Characterization requirements of new excipients Two case studies
T. Schmeller
BASF SE, Lampertheim, Germany
Corresponding Author
T. Schmeller:
BASF SE, G-ENP/ME – G31, D-68623, Lampertheim, Germany
, email:
thorsten.schmeller@basf.com
Schmeller T.,
Characterization requirements of new excipients Two case studies,
Chemistry Today
Excipients – Vol. 29(5) September/October 2011
, 10-12
Abstract
Novel excipients can play a major role in innovation processes,but physico-chemical properties, performance and safetymust be adequately demonstrated. Characterizationrequirements for novel excipients are discussed and illustratedwith two examples, polyvinyl caprolactam polyvinyl acetatepolyethylene glycol grafted copolymer (Soluplus®) andmethyl methacrylate and diethylaminoethyl methacrylatecopolymer dispersion (Kollicoat® Smartseal 30 D).
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