Non-Clinical vs Clinical: Risks & Considerations When Developing Modified Release Dosage Forms

Learn about specialized modified-release formulation technologies that are available in the drug development “toolbox” to achieve an optimal target product profile.

Oral modified-release drug products remain highly prevalent in drug development pipelines. These dosage forms tailor the in vivo drug release profile to achieve improved therapeutic outcomes for drugs intended for both local (gastrointestinal) action and systemic delivery. 

Many modified release technologies are available to drug developers, each designed to fulfill very specific performance requirements, such as gastro-retention or sustained-, pulsatile-, or delayed-release formats. Patients with chronic and acute conditions benefit from the use of modified-release dosage forms given that they offer greater compliance and less frequent dosing regimens, coupled with potentially greater efficacy and fewer side effects in comparison to immediate-release delivery systems.

The design and development of an effective modified release formulation is an inherently complex process. Human gastrointestinal anatomy and physiology strongly influence drug release and performance of modified release dosage forms given regional variations in pH, fluid volumes and compositions, surface area, metabolizing enzymes, and membrane transporters. Challenges are exacerbated by an over-reliance on in vitro and preclinical test results to inform formulation prototype selection, despite evidence that these data often correlate poorly with pharmacokinetic (PK) performance in humans.

In this webinar, Dr. Vanessa Zann describes how adaptive clinical programs can use human PK data to optimize modified release formulation compositions in real time, including the formulation technologies available to achieve an optimal target product profile.

Here's what you'll learn:

• Challenges when developing and manufacturing modified-release formulations
• Benefits when transitioning from immediate release formulations to modified release formulations
• Approaches to deploy in modified release formulation, such as matrix vs. multiparticulates
• Relationships between formulation parameters, in vitro data, and in vivo performance
• Optimizing formulation performance in real-time using clinical data and design spaces