Ceritinib formulation

Abstract

The present disclosure relates to a new pharmaceutical composition comprising Ceritinib. Particularly it is directed to the tablet that is prepared by wet granulation, wherein povidone is used as a binder. Further feature of the composition is that the drug and the binder form the inner phase, whereas all other excipients are added in a powder form as an outer phase. This way, the sticking of the composition is prevented and sufficient tablet hardness can be reached.

1 . A pharmaceutical composition comprising at least 150 mg and up to 750 mg Ceritinib and more than 40 and up to 70 weight percent of Ceritinib based on the total weight of the pharmaceutical composition, wherein the composition comprises granules consisting of or substantially consisting of Ceritinib and a binder and the granules are obtainable by wet granulation. 
     
     
         2 . The pharmaceutical composition according to  claim 1 , wherein the binder is selected from the group consisting of starch, Hypromellose (Hydroxypropylmethyl cellulose), Hydroxypropyl cellulose, Hydroxy ethyl cellulose, Povidone (Polyvinylpyrrolidone), Copovidone (copolyvidone), Gelatine and Polymethacrylate. 
     
     
         3 . The pharmaceutical composition according to  claim 1 , wherein the binder is povidone (polyvinilpyrrolidone). 
     
     
         4 . The pharmaceutical composition according to  claim 1 , further comprising another pharmaceutical excipient. 
     
     
         5 . The pharmaceutical composition according to  claim 1 , further comprising a lubricant. 
     
     
         6 . The pharmaceutical composition according to  claim 5 , wherein the lubricant is magnesium stearate. 
     
     
         7 . The pharmaceutical composition according to  claim 6  comprising at least 0.5 and up to 3 weight percent of magnesium stearate, preferably at least 1 and up to 2 weight percent of magnesium stearate, at least 1.3 and up to 1.7 weight percent of magnesium stearate, particularly 1.5 weight percent of magnesium stearate based on the total weight of the pharmaceutical composition. 
     
     
         8 . The pharmaceutical composition according to  claim 1  in a form of a tablet or capsule. 
     
     
         9 . The pharmaceutical composition according to  claim 1  in a form of a tablet. 
     
     
         10 . A tablet comprising Ceritinib, wherein the tablet comprises at least 40 and up to 70 weight percent of Ceritinib based on the total weight of the uncoated tablet and at least 150 and up to 750 mg Ceritinib, obtainable by
 (i) Preparing granules comprising Ceritinib and a binder by wet granulation,   (ii) mixing the granules with at least one other pharmaceutical excipient to obtain a mixture, and   (iii) compressing the mixture to obtain the tablet.   
     
     
         11 . The tablet comprising Ceritinib according to  claim 10 , wherein the binder is polyvinylpyrrolidone. 
     
     
         12 . A process of preparing a tablet comprising Ceritinib according to  claim 10 , where the process comprises the steps:
 a) Preparing granules comprising Ceritinib and a binder by wet granulation,   b) mixing the granules with at least one other pharmaceutical excipient to obtain a mixture, and   c) compressing the mixture to obtain the tablet.   
     
     
         13 . The pharmaceutical composition according to  claim 1 , or the tablet according to  claim 10 , for use as a medicine.