Oromucosal film preparations: classification and characterization methods.

INTRODUCTION: Recently, the regulatory authorities have enlarged the variety of 'oromucosal preparations' by buccal films and orodispersible films. Various film preparations have entered the market and pharmacopoeias. Due to the novelty of the official monographs, no standardized characterization methods and quality specifications are included. AREAS COVERED: This review reports the methods of choice to characterize oromucosal film preparations with respect to biorelevant characterization and quality control. Commonly used dissolution tests for other dosage forms are not transferable for films in all cases. Alternatives and guidance on decision, which methods are favorable for film preparations are discussed. Furthermore, issues about requirements for film dosage forms are reflected. EXPERT OPINION: Oromucosal film preparations offer a wide spectrum of opportunities. There are a lot of suggestions in the literature on how to control the quality of these innovative products, but no standardized tests are available. Regulatory authorities need to define the standards and quality requirements more precisely.