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Last Updated: March 28, 2024

Details for Patent: 7,276,249


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Title:Nanoparticulate fibrate formulations
Abstract: The present invention is directed to fibrate compositions having improved pharmacokinetic profiles and reduced fed/fasted variability. The fibrate particles of the composition have an effective average particle size of less than about 2000 nm.
Inventor(s): Ryde; Tuula (Malvern, PA), Gustow; Evan E. (Villanova, PA), Ruddy; Stephen B. (Schwenksville, PA), Jain; Rajeev (Collegeville, PA), Patel; Rakesh (Bensalem, PA), Wilkins; Michael John (Co. Cork, IE)
Assignee: Elan Pharma International, Ltd. (Athlone, Co. Westmeath, IE) Fournier Laboratories Ireland Ltd. (Cork, IE)
Filing Date:May 23, 2003
Application Number:10/444,066
Claims:1. A stable fenofibrate composition for oral administration comprising: (a) particles of fenofibrate having a D50 particle size of less than about 500 nm, and (b) at least one surface stabilizer, wherein: (i) the composition exhibits bioequivalence upon administration to a human subject in a fed state as compared to administration to a human subject in a fasted state; where bioequivalency is established by: (a) a 90% Confidence Interval for AUC which is between 80% and 125%, and (b) a 90% Confidence Interval for C.sub.max, which is between 80% and 125%; (ii) the composition redisperses in a biorelevant media; and (iii) the composition is phospholipid-free.

2. The composition of claim 1, which is bioequivalent to a micronized 54 mg fenofibrate oral solid dosage form.

3. The composition of claim 1, which is bioequivalent to a micronized 160 mg fenofibrate oral solid dosage form.

4. The composition of claim 3, which is a single daily dose.

5. The composition of claim 1, which is bioequivalent to a micronized 200 mg fenofibrate oral solid dosage form.

6. The composition of claim 5, which is a single daily dose.

7. The composition of claim 1, wherein the difference in AUC of the fenofibrate composition, when administered to a human subject in the fed versus the fasted state, is selected from the group consisting of less than about 35%, less than about 30%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, and less than about 3%.

8. The composition of claim 1, which when administered to a human subject at a dose of about 160 mg presents an AUC of about 139 .mu.g/mL.h.

9. The composition of claim 1 which exhibits a T.sub.max after administration to fasting human subjects selected from the group consisting of less than about 6 hours, less than about 5 hours, less than about 4 hours, less than about 3 hours, less than about 2 hours, less than about 1 hour, and less than about 30 minutes.

10. The composition of claim 1, wherein in comparative pharmacokinetic testing with a 160 mg micronized fenofibrate tablet or 200 mg micronized fenofibate capsule, which are standard commercial formulations of microcrystalline fenofibrate, the composition of claim 136 exhibits a T.sub.max selected from the group consisting of less than about 90%, less than about 80%, less than about 70%, less than about 50%, less than about 30%, and less than about 25% of the T.sub.max exhibited by the micronized fenofibate tablet or capsule.

11. The composition of claim 1, wherein the fenofibrate is present in an amount selected from the group consisting of: (a) about 50 to about 500 g of fenofibrate per kg of composition; (b) about 100 to about 300 g of fenofibrate per kg of composition; (c) about 200 to about 225 g of fenofibrate per kg of composition; and (d) about 119 to about 224 g of fenofibrate per kg of composition.

12. The composition of claim 1 comprising a dosage of about 145 mg of fenofibrate, wherein: (a) the dosage is therapeutically effective; and (b) the composition is bioequivalent to a 160 mg micronized fenofibate tablet or 200 mg micronized fenofibate capsule, wherein bioequivalency, when administered to a human, is established by a 90% Confidence Interval of between 0.80 and 1.25 for both C.sub.max and AUC.

13. The composition of claim 1 comprising a dosage of about 48 mg of fenofibrate, wherein: (a) the dosage is therapeutically effective; and (b) the composition is bioequivalent to a 54 mg micronized fenofibate tablet, wherein biocquivalency, when administered to a human, is established by a 90% Confidence Interval of between 0.80 and 1.25 for both C.sub.max and AUC.

14. The composition of claim 1 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least 4.5 .mu.g/mL at one hour.

15. The composition of claim 1 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least 6.5 g/mL at two hours.

16. The composition of claim 1 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least 7.0 .mu.g/mL at three hours.

17. The composition of claim 1 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least 1.5 .mu.g/mL at twenty-four hours.

18. The composition of claim 1 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least: (a) 1.0 .mu.g/mL at one hour; (b) 6.5 .mu.g/mL at two hours; (c) 7.0 .mu.g/mL at three hours; and (d) 1.5 .mu.g/mL at twenty-four hours.

19. The composition of claim 1 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 4.5 .mu.g/mL at one hour.

20. The composition of claim 1 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 3.0 .mu.g/mL at two hours.

21. The composition of claim 1 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 6.0 .mu.g/mL at four hours.

22. The composition of claim 1 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 6.5 .mu.g/mL at five hours.

23. The composition of claim 1 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 1.5 .mu.g/mL at twenty-four hours.

24. The composition of claim 1 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least: (a) 4.5 .mu.g/mL at one hour; (b) 3.0 .mu.g/mL at two hours; (c) 6.0 .mu.g/mL at four hours; (d) 6.5 .mu.g/mL at five hours; and (e) 1.5 .mu.g/mL at twenty-four hours.

25. The composition of claim 1, wherein the fenofibrate is selected from the group consisting of a crystalline phase, an amorphous phase, a semi-crystalline phase, a semi-amorphous phase, and mixtures thereof.

26. The composition of claim 1, wherein the D50 particle size of the particles of fenofibrate is selected from the group consisting of less than about 400 nm, less than about 300 nm, less than about 250 nm, less than about 200 nm, less than about 150 nm, less than about 100 nm, less than about 75 nm, and less than about 50 nm.

27. The composition of claim 1, wherein the particles of fenofibrate have a particle size in which the D.sub.99 is less than about 500 nm.

28. The composition of claim 1, wherein the particles of fenofibrate have a particle size in which the D.sub.50 is less than about 350 nm.

29. The composition of claim 1, wherein the particles of fenofibrate have a mean particle size of less than about 100 nm.

