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 3.0 to about 5.0.
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 1 , 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 1 , provided that the pH of the oral liquid pharmaceutical composition is about 3.5 to about 4.5.
5. The oral liquid pharmaceutical composition of claim 1 , further comprising about 0.1 mg/mL to about 4 mg/mL citric acid.
6. The oral liquid pharmaceutical composition of claim 1 , further comprising about 0.5 mg/mL to about 7 mg/mL sodium citrate.
7. The oral liquid pharmaceutical composition of claim 1 , provided that the oral liquid pharmaceutical composition is stored in a polyethylene terephthalate bottle.
8. The oral liquid pharmaceutical composition of claim 1 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;
about 0.1 mg/mL to about 4 mg/mL citric acid;
about 0.5 mg/mL to about 7 mg/mL sodium citrate; and
water;
provided that a pH of the oral liquid pharmaceutical composition is about 3.0 to about 5.0.
9. The oral liquid pharmaceutical composition of claim 8 , 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%.
10. The oral liquid pharmaceutical composition of claim 8 , 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%.
11. The oral liquid pharmaceutical composition of claim 8 , provided that the pH of the oral liquid pharmaceutical composition is about 3.5 to about 4.5.
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 3.0 to about 5.0.
13. The oral liquid pharmaceutical composition of claim 12 , 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%.
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 pH of the oral liquid pharmaceutical composition is about 3.5 to about 4.5.
16. The oral liquid pharmaceutical composition of claim 12 , further comprising about 0.05 mg/mL to about 5 mg/mL citric acid.
17. The oral liquid pharmaceutical composition of claim 12 , further comprising about 0.5 mg/mL to about 7 mg/mL sodium citrate.
18. The oral liquid pharmaceutical composition of claim 12 , provided that the oral liquid pharmaceutical composition is stored in a polyethylene terephthalate bottle.
19. The oral liquid pharmaceutical composition of claim 12 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;
about 0.05 mg/mL to about 5 mg/mL citric acid;
about 0.5 mg/mL to about 7 mg/mL sodium citrate; and
water;
provided that a pH of the oral liquid pharmaceutical composition is about 3.0 to about 5.0.
20. The oral liquid pharmaceutical composition of claim 19 , 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%.
21. The oral liquid pharmaceutical composition of claim 19 , 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%.
22. The oral liquid pharmaceutical composition of claim 19 , provided that the pH of the oral liquid pharmaceutical composition is about 3.5 to about 4.5.
23. A method for treating a medical condition, the method comprising administering a therapeutically effective amount of the oral liquid pharmaceutical composition of claim 1 to a human subject in need thereof, wherein the medical condition is selected from the group consisting of: a manifestation of a psychotic disorder; nausea and vomiting; restlessness and apprehension before surgery; acute intermittent porphyria ; tetanus; a manifestation of a manic type manic-depressive illness; intractable hiccups; and a severe behavioral problem in a child 1 to 12 years of age.
24. A method for treating a medical condition, the method comprising administering a therapeutically effective amount of the oral liquid pharmaceutical composition of claim 12 to a human subject in need thereof, wherein the medical condition is selected from the group consisting of: a manifestation of a psychotic disorder; nausea and vomiting; restlessness and apprehension before surgery; acute intermittent porphyria ; tetanus; a manifestation of a manic type manic-depressive illness; intractable hiccups; and a severe behavioral problem in a child 1 to 12 years of age.