2-Hydroxypropyl-beta-cyclodextrin

2-hydroxypropyl-beta-cyclodextrin (HP-.beta.-CD) is an alpha-, beta- and gamma-cyclodextrins, having improved water solubility and replacement can be more toxicologically benign. This article examines the HP-beta-CD toxicity, using both literature data and new data, and provides new information. In addition, it provides a brief overview of the studies of metabolism and pharmacokinetics of HP-beta-CD in humans and animals. This review concludes that HP-beta-CD is also tolerated in the studied species (rats, mice and dogs), especially when administered orally, and shows only low toxicity. In short-term studies, there was little biochemical changes over the longer term studies, up to three months, generated additional minor hematological changes, but no histopathological changes. Intravenous doses were obtained in the lungs, liver and kidneys, but all results were reversible and no effect level was observed histopathological changes. carcinogenicity studies have shown an increase in tumors in rats in the pancreas and intestine, both of which are considered specific to the rat. There were also non-cancer detected changes in the urinary tract, but these changes were reversible and did not affect renal function. There was no effect on embryo-fetal development in rats or rabbits. HP-beta-CD has been shown in humans to be well tolerated, with the main adverse event was diarrhea, and there were no adverse events on renal function have been documented to date.