Pharmaceutical dosage forms comprising 6′-fluoro-(N-methyl- or N,N-dimethyl-)-4-phenyl-4′,9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano[3,4,b]indol]-4-amine

摘要

A pharmaceutical dosage form for administration twice daily, once daily or less frequently, which contains 6′-fluoro-(N-methyl- or N,N-dimethyl)-4-phenyl-4′,9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano[3,4,b]indol]-4-amine or a physiologically acceptable salt thereof.

主权项

1. A method of treating pain in a subject in need thereof, said method comprising administering to said subject once daily or less frequently a pharmaceutical dosage form which contains a pharmacologically active agent corresponding to formula (I′) wherein R is —H or —CH3, or a physiologically acceptable salt thereof; and wherein said dosage form provides a release profile in vitro of the pharmacologically active agent corresponding to formula (I′), such that under in vitro conditions in 900 mL artificial gastric juice at pH 1.2 and 37±0.5° C. according to the paddle method with sinker at 100 rpm, said dosage form has released at least 50 wt.-% of the pharmacologically active agent corresponding to formula (I′) after 30 minutes, based on the total amount of the pharmacologically active agent originally contained in the pharmaceutical dosage form; and wherein the pharmaceutical dosage form contains a surfactant having a hydrophilic-lipophilic balance (HLB) of at least 10.