Claims for Patent: 7,297,794

Summary for Patent: 7,297,794

Title:	Phenoxy amine compounds and compositions for delivering active agents
Abstract:	Phenoxy amine compounds and compositions for the delivery of active agents are provided. Methods of administration and preparation are provided as well.
Inventor(s):	Gschneidner; David (Thornwood, NY), Kraft; Kelly (Hopewell Junction, NY), Zhu; Chen (Berkeley Heights, NJ), Chen; Yi (Cheshire, CT)
Assignee:	Emisphere Technologies, Inc. (Tarrytown, NY)
Application Number:	10/495,797
Patent Claims:	1. A compound selected from ##STR00004## ##STR00005## and salts thereof. 2. A composition comprising: (A) an active agent; and (B) at least one compound according to claim 1 or a salt thereof. 3. The composition of claim 2, wherein the active agent is selected from the group consisting of a biologically active agent, a chemically active agent, and a combination thereof. 4. The composition of claim 3, wherein the biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaceharide, carbohydrate, or lipid. 5. The composition of claim 3, wherein the biologically active agent is selected from the group consisting of: BJBN-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, interferons, .alpha.-interferon, .beta.-interferon, .gamma.-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, antimicrobials, anti-fungal agents, vitamins; analogs, fragments, mimetics and polyethylene glycol (PEG)-modified derivatives of these compounds; and any combination thereof. 6. The composition of claim 3, wherein the biologically active agent comprises insulin, BIBN-4096BS, calcitonin, parathyroid hormone, erythropoietin, growth hormones or combinations thereof. 7. The composition of claim 3, wherein the biologically active agent comprises BIBN-4096BS. 8. The composition of claim 3, wherein the biologically active agent comprises insulin. 9. A dosage unit form comprising: (A) the composition of claim 6; 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 active agent is selected from the group consisting of a biologically active agent, a chemically active agent, and a combination thereof. 11. The dosage unit form of claim 10, wherein the biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid. 12. The dosage unit form of claim 10, wherein the biologically active agent is selected from the group consisting of: 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, .alpha.-interferon, .beta.-interferon, .gamma.-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, fllgrastim. postaglandins, cyclosporin, vasopressin, cromolyn sodium, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine, parathyroid hormone, fragments of PTH, antimicrobials, anti-fungal agents, vitamins; analogs, fragments, mimetics and polyethylene glycol-modified derivatives of these compounds; and any combination thereof. 13. The dosage unit form of claim 10, wherein the biologically active agent comprises insulin, BJBN-4096BS, calcitonin, parathyroid hormone, erythropoietin, human growth hormones or combinations thereof. 14. The dosage unit form of claim 9, wherein the active agent comprises recombinant BIBN-4096BS. 15. The dosage unit form of claim 9, wherein the active agent comprises insulin. 16. The dosage unit form of claim 9, wherein the dosage unit form comprises a dosing vehicle comprising a tablet, a capsule, a powder, or a liquid. 17. The dosage unit form of claim 9, wherein the dosing vehicle is a liquid selected from the group consisting of water, 1,2-propane diol, ethanol, and any combination thereof. 18. 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 3. 19. The composition of claim 2, wherein the active agent is a bisphosphonate. 20. The composition of claim 19, wherein the bisphosphonate is selected from alendronate, tiludronate, etidronate, clodronate, pamidronate, olpadronate, incadronate, and mixtures thereof. 21. The compound of claim 1, wherein the compound is ##STR00006## or a salt thereof. 22. The compound of claim 1, wherein the compound is ##STR00007## or a salt thereof. 23. The compound of claim 1, wherein the compound is ##STR00008## or a salt thereof. 24. The compound of claim 1, wherein the compound is ##STR00009## or a salt thereof. 25. The compound of claim 1, wherein the compound is ##STR00010## or a salt thereof. 26. The compound of claim 1, wherein the compound is ##STR00011## or a salt thereof. 27. The compound of claim 1, wherein the compound is ##STR00012## or a salt thereof. 28. The compound of claim 1, wherein the compound is ##STR00013## or a salt thereof. 29. The composition of claim 5, wherein the compound in (B) is ##STR00014## or a salt thereof. 30. The composition of claim 5, wherein the compound in (B) is ##STR00015## or a salt thereof. 31. The composition of claim 5, wherein the compound in (B) is ##STR00016## or a salt thereof. 32. The composition of claim 5, wherein the compound in (B) is ##STR00017## or a salt thereof. 33. The composition of claim 5, wherein the compound in (B) is ##STR00018## or a salt thereof. 34. The composition of claim 5, wherein the compound in (B) is ##STR00019## or a salt thereof. 35. The composition of claim 5, wherein the compound in (B) is ##STR00020## or a salt thereof. 36. The composition of claim 5, wherein the compound in (B) is ##STR00021## or a salt thereof. 37. 8-(2-hydroxyphenoxy)octyldiethanolamine or a salt thereof. 38. 4-(6-(2-hydroxyphenoxy)hexyl)morpholine or a salt thereof. 39. A pharmaceutical composition comprising: (A) an active agent; and (B) 8-(2-hydroxyphenoxy)octyldiethanolamine or a salt thereof. 40. The pharmaceutical composition of claim 39, wherein the active agent is a bisphosphonate. 41. The composition of claim 40, wherein the bisphosphonate is selected from alendronate, tiludronate, etidronate, clodronate, pamidronate, olpadronate, incadronate, and mixtures thereof. 42. The pharmaceutical composition of claim 39, wherein the active agent is erythropoietin. 43. The pharmaceutical composition of claim 39, wherein the active agent is follicle stimulating hormone. 44. A pharmaceutical composition comprising: (A) an active agent; and (B) 4-(6-(2-hydroxyphenoxy)hexyl)morpholine or a salt thereof.

Details for Patent 7,297,794

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	10/28/1982		2021-11-13
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	12/29/2015		2021-11-13
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	08/06/1998		2021-11-13
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	03/31/1994		2021-11-13
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	05/25/2018		2021-11-13