	US 12,440,583 B2
	Pharmaceutical composition comprising tetrofosmin and pharmaceutically acceptable salts thereof
Umamaheshwar M. Prasad, Kirkland (CA); Harmik Sohi, Spokane (CA); Rahul Hasija, Greater Noida (IN); Dinesh Kumar, Greater Noida (IN); Kamal S. Mehta, Noida (IN); Raj Vijaya Kuniyil Kulangara, Kirkland (CA); Ashutosh Agarwal, Greater Noida (IN); and Dharam Vir, Greater Noida (IN)
Assigned to Jubilant Draximage, Inc., Kirkland (CA)
Filed by Jubilant Draximage inc., Kirkland (CA)
Filed on Sep. 27, 2023, as Appl. No. 18/475,470.
Application 18/475,470 is a continuation of application No. 16/627,466, granted, now 11,857,647, previously published as PCT/IB2018/059209, filed on Nov. 22, 2018.
Claims priority of application No. 201711042108 (IN), filed on Nov. 23, 2017.
Prior Publication US 2024/0050598 A1, Feb. 15, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 51/04 (2006.01); A61K 9/19 (2006.01); A61K 31/66 (2006.01); A61K 51/02 (2006.01)

CPC A61K 51/0478 (2013.01) [A61K 9/19 (2013.01); A61K 31/66 (2013.01); A61K 51/025 (2013.01)]

20 Claims

1. A lyophilized composition comprising:

(a) tetrofosmin disulfosalicylate in an amount between about 13.0-15.0% (w/w) of the lyophilized composition;

(b) gentisic acid in an amount between about 13.54-18.03% (w/w) of the lyophilized composition;

(d) a transchelator in an amount between about 12.0-16.0% (w/w) of the lyophilized composition; and

(e) a buffering agent at an amount of between about 50.0-62.0% (w/w) of the lyophilized composition,

wherein the tetrofosmin disulfosalicylate and reducing agent are present in a ratio by weight of about 30:1 to about 35:1,

wherein the lyophilized composition is free of ascorbate or ascorbic acid and antimicrobial preservative, and

wherein upon reconstituting the lyophilized composition with an aqueous solution of ^99mTc pertechnetate to form a reconstituted composition, the reconstituted composition has a radiochemical purity of at least 90% after 12 hours of storage at a temperature of 2-30° C.