Details for Patent: 7,320,802

Title:	Methods of treatment using nanoparticulate fenofibrate compositions
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 (Midleton, IE)
Assignee:	Elan Pharma International, Ltd. (Athlone, County Westmath, IL) Fournier Laboratories Ireland Ltd. (Cork, IL)
Filing Date:	Oct 27, 2003
Application Number:	10/692,855
Claims:	1. A method of treating a condition selected from the group consisting of hypercholesterolemia, hypertriglyceridemia, coronary heart disease, cardiovascular disorders, peripheral vascular disease, symptomatic carotid artery disease, mixed dyslipidemia, and increased risk of pancreatitis comprising administering to a subject an effective amount of a composition, wherein: (a) the composition comprises particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof having a D50 particle size of less than 500 nm and at least one surface stabilizer; (b) the 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof particles present in the composition redisperse in a biorelevant media; and (c) administration of the composition to a human subject in a fasted state is bioequivalent to administration of the composition to a human subject in a fed state, wherein bioequivalency of the composition is established by: (i) a 90% Confidence Interval for AUC which is between 0.80 and 1.25; and (ii) a 90% Confidence Interval for C.sub.max, which is between 0.80 and 1.25. 2. The method of claim 1, wherein the composition is bioequivalent to a micronized 54 mg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof oral solid dosage form. 3. The method of claim 1, wherein the composition is bioequivalent to a micronized 160 mg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof oral solid dosage form. 4. The method of claim 3, wherein the composition is a single daily dose. 5. The method of claim 1, wherein the composition is bioequivalent to a micronized 200 mg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof oral solid dosage form. 6. The method of claim 5, wherein the composition is a single daily dose. 7. The method of claim 1, wherein the difference in AUC of the 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof composition, when administered to a human subject in the fed versus the fasted state, is selected from the group consisting of less than 35%, less than 30%, less than 25%, less than 20%, less than 15%, less than 10%, less than 5%, and less than 3%. 8. The method of claim 1, wherein the composition, when administered to a human subject at a dose of about 160 mg, presents an AUC of about 139 .mu.g/mLh. 9. The method of claim 1, wherein the composition exhibits a T.sub.max after administration to fasting human subjects selected from the group consisting of less than 6 hours, less than 5 hours, less than 4 hours, less than 3 hours, less than 2 hours, less than 1 hour, and less than 30 minutes. 10. The method of claim 1, wherein in comparative pharmacokinetic testing with a micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof 160 mg tablet or micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof 200 mg capsule, which are standard commercial formulations of microcrystalline 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, the composition exhibits a T.sub.max selected from the group consisting of less than 90%, less than 80%, less than 70%, less than 50%, less than 30%, and less than 25% of the T.sub.max exhibited by micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof tablet or capsule. 11. The method of claim 1, wherein the 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof is present in the composition in an amount selected from the group consisting of: (a) about 50 to about 500 g/kg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof per kg of composition; (b) about 100 to about 300 g/kg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof per kg of composition; (c) about 200 to about 225 g/kg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof per kg of composition; and (d) about 119 to about 224 g/kg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof per kg of composition. 12. The method of claim 1, wherein the composition comprises a dosage of about 145 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, wherein: (a) the dosage is therapeutically effective; and (b) the composition is bioequivalent to a micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof 160 mg tablet or 200 mg 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 method of claim 1, wherein the composition comprises a dosage of about 48 mg of articles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, wherein: (a) the dosage is therapeutically effective; and (b) the composition is bioequivalent to a micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof 54 mg 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. 14. The method of claim 1, wherein the composition comprises a dosage of about 160 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least 4.5 mg/mL at one hour. 15. The method of claim 14, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to fasting human subjects the blood levels of fenofibric acid are at least 6.5 mg/mL at two hours. 