Patent ID: 6369219
Filing Date: 2002-04-09
Classification: A61P,C07D

Abstract:
A process for the preparation of a purified alkaline metal salt of clavulanic 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 an additional dry solvent selected from C1 to C6 alcohols and mixtures thereof to the dry organic phase solution; (f) contacting the solution with a diamine of Formula I: wherein the substitutents R, R2, R3 and R4 are independently: hydrogen, C1 to C8 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.