次世代型口腔内崩壊錠に求められる臨床的機能性とは？

抄録

  Orally disintegrating tablets (ODTs) are currently widely used in drug therapy and are clinically attractive, because they are suitable for administration to patients with dysphagia and improve adherence, both of which increase the possibility of achieving the expected therapeutic effect. These properties of ODTs, which increase treatment effectiveness, are termed their “clinical functionality”, and ODTs with a high clinical functionality are required to meet the increasing need for these tablets. For example, there is a need for development of a clinically effective ODT with superior disintegrating properties while maintaining high tablet strength, bioequivalence with normal tablets while masking the bitterness with a fine particle coating, and a disintegration mechanism while maintaining moisture resistance and good storage quality. Thus, next-generation ODTs that overcome these conflicting properties, “trade-offs”, will be developed, using innovative formulation research technology. In this symposium, we will discuss a next-generation OD formulation known as PLETAAL OD, a high-dose antiplatelet agent, and will present the results of validation tests performed in our laboratory pertaining to high tablet strength, superior disintegration property, high wicking capacity, and storage stability with high moisture resistance. We will also introduce a second-generation antihistamine ALLELOCK OD and discuss its high clinical functionality achieved by masking the bitterness and obtaining bioequivalence with normal tablets by using granules while maintaining high tablet strength with EXLUB and SOLBLET technology.