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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.,

(2011

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).