Claims for Patent: 6,309,663

Summary for Patent: 6,309,663

Title:	Triglyceride-free compositions and methods for enhanced absorption of hydrophilic therapeutic agents
Abstract:	The present invention relates to pharmaceutical compositions, pharmaceutical systems, and methods for enhanced absorption of hydrophilic therapeutic agents. Compositions and systems of the present invention include an absorption enhancing carrier, where the carrier is formed from a combination of at least two surfactants, at least one of which is hydrophilic. A hydrophilic therapeutic agent can be incorporated into the composition, or can be co-administered with the composition as part of a pharmaceutical system. The invention also provides methods of treatment with hydrophilic therapeutic agents using these compositions and systems.
Inventor(s):	Patel; Mahesh V. (Salt Lake City, UT), Chen; Feng-Jing (Salt Lake City, UT)
Assignee:	Lipocine Inc. (Salt Lake City, UT)
Application Number:	09/375,636
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,309,663
Patent Claims:	1. A pharmaceutical system for enhanced absorption of a hydrophilic therapeutic agent, the system consisting essentially of: (a) a dosage form of an absorption enhancing composition, the composition comprising: (i) at least one hydrophilic surfactant selected from the group consisting of ionized ionizable surfactants, non-ionic hydrophilic surfactants having an HLB value greater than or equal to about 10, and combinations thereof, and (ii) at least one hydrophobic surfactant selected from the group consisting of hydrophobic (a) alcohols, polyoxyethylene alkylethers, bile acids, glycerol fatty acid monoesters, glycerol fatty acid diesters, acetylated glycerol fatty acid monoesters, acetylated glycerol fatty acid diesters, lower alcohol fatty acid monoesters, lower alcohol fatty acid diesters, polyethylene glycol fatty acid esters, polyethylene glycol glycerol fatty acid esters, polypropylene glycol fatty acid esters, polyoxyethylene glycerides, lactic acid derivatives of mono- and diglycerides, propylene glycol diglycerides, sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene-polyoxypropylene block copolymers, transesterified vegetable oils, sugar esters, sugar ethers, sucroglycerides, polyoxyethylene vegetable oils, polyoxyethylene hydrogenated vegetable oils, reaction products of polyols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, and hydrogenated vegetable oils, and hydrophobic, un-ionized (b) fatty acids, carnitine fatty acid esters, alkylsulfates, acyl lactylates, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, succinylated monoglycerides, citric acid esters of mono- and diglycerides, and mixtures thereof, wherein the hydrophilic and hydrophobic surfactants are present in amounts such that upon mixing with an aqueous diluent at 100.times. dilution, the composition forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm; and (b) a therapeutically effective amount of a hydrophilic therapeutic agent, wherein the pharmaceutical system is free of triglycerides. 2. The pharmaceutical system of claim 1, wherein the hydrophilic surfactant comprises at least one ionized ionizable surfactant. 3. The pharmaceutical system of claim 2, wherein the ionized ionizable surfactant is the ionized form of a surfactant selected from the group consisting of bile acids and salts, analogues, and derivatives thereof; carntine fatty acid ester salts; salts of alkylsulfates; salts of fatty acids; sodium docusate; acyl lactylates; mono-acetylated tartaric esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides; succinylated monoglycerides; citric acid esters of mono- and diglycerides; and mixtures thereof. 4. The pharmaceutical system of claim 2, wherein the ionized ionizable surfactant is the ionized form of a surfactant selected from the group consisting of lactylic esters of fatty acids, stearoyl-2-lactylate, stearoyl lactylate, succinylated monoglycerides, mono-acetylated tartaric esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, citric acid esters of mono- and diglycerides, cholate, taurocholate, glycocholate, deoxycholate, taurodeoxycholate, chenodeoxycholate, glycodeoxycholate, glycochenodeoxycholate, taurochenodeoxycholate, ursodeoxycholate, lithocholate, tauroursodeoxycholate, glycoursodeoxycholate, cholylsarcosine, N-methyl taurocholate, caproate, caprylate, caprate, laurate, myristate, palmitate, oleate, ricinoleate, linoleate, linolenate, stearate, lauryl sulfate, tetraacetyl sulfate, docusate, lauroyl carnitine, palmitoyl carnitine, myristoyl carnitine, and salts and mixtures thereof. 5. The pharmaceutical system of claim 2, wherein the ionized ionizable surfactant is the ionized form of a surfactant selected from the group consisting of lactylic esters of fatty acids, stearoyl-2-lactylate, stearoyl lactylate, succinylated monoglycerides, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, citric acid esters of mono- and diglycerides, cholate, taurocholate, glycocholate, deoxycholate, chenodeoxycholate, lithocholate, ursodeoxycholate, taurodeoxycholate, glycodeoxycholate, cholylsarcosine, caproate, caprylate, caprate, laurate, oleate, lauryl sulfate, docusate, lauroyl carnitine, palmitoyl carnitine, myristoyl carnitine, and salts and mixtures thereof. 6. The pharmaceutical system of claim 2, wherein the ionized ionizable surfactant is the ionized form of a surfactant selected from the group consisting of lactylic esters of fatty acids, stearoyl-2-lactylate, stearoyl lactylate, succinylated monoglycerides, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, citric acid esters of mono- and diglycerides, chenodeoxycholate, lithocholate, ursodeoxycholate, taurocholate, caprylate, caprate, oleate, lauryl sulfate, docusate, lauroyl carnitine, palmitoyl carnitine, myristoyl carnitine, and salts and mixtures thereof. 7. The pharmaceutical system of claim 1, wherein the hydrophilic surfactant comprises at least one non-ionic hydrophilic surfactant having an HLB value greater than or equal to about 10. 8. The pharmaceutical system of claim 7, wherein the non-ionic surfactant is selected from the group consisting of alkylglucosides; alkylmaltosides; alkylthioglucosides; lauryl macrogolglycerides; polyoxyethylene alkyl ethers; polyoxyethylene alkylphenols; polyethylene glycol fatty acids esters; polyethylene glycol glycerol fatty acid esters; polyoxyethylene sorbitan fatty acid esters; polyoxyethylene-polyoxypropylene block copolymers; polyglycerol fatty acid esters; polyoxyethylene glycerides; polyoxyethylene vegetable oils; polyoxyethylene hydrogenated vegetable oils; reaction products of polyols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, and hydrogenated vegetable oils; sugar esters, sugar ethers; sucroglycerides; and mixtures thereof. 9. The pharmaceutical system of claim 7, wherein the non-ionic hydrophilic surfactant is selected from the group consisting of polyoxyethylene alkylethers; polyethylene glycol fatty acids esters; polyethylene glycol glycerol fatty acid esters; polyoxyethylene sorbitan fatty acid esters; polyoxyethylene-polyoxypropylene block copolymers; polyglycerol fatty acid esters; polyoxyethylene glycerides; polyoxyethylene vegetable oils; polyoxyethylene hydrogenated vegetable oils; reaction products of polyols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, and hydrogenated vegetable oils; and mixtures thereof. 10. The pharmaceutical system of claim 9, wherein the non-ionic hydrophilic surfactant is the reaction product of a polyol and a monoglyceride, diglyceride, triglyceride, or a mixture thereof. 11. The pharmaceutical system of claim 10, wherein the reaction product comprises a transesterification product. 12. The pharmaceutical system of claim 10, wherein the polyol is glycerol, ethylene glycol, polyethylene glycol, sorbitol, propylene glycol, pentaerythritol, a saccharide, or a mixture thereof. 13. The pharmaceutical system of claim 7, wherein the hydrophilic surfactant is selected from the group consisting of PEG-10 laurate, PEG-12 laurate, PEG-20 laurate, PEG-32 laurate, PEG-32 dilaurate, PEG-12 oleate, PEG-15 oleate, PEG-20 oleate, PEG-20 dioleate, PEG-32 oleate, PEG-200 oleate, PEG-400 oleate, PEG-15 stearate, PEG-32 distearate, PEG40 stearate, PEG-100 stearate, PEG-20 dilaurate, PEG-32 dioleate, PEG-20 glyceryl laurate, PEG-30 glyceryl laurate, PEG-20 glyceryl stearate, PEG-20 glyceryl oleate, PEG-30 glyceryl oleate, PEG-30 glyceryl laurate, PEG-40 glyceryl laurate, PEG-40 palm kernel oil, PEG-50 hydrogenated castor oil, PEG-40 castor oil, PEG-35 castor oil, PEG-60 castor oil, PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, PEG-60 corn oil, PEG-6 caprate/caprylate monoglycerides, PEG-6 caprate/caprylate diglycerides, PEG-8 caprate/caprylate monoglycerides, PEG -8 caprate/caprylate diglycerides, polyglyceryl-10 laurate, PEG-40 sorbitan oleate, PEG-80 sorbitan laurate, polysorbate 20, polysorbate 80, POE-9 lauryl ether, POE-23 lauryl ether, POE-10 oleyl ether, POE-20 oleyl ether, POE-20 stearyl ether, tocopheryl PEG-100 succinate, polyglyceryl-10 oleate, Tween 40, Tween 60, sucrose monostearate, sucrose monolaurate, sucrose monopalmitate, PEG 10-100 nonyl phenol series, PEG 15-100 octyl phenol series, a poloxamer, and combinations thereof. 14. The pharmaceutical system of claim 7, wherein the hydrophilic surfactant is selected from the group consisting of PEG-20 laurate, PEG-20 oleate, PEG-35 castor oil, PEG-40 palm kernel oil, PEG-40 hydrogenated castor oil, PEG-60 corn oil, polyglyceryl-10 laurate, PEG-6 caprate/caprylate monoglycerides, PEG-6 caprate/caprylate diglycerides, PEG-8 caprate/caprylate monoglycerides, PEG-8 caprate/caprylate diglycerides, polysorbate 20, polysorbate 80, POE-9 lauryl ether, POE-23 lauryl ether, POE-10 oleyl ether, sucrose monostearate, sucrose monolaurate, a poloxamer, and combinations thereof. 15. The pharmaceutical system of claim 7, wherein the hydrophilic surfactant is selected from the group consisting of PEG-35 castor oil, PEG-40 hydrogenated castor oil, PEG-60 corn oil, PEG-6 caprate/caprylate monoglycerides, PEG-6 caprate/caprylate diglycerides, PEG-8 caprate/caprylate monoglycerides, PEG-8 caprate/caprylate diglycerides, polysorbate 20, polysorbate 80, tocopheryl PEG-1000 succinate, a poloxamer, and combinations thereof. 16. The pharmaceutical system of claim 1, wherein the composition comprises at least two hydrophilic surfactants. 17. The pharmaceutical system of claim 1, wherein the hydrophobic surfactant comprises an un-ionized ionizable surfactant. 18. The pharmaceutical system of claim 17, wherein the un-ionized ionizable surfactant is the un-ionized form of a surfactant selected from the group consisting of bile acids and analogues and derivatives thereof; carnitine fatty acid esters; alkylsulfates; fatty acids; acyl lactylates; mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides; succinylated monoglycerides; citric acid esters of mono- and diglycerides; and mixtures thereof. 19. The pharmaceutical system of claim 17 wherein the un-ionized ionizable surfactant is the un-ionized form of a surfactant selected from the group consisting of lactylic esters of fatty acids, stearoyl-2-lactylate, stearoyl lactylate, succinylated monoglycerides, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, citric acid esters of mono- and diglycerides, cholic acid, taurocholic acid, glycocholic acid, deoxycholic acid, taurodeoxycholic acid, chenodeoxycholic acid, glycodeoxycholic acid, glycochenodeoxycholic acid, taurochenodeoxycholic acid, ursodeoxycholic acid, lithocholic acid, tauroursodeoxycholic acid, glycoursodeoxycholic acid, cholylsarcosine, N-methyl taurocholic acid, caproic acid, caprylic acid, capric acid, lauric acid, myristic acid, palmitic acid, oleic acid, ricinoleic acid, linoleic acid, linolenic acid, stearic acid, lauryl sulfate, tetraacetyl sulfate, lauroyl carnitine, palmitoyl carnitine, myristoyl carnitine, and mixtures thereof. 