16. The method of claim 14, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to fasting human subjects the blood levels of fenofibric acid are at least 7.0 mg/mL at three hours. 17. The method of claim 14, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to fasting human subjects the blood levels of fenofibric acid are at least 1.5 mg/mL at twenty-four hours. 18. The method of claim 1, wherein the composition comprises a dosage of about 160 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, and wherein following administration of the composition to fasting human subjects the blood levels of fenofibric acid are at least: (a) 1.0 mg/mL at one hour; (b) 6.5 mg/mL at two hours; (c) 7.0 mg/mL at three hours; and (d) 1.5 mg/mL at twenty-four hours. 19. The method of claim 1, wherein the composition comprises a dosage of about 160 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, wherein following administration of the composition to high fat fed human subjects the blood levels of fenofibric acid are at least 4.5 mg/mL at one hour. 20. The method of claim 19, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to high fat fed human subjects the blood levels of fenofibric acid are at least 3.0 mg/mL at two hours. 21. The method of claim 19, wherein following administration of the composition to high fat fed human subjects the blood levels of fenofibric acid are at least 6.0 mg/mL at four hours. 22. The method of claim 19, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to high fat fed human subjects the blood levels of fenofibric acid are at least 6.5 mg/mL at five hours. 23. The method of claim 19, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to high fat fed human subjects the blood levels of fenofibric acid are at least 1.5 mg/mL at twenty-four hours. 24. The method of claim 1, wherein the composition comprises a dosage of about 160 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, and wherein following administration of the composition to high fat fed human subjects the blood levels of fenofibric acid are at least: (a) 4.5 mg/mL at one hour; (b) 3.0 mg/mL at two hours; (c) 6.0 mg/mL at four hours; (d) 6.5 mg/mL at five hours; and (e) 1.5 mg/mL at twenty-four hours. 25. The method of claim 1, wherein the 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof 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 method of claim 1, wherein the D50 particle size of the particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof are selected from the group consisting of less than 400 nm, less than 300 nm, less than 250 nm, less than 200 nm, less than 150 nm, less than 100 nm, less than 75 nm, and less than 50 nm. 27. The method of claim 1, wherein the particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a D.sub.99 of less than 500 nm. 28. The method of claim 1, wherein the particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a D.sub.50 of less than 350 nm. 29. The method of claim 1, wherein the particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a mean particle size of less than 100 nm. 30. The method of claim 1, wherein the composition is formulated for administration selected from the group consisting of oral, pulmonary, rectal, opthalmic, colonic, parenteral, intracisternal, intravaginal, intraperitoneal, local, buccal, nasal, and topical administration. 31. The method of claim 1, wherein the composition is formulated into a dosage form selected from the group consisting of liquid dispersions, oral suspensions, gels, aerosols, ointments, creams, tablets, and capsules. 32. The method of claim 31, wherein the composition is formulated into a dosage form selected from the group consisting of tablets and capsules. 33. The method of claim 32, wherein the composition is formulated into a tablet dosage form. 34. The method of claim 1, wherein the composition is 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 method of claim 1, wherein the composition further comprises one or more pharmaceutically acceptable excipients, carriers, or a combination thereof. 36. The method of claim 1, wherein within about 5 minutes at least 20%, at least 30%, or at least 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. 37. The method of claim 1, wherein within about 10 minutes at least 40%, at least 50%, at least 60%, at least 70%, or at least 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. 38. The method of claim 1, wherein within about 20 minutes at least 70%, at least 80%, at least 90%, or at least 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. 