Synthesis and evaluation of β-Cyclodextrin-Epichlorohydrin inclusion complex as a pharmaceutical excipient

Abstract

A water soluble Beta-cyclodextrin-epichlorohydrin complex (Beta-CDEPI) was synthesized by one-step condensation polymerization. Drug- Beta-CDEPI inclusion complexes were prepared and characterized. Inclusion complexes prepared using lyophilization technique was used to formulate orodispersible tablets. Compatibility studies showed no interaction and characterization proved substantial inclusion complex formation. Drug content was found between 97-99%. In-vitro disintegration time was found to be less than 3 minutes and all the formulations showed complete drug release of 100% within 15 minutes. The formulations were found to be stable for a period of 6 months. Beta-CDEPI polymer enhances the solubility and thus effectively can be utilized to improve the aqueous solubility of poorly water soluble drugs.