Risks and Considerations When Developing Modified-Release Dosage Forms, Upcoming Webinar Hosted by Xtalks
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.
August 29, 2022
Modified-release oral drug products remain prevalent in drug development pipelines. These dosage forms tailor the in vivo drug release profile to achieve improved therapeutic results for drugs intended for both local (gastrointestinal) action and systemic administration. Patients with chronic and acute diseases benefit from the use of modified-release dosage forms as they offer greater compliance and less frequent dosing regimens, associated with potentially greater efficacy and fewer side effects than compared to immediate-release delivery systems.
Many modified release technologies are available to drug developers, each designed to meet very specific performance requirements, such as gastro-retention or extended, pulsatile or delayed release formats. Designing and developing an effective modified-release formulation is, however, an inherently complex process, presenting many challenges for the development team. 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. The challenges are exacerbated by an overreliance 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, the featured speaker will use case studies to describe the specialized formulation technologies available in the “toolbox” to achieve an optimal Target Product Profile (TPP), and the use of innovative clinical and manufacturing programs integrated and adaptive where human PK data is used to optimize modified release formulation compositions in real time.
Join Dr Vanessa Zann, Senior Drug Development Consultant, Quotient Sciences, for the live webinar on Tuesday, September 13, 2022 at 8:30 a.m. EDT (1:30 p.m. BST/UK).
For more information or to register for this event, visit Non-Clinical vs. Clinical: Risks & Considerations When Developing Modified Release Dosage Forms.
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