SALTS OF FENOFIBRIC ACID AND PHARMACEUTICAL FORMULATIONS THEREOF
In one aspect, the present invention relates to a formulation in the form of molecular dispersion comprising i) fenofibric acid, a physiologically acceptable salt or derivative thereof and optionally other active substances, ii) a binder component comprising at least one enteric binder, and optionally iii) other physiologically acceptable excipients. In a second aspect, the present invention relates to novel salts of fenofibric acid that are photostable when compared to other salts of fenofibric acid.
1 . A salt of fenofibric acid selected from the group consisting of choline, ethanolamine, diethanolamine, piperazine, calcium and tromethamine.
2 . The salt of claim 1 wherein said salt is choline.
3 . The salt of claim 1 wherein said salt is ethanolamine.
4 . The salt of claim 1 wherein said salt is diethanolamine.
5 . The salt of claim 1 wherein said salt is piperazine.
6 . The salt of claim 1 wherein said salt is calcium.
7 . The salt of claim 1 wherein said salt is tromethamine.
8 . A pharmaceutical formulation in a form of a molecular dispersion comprising:
i. a salt of fenofibric acid selected from the group consisting of choline, ethanolamine, diethanolamine, piperazine, calcium and tromethamine; and
ii. a binder component comprising at least one enteric binder.
9 . The formulation of claim 8 further comprising a physiologically acceptable excipient.
10 . The formulation as claimed in claim 8 , wherein the enteric binder is an enteric polymer.
11 . The formulation as claimed in claim 10 , wherein the enteric polymer is selected from hydroxypropylmethylcellulose phthalate, hydroxypropylmethylcellulose acetate succinate, carboxymethylethylcellulose, cellulose acetate phthalate, cellulose acetate trimellitate and carboxymethylcellulose sodium.
12 . The formulation as claimed in claim 10 , wherein the enteric polymer is a copolymer of (meth)acrylic acid and at least one alkyl (meth)acrylic acid ester.
13 . The formulation as claimed in claim 12 , wherein the alkyl (meth)acrylic acid ester is methyl methacrylate.
14 . The formulation as claimed in claim 8 , wherein the formulation comprises about 5 to about 60% by weight of said salt and about 20 to about 95% by weight of a binder component.
15 . The formulation of claim 9 , wherein the formulation comprises about 1 to about 60% of a physiologically acceptable excipient.