Claims for Patent: 6,693,208

Summary for Patent: 6,693,208

Title:	Compounds and compositions for delivering active agents
Abstract:	Amino acid derivative as carrier compounds and compositions which are useful in the delivery of active agents are provided. The active agents can be a peptide, mucopolysaccharide, carbohydrate, or lipid. Methods of administration, including oral administration, and preparation are provided as well.
Inventor(s):	Gscheidner; David (Stamford, CT), Leone-Bay; Andrea (Ridgefield, CT), Wang; Eric (Ellicott City, MD), Freeman; John J. (Fairfield, CT), O\'Toole; Doris C. (Carmel, NY), Shields; Lynn (Port Chester, NY)
Assignee:	Emisphere Technologies, Inc. (Tarrytown, NY)
Application Number:	10/168,275
Patent Claims:	1. A compound selected from the group consisting of compounds: ##STR3## ##STR4## and salts thereof. 2. A composition comprising: (A) an active agent; and (B) the compound of claim 1, and mixtures 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, hormome, polysaccharide, mucopolysaccharide, carbohydrate, or lipid. 5. The composition of claim 3, wherein the biologically active agent is selected from the group consisting of: 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, cromolym 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, heparin, calcitonin, parathyroid hormone, erythropoietin, growth hormones or combinations thereof. 7. The composition of claim 3, wherein the biologically active agent comprises recombinant human growth hormones. 8. The composition of claim 3, wherein the biologically active agent comprises parathyroid hormone. 9. The composition of claim 3, wherein the biologically active agent comprises insulin. 10. The composition of claim 3, wherein the biologically active agent comprises heparin. 11. The composition of claim 3, wherein the biologically active agent comprises calcitonin. 12. The composition of claim 3, wherein the biologically active agent comprises interferon. 13. A composition comprising: (A) an active agent; and (B) a poly(amino acid) comprising a compound having a formula selected from the group consisting of the compounds of claim 1, salts thereof and mixtures thereof. 14. The composition of claim 13 wherein the poly (amino acid) is a polypeptide. 15. A dosage unit form comprising: (A) the composition of claim 2; and (B) (a) an excipient (b) a dilutent (c) a disintegrant, (d) a lubricant, (e) a plasticizer, (f) a colorant, (g) a dosing vehicle, or (h) any combination thereof. 16. The dosage unit form of claim 15, wherein the active agent is selected from the group consisting of a biologically active agent, a chemically active agent, and a combination thereof. 17. The dosage unit form of claim 16, wherein the biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid. 18. The dosage unit form of claim 16, 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, 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, filgrastim, postaglandins, cyclosporin, vasopressin, cromolym 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. 19. The dosage unit form of claim 16, wherein the biologically active agent comprises insulin, heparin, calcitonin, parathyroid hormone, erythropoietin, human growth hormones or combinations thereof. 20. The dosage unit form of claim 15, wherein the active agent comprises recombinant human growth hormone. 21. The dosage unit form of claim 15, wherein the active agent comprises parathyroid hormone. 22. The dosage unit form of claim 15, wherein the active agent comprises insulin. 23. The dosage unit form of claim 15, wherein the active agent comprises heparin. 24. The dosage unit form of claim 15, wherein the active agent comprises calcitonin. 25. The dosage unit form of claim 15, wherein the active agent comprises interferon. 26. The dosage unit form of claim 15, wherein the dosage unit form comprises a dosing vehicle comprising a tablet, a capsule, a powder, or a liquid. 27. The dosage unit form of claim 15, wherein the dosing vehicle is liquid selected from the group consisting or water, 1,2-propane diol, ethanol, and any combination. 28. 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. 29. A method for preparing a composition comprising mixing: (A) at least one active agent; (B) the compound of claim 1; and (C) optionally, a dosing vehicle.

Details for Patent 6,693,208

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		2019-12-16
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	12/29/2015		2019-12-16
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	08/06/1998		2019-12-16
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	03/31/1994		2019-12-16
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	05/25/2018		2019-12-16
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	02/20/1991		2019-12-16