Formation and Evaluation of Valganciclovir Hydrochloride Immediate Release Tablets

S. Revathi*, T. Nikitha, V. Deepthi, S. Geethanjili, C. Udayasree, A. Uday Simha
Ratnam Institute of Pharmacy, Pidthapolur (V), Muthukur (M), Nellore (Dt), Andhra Pradesh – 524343, India

A B S T R A C T
Valganciclovir HCl (VGH) is the widely used drug for the treatment of cytomegalovirus (CMV) retinitis infection with an induction dose of 900 mg per oral (p.o.) twice a day and a maintenance dose of 900 mg (p.o.). This required dose of the drug also leads to multiple side effects due to repeated administration. The research was highlighted to formulate and evaluate tablets of VGH with the dose of 455 mg to reduce dosing frequency and associated side effects. The formulation methods are done in two methods i.e., Dry and Wet granulation. The decrease in dose also minimizes the hepatic and nephrotic load. The optimized batch of the formulation was subjected to comparative in vitro and in vivo evaluation. The tablet core composition is the primary influencer of the drug delivery fraction in a first order, whereas the membrane characteristics control the drug release rate. In vivo pharmacokinetic studies revealed that the newly developed formulation has first-order release for 24 h with a single dose of 455 mg while the marketed formulation requires twice administration within 24 h to maintain the plasma concentration in the therapeutic window.
Keywords: Valganciclovir hydrochloride, anti-viral, Therapeutic window, Immediate release tablets.