Oral liquid compositions including chlorpromazine
Stable oral liquid compositions including chlorpromazine or a pharmaceutically acceptable salt or solvate of chlorpromazine, and methods of administering the compositions, are disclosed.
1. An oral liquid pharmaceutical composition comprising:
about 25 mg/mL to about 35 mg/mL chlorpromazine or a pharmaceutically acceptable salt or solvate thereof;
about 0.1 mg/mL to about 5 mg/mL sodium benzoate;
about 0.5 mg/mL to about 5 mg/mL EDTA; and
water;
provided that a pH of the oral liquid pharmaceutical composition is about 2.0 to about 5.0; and
provided that the oral liquid pharmaceutical composition retains at least about 90% of an initial amount of chlorpromazine or pharmaceutically acceptable salt or solvate thereof after three months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
2. The oral liquid pharmaceutical composition of claim 1 , provided that the oral liquid pharmaceutical composition comprises less than 5% of chlorpromazine sulfoxide after three months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
3. The oral liquid pharmaceutical composition of claim 2 , provided that the oral liquid pharmaceutical composition contains less than 1% of chlorpromazine sulfoxide after three months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
4. The oral liquid pharmaceutical composition of claim 2 , provided that the oral liquid pharmaceutical composition is stored in a polyethylene terephthalate bottle.
5. The oral liquid pharmaceutical composition of claim 1 , provided that the oral liquid pharmaceutical composition retains at least about 95% of an initial amount of chlorpromazine or pharmaceutically acceptable salt or solvate thereof after three months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
6. The oral liquid pharmaceutical composition of claim 5 , provided that the oral liquid pharmaceutical composition contains less than 5% of chlorpromazine sulfoxide after three months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
7. The oral liquid pharmaceutical composition of claim 6 , provided that the oral liquid pharmaceutical composition contains less than 1% of chlorpromazine sulfoxide after three months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
8. The oral liquid pharmaceutical composition of claim 5 , provided that the oral liquid pharmaceutical composition is stored in a polyethylene terephthalate bottle.
9. The oral liquid pharmaceutical composition of claim 1 , provided that the oral liquid pharmaceutical composition retains at least about 95% of an initial amount of chlorpromazine or pharmaceutically acceptable salt or solvate thereof after six months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
10. The oral liquid pharmaceutical composition of claim 9 , provided that the oral liquid pharmaceutical composition contains less than 1% of chlorpromazine sulfoxide after six months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
11. The oral liquid pharmaceutical composition of claim 1 , wherein a pH of the oral liquid pharmaceutical composition is about 3.0 to about 5.0.
12. An oral liquid pharmaceutical composition comprising:
about 90 mg/mL to about 110 mg/mL chlorpromazine or a pharmaceutically acceptable salt or solvate thereof;
about 0.1 mg/mL to about 5 mg/mL sodium benzoate;
about 0.5 mg/mL to about 5 mg/mL EDTA; and
water;
provided that a pH of the oral liquid pharmaceutical composition is about 2.0 to about 5.0; and
provided that the oral liquid pharmaceutical composition retains at least about 90% of an initial amount of chlorpromazine or pharmaceutically acceptable salt or solvate thereof after three months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
13. The oral liquid pharmaceutical composition of claim 12 , provided that the oral liquid pharmaceutical composition contains less than 5% of chlorpromazine sulfoxide after three months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
14. The oral liquid pharmaceutical composition of claim 12 , provided that the oral liquid pharmaceutical composition contains less than 1% of chlorpromazine sulfoxide after three months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
15. The oral liquid pharmaceutical composition of claim 12 , provided that the oral liquid pharmaceutical composition is stored in a polyethylene terephthalate bottle.
16. The oral liquid pharmaceutical composition of claim 12 , provided that the oral liquid pharmaceutical composition retains at least about 95% of an initial amount of chlorpromazine or pharmaceutically acceptable salt or solvate thereof after three months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
17. The oral liquid pharmaceutical composition of claim 15 , provided that the oral liquid pharmaceutical composition contains less than 5% of chlorpromazine sulfoxide after three months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
18. The oral liquid pharmaceutical composition of claim 16 , provided that the oral liquid pharmaceutical composition contains less than 1% of chlorpromazine sulfoxide after three months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
19. The oral liquid pharmaceutical composition of claim 12 , provided that the oral liquid pharmaceutical composition retains at least about 95% of an initial amount of chlorpromazine or pharmaceutically acceptable salt or solvate thereof after six months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
20. The oral liquid pharmaceutical composition of claim 15 , provided that the oral liquid pharmaceutical composition contains less than 1% of chlorpromazine sulfoxide after six months stored at a temperature ranging from about 38° C. to about 42° C. and a relative humidity ranging from about 70% to about 80%.
21. The oral liquid pharmaceutical composition of claim 12 , wherein a pH of the oral liquid pharmaceutical composition is about 3.0 to about 5.0.