AN INJECTABLE PHARMACEUTICAL COMPOSITION CONTAINING A NON-STERIODAL ANTI-INFLAMMATORY DRUG AND METHOD FOR PREPARING THE SAME

摘要

. ABSTRACTAN INJECTABLE PHARMACEUTICAL COMPOSITION CONTAINING A NON-STEROIDAL ANTI-INFLAMMATORY DRUG AND METHOD FOR PREPARING THE SAMEThe present invention provides a stable pharmaceutical composition which contains an acetic acid class of non-steroidal anti-inflammatory drug (NSAID), a phosphate solution. an isotonic agent, and water. The pharmaceutical composition isparticularly suitable for parenteral injection such as intravenous or intramuscular injection. The preferred NSAID is ketorolac tromethamine, which includes any racemic mixture of [-]S and [+]R ketorolac tromethamine. The preferred phosphate solution contains sodium phosphate monobasic (NaH2PO4) or potassium phosphate monobasic (KH,PO4), with or without crystalline water. The preferred isotonic agent is NaCl. The10 pharmaceutical composition is preferably at pH 6.0 to 8.5 and with osmolarity within 0.5 to 3.~