30. The composition of claim 1, wherein the composition is formulated for administration selected from the group consisting of oral, pulmonary, rectal, opthalmic, colonic, parenteral, intracistemal, intravaginal, intraperitoneal, local, buccal, nasal, and topical administration.

31. The composition of claim 1 formulated into a dosage form selected from the group consisting of liquid dispersions, oral suspensions, gels, aerosols, ointments, creams, tablets, and capsules.

32. The composition of claim 31 formulated into a dosage form selected from the group consisting of tablets and capsules.

33. The composition of claim 32 formulated into a tablet.

34. The composition of claim 1 formulated into a dosage form selected from the group consisting of controlled release formulations, fast melt formulations, lyophilized formulations, delayed release formulations, extended release formulations, pulsatile release formulations, and mixed immediate release and controlled release formulations.

35. The composition of claim 1 further comprising one or more pharmaceutically acceptable excipients, carriers, or a combination thereof.

36. The composition of claim 1, wherein within about 5 minutes at least about 20% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

37. The composition of claim 1, wherein within about 10 minutes at least about 40% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

38. The composition of claim 1, wherein within about 20 minutes at least about 70% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

39. The composition of claim 1, wherein: (a) within about 5 minutes at least about 30% of the composition is dissolved; (b) within about 10 minutes at least about 70% of the composition is dissolved; and (c) within about 20 minutes at least about 90% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

40. The composition of claim 1, wherein: (a) within about 5 minutes at least about 40% of the composition is dissolved; (b) within about 10 minutes at least about 80% of the composition is dissolved; and (c) within about 20 minutes at least about 100% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

41. The composition of claim 1, additionally comprising one or more active agents selected from the group consisting of HMG CoA reductase inhibitors and antihypertensives.

42. The composition of claim 1, wherein within about 5 minutes at least about 30% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

43. The composition of claim 1, wherein within about 5 minutes at least about 40% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

44. The composition of claim 1, wherein within about 10 minutes at least about 50% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

45. The composition of claim 1, wherein within about 10 minutes at least about 60% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

46. The composition of claim 1, wherein within about 10 minutes at least about 70% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

47. The composition of claim 1, wherein within about 10 minutes at least about 80% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

48. The composition of claim 1, wherein within about 20 minutes at least about 80% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

49. The composition of claim 1, wherein within about 20 minutes at least about 90% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

50. The composition of claim 1, wherein within about 20 minutes at least about 100% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

51. The composition of claim 1, wherein upon administration the composition redisperses such that the redispersed particles of fenofibrate or a salt thereof have a D50 particle size selected from the group consisting of less than about 500 nm, less than about 400 nm, less than about 300 nm, less than about 250 nm, less than about 200 nm, less than about 150 nm, less than about 100 nm, less than about 75 nm, and less than about 50 nm.

52. The composition of claim 1, wherein the composition redisperses in a biorelevant media such that the redispersed particles of fenofibrate or a salt thereof have a D50 particle size selected from the group consisting of less than about 500 nm, less than about 400 nm, less than about 300 nm, less than about 250 nm, less than about 200 nm, less than about 150 nm, less than about 100 nm, less than about 75 nm, and less than about 50 nm.

53. A stable fenofibrate composition for oral administration comprising: (a) particles of fenofibrate having a D50 particle size of less than about 500 nm in a dosage form for oral administration which is a tablet or capsule of about 145 mg of fenofibrate, and (b) at least one surface stabilizer, wherein: (i) the composition exhibits bioequivalence upon administration to a human subject in a fed state as compared to administration to a human subject in a fasted state; where bioequivalency is established by: (a) a 90% Confidence Interval for AUC which is between 80% and 125%, and (b) a 90% Confidence Interval for C.sub.max, which is between 80% and 125%; (ii) the composition redisperses in a biorelevant media; and (iii) the composition is phospholipid-free.

54. The composition of claim 1, comprising at least one primary surface stabilizer and at least one secondary surface stabilizer.

55. The composition of claim 1, wherein the surface stabilizer is selected from the group consisting of an anionic surface stabilizer, a non-ionic surface stabilizer, a eationic surface stabilizer, a zwitterionic surface stabilizer, and an ionic surface stabilizer.

56. The composition of claim 1, wherein the at least one surface stabilizer is selected from the group consisting of cetyl pyridinium chloride, gelatin, casein, phosphatides, dextran, glycerol, gum acacia, cholesterol, tragacanth, stearic acid, benzalkonium chloride, calcium stearate, glycerol monostearate, cetostearyl alcohol, cetomacrogol emulsifying wax, sorbitan esters, polyoxyethylene alkyl ethers, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, polyethylene glycols, dodecyl trimethyl ammonium bromide, polyoxyethylene stearates, colloidal silicon dioxide, phosphates, sodium dodecylsulfate, carboxymethylcellulose calcium, hydroxypropyl celluloses, hypromellose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylcellulose, hypromellose phthalate, noncrystalline cellulose, magnesium aluminum silicate, triethanolamine, polyvinyl alcohol, polyvinylpyrrolidone, 4-(1,1,3,3-tetramethylbutyl)-phenol polymer with ethylene oxide and formaldehyde, poloxamers; poloxamines, dioctylsulfosuccinate, dialkylesters of sodium sulfosuccinic acid, sodium lauryl sulfate, alkyl aryl polyether sulfonates, mixtures of sucrose stearate and sucrose distearate, p-isononylphenoxypoly-(glycidol), decanoyl-N-methylglucamide; n-decyl .beta.-D-glucopyranoside; n-decyl .beta.-D-maltopyranoside; n-dodecyl .beta.-D-glucopyranoside; n-dodecyl .beta.-D-maltoside; heptanoyl-N-methylglucamide; n-heptyl-.beta.-D-glucopyranoside; n-heptyl .beta.-D-thioglucoside; n-hexyl .beta.-D-glucopyranoside; nonanoyl-N-methylglucamide; n-noyl .beta.-D-glucopyranoside; octanoyl-N-methylglucamide; n-octyl-.beta.-D-glucopyranoside; octyl .beta.-D-thioglucopyranoside; lysozyme, PEG-cholesterol, PEG-cholesterol derivative, PEG-vitamin A, and random copolymers of vinyl acetate and vinyl pyrrolidone.

