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Last Updated: September 20, 2020

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Claims for Patent: 9,585,912

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Summary for Patent: 9,585,912
Title:Sodium thiosulfate-containing pharmaceutical compositions
Abstract: Provided herein are pharmaceutically acceptable sodium thiosulfate and pharmaceutical compositions thereof. Also provided herein are methods for determining the total non-purgeable organic carbon in a sodium thiosulfate-containing sample. Further provided herein are methods for producing pharmaceutically acceptable sodium thiosulfate. Still further provided herein are methods of treatment comprising the administration of pharmaceutically acceptable sodium thiosulfate.
Inventor(s): Sherman; Craig (Scottsdale, AZ), Smith; Catherine Marie (Grafton, WI), Wirtz; Kevin Robert (Belgium, WI), Schulze; Erich (Mission Viejo, CA)
Assignee: Hope Medical Enterprises, Inc. (Scottsdale, AZ)
Application Number:15/252,324
Patent Claims: 1. A pharmaceutical composition comprising sodium thiosulfate pentahydrate and one or more pharmaceutically acceptable carriers or excipients, wherein the sodium thiosulfate pentahydrate contains no greater than 8 ppm of non-purgeable organic carbon, contains no greater than 0.05 ppm of mercury, contains no greater than 2 ppm of aluminum, contains no greater than 0.003% by weight of selenium, contains no less than 98% by weight and no greater than 102% by weight of sodium thiosulfate on an anhydrous basis measured by ion chromatography, has a water content between 32% and 37% by weight, has a heavy metal content of no greater than 10 ppm, contains no greater than 200 ppm of chloride, contains no greater than 0.001% by weight of sulfide, contains no greater than 0.002% by weight of iron, contains no greater than 0.01% by weight of calcium, contains no greater than 0.005% by weight of potassium, contains no greater than 0.1% of sulfite, contains no greater than 0.5% of sulfate, contains no greater than 3 ppm of arsenic, contains no greater than 0.001% by weight of lead, has total aerobic count of microbial load of no greater than 100 CFU/g, has total yeast and mold count of no greater than 20 CFU/g, contains no greater than 0.02 EU/mg of bacterial endotoxins, contains no greater than 0.002% by weight of nitrogen compounds, contains no greater than 0.005% by weight of insoluble matter, contains no greater than 0.01% by weight of residual anti-caking agent, and contains no greater than ICH Q3C (R3) limits of organic volatile impurities, wherein a 10% aqueous solution of the solid sodium thiosulfate pentahydrate at 25.degree. C. is colorless and has a pH between 6.0 and 8.0, and wherein the solid sodium thiosulfate pentahydrate is odorless crystals, wherein the pharmaceutical composition is formulated for intravenous, intraarterial, intraperitoneal, intrathecal, intraventricular, intraurethral, intrasternal, intracranial, intramuscular, intrasynovial, intravesical, or subcutaneous administration.

2. The pharmaceutical composition of claim 1, wherein the sodium thiosulfate pentahydrate has a positive identification test for sodium.

3. The pharmaceutical composition of claim 1, wherein the sodium thiosulfate pentahydrate has a positive identification test for thiosulfate.

4. The pharmaceutical composition of claim 1, wherein the composition is formulated as a single dosage form.

5. The pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable excipient is water.

6. The pharmaceutical composition of claim 1, further comprising one or more pH adjusting agents.

7. The pharmaceutical composition of claim 6, further comprising one or more isotonic agents.

8. The pharmaceutical composition of claim 1, formulated for intravenous administration.

9. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a sterile aqueous solution intended for intravenous injection, infusion, or implantation.

10. The pharmaceutical composition of claim 1, formulated for intraarterial administration.

11. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a sterile aqueous solution intended for intraarterial injection, infusion, or implantation.

12. The pharmaceutical composition of claim 1, formulated for intraperitoneal administration.

13. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a sterile aqueous solution intended for intraperitoneal injection, infusion, or implantation.

14. The pharmaceutical composition of claim 1, formulated for intrathecal administration.

15. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a sterile aqueous solution intended for intrathecal injection, infusion, or implantation.

16. The pharmaceutical composition of claim 1, formulated for intraventricular administration.

17. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a sterile aqueous solution intended for intraventricular injection, infusion, or implantation.

18. The pharmaceutical composition of claim 1, formulated for intraurethal administration.

19. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a sterile aqueous solution intended for intraurethral injection, infusion, or implantation.

20. The pharmaceutical composition of claim 1, formulated for intrasternal administration.

21. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a sterile aqueous solution intended for intrasternal injection, infusion, or implantation.

22. The pharmaceutical composition of claim 1, formulated for intracranial administration.

23. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a sterile aqueous solution intended for intracranial injection, infusion, or implantation.

24. The pharmaceutical composition of claim 1, formulated for intramuscular administration.

25. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a sterile aqueous solution intended for intramuscular injection, infusion, or implantation.

26. The pharmaceutical composition of claim 1, formulated for intrasynovial administration.

27. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a sterile aqueous solution intended for intrasynovial injection, infusion, or implantation.

28. The pharmaceutical composition of claim 1, formulated for intravesical administration.

29. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a sterile aqueous solution intended for intravesical injection, infusion, or implantation.

30. The pharmaceutical composition of claim 1, formulated for administration by subcutaneous injection.

31. The pharmaceutical composition of claim 1, wherein the pharmaceutical composition is a sterile aqueous solution intended for subcutaneous injection, infusion, or implantation.

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