High-purity large-scale preparation of stannsoporfin
View Patent ↗Large scale (bulk) compositions comprising high-purity stannsoporfin are disclosed, as well as methods of synthesizing such compositions.
1. A composition comprising stannsoporfin in an amount of at least about 10 grams, wherein said stannsoporfin is at least about 97.0% pure and wherein any individual impurity present is present in an amount of less than about 0.1%.
2. The composition of claim 1 , comprising at least about 100 grams of stannsoporfin.
3. The composition of claim 1 , wherein said stannsoporfin is at least about 99% pure.
4. The composition of claim 3 , wherein any individual impurity present is present in an amount of less than about 0.09%.
5. The composition of claim 4 , comprising at least about 100 grams of stannsoporfin.
6. The composition of claim 1 , wherein said stannsoporfin is a single-batch preparation of stannsoporfin.
7. The composition of claim 1 , wherein said stannsoporfin is at least about 98.5% pure.
8. A pharmaceutical composition comprising stannsoporfin and a pharmaceutically acceptable carrier, wherein said stannsoporfin is at least about 97.0% pure and wherein any individual impurity is present in an amount of less than about 0.1%.
9. The pharmaceutical composition of claim 8 , wherein said stannsoporfin is at least about 99% pure.
10. The pharmaceutical composition of claim 8 , wherein any individual impurity present is present in an amount of less than about 0.1%.
11. The pharmaceutical composition of claim 8 , wherein any individual impurity present is present in an amount of less than about 0.09%.
12. The pharmaceutical composition of claim 8 , wherein any individual impurity present is present in an amount of less than about 0.08%.
13. The pharmaceutical composition of claim 8 , wherein any individual impurity present is present in an amount of less than about 0.07%.
14. The pharmaceutical composition of claim 8 , wherein the composition contains less than about 20 ppm of palladium.
15. The pharmaceutical composition of claim 8 , wherein said composition further comprises a buffer.
16. The pharmaceutical composition of claim 15 , wherein said buffer is selected from a phosphate, citrate, gluconate, lactate, tartrate, glycinate, glycylglycinate, bicarbonate, carbonate, maleate, acetate, histidine, imidazole and combinations thereof.
17. The pharmaceutical composition of claim 8 , wherein said composition has a pH of about 7.0 to about 8.0.
18. The pharmaceutical composition of claim 8 , wherein said composition has a pH of about 7.4.
19. The pharmaceutical composition of claim 8 , wherein said stannsoporfin is present in an amount suitable for delivering up to a 4.5 mg/kg dose by birth weight.
20. The pharmaceutical composition of claim 8 , wherein said stannsoporfin is present in an amount suitable for delivering from about 1.5 mg/kg to about 3.0 mg/kg by birth weight.