US2020390771A1PendingUtilityA1

Ribociclib Tablet

68
Assignee: NOVARTIS AGPriority: Apr 16, 2015Filed: Aug 26, 2020Published: Dec 17, 2020
Est. expiryApr 16, 2035(~8.8 yrs left)· nominal 20-yr term from priority
Inventors:Rui CostaArnaud GrandeuryBindhumadhavan Gururajan
A61K 9/2077A61K 9/284A61K 9/2054A61K 9/20A61K 9/2027A61K 31/496A61K 9/0053A61K 31/519A61P 35/00A61P 43/00
68
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Claims

Abstract

The present disclosure is directed to oral tablet of ribociclib including its salt(s). One embodiment of the present disclosure is directed to tablet of ribociclib with high drug load with an immediate release profile. One embodiment of the present disclosure is directed to coated tablet of ribociclib. Another embodiment of the present disclosure is directed to coated tablet of ribociclib where the coating is an advanced moisture barrier coating (e.g., Opadry® amb II coating where the coating is PVA based).

Claims

exact text as granted — not AI-modified
We claim: 
     
         1 . A pharmaceutical oral tablet comprising ribociclib or its pharmaceutically acceptable salt. 
     
     
         2 . The tablet of  claim 1  comprising ribociclib succinate. 
     
     
         3 . The tablet of  claim 1  comprising ribociclib or its salt wherein the tablet releases at least 75% of the ribociclib or its salt after 45 minutes when tested with the rotating basket at 100 rpm with 900 ml of dissolution media pH 2 or pH4.5, at 37° C., according to USP <711>. 
     
     
         4 . The tablet of  claim 1  comprising ribociclib or its salt in a tablet core wherein the tablet core comprises at least 32% (w/w) of ribociclib measured in terms of ribociclib free base. 
     
     
         5 . The tablet of  claim 4  wherein the % of ribociclib (w/w) is at least 40% of the tablet core. 
     
     
         6 . The tablet of  claim 5  wherein the % of ribociclib (w/w) is at least 44% of the tablet core. 
     
     
         7 . The tablet of  claim 6 , wherein the % of ribociclib (w/w) is at about 44% to 52% of the tablet core. 
     
     
         8 . The tablet of  claim 4  wherein the % of ribociclib (w/w) is at about 47% of the tablet core. 
     
     
         9 . A pharmaceutical oral tablet comprising ribociclib succinate, wherein the % of ribociclib succinate (w/w) is at least 40% of the tablet core. 
     
     
         10 . The tablet of  claim 9  wherein the % of ribociclib succinate (w/w) is at least 50% of the tablet core. 
     
     
         11 . The tablet of  claim 10  wherein the % of ribociclib succinate (w/w) is at least 55% of the tablet core. 
     
     
         12 . The tablet of  claim 11 , wherein the % of ribociclib succinate (w/w) is at about 55% to 65% of the tablet core. 
     
     
         13 . The tablet of  claim 9  wherein the % of ribociclib (w/w) is at about 60% of the tablet core. 
     
     
         14 . A coated pharmaceutical oral tablet comprising ribociclib or its pharmaceutically acceptable salt wherein the coating comprises polyvinyl alcohol (PVA). 
     
     
         15 . A coated pharmaceutical oral tablet comprising ribociclib succinate wherein the coating comprises PVA. 
     
     
         16 . A coated pharmaceutical oral tablet comprising ribociclib or its salt wherein the tablet releases at least 75% of the ribociclib or its salt after 45 minutes when tested with the rotating basket at 100 rpm with 900 ml of dissolution media pH 2 or pH4.5, at 37° C., according to USP <711> and wherein the coating comprises PVA. 
     
     
         17 . A coated pharmaceutical oral tablet comprising ribociclib or its salt wherein, measured in terms of ribociclib free base, the % of ribociclib (w/w) is at least 32% of the tablet core, and wherein the coating comprises PVA. 
     
     
         18 . The tablet of  claim 17  wherein the % of ribociclib (w/w) is at least 40% of the tablet core. 
     
     
         19 . The tablet of  claim 18  wherein the % of ribociclib (w/w) is at least 44% of the tablet core. 
     
     
         20 . The tablet of  claim 19 , wherein the % of ribociclib (w/w) is at about 44% to 52% of the tablet core. 
     
     
         21 . The tablet of  claim 17  wherein the % of ribociclib (w/w) is at about 47% of the tablet core. 
     
     
         22 . A coated pharmaceutical oral tablet comprising ribociclib succinate, wherein the % of ribociclib succinate (w/w) is at least 40% of the tablet core. 
     
     
         23 . The tablet of  claim 22  wherein the % of ribociclib succinate (w/w) is at least 50% of the tablet core. 
     
     
         24 . The tablet of  claim 23  wherein the % of ribociclib succinate (w/w) is at least 55% of the tablet core. 
     
     
         25 . The tablet of  claim 24 , wherein the % of ribociclib succinate (w/w) is at about 55% to 65% of the tablet core. 
     
     
         26 . The tablet of  claim 22  wherein the % of ribociclib (w/w) is at about 60% of the tablet core.

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