Journal of Engineering Research

As global warming and temperature fluctuations in the pharmaceutical distribution process increase, the impact of high-temperature environments on the quality characteristics of oral solid dosage forms has garnered significant attention. This paper elucidates how high temperatures cause physical and chemical changes in oral solid dosage forms, compromising drug stability, disintegration, and dissolution, thereby affecting efficacy and safety. It analyzes the mechanisms by which high temperatures accelerate drug degradation and alter the physical properties of formulations, proposing strategies such as optimizing formulation processes, improving packaging materials, and enhancing storage and transportation conditions. Through systematic research, the relationship between high temperatures and the quality characteristics of oral solid dosage forms is clarified, providing theoretical and practical support for ensuring drug quality.

High temperature environment; Oral solid dosage form; Quality characteristics; Stability; Coping strategies