Patent ID: 7985733
Filing Date: 2011-07-26
Classification: A61K

Abstract:
1. A method for preventing the formation of a bivalirudin precipitate and controlling generation of Asp 9 -bivalirudin during preparation of a pharmaceutical drug product comprising about 250 mg of bivalirudin, wherein the method comprises: (i) preparing an aqueous solution comprising (a) a buffer having a pK (ii) adding bivalirudin salt to the aqueous solution to form a bulk solution, wherein (a) the pH of the bulk solution is maintained at a level greater than the isoelectric point of bivalirudin, and (b) the bulk solution has a final pH of between 5 and about 6; (iii) transferring the bulk solution to one or more vessels such that each vessel contains about 250 mg of bivalirudin; (iv) drying the bulk solution to obtain a pharmaceutical drug product; and (v) measuring Asp