Formulation development of sustained release swellable matrix tablet of venlafaxine HCl using a combination of hydrophilic and hydrophobic polymers

The objective of this work was to develop a sustained-release swellable matrix tablet of highly water-soluble Venlafaxine HCl. Venlafaxine is a unique antidepressant that differs structurally from other currently available antidepressants. The anti-depressive drug Venlafaxine HCl was selected as a model drug due to its low bioavailability &short biological half-life of 5 ± 2hrs. The tablets were prepared using the wet granulation method. Eudragit RSPO, HPMC K4M, and Glyceryl monostearate were used as the rate-controlling polymers. After the preparation of the matrix tablet, it was evaluated for physical characteristics such as hardness, friability, thickness, weight variation, drug content, and dissolution study. The in-vitro release profile of the optimized batch showed the sustaining ability of the drug for 12 hrs. The optimized formulation was subjected to stability studies at different temperature and humidity conditions as per ICH guidelines and it displayed the stability for a given period.