20. The pharmaceutical system of claim 17, wherein the un-ionized ionizable surfactant is the unionized form of a surfactant selected from the group consisting of lactylic esters of fatty acids, stearoyl-2-lactylate, stearoyl lactylate, succinylated monoglycerides, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, citric acid esters of mono- and diglycerides, cholic acid, taurocholic acid, glycocholic acid, deoxycholic acid, chenodeoxycholic acid, lithocholic acid, ursodeoxycholic acid, taurodeoxycholic acid, glycodeoxycholic acid, cholylsarcosine, caproic acid, caprylic acid, capric acid, lauric acid, oleic acid, lauryl sulfate, lauroyl carnitine, palmitoyl carnitine, myristoyl carnitine, and mixtures thereof. 21. The pharmaceutical system of claim 17, wherein the un-ionized ionizable surfactant is the un-ionized form of a surfactant selected from the group consisting of lactylic esters of fatty acids, stearoyl-2-lactylate, stearoyl lactylate, succinylated monoglycerides, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, citric acid esters of mono- and diglycerides, chenodeoxycholic acid, lithocholic acid, ursodeoxycholic acid, taurocholic acid, caprylic acid, capric acid, oleic acid, lauryl sulfate, docusate, lauroyl carnitine, palmitoyl carnitine, myristoyl carnitine, and mixtures thereof. 22. The pharmaceutical system of claim 1, wherein the hydrophobic surfactant comprises at least one surfactant having an HLB value less than about 10. 23. The pharmaceutical system of claim 22, wherein the hydrophobic surfactant is selected from the group consisting of alcohols; polyoxyethylene alkylethers; fatty acids; bile acids; glycerol fatty acid esters; acetylated glycerol fatty acid esters; lower alcohol fatty acids esters; polyethylene glycol fatty acids esters; polyethylene glycol glycerol fatty acid esters; polypropylene glycol fatty acid esters; polyoxyethylene glycerides; lactic acid derivatives of mono- and diglycerides; propylene glycol diglycerides; sorbitan fatty acid esters; polyoxyethylene sorbitan fatty acid esters; polyoxyethylene-polyoxypropylene block copolymers; transesterified vegetable oils; sugar esters; sugar ethers; sucroglycerides; polyoxyethylene vegetable oils; polyoxyethylene hydrogenated vegetable oils; reaction products of polyols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, and hydrogenated vegetable oils; and mixtures thereof. 24. The pharmaceutical system of claim 22, wherein the hydrophobic surfactant is selected from the group consisting of fatty acids; bile acids; lower alcohol fatty acid esters; polyethylene glycol glycerol fatty acid esters; polypropylene glycol fatty acid esters; polyoxyethylene glycerides; glycerol fatty acid esters; acetylated glycerol fatty acid esters; lactic acid derivatives of mono- and diglycerides; sorbitan fatty acid esters; polyoxyethylene sorbitan fatty acid esters; polyoxyethylene-polyoxypropylene block copolymers; polyoxyethylene vegetable oils; polyoxyethylene hydrogenated vegetable oils; reaction products of polyols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, and hydrogenated vegetable oils; and mixtures thereof. 25. The pharmaceutical system of claim 22, wherein the hydrophobic surfactant is selected from the group consisting of bile acids; lower alcohol fatty acids esters; polypropylene glycol fatty acid esters; propylene glycol fatty acid esters; glycerol fatty acid esters; acetylated glycerol fatty acid esters; lactic acid derivatives of mono- and diglycerides; sorbitan fatty acid esters; polyoxyethylene vegetable oils; and mixtures thereof. 26. The pharmaceutical system of claim 22, wherein the hydrophobic surfactant is a glycerol fatty acid ester selected from the group consisting of glycerol fatty acid monoesters, glycerol fatty acid diesters, acetylated glycerol fatty acid monoesters, acetylated glycerol fatty acid diesters, or a mixture thereof. 27. The pharmaceutical system of claim 26, wherein the glycerol fatty acid ester is selected from the group consisting of glycerol fatty acid monoesters, glycerol fatty acid diesters, and mixtures thereof. 28. The pharmaceutical system of claim 27, wherein the fatty acid of the glycerol fatty acid ester is a C.sub.6 to C.sub.22 fatty acid or a mixture thereof. 29. The pharmaceutical system of claim 22, wherein the hydrophobic surfactant is a reaction product of a polyol and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, and hydrogenated vegetable oils. 30. The pharmaceutical system of claim 29, wherein the reaction product is a transesterification product of a polyol and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, and hydrogenated vegetable oils. 31. The pharmaceutical system of claim 29, wherein the polyol is polyethylene glycol, sorbitol, propylene glycol, pentaerythritol, a saccharide, or a mixture thereof. 32. The pharmaceutical system of claim 22, wherein the hydrophobic surfactant is selected from the group consisting of myristic acid; oleic acid; lauric acid; stearic acid; palmitic acid; PEG 1-4 stearate; PEG 2-4 oleate; PEG-4 dilaurate; PEG-4 dioleate; PEG-4 distearate; PEG-6 dioleate; PEG-6 distearate; PEG-8 dioleate; PEG 3-16 castor oil; PEG 5-10 hydrogenated castor oil; PEG 6-20 corn oil; PEG 6-20 almond oil; PEG-6 olive oil; PEG-6 peanut oil; PEG-6 palm kernel oil; PEG-6 hydrogenated palm kernel oil; PEG-4 capric/caprylic triglyceride, mono, di, tri, tetra esters of vegetable oil and sorbitol; pentaerythrityl di, tetra stearate, isostearate, oleate, caprylate, or caprate; polyglyceryl 2-4 oleate, stearate, or isostearate; polyglyceryl 4-10 pentaoleate; polyglyceryl-3 dioleate; polyglyceryl-6 dioleate; polyglyceryl-10 trioleate; polyglyceryl-3 distearate; propylene glycol mono- or diesters of a C.sub.6 to C.sub.22 fatty acid; monoglycerides of a C.sub.6 to C.sub.22 fatty acid; acetylated monoglycerides of C.sub.6 to C.sub.22 fatty acid; diglycerides of C.sub.6 to C.sub.22 fatty acids; lactic acid derivatives of monoglycerides; lactic acid derivatives of diglycerides; PEG-6 sorbitan tetra, hexastearate; PEG-6 sorbitan tetraoleate; sorbitan monolaurate; sorbitan monopalmitate; sorbitan mono, trioleate; sorbitan mono, tristearate; sorbitan monoisostearate; sorbitan sesquioleate; sorbitan sesquistearate; PEG 2-5 oleyl ether; POE 2-4 lauryl ether; PEG-2 cetyl ether; PEG-2 stearyl ether; sucrose distearate; sucrose dipalmitate; ethyl oleate; isopropyl myristate; isopropyl palmitate; ethyl linoleate; isopropyl linoleate; poloxamers; cholic acid; ursodeoxycholic acid; glycocholic acid; taurocholic acid; lithocholic acid; deoxycholic acid; chenodeoxycholic acid; and mixtures thereof. 33. The pharmaceutical system of claim 22, wherein the hydrophobic surfactant is selected from the group consisting of myristic acid; oleic acid; lauric acid; stearic acid; palmitic acid, PEG 1-4 stearate; PEG 2-4 oleate; PEG-4 dilaurate; PEG-4 dioleate; PEG-4 distearate; PEG-6 dioleate; PEG-6 distearate; PEG-8 dioleate; PEG-3-16 castor oil; PEG 5-10 hydrogenated castor oil; PEG 6-20 corn oil; PEG 6-20 almond oil; PEG-6 olive oil; PEG-6 peanut oil; PEG-6 palm kernel oil; PEG-6 hydrogenated palm kernel oil; mono, di, tri, tetra esters vegetable oil and sorbitol; pentaerythrityl di, tetra stearate, isostearate, oleate, caprylate, or caprate; polyglyceryl 2-4 oleate, stearate, or isostearate; polyglyceryl 4-10 pentaoleate; polyglyceryl-3 dioleate; polyglyceryl-6 dioleate; polyglyceryl-3 distearate; propylene glycol mono- or diesters of a C.sub.6 to C.sub.22 fatty acid; monoglycerides of a C.sub.6 to C.sub.22 fatty acid; acetylated monoglycerides of C.sub.6 to C.sub.22 fatty acid; diglycerides of C.sub.6 to C.sub.22 fatty acids; laetic acid derivatives of monoglycerides; lactic acid derivatives of diglycerides; PEG-6 sorbitan tetra, hexastearate; PEG-6 sorbitan tetraoleate; sorbitan monolaurate; sorbitan monopalmitate; sorbitan monooleate; sorbitan monostearate; sorbitan monoisostearate; sorbitan sesquioleate; sorbitan sesquistearate; PEG 2-5 oleyl ether; POE 2-4 lauryl ether; PEG-2 cetyl ether; PEG-2 stearyl ether; sucrose distearate; sucrose dipalmitate; ethyl oleate; isopropyl myristate; isopropyl palmitate; ethyl linoleate; isopropyl linoleate; poloxamers; cholic acid; ursodeoxycholic acid; glycocholic acid; taurocholic acid; lithocholic acid; deoxycholic acid; chenodeoxycholic acid; and mixtures thereof. 34. The pharmaceutical system of claim 1, wherein each of the at least two surfactants is selected from the group consisting of sodium lauryl sulfate, oleic acid, linoleic acid, monoolein, deoxycholate, taurodeoxycholate, glycochenodeoxycholate, polyoxyethylene X-lauryl ether, where X is from 9 to 20, sodium tauro-24,25-dihydrofusidate, polyoxyethylene ether, polyoxyethylene sorbitan esters, p-t-octylphenoxypolyoxyethylene, N-lauryl-.beta.-D-maltopyranoside, and 1-dodecylazacycloheptane-2-azone, and is present in an amount of greater than 10% by weight, based on the total weight of the pharmaceutical system. 35. The pharmaceutical system of claim 1, wherein the hydrophilic therapeutic agent is a drug, a vitamin, a nutritional supplement, a cosmeceutical, a diagnostic agent, or a mixture thereof. 36. The pharmaceutical system of claim 1, wherein the hydrophilic therapeutic agent has an apparent water solubility of at least about 1 mg/mL. 37. The pharmaceutical system of claim 1, wherein the hydrophilic therapeutic agent is a hydrophilic drug, a cytokine, a peptidomimetic, a peptide, a protein, a toxoid, a serum, an antibody, a vaccine, a nucleoside, a nucleotide, a portion of genetic material, a nucleic acid, or a mixture thereof. 38. The pharmaceutical system of claim 1, wherein the hydrophilic therapeutic agent is selected from the hydrophilic members of the group consisting of analgesics, anti-inflammatory agents, anthelmintics, anti-arrhythmic agents, anti-asthma agents, anti-bacterial agents, anti-viral agents, anti-coagulants, anti-depressants, anti-diabetics, anti-epileptics, anti-fungal agents, anti-gout agents, anti-hypertensive agents, anti-malarials, anti-migraine agents, anti-muscarinic agents, anti-neoplastic agents, immunosuppressants, anti-protozoal agents, anti-thyroid agents, anti-tussives, anxiolytic, sedatives, hypnotics, neuroleptics, .beta.-Blockers, cardiac inotropic agents, corticosteriods, diuretics, anti-parkinsonian agents, gastro-intestinal agents, histamine H,-receptor antagonists, keratolytics, lipid regulating agents, muscle relaxants, anti-anginal agents, nutritional agents, analgesics, sex hormones, stimulants, cytokines, peptidomimetics, peptides, proteins, toxoids, sera, antibodies, vaccines, nucleosides, nucleotides, genetic material, nucleic acids, and mixtures thereof. 