FOR INJECTABLE FORMULATIONS CONTAINING ASENAPINE AND METHOD OF TREATMENT USING SAME
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.