Ribociclib Tablet
AssigneeNovartis AG
InventorsRui Costa, Arnaud Grandeury, Bindhumadhavan Gururajan
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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).
Claims26
A pharmaceutical oral tablet comprising ribociclib or its pharmaceutically acceptable salt.
A pharmaceutical oral tablet comprising ribociclib succinate, wherein the % of ribociclib succinate (w/w) is at least 40% of the tablet core.
A coated pharmaceutical oral tablet comprising ribociclib or its pharmaceutically acceptable salt wherein the coating comprises polyvinyl alcohol (PVA).
A coated pharmaceutical oral tablet comprising ribociclib succinate wherein the coating comprises PVA.
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.
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.
A coated pharmaceutical oral tablet comprising ribociclib succinate, wherein the % of ribociclib succinate (w/w) is at least 40% of the tablet core.
Dependencies are inferred from the claim text.