57. The composition of claim 1, wherein the at least one cationic surface stabilizer is selected from the group consisting of a polymer, a biopolymer, a polysaccharide, a cellulosic, an alginate, a nonpolymeric compound, cationic lipids, polymethylmethacrylate trimethylammonium bromide, sulfonium compounds, polyvinylpyrrolidone-2-dimethylaminoethyl methacrylate dimethyl sulfate, hexadecyltrimethyl ammonium bromide, phosphonium compounds, quarternary ammonium compounds, benzyl-di(2-chloroethyl)ethylammonium bromide, coconut trimethyl ammonium chloride, coconut trimethyl ammonium bromide, coconut methyl dihydroxyethyl ammonium chloride, coconut methyl dihydroxyethyl ammonium bromide, decyl triethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride bromide, C.sub.12-15dimethyl hydroxyethyl ammonium chloride, C.sub.12-15dimethyl hydroxyethyl ammonium chloride bromide, coconut dimethyl hydroxyethyl ammonium chloride, coconut dimethyl hydroxyethyl ammonium bromide, myristyl trimethyl ammonium methyl sulphate, lauryl dimethyl benzyl ammonium chloride, lauryl dimethyl benzyl ammonium bromide, lauryl dimethyl (ethenoxy).sub.4 ammonium chloride, lauryl dimethyl (ethenoxy).sub.4 ammonium bromide, N-alkyl (C.sub.12-18)dimethylbenzyl ammonium chloride, N-alkyl (C.sub.14-18)dimethyl-benzyl ammonium chloride, N-tetradecylidmethylbenzyl ammonium chloride monohydrate, dimethyl didecyl ammonium chloride, N-alkyl and (C.sub.12-14) dimethyl 1-napthylmethyl ammonium chloride, trimethylammonium halide, alkyl-trimethylammonium salts, dialkyl-dimethylammonium salts, lauryl trimethyl ammonium chloride, ethoxylated alkyamidoalkyldialkylammonium salt, an ethoxylated trialkyl ammonium salt, dialkylbenzene dialkylammonium chloride, N-didecyldimethyl ammonium chloride, N-tetradecyldimethylbenzyl ammonium, chloride monohydrate, N-alkyl(C.sub.12-14) dimethyl 1-naphthylmethyl ammonium chloride, dodecyldimethylbenzyl ammonium chloride, dialkyl benzenealkyl ammonium chloride, lauryl trimethyl ammonium chloride, alkylbenzyl methyl ammonium chloride, alkyl benzyl dimethyl ammonium bromide, C.sub.12 trimethyl ammonium bromides, C.sub.15 trimethyl ammonium bromides, C.sub.17 trimethyl ammonium bromides, dodecylbenzyl triethyl ammonium chloride, poly-diallyldimethylammonium chloride (DADMAC), dimethyl ammonium chlorides, alkyldimethylammonium halogenides, tricetyl methyl ammonium chloride, decyltrimethylammonium bromide, dodecyltriethylammonium bromide, tetradecyltrimethylammonium bromide, methyl trioctylammonium chloride, polyquaternium-10, tetrabutylammonium bromide, benzyl trimethylammonium bromide, choline esters, benzalkonium chloride, stearalkonium chloride compounds, cetyl pyridinium bromide, cetyl pyridinium chloride, halide salts of quaternized polyoxyethylalkylamines, polyquaternium compounds, alkyl pyridiium salts; amines, amine salts, amine oxides, imide azolinium salts, protonated quaternary acrylamides, methylated quaternary polymers, and cationic guar.

58. The composition of claim 1, comprising hypromellose, dioctyl sodium sulfosuccinate, and sodium lauryl sulfate as surface stabilizers.

59. The composition of claim 53, comprising at least one primary surface stabilizer and at least one secondary surface stabilizer.

60. The composition of claim 53, wherein the surface stabilizer is selected from the group consisting of an anionic surface stabilizer, a non-ionic surface stabilizer, a cationic surface stabilizer, a zwitterionic surface stabilizer, and an ionic surface stabilizer.

61. The composition of claim 53, wherein the at least one surface stabilizer is selected from the group consisting of cetyl pyridinium chloride, gelatin, casein, phosphatides, dextran, glycerol, gum acacia, cholesterol, tragacanth, stearic acid, benzalkonium chloride, calcium stearate, glycerol monostearate, cetostearyl alcohol, cetomacrogol emulsifying wax, sorbitan esters, polyoxyethylene alkyl ethers, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, polyethylene glycols, dodecyl trimethyl ammonium bromide, polyoxyethylene stearates, colloidal silicon dioxide, phosphates, sodium dodecylsulfate, carboxymethylcellulose calcium, hydroxypropyl celluloses, hypromellose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylcellulose, hypromellose phthalate, noncrystalline cellulose, magnesium aluminum silicate, triethanolamine, polyvinyl alcohol, polyvinylpyrrolidone, 4-(1,1,3,3-tetramethylbutyl)-phenol polymer with ethylene oxide and formaldehyde, poloxamers; poloxamines, dioctylsulfosuccinate, dialkylesters of sodium sulfosuccinic acid, sodium lauryl sulfate, alkyl aryl polyether sulfonates, mixtures of sucrose stearate and sucrose distearate, p-isononylphenoxypoly-(glycidol), decanoyl-N-methylglucamide; n-decyl .beta.-D-glucopyranoside; n-decyl .beta.-D-maltopyranoside; n-dodecyl .beta.-D-glucopyranoside; n-dodecyl .beta.-D-maltoside; heptanoyl-N-methylglucamide; n-heptyl-.beta.-D-glucopyranoside; n-heptyl .beta.-D-thioglucoside; n-hexyl .beta.-D-glucopyranoside; nonanoyl-N-methylglucamide; n-noyl .beta.-D-glucopyranoside; octanoyl-N-methylglucamide; n-octyl-.beta.-D-glucopyranoside; octyl .beta.-D-thioglucopyranoside; lysozyme, PEG-cholesterol, PEG-cholesterol derivative, PEG-vitamin A, and random copolymers of vinyl acetate and vinyl pyrrolidone.

