Claims for Patent: 9,549,999

Summary for Patent: 9,549,999

Title:	Radiopharmaceutical composition
Abstract:	The present invention provides a .sup.99mTc-tetrofosmin radiopharmaceutical composition comprising tetrofosmin and a radioprotectant at a particular range of molar ratios. A kit and a multi-dose kit for the preparation of the radiopharmaceutical composition of the invention are also provided, as well as a process for the preparation of multiple unit patient doses of the radiopharmaceutical composition and a unit dose of the radiopharmaceutical composition.
Inventor(s):	Veggeland; Janne (Oslo, NO), Madsen; Grethe Karin (Oslo, NO), Hemsted; Stig (Oslo, NO)
Assignee:	GE Healthcare Limited (GB)
Application Number:	12/677,528
Patent Claims:	1. A radiopharmaceutical composition consisting essentially of: (i) a .sup.99mTc complex of tetrofosmin in a biocompatible carrier; (ii) non-radioactive tetrofosmin; and, (iii) a radioprotectant chosen from ascorbic acid or a salt thereof with a biocompatible cation; wherein the molar ratio of total tetrofosmin (i)+(ii) to radioprotectant (iii) is in the range 0.2:1.0 to 1.0:1.0, the concentration of said radioprotectant is in the range 0.3-0.6 mM, the pH of the composition is 8.0 to 9.2, and the concentration of total tetrofosmin is in the range 0.12-0.40 mM. 2. The radiopharmaceutical composition of claim 1 wherein said molar ratio of total tetrofosmin to radioprotectant is in the range 0.2:1.0 to 0.5:1.0. 3. The radiopharmaceutical composition of claim 1 which further comprises a biocompatible reductant. 4. The radiopharmaceutical composition of claim 3, where said biocompatible reductant comprises stannous ion. 5. The radiopharmaceutical composition of claim 1 which further comprises a pH adjusting agent. 6. The radiopharmaceutical composition of claim 5 where said pH-adjusting agent comprises sodium bicarbonate. 7. The radiopharmaceutical composition of claim 1, which further comprises 5-sulfosalicylic acid and gluconic acid or salts thereof with a biocompatible cation. 8. The radiopharmaceutical composition of claim 1, wherein the radioprotectant is ascorbic acid. 9. The radiopharmaceutical composition of claim 1, wherein the biocompatible carrier comprises saline solution. 10. A unit patient dose of the radiopharmaceutical .sup.99mTc-tetrofosmin which comprises the radiopharmaceutical composition of claim 1 in a clinical grade container or syringe, wherein the .sup.99mTc radioactive content of the radiopharmaceutical is suitable for imaging a single patient. 11. The unit patient dose of claim 10, which is provided in a syringe having a syringe shield to protect the operator against radiation dose. 12. A process for the preparation of multiple unit patient doses of the radiopharmaceutical .sup.99mTc-tetrofosmin, which comprises: (i) reconstituting a lyophilized formulation consisting essentially of: (a) tetrofosmin; (b) a radioprotectant chosen from ascorbic acid or a salt thereof with a biocompatible cation; and, (c) a biocompatible reductant; wherein the molar ratio of tetrofosmin to radioprotectant is in the range 0.2:1.0 to 1.0:1.0, the concentration of said radioprotectant is in the range 0.3-0.6 mM, and the concentration of tetrofosmin is in the range 0.12-0.40 mM, with either a sterile solution of .sup.99mTc-pertechnetate or first a biocompatible carrier followed by a sterile solution of .sup.99mTc-pertechnetate; (ii) allowing .sup.99mTc-tetrofosmin complex formation to take place to give a solution comprising a bulk supply of the desired .sup.99mTc-tetrofosmin radiopharmaceutical; (iii) optionally checking the radiochemical purity of the bulk supply of the .sup.99mTc-tetrofosmin complex; (iv) withdrawing a unit dose from the bulk supply of step (iii) into a plastic syringe or container; repeating step (iv) with an additional plastic syringe or container at later times to give further unit doses. 13. The process of claim 12, wherein the .sup.99mTc-pertechnetate used in step (i) has a radioactive content in the range 0.2 to 100 GBq.