AN INJECTABLE PREPARATION OF DICLOFENAC SALTS WITH HYDROXYPROPYL- BETA CYCLODEXTRIN AND POLYSORBATE 80

摘要

The present invention relates to injectable preparations containing 75 mg to 100 mg of water soluble salts of diclofenac in about 1ml injection solution, wherein the pH of the solution is maintained at 8-9 using alkali. The composition is suitable for parenteral administration through intramuscular, intravenous, subcutaneous, intradeltoid, intragluteal route of administration. More specifically, the injectable preparations comprise 75 mg/ml of diclofenac sodium in a solvent system containing water and two or more solubilizers along with antioxidants and buffering agents. The invention also provides a method of preparing the injectable preparations. WO2016170401A1