Proprietary Technology

  • 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.

infographic-6_2015-650-2

 

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.