Claims for Patent: 9,907,756

Summary for Patent: 9,907,756

Title:	Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative
Abstract:	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)-a- nilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulph- onate, to a capsule pharmaceutical dosage form containing said suspension formulation, to a process for preparing said suspension formulation, to a process for preparing said capsule comprising said suspension formulation and to the packaging material for the finished capsule.
Inventor(s):	Messerschmid; Roman (Kobe, JP), Binder; Rudolf (Mittelbiberach, DE), Bock; Thomas (Walchwil, CH), Brox; Werner (Beerfelden, DE)
Assignee:	Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE)
Application Number:	15/204,277
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,907,756
Patent Claims:	1. A formulation of the active substance 3-Z-[1-(4-(N-((4-methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-a- nilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulph- onate which comprises a lipid suspension of the active substance in 1 to 90 wt. % of medium chain triglycerides, 1 to 30 wt. % of hard fat and 0.1 to 10 wt. % of lecithin. 2. A capsule comprising a capsule shell and a capsule formulation, wherein the capsule formulation comprises the formulation in accordance with claim 1. 3. The capsule according to claim 2, wherein the capsule is a soft gelatin capsule. 4. The capsule according to claim 2, wherein the capsule shell comprises glycerol as plasticizing agent. 5. The capsule according to claim 2, wherein the capsule is a hard gelatin or a hydroxypropylmethylcellulose (HPMC) capsule, a polyvinyl alcohol polymer capsule or a pullulan capsule, optionally with a sealing or banding. 6. A lipid suspension consisting essentially of 3-Z-[1-(4-(N-((4-methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-a- nilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulph- onate, medium chain triglycerides, hard fat and lecithin, wherein the medium chain triglycerides, hard fat and lecithin are present in the lipid suspension in the following amounts: 1 to 90 wt. % of medium chain triglycerides, 1 to 30 wt. % of hard fat, and 0.1 to 10 wt. % of lecithin. 7. A capsule comprising a capsule shell and a capsule formulation, wherein the capsule formulation comprises the lipid suspension in accordance with claim 6. 8. The capsule according to claim 7, wherein the capsule is a soft gelatin capsule.