Compounds and compositions for delivering active agents
View Patent ↗Compounds and compositions for the delivery of active agents are provided. Methods of administration and preparation are provided as well.
1. A compound comprising:
or a pharmaceutically acceptable salt thereof.
2. The compound of claim 1 wherein said salt is a sodium salt.
3. A composition comprising:
(A) at least one biologically active agent; and
(B) the compound of claim 1 .
4. The composition of claim 3 wherein said salt is a sodium salt.
5. The composition of claim 3 , wherein said biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.
6. The composition of claim 5 , wherein said biologically active agent comprises a protein, polypeptide or peptide.
7. The composition of claim 6 , wherein said biologically active agent comprises a mucopolysaccharide.
8. The composition of claim 3 , wherein said biologically active agent is selected from the group consisting of: growth hormone, growth hormone-releasing hormones, interferons, interleukin- 1, interleukin-2, insulin, insulin-like growth factor(IGF), heparin, 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, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), antimicrobials, anti-fungal agents; analogs, fragments, mimetics and polyethylene glycol (PEG)-modified derivatives of these compounds; and any combination thereof.
9. The composition of claim 8 , wherein said biologically active agent comprises a growth hormone, interferon, insulin, heparin, cromolyn sodium, an antigen, an anti-microbial agent, calcitonin, parathyroid hormone, erythropoietin, and combinations thereof.
10. The composition of claim 9 , wherein said growth hormone comprises human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, or a combination thereof.
11. The composition of claim 8 , wherein said biologically active agent comprises interferon.
12. The composition of claim 8 , wherein said biologically active agent comprises insulin.
13. The composition of claim 8 , wherein said insulin comprises porcine insulin, bovine insulin, human insulin, and human recombinant insulin.
14. The composition of claim 8 , wherein said biologically active agent comprises heparin.
15. The composition of claim 14 , wherein said heparin comprises low molecular weight heparin, very low molecular weight heparin, ultra low molecular weight heparin, heparinoids, dermatans, chondroitins, or a combination thereof.
16. The composition of claim 15 , wherein said biologically active agent comprises low molecular weight heparin.
17. The composition of claim 8 , wherein said biologically active agent comprises cromolyn sodium.
18. The composition of claim 17 , wherein said cromolyn sodium comprises sodium chromoglycate, disodium chromoglycate or a combination thereof.
19. The composition of claim 8 , wherein said biologically active agent comprises an antigen.
20. The composition of claim 8 , wherein said biologically active agent comprises an anti-microbial agent.
21. The composition of claim 8 , wherein said biologically active agent comprises calcitonin.
22. The composition of claim 21 , wherein said calcitonin comprises salmon calcitonin, eel calcitonin, human calcitonin or a combination thereof.
23. The composition of claim 8 , wherein said biologically active agent comprises parathyroid hormone.
24. The composition of claim 8 , wherein said biologically active agent comprises erythropoietin.
25. A dosage unit form comprising
(A) a composition as defined in claim 3 ; 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.
26. The dosage unit of claim 25 wherein said salt of said compound is a sodium salt.
27. The dosage unit form of claim 25 , comprising a powder.
28. The dosage unit form of claim 25 comprising a tablet.
29. The dosage unit form of claim 25 comprising a capsule.
30. The dosage unit form of claim 25 comprising a liquid.
31. The dosage unit form of claim 25 , wherein said biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.
32. The dosage unit form of claim 25 , wherein said biologically active agent comprises a protein, polypeptide, peptide.
33. The dosage unit form of claim 25 , wherein said biologically active agent comprises a mucopolysaccharide.
34. The dosage unit form of claim 25 , wherein said dosing vehicle is selected from the group consisting of water, 1,2-propane diol, ethanol, olive oil or any combination thereof.
35. The dosage unit form of claim 25 , wherein said biologically active agent is selected from the group consisting of: growth hormone, growth hormone-releasing hormones, interferons, interleukin-1, interleukin-2, insulin, insulin-like growth factor(IGF), heparin, 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, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), antimicrobials, anti-fungal agents; analogs, fragments, mimetics and polyethylene glycol (PEG)-modified derivatives of these compounds; and any combination thereof.
36. The dosage unit form of claim 35 , wherein said biologically active agent comprises a growth hormone, interferon, insulin, heparin, cromolyn sodium, an antigen, an anti-microbial agent, calcitonin, parathyroid hormone, erythropoietin, and combinations thereof.
37. The dosage unit form of claim 35 , wherein said growth hormone comprises human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, or a combination thereof.
38. The dosage unit form of claim 35 , wherein said biologically active agent comprises interferon.
39. The dosage unit form of claim 35 , wherein said biologically active agent comprises insulin.
40. The dosage unit form of claim 39 , wherein said insulin comprises porcine insulin, bovine insulin, human insulin, and human recombinant insulin.
41. The dosage unit form of claim 35 , wherein said biologically active agent comprises heparin.
42. The dosage unit form of claim 41 , wherein said heparin comprises low molecular weight heparin, very low molecular weight heparin, ultra low molecular weight heparin, heparinoids, dermatans, chondroitins, or a combination thereof.