39. The pharmaceutical system of claim 1, wherein the hydrophilic therapeutic agent is selected from the group consisting of acarbose; acyclovir; acetyl cysteine; acetylcholine chloride; alatrofloxacin; alendronate; alglucerase; amantadine hydrochloride; ambenomium; amifostine; amiloride hydrochloride; aminocaproic acid; amphotericin B; antihemophilic factor (human); antihemophilic factor (porcine); antihemophilic factor (recombinant); aprotinin; asparaginase; atenolol; atracurium besylate; atropine; azithromycin; aztreonam; BCG vaccine; bacitracin; becalermin; belladona; bepridil hydrochloride; bleomycin sulfate; calcitonin human; calcitonin salmon; carboplatin; capecitabine; capreomycin sulfate; cefamandole nafate; cefazolin sodium; cefepime hydrochloride; cefixime; cefonicid sodium; cefoperazone; cefotetan disodium; cefotoxime; cefoxitin sodium; ceftizoxime; ceftriaxone; cefuroxime axetil; cephalexin; cephapirin sodium; cholera vaccine; chrionic gonadotropin; cidofovir; cisplatin; cladribine; clidinium bromide; clindamycin and clindamycin derivatives; ciprofloxacin; clondronate; colistimethate sodium; colistin sulfate; cortocotropin; cosyntropin; cromalyn sodium; cytarabine; daltaperin sodium; danaproid; deforoxamine; denileukin diftitox; desmopressin; diatrizoate megluamine and diatrizoate sodium; dicyclomine; didanosine; dirithromycin; dopamine hydrochloride; dornase alpha; doxacurium chloride; doxorubicin; editronate disodium; elanaprilat; enkephalin; enoxacin; enoxaprin sodium; ephedrine; epinephrine; epoetin alpha; erythromycin; esmol hydrochloride; factor IX; famiciclovir; fludarabine; fluoxetine; foscarnet sodium; ganciclovir; granulocyte colony stimulating factor; granulocyte-macrophage stimulating factor; growth hormones-recombinant human; growth hormone-bovine; gentamycin; glucagon; glycopyrolate; gonadotropin releasing hormone and synthetic analogs thereof; GnRH; gonadorelin; grepafloxacin; hemophilus B conjugate vaccine; Hepatitis A virus vaccine inactivated; Hepatitis B virus vaccine inactivated; heparin sodium; indinavir sulfate; influenza virus vaccine; interleukin-2; interleukin-3; insulin-human; insulin lispro; insulin procine; insulin NPH; insulin aspart; insulin glargine; insulin detemir; interferon alpha; interferon beta; ipratropium bromide; isofosfamide; japanese encephalitis virus vaccine; lamivudine; leucovorin calcium; leuprolide acetate; levofloxacin; lincomycin and lincomycin derivatives; lobucavir; lomefloxacin; loracarbef; mannitol; measles virus vaccine; meningococcal vaccine; menotropins; mephenzolate bromide; mesalmine; methanamine; methotrexate; methscopolamine; metformin hydrochloride; metroprolol; mezocillin sodium; mivacurium chloride; mumps viral vaccine; nedocromil sodium; neostigmine bromide; neostigmine methyl sulfate; neutontin; norfloxacin; octreotide acetate; ofloxacin; olpadronate; oxytocin; pamidronate disodium; pancuronium bromide; paroxetine; pefloxacin; pentamindine isethionate; pentostatin; pentoxifylline; periciclovir; pentagastrin; phentolamine mesylate; phenylalanine; physostigmine salicylate; plague vaccine; piperacillin sodium; platelet derived growth factor-human; pneumococcal vaccine polyvalent; poliovirus vaccine inactivated; poliovirus vaccine live (OPV); polymixin B sulfate; pralidoxine chloride; pramlintide; pregabalin; propofenone; propenthaline bromide; pyridostigmine bromide; rabies vaccine; residronate; ribavarin; rimantadine hydrochloride; rotavirus vaccine; salmetrol xinafoate; sincalide; small pox vaccine; solatol; somatostatin; sparfloxacin; spectinomycin; stavudine; streptokinase; streptozocin; suxamethonium chloride; tacrine hydrochloride; terbutaline sulfate; thiopeta; ticarcillin; tiludronate; timolol; tissue type plasminogen activator; TNFR:Fc; TNK-tPA; trandolapril; trimetrexate gluconate; trospectinomycin; trovafloxacin; tubocurarine chloride; tumor necrosis factor; typhoid vaccine live; urea; urokinase; vancomycin; valaciclovir; valsartan; varicella virus vaccine live; vasopressin and vasopressin derivatives; vecoronium bromide; vinblastin; vincristine; vinorelbine; vitamin B12; warfarin sodium; yellow fever vaccine; zalcitabine; zanamavir; zolandronate; and zidovudine. 40. The pharmaceutical system of claim 1, wherein the hydrophilic therapeutic agent is selected from the group consisting of acarbose; acyclovir; atracurium besylate; alendronate; alglucerase; amantadine hydrochloride; amphotericin B; antihemophilic factor (human); antihemophilic factor (porcine); antihemophilic factor (recombinant; azithromycin; calcitonin human; calcitonin salmon; capecitabine; cefazolin sodium; cefonicid sodium; cefoperazone; cefoxitin sodium; ceftizoxime; ceftriaxone; cefuiroxime axetil; cephalexin; chrionic gonadotropin; cidofovir; cladribine; clindamycin and clindamycin derivatives; cortocotropin; cosyntropin; cromalyn sodium; cytarabine; daltaperin sodium; danaproid; desmopressin; didanosine; dirithromycin; editronate disodium; enoxaprin sodium; epoetin alpha; factor IX; farmiciclovir; fluradabine; foscarnet sodium; ganciclovir; granulocyte colony stimulating factor; granulocyte-macrophage stimulating factor; growth hormones-recombinant human; growth hormone-Bovine; gentamycin; glucagon; gonadotropin releasing hormone and synthetic analogs thereof; GnRH; gonadorelin; hemophilus B conjugate vaccine; Hepatitis A virus vaccine inactivated; Hepatitis B virus vaccine inactivated; heparin sodium; indinavir sulfate; influenza virus vaccine; interleukin-2; interleukin-3; insulin-human; insulin lispro; insulin procine; insulin NPH; insulin aspart; insulin glargine; insulin detemir; interferon alpha; interferon beta; ipratropium bromide; isofosfamide; lamivudine; leucovorin calcium; leuprolide acetate; lincomycin and lincomycin derivatives; metforrmin hydrochloride; nedocromil sodium; neostigmine bromide; neostigmine methyl sulfate; neutontin; octreotide acetate; olpadronate; pamidronate disodium; pancuronium bromide; pentamindine isethionate; pentagastrin; physostigmine salicylate; poliovirus vaccine live (OPV); pyridostigmine bromide; residronate; ribavarin; rimantadine hydrochloride; rotavirus vaccine; salmetrol xinafoate; somatostatin; spectinomycin; stavudine; streptokinase; ticarcillin; tiludronate; tissue type plasminogen activator; TNFR:Fc; TNK-tPA; trimetrexate gluconate; trospectinomycin; tumor necrosis factor; typhoid vaccine live; urokinase; vancomycin; valaciclovir; vasopressin and vasopressin derivatives; vinblastin; vincristine; vinorelbine; warfarin sodium; zalcitabine; zanamavir; and zidovudine. 41. The pharmaceutical system of claim 1, wherein the hydrophilic therapeutic agent is selected from the group consisting of acarbose; alendronate; amantadine hydrochloride; azithromycin; calcitonin human; calcitonin salmon; ceftriaxone; cefuroxime axetil; chrionic gonadotropin; cromalyn sodium; daltaperin sodium; danaproid; desmopressin; didanosine; editronate disodium; enoxaprin sodium; epoetin alpha; factor IX; famiciclovir; foscarnet sodium; ganciclovir; granulocyte colony stimulating factor; granulocyte-macrophage stimulating factor; growth hormones-recombinant human; growth hormone-Bovine; glucagon; gonadotropin releasing hormone and synthetic analogs thereof; GnRH; gonadorelin; heparin sodium; indinavir sulfate; influenza virus vaccine; interleukin-2; interleukin-3; insulin-human; insulin lispro; insulin procine interferon alpha; interferon beta; leuprolide acetate; metformin hydrochloride; nedocromil sodium; neostigmine bromide; neostigmine methyl sulfate; neutontin; octreotide acetate; olpadronate; pamidronate disodium; residronate; rimantadine hydrochloride; salmetrol xinafoate; somatostatin; stavudine; ticarcillin; tiludronate; tissue type plasminogen activator; TNFR:Fc; TNK-tPA; tumor necrosis factor; typhoid vaccine live; vancomycin; valaciclovir; vasopressin and vasopressin derivatives; zalcitabine; zanamavir and zidovudine. 42. The pharmaceutical system of claim 1, wherein the composition further includes at least one pharmaceutical additive selected from the group consisting of an antioxidanl, a bufferant, an antifoaming agent, a detackifier, a preservative, a chelating agent, a viscomodulator, a tonicifier, a flavorant, a colorant, an odorant, an opacifier, a suspending agent, a binder, a filler, a plasticizer, a lubricant, an enzyme inhibiting agent, and combinations thereof. 43. The pharmaceutical system of claim 42, wherein the composition includes an enzyme inhibiting agent present in an amount sufficient to at least partially inhibit enzymatic degradation of the hydrophilic therapeutic agent. 44. The pharmaceutical system of claim 43, wherein the enzyme inhibiting agent is P-aminobenzamidine, FK-448, camostat mesylate, sodium glycocholate, an amino acid, a modified amino acid, a peptide, a modified peptide, a polypeptide protease inhibitor, a complexing agent, a mucoadhesive polymer, a polymer-inhibitor conjugate, or a mixture thereof. 45. The pharmaceutical system of claim 44, wherein the enzyme inhibiting agent is selected from the group consisting of P-aminobenzamidine, FK-448, camostat mesylate, sodium glycocholate, aminoboronic acid derivatives, n-acetylcysteine, bacitracin, phosphinic acid dipeptide derivatives, pepstatin, antipain, leupeptin, chymostatin, elastatin, bestatin, hosphoramindon, puromycin, cytochalasin potatocarboxy peptidase inhibitor, amastatin, protinin, Bowman-Birk inhibitor, soybean trypsin inhibitor, chicken egg white trypsin inhibitor, chicken ovoinhibitor, human pancreatic trypsin inhibitor, EDTA, EGTA, 1,10-phenanthroline, hydroxychinoline, polyacrylate derivatives, chitosan, cellulosics, chitosan-EDTA, chitosan-EDTA-antipain, polyacrylic acid-bacitracin, carboxymethyl cellulose-pepstatin, polyacrylic acid-Bowman-Birk inhibitor, and mixtures thereof. 46. The pharmaceutical system of claim 1, wherein the composition further comprises a pharmaceutically acceptable acid. 47. The pharmaceutical system of claim 46, wherein the acid is selected from the group consisting of hydrochloric acid, hydrobromic acid, hydriodic acid, sulfuric acid, carbonic acid, nitric acid, boric acid, phosphoric acid, acetic acid, acrylic acid, adipic acid, alginic acid, alkanesulfonic acid, an amino acid, ascorbic acid, benzoic acid, boric acid, butyric acid, carbonic acid, citric acid, a fatty acid, formic acid, fumaric acid, gluconic acid, hydroquinosulfonic acid, isoascorbic acid, lactic acid, maleic acid, methanesulfonic acid, oxalic acid, para-bromophenylsulfonic acid, propionic acid, p-toluenesulfonic acid, salicylic acid, stearic acid, succinic acid, tannic acid, tartaric acid, thioglycolic acid, toluenesulfonic acid, uric acid, and mixtures thereof. 48. The pharmaceutical system of claim 1, wherein the composition further comprises a pharmaceutically acceptable base. 49. The pharmaceutical system of claim 48, wherein the base is an amino acid, an amino acid ester, ammonium hydroxide, potassium hydroxide, sodium hydroxide, sodium hydrogen carbonate, aluminum hydroxide, calcium carbonate, magnesium hydroxide, magnesium aluminum silicate, synthetic aluminum silicate, synthetic hydrotalcite, magnesium aluminum hydroxide, diisopropylethylamine, ethanolamine, ethylenediamine, triethanolamine, triethylamine, triisopropanolamine, or a salt of a pharmaceutically acceptable cation and acetic acid, acrylic acid, adipic acid, alginic acid, alkanesulfonic acid, an amino acid, ascorbic acid, benzoic acid, boric acid, butyric acid, carbonic acid, citric acid, a fatty acid, formic acid, fumaric acid, gluconic acid, hydroquinosulfonic acid, isoascorbic acid, lactic acid, maleic acid, methanesulfonic acid, oxalic acid, para-bromophenylsulfonic acid, propionic acid, p-toluenesulfonic acid, salicylic acid, stearic acid, succinic acid, tannic acid, tartaric acid, thioglycolic acid, toluenesulfonic acid, and uric acid, or a mixture thereof. 50. The pharmaceutical system of claim 1, wherein the aqueous dispersion formed by the composition upon contact with an aqueous medium has an average particle size of less than about 200 nm upon mixing with an aqueous diluent. 