(5-(2-hydroxy-4-chlorobenzoyl) aminovaleric acid and salts thereof and compositions containing the same for delivering active agents

1. A compound selected from the group consisting of

and salts thereof.

2. A composition comprising:

(A) a biologically active agent; and

(B) a compound selected from the group consisting of

salts thereof, and mixtures thereof.

3. The composition of claim 2 , wherein the biologically active agent is at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.

4. The composition of claim 2 , wherein the biologically active agent is selected from the group consisting of:

growth hormones, human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, growth hormone-releasing hormones, 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; erytliropojetin (EPO), atrial naturetic factor, antigens, monoclonal antibodies, somatostatin, protease inhibitors, adrenocorticotropin, gonadotropin releasing hormone, oxytocin, leutinizing-hormone-releasing-hormone, follicle stimulating hormone, glucocerebrosidase, thrombopoietin, fligrastim, prostaglandins, cyclosporin, vasopressin, cromolyn sodium, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), antimicrobials, antibiotics, antibacterial agents, anti-fungal agents, daptomycin, and vitamins; and any combination thereof.

5. The composition of claim 2 , wherein the biologically active agent is selected from the group consisting of interferon, cromolyn sodium, sodium chromoglycate, disodium chromoglycate, and daptomycin, or a combination thereof.

6. The composition of claim 2 , wherein the biologically active agent is interferon.

7. The composition of claim 2 , wherein the biologically active agent is cromolyn sodium.

8. The composition of claim 2 , wherein the biologically active agent is daptomycin.

9. A dosage unit form comprising:

(A) the composition of claim 2 ; and

(B) (a) an excipient

(b) a diluent,

(c) a disintegrant,

(d) a lubricant,

(e) a plasticizer,

(f) a colorant,

(g) a dosing vehicle, or

(h) any combination thereof.

10. The dosage unit form of claim 9 , wherein the biologically active agent is a protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.

11. The dosage unit form of claim 9 , wherein the biologically active agent is selected from the group consisting of:

growth hormones, human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, growth hormone-releasing hormones, 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, thrombopoietin, filgrastim, prostaglandins, cyclosporin, vasopressin, cromolyn sodium, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), antimicrobials, antibiotics, antibacterial agents, anti-fungal agents, daptomycin, and vitamins; and any combination thereof.

12. The dosage unit form of claim 9 , wherein the biologically active agent is selected from the group consisting of interferon, cromolyn sodium, sodium chromoglycate, disodium chromoglycate and daptomycin, or a combination thereof.

13. The dosage unit form of claim 9 , wherein the biologically active agent is interferon.

14. The dosage unit form of claim 9 , wherein the biologically active agent is cromolyn sodium.

15. The dosage unit form of claim 9 , wherein the biologically active agent is daptomycin.

16. The dosage unit form of claim 9 , wherein the dosage unit form is in the form of a tablet, a capsule, a particle, a powder, a sachet, or a liquid.

17. The dosage unit form of claim 9 , wherein the dosing vehicle is liquid selected from the group consisting of water, 25% aqueous propylene glycol, phosphate buffer, 1,2-propane diol, ethanol, and any combination thereof.

18. A method for preparing a composition comprising mixing:

(A) at least one biologically active agent;

(B) the compound of claim 1 ; and

(C) optionally, a dosing vehicle.

19. The method according to claim 18 , wherein the biologically active agent is at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.

20. The method according to claim 19 , wherein the biologically active agent is selected from the group consisting of:

growth hormones, human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, growth hormone-releasing hormones, 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, thrombopoietin, filgrastim, prostaglandins, cyclosporin, vasopressin, cromolyn sodium, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), antimicrobials, antibiotics, antibacterial agents, anti-fungal agents, daptomycin, and vitamins; and any combination thereof.