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Last Updated: October 17, 2019

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Claims for Patent: 7,227,033

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Summary for Patent: 7,227,033
Title:Polymorphs of sodium 4-[(4-chloro-2-hydroxybenzoyl) amino] butanoate
Abstract: The present invention relates to amorphous and polymorphic forms of sodium 4-[(4-chloro-2-hydroxybenzoyl)amino]butanoate and their use for facilitating the delivery of active agents, such as insulin, to a target.
Inventor(s): Bhandarkar; Satej (Downingtown, PA), Majuru; Shingai (Brewster, NY), Levchik; Halina (Croton On Hudson, NY)
Assignee: Emisphere Technologies, Inc. (Tarrytown, NY)
Application Number:10/501,205
Patent Claims:1. A crystalline polymorph of anhydrous sodium 4-[(4-chloro-2-hydroxybenzoyl)amino]butanoate exhibiting an x-ray powder diffraction pattern substantially as shown in FIG. 5.

2. A crystalline polymorph of anhydrous sodium 4-[(4-chloro-2-hydroxybenzoyl)amino]butanoate exhibiting an x-ray powder diffraction pattern having peaks in degrees 2.THETA.0.20.degree. 2.THETA.at 9.1, 12.3, 17.9, 19.8, 23.0, 24.1, 24.4, 26.1, 28.2, and 28.5.

3. The crystalline polymorph of claim 2, wherein the crystalline polymorph has a melting point onset as determined by differential scanning calorimetry at about 222.02.degree. C.

4. A composition comprising: (a) a crystalline polymorph of claim 1, (b) a biologically active agent.

5. The composition of claim 4, wherein the biologically active agent comprises at least one protein, polypeptide, peptide, hormone, polysaccharide, mucopolysaccharide, small polar organic molecules, carbohydrate, or lipid.

6. The composition of claim 4, wherein the biologically active agent is selected from the group consisting of growth hormones, human growth hormones (hGH), recombinant human growth hormones (rhGH), bovine growth hormones, porcine growth hormones, growth hormone-releasing hormones, interferons, .alpha.-interferon, .beta.-interferon, .gamma.-interferon, interleukin-1, interlcukin-2, insulin, porcine insulin, bovine insulin, human insulin, human recombinant 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 honnone, glucocerebrosidase, thrombopoictin, filgrastim, prostaglandins, cyclosporin, vasopressin, cromolyn sodium, sodium chromoglycate, disodium chromoglycate, vancomycin, desferrioxamine, bisphosphonates, alendronate, tiludronate, etidronate, clodronate, pamidronate, olpadronate, incadronate, BIBN-4096BS, parathyroid hormone, fragments of parathyroid hormone, antimicrobials, daptomycin, anti-fungal agents, vitamins, analogs, fragments, mimetics and polyethylene glycol-modified derivatives of these compounds, and any combination thereof.

7. A composition comprising (a) a crystalline polymorph of claim 1, (b) insulin.

8. A dosage unit form comprising: (A) the composition of claim 4; 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.

9. A dosage unit form comprising: (A) the composition of claim 7; 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. A method of administering an active agent to an animal in need thereof, the method comprising the step of administering the composition of claim 4 to the animal.

11. A method of treating diabetes in an animal in need thereof, comprising the step of administering a composition of claim 7 to the animal.

12. A method of treating diabetes in a human in need thereof, comprising the step of administering a composition of claim 7 to the human.

Summary for Patent:   Start Trial

PCT Information
PCT FiledJanuary 09, 2003PCT Application Number:PCT/US03/00878
PCT Publication Date:July 17, 2003PCT Publication Number:WO03/057650

Details for Patent 7,227,033

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Amgen NEUPOGEN filgrastim VIAL 103353 001 1991-02-20   Start Trial Emisphere Technologies, Inc. (Tarrytown, NY) 2022-01-09 RX search
Amgen NEUPOGEN filgrastim VIAL 103353 002 1991-02-20   Start Trial Emisphere Technologies, Inc. (Tarrytown, NY) 2022-01-09 RX search
Amgen NEUPOGEN filgrastim SYRINGE 103353 003 1991-02-20   Start Trial Emisphere Technologies, Inc. (Tarrytown, NY) 2022-01-09 RX search
Amgen NEUPOGEN filgrastim SYRINGE 103353 004 1991-02-20   Start Trial Emisphere Technologies, Inc. (Tarrytown, NY) 2022-01-09 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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