PHARMACEUTICAL COMPOSITION COMPRISING MELATONIN AND DIPHENHYDRAMINE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, DOSAGE FORM BASED ON PHARMACEUTICAL COMPOSITION COMPRISING MELATONIN AND DIPHENHYDRAMINE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, METHOD FOR PREPARING AND USING DOSAGE FORM BASED ON PHARMACEUTICAL COMPOSITION CONTAINING MELATONIN AND DIPHENHYDRAMINE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF Russian patent published in 2024 - IPC A61K31/4045 A61K31/165 A61K47/02 A61K47/36 A61K47/38 A61K47/58 A61K9/22 A61K9/52 A61P25/20 

FIELD: medicine; pharmaceutics.

SUBSTANCE: declared group of inventions relates to pharmaceutics and discloses a dosage form intended for regulating the biological rhythm of sleep and wakefulness and normalizing nocturnal sleep, which is a solid gelatinous capsule containing powder and granules containing diphenhydramine or a pharmaceutically acceptable salt thereof with immediate release in amount of 20 to 60 mg and pharmaceutically acceptable auxiliary components, and a prolonged release microtablet containing 1.5 to 6.0 mg of prolonged release melatonin and pharmaceutically acceptable adjuvants (embodiments). Also disclosed is a method of producing a modified release dosage form for regulating the biological rhythm of sleep and wakefulness and normalizing nocturnal sleep (embodiments), and the use of the dosage form for regulating the biological rhythm of sleep and wakefulness and normalizing night sleep.

EFFECT: technical result consists in increasing the therapeutic activity of the claimed quantitative and qualitative composition of the ingredients, simplifying the scheme of action on daily rhythms of sleep and wakefulness, as well as in relieving symptoms of episodic and acute insomnia and expanding the range of drugs intended for regulating the biological rhythm of sleep and wakefulness and normalizing night sleep.

10 cl, 6 tbl