Fibrate-statin Combinations with Reduced Fed-fasted Effects

A dosage form of a pharmaceutical composition comprising a combination of a statin and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a human patient in need of treatment by the statin and fenofibrate a therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species to said patient when fasted that is greater than 80% of the quantity of fenofibrate active species provided by said amount to said patient when fed at least 1000 calories 50% of which are from fat.

An oral dosage form of a pharmaceutical composition comprising a combination of a statin and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a human patient in need of treatment by the statin and fenofibrate a therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species into the blood of said patient when fasted that is between 85% and 115% of the quantity of fenofibrate active species provided by said amount into the blood of said patient when fed at least 1000 calories 50% of which are from fat.

An oral dosage form of a pharmaceutical composition comprising a combination of a statin and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a human patient in need of treatment by the statin and fenofibrate therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species to said patient when fasted that is at least 85% of the AUC quantity of fenofibrate active species provided by said amount to said patient when fed at least 1000 calories 50% of which are from fat.

A method of treatment of dyslipidemia and dyslipoproteinemia in a patient comprising the administration to said patient of a dosage form of a pharmaceutical composition comprising a combination of a statin and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a patient in need of treatment by the statin and fenofibrate a therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species to said patient when fasted that is at least 80% of the quantity of fenofibrate active species provided by said amount to said patient when fed a meal containing fat.

A method of treatment of dyslipidemia and dyslipoproteinemia in a patient comprising the administration to said patient of a dosage form of a pharmaceutical composition comprising a combination of a statin and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a human patient in need of treatment by the statin and fenofibrate a therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species to said patient when fasted that is greater than 80% of the quantity of fenofibrate active species provided by said amount to said patient when fed at least 1000 calories 50% of which are from fat.

A method of treatment of dyslipidemia and dyslipoproteinemia in a patient comprising the administration to said patient of an oral dosage form of a pharmaceutical composition comprising a combination of a statin and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a human patient in need of treatment by the statin and fenofibrate a therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species into the blood of said patient when fasted that is between 85% and 115% of the quantity of fenofibrate active species provided by said amount into the blood of said patient when fed at least 1000 calories 50% of which are from fat.

A method of treatment of dyslipidemia and dyslipoproteinemia in a patient comprising the administration to said patient of an oral dosage form of a pharmaceutical composition comprising a combination of a statin and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a human patient in need of treatment by the statin and fenofibrate a therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species to said patient when fasted that is at least 85% of the AUC quantity of fenofibrate active species provided by said amount to said patient when fed at least 1000 calories 50% of which are from fat.

A capsule or tablet dosage form for oral administration comprising a pharmaceutically effective amount of a composition containing a statin and small particles of a fibrate stabilized by a phospholipid stabilizing agent, a sugar, and optionally a carbohydrate-derived alcohol wherein said amount of said dosage form provides a therapeutically effective dose of the statin and a therapeutically effective level of fibrate active species into the blood of a patient in a fasted state that differs by less than 20% of the level of said fibrate active species that said patient receives in a fed state.

A dosage form of a pharmaceutical composition comprising a combination of a statin, a carbohydrate bulking agent, and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a patient in need of treatment by the statin and fenofibrate a therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species to said patient when fasted that is at least 80% of the quantity of fenofibrate active species provided by said amount to said patient when fed a meal containing fat.

A dosage form of a pharmaceutical composition comprising a combination of a statin, a carbohydrate bulking agent, and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a human patient in need of treatment by the statin and fenofibrate a therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species to said patient when fasted that is greater than 80% of the quantity of fenofibrate active species provided by said amount to said patient when fed at least 1000 calories 50% of which are from fat.

An oral dosage form of a pharmaceutical composition comprising a combination of a statin, a carbohydrate bulking agent, and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a human patient in need of treatment by the statin and fenofibrate a therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species into the blood of said patient when fasted that is between 85% and 115% of the quantity of fenofibrate active species provided by said amount into the blood of said patient when fed at least 1000 calories 50% of which are from fat.

An oral dosage form of a pharmaceutical composition comprising a combination of a statin, a carbohydrate bulking agent, and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a human patient in need of treatment by the statin and fenofibrate a therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species to said patient when fasted that is at least 85% of the AUC quantity of fenofibrate active species provided by said amount to said patient when fed at least 1000 calories 50% of which are from fat.

A method of treatment of dyslipidemia and dyslipoproteinemia in a patient comprising the administration to said patient of a dosage form of a pharmaceutical composition comprising a combination of a statin, a carbohydrate bulking agent, and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a patient in need of treatment by the statin and fenofibrate a therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species to said patient when fasted that is at least 80% of the quantity of fenofibrate active species provided by said amount to said patient when fed a meal containing fat.

A method of treatment of dyslipidemia and dyslipoproteinemia in a patient comprising the administration to said patient of a dosage form of a pharmaceutical composition comprising a combination of a statin, a carbohydrate bulking agent, and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a human patient in need of treatment by the statin and fenofibrate a therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species to said patient when fasted that is greater than 80% of the quantity of fenofibrate active species provided by said amount to said patient when fed at least 1000 calories 50% of which are from fat.

A method of treatment of dyslipidemia and dyslipoproteinemia in a patient comprising the administration to said patient of an oral dosage form of a pharmaceutical composition comprising a combination of a statin, a carbohydrate bulking agent, and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a human patient in need of treatment by the statin and fenofibrate a therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species into the blood of said patient when fasted that is between 85% and 115% of the quantity of fenofibrate active species provided by said amount into the blood of said patient when fed at least 1000 calories 50% of which are from fat.

A method of treatment of dyslipidemia and dyslipoproteinemia in a patient comprising the administration to said patient of an oral dosage form of a pharmaceutical composition comprising a combination of a statin, a carbohydrate bulking agent, and microparticles of fenofibrate that are stabilized by a phospholipid surface active substance, wherein the dosage form provides to a human patient in need of treatment by the statin and fenofibrate a therapeutically effective dose of the statin and a therapeutically effective quantity of fenofibrate active species to said patient when fasted that is at least 85% of the AUC quantity of fenofibrate active species provided by said amount to said patient when fed at least 1000 calories 50% of which are from fat.