Formulation and Evaluation of Digestion Enhancer Soft Gel Lozenges

Abstract

Digestive disorders such as dyspepsia, bloating, flatulence and indigestion account for a huge global health burden with millions of individuals suffering from them leading to decrease in quality of life. This study reports the design and characterization of soft gel lozenges incorporating bitter leaf (Vernonia amygdalina) extract as the active pharmaceutical ingredient, integrated with fennel oil (Foeniculum vulgare) and cardamom oil (Elettaria cardamomum) as a synergistic combination. Excipients used with these active components include gulkand (rose petal preserve), rose water, gelatine. Soft gel lozenges represent a novel and patient-friendly delivery system for herbal actives, offering advantages such as ease of administration, pleasant organoleptic properties, and enhanced mucosal absorption.

The formulations were characterized for physicochemical parameters including weight variation, hardness, friability, disintegration time, and in vitro drug release. The optimized formulation exhibited acceptable organoleptic properties, satisfactory stability, and effective digestive activity. These results support the potential of this herbal lozenge as a safe, effective, and palatable alternative for managing common digestive ailments.