Design, Characterisation and Evaluation Study for Immediate Release Formulation of Canagliflozin

ABSTRACTType 2 diabetes mellitus is a complex metabolic disorder in which the glucose levels in the human body cannot be easily controlled due to insufficient insulin production by the pancreas. Canagliflozin is a widely used and effective drug for managing this condition, known for its safety and efficacy, with a half-life of approximately 10.6 hours. The primary objective of this study was to modify the drug release pattern to achieve an immediate release formulation, particularly for emergencies where rapid therapeutic action is required. To accomplish this, a comprehensive preformulation study was conducted, which included analytical techniques such as IR Spectra, UV-Spectrophotometry, solubility analysis, and melting point determination to evaluate the compatibility of the drug with excipients. Subsequently, formulation studies were performed using sodium starch glycolate as a special polymer in three consecutive batches to optimise the drug release profile. The in-vitro evaluation involved a detailed analysis of physical and chemical parameters, including disintegration time, dissolution studies, friability testing, and hardness measurements, using different polymer ratios to achieve the desired release characteristics. Based on the experimental findings, it was observed that the drug release time of Canagliflozin could be significantly reduced from 10 hours to just 15 minutes for 100 mg tablets through a polymer-based approach, demonstrating its potential for rapid onset of action. This study successfully establishes that Canagliflozin can be effectively formulated for immediate release, enhancing its therapeutic efficacy and providing a faster response in critical conditions, thereby improving patient outcomes in the management of type 2 diabetes mellitus.