The Islatravir polymeric (EVA9) subdermal Implant under development for HIV pre-exposure prophylaxis (HIV-PrEP) targets prolonged prophylaxis through sustained release of drug for a long term such a year or two. Developing and optimizing an accelerated in-vitro release (Acc-IVR) method has been a core strategy to evaluate the dissolution performance and to enable more efficient and relevant formulation development. The Acc-IVR method is expected to reveal the release behavior in a much shorter time scale, while being predictive of real-time IVR (RT-IVR), which is expected to follow the Higuchi model equation.
In this study, an Agilent 400-DS Apparatus 7 was used to establish a consistent relationship between the RT- and Acc-IVR methods across multiple strengths of the implant. The solubility of Islatravir in diluents was found to be the major driving force of acceleration, explaining the potential applicability of this Acc-IVR or similar methods on other long-acting drug formulation form.
Learning Objectives:
Upon completion, participant will be able to learn about on general release mechanism of the long-acting drug formulation implant form.
Upon completion, participant will be able to learn about on general relationship between Higuchi model and drug release of the long-acting drug formulation implant form.
Upon completion, participant will be able to learn about the potential applicability of an accelerated in-vitro release method on the long-acting drug formulation implant form.