Long-Acting Injectables: Successful Microsphere Development and Scale-Up

Previously Aired on December 8th, 2022

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Overview

Ashland and Oakwood Laboratories will showcase application of Viatel™ bioresorbable polymers and customized chemistry in long-acting injectable (LAI) microsphere formulations from the Chroniject™ platform exploring:

  • An overview of the LAI field
  • Relevant polymer selection per API and target release profiles
  • Microsphere manufacturing technologies and problem solving
  • Tuning drug release and profiles for weeks to several months
  • Customized chemistry options to solve stability challenges
  • Successful scale-up and manufacture of robust microspheres
 
Ashland will show how chemistry can be coupled with formulation knowledge for in-situ forming depots, microspheres/nanoparticles, and pre-formed solid implants. Viatel™ customized chemistry and its versatility to solve formulation challenges will be discussed.

Oakwood Labs will showcase their Chroniject™ microsphere technology platform, specifically the effect of polymer selection and process parameters for optimizing drug load, release duration, particle size, and encapsulation efficiency. These results will be based on (1) a small molecule, and (2) a peptide with varied release needs.

Chroniject™ allows for release durations ranging from weeks to one year, using a process that is reproducible, scalable, and able to achieve consistent critical quality attributes under cGMP for multiple therapeutic indications.


Ashland offers multiple excipients | parenteral dosage form for long-acting injectables including:

Presenters

Presenter
Seán McMahon, B.Eng., M.Sc., Ph.D.
(Presenter)
Business & Technical Manager for Bioresorbable Polymers
Ashland
View Biography
Presenter
Rachel Galaska
(Presenter)
Engineer II | R&D – Formulations
Oakwood Laboratories
View Biography
Presenter
Mike Auerbach
(Moderator)
Editor-in-Chief,
American Pharmaceutical Review