IP Library › Patent Application 19275772
Patent Application
App. No. 19/275,772

ANHYDROUS SODIUM THIOSULFATE AND FORMULATIONS THEREOF

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Patent No.
US None
App. No.
19/275,772
Abstract

Described herein is anhydrous sodium thiosulfate, methods for synthesizing anhydrous sodium thiosulfate, pharmaceutical compositions thereof, and methods of treating ototoxicity. Anhydrous sodium thiosulfate is synthesized from sodium sulfite, sulfur, and cetylpyridinium chloride. The anhydrous sodium thiosulfate is formulated into a pharmaceutical composition comprising a buffer and solvent. These compositions are useful for eliminating or reducing ototoxicity in pediatric patients receiving platinum-based chemotherapeutics.

Claims (30)

1 . A method of reducing ototoxicity in an adult human patient receiving a platinum based chemotherapeutic for the treatment of a germ cell cancer sensitive to the platinum based chemotherapeutic comprising administering an effective amount of a pharmaceutical composition comprising sodium thiosulfate, wherein the sodium thiosulfate is at a concentration of about 0.5 M and further comprising about 0.004 M borate buffer.

2 . The method of claim 1 , wherein the pharmaceutical composition further comprises hydrochloric acid.

3 . The method of claim 1 , wherein the pharmaceutical composition further comprises sodium hydroxide.

4 . The method of claim 1 , wherein the pharmaceutical composition has a pH between 5 and 9.5.

5 . The method of claim 1 , wherein the pharmaceutical composition has a pH between 6.5 and 8.9.

6 . The method of claim 1 , wherein the pharmaceutical composition has a pH between 8.6 and 8.8.

7 . The method of claim 1 , wherein the platinum based chemotherapeutic is cisplatin.

8 . The method of claim 7 , wherein cisplatin is administered to the human patient as an infusion over 1 to 6 hours.

9 . The method of claim 8 , wherein the pharmaceutical composition is administered to the human patient about 6 hours after the completion of the administration of cisplatin.

10 . The method of claim 9 , wherein the pharmaceutical composition is administered as an infusion over about 15 minutes.

11 . The method of claim 1 , wherein the germ cell cancer is localized.

12 . The method of claim 1 , wherein the germ cell cancer is disseminated.

13 . The method of claim 1 , wherein the germ cell cancer is metastasized.

14 . The method of claim 1 , wherein the germ cell cancer is testicular cancer.

15 . The method of claim 1 , wherein the germ cell cancer is ovarian cancer.

16 . A method of reducing ototoxicity in an adult human patient receiving a platinum based chemotherapeutic for the treatment of germ cell cancer sensitive to the platinum based chemotherapeutic comprising administering an effective amount of a pharmaceutical composition comprising sodium thiosulfate, wherein the sodium thiosulfate is at a concentration of about 0.5 M and further comprising borate ions wherein the concentration of borate ions is less than 0.05%.

17 . The method of claim 16 , wherein the pharmaceutical composition further comprises hydrochloric acid.

18 . The method of claim 16 , wherein the pharmaceutical composition further comprises sodium hydroxide.

19 . The method of claim 16 , wherein the pharmaceutical composition has a pH between 5 and 9.5.

20 . The method of claim 16 , wherein the pharmaceutical composition has a pH between 6.5 and 8.9.

21 . The method of claim 16 , wherein the pharmaceutical composition has a pH between 8.6 and 8.8.

22 . The method of claim 16 , wherein the platinum based chemotherapeutic is cisplatin.

23 . The method of claim 22 , wherein cisplatin is administered to the human patient as an infusion over 1 to 6 hours.

24 . The method of claim 23 , wherein the pharmaceutical composition is administered to the human patient about 6 hours after the completion of the administration of cisplatin.

25 . The method of claim 24 , wherein the pharmaceutical composition is administered as an infusion over about 15 minutes.

26 . The method of claim 16 , wherein the germ cell cancer is localized.

27 . The method of claim 16 , wherein the germ cell cancer is disseminated.

28 . The method of claim 16 , wherein the germ cell cancer has metastasized.

29 . The method of claim 16 , wherein the germ cell cancer is testicular cancer.

30 . The method of claim 16 , wherein the germ cell cancer is ovarian cancer.