Patent ID: 8470375
Filing Date: 2013-06-25
Classification: A61K,G01N

Abstract:
1. A test method for characterizing how a liquid test drug suspension correlates to a controlled release liquid suspension drug product suitable for commercial distribution 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 by introducing an aliquot of the liquid test drug suspension into an in vitro dissolution medium to generate a test in vitro dissolution profile for the test drug suspension, wherein there is a pre-determined hold period between the formation of said test drug suspension and initiation of said dissolution assay for said 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, wherein there is a pre-determined hold period between the formation of said control drug suspension and initiation of said dissolution assay for said control drug suspension, to determine whether the test in vitro dissolution profile matches the control in vitro dissolution profile, wherein the pre-determined hold period between the formation of said test drug suspension and initiation of said dissolution assay for said test drug suspension, and the pre-determined hold period between the formation of said control drug suspension and initiation of said dissolution assay for said control drug suspension are substantially identical and are substantially less than a period necessary for a drug suspension to become thermodynamically stable, and further wherein said control in vitro dissolution profile correlates to a target in vivo profile of said controlled release liquid suspension drug product.