OECD GUIDED- REPEATED DOSE 28-DAY ORAL TOXICITY STUDY OF THE NEWLY FORMULATED VALACYCLOVIR MICROBEADS

Sankar Narayan Bhunia,#, Dipankar Saha#, Sudipta Das*, Trishna Das, Sawan Das, Piyali Devroy, Bishal Saha, Pallab Kanti Haldar, Asis Bala

ABSTRACT

The study aimed to evaluate the oral toxicity of a newly formulated valacyclovir microbeads, following OECD-guided, repeated-dose, 28-day testing protocols. The experiment was conducted in accordance with OECD 407 guidelines for acute oral toxicity. A total of 24 healthy young adult Wistar rats were divided into four groups (n=6; Male: Female = 1:1). The groups were treated as follows: a control group and three dose groups receiving low, medium, and high doses of 100, 200, and 400 mg/kg body weight, respectively, daily for 28 days. No significant differences were observed in terms of body weight changes, food consumption, or histological analysis of liver and kidney tissues. Furthermore, there was no hematological difference between the treated and untreated groups. These findings confirm the safety of the newly formulated valacyclovir drug.

Keywords: Valacyclovir microbeads; adult Wistar rats: 28-day repeated Toxicity Study.