CAPSULE PHARMACEUTICAL DOSAGE FORM COMPRISING SUSPENSION FORMULATION OF INDOLINONE DERIVATIVE

摘要

PROBLEM TO BE SOLVED: To obtain, for a specific drug substance, an oral pharmaceutical dosage form which meets adequate chemical stability as well as bioavailability requirements for the desired dosage range tailored to treatment, and to obtain a packaging material suitable for the product.SOLUTION: The present invention relates to a suspension formulation containing the active substance 3-Z-[1-(4-(N-((4-methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulphonate, to a capsule pharmaceutical dosage form containing the suspension formulation, to a process for preparing the suspension formulation, to a process for preparing the capsule comprising the suspension formulation and to the packaging material for the finished capsule.