Forced Degradation and Stability Studies of a Novel Famotidine/Domperidone ODF

This study aimed to develop and comprehensively evaluate the stability of a novel orodispersible film (ODF) containing Famotidine and Domperidone, a combination therapy for gastroesophageal reflux disease (GERD), in accordance with International Council for Harmonisation (ICH) guidelines. The optimized ODF formulation was subjected to forced degradation studies under thermal (60°C), photolytic (UV light), and oxidative (3% H₂O₂) stress conditions for 5 days. Samples were analyzed at predetermined intervals for drug content and key physicochemical parameters. Furthermore, accelerated stability studies were conducted on samples packaged in aluminum packaging and stored at 40°C ± 2°C/75% RH ± 5% for six months. These samples were evaluated for appearance, thickness, weight variation, folding endurance, disintegration time, drug content, and dissolution. The forced degradation studies demonstrated that the ODF possesses excellent stability under thermal and photolytic stress, with drug content for both APIs remaining well within acceptable limits and no significant changes in physicochemical properties. However, oxidative stress induced a gradual decrease in the drug content of both Famotidine and Domperidone, indicating a susceptibility to oxidation. The accelerated stability study confirmed the formulation's robustness over time, with no significant change in critical quality attributes and drug content remaining above 97% for both drugs after six months. A stable orodispersible film of Famotidine and Domperidone was successfully developed. While the film exhibits high stability under thermal and photolytic conditions, it requires protective packaging to mitigate oxidative degradation. The formulation demonstrated excellent stability under accelerated ICH conditions, confirming its potential as a stable and patient-compliant dosage form for effective GERD management.