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

13 September 2022

Join us on September 13, 2022 at 1:30pm (London-BST) / 2:30pm (Paris- CEST) / 08:30am (New York-EDT) / 5:30am (Los Angeles-PDT) for our live webinar entitled: 

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

Webinar Presentation Summary 

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, the featured speaker will use 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.

Key discussion points to look forward to:

  • Challenges when developing and manufacturing modified release formulations
  • Bridging from an immediate-release formulation to modified release — What drives the need and what are the benefits?
  • Key formulation design strategies and technologies — Which approaches to deploy? Matrix vs Multiparticulates
  • The relationships between formulation parameters, in vitro data and in vivo performance (human data vs animal data) — Can we establish an in vitro – in vivo correlation (IVIVC)?
  • Leveraging gamma scintigraphy to understand bioavailability
  • The use of design space concepts — How to evaluate and optimize formulation performance in real-time using clinical data
  • The benefits of an integrated CMC (chemistry, manufacturing and controls) clinical strategy for accelerated development
  • Featured case studies on modified-release drug programs in early development and accelerating to proof-of-concept

Join Dr. Zann for a discussion on the drivers for modified release development and key considerations for rational formulation design and technology selection.

Register now