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. A method for treating a medical condition, the method comprising administering to a human subject in need thereof a therapeutically effective amount of 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 0.5 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; and
wherein the medical condition is selected from the group consisting of a manifestation of a psychotic disorder, a manifestation of a manic type manic-depressive disorder, nausea and vomiting, restlessness and apprehension before surgery, acute intermittent porphyria, tetanus, intractable hiccups, and a behavioral problem in a child 1 to 12 years of age.
2. The method 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 method 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 method of claim 1 , provided that the pH of the oral liquid pharmaceutical composition is about 3.5 to about 4.5.
5. The method of claim 1 , provided that the oral liquid pharmaceutical composition further comprises about 0.1 mg/mL to about 4 mg/mL citric acid.
6. The method of claim 1 , provided that the oral liquid pharmaceutical composition further comprises about 0.5 mg/mL to about 7 mg/mL sodium citrate.
7. The method of claim 1 , provided that the oral liquid pharmaceutical composition further comprises sodium benzoate.
8. The method of claim 1 , provided that the oral liquid pharmaceutical composition comprises:
about 25 mg/mL to about 35 mg/mL chlorpromazine or a pharmaceutically acceptable salt or solvate thereof;
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 method 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 method 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 method of claim 8 , provided that the oral liquid pharmaceutical composition further comprises sodium benzoate.
12. A method for treating a medical condition, the method comprising administering to a human subject in need thereof a therapeutically effective amount of 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 0.5 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; and
wherein the medical condition is selected from the group consisting of a manifestation of a psychotic disorder, a manifestation of a manic type manic-depressive disorder, nausea and vomiting, restlessness and apprehension before surgery, acute intermittent porphyria, tetanus, intractable hiccups, and a behavioral problem in a child 1 to 12 years of age.
13. The method 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 method 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 method of claim 12 , provided that the pH of the oral liquid pharmaceutical composition is about 3.5 to about 4.5.
16. The method of claim 12 , provided that the oral liquid pharmaceutical composition further comprises about 0.05 mg/mL to about 5 mg/mL citric acid.
17. The method of claim 12 , provided that the oral liquid pharmaceutical composition further comprises about 0.5 mg/mL to about 7 mg/mL sodium citrate.
18. The method of claim 12 , provided that the oral liquid pharmaceutical composition further comprises sodium benzoate.
19. The method of claim 12 , provided that the oral liquid pharmaceutical composition comprises:
about 90 mg/mL to about 110 mg/mL chlorpromazine or a pharmaceutically acceptable salt or solvate thereof;
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 method 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 method 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 method of claim 19 , provided that the oral liquid pharmaceutical composition further comprises sodium benzoate.