39. The method of claim 1, wherein: (a) within about 5 minutes at least 30% of the composition is dissolved; (b) within about 10 minutes at least 70% of the composition is dissolved; and (c) within about 20 minutes at least 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 method of claim 1, wherein: (a) within about 5 minutes at least 40% of the composition is dissolved; (b) within about 10 minutes at least 80% of the composition is dissolved; and (c) within about 20 minutes at least 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 method of claim 1, wherein upon administration, the composition redisperses such that the redispersed particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a D50 particle size of less than 500 nm. 42. The method of claim 41, wherein the redispersed particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a D50 particle size selected from the group consisting of less than 400 nm, less than 300 nm, less than 250 nm, less than 200 nm, less than 150 nm, less than 100 nm, less than 75 nm, and less than 50 nm. 43. The method of claim 1, wherein the composition redisperses in a biorelevant media such that the redispersed particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a D50 particle size of less than 500 nm. 44. The method of claim 43, wherein the redispersed particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a D50 particle size selected from the group consisting of less than 400 nm, less than 300 nm, less than 250 nm, less than 200 nm, less than 150 nm, less than 100 nm, less than 75 nm, and less than 50 nm. 45. The method of claim 1, wherein the composition additionally comprises one or more active agents selected from the group consisting of HMG CoA reductase inhibitors and antihypertensives. 46. The method of claim 1, wherein the subject is a human. 47. The method of claim 1, wherein the method is used as adjunctive therapy to diet for the reduction of LDL-C, total-C, triglycerides, or Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia. 48. The method of claim 1, wherein the method is used as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia. 49. The method of claim 1, wherein the method is used to decrease the risk of pancreatitis. 50. The method of claim 1, wherein the method is used to treat indications where lipid regulating agents are typically used. 51. The method of claim 1, wherein the composition comprises at least one primary surface stabilizer and at least one secondary surface stabilizer. 52. The method of claim 1, wherein the surface stabilizer is selected from the group consisting of a non-ionic surface stabilizer, an ionic surface stabilizer, an anionic surface stabilizer, a cationic surface stabilizer, and a zwitterionic surface stabilizer. 53. The method 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, a charged phospholipid, 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-methylgiucamide; 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-methylgiucamide; n-noyl .beta.-D-glucopyranoside; octanoyl-N-methylglucamide; n-octyl-.beta.-D-glucopyranoside; octyl .beta.-D-thioglucopyranoside; lysozyme, PEG-phospholipid, PEG-cholesterol, PEG-cholesterol derivative, PEG-vitamin A, random copolymers of vinyl acetate and vinyl pyrrolidone, a cationic polymer, a cationic biopolymer, a cationic polysaccharide, a cationic cellulosic, a cationic alginate, a cationic nonpolymeric compound, cationic phospholipids, 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, tetrabutylammonium bromide, benzyl trimethylammonium bromide, choline esters, benzalkonium chloride, stearalkonium chloride compounds, cetyl pyridinium bromide, cetyl pyridinium chloride, halide salts of quaternized polyoxyethylalkylamines, alkyl pyridinium salts; amines, amine salts, amine oxides, imide azolinium salts, protonated quatemary acrylamides, methylated quatemary polymers, and cationic guar. 54. The method of claim 1, wherein the composition comprises hypromellose, dioctyl sodium sulfosuccinate, and sodium lauryl sulfate as surface stabilizers. 55. A method of treating a condition selected from the group consisting of hypercholesterolemia, hypertriglyceridemia, coronary heart disease, cardiovascular disorders, peripheral vascular disease, symptomatic carotid artery disease, mixed dyslipidemia, and increased risk of pancreatitis comprising administering to a subject an effective amount of a composition, wherein: (a) the composition comprises particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof having a mean particle size of less than 500 nm and at least one surface stabilizer; (b) the 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof particles present in the composition redisperse in a biorelevant media; and (c) administration of the composition to a human subject in a fasted state is bioequivalent to administration of the composition to a human subject in a fed state, wherein bioequivalency of the composition is established by: (i) a 90% Confidence Interval for AUC which is between 0.80 and 1.25; and (ii) a 90% Confidence Interval for C.sub.max, which is between 0.80 and 1.25. 56. The method of claim 55, wherein the composition is bioequivalent to a micronized 54 mg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof oral solid dosage form. 57. The method of claim 55, wherein the composition is bioequivalent to a micronized 160 mg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof oral solid dosage form. 58. The method of claim 57, wherein the composition is a single daily dose. 59. The method of claim 55, wherein the composition is bioequivalent to a micronized 200 mg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof oral solid dosage form. 60. The method of claim 59, wherein the composition is a single daily dose. 61. The method of claim 55, wherein the difference in AUC of the 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof composition, when administered to a human subject in the fed versus the fasted state, is selected from the group consisting of less than 35%, less than 30%, less than 25%, less than 20%, less than 15%, less than 10%, less than 5%, and less than 3%. 