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Last Updated: April 25, 2024

Claims for Patent: 7,727,558

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Summary for Patent: 7,727,558

Title:	Polymeric delivery agents and delivery agent compounds
Abstract:	Polymeric delivery agents, delivery agent compounds and compositions comprising them which are useful in the delivery of active agents are provided. Methods of administration and preparation are provided as well.
Inventor(s):	Milstein; Sam J. (Larchmont, NY), Barantsevitch; Eugene N. (Scarsdale, NY), Wang; Nai Fang (Long Island City, NY), Liao; Jun (Yorktown Heights, NY), Smart; John (Katonah, NY), Conticello; Richard (Ossining, NY), Ottenbrite; Raphael (Midlothian, VA)
Assignee:	Emisphere Technologies, Inc. (Tarrytown, NY) Virginia Commonwealth University (Richmond, VA)
Application Number:	11/669,649
Patent Claims:	1. A polymeric delivery agent having the formula: ##STR00019## or a salt thereof, wherein R.sup.16 is --R.sup.3-R.sup.4; R.sup.3--NHC(O)NH--, --C(O)NH--, --NHC(O)--, --OOC--, --COO--, --NHC(O)O--, --OC(O)NH--, --CH.sub.2NH--, --NHCH.sub.2--, --CH.sub.2NHC(O)O--, --OC(O)NHCH.sub.2--, --CH.sub.2NHCOCH.sub.2O--, --OCH.sub.2C(O)NHCH.sub.2--, --NHC(O)CH.sub.2O--, --OCH.sub.2C(O)NH--, --NH--, --O--, or carbon-carbon bond; R.sup.4 the formula ##STR00020## R.sup.5, R.sup.6, R.sup.7, R.sup.8, and R.sup.9 are independently a bond to R.sup.3, or H, Cl, Br, F, --OH, --CH.sub.3, --OCH.sub.3, or --(CH.sub.2).sub.mCH.sub.3; R.sup.10 is a bond to R.sup.3--COOH, or --C(O)NH--R.sup.11-R.sup.12; R.sup.11 is a substituted or unsubstituted, linear or branched alkylene having a chain length of from about 1 to about 11 or --R.sup.13-R.sup.14--; R.sup.12 is a bond to R.sup.3 is --COOH, --NH.sub.2, --OH, --C(O)--R.sup.15, --COO--R.sup.15, --NHR.sup.15, --OR.sup.15, Cl, or Br; R.sup.13 is a substituted or unsubstituted phenylene; R.sup.14 is a substituted or unsubstituted, linear or branched alkylene having a chain length of from about 1 to about 5; R.sup.15 is a bond to R.sup.3; m is from about 1 to about 4; R.sup.17--OH or --OCH.sub.3; R.sup.23 is H or --CH.sub.3; and n is from about 3 to about 200. 2. The polymeric delivery agent of claim 1, wherein n is from about 4 to about 15. 3. The polymeric delivery agent of claim 1, wherein R.sup.9 is --OCH.sub.3 or --OH. 4. The polymeric delivery agent of claim 1, wherein R.sup.16 is --OOC--R.sup.4. 5. The polymeric delivery agent of claim 1, wherein R.sup.17 is --OH. 6. The polymeric delivery agent of claim 1, wherein R.sup.17 is --OCH.sub.3. 7. The polymeric delivery agent of claim 1, wherein R.sup.23 is H. 8. The polymeric delivery agent of claim 1, wherein the molecular weight of the polymer component ##STR00021## ranges from about 200 to about 600 daltons. 9. The polymeric delivery agent of claim 8, wherein the molecular weight of the polymer component ranges from about 300 to about 550 daltons. 10. A pharmaceutical composition comprising a polymeric delivery agent of claim 1 and a biologically active agent. 11. The pharmaceutical composition of claim 10, wherein the biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, carbohydrate, or lipid. 12. The pharmaceutical composition of claim 10, wherein the biologically active agent is selected from human growth hormone, recombinant human growth hormone, bovine growth hormone, porcine growth hormone, growth hormone-releasing hormone, an interferon, .alpha.-interferon, .beta.-interferon, .gamma.-interferon, interleukin-1, interleukin-2, insulin, porcine insulin, bovine insulin, human insulin, human recombinant insulin, insulin-like growth factor (JGF), JGF-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, an antigen, a monoclonal antibody, somatostatin, protease inhibitors, adrenocorticotropin, gonadotropin releasing hormone, oxytocin, leutinizing-hormone-releasing-hormone, follicle stimulating hormone, glucocerebrosidase, thrombopoietin, filgrastim, prostaglandins, cyclosporin, vasopressin, cromolyn sodium, soium chromoglycate, disodium chromoglycate, vancomycin, parathyroid hormone, fragments of parathyroid hormone, desferrioxamine, antimicrobials, anti-fungal agents, vitamins, analogs, fragments, mimetics and polyethylene glycol-modified derivatives of these compounds, and any combination thereof. 13. The pharmaceutical composition of claim 10, wherein the biologically active agent is insulin, unfractionated heparin, low molecular weight heparin, very low molecular weight heparin, ultra low molecular weight heparin, calcitonin, parathyroid hormone, erythropoietin, human growth hormone, recombinant human growth hormone, or a combination thereof. 14. The pharmaceutical composition of claim 13, wherein the biologically active agent is human growth hormone. 15. The pharmaceutical composition of claim 13, wherein the biologically active agent is recombinant human growth hormone. 16. The pharmaceutical composition of claim 10, wherein the pharmaceutical composition is a dosage unit form and further comprises (a) an excipient, (b) a diluent, (c) a disintegrant, (d) a lubricant, (e) a plasticizer, a colorant, (g) a dosing vehicle, or (h) any combination thereof. 17. The pharmaceutical composition of claim 16, wherein the dosage unit form is a tablet, a capsule, a powder, or a liquid. 18. A method for administering a biologically active agent to a human in need of the agent comprising administering to the human the pharmaceutical composition of claim 10 orally, intracolonically, or intraduodenally. 19. The method of claim 18, wherein the pharmaceutical composition is administered orally. 20. The method of claim 18, wherein the pharmaceutical composition is administered intracolonically.

Details for Patent 7,727,558

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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	⤷ Try a Trial	2019-01-08
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	12/29/2015	⤷ Try a Trial	2019-01-08
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	08/06/1998	⤷ Try a Trial	2019-01-08
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	03/31/1994	⤷ Try a Trial	2019-01-08
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	05/25/2018	⤷ Try a Trial	2019-01-08
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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