43. The dosage unit form of claim 35 , wherein said biologically active agent comprises low molecular weight heparin.
44. The dosage unit form of claim 35 , wherein said biologically active agent comprises cromolyn sodium.
45. The composition of claim 44 , wherein said cromolyn sodium comprises sodium chromoglycate, disodium chromoglycate or a combination thereof.
46. The dosage unit form of claim 35 , wherein said biologically active agent comprises an antigen.
47. The dosage unit form of claim 35 , wherein said biologically active agent comprises an anti-microbial agent.
48. The dosage unit form of claim 35 , wherein said biologically active agent comprises calcitonin.
49. The dosage unit form of claim 35 , wherein said calcitonin comprises salmon calcitonin, eel calcitonin, human calcitonin or a combination thereof.
50. The dosage unit form of claim 35 , wherein said biologically active agent comprises parathyroid hormone.
51. The dosage unit form of claim 35 , wherein said biologically active agent comprises erythropoietin.
52. A method for administering a biologically-active agent to an animal, said method comprising administering to said animal the composition of claim 3 .
53. The method of claim 52 wherein said salt of said compound is a sodium salt.
54. The method of claim 52 , wherein said biologically-active agent is administered by a route which is: oral, intranasal, sublingual, intraduodenal, subcutaneous, buccal, intracolonic, rectal, vaginal, mucosal, pulmonary, transdermal, intradermal, parenteral, intravenous, intramuscular or intraocular.
55. The method of claim 54 , wherein said biologically-active agent is administered by oral route.
56. The method of claim 52 , wherein said biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.
57. The method of claim 52 , wherein said biologically active agent comprises a protein, a polypeptide, or a peptide.
58. The method of claim 52 , wherein said biologically active agent comprises a mucopolysaccharide.
59. The method of claim 52 , wherein said biologically active agent is selected from the group consisting of: growth hormone, growth hormone-releasing hormones, interferons, interleukin-1, interleukin-2, insulin, insulin-like growth factor(IGF), heparin, 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, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), antimicrobials, anti-fungal agents; analogs, fragments, mimetics and polyethylene glycol (PEG)-modified derivatives of these compounds; and any combination thereof.
60. The method of claim 52 , wherein said biologically active agent comprises a growth hormone, interferon, insulin, heparin, cromolyn sodium, an antigen, an anti-microbial agent, calcitonin, parathyroid hormone, erythropoietin, and combinations thereof.
61. The method of claim 60 , wherein said growth hormone comprises human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, or a combination thereof.
62. The method of claim 52 , wherein said biologically active agent comprises interferon.
63. The method of claim 51 , wherein said biologically active agent comprises insulin.
64. The method of claim 63 , wherein said insulin comprises porcine insulin, bovine insulin, human insulin, and human recombinant insulin.
65. The method of claim 52 , wherein said biologically active agent comprises heparin.
66. The method of claim 65 , wherein said heparin comprises low molecular weight heparin, very low molecular weight heparin, ultra low molecular weight heparin, heparinoids, dermatans, chondroitins, or a combination thereof.
67. The method of claim 66 , wherein said biologically active agent comprises low molecular weight heparin.
68. The method of claim 52 , wherein said biologically active agent comprises cromolyn sodium.
69. The method of claim 68 , wherein said cromolyn sodium comprises sodium chromoglycate, disodium chromoglycate or a combination thereof.
70. The method of claim 52 , wherein said biologically active agent comprises an antigen.
71. The method of claim 52 , wherein said biologically active agent comprises an anti-microbial agent.
72. The method of claim 52 , wherein said biologically active agent comprises calcitonin.
73. The method of claim 52 , wherein said calcitonin comprises salmon calcitonin, eel calcitonin, human calcitonin or a combination thereof.
74. The method of claim 52 , wherein said biologically active agent comprises parathyroid hormone.
75. The method of claim 52 , wherein said biologically active agent comprises erythropoietin.
76. A method for preparing a composition, said method comprising mixing:
(A) at least one biologically active agent;
(B) at least one compound as defined in claim 1 ; and
(C) optionally, a dosing vehicle.
77. The method of claim 76 wherein said salt of said compound is a sodium salt.
78. The method of claim 76 , wherein said biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.
79. The method of claim 76 , wherein said biologically active agent comprises a protein, polypeptide, peptide.
80. The method of claim 76 , wherein said biologically active agent comprises a mucopolysaccharide.
81. The method of claim 76 , wherein said biologically active agent is selected from the group consisting of: growth hormone, growth hormone-releasing hormones, interferons, interleukin-1, interleukin-2, insulin, insulin-like growth factor(IGF), heparin, 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, vancomycin, desferrioxamine (DFO), parathyroid hormone (PTH), antimicrobials, anti-fungal agents; analogs, fragments, mimetics and polyethylene glycol (PEG)-modified derivatives of these compounds; and any combination thereof.