Raman monitoring of semi-continuously manufactured orodispersible films for individualized dosing

Abstract

Orodispersible films are promising oral dosage forms for special populations. To enable continuous manufacturing of orodispersible films, monitoring of the active pharmaceutical ingredient contained in the final product is essential. However, there are few methods to confirm the target contents in the final film product without destruction. Raman spectroscopy is well known for providing non-destructive and real-time specific component information of pharmaceutical products. This study has proved the feasibility of Raman monitoring of active pharmaceutical ingredients within continuously manufactured orodispersible films for individual dosing. To determine the active pharmaceutical ingredient contents in the orodispersible films, both off-line measurements on non-moving and measurements continuously conveying film were investigated. To evaluate the quantitative ability of this method, the root means-square error of cross-validation was determined by comparing the actual concentration and predicted content by a calibration curve. The active pharmaceutical ingredients in an off-line of orodispersible films were successfully determined by Raman spectroscopy. For Raman measurement, signal-to-noise ratio increased with increasing conveying speed, nevertheless, the active pharmaceutical ingredient content could be monitored in the continuously conveying film. In this study, the API content in the film can be monitored even for conveys faster (180 mm/min) than the actual conveying speed during the drying procedure (105 mm/min). The results indicate that Raman spectroscopy can quantify the content of active pharmaceutical ingredients in continuously produced orodispersible films.