AN INTRAVENOUS TOXICITY STUDY OF 2-HYDROXYPROPYL-BETA-CYCLODEXTRIN, A USEFUL DRUG SOLUBILIZER, IN RATS AND MONKEYS

The subacute and subchronic intravenous (i.v.) toxicity of 2-hydroxypropyl-β-cyclodextrin (HPCD) was examined in Sprague-Dawley rats and cynomolgus monkeys. After either 14 or 90 days of alternate day dosing with either saline or 200 mg/kg HPCD, no toxicologically meaningful differences were observed in the following parameters: body weight, body weight gain, food consumption, hematology, clinical chemistry, organ weights, organ to brain weight ratio, organ to body weight ratio and macroscopic and microscopic histopathology. Subsequent to these studies, an acute high-dose study was performed in cynomolgus monkeys which indicated that a single i.v. dose of HPCD as high as 10 g/kg was not lethal. © 1990.