Pharmaceutical Compositions Comprising Effervescent Agents And Fenofibrate
A pharmaceutical composition comprising at least one effervescent agent and a fibrate and a process for making such composition. The fibrate is fenofibrate and the effervescent agent are in a dosage form. The dosage form increases dissolution and absorption of fenofibrate in biological conditions where the form contacts acidic gastric fluid after oral administration.
1 . A pharmaceutical composition comprising an effervescent agent and a fibrate.
2 . The composition of claim 1 wherein the fibrate is fenofibrate.
3 . The composition of claim 1 further comprising pharmaceutical excipients.
4 . The composition of claim 2 wherein the effervescent agent is a carbonate.
5 . The composition of claim 4 wherein said carbonate is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, sodium sesquicarbonate, sodium glycine carbonate, L-lysine carbonate, arginine carbonate and calcium carbonate.
6 . The composition of claim 3 wherein the pharmaceutical excipients are selected from the group consisting of disintegrants, fillers, lubricants and antiadherents.
7 . A process for making the composition of claim 2 wherein said process is selected from the group consisting of a mixing process, a granulation process, a coating process and a melt-congealing process.
8 . The process of claim 7 wherein the melt-congealing process comprises the steps of:
incorporating the effervescent agent and other excipients into molten fenofibrate; and
forming a solid dispersion of the effervescent agent and other excipients in fenofibrate that is suitable for manufacturing a finished dosage form.
9 . The process of claim 7 wherein the step of forming a solid dispersion is a rotary atomization process, an extrusion process or a milling process.
10 . The process of claim 7 further comprising the step of preparing a finished dosage form.
11 . The process of claim 10 wherein the finished dosage form is a tablet.
12 . The process of claim 10 wherein the finished dosage form is a capsule.
13 . A method for lowering lipids comprising the administration to a patient in need of such treatment of an effective amount of the pharmaceutical composition of claim 2 .
14 . A method for lowering lipids comprising the administration to a patient in need of such treatment of an effective amount of the pharmaceutical composition prepared by the process of claim 7.