DEVELOPMENT AND CHARACTERIZATION OF A CAFFEINE-SHILAJIT (ASPHALTUM PUNJABIANUM) CHEWING GUM AS AN INNOVATIVE ORAL DELIVERY SYSTEM: ANXIOLYTIC AND COGNITIVE ENHANCER

Abstract

The present study was undertaken to develop and evaluate a natural medicated chewing gum containing caffeine and Asphaltum punjabianum using mastic gum as the gum base. Caffeine (50 mg) and Asphaltum punjabianum (150 mg) were incorporated into five formulations (MCGF1-MCGF5) prepared by a modified fusion method, with different proportions of mastic gum and olive oil. The prepared formulations were evaluated for their physicochemical and mechanical properties, including appearance, weight variation, thickness, elasticity, stickiness, softening point, and drug content uniformity. The raw materials and formulation components were also examined by UV-visible spectroscopy and FTIR spectroscopy to support their identification and compatibility. The λmax values of caffeine and Asphaltum punjabianum were found to be 272 nm and 221 nm, respectively, with good linearity over the selected concentration ranges. FTIR analysis showed retention of the characteristic absorption bands of the individual components without significant changes in the physical mixture, indicating compatibility between the active ingredients and mastic gum. The formulations showed satisfactory physical properties and uniform drug content, with caffeine content ranging from 98.42-99.11% and Asphaltum punjabianum content ranging from 98.15-99.02%. In-vitro drug release was evaluated using an in-house mechanical mastication simulator in phosphate buffer pH 6.8 at 37 ± 0.5 °C. Within 20 min, caffeine release ranged from 87.67-95.00%, whereas Asphaltum punjabianum release ranged from 79.07-89.47%. Among the prepared formulations, MCGF3 showed a suitable balance of chewability, mechanical properties, drug content, and release characteristics and was selected as the optimized formulation. Overall, the study demonstrates the feasibility of developing a natural medicated chewing gum containing caffeine and Asphaltum punjabianum, although further in-vivo and clinical studies are required to establish its pharmacokinetic and therapeutic potential.