The choice of modified release dosage form for drugs is mainly determined by their physicochemical properties. In general, modified release systems are considered unsuitable for APIs which undergo extensive first-pass metabolism. The lack of technologies that fulfil the function of delivering such actives puts limitations on the ability to achieve further therapeutic benefits and consumer benefit for these classes of APIs.
The target is therefore to access orally delivered modified release drug delivery systems that extend the efficacy of certain APIs by avoiding and/or overcoming pre-systemic metabolism. Potential dosage forms include tablet, liquid, capsule, granules, etc. The release may occur in the gastrointestinal tract ranging from the oral cavity to the large intestine. There will be a requirement to potentially meet a variety of local and/or global regulatory requirements.
Preferred additional supporting data required -
• A theoretically convincing principle that could enable extended efficacy over a certain period of time (12 hours or more), AND
• Preliminary data/models (not limited to dissolution test) that demonstrate proof of principle against APIs that face similar issues described above.
• In vivo data that demonstrates the proof of the principle against APIs described above.
• Compatibility with other drug delivery platforms.
In-licensing or acquisition.
Clients in focus...