Patent ID: 6180782
Filing Date: 2001-01-30
Classification: A61P,C07D

Abstract:
A process for the preparation of a purified alkaline metal salt of clavulanic acid comprising:(a) removing solids from a clavulanic acid-containing fermentation broth by microfiltration to form a filtrate;(b) concentrating the filtrate by removal of water to form a concentrate;(c) extracting the concentrate with a water immiscible solvent to form an organic phase solution comprising clavulanic acid;(d) drying the organic phase solution;(e) adding dry methanol to the dry organic phase solution;(f) contacting the solution with a diamine of Formula I: ##STR2##wherein the substituents R, R.sub.2, R.sub.3 and R.sub.4 are independently: hydrogen; C.sub.1 to C.sub.8 straight or branched alkyl;(g) isolating alkylene diammonium diclavulanate formed; and(h) reacting the alkylene diammonium diclavulanate with a source of a pharmaceutically acceptable alkaline metal to form a purified alkaline metal clavulanate salt.