Development of mucoadhesive films with high polaprezinc content for oral mucositis: A study on formulation and near-infrared spectroscopy-based quality control.

Polaprezinc (PLZ) has drawn attention to its potential to prevent oral mucositis caused by chemotherapy and radiotherapy. PLZ-containing lozenges have been developed in previous reports; however, for patients with mucositis, taking them may be challenging because of pain. Therefore, this study aimed to develop a mucoadhesive film containing the same amount (18.75 mg) of PLZ as a lozenge as a new dosage form to replace lozenges and evaluate its characteristics. First, various films were created using solvent casting to screen polymers with high PLZ content. Thus, hydroxypropyl cellulose (HPC) was selected; however, film curvature and reduced flexibility necessitated formulation optimization. The optimized films exhibited excellent content uniformity, stability, and mucoadhesive properties, with no significant changes in the drug content after storage. Furthermore, the possibility of using portable near-infrared spectroscopy (Micro NIR™) for the quality control of PLZ films was investigated. Multivariate analysis revealed that the Micro NIR calibration model predicted drug concentrations comparable to those measured by high-performance liquid chromatography. These results suggest that a mucoadhesive film with high PLZ content has been developed and that efficient quality control is possible using Micro NIR™.