| abstract |
(57) [Summary] (Modified) [Purpose] To provide a novel inclusion complex of clavulanic acid and hydrophilic or hydrophobic β-cyclodextrin. An inclusion complex having a molar ratio of clavulanic acid of formula (I) or a pharmaceutically acceptable alkali salt thereof to a hydrophilic or hydrophobic β-cyclodextrin derivative is about 1: 1. A process for its preparation, the use of the inclusion complex as an intermediate compound in the isolation of pure clavulanic acid or its alkali salt and a stable, sustained-release galenic formulation containing the inclusion complex, Further, an inclusion complex of clavulanic acid and a pharmacologically acceptable alkali salt thereof, and a hydrophilic β-CD derivative or a hydrophobic β-CD derivative, a method for producing the same, a complex of the inclusion complex and amoxicillin trioxide. A galenic preparation which is a drug useful for the treatment of infectious diseases, which has immediate release and sustained release properties in combination with a hydrate. (In the formula, R represents hydrogen or an alkali metal). |