Crystalline (1r,4r)-6'-fluoro-N,N-dimethyl-4-phenyl-4',9'-dihydro-3'H-spiro[cyclohexane-1,1'-pyrano[3,4,b]indol]-4-amine
AssigneeGruenenthal GmbH
InventorsMichael Gruss, Stefan Kluge, Stefan Pruehs
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Abstract
Crystalline forms of (1r,4r)-6′-fluoro-N,N-dimethyl-4-phenyl-4′,9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano[3,4,b]indol]-4-amine, pharmaceutical compositions and medicaments comprising these crystalline modifications, the use of these modifications as well as a process for the enrichment of such crystalline modifications.
Claims40
A method of treating pain in a patient diagnosed with a pain disorder comprising orally administering to the patient an effective amount of a pharmaceutical composition comprising at least one pharmaceutically acceptable additive or adjuvant and an active ingredient comprising a crystalline form of (1r,4r)-6′-fluoro-N,N-dimethyl-4-phenyl-4′,9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano[3,4,b]indol]-4-amine having an X-ray powder diffraction pattern comprising characteristic peaks at about 18.3±0.2 degrees 2θ, at about 26.3±0.2 degrees 2θ, and at one or both of about 7.8±0.2 degrees 2θ and about 31.6±0.2 degrees 2θ.
A pharmaceutical composition comprising at least one pharmaceutically acceptable additive and/or adjuvant and an active ingredient that comprises a crystalline form of (1r,4r)-6′-fluoro-N,N-dimethyl-4-phenyl-4′,9′-dihydro-3′H-spiro[cyclohexane-1,1′-pyrano[3,4,b]indol]-4-amine having an X-ray powder diffraction pattern comprising characteristic peaks at about 18.3±0.2 degrees 2θ, at about 26.3±0.2 degrees 2θ, and at one or both of about 7.8±0.2 degrees 2θ and about 31.6±0.2 degrees 2θ.
Dependencies are inferred from the claim text.