51. The pharmaceutical system of claim 50, wherein the average particle size is less than about 100 nm. 52. The pharmaceutical system of claim 50, wherein the average particle size is less than about 50 nm. 53. The pharmaceutical system of claim 1, wherein the system is free of polyethylene glycol diesters. 54. The pharmaceutical system of claim 1, wherein the dosage form is free of water. 55. The pharmaceutical system of claim 1 in the form of a preconcentrate in a liquid, semi-solid, or solid form, or as an aqueous or organic diluted preconcentrate. 56. The pharmaceutical system of claim 1, wherein the dosage form of the composition is processed by balling, lyophilization, encapsulation, extruding, compression, melting, molding, spraying, spray congealing, coating, comminution, mixing, cryopelletization, spheronization, homogenization, sonication, granulation, or a combination thereof. 57. The pharmaceutical system of claim 1, wherein the dosage form of the composition is a pill, capsule, caplet, tablet, granule, pellet, bead or powder. 58. The pharmaceutical system of claim 1, wherein the dosage form of the composition is a starch capsule, a cellulosic capsule, a hard gelatin capsule or a soft gelatin capsule. 59. The pharmaceutical system of claim 1, wherein the dosage form is formulated for immediate release, controlled release, extended release, delayed release, targeted release, or targeted delayed release. 60. The pharmaceutical system of claim 57, coated with at least one enteric coating, seal coating, extended release coating, or targeted delayed release coating. 61. The pharmaceutical system of claim 60, wherein the coating is comprised of a material selected from the group consisting of shellac, acrylic polymers, cellulosic derivatives, polyvinyl acetate phthalate, and mixtures thereof. 62. The pharmaceutical system of claim 60, herein the coating is comprised of a material selected from the group consisting of acrylic acid and methacrylic acid resins, cellulose acetate phthalate, cellulose acetate trimellitate, ethyl cellulose, hydroxypropyl methyl cellulose phthalate, hydroxypropyl methyl cellulose succinate, polyvinylacetate phthalate, and mixtures thereof. 63. The pharmaceutical system of claim 60, wherein the coating is comprised of a material selected from the group consisting of acrylic acid and methacrylic acid resins, cellulose acetate phthalate, ethyl cellulose, hydroxypropyl methyl cellulose phthalate, hydroxypropyl methyl cellulose succinate, polyvinylacetate phthalate, and mixtures thereof. 64. The pharmaceutical system of claim 1, wherein the dosage form of the composition is a solution, suspension, emulsion, cream, ointment, lotion, suppository, spray, aerosol, paste, gel, drops, douche, ovule, wafer, troche, cachet, syrup or elixir. 65. The pharmaceutical system of claim 1, wherein the dosage form is a multiparticulate carrier coated onto a substrate with the composition. 66. The pharmaceutical system of claim 65, wherein the substrate is a particle, a granule, a pellet or a bead, and is formed of the therapeutic agent, a pharmaceutically acceptable material, or a mixture thereof. 67. The pharmaceutical system of claim 65, wherein the multiparticulate carrier is coated with at least one enteric coating, seal coating, extended release coating, or targeted delayed release coating. 68. The pharmaceutical system of claim 65, wherein the dosage form is further processed by encapsulation, compression, extrusion, molding, spheronization or cryopelletization. 69. The pharmaceutical system of claim 65, wherein the dosage form is further processed to form a starch capsule, a cellulosic capsule, a hard gelatin capsule, or a soft gelatin capsule. 70. The pharmaceutical system of claim 69, wherein the capsule is coated with at least one enteric coating, seal coating, extended release coating, or targeted delayed release coating. 71. The pharmaceutical system of claim 1, wherein the hydrophilic therapeutic agent is present in the dosage form. 72. The pharmaceutical system of claim 71, wherein the hydrophilic therapeutic agent is solubilized in the composition, suspended in the composition, or partially solubilized and partially suspended in the composition. 73. The pharmaceutical system of claim 1, wherein the hydrophilic therapeutic agent is present in a second dosage form separate from the dosage form containing the absorption enhancing composition. 74. The pharmaceutical system of claim 1, wherein the dosage form of the composition is formulated for oral, mucosal, nasal, pulmonary, vaginal, transmembrane, buccal or rectal administration. 75. The pharmaceutical system of claim 73, wherein the dosage form of the hydrophilic therapeutic agent is formulated for oral, mucosal, nasal, pulmonary, vaginal, transmembrane, buccal or rectal administration. 76. A pharmaceutical system for enhanced absorption of a hydrophilic therapeutic agent, the system consisting essentially of: (a) a dosage form of an absorption enhancing composition, the composition comprising: (i) at least one hydrophilic surfactant selected from the group consisting of ionized surfactants, non-ionic hydrophilic surfactants having an HLB value greater than or equal to about 10, and combinations thereof, (ii) at least one hydrophobic surfactant selected from the group consisting of hydrophobic (a) alcohols, polyoxyethylene alkylethers, bile acids, glycerol fatty acid monoesters, glycerol fatty acid diesters, acetylated glycerol fatty acid monoesters, acetylated glycerol fatty acid diesters, lower alcohol fatty acid monoesters, lower alcohol fatty acid diesters, polyethylene glycol fatty acid esters, polyethylene glycol glycerol fatty acid esters, polypropylene glycol fatty acid esters, polyoxyethylene glycerides, lactic acid derivatives of mono- and diglycerides, propylene glycol diglycerides, sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene-polyoxypropylene block copolymers, transesterified vegetable oils, sugar esters, sugar ethers, sucroglycerides, polyoxyethylene vegetable oils, polyoxyethylene hydrogenated vegetable oils, reaction products of polyols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, and hydrogenated vegetable oils, and hydrophobic, un-ionized (b) fatty acids, carnitine fatty acid esters, alkylsulfates, acyl lactylates, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, succinylated monoglycerides, citric acid esters of mono- and diglycerides, and mixtures thereof, wherein the hydrophilic and hydrophobic surfactants are present in amounts such that upon mixing with an aqueous diluent at 100.times. dilution, the composition forms an aqueous dispersion having an average particle size of less than about 200 nm, and (iii) at least one solubilizer; and (b) a therapeutically effective amount of a hydrophilic therapeutic agent, wherein the pharmaceutical system is free of triglycerides. 77. The pharmaceutical system of claim 76, wherein the hydrophilic surfactant comprises at least one ionized ionizable surfactant. 78. The pharmaceutical system of claim 77, wherein the ionized ionizable surfactant is the ionized form of a surfactant selected from the group consisting of bile acids and salts, analogues, and derivatives thereof; lecithins, lysolecithin, phospholipids, lysophospholipids and derivatives thereof; carnitine fatty acid ester salts; salts of alkylsulfates; salts of fatty acids; sodium docusate; acyl lactylates; mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides; succinylated monoglycerides; citric acid esters of mono- and diglycerides; and mixtures thereof. 79. The pharmaceutical system of claim 77, wherein the ionized ionizable surfactant is the ionized form of a surfactant selected from the group consisting of lecithin, lysolecithin, phosphatidylcholine, phosphatidylethanolamine, phosphatidylglycerol, phosphatidic acid, phosphatidylserine, lysophosphatidylcholine, lysophosphatidylethanolamnine, lysophosphatidylglycerol, lysophosphatidic acid, lysophosphatidylserine, PEG-phosphatidylethanolamine, PVP-phosphatidylethanolamine, lactylic esters of fatty acids, stearoyl-2-lactylate, stearoyl lactylate, succinylated monoglycerides, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, citric acid esters of mono- and diglycerides, cholate, taurocholate, glycocholate, deoxycholate, taurodeoxychorate, chenodeoxycholate, glycodeoxycholate, glycochenodeoxycholate, taurochenodeoxycholate, ursodeoxycholate, lithocholate, tauroursodeoxycholate, glycoursodeoxycholate, cholylsarcosine, N-methyl taurocholate, caproate, caprylate, caprate, laurate, myristate, palmitate, oleate, ricinoleate, linoleate, linolenate, stearate, lauryl sulfate, tetraacetyl sulfate, docusate, lauroyl carnitine, palmitoyl carnitine, myristoyl carnitine, and salts and mixtures thereof. 80. The pharmaceutical system of claim 77, wherein the ionized ionizable surfactant is the ionized form of a surfactant selected from the group consisting of lecithin, lysolecithin, phosphatidylcholine, phosphatidylethanolamine, phosphatidylglycerol, lysophosphatidylcholine, PEG-phosphatidylethanolamine, lactylic esters of fatty acids, stearoyl-2-lactylate, stearoyl lactylate, succinylated monoglycerides, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, citric acid esters of mono- and diglycerides, cholate, taurocholate, glycocholate, deoxycholate, chenodeoxycholate, lithocholate, ursodeoxycholate, taurodeoxycholate, glycodeoxycholate, cholylsarcosine, caproate, caprylate, caprate, laurate, oleate, lauryl sulfate, docusate, lauroyl carnitine, palmitoyl carnitine, myristoyl carnitine, and salts and mixtures thereof. 81. The pharmaceutical system of claim 77, wherein the ionized ionizable surfactant is the ionized form of a surfactant selected from the group consisting of lecithin, lactylic esters of fatty acids, stearoyl-2-lactylate, stearoyl lactylate, succinylated monoglycerides, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, citric acid esters of mono- and diglycerides, chenodeoxycholate, lithocholate, ursodeoxycholate, taurocholate, caprylate, caprate, oleate, lauryl sulfate, docusate, lauroyl carnitine, palmitoyl carnitine, myristoyl carnitine, and salts and mixtures thereof. 82. The pharmaceutical system of claim 76, wherein the hydrophilic surfactant comprises at least one non-ionic hydrophilic surfactant having an HLB value greater than or equal to about 10. 83. The pharmaceutical system of claim 82, wherein the non-ionic surfactant is selected from the group consisting of alkylglucosides; alkylmaltosides; alkylthioglucosides; lauryl macrogolglycerides; polyoxyethylene alkyl ethers; polyoxyethylene alkylphenols; polyethylene glycol fatty acids esters; polyethylene glycol glycerol fatty acid esters; polyoxyethylene sorbitan fatty acid esters; polyoxyethylene-polyoxypropylene block copolymers; polyglycerol fatty acid esters; polyoxyethylene glycerides; polyoxyethylene sterols, derivatives, and analogues thereof; polyoxyethylene vegetable oils; polyoxyethylene hydrogenated vegetable oils; reaction products of polyols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, hydrogenated vegetable oils, and sterols; sugar esters, sugar ethers; sucroglycerides; and mixtures thereof. 