62. The composition of claim 53, wherein the at least one cationic surface stabilizer is selected from the group consisting of a polymer, a biopolymer, a polysaccharide, a cellulosic, an alginate, a nonpolymeric compound, cationic lipids, polymethylmethacrylate trimethylammonium bromide, sulfonium compounds, polyvinylpyrrolidone-2-dimethylaminoethyl methacrylate dimethyl sulfate, hexadecyltrimethyl ammonium bromide, phosphonium compounds, quartemary ammonium compounds, benzyl-di(2-chloroethyl)ethylammonium bromide, coconut trimethyl ammonium chloride, coconut trimethyl ammonium bromide, coconut methyl dihydroxyethyl ammonium chloride, coconut methyl dihydroxyethyl ammonium bromide, decyl triethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride bromide, C.sub.12-15dimethyl hydroxyethyl ammonium chloride, C.sub.12-15dimethyl hydroxyethyl ammonium chloride bromide, coconut dimethyl hydroxyethyl ammonium chloride, coconut dimethyl hydroxyethyl ammonium bromide, myristyl trimethyl ammonium methyl sulphate, lauryl dimethyl benzyl ammonium chloride, lauryl dimethyl benzyl ammonium bromide, lauryl dimethyl (ethenoxy).sub.4 ammonium chloride, lauryl dimethyl (ethenoxy).sub.4 ammonium bromide, N-alkyl (C.sub.12-18)dimethylbenzyl ammonium chloride, N-alkyl (C.sub.14-18)dimethyl-benzyl ammonium chloride, N-tetradecylidmethylbenzyl ammonium chloride monohydrate, dimethyl didecyl ammonium chloride, N-alkyl and (C.sub.12-14) dimethyl 1-napthylmethyl ammonium chloride, trimethylammonium halide, alkyl-trimethylammonium salts, dialkyl-dimethylammonium salts, lauryl trimethyl ammonium chloride, ethoxylated alkyamidoalkyldialkylammonium salt, an ethoxylated trialkyl ammonium salt, dialkylbenzene dialkylammonium chloride, N-didecyldimethyl ammonium chloride, N-tetradecyldimethylbenzyl ammonium, chloride monohydrate, N-alkyl(C.sub.12-14) dimethyl 1-naphthylmethyl ammonium chloride, dodecyldimethylbenzyl ammonium chloride, dialkyl benzenealkyl ammonium chloride, lauryl trimethyl ammonium chloride, alkylbenzyl methyl ammonium chloride, alkyl benzyl dimethyl ammonium bromide, C.sub.12 trimethyl ammonium bromides, C.sub.15 trimethyl ammonium bromides, C.sub.17 trimethyl ammonium bromides, dodecylbenzyl triethyl ammonium chloride, poly-diallyldimethylammonium chloride (DADMAC), dimethyl ammonium chlorides, alkyldimethylammonium halogenides, tricetyl methyl ammonium chloride, decyltrimethylammonium bromide, dodecyltriethylammonium bromide, tetradecyltrimethylammonium bromide, methyl trioctylammonium chloride, polyquaternium-10, tetrabutylammonium bromide, benzyl trimethylammonium bromide, choline esters, benzalkonium chloride, stearalkonium chloride compounds, cetyl pyridinium bromide, cetyl pyridinium chloride, halide salts of quaternized polyoxyethylalkylamines, polyquaternium compounds, alkyl pyridinium salts; amines, amine salts, amine oxides, imide azolinium salts, protonated quaternary acrylamides, methylated quaternary polymers, and cationic guar.

63. The composition of claim 53, comprising hypromellose, dioctyl sodium sulfosuccinate, and sodium lauryl sulfate as surface stabilizers.

64. A stable fenofibrate composition for oral administration comprising: (a) particles of fenofibrate having a mean particle size of less than about 500 nm, and (b) at least one surface stabilizer, wherein, the surface stabilizer is not selected from the group consisting of sorbitan esters, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters and polyoxylene stearates, wherein: (i) the composition exhibits bioequivalence upon administration to a human subject in a fed state as compared to administration to a human subject in a fasted state; where bioequivalency is established by: (a) a 90% Confidence Interval for AUC which is between 80% and 125%, and (b) a 90% Confidence Interval for C.sub.max, which is between 80% and 125%; (ii) the composition redisperses in a biorelevant media; and (iii) the composition is phospholipid-free.

65. The composition of claim 64, which is bioequivalent to a micronized 54 mg fenofibrate oral solid dosage form.

66. The composition of claim 64, which is bioequivalent to a micronized 160 mg fenofibrate oral solid dosage form.

67. The composition of claim 66, which is a single daily dose.

68. The composition of claim 64, which is bioequivalent to a micronized 200 mg fenofibrate oral solid dosage form.

69. The composition of claim 68, which is a single daily dose.

70. The composition of claim 64, wherein the difference in AUC of the fenofibrate composition, when administered to a human subject in the fed versus the fasted state, is selected from the group consisting of less than about 35%, less than about 30%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, and less than about 3%.

71. The composition of claim 64, which when administered to a human subject at a dose of about 160 mg presents an AUC of about 139 .mu.g/mL.h.

72. The composition of claim 64 which exhibits a T.sub.max after administration to fasting human subjects selected from the group consisting of less than about 6 hours, less than about 5 hours, less than about 4 hours, less than about 3 hours, less than about 2 hours, less than about 1 hour, and less than about 30 minutes.

73. The composition of claim 64, wherein in comparative pharmacokinetic testing with a 160 mg micronized fenofibrate tablet or 200 mg micronized fenofibate capsule, which are standard commercial formulations of microcrystalline fenofibrate, the composition of claim 136 exhibits a T.sub.max selected from the group consisting of less than about 90%, less than about 80%, less than about 70%, less than about 50%, less than about 30%, and less than about 25% of the T.sub.max exhibited by the micronized fenofibate tablet or capsule.

74. The composition of claim 64, wherein the fenofibrate is present in an amount selected from the group consisting of: (a) about 50 to about 500 g of fenofibrate per kg of composition; (b) about 100 to about 300 g of fenofibrate per kg of composition; (c) about 200 to about 225 g of fenofibrate per kg of composition; and (d) about 119 to about 224 g of fenofibrate per kg of composition.

