DRUG DOSAGE FORM CONTAINING 6'-FLUORO-(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 A61K31/407 A61K9/107 A61K47/12 A61P25/04 

FIELD: medicine.

SUBSTANCE: invention relates to medicine. Disclosed is a therapeutic dosage form for pain management, which contains 6'-fluoro-(N-methyl- or N,N-dimethyl)-4-phenyl-4',9'-dihydro-3'N-spiro[cyclohexane-1,1'-pirano [3,4,b]indole]-4-amine or its physiologically acceptable salt and self-emulsifying preparation containing surfactant having hydrophilic-lipophilic balance (HLB) at least of 10 and oil, wherein oil is selected from group comprising saturated C₈-C₁₄ fatty acids, unsaturated C₈-C₁₈ fatty acids and their esters, mixture of saturated and unsaturated C₈-C₁₄ fatty acids, triglycerides of fatty acids, esters of propylene glycol and fatty acid. Drug dosage form is intended for introduction of twice a day, once a day or less frequently.

EFFECT: technical result consists in the immediate release 6'-fluoro-(N-methyl- or N,N-dimethyl)-4-phenyl-4',9'-dihydro-3'N-spiro[cyclohexane-1,1'-pirano[3,4,b]indole]-4-amine of the dosage form, in good bioavailability, despite low solubility in water and providing a long period of semi-elimination from body.

13 cl, 1 dwg, 28 tbl