Drug Development & Delivery published an interesting review on sulfobutyl ether beta-cyclodextrin (Captisol) in its October issue (2023). In addition to the story of the development the renal safety studies have been overviewed. “Despite the 20-plus years of patient experience, partners and regulatory agencies still had concerns about the renal safety of Captisol in severely renally impaired patients. Such concerns have been raised because Captisol is eliminated by glomerular filtration and has the potential to accumulate in patients with compromised renal function.” Clinical studies, especially those with VEKLURY including subjects with acute kidney injury or chronic kidney disease with end-stage kidney disease requiring hemodialysis, concluded that no adverse effects on renal functions were observed. These studies resulted in changed regulations: “No dosage adjustment of VEKLURY is recommended for patients with any degree of renal impairment, including those on dialysis…” is necessary.
V. Antle, J.D. Pipkin, L. Rejewsk: SOLUBILIZING & STABILIZING TECHNOLOGY – CAPTISOL® – Part Perseverance & Part Serendipity. Drug Development & Delivery 2023, 7, 32-38. https://drug-dev.com/solubilizing-stabilizing-technology-captisol-part-perseverance-part-serendipity/