Cyclosporine emulsion
The present invention relates to a cyclosporine emulsion containing: i) a cyclosporine ii) a natural oil (long chain triglyceride) iii) a phosphatidylcholine, iv) glycerol, v) a pharmaceutically tolerable alkali salt of a free fatty acid, vi) a medium chain triglyceride-oil vii) optionally, hydrochloric acid or sodium hydroxide for pH adjustment viii) water.
1. A cyclosporine oil-in-water emulsion comprising
i) 5 g/L cyclosporine,
ii) 100 g/L soya bean oil,
iii) 12 g/L egg lecithin,
iv) 25 g/L water-free glycerol,
v) 0.3 g/L sodium oleate,
vi) 100 g/L medium chain triglyceride-oil selected from the group consisting of coconut oil, palm oil, and combinations thereof, and
vii) water for injection,
wherein the emulsion is isoosmolar and has an osmolarity of from 280 to 305 mosm/l, and
wherein the composition does not contain polyethoxylated castor oil.
2. The cyclosporine emulsion according to claim 1 having an osmolarity of from about 295 to about 300 mosm/1.
3. The emulsion according to claim 1 , wherein pH of the emulsion is from about 6 to about 8.8.
4. The cyclosporine emulsion of claim 1 , further comprising: hydrochloric acid or sodium hydroxide for pH adjustment.