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Published on: June 15, 2016
Effect of unconventional curing conditions and storage on pellets coated with Aquacoat ECD
M Körber1, V Hoffart, M Walther
1College of Pharmacy, Freie Universitaet Berlin, Berlin, Germany. koerberm@zedat.fu-berlin.de
Purpose:
Purpose of this study was to develop storage stable pellets coated with the aqueous ethylcellulose dispersion Aquacoat ECD.
Methods:
The influence of accelerated curing/storage conditions on the release behavior of Aquacoat/HPMC-coated drug pellets were investigated as a function of various formulations (sealing, plasticizer content, and pore-former type/amount) and process parameters (process humidity, thermal curing, and organic processing).
Results:
Conventionally cured Aquacoat/hydroxypropyl methylcellulose- coated pellets were storage stable at ambient conditions and 25 degrees C/60% relative humidity (RH) but showed a decreasing drug release at 40 degrees C/75% RH, which is a required test condition according to ICH guidelines.
Conclusion:
Only organic processing of dried Aquacoat or unconventionally harsh curing conditions (60 degrees C/75% RH or 80 degrees C) improved the storage stability of Aquacoat-coated pellets at accelerated conditions.
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