Evaluation of various properties of alternative salt forms of sulfobutylether-β-cyclodextrin, (SBE) 7M-β-CD

Abstract

The goal of this study was to evaluate alternative salt forms of (SBE) 7M-β-CD (currently the sodium salt). The potential salt form would ideally decrease the rate of (SBE) 7M-β-CD release from osmotic pump formulations and result in an increase in the rate and extent of drug release in osmotic pump tablet and pellet dosage forms. Several (SBE) 7M-β-CD salt forms (potassium, calcium, and two ethylene diamine salt forms) were prepared by either titration or ultrafiltration and characterized by elemental analysis and capillary electrophoresis, CE. The physical properties (water uptake behavior, osmolality, complexation characteristics, etc.) were then compared to the sodium salt form. Although the water isotherm and the binding characteristics using various model drugs were similar among all the salt forms, the calcium salt form appeared to be the best alternative candidate due to its lower osmolality and slower intrinsic dissolution rate.