FIELD: adhesives.
SUBSTANCE: invention relates to a multilayer oral film with an active substance and to a method of producing such film. The described film is comprised of at least two non-adhesive layers, wherein each of the layers is comprised of at least one hydrophilic polymer and at least one water-soluble adhesive layer containing at least one water-dissoluble polymer and at least one plasticizer. At least one of the at least two non-adhesive layers and/or at least one water-dissoluble adhesive layer is comprised of a pharmaceutically active substance. At least two non-adhesive layers and at least one water-dissoluble adhesive layer are alternated so that at least one water-dissoluble adhesive layer is covered on both sides with at least one non-adhesive layer. At least two non-adhesive layers in each case have a unit surface mass of 20 to 200 g/m2. At least one water-dissoluble polymer in at least one water-dissoluble adhesive layer includes shellac, vinyl pyrrolidone/vinyl acetate copolymer, polyvinyl caprolactam/polyvinyl acetate/polyethylene glycol copolymer, hydroxypropyl cellulose or hydroxypropyl methylcellulose and/or polyvinylpyrrol. At least one plasticizer of said adhesive layer comprises glycerin, polyethylene glycol and/or tributyl citrate. The weight ratio of at least one water-dissoluble polymer and at least one plasticizer in at least one water-dissoluble adhesive layer is 80 to 50: 20 to 50.
EFFECT: provided strong composite of said layers and at least one pharmaceutically active substance not exposed to multiple thermal and/or chemical influences.
12 cl, 2 tbl, 2 ex
