ANHYDROUS SODIUM THIOSULFATE AND FORMULATIONS THEREOF
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.
1 . A pharmaceutical composition comprising a sodium thiosulfate at a concentration between about 0.3 M and about 0.6 M and further comprising tris(hydroxymethyl)aminomethane at a concentration between about 0.01 M and about 0.05 M.
2 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition has a pH between about 8.5 and 8.9.
3 . The pharmaceutical composition of claim 2 , wherein the sodium thiosulfate is aqueous anhydrous sodium thiosulfate.
4 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further comprises a base.
5 . The pharmaceutical composition of claim 4 , wherein the base is sodium hydroxide.
6 . The pharmaceutical composition of claim 4 , wherein the sodium thiosulfate is aqueous anhydrous sodium thiosulfate.
7 . The pharmaceutical composition of claim 1 , wherein the concentration of tris(hydroxymethyl)aminomethane is about 0.01 M.
8 . The pharmaceutical composition of claim 1 , wherein the concentration of tris(hydroxymethyl)aminomethane is about 0.02 M.
9 . The pharmaceutical composition of claim 1 , wherein the concentration of tris(hydroxymethyl)aminomethane is about 0.03 M.
10 . The pharmaceutical composition of claim 1 , wherein the concentration of tris(hydroxymethyl)aminomethane is about 0.05 M.
11 . The pharmaceutical composition of claim 1 , wherein the concentration of the sodium thiosulfate is about 0.5 M.
12 . The pharmaceutical composition of claim 11 , wherein the pharmaceutical composition has a pH between about 8.5 and 8.9.
13 . The pharmaceutical composition of claim 12 , wherein the sodium thiosulfate is aqueous anhydrous sodium thiosulfate.
14 . The pharmaceutical composition of claim 11 , wherein the pharmaceutical composition further comprises a base.
15 . The pharmaceutical composition of claim 14 , wherein the base is sodium hydroxide.
16 . The pharmaceutical composition of claim 14 , wherein the sodium thiosulfate is aqueous anhydrous sodium thiosulfate.
17 . The pharmaceutical composition of claim 11 , wherein the concentration of tris(hydroxymethyl)aminomethane is about 0.01 M.
18 . The pharmaceutical composition of claim 11 , wherein the concentration of tris(hydroxymethyl)aminomethane is about 0.02 M.
19 . The pharmaceutical composition of claim 11 , wherein the concentration of tris(hydroxymethyl)aminomethane is about 0.03 M.
20 . The pharmaceutical composition of claim 11 , wherein the concentration of tris(hydroxymethyl)aminomethane is about 0.05 M.