Patent ID: 9057675
Filing Date: 2015-06-16
Classification: A61K,G01N

Abstract:
1. A test method comprising (a) obtaining drug-resin complex particles; (b) combining said drug-resin complex particles with a plurality of excipients in a liquid carrier to form a liquid test drug suspension; (c) performing an in vitro dissolution assay to generate a test in vitro dissolution profile for the test drug suspension; and (d) comparing said test in vitro dissolution profile to a control in vitro dissolution profile generated by an in vitro dissolution assay for a control drug suspension, to determine whether the test in vitro dissolution profile matches the control in vitro dissolution profile, wherein said dissolution profiles are obtained prior to either suspension becoming stable to time-dependent changes to its release profile, wherein said test drug suspension and said control drug suspension are substantially similar in physicochemical characteristics to a finally formulated suspension which is stable to time-dependent changes to its release profile, and further wherein said control in vitro dissolution profile correlates to a target in vivo profile of a controlled release liquid suspension drug product.