Development of a dissolution testing methodology for orally rapid disintegration films

抄録

Orally disintegrating tablets (ODT) and films (ODF) with its rapid disintegration in the oral cavity are useful for elderly and pediatric patients to reduce choking risks. Research investigations focused on the methods and formulations of ODT and ODF has led to significant progress; however, disintegration testing methods and adequate testing devices have yet to be defined in the current Japanese Pharmacopoeia (JP17) and United State Pharmacopoeia (USP39). Hence the development of a robust and standardized method for the evaluation of disintegration and drug release properties is necessary. In the present study, the drug release mechanisms of three-layered ODF were investigated through the use of an originally developed testing system imitating the physiological conditions of the oral cavity. The drug layer was composed of hydroxypropyl cellulose (HPC) and polyethylene glycol (PEG) and was sandwiched between two coating layers composed of hydroxypropylmethyl cellulose (HPMC) and PEG. We found that the drug release of three-layered ODF was faster than that of the single drug layered ODF. We suggest that the drug release was accelerated as a result of the fast disintegration of the coating HPMC layer preceded by swelling of the drug HPC layer.