PHARMACEUTICALLY ACCEPTABLE SALTS OF FATTY ACIDS
The present disclosure provides pharmaceutically acceptable stable salt forms of 15-lipoxygenase products, such as 15-HETrE lysine salt, compositions comprising same and methods of making and using same.
1 . A salt of a 15-lipoxygenase product.
2 . The salt of claim 1 , wherein the salt is a pharmaceutically acceptable salt.
3 . The salt of claim 1 , wherein the salt comprises a lysine salt of the 15-lipoxygenase product.
4 . The salt of claim 1 , wherein the salt comprises a sodium salt of the 15-lipoxygenase product.
5 . The salt of claim 1 , wherein the salt comprises an ornithine salt of the 15-lipoxygenase product.
6 . The salt of claim 1 , wherein the salt comprises a piperazine salt of the 15-lipoxygenase product.
7 . The salt of claim 1 , wherein the salt comprises a meglumine salt of the 15-lipoxygenase product.
8 . The salt of claim 1 further comprising the 15-lipoxygenase product in free acid form.
9 . The salt of claim 1 , wherein the salt is selected from the group consisting of: sodium, lysine, ornithine, piperazine, meglumine, and combinations thereof.
10 . The salt of claim 1 , wherein the 15-lipoxygenase product is selected from the group consisting of: 13-HODE, 15-HETrE, 15-OHEPA, 15-HETE, and combinations thereof.
11 . 15-Hydroxy-5,8,11,13-eicosatetraenoic acid lysine salt.
12 . A pharmaceutical composition comprising a salt form of a 15-lipoxygenase product.
13 . The pharmaceutical composition of claim 12 further comprising an excipient.
14 . The pharmaceutical composition of claim 12 , wherein after storage for at least about 4 weeks, the pharmaceutical composition comprises at least about 98%, at least about 99%, or about 100% of an initial amount of the salt form of the 15-lipoxygenase product.
15 . The pharmaceutical composition of claim 12 , wherein after storage for at least about 10 weeks or at least 24 weeks, the pharmaceutical composition comprises at least about 90%, at least about 91%, at least about 92%, at least about 93%, at least about 94%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, or about 100% of an initial amount of the salt form of the 15-lipoxygenase product.
16 . The pharmaceutical composition of claim 12 , wherein the pharmaceutical composition comprises a therapeutically effective amount of the salt of the 15-lipoxygenase product.
17 . The pharmaceutical composition of claim 12 , wherein the pharmaceutical composition is in a form suitable for topical administration.
18 . A method of treating a disease or disorder in subject in need thereof, the method comprising administering to the subject the pharmaceutical composition of claim 12 .
19 . The method of claim 18 , wherein the disease or disorder is selected from the group consisting of: acne, erythema, infection, fatty liver, neuropathy, and skin inflammation.