	US 12,403,173 B2
	Micafungin compositions
Sydney J. Cope, Chicago, IL (US); Christine L. Rebbeck, Lake Barrington, IL (US); and Mark J. Doty, Grayslake, IL (US)
Assigned to Baxter International Inc., Deerfield, IL (US); and Baxter Healthcare SA, Glattpark (CH)
Filed by BAXTER INTERNATIONAL INC., Deerfield, IL (US); and BAXTER HEALTHCARE SA, Glattpark (CH)
Filed on Dec. 15, 2017, as Appl. No. 15/843,634.
Claims priority of provisional application 62/435,695, filed on Dec. 16, 2016.
Prior Publication US 2018/0169180 A1, Jun. 21, 2018
Int. Cl. A61K 38/08 (2019.01); A61K 9/00 (2006.01); A61K 9/08 (2006.01); A61K 31/375 (2006.01); A61K 47/02 (2006.01); A61K 47/36 (2006.01); A61P 31/10 (2006.01)

CPC A61K 38/08 (2013.01) [A61K 9/0019 (2013.01); A61K 9/08 (2013.01); A61K 31/375 (2013.01); A61K 47/02 (2013.01); A61K 47/36 (2013.01); A61P 31/10 (2018.01)]

8 Claims

1. A packaged sealed container comprising an aqueous pharmaceutical composition suitable for parenteral administration, the container comprising:

an aqueous pharmaceutical composition consisting of:

(i) between 0.5 mg/ml and 2.5 mg/ml micafungin sodium;

(ii) between 1 mM and 20 mM citrate buffering agent;

(iii) between 4 mg/ml and 10 mg/ml sodium chloride; and

(iv) water,

wherein the pH of the aqueous pharmaceutical composition is between 4.0 and 5.5,

and the aqueous pharmaceutical composition is provided in the packaged sealed container,

wherein the aqueous pharmaceutical composition is sterile and ready to use without further compounding or processing, and

wherein the aqueous pharmaceutical composition has less than 1.5% area total impurities after formulation and storage thereof at room temperature for three weeks, as determined by HPLC analysis.