US 11,857,647 B2
Pharmaceutical composition comprising tetrofosmin and pharmaceutically acceptable salts thereof
Umamaheshwar M. Prasad, Noida (IN); Harmik Sohi, Noida (IN); Rahul Hasija, Noida (IN); Dinesh Kumar, Noida (IN); Kamal S. Mehta, Noida (IN); Raj Vijaya Kuniyil Kulangara, Noida (IN); Ashutosh Agarwal, Noida (IN); and Dharam Vir, Noida (IN)
Assigned to Jubilant Draximage, Inc.
Appl. No. 16/627,466
Filed by Jubilant Generics Limited, Noida (IN)
PCT Filed Nov. 22, 2018, PCT No. PCT/IB2018/059209
§ 371(c)(1), (2) Date Dec. 30, 2019,
PCT Pub. No. WO2019/102388, PCT Pub. Date May 31, 2019.
Claims priority of application No. 201711042108 (IN), filed on Nov. 23, 2017.
Prior Publication US 2021/0145987 A1, May 20, 2021
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 reconstituted radiopharmaceutical composition comprising:
i) a first component comprising an aqueous solution of 99mTc pertechnetate; and
ii) a second component comprising:
a) tetrofosmin disulfosalicylate in an amount between about 13.0-15.0% (w/w) of the second component;
b) gentisic acid in an amount between about 13.54-18.03% (w/w) of the second component;
c) a reducing agent in an amount between about 0.37-0.5% (w/w) of the second component;
d) a transchelator in an amount between about 12.0-16.0% (w/w) of the second component; and
e) sodium bicarbonate at an amount between about 50.0-62.0% (w/w) of the second component,
wherein the tetrofosmin disulfosalicylate and reducing agent are present in a ratio by weight of about 30:1 to about 35:1,
wherein the reconstituted radiopharmaceutical composition is free of ascorbate or ascorbic acid and an antimicrobial preservative, and
the reconstituted radiopharmaceutical composition is reconstituted from the first component and second component, and has a radiochemical purity of at least 90% after 12 hours of storage at a temperature of 2-30° C.