The market demand for affordable, regulator-ready ARV generics continues to grow, yet many molecules remain difficult to formulate and scale. One such molecule, Etravirine, presented thermal sensitivity, solubility and stability hurdles that made conventional approaches risky and resource-intensive. Using STEER’s solvent-free FragMelt™ continuous hot-melt fusion platform, STEERLife applied DoE, defined critical process parameters, produced consecutive commercial batches, and developed a robust amorphous solid dispersion (ASD) without using organic solvents.
A biorelevant dissolution method was established when the USP/OGD method proved non-discriminatory. Impurity risks (including N-nitroso) were managed per ICH guidance. The program delivered bioequivalence (fed & fasted), met ICH impurity limits, supported ANDA approval, and validated FragMelt™ as a scalable, regulator-ready route for complex generics.
This case study outlines how STEERLife executed this innovation-driven project to enable the development and manufacturing of generic Etravirine Tablets not just with a difference but key differentiators as well. This end-to-end development project was executed for a partner in North America, resulting in a successful ANDA approval for the drug product despite notable differences from the RLD product both in terms of processes and in-vitro product performance.