62. The method of claim 55, wherein the composition, when administered to a human subject at a dose of about 160 mg, presents an AUC of about 139 .mu.g/mLh. 63. The method of claim 55, wherein the composition exhibits a T.sub.max after administration to fasting human subjects selected from the group consisting of less than 6 hours, less than 5 hours, less than 4 hours, less than 3 hours, less than 2 hours, less than 1 hour, and less than 30 minutes. 64. The method of claim 55, wherein in comparative pharmacokinetic testing with a micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof 160 mg tablet or micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof 200 mg capsule, which are standard commercial formulations of microcrystalline 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, the composition exhibits a T.sub.max selected from the group consisting of less than 90%, less than 80%, less than 70%, less than 50%, less than 30%, and less than 25% of the T.sub.max exhibited by micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof tablet or capsule. 65. The method of claim 55, wherein the 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof is present in the composition in an amount selected from the group consisting of: (a) about 50 to about 500 g/kg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof per kg of composition; (b) about 100 to about 300 g/kg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof per kg of composition; (c) about 200 to about 225 g/kg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof per kg of composition; and (d) about 119 to about 224 g/kg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof per kg of composition. 66. The method of claim 55, wherein the composition comprises a dosage of about 145 mg of articles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof wherein: (a) the dosage is therapeutically effective; and (b) the composition is bioequivalent to a micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof 160 mg tablet or 200 mg 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. 67. The method of claim 55, wherein the composition comprises a dosage of about 48 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, wherein: (a) the dosage is therapeutically effective; and (b) the composition is bioequivalent to a micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof 54 mg 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. 68. The method of claim 55, wherein the composition comprises a dosage of about 160 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least 4.5 mg/mL at one hour. 69. The method of claim 68, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to fasting human subjects the blood levels of fenofibric acid are at least 6.5 mg/mL at two hours. 70. The method of claim 68, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to fasting human subjects the blood levels of fenofibric acid are at least 7.0 mg/mL at three hours. 71. The method of claim 68, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to fasting human subjects the blood levels of fenofibric acid are at least 1.5 mg/mL at twenty-four hours. 72. The method of claim 55, wherein the composition comprises a dosage of about 160 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, and wherein following administration of the composition to fasting human subjects the blood levels of fenofibric acid are at least: (a) 1.0 mg/mL at one hour; (b) 6.5 mg/mL at two hours; (c) 7.0 mg/mL at three hours; and (d) 1.5 mg/mL at twenty-four hours. 73. The method of claim 55, wherein the composition comprises a dosage of about 160 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, wherein following administration of the composition to high fat fed human subjects the blood levels of fenofibric acid are at least 4.5 mg/mL at one hour. 74. The method of claim 73, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to high fat fed human subjects the blood levels of fenofibric acid are at least 3.0 mg/mL at two hours. 75. The method of claim 73, wherein following administration of the composition to high fat fed human subjects the blood levels of fenofibric acid are at least 6.0 mg/mL at four hours. 76. The method of claim 73, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to high fat fed human subjects the blood levels of fenofibric acid are at least 6.5 mg/mL at five hours. 77. The method of claim 73, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to high fat fed human subjects the blood levels of fenofibric acid are at least 1.5 mg/mL at twenty-four hours. 