Patent ID: 6911455

Claim:
A method for preparing a pharmaceutical formulation containing a histamine releaser and a physiologically acceptable excipient, said method comprising combining a therapeutically effective amount of said histamine releaser with a concentration of the physiologically acceptable excipient; wherein said concentration of the physiologically acceptable excipient, when combined in an aqueous solution with the histamine releaser at or above critical micelle concentration, is sufficient to reduce aggregation of the histamine releaser in the aqueous solution by at least about 25 percent compared to aggregation of the histamine releaser in the aqueous solution containing substantially no physiologically acceptable excipient; wherein the histamine releaser is (Z)-2-chloror-1-{(3-{(1R, 2S)-6,7-dimethoxy-2-methyl-1-[(3,4,5-trimethoxyphenyl)methyl]-1,2,3,4 -tetrahydro-2-isoquinolinio}propyl}-4-{3-[(1S, 2R)-6,7-dimethoxy-2-methyl-1-(3,4,5-trimethoxyphenyl)-1,2,3,4 -tetrahydro-2-isoquinolinio]propyl}-2-butenedioate dichloride or a pharmaceutically acceptable salt thereof, and the physiologically acceptable excipient is selected from the group consisting of divalent inorganic salts, organic carboxylic acids, phosphoric acid, amino acids, chelating agents, albumins and combinations thereof.