Stable compositions of fenofibrate with fatty acid esters
A pharmaceutical composition in unit dose form of fenofibrate and a solvent system of fatty acid esters, wherein the fenofibrate is substantially dissolved in the solvent system.
1 . A pharmaceutical composition in unit dose form, comprising fenofibrate and a solvent system comprising fatty acid esters, wherein the fenofibrate is substantially dissolved in the solvent system.
2 . The pharmaceutical composition of claim 1 , wherein the fenofibrate is essentially completely dissolved in the solvent system.
3 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is stable for at least six months at room temperature.
4 . The pharmaceutical composition of claim 1 , wherein either the acid portion or the alcohol portion of the fatty acid esters comprises a C 1 to C 15 group.
5 . The pharmaceutical composition of claim 1 , wherein either the acid portion or the alcohol portion of the fatty acid esters comprises a C 1 to C 6 group.
6 . The pharmaceutical composition of claim 1 , wherein either the acid portion or the alcohol portion of the fatty acid esters comprises a C 1 to C 4 group.
7 . The pharmaceutical composition of claim 1 , wherein the fatty acid esters comprise omega-3, omega-5, omega-6, omega-7, or omega-9 fatty acid esters or pharmaceutically acceptable derivatives, conjugates, precursors or salts thereof, or mixtures thereof.
8 . The pharmaceutical composition of claim 1 , wherein the fatty acid esters comprise sterol or stanol fatty acid esters or pharmaceutically acceptable derivatives, conjugates, precursors or salts thereof, or mixtures thereof.
9 . The pharmaceutical composition of claim 1 , wherein the solvent system contains less than 50% w/w, based on the total weight of the solvent system, of at least one solubilizer other than the fatty acid esters.
10 . The pharmaceutical composition of claim 1 , wherein the solvent system consists of the fatty acid esters.
11 . The pharmaceutical composition of claim 1 , wherein the solvent system further comprises at least one solubilizer other than the fatty acid esters in a weight ratio of fatty acid esters to solubilizer of at least 0.5 to 1.
12 . The pharmaceutical composition of claim 1 , wherein the solvent system contains less than 20% w/w, based on the total weight of the solvent system, of at least one hydrophilic solvent.
13 . The pharmaceutical composition of claim 1 , wherein the fenofibrate is crystalline fenofibrate that has not been micronized or exposed to other mechanical techniques.
14 . The pharmaceutical composition of claim 1 , wherein the fenofibrate has a mean particle size of at least 25 μm.
15 . A method of making a pharmaceutical composition, comprising providing crystalline fenofibrate that has not been micronized or exposed to other mechanical techniques, and substantially dissolving the fenofibrate in a solvent system comprising fatty acid esters.
16 . The method of claim 15 , wherein the fenofibrate has a mean particle size of at least 25 μm.
17 . The method of claim 15 , wherein the fenofibrate is essentially completely dissolved in the solvent system.
18 . The method of claim 15 , wherein the fatty acid esters comprise omega-3, omega-5, omega-6, omega-7, or omega-9 fatty acid esters or pharmaceutically acceptable derivatives, conjugates, precursors or salts thereof, or mixtures thereof.
19 . The method of claim 15 , wherein the fatty acid esters comprise sterol or stanol fatty acid esters or pharmaceutically acceptable derivatives, conjugates, precursors or salts thereof, or mixtures thereof.