78. The method of claim 55, wherein the composition comprises a dosage of about 160 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, and wherein following administration of the composition to high fat fed human subjects the blood levels of fenofibric acid are at least: (a) 4.5 mg/mL at one hour; (b) 3.0 mg/mL at two hours; (c) 6.0 mg/mL at four hours; (d) 6.5 mg/mL at five hours; and (e) 1.5 mg/mL at twenty-four hours. 79. The method of claim 55, wherein the 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof is selected from the group consisting of a crystalline phase, and an amorphous phase, a semi-crystalline phase, a semi-amorphous phase, and mixtures thereof. 80. The method of claim 55, wherein the mean particle size of the particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof is selected from the group consisting of less than 400 nm, less than 300 nm, less than 250 nm, less than 200 nm, less than 150 nm, less than 100 nm, less than 75 nm, and less than 50 nm. 81. The method of claim 55, wherein the particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a D.sub.99 of less than 500 nm. 82. The method of claim 55, wherein the particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a D.sub.50 of less than 350 nm. 83. The method of claim 55, wherein the particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a mean particle size of less than 100 nm. 84. The method of claim 55, wherein the composition is formulated for administration selected from the group consisting of oral, pulmonary, rectal, opthalmic, colonic, parenteral, intracisternal, intravaginal, intraperitoneal, local, buccal, nasal, and topical administration. 85. The method of claim 55, wherein the composition is formulated into a dosage form selected from the group consisting of liquid dispersions, oral suspensions, gels, aerosols, ointments, creams, tablets, and capsules. 86. The method of claim 85, wherein the composition is formulated into a dosage form selected from the group consisting of tablets and capsules. 87. The method of claim 86, wherein the composition is formulated into a tablet dosage form. 88. The method of claim 55, wherein the composition is 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. 89. The method of claim 55, wherein the composition further comprises one or more pharmaceutically acceptable excipients, carriers, or a combination thereof. 90. The method of claim 55, wherein within about 5 minutes at least 20%, at least 30%, or at least 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. 91. The method of claim 55, wherein within about 10 minutes at least 40%, at least 50%, at least 60%, at least 70%, or at least 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. 92. The method of claim 55, wherein within about 20 minutes at least 70%, at least 80%, at least 90%, or at least 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. 93. The method of claim 55, wherein: (a) within about 5 minutes at least 30% of the composition is dissolved; (b) within about 10 minutes at least 70% of the composition is dissolved; and (c) within about 20 minutes at least 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. 94. The method of claim 55, wherein: (a) within about 5 minutes at least 40% of the composition is dissolved; (b) within about 10 minutes at least 80% of the composition is dissolved; and (c) within about 20 minutes at least 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. 95. The method of claim 55, wherein upon administration, the composition redisperses such that the redispersed particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a mean particle size of less than 500 nm. 96. The method of claim 95, wherein the redispersed particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a mean particle size selected from the group consisting of less than 400 nm, less than 300 nm, less than 250 nm, less than 200 nm, less than 150 nm, less than 100 nm, less than 75 nm, and less than 50 nm. 97. The method of claim 55, wherein the composition redisperses in a biorelevant media such that the redispersed particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a mean particle size of less than 500 nm. 98. The method of claim 97, wherein the redispersed particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a mean particle size selected from the group consisting of less than 400 nm, less than 300 nm, less than 250 nm, less than 200 nm, less than 150 nm, less than 100 nm, less than 75 nm, and less than 50 nm. 99. The method of claim 55, wherein the composition additionally comprises one or more active agents selected from the group consisting of HMG CoA reductase inhibitors and antihypertensives. 100. The method of claim 55, wherein the subject is a human. 101. The method of claim 55, wherein the method is used as adjunctive therapy to diet for the reduction of LDL-C, total-C, triglycerides, or Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia. 102. The method of claim 55, wherein the method is used as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia. 103. The method of claim 55, wherein the method is used to decrease the risk of pancreatitis. 104. The method of claim 55, wherein the method is used to treat indications where lipid regulating agents are typically used. 105. The method of claim 55, wherein the composition comprises at least one primary surface stabilizer and at least one secondary surface stabilizer. 