PharmPC Discussion - Excipient: Trehalose

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On 15 Mar 1996 at 15:32:24, John Ludwig (jdludw.at.searle.monsanto.com) sent the message


I'm searching for information on the use of trehalose in lyophilized
parenteral formulations.  Specifically, are there any opened INDs or
approved NDAs for injectable products containing trehalose?  What about
regulatory filings in Europe or Japan?  Does anyone know of any
toxicology related issues concerning trehalose?  Are there other
suppliers of GMP bulk trehalose other than Pfanstiehl?

From a formulation viewpoint, most of the literature reports are quite
favorable towards trehalose.  Has anyone had any negative experiences?

Thank you
John Ludwig
G.D.Searle
jdludw.at.searle.monsanto.com

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