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

Life Sciences, Clinical Trials, Drug Discovery & Development, Preclinical,
  • Tuesday, September 13, 2022

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

Speaker

http://Dr.%20Vanessa%20Zann,%20Quotient%20Sciences

Dr. Vanessa Zann, Senior Drug Development Consultant, Quotient Sciences

Vanessa has over 19 years’ industry experience providing biopharmaceutics support to discovery, development and clinical programs. Vanessa has previous experience at AstraZeneca as a Permeability Expert working in the Pharmaceutical Development department where she led the global Caco-2 facility for development, liaising with discovery scientists to ensure selection of NCE with appropriate biopharmaceutical properties, introduced the IV microtracer technique and provided biopharmaceutical support to both discovery and development programs. Vanessa joined Quotient Sciences in 2012 and has led the implementation of modelling and simulation. Vanessa has also been heavily involved in the pharmaceutical science’s in vitro characterisation strategy, as well as designing clinical studies and providing scientific support through clinical study delivery.

Message Presenter

Who Should Attend?

  • Chief Scientific Officers
  • Formulations Scientists
  • Drug Product Development/CMC Management
  • Technical Operations
  • Outsourcing Managers
  • Drug Product Process Development Engineers
  • Scale-Up Specialists
  • Clinical Supplies & Tech Transfer Specialists
  • Clinical Operations
  • Project Managers
  • Manufacturing Director
  • Drug Product Development/CMC Consultants

What You Will Learn

Attendees will gain insights into:

  • An introduction into modified release formulations
  • Considerations when selecting a modified release technology
  • Integrated CMC (chemistry, manufacturing and controls) clinical strategies for accelerated development

Xtalks Partner

Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated services across the entire development pathway for small molecules & peptide drug programs. We cut through silos across a range of drug development capabilities, saving precious time and money in getting drugs to patients.

We work with customers in a flexible way by either designing and delivering fully integrated programs at each stage of the development lifecycle, or by providing them support through tailored individual services in Drug Substance Synthesis & Manufacturing, Formulation Development, Clinical Trial Manufacturing, Commercial Manufacturing, Clinical Pharmacology, Data Sciences, Bioanalysis and Drug Development Consulting.

Quotient Sciences has over 30 years of experience developing a breadth of formulations across a range of indications and across an array of drug product formats including oral, inhaled, parenteral & topical. We also have a depth of expertise in modified release, oral peptides, ADME studies, Radiolabelling, Scintigraphy, Pediatrics, and we have the ability to handle highly potent compounds. Our innovative approach to formulation development is based on our proven track record in early clinical evaluation delivering phase-appropriate formulations across the product development pathway from candidate selection thru commercial product launch.

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