Lipid-based ayurvedic formulations of a single herb-Yashtimadhu (Glycyrrhiza glabra): Pharmaceutical standardization, shelf-life estimation and comparative characterization

BACKGROUND: Single herb Ayurvedic lipid-based formulations of Glycyrrhiza glabra are used as oral, nasal and topical applications for reducing radiotherapy induced side effects in oral cavity cancer patients. These formulations are reported to be de-glycyrrhized, thus minimizing adverse effects of glycyrrhizin on longer consumption. Being a proprietary formulation with specific ratio of herb, lipid and liquid media, there is a need of pharmaceutical standardization and stability study to be conducted for quality control and quality assurance. OBJECTIVE: Standardization of Yashtimadhu Ghrut (YG) and Yashtimadhu Taila (YT) based on pharmaceutical characters, safety tests, chromatographic analysis and stability study. MATERIAL AND METHODS: Two formulations viz., YG and YT were prepared using cow's ghee and sesame oil, respectively. Basic physicochemical analysis, Thin Layer Chromatography, High Pressure Liquid Chromatography of glabridin and 18-β glycyrrhetinic acid, microbial load and heavy metal analysis were performed. Long term (0,3,6,9,12 months) as well as accelerated (0,3,6 months) stability study was conducted and extrapolated shelf-life was calculated for both the drugs. RESULT: Organoleptic and basic physicochemical characters were comparable for both the products while safety parameters were within permissible limits. Extrapolated shelf-life was deduced as 1.74 and 0.67 years for YG and YT, respectively. CONCLUSION: Single herb- G. glabra based lipid formulations were standardized and monographs were established. Shelf-life, though complying with classical Ayurvedic texts, indicates further research work with respect to pre-treatment of lipids and packaging systems for its enhancement.