Patent ID: 8420122
Filing Date: 2013-04-16
Classification: A61K,A61P,Y10T

Abstract:
1. A granular pharmaceutical formulation comprising 50 wt. % API, 14 wt. % lactose monohydrate (intragranular), 5 wt. % intragranular microcrystalline cellulose, 5 wt. % extragranular microcrystalline cellulose, 3 wt. % intragranular croscarmellose sodium, 3 wt. % extragranular croscarmellose sodium, 15 wt. % pregelatinized starch (intragranular), 3 wt. % sodium lauryl sulfate (intragranular), and 2 wt. % magnesium stearate (extragranular), wherein said API is an agglomerated particulate comprising a compound of Formula B, said agglomerated particulate having a median bulk surface area of from about 5 m said agglomerated particulate is prepared by a process comprising combining a 0° C. stream of a solution comprising methyltertiarybutyl ether (MTBE) having dissolved therein 166 mg/ml of the compound of 3-[2-(3-tert-Butyl-ureido)-3,3-dimethyl-butyryl]-6,6-diMethyl-3-aza-bicyclo [3.1.0]hexane-2-carboxylic acid (2-carbamoyl-1-cyclobutylmethyl-2-oxo-ethyl)-amide (the compound of Formula B), with a -20° C. stream of heptane wherein the solution stream is provided under conditions yielding a Reynolds number of 10650, the heptane stream is supplied under conditions yielding a Reynolds number of 23,650 and the solution stream is combined at substantially a 90 degree angle to the anti-solvent stream, thereby providing a slurry comprising precipitated particles of the compound of Formula B, collecting said slurry and distilling supernatant liquid from the collected slurry at subatmospheric pressure and at a temperature that forms an agglomerated particulate having a softening point of greater than about 25° C., and the compound of Formula B has the following structural formula: