Injectable preparations of diclofenac and its pharmaceutically acceptable salts

摘要

Injectable formulations of water-soluble salts of diclofenac, which cause significantly less pain at the site of injection and can be administered by intradeltoid route, in addition to intragluteal and slow intravenous route.

主权项

1. An injectable preparation comprising:
(A) at least one water-soluble salt of diclofenac (75 mg); (B) a single co-solvent selected from the group consisting of:
a monohydric alcohol (4% to 25% v/v) selected from the group consisting of benzyl alcohol and ethyl alcohol,a polyhydric alcohol (27% to 45% v/v) selected from the group consisting of propylene glycol, polyethylene glycols having a molecular weight of between 300 to 600 Dalton, glycerin, and 1,3-butylene glycol, andglycofurol (18% to 35% v/v),in combination with water; (C) an alkali selected from the group consisting of sodium hydroxide and potassium hydroxide; and (D) a buffer system selected from the group consisting of phosphate buffer and bicarbonate buffer; wherein the viscosity of the preparation ranges from 1.50 to 4.7 centipoise (CPS); the final volume of the injectable solution is approximately 1 ml; the pH of the injectable solution is maintained at between 8 and 9 by said alkali and said buffer system; and the injectable solution is capable of being administered by the intradeltoid, intragluteal route, and/or slow intravenous route.