FORMULATION AND DEVELOPMENT OF HIGH COCENTRATION DICLOFENAC SODIUM INJECTION USING MIXED SOLVENCY CONCEPT AND ITS EVALUATION

The objective of Present research is explore the application of mixed solvency concept in formulation development of injectable dosage form and to provide single dose aqueous injection formulation (in the form of aqueous solution) of sparingl y soluble salt of diclofenac in concentration of 75mg/ml, which cause significantly less pain at site of administration and can be administered by intradeltoid route, in addition to intragluteal and slow IV route. Mixed Solvency concept proposed the every substance present on the earth whether solid, liquid or gas posses solubilising power. Hence for the first time solid solublisers were introduced for formulation development of diclofenac sodium injection (75mg/ml). Present study suggests that diclofenac can be solublised in maximum concentration of 115 mg/ml in solution of niacinamide and caffeine (10% w/w of each solubliser). It is important to note that caffeine is itself poorly water soluble substance. Niacinamide act as a solvent for caffeine and then both solids solublises diclofenac sodium.