POUCH-TYPE ORALLY DISSOLVING FILMS WITH HIGH ACTIVE INGREDIENT CONCENTRATION

摘要

The invention relates to a dosage form for an active ingredient, to be dissolved in the oral cavity, comprising a first film layer and a second film layer that is arranged over the first film layer, wherein the composition of the first film layer can be identical to that of the second and comprises a water-soluble polymer, said first and the second film layers being interconnected by their overlapping edges so as to form at least one cavity and this cavity being filled with an active ingredient. In this configuration, the dosage form takes the form of a pouch made from two water-soluble film layers so that said film layers dissolve when the pouch is put in the mouth, and an active ingredient contained in said pouch can be released. This pouch configuration makes it possible to have a higher content of the active ingredient than comparable OTF films while avoiding thermal stress on said active ingredient during production of the dosage form. The advantageous properties of known thin-film dosage forms are substantially retained. The invention also relates to a method for producing the dosage form.