NMDA receptor agonist pharmaceutical compositions

A pharmaceutical composition comprising (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol or a pharmaceutically acceptable salt thereof, water and a pharmaceutically acceptable chelating agent at a concentration effective to chelate with trace metal ions present in said composition.

A pharmaceutical composition comprising (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol or a pharmaceutically acceptable salt thereof in an aqueous solution, wherein the percent of the degradation product, 4-hydroxybenzaldehyde, is no more than about 0.15 percent of said composition following storage at 50° C. for 12 weeks.

A pharmaceutical composition comprising (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol or a pharmaceutically acceptable salt thereof in an aqueous solution, wherein the percent of the degradation product, 4-hydroxy-4-phenylpiperidine, is no more than about 0.2 percent of said composition following storage at 50° C. for 12 weeks.

A method of preparing a pharmaceutical composition of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol comprising combining a pharmaceutically effective amount of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol or a pharmaceutically acceptable salt thereof with a vehicle comprising water wherein said vehicle has been treated with a means to remove trace metal ions.

A method of preparing a pharmaceutical composition of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol comprising:

• combining a pharmaceutically effective amount of (1S,2S)-1-(4-hydroxyphenyl)-2-(4-hydroxy-4-phenylpiperidin-1-yl)-1-propanol or a pharmaceutically acceptable salt thereof with a vehicle comprising water to form an aqueous solution;
• and
• treating said aqueous solution with a means to remove trace metal ions.