Novartis Ag

Emisphere Technologies, Inc.

Joseph Zielinski

Simon David Bateman

Michael M Goldberg

Rajesh K Agarwal

Joseph Ault

Joseph Sikora

Kiran Chaudhary

Subash Patel

Rebecca F Yang

Shingai Majuru

Moise Azria

JoAnne P Corvino

William Elliot Bay

William Elliott Bay

Shingai Majura

JoAnne P Russo

Mosise Azria

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. 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.

Disodium salts, monohydrates, and ethanol solvates for delivering active agents

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 wherein

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Florham Park, NJ, United States of America

Joseph Zielinski