106. The method of claim 55, wherein the surface stabilizer is selected from the group consisting of a non-ionic surface stabilizer, an ionic surface stabilizer, an anionic surface stabilizer, a cationic surface stabilizer, and a zwitterionic surface stabilizer. 107. The method of claim 55, 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, a charged phospholipid, 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-phospholipid, PEG-cholesterol, PEG-cholesterol derivative, PEG-vitamin A, random copolymers of vinyl acetate and vinyl pyrrolidone, a cationic polymer, a cationic biopolymer, a cationic polysaccharide, a cationic cellulosic, a cationic alginate, a cationic nonpolymeric compound, cationic phospholipids, 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, tetrabutylammonium bromide, benzyl trimethylammonium bromide, choline esters, benzalkonium chloride, stearalkonium chloride compounds, cetyl pyridinium bromide, cetyl pyridinium chloride, halide salts of quaternized polyoxyethylalkylamines, alkyl pyridinium salts; amines, amine salts, amine oxides, imide azolinium salts, protonated quatemary acrylamides, methylated quatemary polymers, and cationic guar. 108. The method of claim 55, wherein the composition comprises hypromellose, dioctyl sodium sulfosuccinate, and sodium lauryl sulfate as surface stabilizers. 109. A method of treating a condition selected from the group consisting of hypercholesterolemia, hypertriglyceridemia, coronary heart disease, cardiovascular disorders, peripheral vascular disease, symptomatic carotid artery disease, mixed dyslipidemia, and increased risk of pancreatitis comprising administering to a subject an effective amount of a composition, wherein: (a) the composition comprises particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof having a D90 particle size of less than 700 nm and at least one surface stabilizer; (b) the 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof particles present in the composition redisperse in a biorelevant media; and (c) administration of the composition to a human subject in a fasted state is bioequivalent to administration of the composition to a human subject in a fed state, wherein bioequivalency of the composition is established by: (i) a 90% Confidence Interval for AUC which is between 0.80 and 1.25; and (ii) a 90% Confidence Interval for C.sub.max, which is between 0.80 and 1.25. 110. The method of claim 109, wherein the composition is bioequivalent to a micronized 54 mg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof oral solid dosage form. 111. The method of claim 109, wherein the composition is bioequivalent to a micronized 160 mg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof oral solid dosage form. 112. The method of claim 111, wherein the composition is a single daily dose. 113. The method of claim 109, wherein the composition is bioequivalent to a micronized 200 mg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof oral solid dosage form. 114. The method of claim 113, wherein the composition is a single daily dose. 115. The method of claim 109, wherein the difference in AUC of the 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof composition, when administered to a human subject in the fed versus the fasted state, is selected from the group consisting of less than 35%, less than 30%, less than 25%, less than 20%, less than 15%, less than 10%, less than 5%, and less than 3%. 116. The method of claim 109, wherein the composition, when administered to a human subject at a dose of about 160 mg, presents an AUC of about 139 .mu.g/mLh. 117. The method of claim 109, wherein the composition exhibits a T.sub.max after administration to fasting human subjects selected from the group consisting of less than 6 hours, less than 5 hours, less than 4 hours, less than 3 hours, less than 2 hours, less than 1 hour, and less than 30 minutes. 118. The method of claim 109, wherein in comparative pharmacokinetic testing with a micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof 160 mg tablet or micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof 200 mg capsule, which are standard commercial formulations of microcrystalline 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, the composition exhibits a T.sub.max selected from the group consisting of less than 90%, less than 80%, less than 70%, less than 50%, less than 30%, and less than 25% of the T.sub.max exhibited by micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof tablet or capsule. 119. The method of claim 109, wherein the 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof is present in the composition in an amount selected from the group consisting of: (a) about 50 to about 500 g/kg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof per kg of composition; (b) about 100 to about 300 g/kg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof per kg of composition; (c) about 200 to about 225 g/kg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof per kg of composition; and (d) about 119 to about 224 g/kg 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof per kg of composition. 