Patent ID: 11278634

Abstract:
In some embodiments, the disclosure provides a method of making a sterile lacosamide composition, the method comprising; (a) obtaining a composition comprising (i) about 5 mg/mL to about 20 mg/mL lacosamide, (ii) about 5 mg/mL to about 12 mg/mL sodium chloride, and (iii) water, (b) placing the composition of (a) into a glass vial, wherein the glass vial has an ammonium sulfate coating, (c) sealing the composition inside the glass vial; and (d) autoclaving the sealed glass vial of (c) at 121° C. at 15 lbs pressure for 15 minutes, wherein the pH of the composition in (d) is substantially the same as the pH of the composition after (a), and wherein the composition of (d) comprises less than about 0.2% (wt/wt) of Impurity A, Impurity B, Impurity C, Impurity D, Impurity E or Impurity F.