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Generated: January 16, 2018

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Claims for Patent: 6,429,210

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Summary for Patent: 6,429,210
Title: Polymorphic clopidogrel hydrogenesulphate form
Abstract:Novel orthorombic polymorph of clopidogrel hydrogen sulfate or hydrogen sulfate of methyl (+)-(S)-.alpha.-(2-chlorophenyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine-5 -acetate and a process for its preparation.
Inventor(s): Bousquet; Andre (Sisteron, FR), Castro; Bertrand (Kremlin-Bicetre, FR), Saint-Germain; Jean (Sisteron, FR)
Assignee: Sanofi-Synthelabo (Paris, FR)
Application Number:09/623,333
Patent Claims: 1. A crystalline polymorph of (+)-(S) clopidogrel hydrogen sulfate (Form 2), the X ray powder diffractogram of which shows characteristic peaks expressed as interplanar distance at approximately 4.11; 6.86; 3.60; 5.01; 3.74; 6.49 and 5.66 .ANG..

2. A crystalline polymorph of (+)-(S) clopidogrel hydrogen sulfate (Form 2), the infrared spectrum of which exhibits characteristic absorptions expressed in cm.sup.-1 at 2551, 1497, 1189 and 1029, with respective transmittance percentages of approximately 43; 63.7; 18 and 33.2.

3. A crystalline polymorph of (+)-(S) clopidogrel hydrogen sulfate (Form 2) having a melting point of 176+/-3.degree. C.

4. A crystalline polymorph of clopidogrel hydrogen sulfate (Form 2) exhibiting the X ray powder diffractogram of FIG. 2.

5. A crystalline polymorph of clopidogrel hydrogen sulfate (Form 2) exhibiting the infrared spectrum of FIG. 3.

6. A crystalline polymorph of clopidogrel hydrogen sulfate (Form 2) exhibiting the X ray powder diffractogram which shows characteristic peaks expressed as interplanar distance at approximately 4.11; 6.86; 3.60; 5.01; 3.74; 6.49 and 5.66 .ANG. and an infrared spectrum which shows characteristic absorptions expressed in cm.sup.-1 at 2551, 1497, 1189 and 1029, with respective transmittance percentages of approximately 43, 63.7, 18 and 33.2.

7. A pharmaceutical composition comprising an effective amount of the polymorph Form 2 of clopidogrel hydrogen sulfate according to claim 1 in combination with at least one pharmaceutical excipient.

8. (+)-(S) Clopidogrel hydrogen sulfate, the x-ray powder diffraction pattern of which shows a characteristic peak, expressed in terms of interplanar distance, at approximately 4.11 .ANG..

9. (+)-(S) Clopidogrel hydrogen sulfate, the x-ray powder diffraction pattern of which shows a characteristic peak, expressed in terms of interplanar distance, at approximately 6.86 .ANG..

10. (+)-(S) Clopidogrel hydrogen sulfate, the x-ray powder diffraction pattern of which shows a characteristic peak, expressed in terms of interplanar distance, at approximately 3.60 .ANG..

11. (+)-(S) Clopidogrel hydrogen sulfate, the x-ray powder diffraction pattern of which shows a characteristic peak, expressed in terms of interplanar distance, at approximately 3.87 .ANG..

12. (+)-(S) Clopidogrel hydrogen sulfate according to claim 8 wherein the x-ray powder diffraction pattern further shows a characteristic peak at approximately 6.86 .ANG..

13. (+)-(S) Clopidogrel hydrogen sulfate according to claim 12 wherein the x-ray powder diffraction pattern further shows a characteristic peak at approximately 3.60 .ANG..

14. (+)-(S) Clopidogrel hydrogen sulfate according to claim 9 wherein the x-ray powder diffraction pattern further shows a characteristic peak at approximately 3.60 .ANG..

15. (+)-(S) Clopidogrel hydrogen sulfate having an enthalpy of fusion of 87 J/g.

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Serving leading biopharmaceutical companies globally:

Moodys
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Queensland Health
US Department of Justice
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US Army
McKinsey
Chinese Patent Office

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