ionic Masking
Our Rapidly Disintegrating Ionic Masking, or RDIM, technology utilizes an oral-disintegrating, extended-release, taste-masked pharmaceutical composition that can withstand compression forces associated with standard tableting technology, allowing for a drug to be incorporated into the ODT dosage form using ion resin technology. This technology not only provides extended-release and controlled-release properties, it is designed to mask the taste of the active drug.
Our XR Oral Suspension Technology: Dynamic Time Release Suspension®
Our Dynamic Time Release Suspension®, or DTRS®, technology encompasses a set of process technologies and know-how to manufacture and test extended-release oral suspension products that are shelf-stable. Our DTRS® technology not only provides for an extended-release, ready-to-use oral suspension, but may offer taste-masking of the active pharmaceutical ingredient.
Our Tamper Resistant Technology: Kinetically Controlled Tamper Protection
Our Kinetically Controlled Tamper Protection™, or KCTP™, technology is designed to deter abuse by altering the kinetics of the drug product and can be used in conjunction with both our XR-ODT and XR oral suspension dosage forms. We believe that our KCTP™ technology can be applied to opioid-based pain products or other DEA scheduled drug products for which abuse and dose dumping are known problems.