Crystalline hydrates of (6R-(6α,7β(Z))-7-((2-amino-4-thiazolyl)(hydroxyimino)acetyl)amino)-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (cefdinir), calcium salt, ways to make them, compositions comprising them and made with them, and methods of treatment using them are disclosed.
Description
BRIEF DESCRIPTION OF THE FIGURES
FIG. 1 shows a powder X-ray diffraction (PXRD) pattern of cefdinir, calcium salt pentahydrate.
Claims
1. An isolated crystalline hydrate of cefdinir, calcium salt.
2. Crystalline cefdinir, calcium salt pentahydrate.
3. Crystalline cefdinir, calcium salt pentahydrate, when measured with radiation at 1.54178 Å, comprising a powder diffraction pattern with at least five peaks having respective 2θ values of about 12.1°, 12.8°, 13.6°, 14.2°, 15.6°, 18.1°, 20.8°, 22.7°, 23.7°, 24.2°, 25.8°, 27.5°, 30.0°, 34.1° and 36.6°.
4. A composition comprising or made with an excipient and cefdinir, calcium salt pentahydrate, when measured with radiation at 1.54178 Å, comprising a powder diffraction pattern with at least five peaks having respective 2θ values of about 12.1°, 12.8°, 13.6°, 14.2°, 15.6°, 18.1°, 20.8°, 22.7°, 23.7°, 24.2°, 25.8°, 27.5°, 30.0°, 34.1° and 36.6°.
5. A method of treating bacterial infection in a mammal comprising administering thereto a therapeutically effective amount of a crystalline cefdinir, calcium salt pentahydrate, when measured with radiation at 1.54178 Å, comprising a powder diffraction pattern with at least five peaks having respective 2θ values of about 12.1°, 12.8°, 13.6°, 14.2°, 15.6°, 18.1°, 20.8°, 22.7°, 23.7°, 24.2°, 25.8°, 27.5°, 30.0°, 34.1° and 36.6°.
6. A process for making a crystalline cefdinir, calcium salt pentahydrate, said process comprising:
providing a mixture comprising cefdinir, water and acetone;causing crystalline cefdinir, calcium salt pentahydrate to exist in said mixture, said crystalline cefdinir, calcium salt pentahydrate, when measured with radiation at 1.54178 Å, comprising a powder diffraction pattern with at least five peaks having respective 2θ values of about 12.1°, 12.8°, 13.6°, 14.2°, 15.6°, 18.1°, 20.8°, 22.7°, 23.7°, 24.2°, 25.8°, 27.5°, 30.0°, 34.1° and 36.6°; andisolating said crystalline cefdinir, calcium salt pentahydrate.
7. Crystalline cefdinir, calcium salt pentahydrate prepared by the method of claim 6.
8. A process for making Cefdinir Crystalline Form A, said process comprising:
providing a mixture comprising a hydrate of cefdinir, calcium salt, water and an alcohol;causing crystalline Cefdinir Crystalline Form A to exist in said mixture, said crystalline Cefdinir Crystalline Form A, when measured with radiation at 1.54178 Å, comprising a powder diffraction pattern with at least five peaks having respective 2θ values of about 11.8°, 12.6°, 14.7°, 16.6°, 17.8°, 18.9°, 19.2°, 21.5°, 22.0°, 23.4°, 24.5°, 25.4°, 26.9°, 27.7°, 28.1° and 29.7°; andisolating said Cefdinir Crystalline Form A.
9. The process of claim 8 wherein the hydrate of cefdinir, calcium salt is cefdinir, calcium salt pentahydrate.
10. Cefdinir Crystalline Form A prepared by the process of claim 9.
11. A process for making Cefdinir Crystalline Form A, said process comprising:
providing a mixture comprising a hydrate of cefdinir, calcium salt, water and methanol between about 75° C. to about 100° C.;adjusting the pH of the mixture to about 1 to about 4 and causing crystalline Cefdinir Crystalline Form A to form in said mixture, said crystalline Cefdinir Crystalline Form A, when measured with radiation at 1.54178 Å, comprising a powder diffraction pattern with at least five peaks having respective 2θ values of about 11.8°, 12.6°, 14.7°, 16.6°, 17.8°, 18.9°, 19.2°, 21.5°, 22.0°, 23.4°, 24.5°, 25.4°, 26.9°, 27.7°, 28.1° and 29.7°; andisolating said Cefdinir Crystalline Form A.
12. The process of claim 11 wherein the hydrate of cefdinir, calcium salt is cefdinir, calcium salt pentahydrate.
13. Cefdinir Crystalline Form A prepared by the process of claim 12.
Patent Application
20070208173
