Duloxetine sprinkles

Abstract

The present invention relates in part to a multiparticulate sprinkle dosage form comprising duloxetine or a pharmaceutically acceptable salt thereof, having higher acid resistance as compared to commercially available delayed release formulations. It further relates to various methods of administering the multiparticulate sprinkle dosage forms.

1 . A multiparticulate sprinkle dosage form comprising a plurality of discrete units,
 wherein each unit comprises:   (a) a core subunit comprising a drug layered subunit surrounding an inert core, wherein the drug layer comprises duloxetine or a pharmaceutically acceptable salt thereof; and   (b) an enteric coating layer surrounding the core subunit;   wherein, the discrete units are stable when sprinkled on a soft food having pH less than or equal to 5.   
     
     
         2 . The multiparticulate sprinkle dosage form according to  claim 1 , wherein the soft food having pH less than or equal to 5 comprises apple sauce, mango pudding, yoghurt or cheese. 
     
     
         3 . A multiparticulate sprinkle dosage form comprising a plurality of discrete units,
 wherein each unit comprises:   (a) a core subunit comprising a drug layered subunit surrounding an inert core, wherein the drug layer comprises duloxetine or a pharmaceutically acceptable salt thereof; and   (b) an enteric coating layer surrounding the core subunit;   wherein, the discrete units are stable for at least 90 minutes when sprinkled on a soft food having pH less than or equal to 5.   
     
     
         4 . The multiparticulate sprinkle dosage form according to  claim 3 , wherein, the discrete units are stable for at least 30 minutes when sprinkled on apple sauce.