Adaptive perfusion: An in vitro release test (IVRT) for complex drug products

In this work, adaptive perfusion, a pressure-driven separation method based on the principle of tangential flow filtration (TFF) was developed for investigating rate and extent drug release from products containing particulates, such as emulsions, suspensions, liposomes, drug-protein complexes. The TFF filters were pre-conditioned with unique conditioning solutions processes to improve fiber reproducibility robustness. perfusion achieved size-based particulates simultaneous analysis released well remaining drug. By contrast conventional dialysis methods, can be used measure solution, loaded micelles nanoemulsions via adjustment filter molecular weight cutoff, feed or back-pressure. Notably, provided discriminatory profiles in micelles, small, medium, large globule size nanoemulsions. profile obtained using found significantly faster (e.g., minutes rather than hours) higher >60%) method. IVRT presented here is free constraints rate-limiting factors, diffusion through membrane, has potential extended further examine impact manufacturing process distribution characteristics other challenging complex products.