Claims for Patent: 6,642,411

Summary for Patent: 6,642,411

Title:	Compounds and compositions for delivering active agents
Abstract:	Carrier compounds and compositions therewith which are useful in the delivery of active agents are provided Methods of administration and preparation are provided as well.
Inventor(s):	Leone-Bay; Andrea (Ridgefield, CT), O\'Toole; Doris (Carmel, NY)
Assignee:	Emisphere Technologies, Inc. (Tarrytown, NY)
Application Number:	09/744,862
Patent Claims:	1. A salt of the compound having the formula ##STR6## wherein the salt is not a sodium salt. 2. A composition comprising: (A) at least one active agent; and (B) a carrier comprising a compound having the formula ##STR7## or salt thereof. 3. A composition as defined in claim 2, wherein said active agent is selected from the group consisting of a biologically active agent, a chemically active agent, or a combination thereof. 4. A composition as defined in claim 3, wherein said biologically active agent comprises at least one peptide, mucopolysaccharide, carbohydrate, or lipid. 5. A composition as defined in claim 3, wherein said biologically active agent is selected from the group consisting of growth hormones, human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormone, porcine growth hormones, growth hormone-releasing hormones, interferons, .alpha.-interferon, .beta.-interferon, .gamma.-interferon, interleukin-1, interleukin-II; 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, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), fragments of PTH, antimicrobials, anti-fungal agents, analogs, fragments, mimetics and polyethylene glycol (PEG)-modified derivatives of these compounds; and any combination thereof. 6. A composition as defined in claim 3, wherein said biologically active agent is selected from the group consisting of human growth hormones (hGH), bovine growth hormone, growth hormone-releasing hormones, interferons, interleukin-1, interleukin-II, insulin, heparin, low molecular weight heparin, very low molecular weight heparin, calcitonin, erythropoietin (EPO), atrial naturetic factor, antigens, monoclonal antibodies, somatostatin, adrenocorticotropin, gonadotropin releasing hormone, oxytocin, vasopressin, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), antimicrobials, anti-fungal agents, and any combination thereof. 7. A composition as defined in claim 3, wherein said biologically active agent comprises an interferon, interleukin-II, insulin, heparin, low molecular weight heparin, very low molecular weight heparin, calcitonin, parathyroid hormone (PTH), erythropoietin (EPO), human growth hormone (hGH), oxytocin, vasopressin, vancomycin, desferrioxamine (DFO), parathyroid hormone, and combinations thereof. 8. A composition as defined in claim 3, wherein said biologically active agent comprises unfractionated heparin, ultra low molecular weight heparin, and combinations thereof. 9. A composition as defined in claim 3, wherein said biologically active agent comprises insulin. 10. A composition as defined in claim 3, wherein said biologically active agent comprises parathyroid hormone. 11. A composition as defined in claim 3, wherein said biologically active agent comprises human growth hormone. 12. A composition as defined in claim 3, wherein said biologically active agent comprises erythropoietin. 13. A composition as defined in claim 2, wherein said carrier comprises a poly(amino acid) or a polypeptide. 14. A dosage unit form comprising: (A) a composition as defined in 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. 15. A dosage unit form as defined in claim 13, wherein said active agent is selected from the group consisting of a biologically active agent, a chemically active agent, or a combination thereof. 16. A dosage unit form as defined in claim 14, wherein said biologically active agent comprises at least one peptide, mucopolysaccharide, carbohydrate, or lipid. 17. A dosage unit form as defined in claim 14, wherein said biologically active agent is selected from the group consisting of growth hormones, human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormone, porcine growth hormones, growth hormone-releasing hormones, interferons, .alpha.-interferon, .beta.-interferon, .gamma.-interferon, interleukin-1, interleukin-II, 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, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), fragments of PTH, antimicrobials, anti-fungal agents, analogs, fragments, mimetics and polyethylene glycol (PEG)-modified derivatives of these compounds, and any combination thereof. 18. A dosage unit form as defined in claim 14, wherein said biologically active agent is selected from the group consisting of human growth hormones (hGH), bovine growth hormone, growth hormone-releasing hormones, interferons, interleukin-1, interleukin-II, insulin, heparin, low molecular weight heparin, very low molecular weight heparin, calcitonin, erythropoietin (EPO), atrial naturetic factor, antigens, monoclonal antibodies, somatostatin, adrenocorticotropin, gonadotropin releasing hormone, oxytocin, vasopressin, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), antimicrobials, anti-fungal agents, and any combination thereof. 19. A dosage unit form as defined in claim 14, wherein said biologically active agent comprises an interferon, interleukin-II, insulin, heparin, low molecular weight heparin, very low molecular weight heparin, calcitonin, parathyroid hormone (PTH), erythropoietin (EPO), human growth hormone (hGH), oxytocin, vasopressin, vancomycin, desferrioxamine (DFO), parathyroid hormone, and combinations thereof. 20. A dosage unit form as defined in claim 14, wherein said biologically active agent comprises unfractionated heparin, ultra low molecular weight heparin, and combinations thereof. 21. A dosage unit form as defined in claim 14, wherein said biologically active agent comprises insulin. 22. A dosage unit form as defined in claim 14, wherein said biologically active agent comprises parathyroid hormone. 23. A dosage unit form as defined in claim 14, wherein said biologically active agent comprises human growth hormone. 24. A dosage unit form as defined in claim 14, wherein said biologically active agent comprises erythropoietin. 25. A dosage unit form as defined in claim 13, comprising a tablet, a powder, a capsule, or a liquid. 26. A method for administering a biologically-active agent to an animal in need of said agent, said method comprising administering orally to said animal a composition as defined in claim 3. 27. 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 6,642,411

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	02/20/1991		2018-07-27
Amgen, Inc.	NEUPOGEN	filgrastim	Injection	103353	06/28/2000		2018-07-27
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2018-07-27