Virtual Booth

Post-marketing degradation of pharmaceutical products due to thermal exposure remains a concern in community pharmacy settings, particularly in tropical climates. This study aimed to develop and preliminarily evaluate an irreversible colorimetric stability indicator designed to detect temperature conditions that may compromise the quality of paracetamol tablets. A temperature-sensitive color-changing indicator label was conceptualized and integrated into pharmaceutical packaging. The indicator response was evaluated alongside dissolution performance and assay content of innovator and generic paracetamol tablets obtained from community pharmacies. Dissolution testing was performed using USP Apparatus II, while drug content was determined using UV spectrophotometry. Results showed that one generic product exhibited reduced dissolution performance (58.011 ± 4.944%), while several products demonstrated assay variability. The indicator exhibited irreversible color change upon exposure to elevated temperature conditions associated with potential degradation. These findings demonstrate the feasibility of integrating simple visual indicators into pharmaceutical packaging to support real-time monitoring of thermal exposure and improve medicine quality assurance.

Keywords: paracetamol, irreversible indicator, temperature sensor, post-marketing surveillance, pharmaceutical quality