Formulation Development of Mucoadhesive Tablets for Treatment of Hypertension using Losartan Potassium

Abstract

Controlled-release losartan potassium incorporated bucccoadhesive tablets were prepared using guar gum and hydroxy propyl methylcellulose K4M (HPMC K4M). The polymers had demonstrated considerable influence for all reactions. Ethylcellulose, a naturally impermeable material, was employed as a backing layer. The direct compression approach was used to create nine distinct losartan potassium formulations. Drug and polymer compatibility was determined through preformulation research utilizing fourier transform infrared (FTIR) spectroscopy. Buccoadhesive tablets were evaluated by swelling, bioadhesive characteristics, pH and in-vitro drug dissolution. The bioadhesive strength of guar gum was found to be greater than that of HPMC K4M. The swelling effect provided by both polymers was adequate. All formulations were judged to have an adequate surface pH, with values falling between 7 and 5, suggesting no discomfort to the buccal cavity. Ex-vivo residence times ranging from 7.2 to >10 hours for all tablets tested demonstrated a high degree of adhesion. The improved formulation follows Fickian diffusion release process. The optimized formulation underwent a stability investigation in accordance with International Council for Harmonisation (ICH) criteria, and no significant changes were found.