Patent ID: 8785168
Filing Date: 2014-07-22
Classification: A61K,A61P

Abstract:
1. A pharmaceutical composition for treating Pompe disease comprising a recombinant human acid alpha-glucosidase (GAA) in a formulation comprising: a) a buffering agent selected from the group consisting of histidine, sodium acetate, citrate, phosphate, succinate, Tris and combinations thereof; b) a stabilizing agent selected from the group consisting of sucrose, arginine, sorbitol, mannitol, glycine, trehalose and combinations thereof; c) a tonicity modifier selected from the group consisting of glycine, sorbitol, sucrose, mannitol, sodium chloride, dextrose, arginine and combinations thereof; d) a bulking agent selected from the group consisting of sucrose, mannitol, glycine, sodium chloride, dextran, trehalose and combinations thereof; and e) a poloxamer, wherein the poloxamer is Pluronic® F-68 at a concentration ranging between 0.001% and 0.2%, wherein the pH ranges from approximately 4.0 to 7.0.