75. The composition of claim 64 comprising a dosage of about 145 mg of fenofibrate, wherein: (a) the dosage is therapeutically effective; and (b) the composition is biocquivalent to a 160 mg micronized fenofibate tablet or 200 mg micronized fenofibate capsule, wherein bioequivalency, when administered to a human, is established by a 90% Confidence Interval of between 0.80 and 1.25 for both C.sub.max and AUC.

76. The composition of claim 64 comprising a dosage of about 48 mg of fenofibrate, wherein: (a) the dosage is therapeutically effective; and (b) the composition is bioequivalent to a 54 mg micronized fenofibate tablet, wherein bioequivalency, when administered to a human, is established by a 90% Confidence Interval of between 0.80 and 1.25 for both C.sub.max and AUC.

77. The composition of claim 64 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least 4.5 .mu.g/mL at one hour.

78. The composition of claim 64 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of. fenofibric acid are at least 6.5 .mu.g/mL at two hours.

79. The composition of claim 64 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least 7.0 .mu.g/mL at three hours.

80. The composition of claim 64 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least 1.5 .mu.g/mL at twenty-four hours.

81. The composition of claim 64 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least: (a) 1.0 .mu.g/mL at one hour; (b) 6.5 .mu.g/mL at two hours; (c) 7.0 .mu.g/mL at three hours; and (d) 1.5 .mu.g/mL at twenty-four hours.

82. The composition of claim 64 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 4.5 .mu.g/mL at one hour.

83. The composition of claim 64 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 3.0 g/mL at two hours.

84. The composition of claim 64 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 6.0 .mu.g/mL at four hours.

85. The composition of claim 64 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 6.5 .mu.g/mL at five hours.

86. The composition of claim 64 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 1.5 .mu.g/mL at twenty-four hours.

87. The composition of claim 64 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least: (a) 4.5 .mu.g/mL at one hour; (b) 3.0 .mu.g/mL at two hours; (c) 6.0 .mu.g/mL at four hours; (d) 6.5 .mu.g/mL at five hours; and (e) 1.5 .mu.g/mL at twenty-four hours.

88. The composition of claim 64, wherein the fenofibrate is selected from the group consisting of a crystalline phase, an amorphous phase, a semi-crystalline phase, a semi-amorphous phase, and mixtures thereof.

89. The composition of claim 64, wherein the mean particle size of the particles of fenofibrate is selected from the group consisting of less than about 400 nm, less than about 300 nm, less than about 250 nm, less than about 200 nm, less than about 150 nm, less than about 100 nm, less than about 75 nm, and less than about 50 nm.

90. The composition of claim 64, wherein the particles of fenofibrate have a particle size in which the D.sub.99 is less than about 500 nm.

91. The composition of claim 64, wherein the particles of fenofibrate have a particle size in which the D.sub.50 is less than about 350 nm.

92. The composition of claim 64, wherein the particles of fenofibrate have a mean particle size of less than about 100 nm.

93. The composition of claim 64, wherein the composition is formulated for administration selected from the group consisting of oral, pulmonary, rectal, opthalmic, colonic, parenteral, intracistemal, intravaginal, intraperitoneal, local, buccal, nasal, and topical administration.

94. The composition of claim 64 formulated into a dosage form selected from the group consisting of liquid dispersions, oral suspensions, gels, aerosols, ointments, creams, tablets, and capsules.

95. The composition of claim 94 formulated into a dosage form selected from the group consisting of tablets and capsules.

96. The composition of claim 95 formulated into a tablet.

97. The composition of claim 64 formulated into a dosage form selected from the group consisting of controlled release formulations, fast melt formulations, lyophilized formulations, delayed release formulations, extended release formulations, pulsatile release formulations, and mixed immediate release and controlled release formulations.

98. The composition of claim 64 further comprising one or more pharmaceutically acceptable excipients, carriers, or a combination thereof.

99. The composition of claim 64, wherein within about 5 minutes at least about 20% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.02 5 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

100. The composition of claim 64, wherein within about 10 minutes at least about 40% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

101. The composition of claim 64, wherein within about 20 minutes at least about 70% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

102. The composition of claim 64, wherein: (a) within about 5 minutes at least about 30% of the composition is dissolved; (b) within about 10 minutes at least about 70% of the composition is dissolved; and (c) within about 20 minutes at least about 90% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

103. The composition of claim 64, wherein: (a) within about 5 minutes at least about 40% of the composition is dissolved; (b) within about 10 minutes at least about 80% of the composition is dissolved; and (c) within about 20 minutes at least about 100% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

104. The composition of claim 64, additionally comprising one or more active agents selected from the group consisting of HMG CoA reductase inhibitors and antihypertensives.

105. The composition of claim 64, wherein within about 5 minutes at least about 30% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

106. The composition of claim 64, wherein within about 5 minutes at least about 40% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

107. The composition of claim 64, wherein within about 10 minutes at least about 50% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

108. The composition of claim 64, wherein within about 10 minutes at least about 60% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

109. The composition of claim 64, wherein within about 10 minutes at least about 70% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

110. The composition of claim 64, wherein within about 10 minutes at least about 80% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

111. The composition of claim 64, wherein within about 20 minutes at least about 80% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

112. The composition of claim 64, wherein within about 20 minutes at least about 90% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

113. The composition of claim 64, wherein within about 20 minutes at least about 100% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

114. The composition of claim 64, wherein upon administration the composition redisperses such that the redispersed particles of fenofibrate or a salt thereof have a mean particle size selected from the group consisting of less than about 500 nm, less than about 400 nm, less than about 300 nm, less than about 250 nm, less than about 200 nm, less than about 150 nm, less than about 100 nm, less than about 75 nm, and less than about 50 nm.

115. The composition of claim 64, wherein the composition redisperses in a biorelevant media such that the redispersed particles of fenofibrate or a salt thereof have a mean particle size selected from the group consisting of less than about 500 nm, less than about 400 nm, less than about 300 nm, less than about 250 nm, less than about 200 nm, less than about 150 nm, less than about 100 nm, less than about 75 nm, and less than about 50 nm.

116. The composition of claim 64, comprising at least one primary surface stabilizer and at least one secondary surface stabilizer.

117. The composition of claim 64, wherein the surface stabilizer is selected from the group consisting of an anionic surface stabilizer, a non-ionic surface stabilizer, a cationic surface stabilizer, a zwitterionic surface stabilizer, and an ionic surface stabilizer.

