PHENYLALKYLCARBOXYLIC ACID DELIVERY AGENTS

1 . A composition comprising:

(A) at least one biologically active agent; and

(B) at least one delivery agent compound represented by formula I

or a pharmaceutically acceptable salt thereof, wherein

R 1 -R 5 are independently hydrogen, C 1 -C 6 alkyl, C 2 -C 4 alkenyl, halo, C 1 -C 4 alkoxy, hydroxyl, C 6 -C 14 aryloxy, or C 1 -C 6 alkylhalo group; and

(a) n is 1 or 3-12; or

(b) n is 1-12 and at least one of R 1 -R 5 is not hydrogen.

2 . The composition of claim 1 , wherein the delivery agent is selected from 4-(4-methoxyphenyl)butanoic acid, 5-(2-methoxyphenyl)pentanoic acid, 5-(3-fluorophenyl)pentanoic acid, 5-(3-methoxyphenyl)pentanoic acid, 6-(3-fluorophenyl)hexanoic acid, 3-(4-t-butylphenyl)propanoic acid, 3-(4-n-butylphenyl)propanoic acid, 3-(4-n-propylphenyl)propanoic acid, 3-(4-n-propoxyphenyl)propanoic acid, 3-(4-isopropoxyphenyl)propanoic acid, 3-(4-n-Butoxyphenyl)propanoic acid, 3-(3-phenoxyphenyl)propanoic acid, 3-(3-ethoxyphenyl)propanoic acid, 3-(3-isopropoxyphenyl)propanoic acid, 3-(3-n-butoxyphenyl)propanoic acid, 3-(3-n-propoxyphenyl)propanoic acid, 3-(3-isobutoxyphenyl)propanoic acid, 3-(4-isobutoxyphenyl)propanoic acid, 4-(4-ethylphenyl)butanoic acid, 4-(4-isopropylphenyl)butanoic acid, and 5-(4-ethylphenyl)pentanoic acid, or pharmaceutically acceptable salts thereof.

3 . (canceled)

4 . The composition of claim 1 , wherein the biologically active agent is a protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, lipid, or combination thereof.

5 . The composition of claim 1 , wherein the biologically active agent is selected from the group consisting of: argatroban, BIBN-4096BS, growth hormones, human growth hormones recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, growth hormone releasing hormones, growth hormone releasing factor, glucagon, interferons, α-interferon, β-interferon, γ-interferon, interleukin-1, interleukin-2, insulin, porcine insulin, bovine insulin, human insulin, human recombinant insulin, insulin-like growth factor (IGF), IGF-1, heparin, unfractionated heparin, heparinoids, dermatans, chondroitins, low molecular weight heparin, very low molecular weight heparin, ultra low molecular weight heparin, calcitonin, salmon calcitonin, eel calcitonin, human calcitonin; erythropoietin (EPO), atrial naturetic factor, antigens, monoclonal antibodies, somatostatin, protease inhibitors, adrenocorticotropin, gonadotropin releasing hormone, oxytocin, leutinizing-hormone-releasing-hormone, follicle stimulating hormone, glucocerebrosidase, thrombopoeitin, filgrastim, postaglandins, cyclosporin, vasopressin, cromolyn sodium, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), fragments of PTH, glucagon-like peptide 1 (GLP-1), antimicrobials, anti-fungal agents, vitamins; analogs, fragments, mimetics and polyethylene glycol (PEG)-modified derivatives of these compounds; gallium or gallium salts; glucagons; zanamivir, sumatriptan, almotriptan, naratriptan, rizatriptan, frovatriptan, eletriptan, caspofungin acetate, CPHPC, siRNA and any combination thereof.

6 . (canceled)

7 . (canceled)

8 . The composition of claim 1 , wherein the biologically active agent is insulin.

9 . (canceled)

10 . The composition of claim 9 , wherein the weight ratio of delivery agent to active agent ranges from about 800:1 to about 10:1.

11 - 13 . (canceled)

14 . A dosage unit form comprising:

(A) a delivery agent according to claim 1 ; and

(B) a biologically active agent; and

(C) (a) an excipient,

(b) a diluent,

(c) a disintegrant,

(d) a lubricant,

(e) a plasticizer,

(f) a colorant,

(g) an enzyme inhibitor

(h) a dosing vehicle, or

(i) any combination thereof.

15 - 19 . (canceled)

20 . The dosage unit form of claim 14 , wherein the dosage unit form comprises a dosing vehicle comprising a tablet, a capsule, a powder, or a liquid.

21 . (canceled)

22 . A method for administering a biologically-active agent to an animal in need of the agent, the method comprising administering orally to the animal the composition of claim 1 .

23 . (canceled)

24 . A method for administering a biologically-active agent to an animal in need of the agent, the method comprising administering to the animal the composition of claim 1 intranasally, sublingually, intraduodenally, subcutaneously, buccally, intracolonicly, rectally, vaginally, mucosally, pulmonary, transdermally, intradermally, parenterally, intravenously, intramuscularly, via the ocular system, or by traversing the blood-brain barrier.

25 - 30 . (canceled)

31 . A compound selected from the group consisting of 4-(4-methoxyphenyl)butanoic acid, 5-(2-methoxyphenyl)pentanoic acid, 5-(3-fluorophenyl)pentanoic acid, 5-(3-methoxyphenyl)pentanoic acid, 6-(3-fluorophenyl)hexanoic acid, 3-(4-t-butylphenyl) propanoic acid, 3-(4-n-butylphenyl)propanoic acid, 3-(4-n-propylphenyl)propanoic acid, 3-(4-n-propoxyphenyl)propanoic acid, 3-(4-isopropoxyphenyl)propanoic acid, 3-(4-n-butoxyphenyl)propanoic acid, 3-(3-phenoxyphenyl)propanoic acid, 3-(3-ethoxyphenyl)propanoic acid, 3-(3-isopropoxyphenyl)propanoic acid, 3-(3-n-butoxyphenyl)propanoic acid, 3-(3-n-propoxyphenyl)propanoic acid, 3-(3-isobutoxyphenyl)propanoic acid, 3-(4-isobutoxyphenyl)propanoic acid, 4-(4-ethylphenyl)butanoic acid, 4-(4-isopropylphenyl)butanoic acid, and 5-(4-ethylphenyl)pentanoic acid, or pharmaceutically acceptable salts thereof.

32 . The composition of claim 1 , wherein at least one of R 1 to R 5 is methyl, methoxy, C 1 -C 4 alkoxy, hydroxy or halogen.

33 . The composition of claim 1 , wherein at least one of R 1 to R 5 is methyl, methoxy, hydroxy or halogen.

34 . The composition of claim 1 , wherein at least one of R 1 to R 5 is methyl.

35 . The composition of claim 1 , wherein at least one of R 1 to R 5 is methoxy.

36 . The composition of claim 1 , wherein at least one of R 1 to R 5 is hydroxy.

37 . The composition of claim 1 , wherein at least one of R 1 to R 5 is C 6 -C 14 aryloxy.

38 . The composition of claim 1 , wherein at least one of R 1 to R 5 is C 1 -C 4 alkoxy.

39 . The composition of claim 1 , wherein at least one of R 1 to R 5 is C 1 -C 6 alkylhalo.

40 . The composition of claim 1 , wherein at least one of R 1 to R 5 is halogen.

41 . The composition of claim 1 , wherein at least one of R 1 to R 5 is chlorine.

42 . The composition of claim 1 , wherein at least one of R 1 to R 5 is fluorine.