title: Effect of unconventional curing conditions and storage  on pellets coated with Aquacoat ECD.
abstract: 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.
authors: College of Pharmacy, Freie Universitaet Berlin, Berlin, Germany. koerberm@zedat.fu-berlin.de
authors: M
authors: M
authors: Körber
authors: V
authors: V
authors: Hoffart
authors: M
authors: M
authors: Walther
authors: R J
authors: RJ
authors: Macrae
authors: R
authors: R
authors: Bodmeier
mesh_terms: 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
chemical_list: D003692:Delayed-Action Preparations; D004343:Drug Implants; D005079:Excipients; D010968:Plasticizers; C013517:ethyl cellulose; D002482:Cellulose