84. The pharmaceutical system of claim 82, wherein the non-ionic hydrophilic surfactant is selected from the group consisting of polyoxyethylene alkylethers; polyethylene glycol fatty acids esters; polyethylene glycol glycerol fatty acid esters; polyoxyethylene sorbitan fatty acid esters; polyoxyethylene-polyoxypropylene block copolymers; polyglycerol fatty acid esters; polyoxyethylene glycerides; polyoxyethylene vegetable oils; polyoxyethylene hydrogenated vegetable oils; reaction products of polyols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, hydrogenated vegetable oils, and sterols; and mixtures thereof. 85. The pharmaceutical system of claim 84, wherein the non-ionic hydrophilic surfactant is the reaction product of a polyol and a monoglyceride, diglyceride, triglyceride, or a mixture thereof. 86. The pharmaceutical system of claim 85, wherein the reaction product comprises the transesterification product of a polyol and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, hydrogenated vegetable oils, and sterols. 87. The pharmaceutical system of claim 85, wherein the polyol is glycerol, ethylene glycol, polyethylene glycol, sorbitol, propylene glycol, pentaerythritol, a saccharide, or a mixture thereof. 88. The pharmaceutical system of claim 82, wherein the hydrophilic surfactant is selected from the group consisting of PEG-10 laurate, PEG-12 laurate, PEG-20 laurate, PEG-32 laurate, PEG-32 dilaurate, PEG-12 oleate, PEG-15 oleate, PEG-20 oleate, PEG-20 dioleate, PEG-32 oleate, PEG-200 oleate, PEG-400 oleate, PEG-15 stearate, PEG-32 distearate, PEG40 stearate, PEG-100 stearate, PEG-20 dilaurate, PEG-32 dioleate, PEG-20 glyceryl laurate, PEG-30 glyceryl laurate, PEG-20 glyceryl stearate, PEG-20 glyceryl oleate, PEG-30 glyceryl oleate, PEG-30 glyceryl laurate, PEG40 glyceryl laurate, PEG-40 palm kernel oil, PEG-50 hydrogenated castor oil, PEG-40 castor oil, PEG-35 castor oil, PEGG-60 castor oil, PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, PEG-60 corn oil, PEG-6 caprate/caprylate monoglycerides, PEG-6 caprate/caprylate diglycerides, PEG-8 caprate/caprylate monoglycerides, PEG-8 caprate/caprylate diglycerides, polyglyceryl-10 laurate, PEG-30 cholesterol, PEG-25 phyto sterol, PEG-30 soya sterol, PEG-40 sorbitan oleate, PEG-80 sorbitan laurate, polysorbate 20, polysorbate 80, POE-9 lauryl ether, POE-23 lauryl ether, POE-10 oleyl ether, POE-20 oleyl ether, POE-20 stearyl ether, tocopheryl PEG-100 succinate, PEG-24 cholesterol, polyglyceryl-10 oleate, Tween 40, Tween 60, sucrose monostearate, sucrose monolaurate, sucrose monopalmitate, PEG 10-100 nonyl phenol series, PEG 15-100 octyl phenol series, a poloxamer, aid combinations thereof. 89. The pharmaceutical system of claim 82, wherein the hydrophilic surfactant is selected from the group consisting of PEG-20 laurate, PEG-20 oleate, PEG-35 castor oil, PEG-40 palm kernel oil, PEG-40 hydrogenated castor oil, PEG-60 corn oil, polyglyceryl-10 laurate, PEG-6 caprate/caprylate monoglycerides, PEG-6 caprate/caprylate diglycerides, PEG-8 caprate/caprylate monoglycerides, PEG-8 caprate/caprylate diglycerides, PEG-30 cholesterol, polysorbate 20, polysorbate 80, POE-9 lauryl ether, POE-23 lauryl ether, POE-10 oleyl ether, PEG-24 cholesterol, sucrose monostearate, sucrose monolaurate, a poloxamer, and combinations thereof. 90. The pharmaceutical system of claim 82, wherein the hydrophilic surfactant is selected from the group consisting of PEG-35 castor oil, PEG-40 hydrogenated castor oil, PEG-60 corn oil, PEG-6 caprate/caprylate monoglycerides, PEG-6 caprate/caprylate diglycerides, PEG-8 caprate/caprylate monoglycerides, PEG-8 caprate/caprylate diglycerides, polysorbate 20, polysorbate 80, tocopheryl PEG-1000 succinate, PEG-24 cholesterol, a poloxamer, and combinations thereof. 91. The pharmaceutical system of claim 76, wherein the composition comprises at least two hydrophilic surfactants. 92. The pharmaceutical system of claim 76, wherein the hydrophobic surfactant comprises an un-ionized ionizable surfactant. 93. The pharmaceutical system of claim 92, wherein the un-ionized ionizable surfactant is the un-ionized form of a surfactant selected from the group consisting of bile acids and analogues and derivatives thereof; lecithins, lysolecithin, phospholipids, lysophospholipids and derivatives thereof; carnitine fatty acid esters; alkylsulfates; fatty acids; acyl lactylates; mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides; succinylated monoglycerides; citric acid esters of mono- and diglycerides; and mixtures thereof. 94. The pharmaceutical system of claim 92, wherein the un-ionized ionizable surfactant is the un-ionized form of a surfactant selected from the group consisting of lecithin, lysolecithin, phosphatidylcholine, phosphatidylethanolamine, phosphatidylglycerol, phosphatidic acid, phosphatidylserine, lysophosphatidylcholine, lysophosphatidylethanolamine, lysophosphatidylglycerol, lysophosphatidic acid, lysophosphatidylserine, PEG-phosphatidylethanolamine, PVP-phosphatidylethanolamine, lactylic esters of fatty acids, stearoyl-2-lactylate, stearoyl lactylate, succinylated monoglycerides, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, citric acid esters of mono- and diglycerides, cholic acid, taurocholic acid, glycocholic acid, deoxycholic acid, taurodeoxycholic acid, chenodeoxycholic acid, glycodeoxycholic acid, glycochenodeoxycholic acid, taurochenodeoxycholic acid, ursodeoxycholic acid, lithocholic acid, tauroursodeoxycholic acid, glycoursodeoxycholic acid, cholylsarcosine, N-methyl taurocholic acid, caproic acid, caprylic acid, capric acid, lauric acid, myristic acid, palmitic acid, oleic acid, ricinoleic acid, linoleic acid, linolenic acid, stearic acid, lauryl sulfate, tetraacetyl sulfate, lauroyl carnitine, palmitoyl carnitine, myristoyl carnitine, and mixtures thereof. 95. The pharmaceutical system of claim 92, wherein the un-ionized ionizable surfactant is the unionized form of a surfactant selected from the group consisting of lecithin, lysolecithin, phosphatidylcholine, phosphatidylethanolamine, phosphatidylglycerol, lysophosphatidylcholine, PEG-phosphatidylethanolamine, lactylic esters of fatty acids, stearoyl-2-lactylate, stearoyl lactylate, succinylated monoglycerides, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, citric acid esters of mono- and diglycerides, cholic acid, taurocholic acid, glycocholic acid, deoxycholic acid, chenodeoxycholic acid, lithocholic acid, ursodeoxycholic acid, taurodeoxycholic acid, glycodeoxycholic acid, cholylsarcosine, caproic acid, caprylic acid, capric acid, lauric acid, oleic acid, lauryl sulfate, lauroyl carnitine, palmitoyl carnitine, myristoyl carnitine, and mixtures thereof. 96. The pharmaceutical system of claim 92, wherein the un-ionized ionizable surfactant is the un-ionized form of a surfactant selected from the group consisting of lecithin, lactylic esters of fatty acids, stearoyl-2-lactylate, stearoyl lactylate, succinylated monoglycerides, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, citric acid esters of mono- and diglycerides, chenodeoxycholic acid, lithocholic acid, ursodeoxycholic acid, taurocholic acid, caprylic acid, capric acid, oleic acid, lauryl sulfate, docusate, lauroyl carnitine, palmitoyl carnitine, myristoyl carnitine, and mixtures thereof. 97. The pharmaceutical system of claim 92 wherein the hydrophobic surfactant comprises at least one surfactant having an HLB value less than about 10. 98. The pharmaceutical system of claim 97, wherein the hydrophobic surfactant is selected from the group consisting of alcohols; polyoxyethylene alkylethers; fatty acids; bile acids; glycerol fatty acid esters; acetylated glycerol fatty acid esters; lower alcohol fatty acids esters; polyethylene glycol fatty acids esters; polyethylene glycol glycerol fatty acid esters; polypropylene glycol fatty acid esters; polyoxyethylene glycerides; lactic acid derivatives of mono- and diglycerides; propylene glycol diglycerides; sorbitan fatty acid esters; polyoxyethylene sorbitan fatty acid esters; polyoxyethylene-polyoxypropylene block copolymers; transesterified vegetable oils; sterols; sterol derivatives; sugar esters; sugar ethers; sucroglycerides; polyoxyethylene vegetable oils; polyoxyethylene hydrogenated vegetable oils; reaction products of polyols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, hydrogenated vegetable oils, and sterols; and mixtures thereof. 99. The pharmaceutical system of claim 97, wherein the hydrophobic surfactant is selected from the group consisting of fatty acids; bile acids; lower alcohol fatty acid esters; polyethylene glycol glycerol fatty acid esters; polypropylene glycol fatty acid esters; polyoxyethylene glycerides; glycerol fatty acid esters; acetylated glycerol fatty acid esters; lactic acid derivatives of mono- and diglycerides; sorbitan fatty acid esters; polyoxyethylene sorbitan fatty acid esters; polyoxyethylene-polyoxypropylene block copolymers; polyoxyethylene vegetable oils; polyoxyethylene hydrogenated vegetable oils; reaction products of polyols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, hydrogenated vegetable oils, and sterols; and mixtures thereof. 100. The pharmaceutical system of claim 97, wherein the hydrophobic surfactant is selected from the group consisting of bile acids; lower alcohol fatty acids esters; polypropylene glycol fatty acid esters; propylene glycol fatty acid esters; glycerol fatty acid esters; acetylated glycerol fatty acid esters; lactic acid derivatives of mono- and diglycerides; sorbitan fatty acid esters; polyoxyethylene vegetable oils; and mixtures thereof. 101. The pharmaceutical system of claim 97, wherein the hydrophobic surfactant is a glycerol fatty acid ester selected from the group consisting of glycerol fatty acid monoesters, glycerol fatty acid diesters, acetylated glycerol fatty acid monoesters, acetylated glycerol fatty acid diesters, and mixtures thereof. 102. The pharmaceutical system of claim 97, wherein the glycerol fatty acid ester is selected from the group consisting of glycerol fatty acid monoesters, glycerol fatty acid diesters, and mixtures thereof. 103. The pharmaceutical system of claim 102, wherein the fatty acid of the glycerol fatty acid ester is a C.sub.6 to C.sub.22 fatty acid or a mixture thereof. 104. The pharmaceutical system of claim 97, wherein the hydrophobic surfactant is a reaction product of a polyol and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, hydrogenated vegetable oils, and sterols. 105. The pharmaceutical system of claim 104, wherein the reaction product is a transesterification product of a polyol and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, hydrogenated vegetable oils, and sterols. 106. The pharmaceutical system of claim 105, wherein the hydrophobic surfactant is selected from the group consisting of myristic acid; oleic acid; lauric acid; stearic acid; palmitic acid; PEG 1-4 stearate; PEG 2-4 oleate; PEG-4 dilaurate; PEG-4 dioleate; PEG-4 distearate; PEG-6 dioleate; PEG-6 distearate; PEG-8 dioleate; PEG 3-16 castor oil; PEG 5-10 hydrogenated castor oil; PEG 6-20 corn oil; PEG 6-20 almond oil; PEG-6 olive oil; PEG-6 peanut oil; PEG-6 palm kernel oil; PEG-6 hydrogenated palm kernel oil; PEG-4 capric/caprylic triglyceride, mono, di, tri, tetra esters of vegetable oil and sorbitol; pentaerythrityl di, tetra stearate, isostearate, oleate, caprylate, or caprate; polyglyceryl 2-4 oleate, stearate, or isostearate; polyglyceryl 4-10 pentaoleate; polyglyceryl-3 dioleate; polyglyceryl-6 dioleate; polyglyceryl-10 trioleate; polyglyceryl-3 distearate; propylene glycol mono- or diesters of a C.sub.6 to C.sub.22 fatty acid; monoglycerides of a C.sub.6 to C.sub.22 fatty acid; acetylated monoglycerides of C.sub.6 to C.sub.22 fatty acid; diglycerides of C.sub.6 to C.sub.22 fatty acids; lactic acid derivatives of monoglycerides; lactic acid derivatives of diglycerides; cholesterol; phytosterol; PEG 5-20 soya sterol; PEG-6 sorbitan tetra, hexastearate; PEG-6 sorbitan tetraoleate; sorbitan monolaurate; sorbitan monopalmitate; sorbitan mono, trioleate; sorbitan mono, tristearate; sorbitan monoisostearate; sorbitan sesquioleate; sorbitan sesquistearate; PEG 2-5 oleyl ether; PEG 2-4 lauryl ether; PEG-2 cetyl ether; PEG-2 stearyl ether; sucrose. 