FIELD: pharmaceuticals.
SUBSTANCE: group of inventions relates to a pharmaceutical composition containing a medicinal product carrier core coated with a film, and to the use of the said composition. A pharmaceutical composition comprising a film-coated medicinal product carrier core, wherein the medicinal product carrier core comprises gamma-hydroxybutyrate (GHB) or a pharmaceutically acceptable salt or prodrug thereof, and wherein the film coating comprises a polymer mixture comprising ethylcellulose and a polymethacrylate polymer positioned on top of the medicinal product carrier core; and wherein the polymethacrylate polymer in the polymer mixture is a methacrylic acid-ethyl acrylate copolymer, a methacrylic acid-methyl methacrylate copolymer, or a methyl acrylate-methyl methacrylate-methacrylic acid copolymer, and wherein the ethylcellulose and the polymethacrylate polymer are present in a weight ratio of ethylcellulose:polymethacrylate polymer of 3:1 to 1:3. Use of the above composition for the treatment of sleep disorders, drug abuse, alcohol and/or opiate withdrawal, decreased growth hormone levels, anxiety, analgesia, effects in certain neurological disorders such as Parkinson's disease, depression, fibromyalgia, certain endocrine disorders and for protection tissues after hypoxia/anoxia, for example, with stroke or myocardial infarction, or increased levels of intracranial pressure, excessive daytime sleepiness, cataplexy, sleep paralysis, apnea, narcolepsy, sleep timing disorders, REM sleep behavior disorder (RBD), hypnagogic hallucinations, micro-awakenings during sleep, insomnia, essential tremor and nocturnal myoclonus.
EFFECT: above group of inventions represents dosage forms resistant to dose reset under the influence of alcohol.
8 cl, 33 dwg, 15 tbl, 15 ex
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Authors
Dates
2024-01-11—Published
2019-11-19—Filed