ORODISPERSIBLE FILMS FOR THE MANUFACTURING OF INDIVIDUALISED MEDICINE OR FOR LARGE SCALE PRODUCTION

摘要

The present invention pertains to oral applicable therapeutic dosage forms, in particular to orodispersible films. The present invention especially is directed to orodispersible films comprising a base layer substantially free of therapeutically active agents and a top layer comprising the desired therapeutically active agents. The present invention also concerns suitable base layers for such orodispersible films as well as therapeutical uses thereof and methods for manufacturing them.

主权项

1. An orodispersible film (ODF) comprising
a base layer comprising at least one first film-forming substance and a top layer attached onto the base layer, the top layer comprising at least one second film-forming substance and at least one oral applicable, therapeutically active agent, said orodispersible film is obtainable by casting a base formulation comprising the at least one first film-forming substance and a first solvent and not comprising a therapeutically active agent to form the base layer; and applying a top formulation comprising the at least one second film-forming substance, the at least one oral applicable, therapeutically active agent and a second solvent onto the base layer to form the top layer, wherein said at least one first film-forming substance has a lower solubility in the second solvent than said at least one second film-forming substance.