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AssigneeBayer Aktiengesellschaft
InventorsSusanne Weisweg-Merkel, Peter Serno
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The present invention relates to amorphous solid dispersions (ASD) and solid pharmaceutical dosage forms for oral administration comprising (4S)-24-chloro-4-ethyl-73-fluoro-35-methoxy-32,5-dioxo-14-(trifluoromethyl)-32H-6-aza-3(4,1)-pyridina-1(1)-[1,2,3]triazola-2(1,2),7(1)-dibenzena-heptaphane-74-carboxamide (active ingredient (I)), characterized in that the active ingredient (I) is immediately released from the amorphous solid dispersions (ASD) and the solid pharmaceutical dosage forms for oral administration, and also methods for the preparation thereof, use thereof as medicaments, and also use thereof for the treatment and/or prophylaxis of diseases, in particular cardiovascular disorders, preferably thrombotic or thromboembolic disorders, and oedemas, and also ophthalmic disorders.
A solid pharmaceutical dosage form for oral administration comprising an amorphous solid dispersion (ASD), containing (4S)-24-chloro-4-ethyl-73-fluoro-35-methoxy-32,5-dioxo-14-(trifluoromethyl)-32H-6-aza-3(4,1)-pyridina-1(1)-[1,2,3]triazola-2(1,2),7(1)-dibenzena-heptaphane-74-carboxamide (active ingredient (I)) in a pharmaceutically acceptable matrix.
An amorphous solid dispersion (ASD) comprising (4S)-24-chloro-4-ethyl-73-fluoro-35-methoxy-32,5-dioxo-14-(trifluoromethyl)-32H-6-aza-3(4,1)-pyridina-1(1)-[1,2,3]triazola-2(1,2),7(1)-dibenzenaheptaphane-74-carboxamide (active ingredient (I)) in a pharmaceutically acceptable matrix.
A method for preparing an amorphous solid dispersion (ASD) containing (4S)-24-chloro-4-ethyl-73-fluoro-35-methoxy-32,5-dioxo-14-(trifluoromethyl)-32H-6-aza-3(4,1)-pyridina-1(1)-[1,2,3]triazola-2(1,2),7(1)-dibenzenaheptaphane-74-carboxamide (active ingredient (I)), characterized in that the amorphous solid dispersion (ASD) is prepared by wet granulation.
Dependencies are inferred from the claim text.