This webinar will provide scientists and technical stakeholders working in drug delivery with a detailed explanation of theory and application of an exciting extended release technology platform for parenteral applications based on bioresorbable polymers.

Ashland will explore control mechanisms demonstrating how theoretical chemistry is coupled with formulation knowledge in different formulation formats including in-situ forming implants, microspheres/nanoparticles and pre-formed solid implants to successfully accomplish extended release drug delivery over periods of days, weeks and up to several months. Ashland’s team will also explain how customized chemistry at Ashland can be used to overcome technical challenges for respective molecule delivery strategies.

Existing commercial products will be examined to highlight the breadth of release profile, types of molecules, indications, drug loading limits achieved to-date, successful formulation formats as well as going into detail on the technical challenges beyond formulation including process consistency, processing, stability and sterilization.

Part 2 of the webinar will focus on the application of Viatel^TM Bioresorbable polymers using the Chroniject^TM microsphere technology platform developed by Oakwood Laboratories, demonstrating the application of extended release of small molecules and peptides using injectable polymeric microspheres. This work will showcase application of polymer selection and process parameters to tune performance in terms of drug load, release rate, duration, and other factors. Particle size tuning and encapsulation efficiency will be covered, demonstrating how Viatel^TM Bioresorbable polymers can be successfully formulated into extended release microsphere systems. Specifically, this presentation outlines some of the factors involved in formulating an antipsychotic small molecule with an intended one-month duration; and a small peptide with an intended two-month duration, for the purposes of displaying two differing active pharmaceutical ingredients and release profiles.

Chroniject^TM is Oakwood’s patented polymer based injectable microsphere system for drug delivery. It can be used with a wide range of active pharmaceutical ingredients, including small molecules, hormones, and peptides, as well as select proteins and monoclonal antibodies. Oakwood maintains a wide variety of polymers in inventory for formulation development, and has considerable experience working with various polymers to achieve desired product characteristics. The finished product composition is a lyophilized vial, containing microspheres and excipients, with only WFI needed for reconstitution

Oakwood’s Chroniject^TM technology solves key challenges for sustained release delivery. It allows for durations ranging from weeks to one year, using a process that is reproducible, scalable, and able to achieve consistent critical quality attributes under cGMP. Chroniject^TM has applications in multiple therapeutic indications, including but not limited to CNS, endocrinology, pain management, and ophthalmology. Formulations can be rapidly developed at lab scale with well controlled process parameters and seamlessly scaled-up to commercial batch sizes. Moreover, critical process parameters can be established using small batches, enabling economic and timely process and product development.

Learning Objectives/Outcomes for attendees:

• Understand the Viatel^TM bioresorbable polymer (BRP) chemistry platforms that exist at Ashland and how chemistry controls are properly utilized to affect change in performance of an extended release long acting drug formulation utilizing BRP’s.

• Explanation of the existing delivery formats including in-situ forming systems, solid implants and particle technologies that have been successful in the market as well as a good understanding of new delivery formats that are being explored in research.

• Consider whether their organization could utilize bioresorbable polymer-based drug delivery platforms as extended release strategies for their drug molecules and how these may be realized

• Understand the development challenges and strategies that exist for a bioresorbable polymer based extended release technology with a good basis to identify challenges per respective molecules and highlight some past-learning outcomes that could accelerate the development timeline.

• Understanding of some common sterilization and processing options that may be applied for bioresorbable polymer-based formulations • detailed case examples of Chroniject^TM microsphere technology at Oakwood labs and how this can be coupled with appropriate bioresorbable polymers to deliver various molecules and tune release

• Demonstrate how well-controlled process parameters can be varied to achieve the desired release of a sustained release injectable product• Understanding how Chroniject^TM microsphere technology is used to solve typical scale up problems with microsphere products, allowing for an increased scale without losing any key product characteristics

• Explore the challenges of producing sterile injectable microsphere-based products under cGMP.

Who Should Attend:

• Scientists

• Pharmaceutical formulators

• Technology stakeholders in the pharmaceutical industry

• Parenteral/injectable stakeholders