2025 年 85 巻 4 号 p. 255-263
This study evaluated a novel correction method for dissolution testing of drugs with deglutition aid jellies, commonly used to improve medication adherence, especially for patients with swallowing difficulties. Five different jellies and four model drugs—pravastatin sodium, eplerenone, omeprazole, and famotidine—were tested using methods from the Japanese Pharmacopeia and the Japanese Orange Book. Ultraviolet-visible (UV-Vis) spectrophotometry yielded overestimated dissolution rates due to interference from the jelly components absorbing light at drug quantification wavelengths. We developed a correction method by subtracting the jelly components' absorbance from the total absorbance. This aligned UV-Vis dissolution profiles with those from high-performance liquid chromatography (HPLC). While HPLC offers superior precision, its high costs and complexity limit routine use in quality control. Our correction method allows accurate dissolution assessments while retaining UV-Vis spectrophotometry's simplicity and cost-effectiveness. This approach has broad applicability for evaluating drug dissolution with various deglutition aids, underscoring the importance of standardized and accurate testing for medication safety and efficacy.
