Development and Characterization of Telmisartan Immediate Release Tablets

Abstract

Hypertension is a chronic illness characterized by chronically high arterial blood pressure. It is not a disease in and of itself, but it is a significant risk factor for cardiovascular death and morbidity. Telmisartan is a drug that belongs to the class of AT1 receptor antagonists, which act on the renin-angiotensin system and lead to the eventual decrease in blood pressure. The candidate is an FDA approved, first line drug in the treatment of hypertension. As the drug is a BCS class II substance, it is practically insoluble in water and shows solubility only in a highly basic media. Thus, the present work aims to prepare immediate release tablets of the drug using wet granulation method, and match all the parameters according to the reference tablets. First of all, the reference tablet was evaluated and the critical processing parameters were identified. The prepared tablets were evaluated for appearance, weight variation, friability, disintegration time and dissolution. Optimization of the formula as well as the processing parameters was also done such a way that it favored similar dissolution, upto 101.5% drug release in 45 minutes, proper disintegration time, 8:30 minute as well as reduction in processing cost. Stability batches were prepared and stability data is being generated according to the ICH guidelines.