Developing an Oral Modified Release (MR) Formulation
Sponsored by: Quotient Sciences
- Oral Modified Release
- Drug Development
Date: 20 May
Time: 10AM London/11AM Brussels
Challenges and Considerations for Achieving Success
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. Using case studies, we will describe the specialized formulation technologies that are available in order to achieve an optimal target product profile, and the use of innovative, adaptive clinical programs where human PK data is used to optimize MR formulation compositions in real-time.
Join us and learn how to overcome challenges in order to deliver a successful MR formulation.
Dr Andrew Lewis,
VP Pharmaceutical Sciences
Andy has over 15 years’ experience in the pharmaceutical and drug delivery industry. He currently leads a team of 120 scientists working on formulation development, clinical manufacturing and pharmaceutical analysis projects. Dr Lewis is dedicated to overcoming drug delivery challenges, including solubility enhancement, controlled release and transmucosal delivery of proteins and peptides. He is a member of the Academy of Pharmaceutical Scientists of Great Britain, and is currently Secretary of the Controlled Release Society.
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
- Director/Manager of Pharmaceutical Development
- Director/Manager of Formulation Development
- Formulation Scientist
- Manufacturing Scientist
- Director/Manager of Manufacturing
- Director/Manager of Clinical Manufacturing
- Director/Manager of R&D
- Heads of Outsourcing
- Chief Scientific Officer