Claims for Patent: 7,351,741

Summary for Patent: 7,351,741

Title:	Compounds and compositions for delivering active agents
Abstract:	Compounds and compositions for the delivery of active agents are provided. Methods of administration and preparation are provide as well.
Inventor(s):	Weidner; John J. (Wappingers Falls, NY), Variano; Bruce F. (White Plains, NY), Majuru; Shingai (Brewster, NY), Bhandarkar; Satej (Garnerville, NY), Bay; William E. (Ridgefield, CT), Sheilds; Lynn (Port Chester, NY)
Assignee:	Emisphere Technologies, Inc. (Cedar Knolls, NJ)
Application Number:	10/312,703
Patent Claims:	1. A compound of the formula ##STR00002## or a salt thereof. 2. A composition comprising: (A) at least one active agent; and (B) a compound having the formula ##STR00003## 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, .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 (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, .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 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 ##STR00004## or a salt thereof.

Details for Patent 7,351,741

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		2039-02-26
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	12/29/2015		2039-02-26
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	08/06/1998		2039-02-26