EP3895692A1 — Oral thin film with smooth fused film

USPTO Abstract

The invention relates to an oral thin film, comprising a polymer matrix and at least one water-insoluble, particulate active pharmaceutical ingredient dispersed in the polymer matrix, wherein the matrix polymer is poly(ethylene oxide) having a melting point of at least 55 °C, the amount of poly(ethylene oxide) having a melting point of at least 55 °C is at least 40% by weight, based on the total weight of the oral thin film, and wherein the oral thin film is obtainable by a process comprising the steps of: a) preparing a suspension comprising the matrix polymer, the at least one water-insoluble, particulate active pharmaceutical ingredient and a solvent which is water or a mixture of water and one or more organic solvents, b) casting the suspension obtained on a support or in a mold, and c) drying the suspension at a temperature above the melting temperature of the poly(ethylene oxide) to obtain the oral thin film.The oral thin film is suitable as a medicament and can be administered in the oral cavity without addition of drinking water. The oral thin film has a very smooth surface providing a good mouth feel. Moreover, an enhanced protection of the active pharmaceutical ingredient against external influences is achieved.