107. The pharmaceutical system of claim 97, wherein the hydrophobic surfactant is selected from the group consisting of myristic acid; oleic acid; lauric acid; stearic acid; palmitic acid; PEG 1-4 stearate; PEG 24 oleate; PEG-4 dilaurate; PEG-4 dioleate; PEG-4 distearate; PEG-6 dioleate; PEG-6 distearate; PEG-8 dioleate; PEG 3-16 castor oil; PEG 5-10 hydrogenated castor oil; PEG 6-20 corn oil; PETG 6-20 almond oil; PEG-6 olive oil; PEG-6 peanut oil; PEG-6 palm kernel oil; PEG-6 hydrogenated palm kernel oil; mono, di, tri, tetra esters of vegetable oil and sorbitol; pentaerythrityl di, tetra stearate, isostearate, oleate, caprylate, or caprate; polyglyceryl 2-4 oleate, stearate, or isostearate; polyglyceryl 4-10 pentaoleate polyglyceryl-3 dioleate; polyglyceryl-6 dioleate; polyglyceryl-3 distearate; propylene glycol mono- or diesters of a C.sub.6 to C.sub.22 fatty acid; monoglycerides of a C.sub.6 to C.sub.22 fatty acid; acetylated monoglycerides of C.sub.6 to C.sub.22 fatty acid; diglycerides or C.sub.6 to C.sub.22 fatty acids; lactic acid derivatives of monoglycerides; lactic acid derivatives of diglycerides; cholesterol; phytosterol: PEG 5-20 soya sterol; PEG-6 sorbitan tetra, hexastearate; PEG-6 sorbitan tetraoleate; sorbitan monolaturate; sorbitan monopalmitate; sorbitan monooleate; sorbitan monostearate; sorbitan monoisostearate; sorbitan sesquioleate; sorbitan sesquistearate; PEG 2-5 oleyl ether; POE 2-4 lauryl ether; PFG-2 cetyl ether; PEG-2 stearyl ether; sucrose distearate; sucrose dipalmitate; ethyl oleate; isopropyl myristate; isopropyl palmitate; ethyl linoleate; isopropyl linoleate; poloxamers; cholic acid; ursodeoxycholic acid; glycocliolic acid; taurocliolic acid; lithocholic acid; deoxycholic acid; chenodeoxycholic acid; and mixtures thereof. 108. The pharmaceutical system of claim 97, wherein the hydrophobic surfactant is selected from the group consisting of oleic acid; lauric acid; glyceryl monocaprate; glyceryl monocaprylate; glyceryl monolaurate; glyceryl monooleate; glyceryl dicaprate; glyceryl dicaprylate; glyceryl dilaurate; glyceryl dioleate; acetylated monoglycerides; propylene glycol oleate; propylene glycol laurate; polyglyceryl-3 oleate; polyglyceryl-6 dioleate; PEG-6 corn oil; PEG-20 corn oil; PEG-20 almond oil; sorbitan monooleate; sorbitan monolaurate; POE-4 lauryl ether; POE-3 oleyl ether; ethyl oleate; poloxamers; cholic acid; ursodeoxycholic acid; glycocholic acid; taurocholic acid; lithocholic acid; deoxycholic acid; chenodeoxycholic acid; and mixtures thereof. 109. The pharmaceutical system of claim 76, wherein the hydrophobic and hydrophilic surfactants are selected from the hydrophobic and hydrophilic members, respectively, of the group consisting of sodium lauryl sulfate, oleic acid, linoleic acid, monoolein, lecithin, lysolecithin, deoxycholate, taurodeoxycholate, glycochenodeoxycholate, polyoxyethylene X-lauryl ether, where X is from 9 to 20, sodium tauro-24,25-dihydrofusidate, polyoxyethylene ether, polyoxyethylene sorbitan esters, p-t-octylphenoxypolyoxyethylene, N-lauryl-.beta.-D-maltopyranoside, 1-dodecylazacycloheptane-2-azone, and phospholipids, and are each present in an amount of greater than 10% by weight, based on the total weight of the pharmaceutical system. 110. The pharmaceutical system of claim 76, wherein the hydrophilic therapeutic agent is a drug, a vitamin, a nutritional supplement, a cosmeceutical, a diagnostic agent, or a mixture thereof. 111. The pharmaceutical system of claim 76, wherein the hydrophilic therapeutic agent has an apparent water solubility of at least about 1 mg/mL. 112. The pharmaceutical system of claim 76, wherein the hydrophilic therapeutic agent is a hydrophilic drug, a cytokine, a peptidomimetic, a peptide, a protein, a toxoid, a serum, an antibody, a vaccine, a nucleoside, a nucleotide, a portion of genetic material, a nucleic acid, or a mixture thereof. 113. The pharmaceutical system of claim 76, wherein the hydrophilic therapeutic agent is selected from the hydrophilic members of the group consisting of analgesics, anti-inflammatory agents, anthelmintics, anti-arrhythmic agents, anti-asthma agents, anti-bacterial agents, anti-viral agents, anti-coagulants, anti-depressants, anti-diabetics, anti-epileptics, anti-fungal agents, anti-gout agents, anti-hypertensive agents, anti-malarials, anti-migraine agents, anti-muscarinic agents, anti-neoplastic agents, immunosuppressants, anti-protozoal agents, anti-thyroid agents, anti-tussives, anxiolytic, sedatives, hypnotics, neuroleptics, .beta.-Blockers, cardiac inotropic agents, corticosteroids, diuretics, anti-parkinsonian agents, gastro-intestinal agents, histamine H,-receptor antagonists, keratolytics, lipid regulating agents, muscle relaxants, anti-anginal agents, nutritional agents, analgesics, sex hormones, stimulants, cytokines, peptidomimetics, peptides, proteins, toxoids, sera, antibodies, vaccines, nucleosides, nucleotides, genetic material, nucleic acids, and mixtures thereof. 114. The pharmaceutical system of claim 76, wherein the hydrophilic therapeutic agent is selected from the group consisting of acarbose; acyclovir; acetyl cysteine; acetylcholine chloride; alatrofloxacin; alendronate; alglucerase; amantadine hydrochloride; ambenomium; amifostine; amiloride hydrochloride; aminocaproic acid; amphotericin B; antihemophilic factor (human); antihemophilic factor (porcine); antihemophilic factor (recombinant); aprotinin; asparaginase; atenolol; atracurium besylate; atropine; azithromycin; aztreonam; BCG vaccine; bacitracin; becalermin; belladona; bepridil hydrochloride; bleomycin sulfate; calcitonin human; calcitonin salmon; carboplatin; capecitabine; capreomycin sulfate; cefamandole nafate; cefazolin sodium; cefepime hydrochloride; cefixime; cefonicid sodium; cefoperazone; cefotetan disodium; cefotoxime: cefoxitin sodium; ceftizoxime; ceftriaxone; cefuroxime axetil; cephalexin; cephapirin sodium; cholera vaccine; chrionic gonadotropin; cidofovir; cisplatin; cladribine; clidinium bromide; clindamycin and clindamycin derivatives; ciprofloxacin; clondronate; colistimethate sodium; colistin sulfate; cortocotropin; cosyntropin; cromalyn sodium; cytarabine; daltaperin sodium; danaproid; deforoxamine; denileukin diftitox; desmopressin; diatrizoate megluamine and diatrizoate sodium; dicyclomine; didanosine; dirithromycin; dopamine hydrochloride; domase alpha; doxacurium chloride; doxorubicin; editronate disodium; elanaprilat; enkephalin; enoxacin; enoxaprin sodium; ephedrine; epinephrine; epoetin alpha; erythromycin; esmol hydrochloride; factor IX; famiciclovir; fludarabine; fluoxetine; foscarnet sodium; ganciclovir; granulocyte colony stimulating factor, granulocyte-macrophage stimulating factor; growth hormones-recombinant human; growth hormone-bovine; gentamycin; glucagon; glycopyrolate; gonadotropin releasing hormone and synthetic analogs thereof; GnRH; gonadorelin; grepafloxacin; hemophilus B conjugate vaccine; Hepatitis A virus vaccine inactivated; Hepatitis B virus vaccine inactivated; heparin sodium; indinavir sulfate; influenza virus vaccine; interleukin-2; interleukin-3; insulin-human; insulin lispro; insulin procine; insulin NPH; insulin aspart; insulin glargine; insulin detemir; interferon alpha; interferon beta; ipratropium bromide; isofosfamide; japanese encephalitis virus vaccine; lamivudine; leucovorin calcium; leuprolide acetate; levofloxacin; lincomycin and lincomycin derivatives; lobucavir; lomefloxacin; loracarbef; mannitol; measles virus vaccine; meningococcal vaccine; menotropins; mephenzolate bromide; mesalmine; methanamine; methotrexate; methscopolamine; metformin hydrochloride; metroprolol; mezocillin sodium; mivacurium chloride; mumps viral vaccine; nedocromil sodium; neostigmine bromide; neostigmine methyl sulfate; neutontin; norfloxacin; octreotide acetate; ofloxacin; olpadronate; oxytocin; pamidronate disodium; pancuronium bromide; paroxetine; pefloxacin; pentamindine isethionate; pentostatin; pentoxifylline; periciclovir; pentagastrin; phentolamine mesylate; phenylalanine; physostigmine salicylate; plague vaccine; piperacillin sodium; platelet derived growth factor-human; pneumococcal vaccine polyvalent; poliovirus vaccine inactivated; poliovirus vaccine live (OPV); polymixin B sulfate; pralidoxine chloride; pramlintide; pregabalin; propofenone; propenthaline bromide; pyridostigmine bromide; rabies vaccine; residronate; ribavarin; rimantadine hydrochloride; rotavirus vaccine; salmetrol xinafoate; sincalide; small pox vaccine; solatol; somatostatin; sparfloxacin; spectinomycin; stavudine; streptokinase; streptozocin; suxamethonium chloride; tacrine hydrochloride; terbutaline sulfate; thiopeta; ticarcillin; tiludronate; timolol; tissue type plasminogen activator; TNFR:Fc; TNK-tPA; trandolapril; trimetrexate gluconate; trospectinomycin; trovafloxacin; tubocurarine chloride; tumor necrosis factor; typhoid vaccine live; urea; urokinase; vancomycin; valaciclovir; valsartan; varicella virus vaccine live; vasopressin and vasopressin derivatives; vecoronium bromide; vinblastin; vincristine; vinorelbine; vitamin B12; warfarin sodium; yellow fever vaccine; zalcitabine; zanamavir; zolandronate; and zidovudine. 115. The pharmaceutical system of claim 76, wherein the hydrophilic therapeutic agent is selected from the group consisting of acarbose; acyclovir; atracurium besylate; alendronate; alglucerase; amantadine hydrochloride; amphotericin B; antihemophilic factor (human); antihemophilic factor (porcine); antihemophilic factor (recombinant; azithromycin; calcitonin human; calcitonin salmon; capecitabine; cefazolin sodium; cefonicid sodium; cefoperazone; cefoxitin sodium; ceftizoxime; ceftriaxone; cefuroxime axetil; cephalexin; chrionic gonadotropin; cidofovir; cladribine; clindamycin and clindamycin derivatives; cortocotropin; cosyntropin; cromalyn sodium; cytarabine; daltaperin sodium; danaproid; desmopressin; didanosine; dirithromycin; editronate disodium; enoxaprin sodium; epoetin alpha; factor IX; famiciclovir; fludarabine; foscarnet sodium; ganciclovir; granulocyte colony stimulating factor; granulocyte-macrophage stimulating factor; growth hormones-recombinant human; growth hormone-Bovine; gentamycin; glucagon; gonadotropin releasing hormone and synthetic analogs thereof; GnRH; gonadorelin; hemophilus B conjugate vaccine; Hepatitis A virus vaccine inactivated; Hepatitis B virus vaccine inactivated; heparin sodium; indinavir sulfate; influenza virus vaccine; interleukin-2; interleukin-3; insulin-human; insulin lispro; insulin procine; insulin NPH; insulin aspart; insulin glargine; insulin detemir; interferon alpha; interferon beta; ipratropium bromide; isofosfamide; lamivudine; leucovorin calcium; leuprolide acetate; lincomycin and lincomycin derivatives; metformin hydrochloride; nedocromil sodium; neostigmine bromide; neostigmine methyl sulfate; neutontin; octreotide acetate; olpadronate; pamidronate disodium; pancuronium bromide; pentamindine isethionate; pentagastrin; physostigmine salicylate; poliovirus vaccine live (OPV); pyridostigmine bromide; residronate; ribavarin; rimantadine hydrochloride; rotavirus vaccine; salmetrol xinafoate; somatostatin; spectinomycin; stavudine; streptokinase; ticarcillin; tiludronate; tissue type plasminogen activator; TNFR:Fc; TNK-tPA; trimetrexate gluconate; trospectinomycin; tumor necrosis factor; typhoid vaccine live; urokinase; vancomycin; valaciclovir; vasopressin and vasopressin derivatives; vinblastin; vincristine; vinorelbine; warfarin sodium; zalcitabine; zanamavir; and zidovudine. 