This invention provides a sublingual film preparation comprising
ramelteon, a film-forming material, and at least one or more of plasticizers, disintegrants,
flavoring agents or sweeteners, and stabilizers, wherein the
ramelteon is in an amorphous state, and a method for preparing the same. This invention is the first to develop
ramelteon as a sublingual film preparation, thereby allowing ramelteon to be administered via the sublingual mucosa. Because the ramelteon of this invention exists in an amorphous state, it is absorbed more easily. The particle size of the ramelteon in the film preparation is dispersed at the
molecular level, resulting in even better absorption. Furthermore, the
drug does not easily aggregate and recrystallize, resulting in even better stability. However, it has relatively good
solubility, so it can be completely dissolved in water within one minute and is rapidly absorbed by the
oral mucosa, achieving the objective of
rapid onset of action. The absolute
bioavailability is significantly higher than tablets and general film preparations in previous studies (>30%), the
onset of action is faster, there is no food interaction, the cost is low, and there are few side effects.