Patent ID: 8361500
Filing Date: 2013-01-29
Classification: A61K,A61P

Abstract:
1. A powdered pharmaceutical formulation comprising: (a) a granulate comprising: at least one crystalline salt of (5S,8S)-8-[{(1R)-1-(3,5-bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diazaspiro[4.5]decan-2-one; intragranular microcrystalline cellulose, optionally wherein the microcrystalline cellulose has a mean average particle diameter of less than about 70 microns; lactose monohydrate; a first disintegrant; and a binder; and dry-blended therewith (b) extragranular microcrystalline cellulose, optionally wherein the microcrystalline cellulose has a mean average particle diameter of greater than about 70 microns; a second disintegrant; and magnesium stearate, wherein optionally the wt. ratio of first disintegrant to second disintegrant is about 1:1.5 and wherein the formulation provides, upon compression in a tablet press, a pressed tablet having a hardness of at least 10 kp.