THIN ORAL FILM Russian patent published in 2025 - IPC A61K9/70 A61K31/135 A61K47/32 A61K47/58 A61P29/00 A61P25/24 

FIELD: medicine; pharmaceutics.

SUBSTANCE: group of inventions relates to a thin film for oral administration as a drug containing at least one matrix layer, wherein the at least one matrix layer contains at least one pharmaceutically active agent, at least one polyvinyl alcohol and at least one graft copolymer of polyvinyl alcohol and polyethylene glycol, wherein at least one pharmaceutically active agent contains ketamine or a pharmaceutically acceptable salt thereof, wherein at least one polyvinyl alcohol includes polyvinyl alcohol with an average molecular weight of 25,000 g/mol to 35,000 g/mol and/or polyvinyl alcohol with an average molecular weight of 200,000 g/mol to 210,000 g/mol, wherein the graft copolymer of polyvinyl alcohol and polyethylene glycol has an average molecular weight in range of 40,000 g/mol to 50,000 g/mol, also relates to a method of producing a thin film for oral use, involving the following steps: a) preparing a solution, dispersion or melt containing at least one pharmaceutically active agent, wherein at least one pharmaceutically active agent comprises ketamine or a pharmaceutically acceptable salt thereof, at least one polyvinyl alcohol and at least one graft copolymer of polyvinyl alcohol and polyethylene glycol, wherein at least one polyvinyl alcohol includes polyvinyl alcohol with average molecular weight from 25,000 g/mol to 35,000 g/mol and/or polyvinyl alcohol with an average molecular weight of 200,000 g/mol to 210,000 g/mol, wherein the graft copolymer of polyvinyl alcohol and polyethylene glycol has an average molecular weight in range of 40,000 g/mol to 50,000 g/mol, b) distributing the solution, dispersion or melt from step a), and also relates to the use of a thin film for oral administration as a drug in the treatment of pain and to the use of a thin film for oral administration as a drug in the treatment of depression.

EFFECT: group of inventions provides the development of a thin film for oral use, which has an acceptable disintegration time and the pharmaceutically active agent is uniformly distributed in said film, wherein the thin film for oral application has a pleasant and soft texture, does not cause a foreign body sensation in the patient and has good puncture strength, despite the high content of the active agent.

15 cl, 32 dwg, 10 tbl, 5 ex