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

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. 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.

Many modified release technologies are available to drug developers, each designed to fulfil very specific performance requirements, such as gastro-retention or sustained-, pulsatile-, or delayed- release formats. The design and development of an effective modified release formulation is however an inherently complex process, presenting many challenges for the development team. Human gastrointestinal anatomy and physiology strongly influences 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, explore case studies to describe the specialized formulation technologies that are available in the “toolbox” to achieve an optimal target product profile and the use of innovative, adaptive clinical programs where human PK data is used to optimize modified release formulation compositions in real-time.