Automated Dissolution for Enteric-Coated Aspirin Tablets: A Case Study for Method Transfer to a RoboDis II.
Dissolution method transfer is a complicated yet common process in the pharmaceutical industry. With increased pharmaceutical product manufacturing and dissolution acceptance requirements, dissolution testing has become one of the most labor-intensive quality control testing methods. There is an increased trend for automation in dissolution testing, particularly for large pharmaceutical companies to reduce variability and increase personnel efficiency. There is no official guideline for dissolution testing method transfer from a manual, semi-automated, to automated dissolution tester. In this study, a manual multipoint dissolution testing procedure for an enteric-coated aspirin tablet was transferred effectively and reproducibly to a fully automated dissolution testing device, RoboDis II. Enteric-coated aspirin samples were used as a model formulation to assess the feasibility and accuracy of media pH change during continuous automated dissolution testing. Several RoboDis II parameters were evaluated to ensure the integrity and equivalency of dissolution method transfer from a manual dissolution tester. This current study provides a systematic outline for the transfer of the manual dissolution testing protocol to an automated dissolution tester. This study further supports that automated dissolution testers compliant with regulatory requirements and similar to manual dissolution testers facilitate method transfer.
Division of Pharmaceutical Sciences, College of Pharmacy, University of Cincinnati, Cincinnati, OH, USA Division of Pharmaceutical Sciences, School of Pharmacy, Fairleigh Dickinson University, Florham Park, NJ, USA ibrahisa@mail.uc.edu.
Sarah A
SA
Ibrahim
Institute of Pharmaceutical Science, King's College London, UK.
Luigi
L
Martini
D001241:Aspirin / Q000032:analysis / Q000737:chemistry; D057205:Automation, Laboratory / Q000379:methods*; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D065546:Drug Liberation; D015203:Reproducibility of Results; D013608:Tablets, Enteric-Coated / Q000032:analysis / Q000737:chemistry
D013608:Tablets, Enteric-Coated; D001241:Aspirin
RoboDis II; automated dissolution; enteric-coated aspirin; method transfer