FORMULATION AND EVALUATION OF A NOVEL POLYHERBAL ORAL MEDICATED JELLY FOR TREATMENT OF UROLITHIASIS

Background: Urolithiasis is a disease of the genitourinary system, characterised by occurrence of urinary stones and affecting approximately 12% of the global population. It is also linked to chronic diseases like chronic renal disease, cardiovascular disease thereby posing significant health risks. Contemporary treatments are symptomatic and fail to produce lithotriptic activity and thus recurrence is common. This study involves development of polyherbal formulation and evaluation of its lithotriptic activity. Methodology: Hydroalcoholic (HA) extracts of Tribulus terrestris, Cynodon dactylon, and Kalanchoe pinnata were formulated into a polyherbal oral medicated jelly (OMJ). The OMJ was evaluated for characteristics like hardness, cohesion, springiness, gumminess, and chewiness using a texture analyser. The lithotriptic activity was evaluated using HPLC analysis. Calcium oxalate crystals were incubated with HA extracts in egg membrane for 72 hours. The residual contents were then analysed using HPLC. Cystone was used as a standard. Results: Texture analysis of OMJ revealed the characteristics such as: gumminess (431g), springiness (36.70), hardness (518g), cohesiveness (0.83), and chewiness (155 mJ) at pH of 4.3. The dissolution of calcium oxalate in presence of OMJ was found to be 73.9%, whereas dissolution of 92.5% was observed with Cystone. Conclusion: The OMJ was developed and its in-vitro lithotriptic effect was evaluated which demonstrated the potential therapeutic efficacy of OMJ in dissolving calcium oxalate crystals thereby envisaging the role of OMJ in management of urolithiasis. Further preclinical investigations are needed to validate its therapeutic efficacy and safety.