For injectable formulations containing asenapine and method of treatment using same

Abstract

The present invention provides a formulation comprising asenapine hemipamoate suspended particles, which formulation can be administered via a Depot provided by an IM injection of the formulation, and which depot does not display a particle-size dependent release rate. The present invention provides also methods of treatment using the same.

1 - 20 . (canceled) 
     
     
         21 . A pharmaceutical formulation comprising an aqueous suspension of particles of crystalline Form II of asenapine hemipamoate, wherein said asenapine hemipamoate is present at a concentration of 5 wt. % or greater of the suspension, and wherein, said particles comprise less than about 10 vol % of particles having a mean diameter of less than 1 micron and have a d 50 -value of from about 1.5 microns to about 40 microns. 
     
     
         22 . The formulation of  claim 21  which is further characterized by providing a consistent release profile of asenapine from a depot injection consistent with that illustrated in  FIGS. 9   a  to  9   c.