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|Title:||Salts of fenofibric acid and pharmaceutical formulations thereof|
|Abstract:||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.|
|Inventor(s):||Cink; Russell Drew (Grayslake, IL), Paterson, Jr.; Joseph B. (Vernon Hills, IL), Gao; Yi (Vernon Hills, IL), Zhang; Geoff G. Z. (Libertyville, IL), Long; Michelle A. (Libertyville, IL), Morris; John B. (Grayslake, IL), Rosenberg; Joerg (Ellerstadt, DE)|
|Assignee:||Abbott Laboratories (Abbott Park, IL)|
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.
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