116. The pharmaceutical system of claim 76, wherein the hydrophilic therapeutic agent is selected from the group consisting of acarbose; alendronate; amantadine hydrochloride; azithromycin; calcitonin human; calcitonin salmon; ceftriaxone; cefuiroxime axetil; chrionic gonadotropin; cromalyn sodium; daltaperin sodium; danaproid; desmopressin; didanosine; editronate disodium; enoxaprin sodium; epoetin alpha; factor IX; famiciclovir; foscarnet sodium; ganciclovir; granulocyte colony stimulating factor; granulocyte-macrophage stimulating factor; growth hormones-recombinant human; growth hormone-Bovine; glucagon; gonadotropin releasing hormone and synthetic analogs thereof; GnRH; gonadorelin; heparin sodium; indinavir sulfate; influenza virus vaccine; interleukin-2; interleukin-3; insulin-human; insulin lispro; insulin procine interferon alpha; interferon beta; leuprolide acetate; metformin hydrochloride; nedocromil sodium; neostigmine bromide; neostigmine methyl sulfate; neutontin; octreotide acetate; olpadronate; pamidronate disodium; residronate; rimantadine hydrochloride; salmetrol xinafoate; somatostatin; stavudine; ticarcillin; tiludronate; tissue type plasminogen activator; TNFR:Fc; TNK-tPA; tumor necrosis factor; typhoid vaccine live; vancomycin; valaciclovir; vasopressin and vasopressin derivatives; zalcitabine; zanamavir and zidovudine. 117. The pharmaceutical system of claim 76, wherein the solubilizer is selected from the group consisting of alcohols, polyols, amides, esters, propylene glycol ethers and mixtures thereof. 118. The pharmaceutical system of claim 76, wherein the composition further comprises includes at least one pharmaceutical additive selected from the group consisting of an antioxidant, a bufferant, an antifoaming agent, a detackifier, a preservative, a chelating agent, a viscomodulator, a tonicifier, a flavorant, a colorant, an odorant, an opacifier, a suspending agent, a binder, a filler, a plasticizer, a lubricant, an enzyme inhibiting agent, and combinations thereof. 119. The pharmaceutical system of claim 118, wherein the composition includes an enzyme inhibiting agent present in an amount sufficient to at least partially inhibit enzymatic degradation of the hydrophilic therapeutic agent. 120. The pharmaceutical system of claim 119, wherein the enzyme inhibiting agent is P-aminobenzamidine, FK-448, camostat mesylate, sodium glycocholate, an amino acid, a modified amino acid, a peptide, a modified peptide, a polypeptide protease inhibitor, a complexing agent, a mucoadhesive polymer, a polymer-inhibitor conjugate, or a mixture thereof. 121. The pharmaceutical system of claim 119, wherein the enzyme inhibiting agent is selected from the group consisting of P-aminobenzamidine, FK-448, camostat mesylate, sodium glycocholate, aminoboronic acid derivatives, n-acetylcysteine, bacitracin, phosphinic acid dipeptide derivatives, pepstatin, antipain, leupeptin, chymostatin, elastatin, bestatin, hosphoramindon, puromycin, cytochalasin potatocarboxy peptidase inhibitor, amastatin, protinin, Bowman-Birk inhibitor, soybean trypsin inhibitor, chicken egg white trypsin inhibitor, chicken ovoinhibitor, human pancreatic trypsin inhibitor, EDTA, EGTA, 1,10-phenanthroline, hydroxychinoline, polyacrylate derivatives, chitosan, cellulosics, chitosan-EDTA, chitosan-EDTA-antipain, polyacrylic acid-bacitracin, carboxymethyl cellulose-pepstatin, polyacrylic acid-Bowman-Birk inhibitor, and mixtures thereof. 122. The pharmaceutical system of claim 76, wherein the composition further comprises a pharmaceutically acceptable acid. 123. The pharmaceutical system of claim 122, wherein the acid is selected from the group consisting of hydrochloric acid, hydrobromic acid, hydriodic acid, sulfuric acid, carbonic acid, nitric acid, boric acid, phosphoric acid, acetic acid, acrylic acid, adipic acid, alginic acid, alkanesulfonic acid, an amino acid, ascorbic acid, benzoic acid, boric acid, butyric acid, carbonic acid, citric acid, a fatty acid, formic acid, fumaric acid, gluconic acid, hydroquinosulfonic acid, isoascorbic acid, lactic acid, maleic acid, methanesulfonic acid, oxalic acid, para-bromophenylsulfonic acid, propionic acid, p-toluenesulfonic acid, salicylic acid, stearic acid, succinic acid, tannic acid, tartaric acid, thioglycolic acid, toluenesulfonic acid, uric acid, and mixtures thereof. 124. The pharmaceutical system of claim 76, wherein the composition further comprises a pharmaceutically acceptable base. 125. The pharmaceutical system of claim 124, wherein the base is an amino acid, an amino acid ester, ammonium hydroxide, potassium hydroxide, sodium hydroxide, sodium hydrogen carbonate, aluminum hydroxide, calcium carbonate, magnesium hydroxide, magnesium aluminum silicate, synthetic aluminum silicate, synthetic hydrotalcite, magnesium aluminum hydroxide, diisopropylethylamine, ethanolamine, ethylenediamine, triethanolamine, triethylamine, triisopropanolamine, or a salt of a pharmaceutically acceptable cation and acetic acid, acrylic acid, adipic acid, alginic acid, alkanesulfonic acid, an amino acid, ascorbic acid, benzoic acid, boric acid, butyric acid, carbonic acid, citric acid, a fatty acid, formic acid, fumaric acid, gluconic acid, hydroquinosulfonic acid, isoascorbic acid, lactic acid, maleic acid, methanesulfonic acid, oxalic acid, para-bromophenylsulfonic acid, propionic acid, p-toluenesulfonic acid, salicylic acid, stearic acid, succinic acid, tannic acid, tartaric acid, thioglycolic acid, toluenesulfonic acid, and uric acid, or a mixture thereof. 126. The pharmaceutical system of claim 76, wherein the average particle size of the aqueous dispersion formed upon mixing the composition with an aqueous diluent is less than about 100 nm. 127. The pharmaceutical system of claim 126, wherein the average particle size is less than about 50 nm. 128. The pharmaceutical system of claim 76, wherein the composition forms a substantially optically clear aqueous dispersion having an absorbance of less than about 0.3 at 400 upon mixing with an aqueous diluent at 100.times. dilution. 129. The pharmaceutical system of claim 76, wherein the system is free of polyethylene glycol diesters. 130. The pharmaceutical system of claim 76, wherein the system is free of cholesterol. 131. The pharmaceutical system of claim 76, wherein the dosage form is free of water. 132. The pharmaceutical system of claim 76 in the form of a preconcentrate in a liquid, semi-solid, or solid form, or as an aqueous or organic diluted preconcentrate. 133. The pharmaceutical system of claim 76, wherein the dosage form of the composition is processed by balling, lyophilization, encapsulation, extruding, compression, melting, molding, spraying, spray congealing, coating, conmminution, mixing, cryopelletization, spheronization, homogenization, sonication, granulation, or a combination thereof. 134. The pharmaceutical system of claim 76, wherein the dosage form of the composition is a pill, capsule, caplet, tablet, granule, pellet, bead or powder. 135. The pharmaceutical system of claim 76, wherein the dosage form of the composition is a starch capsule, a cellulosic capsule, a hard gelatin capsule or a soft gelatin capsule. 136. The pharmaceutical system of claim 76, wherein the dosage form is formulated for immediate release, controlled release, extended release, delayed release, targeted release, or targeted delayed release. 137. The pharmaceutical system of claim 134, which further comprises at least one enteric coating, seal coating, extended release coating, or targeted delayed release coating. 138. The pharmaceutical system of claim 137, wherein the coating is comprised of a material selected from the group consisting of shellac, acrylic polymers, cellulosic derivatives, polyvinyl acetate phthalate, and mixtures thereof. 139. The pharmaceutical system of claim 137, wherein the coating is formed of a material selected from the group consisting of acrylic acid and methacrylic acid resins, cellulose acetate phthalate, cellulose acetate trimellitate, ethyl cellulose, hydroxypropyl methyl cellulose phthalate, hydroxypropyl methyl cellulose succinate, polyvinylacetate phthalate, and mixtures thereof. 140. The pharmaceutical system of claim 137, wherein the coating is formed of a material selected from the group consisting of acrylic acid and methacrylic acid resins, cellulose acetate phthalate, ethyl cellulose, hydroxypropyl methyl cellulose phthalate, hydroxypropyl methyl cellulose succinate, polyvinylacetate phthalate, and mixtures thereof. 141. The pharmaceutical system of claim 76, wherein the dosage form of the composition is a solution, suspension, emulsion, cream, ointment, lotion, suppository, spray, aerosol, paste, gel, drops, douche, ovule, wafer, troche, cachet, syrup or elixir. 142. The pharmaceutical system of claim 76, wherein the dosage form is a multiparticulate carrier coated onto a substrate with the composition. 143. The pharmaceutical system of claim 142, wherein the substrate is a particle, a granule, a pellet or a bead, and is formed of the therapeutic agent, a pharmaceutically acceptable material, or a mixture thereof. 144. The pharmaceutical system of claim 142, wherein the multiparticulate carrier is coated with at least one enteric coating, seal coating, extended release coating, or targeted delayed release coating. 145. The pharmaceutical system of claim 142, wherein the dosage form is further processed by encapsulation, compression, extrusion, molding, spheronization or cryopelletization. 146. The pharmaceutical system of claim 142, wherein the dosage form is further processed to form a starch capsule, a cellulosic capsule, a hard gelatin capsule, or a soft gelatin capsule. 147. The pharmaceutical system of claim 146, wherein the capsule is coated with at least one enteric coating, seal coating, extended release coating, or targeted delayed release coating. 148. The pharmaceutical system of claim 76, wherein the hydrophilic therapeutic agent is present in the dosage form. 149. The pharmaceutical system of claim 147, wherein the hydrophilic therapeutic agent is solubilized in the composition, suspended in the composition, or partially solubilized and partially suspended in the composition. 150. The pharmaceutical system of claim 76, wherein the hydrophilic therapeutic agent is present in a second dosage form separate from the dosage form containing the absorption enhancing composition. 151. The pharmaceutical system of claim 76, wherein the dosage form of the composition is formulated for oral, mucosal, pulmonary, nasal, vaginal, transmembrane, buccal or rectal administration. 152. The pharmaceutical system of claim 151, wherein the dosage form of the hydrophilic therapeutic agent is formulated for oral, mucosal, pulmonary, nasal, vaginal, transmembrane, buccal or rectal administration. 