Effect of unconventional curing conditions and storage  on pellets coated with Aquacoat ECD.
OBJECTIVE
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.


CONCLUSIONS
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.
Körber
M
M
College of Pharmacy, Freie Universitaet Berlin, Berlin, Germany. koerberm@zedat.fu-berlin.de
Hoffart
V
V
Walther
M
M
Macrae
R J
RJ
Bodmeier
R
R
D002482:Cellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations / Q000737:chemistry; D004339:Drug Compounding; D004343:Drug Implants / Q000737:chemistry; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods; D005079:Excipients / Q000737:chemistry*; D006813:Humidity; D007700:Kinetics; D010968:Plasticizers; D012995:Solubility; D013696:Temperature
D003692:Delayed-Action Preparations; D004343:Drug Implants; D005079:Excipients; D010968:Plasticizers; C013517:ethyl cellulose; D002482:Cellulose