Polymorphs of bromfenac sodium and methods for preparing bromfenac sodium polymorphs
AssigneeJohnson Matthey Public Limited Company
InventorsSaroop Singh Matharu, Gurijala Venu Reddy, James J. Mencel, Xiaoyong Sun
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Abstract
Different polymorphs of bromfenac sodium may be prepared and interconverted using crystallization/recrystallization, drying and/or hydration techniques.
Claims20
Bromfenac sodium Form I, characterized by a powder x-ray diffraction pattern having main peaks expressed as 2-theta at about 4.4, 8.8, 9.4, 12.1, 15.2, 15.9, 17.6, 18.2, 18.8, 20.2, 21.2, 24.7, 28.4, and 32.4 degrees and substantially free of any other physical forms of bromfenac sodium.
Bromfenac sodium Form I, characterized by a powder x-ray diffraction pattern in accordance with that shown in FIG. 1 and substantially free of any other physical forms of bromfenac sodium.
Bromfenac sodium Form I, characterized by an XRPD d-spacing/% intensity pattern in accordance with that shown in Table A and substantially free of any other physical forms of bromfenac sodium.
Bromfenac sodium Form I, characterized by an FT-IR spectrum in accordance with FIG. 2 and substantially free of any other physical forms of bromfenac sodium.
A pharmaceutical compound comprising bromfenac sodium Form I, characterized by a powder x-ray diffraction pattern having main peaks expressed as 2-theta at about 4.4, 8.8, 9.4, 12.1, 15.2, 15.9, 17.6, 18.2, 18.8, 20.2, 21.2, 24.7, 28.4, and 32.4 degrees, and wherein the compound does not contain more than 0.15% AUC of any process impurity or bromfenac sodium degradation product, as measured by HPLC.
A pharmaceutical compound comprising bromfenac sodium Form I, characterized by a powder x-ray diffraction pattern in accordance with that shown in FIG. 1, and wherein the compound does not contain more than 0.15% AUC of any process impurity or bromfenac sodium degradation product, as measured by HPLC.
A pharmaceutical compound comprising bromfenac sodium Form I, characterized by an XRPD d-spacing/% intensity pattern in accordance with that shown in Table A, and wherein the compound does not contain more than 0.15% AUC of any process impurity or bromfenac sodium degradation product, as measured by HPLC.
A pharmaceutical compound comprising bromfenac sodium Form I, characterized by an FT-IR spectrum in accordance with FIG. 2, and wherein the compound does not contain more than 0.15% AUC of any process impurity or bromfenac sodium degradation product, as measured by HPLC.
Dependencies are inferred from the claim text.