Abstract

FORMULATION AND EVALUATION OF SOMLATA PLANT LOZENGES FOR BRONCHODILATING AND ANTI ASTHAMATIC EFFECT

*Harsh S. Chavan, Akshay Fulsundar

Abstract

The objective of this research was to develop and pharmaceutically evaluate herbal hard candy lozenges containing Ephedra gerardiana (Somlata) extract to establish a highly palatable, slow-release buccal drug delivery platform for alleviating asthmatic symptoms. Chronic asthma and associated bronchospasms present widespread clinical challenges, yet conventional treatments are frequently limited by delayed therapeutic action or poor patient compliance in pediatric and geriatric populations. In this study, a hydroalcoholic extract of Somlata stems was prepared using a continuous hot Soxhlet extraction process and standardized for its rich concentration of natural, smooth-muscle-relaxing sympathomimetic alkaloids. A series of lozenge formulations (F1–F6) were fabricated using a traditional heating and congealing technique, wherein the critical ratios of sucrose and liquid glucose were systematically altered to optimize the sugar-glass candy matrix. The resulting lozenges were evaluated for vital physicochemical and mechanical attributes, including weight uniformity, crushing strength hardness, percentage friability, and drug content uniformity. In vitro dissolution profiling was performed utilizing a USP Type II apparatus in simulated saliva fluid (pH 6.8), while the in vivo antiasthmatic and bronchodilating efficacy was validated via a histamineinduced bronchospasm model using healthy guinea pigs. Among the evaluated batches, formulation F4 emerged as the optimized candidate, displaying excellent physical integrity with a hardness of (4.5 pm 0.23 ext{ kg/cm}^2), a negligible friability of 0.28%, and an exceptionally uniform drug content of (99.4 pm 0.7%). The in vitro dissolution data for F4 indicated a controlled, steady release pattern, successfully delivering 91.2% of the active herbal phytoconstituents across an ideal 30-minute window. Furthermore, in vivo preclinical testing revealed that the optimized lozenge matrix significantly delayed ((p < 0.01)) the onset of pre-convulsive dyspnea in animal models, yielding a 58.94% protection rate against histamine-induced airway constriction, which closely mirrored the performance of the synthetic ephedrine reference standard. Ultimately, these findings confirm that the formulated Somlata hard candy lozenges represent a physically stable, pharmaceutically viable, and therapeutically potent alternative to traditional oral anti-asthmatic treatments, significantly improving patient compliance and localized absorption.

Keywords: Ephedra gerardiana, Somlata, Lozenges, Bronchodilator, Antiasthmatic, Buccal Drug Delivery.