Parenteral diclofenac composition

A parenteral composition in the form of oil-in-water nanoemulsion that comprises:

• (a) 2% w/w to 5% w/w of diclofenac or a pharmaceutically acceptable salt thereof,
• (b) at least one oil component consisting essentially of a medium-chain triglyceride, wherein the at least one oil component is present between about 1% w/w to about 20% w/w,
• (c) at least one phospholipid component, wherein the at least one phospholipid component is present between about 1% w/w to about 20% w/w,
• (d) about 60% w/w to about 80% w/w of an aqueous phase,
• wherein the total concentration of the medium-chain triglyceride and the phospholipid component is in the range from about 15% w/w to about 35% w/w,
• wherein the nanoemulsion has percentage of fat greater than 5 microns (PFAT5) of less than 0.05% when stored at a temperature of about 2-8° C. or about 25° C. for about 12 to about 24 months, and
• wherein the content of the phospholipid component, the oil component and the aqueous phase within the nanoemulsion region in a ternary phase disgram consisting of a phospholipid component, an oil component and an aqueous phase, and the nanoemulsion region is defined by connecting five compositions (A, B, C, D and E) with lines (A-B;
• B-C;
• C-D;
• D-E, and E-A), but not including the lines, in the said ternary phase diagram and the five compositions (A, B, C, D and E), corresponding to weight ratios of the phospholipid component:
• the oil component:
• the aqueous phase of 10:0:86.25 for A, 8:2:86.25 for B, 3:32:61.25 for C, 18:17:61.25 for D and 20:0:76.25 for E.