IMPROVED PROCESS FOR PREPARING POTASSIUM CLAVULANATE, IST NEW CRYSTALFORM AND MEDICAMENT CONTAINING IT

摘要

Potassium clavulanate in the form of crystalline, rosette-like starbursts such that each rosette-like starburst is clearly discernible under magnification from crystalline starburst form potassium clavulanate and crystalline rosette form potassium clavulanate. Also claimed are (1) preparation of potassium clavulanate in the form of crystalline, rosette-like starbursts comprising (a) concurrently adding a solution of potassium 2-ethyl hexanoate in isopropanol and a solution of t-butylamino clavulanate in aqueous isopropanol to a mixture of isopropanol and acetone; (b) precipitating the crystalline potassium clavulanate (most preferably at 15-17 deg C); and optionally (c) isolating the crystals by filtration; and (2) pharmaceutical composition for treating bacterial infections in humans and animals comprising a synergistically effective amount of rosette-like, starburst form of potassium clavulanate and an antibacterially effective amount of a ~b-lactam compound or its salt or ester in combination with a pharmaceutically acceptable carrier.