Granted Patent B1

US 10,426,834 · App. 15/674,791 · Granted Oct 1, 2019

Inventors: Biswajit Pati (Buffalo Grove, IL); Saeed U. Khan (North Brunswick, NJ)

Assignee: AKORN, INC.

A61K41/0009A61K38/12A61L2/007A61L2202/21

Abstract

Claims (11)

1. A method of sterilizing Bacitracin, comprising exposing a composition comprising Bacitracin to a dose of 17.6-25 kGy electron-beam (E-beam) radiation, wherein the Bacitracin is a micronized powder, and wherein after the E-beam radiation exposure, the composition comprises not more than 4.5% Impurity-F and is characterized by a Sterility Assurance Level of 10 −6 .

2. The method of claim 1 , wherein the Bacitracin is a Bacitracin zinc salt.

3. The method of claim 1 , wherein after the radiation exposure, the composition comprises not more than 5% early eluting peptides.

4. The method of claim 1 , wherein after the radiation exposure, the composition comprises not more than 15% total degradants.

5. The method of claim 1 , wherein after the radiation exposure, the composition comprises a sum of Bacitracin A, B1, B2, and B3 not less than 80%.

6. The method of claim 1 , wherein after the radiation exposure, the composition comprises not more than 5% early eluting peptides, not more than 15% total degradants, and a sum of Bacitracin A, B1, B2, and B3 not less than 80%.

7. The method of claim 1 , wherein the composition is exposed to the radiation for 240-360 minutes.

8. The method of claim 7 , wherein the composition is exposed to the radiation for 208-301 minutes.

9. The method of claim 1 , wherein the Bacitracin has a particle size distribution (PSD) of less than or equal to 10 μm.

10. The method of claim 9 , wherein the PSD is less than or equal to 1 nm.

11. The method of claim 9 , wherein the PSD is an average volume-based PSD.

Assignments (12)