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Last Updated: September 18, 2020

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Patent: 7,659,311

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Summary for Patent: 7,659,311
Title:Disodium salts, monohydrates, and ethanol solvates for delivering active agents
Abstract: The inventors have discovered that the disodium salt of certain delivery agents has surprisingly greater efficacy for delivering active agents than the corresponding monosodium salt. Furthermore, the inventors have discovered that the disodium salts of these delivery agents form solvates with ethanol and hydrates with water. The delivery agents have the formula ##STR00001## wherein R.sup.1, R.sup.2, R.sup.3, and R.sup.4 are independently hydrogen, halogen, C.sub.1-C.sub.4 alkyl, or C.sub.1-C.sub.4 alkoxy; and R.sup.5 is a substituted or unsubstituted C.sub.2-C.sub.16 alkylene, substituted or unsubstituted C.sub.2-C.sub.16 alkenylene, substituted or unsubstituted C.sub.1-C.sub.12 alkyl(arylene), or substituted or unsubstituted aryl(C.sub.1-C.sub.12 alkylene). The hydrates and solvates of present invention also have surprisingly greater efficacy for delivering active agents, such as heparin and calcitonin, than their corresponding monosodium salts and free acids. The present invention provides an alcohol solvate, such as ethanol solvate, of a disodium salt of a delivery agent of the formula above. The invention also provides a hydrate of a disodium salt of a delivery agent of the formula above. Preferred delivery agents include, but are not limited to, N-(5-chlorosalicyloyl)-8-aminocaprylic acid (5-CNAC), N-(10-[2-hydroxybenzoyl]amino)decanoic acid (SNAD), and sodium N-(8-[2-hydroxybenzoyl]amino)caprylate (SNAC). The invention also provides methods of preparing the disodium salt, ethanol solvate, and hydrate and compositions containing the disodium salt, ethanol solvate, and/or hydrate.
Inventor(s): Bay; William Elliott (Ridgefield, CT), Agarwal; Rajesh K. (San Diego, CA), Chaudhary; Kiran (West Nyack, NY), Majuru; Shingai (Brewster, NY), Goldberg; Michael M. (Englewood, NJ), Corvino; JoAnne P. (Harrison, NY), Azria; Moise (Basel, CH), Ault; Joseph (Blairstown, NJ), Bateman; Simon D. (Randolph, NJ), Patel; Subash (Somerville, NJ), Sikora; Joseph (Succasunna, NJ), Yang; Rebecca F. (Randolph, NJ), Zielinski; Joseph L. (Florham Park, NJ)
Assignee: Novartis AG (Basel, CH)
Application Number:12/111,750
Patent Claims:see list of patent claims

Details for Patent 7,659,311

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 Novartis AG (Basel, CH) 2019-04-05 RX search
Amgen NEUPOGEN filgrastim VIAL 103353 002 1991-02-20   Start Trial Novartis AG (Basel, CH) 2019-04-05 RX search
Amgen NEUPOGEN filgrastim SYRINGE 103353 003 1991-02-20   Start Trial Novartis AG (Basel, CH) 2019-04-05 RX search
Amgen NEUPOGEN filgrastim SYRINGE 103353 004 1991-02-20   Start Trial Novartis AG (Basel, CH) 2019-04-05 RX search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 001 2015-01-23   Start Trial Novartis AG (Basel, CH) 2019-04-05 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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