This study aims to investigate the preformulation of liraglutide, a GLP-1 receptor agonist, for the design of an oral dosage form. Using our self-developed AI formulation design software, the essential preformulation parameters of liraglutide tablets were predicted and comparatively evaluated. Transparency and equilibrium solubility tests were conducted using four dissolution media and three organic solvents. Additionally, the compatibility between liraglutide and excipients was evaluated by analyzing the degree of degradation through quantitative analysis. According to the solubility test results based on the standards of the Korean Pharmacopoeia (KP), liraglutide was found to be \"practically insoluble\" in most solvents but \"soluble\" in water and pH 6.8 medium. These findings contrast with the AI software\'s prediction of \"soluble\" across all pH levels. Additionally, compatibility tests revealed interactions between liraglutide and 13 excipients, including two permeation enhancers, under long-term storage conditions (25°C/60% RH) and accelerated storage conditions (40°C/75% RH). The results of this study are expected to serve as fundamental data for the formulation design of an improved oral drug delivery system for liraglutide.
2025 Spring Convention