Formulations of albu-BChE, preparation and uses thereof

摘要

The present invention provides an aqueous pharmaceutical composition comprising the fusion protein whose amino acid sequence is set forth as SEQ ID No:1 and an aqueous solution comprising 40 to 60 mM sodium phosphate. The present invention further provides a lyophilized pharmaceutical composition, an reconstituted solution, a sealed package comprising the lyophilized pharmaceutical composition, and a vial comprising the lyophilized pharmaceutical or the reconstituted solution. The present invention also provides a method of producing the lyophilized pharmaceutical composition and the sealed package. The present invention also provides a method of treating a human having cocaine seeking behavior, and methods of using the aqueous pharmaceutical composition and lyophilized pharmaceutical composition.

主权项

1. An aqueous pharmaceutical composition comprising a fusion protein and an aqueous solution comprising 40 to 60 mM sodium phosphate, 100 to 150 mM mannitol, 20 to 40 mM trehalose, and 0.02 to 0.05 percent polysorbate 80, wherein the pH of the aqueous solution is 6.9-7.5, wherein said fusion protein comprises the amino acid sequence of SEQ ID NO: 1, and wherein a concentration of said fusion protein is 80 to 120 mg/ml.