118. The composition of claim 64, wherein the at least one surface stabilizer is selected from the group consisting of cetyl pyridinium chloride, gelatin, casein, phosphatides, dextran, glycerol, gum acacia, cholesterol, tragacanth, stearic acid, benzalkonium chloride, calcium stearate, glycerol monostearate, cetostearyl alcohol, cetomacrogol emulsifying wax, polyoxyethylene alkyl ethers, polyethylene glycols, dodecyl trimethyl ammonium bromide, colloidal silicon dioxide, phosphates, sodium dodecylsulfate, carboxymethylcellulose calcium, hydroxypropyl celluloses, hypromellose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylcellulose, hypromellose phthalate, noncrystalline cellulose, magnesium aluminum silicate, triethanolamine, polyvinyl alcohol, polyvinylpyrrolidone, 4-(1,1,3,3-tetramethylbutyl)-phenol polymer with ethylene oxide and formaldehyde, poloxamers; poloxamines, dioctylsulfosuccinate, dialkylesters of sodium sulfosuccinic acid, sodium lauryl sulfate, alkyl aryl polyether sulfonates, mixtures of sucrose stearate and sucrose distearate, p-isononylphenoxypoly-(glycidol), decanoyl-N-methylglucamide; n-decyl .beta.-D-glucopyranoside; n-decyl .beta.-D-maltopyranoside; n-dodecyl .beta.-D-glucopyranoside; n-dodecyl .beta.-D-maltoside; heptanoyl-N-methylglucamide; n-heptyl-.beta.-D-glucopyranoside; n-heptyl .beta.-D-thioglucoside; n-hexyl .beta.-D-glucopyranoside; nonanoyl-N-methylglucamide; n-noyl .beta.-D-glucopyranoside; octanoyl-N-methylglucamide; n-octyl-.beta.-D-glucopyranoside; octyl .beta.-D-thioglucopyranoside; lysozyme, PEG-cholesterol, PEG-cholesterol derivative, PEG-vitamin A, and random copolymers of vinyl acetate and vinyl pyrrolidone.

119. The composition of claim 64, wherein the at least one cationic surface stabilizer is selected from the group consisting of a polymer, a biopolymer, a polysaccharide, a cellulosic, an alginate, a nonpolymeric compound, cationic lipids, polymethylmethacrylate trimethylammonium bromide, sulfonium compounds, polyvinylpyrrolidone-2-dimethylaminoethyl methacrylate dimethyl sulfate, hexadecyltrimethyl ammonium bromide, phosphonium compounds, quartemary ammonium compounds, benzyl-di(2-chloroethyl)ethylammonium bromide, coconut trimethyl ammonium chloride, coconut trimethyl ammonium bromide, coconut methyl dihydroxyethyl ammonium chloride, coconut methyl dihydroxyethyl ammonium bromide, decyl triethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride bromide, C.sub.12-15dimethyl hydroxyethyl ammonium chloride, C.sub.12-15dimethyl hydroxyethyl ammonium chloride bromide, coconut dimethyl hydroxyethyl ammonium chloride, coconut dimethyl hydroxyethyl ammonium bromide, myristyl trimethyl ammonium methyl sulphate, lauryl dimethyl benzyl ammonium chloride, lauryl dimethyl benzyl ammonium bromide, lauryl dimethyl (ethenoxy).sub.4 ammonium chloride, lauryl dimethyl (ethenoxy).sub.4 ammonium bromide, N-alkyl (C.sub.12-18)dimethylbenzyl ammonium chloride, N-alkyl (C.sub.14-18)dimethyl-benzyl ammonium chloride, N-tetradecylidmethylbenzyl ammonium chloride monohydrate, dimethyl didecyl ammonium chloride, N-alkyl and (C.sub.12-14) dimethyl 1-napthylmethyl ammonium chloride, trimethylammonium halide, alkyl-trimethylammonium salts, dialkyl-dimethylammonium salts, lauryl trimethyl ammonium chloride, ethoxylated alkyamidoalkyldialkylammonium salt, an ethoxylated trialkyl ammonium salt, dialkylbenzene dialkylammonium chloride, N-didecyldimethyl ammonium chloride, N-tetradecyldimethylbenzyl ammonium, chloride monohydrate, N-alkyl(C.sub.12-14) dimethyl 1-naphthylmethyl ammonium chloride, dodecyldimethylbenzyl ammonium chloride, dialkyl benzenealkyl ammonium chloride, lauryl trimethyl ammonium chloride, alkylbenzyl methyl ammonium chloride, alkyl benzyl dimethyl ammonium bromide, C.sub.12 trimethyl ammonium bromides, C.sub.15 trimethyl ammonium bromides, C.sub.17 trimethyl ammonium bromides, dodecylbenzyl triethyl ammonium chloride, poly-diallyldimethylammonium chloride (DADMAC), dimethyl ammonium chlorides, alkyldimethylammonium halogenides, tricetyl methyl ammonium chloride, decyltrimethylammonium bromide, dodecyltriethylammonium bromide, tetradecyltrimethylammonium bromide, methyl trioctylammonium chloride, polyquaternium-10, tetrabutylammonium bromide, benzyl trimethylammonium bromide, choline esters, benzalkonium chloride, stearalkonium chloride compounds, cetyl pyridinium bromide, cetyl pyridinium chloride, halide salts of quaternized polyoxyethylalkylamines, polyquaternium compounds, alkyl pyridinium salts; amines, amine salts, amine oxides, imide azolinium salts, protonated quaternary acrylamides, methylated quaternary polymers, and cationic guar.

120. The composition of claim 64, comprising hypromellose, dioctyl sodium sulfosuccinate, and sodium lauryl sulfate as surface stabilizers.

121. A stable fenofibrate composition for oral administration comprising: (a) particles of fenofibrate having a D90 particle size of less than about 700 nm, and (b) at least one surface stabilizer, wherein: (i) the composition exhibits bioequivalence upon administration to a human subject in a fed state as compared to administration to a human subject in a fasted state; where bioequivalency is established by: (a) a 90% Confidence Interval for AUC which is between 80% and 125%, and (b) a 90% Confidence Interval for C.sub.max, which is between 80% and 125%; (ii) the composition redisperses in a biorelevant media; and (iii) the composition is phospholipid-free.

