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AssigneeJohnson Matthey Public Limited Company
InventorRobert S. Marmor
Estimating the term…
Processes for reducing the amount of impurities, especially α,β-unsaturated ketones (ABUK), in materials containing morphine. Novel compounds, namely low ABUK morphine sulfate methanolic solvate, and a novel crystal form are also described. The method for making morphine sulfate methanolic solvate comprises mixing a morphine free base composition with methanol to form a solution and adding a liquid comprising sulfuric acid to the solution to form a morphine sulfate methanolic solvate precipitate. A method of making a morphine sulfate compound comprises drying the morphine sulfate methanolic solvate in the presence of water vapor, such that methanol molecules are removed and replaced with water vapor molecules. A composition for treating pain comprises the morphine sulfate compound and at least one pharmaceutically acceptable excipient. A method for treating pain comprises administering to a patient in need thereof the composition comprising the morphine sulfate compound and at least one pharmaceutically acceptable excipient.
A method of making a morphine sulfate methanolic solvate composition comprising:
A method of making a morphine sulfate methanolic solvate composition comprising:
Crystalline morphine sulfate methanolic solvate containing less than 25 ppm of α,β-unsaturated ketones.
Crystalline morphine sulfate methanolic solvate exhibiting an x-ray powder diffraction pattern substantially as shown in FIG. 4.
Crystalline morphine sulfate methanolic solvate exhibiting an x-ray powder diffraction pattern having at least one peak in degrees 2θ selected from 9.3, 9.6, 10.7, 13.5, 14.3, 16.4, and 23.5.
Crystalline morphine sulfate methanolic solvate exhibiting a differential scanning calorimetry curve substantially as shown in FIG. 5.
Crystalline morphine sulfate methanolic solvate having an onset of melt temperature of about 137° C. by differential scanning calorimetry.
Crystalline morphine sulfate methanolic solvate having a melting point temperature of about 143° C. by differential scanning calorimetry.
A method of making a morphine sulfate compound comprising:
A morphine sulfate compound comprising a crystalline morphine product containing water and methanol molecules and containing less than 0.15% by weight methanol.
Dependencies are inferred from the claim text.