Methods for reducing vein irritation
The present invention provides compositions for delivering highly water-soluble drugs (such as vinca alkaloids) and methods of using such compositions.
1. A method for cancer chemotherapy that substantially avoids vein irritation, said method comprising:
administering an oil-in-water emulsion to a cancer patient, wherein said oil-in-water emulsion comprises a vinorelbine salt and a fatty acid in about a 1:4 molar ratio of vinorelbine salt:fatty acid, wherein said vinorelbine salt is vinorelbine bitartrate and said fatty acid is oleic acid;
wherein said vinorelbine salt is no less than 80% dissolved within the oil phase of said oil-in-water emulsion;
wherein the formulation contains sucrose at about 15%;
and
wherein the formulation has a pH from about 3.5 to about 3.75, to thereby treat cancer and substantially avoid vein irritation.
2. The method of claim 1 , wherein the oil-in-water emulsion further comprises a triglyceride oil and an emulsifier.
3. The method of claim 2 , wherein the triglyceride oil is a triglyceride having long chain fatty acids, a triglyceride having medium chain fatty acids, or a mixture thereof.
4. The method of claim 2 , wherein the triglyceride oil is a triglyceride having long chain fatty acids.
5. The method of claim 2 , wherein the triglyceride oil is a triglyceride having medium chain fatty acids.
6. The method of claim 2 , wherein the triglyceride oil is a mixture of triglyceride having long chain fatty acids and a triglyceride having medium chain fatty acids.
7. The method of claim 2 , wherein the emulsifier is a member selected from the group consisting of egg lecithin, soy lecithin, a synthetic phospholipid, or a mixture thereof.
8. The method of claim 2 , wherein the triglyceride oil is a 1:1 ratio of a medium chain triglyceride and a long chain triglyceride.
9. The method of claim 2 , wherein the emulsifier is egg lecithin.
10. The method of claim 2 , wherein the emulsifier is soy lecithin.
11. The method of claim 2 , wherein the emulsifier is a synthetic phospholipid.
12. The method of claim 2 , wherein the triglyceride is in a range of about 2% to about 40% w/w of the oil-in-water emulsion.
13. The method of claim 2 , wherein the triglyceride is in a range of about 5%, 10%, 15%, 20%, 25%, 30%, or 35% w/w of the oil-in-water emulsion.
14. The method of claim 2 , wherein the emulsifier is in a range of about 2% to about 15% of the oil-in-water emulsion.
15. The method of claim 1 , wherein no less than 90% of vinorelbine is present in the oil phase of the emulsion.
16. The method of claim 1 , wherein no less than 95% of the drug is present in the oil phase of the emulsion.