Oral modified release (MR) drug products are 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 MR dosage forms because they offer greater compliance and less frequent dosing regimens, coupled with potentially greater efficacy and fewer side effects in comparison to Immediate Release (IR) delivery systems.

However, the design and development of an effective MR formulation is often a lengthy and complex process, presenting many challenges. This webinar will discuss the drivers for MR development and key considerations for rational formulation design and technology selection.

Key Learning Objectives:
 

• Bridging from an Immediate Release (IR) formulation to Modified Release (MR) – What drives the need and what are the benefits?
• Key formulation design strategies and technologies – Which approaches to deploy?
• The relationships between formulation parameters, in-vitro data and in-vivo performance – Can we establish an IVIVC?
• The use of Design Space concepts – How do evaluate and optimize formulation performance “real-time” using clinical data
• Outcomes from the recent Tufts CSDD whitepaper demonstrating how Translational Pharmaceutics can shorten MR development programs by 12 months

Speaker:
 

Dr Andy Lewis
Vice President, Pharmaceutical Sciences – Quotient Sciences

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