Granted Patent B2

US 12,653,891 · App. 16/885,815 · Granted Jun 16, 2026

Inventors: Theresa Deisher (Seattle, WA); Adalbert Jarzyna (Seattle, WA); Iain Duncan (Seattle, WA)

Assignee: AVM Biotechnology, LLC

A61K47/02A61K31/573A61K47/183

Abstract

Claims (17)

1 . A clear aqueous pharmaceutical formulation comprising a concentration of at least 24 mg/ml of dexamethasone sodium phosphate or dexamethasone phosphate and a concentration of equal to or less than 0.035 mg/ml of a preservative, wherein the formulation is packaged in a container with a headspace volume (ml) to dexamethasone content (mg) ratio of 0.0065 or less, wherein the amount of dexamethasone in the formulation is maintained between ±5% as compared to the date of manufacture when the formulation is stored between 2° C. to 40° C. for at least about 18, 24, 36, or 48 months, wherein the formulation is for intravenous administration, and wherein the volume of the container is at least about 45, 50, 51, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100 ml.

2 . The aqueous pharmaceutical formulation of claim 1 , wherein the headspace volume (ml) to dexamethasone sodium phosphate or dexamethasone phosphate content (mg) ratio is 0.00588 or less.

3 . The aqueous pharmaceutical formulation of claim 1 , wherein the headspace volume comprises less than about 21% oxygen, less than about 10% oxygen, or less than about 5% oxygen.

4 . The aqueous pharmaceutical formulation of claim 1 , wherein the preservative is a sulfite, a paraben, benzyl alcohol, propylene glycol, and/or creatinine.

5 . The aqueous pharmaceutical formulation of claim 4 , wherein the sulfite is sodium sulfite (anhydrous), sodium bisulfite, and/or sodium metabisulfite.

6 . The aqueous pharmaceutical formulation of claim 1 , wherein the formulation does not comprise a preservative.

7 . The aqueous pharmaceutical formulation of claim 1 , wherein the formulation comprises one or more chelating agent, wherein the concentration of chelating agent is or is less than about 0.50 mg/ml.

8 . The aqueous pharmaceutical formulation of claim 7 , wherein the chelating agent is disodium edetate (disodium EDTA).

9 . The aqueous pharmaceutical formulation of claim 1 , wherein the formulation does not comprise a chelating agent.

10 . The aqueous pharmaceutical formulation of claim 1 , wherein the formulation comprises dexamethasone sodium phosphate.

11 . The aqueous pharmaceutical formulation of claim 1 , wherein the shelf-life of the formulation is at least about 18, 24, 36, or 48 months when stored between 2° C. to 40° C.

12 . The aqueous pharmaceutical formulation of claim 1 , wherein the formulation exhibits less than ±0.5 change in pH when stored between 2° C. to 40° C. for at least about 18, 24, 36, or 48 months.

13 . The aqueous pharmaceutical formulation of claim 1 , wherein the formulation exhibits less than about 0.50% accumulation of impurity A when stored between 2° C. to 40° C. for at least about 18, 24, 36, or 48 months.

14 . The aqueous pharmaceutical formulation of claim 1 , wherein the formulation exhibits less than about 0.50% accumulation of impurity B when stored between 2° C. to 40° C. for at least about 18, 24, 36, or 48 months.

15 . The aqueous pharmaceutical formulation of claim 1 , wherein the formulation exhibits less than about 0.50% accumulation of impurity G when stored between 2° C. to 40° C. for at least about 18, 24, 36, or 48 months.

16 . The aqueous pharmaceutical formulation of claim 1 , wherein the formulation exhibits less than about 0.20% accumulation of unspecified impurities when stored between 2° C. to 40° C. for at least about 18, 24, 36, or 48 months.

17 . The aqueous pharmaceutical formulation of claim 1 , wherein the formulation exhibits less than about 3.0% accumulation of total impurities when stored between 2° C. to 40° C. for at least about 18, 24, 36, or 48 months.

Assignments (2)

Continuity (3)

References Cited (64)