122. The composition of claim 121, which is bioequivalent to a micronized 54 mg fenofibrate oral solid dosage form.

123. The composition of claim 121, which is bioequivalent to a micronized 160 mg fenofibrate oral solid dosage form.

124. The composition of claim 123, which is a single daily dose.

125. The composition of claim 121, which is bioequivalent to a micronized 200 mg fenofibrate oral solid dosage form.

126. The composition of claim 125, which is a single daily dose.

127. The composition of claim 121, wherein the difference in AUC of the fenofibrate composition, when administered to a human subject in the fed versus the fasted state, is selected from the group consisting of less than about 35%, less than about 30%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, and less than about 3%.

128. The composition of claim 121, which when administered to a human subject at a dose of about 160 mg presents an AUC of about 139 .mu.g/mL.h.

129. The composition of claim 121 which exhibits a T.sub.max after administration to fasting human subjects selected from the group consisting of less than about 6 hours, less than about 5 hours, less than about 4 hours, less than about 3 hours, less than about 2 hours, less than about 1 hour, and less than about 30 minutes.

130. The composition of claim 121, wherein in comparative pharmacokinetic testing with a 160 mg micronized fenofibrate tablet or 200 mg micronized fenofibate capsule, which are standard commercial formulations of microcrystalline fenofibrate, the composition of claim 136 exhibits a T.sub.max selected from the group consisting of less than about 90%, less than about 80%, less than about 70%, less than about 50%, less than about 30%, and less than about 25% of the T.sub.max exhibited by the micronized fenofibate tablet or capsule.

131. The composition of claim 121, wherein the fenofibrate is present in an amount selected from the group consisting of: (a) about 50 to about 500 g of fenofibrate per kg of composition; (b) about 100 to about 300 g of fenofibrate per kg of composition; (c) about 200 to about 225 g of fenofibrate per kg of composition; and (d) about 119 to about 224 g of fenofibrate per kg of composition.

132. The composition of claim 121 comprising a dosage of about 145 mg of fenofibrate, wherein: (a) the dosage is therapeutically effective; and (b) the composition is bioequivalent to a 160 mg micronized fenofibate tablet or 200 mg micronized fenofibate capsule, wherein bioequivalency, when administered to a human, is established by a 90% Confidence Interval of between 0.80 and 1.25 for both C.sub.max and AUC.

133. The composition of claim 121 comprising a dosage of about 48 mg of fenofibrate, wherein: (a) the dosage is therapeutically effective; and (b) the composition is bioequivalent to a 54 mg micronized fenofibate tablet, wherein bioequivalency, when administered to a human, is established by a 90% Confidence Interval of between 0.80 and 1.25 for both C.sub.max and AUC.

134. The composition of claim 121 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least 4.5 .mu.g/mL at one hour.

135. The composition of claim 121 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least 6.5 .mu.g/mL at two hours.

136. The composition of claim 121 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least 7.0 .mu.g/mL at three hours.

137. The composition of claim 121 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least 1.5 .mu.g/mL at twenty-four hours.

138. The composition of claim 121 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least: (a) 1.0 .mu.g/mL at one hour; (b) 6.5 .mu.g/mL at two hours; (c) 7.0 .mu.g/mL at three hours; and (d) 1.5 .mu.g/mL at twenty-four hours.

139. The composition of claim 121 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 4.5 .mu.g/mL at one hour.

140. The composition of claim 121 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 3.0 .mu.g/mL at two hours.

141. The composition of claim 121 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 6.0 .mu.g/mL at four hours.

142. The composition of claim 121 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 6.5 .mu.g/mL at five hours.

143. The composition of claim 121 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least 1.5 .mu.g/mL at twenty-four hours.

144. The composition of claim 121 comprising a dosage of about 160 mg of fenofibrate, wherein following administration to high fat fed human subjects the blood levels of fenofibric acid are at least: (a) 4.5 .mu.g/mL at one hour; (b) 3.0 .mu.g/mL at two hours; (c) 6.0 .mu.g/mL at four hours; (d) 6.5 .mu.g/mL at five hours; and (e) 1.5 .mu.g/mL at twenty-four hours.

145. The composition of claim 121, wherein the fenofibrate is selected from the group consisting of a crystalline phase, an amorphous phase, a semi-crystalline phase, a semi-amorphous phase, and mixtures thereof.

146. The composition of claim 121, wherein the D90 particle size of the particles of fenofibrate is selected from the group consisting of less than about 400 nm, less than about 300 nm, less than about 250 nm, less than about 200 nm, less than about 150 nm, less than about 100 nm, less than about 75 nm, and less than about 50 nm.

147. The composition of claim 121, wherein the particles of fenofibrate have a particle size in which the D.sub.99 is less than about 500 nm.

148. The composition of claim 121, wherein the particles of fenofibrate have a particle size in which the D.sub.50 is less than about 350 nm.

149. The composition of claim 121, wherein the particles of fenofibrate have a mean particle size of less than about 100 nm.

150. The composition of claim 121, wherein the composition is formulated for administration selected from the group consisting of oral, pulmonary, rectal, opthalmic, colonic, parenteral, intracistemal, intravaginal, intraperitoneal, local, buccal, nasal, and topical administration.

151. The composition of claim 121 formulated into a dosage form selected from the group consisting of liquid dispersions, oral suspensions, gels, aerosols, ointments, creams, tablets, and capsules.

152. The composition of claim 151 formulated into a dosage form selected from the group consisting of tablets and capsules.

153. The composition of claim 152 formulated into a tablet.

154. The composition of claim 121 formulated into a dosage form selected from the group consisting of controlled release formulations, fast melt formulations, lyophilized formulations, delayed release formulations, extended release formulations, pulsatile release formulations, and mixed immediate release and controlled release formulations.

155. The composition of claim 121 further comprising one or more pharmaceutically acceptable excipients, carriers, or a combination thereof.

