Nonclinical Vehicle Formulations:HP-β-CD (Hydroxypropyl-Beta-Cyclodextrin) & The Risk of Hemolysis

Beta-cyclodextrin is a commonly used excipient in nonclinical vehicle formulations. In a recent study, vehicle formulated with 35% HP-β-CD resulted in hemolysis after a 5–10-minute
intravenous (IV) infusion in Sprague Dawley rats, as evidenced by red urine, increased serum bilirubin levels, and increased clinical pathology hemolysis scores.

During subcutaneous (SC) administration using 11.6% HP-β-CD, hemolysis did not occur, though histopathological changes at the injection site indicated local toxicity (edema, mixed inflammation, hemorrhage, and myofiber degeneration) 24 hours post dose.

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