Comparative In Vitro Dissolution Testing of Hydrophilic Controlled Release Venlafaxine Matrix Tablets and Effexor XR Using QbD
A hydrophilic matrix based, controlled release formulation for venlafaxine HCl (Ven HCl) was developed using a combination of various forms of hydroxypropyl methylcellulose (HPMC K4M, K15M, and K100M) The aim of the development was to match the dissolution profile (similarity factor f2 50) of Effexor XR capsules. The dissolution profile studies for the optimized formulation were performed as per the FDA guidelines for modified release (MR) products using a QbD approach. The data show that the matrix based formulation is statistically similar to Effexor XR in multimedia dissolution testing at different rpm, and the results between USP Apparatus 1 and 2 are similar. An alcoholinduced dose dumping study was also performed, and the results are comparable. This indicates that the hydrophilic matrix tablet formulation is equivalent to Effexor XR, which is based on a coated pellet platform.