156. The composition of claim 121, wherein within about 5 minutes at least about 20% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

157. The composition of claim 121, wherein within about 10 minutes at least about 40% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

158. The composition of claim 121, wherein within about 20 minutes at least about 70% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

159. The composition of claim 121, wherein: (a) within about 5 minutes at least about 30% of the composition is dissolved; (b) within about 10 minutes at least about 70% of the composition is dissolved; and (c) within about 20 minutes at least about 90% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

160. The composition of claim 121, wherein: (a) within about 5 minutes at least about 40% of the composition is dissolved; (b) within about 10 minutes at least about 80% of the composition is dissolved; and (c) within about 20 minutes at least about 100% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

161. The composition of claim 121, additionally comprising one or more active agents selected from the group consisting of HMG CoA reductase inhibitors and antihypertensives.

162. The composition of claim 121, wherein within about 5 minutes at least about 30% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

163. The composition of claim 121, wherein within about 5 minutes at least about 40% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

164. The composition of claim 121, wherein within about 10 minutes at least about 50% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

165. The composition of claim 121, wherein within about 10 minutes at least about 60% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

166. The composition of claim 121, wherein within about 10 minutes at least about 70% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

167. The composition of claim 121, wherein within about 10 minutes at least about 80% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

168. The composition of claim 121, wherein within about 20 minutes at least about 80% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

169. The composition of claim 121, wherein within about 20 minutes at least about 90% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

170. The composition of claim 121, wherein within about 20 minutes at least about 100% of the composition is dissolved, wherein dissolution is measured in a discriminating aqueous media comprising sodium lauryl sulfate at 0.025 M, and wherein the rotating blade method (European Pharmacopoeia) is used to measure dissolution.

171. The composition of claim 121, wherein upon administration the composition redisperses such that the redispersed particles of fenofibrate or a salt thereof have a D90 particle size selected from the group consisting of less than about 500 nm, less than about 400 nm, less than about 300 nm, less than about 250 nm, less than about 200 nm, less than about 150 nm, less than about 100 nm, less than about 75 nm, and less than about 50 nm.

172. The composition of claim 121, wherein the composition redisperses in a biorelevant media such that the redispersed particles of fenofibrate or a salt thereof have a D90 particle size selected from the group consisting of less than about 500 nm, less than about 400 nm, less than about 300 nm, less than about 250 nm, less than about 200 nm, less than about 150 nm, less than about 100 nm, less than about 75 nm, and less than about 50 nm.

173. The composition of claim 121, comprising at least one primary surface stabilizer and at least one secondary surface stabilizer.

174. The composition of claim 121, wherein the surface stabilizer is selected from the group consisting of an anionic surface stabilizer, a non-ionic surface stabilizer, a cationic surface stabilizer, a zwitterionic surface stabilizer, and an ionic surface stabilizer.

175. The composition of claim 121, wherein the at least one surface stabilizer is selected from the group consisting of cetyl pyridinium chloride, gelatin, casein, phosphatides, dextran, glycerol, gum acacia, cholesterol, tragacanth, stearic acid, benzalkonium chloride, calcium stearate, glycerol monostearate, cetostearyl alcohol, cetomacrogol emulsifying wax, sorbitan esters, polyoxyethylene alkyl ethers, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, polyethylene glycols, dodecyl trimethyl ammonium bromide, polyoxyethylene stearates, colloidal silicon dioxide, phosphates, sodium dodecylsulfate, carboxymethylcellulose calcium, hydroxypropyl celluloses, hypromellose, carboxymethylcellulose sodium, methylcellulose, hydroxyethylcellulose, hypromellose phthalate, noncrystalline cellulose, magnesium aluminum silicate, triethanolamine, polyvinyl alcohol, polyvinylpyrrolidone, 4-(1,1,3,3-tetramethylbutyl)-phenol polymer with ethylene oxide and formaldehyde, poloxamers; poloxamines, dioctylsulfosuccinate, dialkylesters of sodium sulfosuccinic acid, sodium lauryl sulfate, alkyl aryl polyether sulfonates, mixtures of sucrose stearate and sucrose distearate, p-isononylphenoxypoly-(glycidol), decanoyl-N-methylglucamide; n-decyl .beta.-D-glucopyranoside; n-decyl .beta.-D-maltopyranoside; n-dodecyl .beta.-D-glucopyranoside; n-dodecyl .beta.-D-maltoside; heptanoyl-N-methylglucamide; n-heptyl-.beta.-D-glucopyranoside; n-heptyl .beta.-D-thioglucoside; n-hexyl .beta.-D-glucopyranoside; nonanoyl-N-methylglucamide; n-noyl .beta.-D-glucopyranoside; octanoyl-N-methylglucamide; n-octyl-.beta.-D-glucopyranoside; octyl .beta.-D-thioglucopyranoside; lysozyme, PEG-cholesterol, PEG-cholesterol derivative, PEG-vitamin A, and random copolymers of vinyl acetate and vinyl pyrrolidone.

176. The composition of claim 121, wherein the at least one cationic surface stabilizer is selected from the group consisting of a polymer, a biopolymer, a polysaccharide, a cellulosic, an alginate, a nonpolymeric compound, cationic lipids, polymethylmethacrylate trimethylammonium bromide, sulfonium compounds, polyvinylpyrrolidone-2-dimethylaminoethyl methacrylate dimethyl sulfate, hexadecyltrimethyl ammonium bromide, phosphonium compounds, quartemary ammonium compounds, benzyl-di(2-chloroethyl)ethylammonium bromide, coconut trimethyl ammonium chloride, coconut trimethyl ammonium bromide, coconut methyl dihydroxyethyl ammonium chloride, coconut methyl dihydroxyethyl ammonium bromide, decyl triethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride, decyl dimethyl hydroxyethyl ammonium chloride bromide, C.sub.12-15dimethyl hydroxyethyl ammonium chloride, C.sub.12-15dimethyl hydroxyethyl ammonium chloride bromide, coconut dimethyl hydroxyethyl ammonium chloride, coconut dimethyl hydroxyethyl ammonium bromide, myristyl trimethyl ammonium methyl sulphate, lauryl dimethyl benzyl ammonium chloride, lauryl dimethyl benzyl ammonium bromide, lauryl dimethyl (ethenoxy).sub.4 ammonium chloride, lauryl dimethyl (ethenoxy).sub.4 ammonium bromide, N-alkyl (C.sub.12-18)dimethylbenzyl ammonium chloride, N-alkyl (C.sub.14-18)dimethyl-benzyl ammonium chloride, N-tetradecylidmethylbenzyl ammonium chloride monohydrate, dimethyl didecyl

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