Abstract Introduction Sildenafil citrate Orodispersible film (ODF) is a novel formulation designed to better address the needs and expectations of men with erectile dysfunction (ED). Ensuring the stability of pharmaceutical products is crucial to maintain their efficacy, safety, and quality throughout their shelf-life. Objective This study aimed to perform a stress test on sildenafil ODF by exposing it to elevated temperatures (60 degrees Celsius) mimicking extreme storage conditions and evaluate its physical and chemical stability. Methods This test was conducted in Kyukyu Pharmaceutical Co., Ltd, Toyama Plant, Japan. A thin pale red colored ODF containing 50 mg sildenafil was formulated to dissolve in the oral cavity. Three batches of samples were subjected to a stability study at 60°C stress for three weeks. They were assessed for the amount of active pharmaceutical ingredient assay (95.0% −105.0% of labelled amount), degradation, disintegration, dissolution rate (over 80% for 45 mm) and water content. Results All test items met the specifications and showed negligible differences between the samples. The amount of degradation products demonstrated an increasing trend over time in all conditions, but all met the specification. The purity testing for degradation product (0.2% or less) showed significant (p value <0.05) at initial and 60°C in all the three samples. Conclusions The process was evaluated across a range of manufacturing conditions, and all intermediates and sildenafil ODF showed consistent performance that yields a consistent product meeting all specifications at release and after three weeks of storage under stressed conditions. These results indicate the robust performance of the sildenafil ODF across a range of manufacturing conditions. In addition, the water content stayed in a tight range regardless of the film casting parameters, and this remains true of the packaged product even after 3 weeks at 60°C. Disclosure Yes, this is sponsored by industry/sponsor: Kyukyu Pharmaceutical Co., Ltd, Toyama Plant, Japan and Viatris Inc. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Viatris Inc.
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