Development of bio-predictive in vitro release testing for long acting injectables

Recent innovations in healthcare technology aim to improve patients centricity of parenteral drug delivery. Clinical technologies that can deliver improved compliance while improving patient care and quality of life, include long acting injectable and pain-free intradermal delivery devices. With the growing number of long acting injection programs at GSK, the ability to model such formulations at an early stage will be an important step toward shortening development timelines, reducing cost, annual usage, and gaining an overall better understanding of clinical performance. We have a significant gap in our ability to assess the release rates of long acting injectable formulations prior to annual studies. Randy Mrsny's group developed the scissor system for the sub-Q space; continuing to adapt and develop these systems for the IM space is the next challenge.