120. The method of claim 109, wherein the composition comprises a dosage of about 145 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, wherein: (a) the dosage is therapeutically effective; and (b) the composition is bioequivalent to a micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof 160 mg tablet or 200 mg 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. 121. The method of claim 109, wherein the composition comprises a dosage of about 48 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, wherein: (a) the dosage is therapeutically effective; and (b) the composition is bioequivalent to a micronized 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof 54 mg 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. 122. The method of claim 109, wherein the composition comprises a dosage of about 160 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, wherein following administration to fasting human subjects the blood levels of fenofibric acid are at least 4.5 mg/mL at one hour. 123. The method of claim 122, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to fasting human subjects the blood levels of fenofibric acid are at least 6.5 mg/mL at two hours. 124. The method of claim 122, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to fasting human subjects the blood levels of fenofibric acid are at least 7.0 mg/mL at three hours. 125. The method of claim 122, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to fasting human subjects the blood levels of fenofibric acid are at least 1.5 mg/mL at twenty-four hours. 126. The method of claim 109, wherein the composition comprises a dosage of about 160 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, and wherein following administration of the composition to fasting human subjects the blood levels of fenofibric acid are at least: (a) 1.0 mg/mL at one hour; (b) 6.5 mg/mL at two hours; (c) 7.0 mg/mL at three hours; and (d) 1.5 mg/mL at twenty-four hours. 127. The method of claim 109, wherein the composition comprises a dosage of about 160 mg of articles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, wherein following administration of the composition to high fat fed human subjects the blood levels of fenofibric acid are at least 4.5 mg/mL at one hour. 128. The method of claim 127, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to high fat fed human subjects the blood levels of fenofibric acid are at least 3.0 mg/mL at two hours. 129. The method of claim 127, wherein following administration of the composition to high fat fed human subjects the blood levels of fenofibric acid are at least 6.0 mg/mL at four hours. 130. The method of claim 127, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to high fat fed human subjects the blood levels of fenofibric acid are at least 6.5 mg/mL at five hours. 131. The method of claim 127, wherein following administration of the composition comprising a dosage of about 160 mg of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof to high fat fed human subjects the blood levels of fenofibric acid are at least 1.5 mg/mL at twenty-four hours. 132. The method of claim 109, wherein the composition comprises a dosage of about 160 mg of particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof, and wherein following administration of the composition to high fat fed human subjects the blood levels of fenofibric acid are at least: (a) 4.5 mg/mL at one hour; (b) 3.0 mg/mL at two hours; (c) 6.0 mg/mL at four hours; (d) 6.5 mg/mL at five hours; and (e) 1.5 mg/mL at twenty-four hours. 133. The method of claim 109, wherein the 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof is selected from the group consisting of a crystalline phase, an amorphous phase, a semi-crystalline phase, a semi-amorphous phase, and mixtures thereof. 134. The method of claim 109, wherein the D90 particle size of the particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof is selected from the group consisting of less than 600 nm, less than 500 nm, less than 400 nm, less than 300 nm, less than 250 nm, less than 200 nm, less than 150 nm, less than 100 nm, less than 75 nm, and less than 50 nm. 135. The method of claim 109, wherein the particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a D.sub.99 of less than 500 nm. 136. The method of claim 109, wherein the particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a D.sub.50 of less than 350 nm. 137. The method of claim 109, wherein the particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a mean particle size of less than 100 nm. 138. The method of claim 109, wherein the composition is formulated for administration selected from the group consisting of oral, pulmonary, rectal, opthalmic, colonic, parenteral, intracisternal, intravaginal, intraperitoneal, local, buccal, nasal, and topical administration. 139. The method of claim 109, wherein the composition is formulated into a dosage form selected from the group consisting of liquid dispersions, oral suspensions, gels, aerosols, ointments, creams, tablets, and capsules. 