In-vivo Pharmacokinetic Evaluation of Venlafaxine HCl Sustained Release Tablet Formulation

An optimized Venlafaxine SR tablets formulation, was chosen for in‐vivo study against the commercial marketed Venlafaxine SR formulation. The non-compartmental pharmacokinetic specifications of both reference and standard were determined, after dosing via oral route. The peak plasma concentration (Cmax) of optimized Venlafaxine SR tablets was found as 964.66 ± 53.15ng/ml in 5 hr, while Cmax of marketed Venlafaxine SR tablets formulation was found as 872.33 ± 28.43 ng/ml in same time i.e. 5 hr. The Cmax data suggests that absorption of drug in plasma from was in sustained manner from both the formulations, showing typical absorption pattern of SR product. The AUC0-t for optimized and marketed Venlafaxine SR tablets was found to be 12981.63 ± 505.25 and 12023.83 ± 668.29 ng/ml*h, while AUC0-∞ was found to be 13921.51 ± 417.40 and 13099.63 ± 742.21 ng/ml*h, respectively. The PK parameter showed the Tmax and AUC for optimized Venlafaxine SR tablets as compared to its marketed product formulation. Pharmacokinetic parameter clearly suggested prolong release and availability of Venlafaxine in plasma from SR tablets formulation. Overall, the results suggest that the optimized SR formulation of Venlafaxine provides effective extended and controlled drug delivery, highlighting its potential clinical relevance in the treatment of depression and anxiety disorders.