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 provide as well.
1. A compound of the formula
or a salt thereof.
2. A composition comprising:
(A) at least one active agent; and
(B) a compound having the formula
a salt thereof, or a mixture 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 is at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.
5. The composition of claim 2 , wherein the active agent is selected from the group consisting of:
growth hormones, human growth hormones, recombinant human growth hormones, bovine growth hormones, porcine growth hormones, growth hormone-releasing hormones, 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, 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 (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, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine, parathyroid hormone, fragments of parathyroid hormone, antimicrobials, anti-fungal agents, vitamins; and any combination thereof.
6. The composition of claim 2 , wherein the active agent is insulin, human growth hormone, interferon, cromolyn sodium or combinations thereof.
7. The composition of claim 2 , wherein the active agent is insulin.
8. The composition of claim 2 , wherein the active agent is interferon.
9. 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.
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 is a protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid.
12. The dosage unit form of claim 9 , wherein the active agent is selected from the group consisting of:
growth hormones, human growth hormones, recombinant human growth hormones, bovine growth hormones, porcine growth hormones, growth hormone-releasing hormones, 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, insulin-like growth factor-1, heparin, unfractionated heparin, heparinoids, dermatans, chondroitins, low molecular weight heparin, very low molecular weight heparmn, ultra low molecular weight heparmn, 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, thrombopoietin, filgrastim, prostaglandins, cyclosporin, vasopressin, cromolyn sodium, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine, parathyroid hormone, fragments of parathyroid hormone, antimicrobials, anti-fungal agents, vitamins; and any combination thereof.
13. The dosage unit form of claim 9 , wherein the active agent is insulin, human growth hormone, interferon, cromolyn sodium or combinations thereof.
14. The dosage unit form of claim 9 , wherein the active agent is insulin.
15. The dosage unit form of claim 9 , wherein the active agent is interferon.
16. The dosage unit form of claim 9 , wherein the dosage unit form is in the form of a tablet, a capsule, a particle, a powder, a sachet, 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, 25% aqueous propylene glycol, phosphate buffer, 1,2-propane diol, ethanol, and any combination thereof.
18. 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.
19. Anhydrous sodium 4-[(4-chloro-2-hydroxybenzoyl)amino]butanoate.
20. A composition comprising:
(a) at least one active agent; and
(b) the anhydrous compound of claim 19 .
21. The composition of claim 20 , wherein the active agent is insulin.
22. A solid oral dosage form comprising:
(A) the composition of claim 21 ; 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.
23. Sodium 4-[(4-chloro-2-hydroxybenzoyl)amino]butanoate isopropanol solvate.
24. A composition comprising:
(a) at least one active agent; and
(b)the compound of claim 23 .
25. The composition of claim 24 , wherein the active agent is insulin.
26. A solid oral dosage form comprising:
(A) the composition of claim 25 ; 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.
27. A pharmaceutical composition comprising:
(A) insulin; and
(B) a compound having the formula
or a salt thereof.