Cyclopropyl compounds and compositions for delivering active agents

1. A compound selected from:

and pharmaceutically acceptable salts thereof.

2. A composition comprising:

(A) a biologically active agent; and

(B) at least one compound selected from

and pharmaceutically acceptable salts thereof.

3. The composition of claim 2 , wherein the biologically active agent comprises 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: 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; and polyethylene glycol (PEG)-modified derivatives of these compounds; and any combination thereof.

5. The composition of claim 2 , wherein the biologically active agent comprises insulin, Leutenizing-hormone releasing hormone, GLP-1, heparin, Recombinant Human Growth Hormone, glucagon, Argatraban, and polyethylene glycol (PEG)-modified derivatives of these compounds; and any combination thereof.

6. The composition of claim 2 , wherein the biologically active agent comprises insulin.

7. 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.

8. The dosage unit form of claim 7 , wherein the biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.

9. The dosage unit form of claim 7 , wherein the biologically active agent is selected from the group consisting of: Argatraban, BIBN-4096BS, growth hormones, human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, growth hormone releasing hormones, growth hormone releasing factor, interferons, glucagon, α-interferon, β-interferon, γ-interferon, interleukin-1, interleukin-2, insulin, porcine insulin, bovine insulin, human insulin, human recombinant insulin, insulin-like growth factor, insulin-like growth factor-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, 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, parathyroid hormone, fragments of PTH, glucagon-like peptide 1 (GLP-1), antimicrobials, anti-fungal agents, vitamins; and polyethylene glycol-modified derivatives of these compounds; and any combination thereof.

10. The dosage unit form of claim 7 , wherein the biologically active agent comprises insulin, argatraban, LHRH, BIBN-4096BS, calcitonin, parathyroid hormone, erythropoietin, human growth hormones, glucagon or combinations thereof.

11. The dosage unit form of claim 7 , wherein the active agent comprises insulin.

12. The dosage unit form of claim 7 , wherein the active agent comprises glucagon.

13. The dosage unit form of claim 7 , wherein the dosage unit form comprises a dosing vehicle comprising a tablet, a capsule, a powder, or a liquid.

14. The dosage unit form of claim 13 , wherein the dosing vehicle is a liquid selected from the group consisting of water, 1,2-propane diol, ethanol, and any combination thereof.

15. A method for administering a biologically-active agent to an animal in need of the agent, the method comprising administering orally to the animal a composition of claim 2 .

16. A method for preparing a composition comprising mixing:

(A) at least one biologically active agent;

(B) at least one compound selected from

and pharmaceutically acceptable salts thereof; and

(C) optionally, a dosing vehicle.

17. A compound selected from

and pharmaceutically acceptable salts thereof.

18. A composition comprising:

(A) a biologically active agent; and

(B) at least one compound selected from

and pharmaceutically acceptable salts thereof.