140. The method of claim 139, wherein the composition is formulated into a dosage form selected from the group consisting of tablets and capsules. 141. The method of claim 140, wherein the composition is formulated into a tablet dosage form. 142. The method of claim 109, wherein the composition is 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. 143. The method of claim 109, wherein the composition further comprises one or more pharmaceutically acceptable excipients, carriers, or a combination thereof. 144. The method of claim 109, wherein within about 5 minutes at least 20%, at least 30%, or at least 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. 145. The method of claim 109, wherein within about 10 minutes at least 40%, at least 50%, at least 60%, at least 70%, or at least 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. 146. The method of claim 109, wherein within about 20 minutes at least 70%, at least 80%, at least 90%, or at least 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. 147. The method of claim 109, wherein: (a) within about 5 minutes at least 30% of the composition is dissolved; (b) within about 10 minutes at least 70% of the composition is dissolved; and (c) within about 20 minutes at least 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. 148. The method of claim 109, wherein: (a) within about 5 minutes at least 40% of the composition is dissolved; (b) within about 10 minutes at least 80% of the composition is dissolved; and (c) within about 20 minutes at least 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. 149. The method of claim 109, wherein upon administration, the composition redisperses such that the redispersed particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a D90 particle size of less than 700 nm. 150. The method of claim 149, wherein the redispersed particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a D90 particle size selected from the group consisting of less than 600 nm, less than 500 nm, less than 400 nm, less than 300 nm, less than 250 nm, less than 200 nm, less than 150 nm, less than 100 nm, less than 75 nm, and less than 50 nm. 151. The method of claim 109, wherein the composition redisperses in a biorelevant media such that the redispersed particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a D90 particle size of less than 700 nm. 152. The method of claim 151, wherein the redispersed particles of 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester or a salt thereof have a D90 particle size selected from the group consisting of less than 600 nm, less than 500 nm, less than 400 nm, less than 300 nm, less than 250 nm, less than 200 nm, less than 150 nm, less than 100 nm, less than 75 nm, and less than 50 nm. 153. The method of claim 109, wherein the composition additionally comprises one or more active agents selected from the group consisting of HMG CoA reductase inhibitors and antihypertensives. 154. The method of claim 109, wherein the subject is a human. 155. The method of claim 109, wherein the method is used as adjunctive therapy to diet for the reduction of LDL-C, total-C, triglycerides, or Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia. 156. The method of claim 109, wherein the method is used as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia. 157. The method of claim 109, wherein the method is used to decrease the risk of pancreatitis. 158. The method of claim 109, wherein the method is used to treat indications where lipid regulating agents are typically used. 159. The method of claim 109, wherein the composition comprises at least one primary surface stabilizer and at least one secondary surface stabilizer. 160. The method of claim 109, wherein the surface stabilizer is selected from the group consisting of a non-ionic surface stabilizer, an ionic surface stabilizer, an anionic surface stabilizer, a cationic surface stabilizer, and a zwitterionic surface stabilizer. 161. The method of claim 109, 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, a charged phospholipid, 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-phospholipid, PEG-cholesterol, PEG-cholesterol derivative, PEG-vitamin A, random copolymers of vinyl acetate and vinyl pyrrolidone, a cationic polymer, a cationic biopolymer, a cationic polysaccharide, a cationic cellulosic, a cationic alginate, a cationic nonpolymeric compound, cationic phospholipids, 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, tetrabutylammonium bromide, benzyl trimethylammonium bromide, choline esters, benzalkonium chloride, stearalkonium chloride compounds, cetyl pyridinium bromide, cetyl pyridinium chloride, halide salts of quaternized polyoxyethylalkylamines, alkyl pyridinium salts; amines, a mine salts, amine oxides, imide azolinium salts, protonated quaternary acrylamides, methylated quatemary polymers, and cationic guar. 162. The method of claim 109, wherein the composition comprises hypromellose, dioctyl sodium sulfosuccinate, and sodium lauryl sulfate as surface stabilizers. 163. A method of treating a condition selected from the group consisting of hypercholesterolemia, hy