Pharmaceutical compositions having improved storage stability
The present invention relates to a pharmaceutical composition that provides long-term stability of a hydrolytically labile antipsychotic agent.
1. A pharmaceutical composition comprising:
(a) Compound 1
(b) sorbitan laurate;
(c) polysorbate 20; and
(d) an aqueous vehicle;
wherein the pharmaceutical composition comprises less than 10 parts per million of a hydrolysis product of Compound 1; and
wherein the ratio of components (b) to (c) is approximately 5 to 2, by weight.
2. The pharmaceutical composition of claim 1 , wherein the hydrolysis product of Compound 1 is:
3. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises:
(a) 24-30 weight percent compound I:
(b) 0.3-0.4 weight percent sorbitan laurate;
(c) about 0.1-0.3 weight percent polysorbate 20; and
(d) an aqueous vehicle.
4. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises:
(a) about 26.6 weight percent compound I:
(b) about 0.37 weight percent sorbitan laurate;
(c) about 0.15 weight percent polysorbate 20; and
(d) an aqueous vehicle.
5. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises:
(a) 15-35 weight percent compound I:
(b) about 0.2-1 weight percent sorbitan laurate;
(c) about 0.1-0.3 weight percent polysorbate 20; and
(d) an aqueous vehicle.
6. A method of treating schizophrenia in a subject in need thereof comprising administering to the subject the composition of claim 1 .
7. A method of treating schizophrenia in a subject in need thereof comprising administering to the subject the composition of claim 3 .
8. A method of treating bipolar disorder in a subject in need thereof comprising administering to the subject the composition of claim 1 .
9. A method of treating anxiety in a subject in need thereof comprising administering to the subject the composition of claim 1 .
10. A method of treating depression in a subject in need thereof comprising administering to the subject the composition of claim 1 .
11. A method of treating autism-related irritability in a subject in need thereof comprising administering to the subject the composition of claim 1 .
12. A method of treating acute mania in a subject in need thereof comprising administering to the subject the composition of claim 3 .
13. The pharmaceutical composition of claim 3 , wherein the hydrolysis product of Compound 1 is:
14. The pharmaceutical composition of claim 4 , wherein the hydrolysis product of Compound 1 is:
15. The pharmaceutical composition of claim 5 , wherein the hydrolysis product of Compound 1 is: