Methods for making polymorphs of bromfenac sodium and bromfenac sodium formulations
View Patent ↗Different polymorphs of bromfenac sodium may be prepared and interconverted using crystallization/recrystallization, drying and/or hydration techniques.
1. A crystalline form of bromfenac sodium characterized by a powder x-ray diffraction pattern having peaks expressed as 2-theta at about 21.6, 22.4, 12.2, 24.0 and 26.3 degrees.
2. The bromfenac sodium in accordance with claim 1 , wherein the bromfenac sodium is characterized by a powder x-ray diffraction pattern having at least one or more peaks expressed as 2-theta at about 12.4, 14.1, 17.8, 19.6 and 28.1 degrees.
3. The bromfenac sodium in accordance with claim 1 , wherein the bromfenac sodium is free of any other physical forms of bromfenac sodium.
4. A crystalline form of bromfenac sodium characterized by a powder x-ray diffraction pattern in accordance with that shown in FIG. 3 .
5. The bromfenac sodium in accordance with claim 4 , wherein the bromfenac sodium is characterized by an FT-IR spectrum in accordance with that shown in FIG. 4 .
6. A crystalline form of bromfenac sodium characterized by a powder x-ray diffraction pattern characterized by an XRPD d-spacing/% intensity pattern in accordance with that shown in Table B.