Authors: Susanne Matheus HannsChristian Mahler Wolfgang Friess
Publish Date: 2006/06/21
Volume: 23, Issue: 7, Pages: 1617-1627
Abstract
T mFTIR values of various formulations different pH buffers excipients were compared to the results of a stability study under accelerated conditions 40°C/75 relative humidity using sizeexclusion highperformance liquid chromatography SEHPLC and sodium dodecyl sulfate–polyacrylamide gel electrophoresis SDSPAGE for the detection of soluble aggregates and covalent modificationsThe highest T mFTIR was achieved at pH 55 and similarly SEHPLC and SDSPAGE results suggested a pH optimum between 55 and 60 Transition temperatures were comparable for all tested buffers However the decrease in the monomer fraction upon thermal storage was the lowest for citrate buffers Whereas sugars and polyols resulted in an increase in T mFTIR and enhanced monomer fraction after storage amino acids showed a destabilization according to SEHPLC analysis albeit no change or even an increase in the melting temperature was observedAll examples gave evidence that T mFTIR values did not necessarily correspond to the storage stability at 40°C analyzed by means of SEHPLC and SDSPAGE T m values eg determined by FTIR should only be employed as supportive information to the results from both realtime and accelerated stability studies
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