MEDICINAL DOSAGE FORM, WHICH CONTAINS 6'-FLUOR-(N-METHYL-OR N,N-DIMETHYL)-4-PHENYL-4',9'-DIHYDRO-3'H-SPIRO[CYCLOHEXANE-1,1'-PYRANO[3,4,b]INDOLE]-4-AMINE Russian patent published in 2016 - IPC A61K9/14 A61K9/48 A61K31/407 A61P25/04 A61P29/00 

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to a medicinal dosage form administered two times a day, one time a day or less often, which contains 6'-fluor-(N-methyl- or N,N-dimethyl)-4-phenyl-4′,9′-dihydro-3′H-spiro[cyclohexane-1,1'-pyrano[3,4,b]indole]-4-amine or its pharmaceutically acceptable salt and which releases in vitro at least 50 wt % of a pharmacologically active agent in accordance with European Pharmacopoeia in 900 ml of artificial gastric juice at pH 1.2 and 37±0.5°C 30 minutes later in accordance with the method, with the use of a blade mixer with sinker at 100 rpm; a solid polymeric matrix material specified in a group consisting of polyvinyl pyrrolidone, poly((N-vinylpyrrolidone)-block-poly(vinyl acetate)), and any combinations thereof, wherein the pharmacologically active agent according to general formula (I) is dispersed, and a surfactant having max. HLB of 24; the polymer/pharmacologically active agent ratio falls within the range from 10:1 to 25:1.

EFFECT: invention provides creating the dosage form with good bioavailability and storage stability, which also enables the pharmaceutically active agent to inflow quickly into plasma at the start, and relief the patient's pain quickly due to rapid release, and at the same time to ensure the long-lasting therapeutic effect over a relatively long period (at least 12 hours).

10 cl, 4 ex, 6 dwg