Patent ID: 11857555
Assignee: ANTARES PHARMA, INC.
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 13:
14. A prefilled glass syringe comprising an aqueous pharmaceutical formulation comprising from 130 to 140 mg/mL hydrocortisone sodium phosphate, from 4.5 to 12.5 mg/mL monothioglycerol, from 0.5 to 2.5 mg/mL monobasic sodium phosphate, from 5 to 25 mg/mL dibasic sodium phosphate, from 0.1 to 1 mg/mL disodium EDTA, and water, and having a pH of 7.5 to 8.5, wherein the aqueous pharmaceutical formulation is stored against at least one non-glass pharmaceutically acceptable surface selected from a rubber syringe plunger surface, a metal needle surface, and a plastic needle shield surface, and comprises:
no more than 0.06% soluble impurities upon storage at 25° C. for about 3 months; or
no more than 0.35% soluble impurities upon storage at 40° C. for about 1 month.