153. An absorption enhancing composition for co-administration to a patient with a hydrophilic therapeutic agent, the composition consisting essentially of an effective amount of am absorption enhancer comprising at least one hydrophilic surfactant selected from the group consisting of ionized surfactants, non-ionic hydrophilic surfactants having an HLB value greater than or equal to 10, mid combinations thereof, and at least cast one hydrophobic surfactant selected from the group consisting of hydrophobic (a) alcohols, polyoxyethylene alkylethers, bile acids, glycerol fatty acid monoesters, glycerol fatty acid diesters, acetylated glycerol fatty acid monoesters, acetylated glycerol fatty acid diesters, lower alcohol fatty acid monoesters, lower alcohol fatty acid diesters, polyethylene glycol fatty acid esters, polyethylene glycol glycerol fatty acid esters, polypropylene glycol fatty acid esters, polyoxyethylene glycerides, lactic acid derivatives of mono- and diglycerides, propylene glycol diglycerides, soibitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene-polyoxypropylene block copolymers, transesterified vegetable oils, sugar esters, sugar ethers, sucroglycerides, polyoxyethylene vegetable oils, polyoxyethylene hydrogenated vegetable oils, reaction prodeucts of polyols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, and hydrogenated vegetable oils, and hydrophobic, un-ionized (b) fatty acids, carmitine fatty acid esters, alkylsulfates, acyl lactylates, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, succinylated monoglycerides, citric acid esters of mono- and diglycerides, and mixtures thereof, wherein the hydrophilic and hydrophobic surfactants are present in amounts such that upon mixing with an aqueous diluent the composition forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm, the absorption enhancing composition being free of triglycerides. 154. The composition of claim 153, wherein the effective amount is an amount sufficient to increase the rate, the extent, or both the rate and extent, of bioabsorption of a hydrophilic therapeutic agent, when the composition and the hydrophilic therapeutic agent are administered to a patient. 155. The composition of claim 153, wherein the effective amount is an amount sufficient to improve the consistency of the rate, the extent, or both the rate and extent, of bioabsorption of a hydrophilic therapeutic agent, when the composition and the hydrophilic therapeutic agent are administered to a patient. 156. A method of controlling the rate, the extent, or both the rate ant extent of bioabsorption of a hydrophilic therapeutic agent administered to a patient, the method comprising: (a) providing a dosage form of an absorption enhancing composition, the composition consisting essentially of at least one hydrophilic surfactant selected from the group consisting of ionized surfactants, non-ionic hydrophilic surfactants having an HLB value greater than or equal to 10, and combinations thereof, and at least one hydrophobic surfactant selected from the group consisting of hydrophobic (a) alcohols, polyoxyethylene alkylethers, bile acids, glycerol fatty acid monoesters, glycerol fatty acid diesters, acctylated glycerol fatty acid monoesters, glycerol fatty acid diesters, lower alcohol fatty acid monoesters, lower alcohol fatty acid diesters, polyethylene glycol fatty acid esters, polyethylene glycol glycerol fatty acid esters, polypropylene glycol fatty acid esters, polyoxyethylene glycerides, lactic acid derivatives of mono- and diglycerides, propylene glycol diglycerides, sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene-polyoxypropylene block copolymers, transesterified vegetable oils, sugar esters, sugar ethers, sucroglycerides, polyoxyethylene vegetable oils, polyoxyethylene hydrogenated vegetable oils, reaction products of polyols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, and hydrogenated vegetable oils, and hydrophobic, un-ionized (b) fatty acids, carnitine fatty acid esters, alkylsulfates, acyl lactylates, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerdied, succinylated monoglycerides, citric acid esters of mono- and diglycerides, and mixtures thereof, wherein the hydrophilic and hydrophobic surfactants are present in amounts such that upon mixing with an aqueous diluent the composition forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm, and wherein the composition is free of triglycerides; (b) providing a hydrophilic therapeutic agent; and (c) administering the dosage form of the absorption enhancing composition and the hydrophilic therapeutic agent to the patient. 157. The method of claim 156, wherein the hydrophilic therapeutic agent is contained in the dosage form of the absorption enhancing composition. 158. The method of claim 157, wherein the hydrophilic therapeutic agent is solubilized, suspended, or partially solubilized and partially suspended, in the dosage form of the absorption enhancing composition. 159. The method of claim 156, wherein the hydrophilic therapeutic agent is provided in a second dosage form separate from the dosage form containing the absorption enhancing composition. 160. The method of claim 159, wherein the step of administering comprises administering the dosage form of the absorption enhancing composition and co-administering the dosage form of the hydrophilic therapeutic agent. 161. The method of claim 156, wherein the dosage form of the absorption enhancing composition is formulated for oral, mucosal, pulmonary, nasal, vaginal, transmembrane, buccal or rectal administration. 162. The method of claim 159, wherein the dosage form of the hydrophilic therapeutic agent is formulated for oral, mucosal, pulmonary, nasal, vaginal, transmembrane, buccal or rectal administration. 163. The method of claim 156, wherein the patient is a mammal. 164. The method of claim 156, wherein the patient is a human. 165. A pharmaceutical system for enhanced absorption of a hydrophilic therapeutic agent in the form of a diluted preconcentrate, the system consisting essentially of: (a) a dosage form of an absorption enhancing composition, the composition comprising: (i) at least one hydrophilic surfactant selected from the group consisting of ionized ionizable surfactants, non-ionic hydrophilic surfactants having an HLB value greater than or equal to 10, and combinations thereof, (ii) at least one hydrophobic surfactant selected from the group consisting of hydrophobic (a) alcohols, polyoxyethylene alkylethers, bile acids, glycerol fatty acid monoesters, glycerol fatty acid diesters, acetylated glycerol fatty acid monoesters, acctylated glycerol fatty acid diesters, lower alcohol fatty acid monoesters, lower alcohol fatty acid diestes, polyethylene glycol fatty acid esters, polyethylene glycol glycerol fatty acid esters, polypropylene glycol fatty acid esters, polyoxyethylene glycerides, lactic acid derivatives of mono- and diglycerides, propylene glycol diglycerides, sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene-polyoxypropylene block copolymers, transesterified vegetable oils, sugar esters, sugar ethers, sucroglycerides, polyoxyethylene vegetable oils, polyoxyethylene hydrogenated vegetable oils, reaction products of polyols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, and hydrogenated vegetable oils, and hydrophobic, un-ionized (b) fatty acids, carmitine fatty acid esters, alkylsulfates, acyl lactylates, mono-acetylated tartaric acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, succinylated monoglycerides, citric acid esters of mono- and diglycerides, and mixtures thereof, wherein the hydrophilic aid hydrophobic surfactants are present in amounts such that upon mixing with an aqueous diluent at 100.times. dilution, the composition forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm, (iii) a liquid diluent; and (b) a therapeutically effective amount of a hydrophilic therapeutic agent; wherein the pharmaceutical system is free of triglycerides. 166. A pharmaceutical system for enhancing absorption, or a hydrophilic therapeutic agent in the form of a diluted preconcentrate, the system consisting essentially of: (a) a dosage form of an absorption enhancing composition, the composition comprising: (i) at least one hydrophilic surfactant selected from the group consisting of ionized ionizable surfactants, non-ionic hydrophilic surfactants having an HLB value greater than or equal to 10, and combinations thereof, (ii) at least one hydrophobic surfactant selected from the group consisting of hydrophobic (a) alcohols, polyoxyethylene alkylethers, bile acids, glycerol fatty acid monoesters, glycerol fatty acid diesters, acetylated glycerol fatty acid monoesters, acetylated glycerol fatty acid diesters, lower alcohol fatty acid monoesters, lower alcohol fatty acid diesters, polyethylene glycol fatty acid monoesters, polyethylene glycol glycerol fatty acid esters, polypropylene glycol fatty acid esters, polyoxyethylene glycerides, lactic acid derivatives of mono- and diglycerides, propylene glycol diglycerides, sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene-polyoxypropylene block copolymers, transesterified vegetable oils, sugar esters, sugar ethers, sucroglycerides, polyoxyethylene vegetable oils, polyoxyethylene hydrogenated vegetable oils, reaction products of polyols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, and hydrogenated vegetable oils, and hydrophobic, un-ionized (b) fatty acids, carnitine fatty acid esters, alkylsulfates, acyl lactylates, mono-acetylated tartarie acid esters of mono- and diglycerides, diacetylated tartaric acid esters of mono- and diglycerides, succinylated monoglycerides, citric acid esters of mono- and diglycerides, and mixtures thereof, wherein the hydrophilic and hydrophobic surfactants are present in amounts such that upon mixing with an aqueous diluent at 100.times. dilution, the composition forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm, wherein the hydrophilic and hydrophobic surfactants are present in amounts such that upon mixing with an aqueous diluent at 100.times. dilution, The composition forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm, (iii) at least one solubilizer, and (iv) a liquid diluent; and (b) a therapeutically effective amount of a hydrophilic therapeutic agent; wherein the pharmaceutical system is free of triglycerides. 167. The pharmaceutical system of claim 165, wherein the therapeutic agent is provided to the system in the liquid diluent. 168. The pharmaceutical system of claim 165, further comprising an amount of an enzyme inhibiting agent sufficient to at least partially inhibit enzymatic degradation of the hydrophilic therapeutic agent, the enzyme inhibiting agent being solubilized, suspended, or partially solubilized and partially suspended, in the aqueous medium. 169. The pharmaceutical system of claim 166, wherein the therapeutic agent is provided to the system in the liquid diluent. 170. The pharmaceutical system of claim 166, further comprising an amount of an enzyme inhibiting agent sufficient to at least partially inhibit enzymatic degradation of the hydrophilic therapeutic agent, the enzyme inhibiting agent being solubilized, suspended, or partially solubilized and partially suspended, in the aqueous medium.

Details for Patent 6,309,663

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	August 22, 1975	6,309,663	2039-02-26
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	May 20, 1985	6,309,663	2039-02-26
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	October 28, 1982	6,309,663	2039-02-26
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	December 29, 2015	6,309,663	2039-02-26
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	August 06, 1998	6,309,663	2039-02-26