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Claims for Patent: 5,736,541

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Claims for Patent: 5,736,541

Title: Olanzapine polymorph crystal form
Abstract:The invention provides Form II, a pharmaceutically elegant, stable polymorph of olanzapine useful for treating a condition selected from the group consisting of a psychotic condition, mild anxiety and gastrointestinal conditions.
Inventor(s): Bunnell; Charles Arthur (Lafayette, IN), Hendriksen; Barry Arnold (Guildford, GB), Larsen; Samuel Dean (West Lafayette, IN)
Assignee: Eli Lilly and Company (Indianapolis, IN) Eli Lilly and Company (Basingstoke, GB2)
Application Number:08/686,989
Patent Claims: 1. Form II olanzapine polymorph having a typical x-ray powder diffraction pattern as represented by the following interplanar spacings:

2. Form II as claimed in claim 1 which is substantially pure.

3. Form II as claimed in claim 2 which contains less than about 5% Form I as hereinbefore defined.

4. Form II as claimed in claim 3 which contains less than about 2% content of Form I as hereinbefore defined.

5. Form II as claimed in claim 1 which is solvate free.

6. Form II as claimed in claim 2 which is anhydrous.

7. A pharmaceutical formulation comprising as an active ingredient Form II as claimed in claim 1 associated with one or more pharmaceutically acceptable carriers, excipients, or diluents therefor.

8. A pharmaceutical formulation as claimed in claim 7 which is a tablet.

9. A pharmaceutical formulation of claim 7 wherein the formulation is solvate free.

10. A process for preparing Form II olanzapine polymorph comprising slurrying technical grade olanzapine in ethyl acetate under anhydrous conditions and crystallizing Form II from the solution so formed.

11. A method for treating a condition selected from the group consisting of a psychotic condition, mild anxiety and gastrointestinal conditions comprising administering an effective amount of Form II as claimed in claim 1 to a patient in need thereof.

12. A method of claim 11 wherein the condition is schizophrenia or a schizophreniform disorder.

13. A pharmaceutical formulation comprising as an active ingredient Form II as claimed in claim 2 associated with one or more pharmaceutically acceptable carriers, excipients, or diluents therefor.

14. A Form II olanzapine polymorph as claimed by claim 2 which contains less than about ten percent (10%) Form I olanzapine polymorph.

15. A Form II olanzapine polymorph as claimed by claim 2 which contains less than one half percent (0.5%) related substances.

16. A Form II olanzapine polymorph as claimed in claim 1 further characterized by substantially the following x-ray powder diffraction pattern wherein d represents the interplanar spacing and I/I.sub.1 represents the typical relative intensities:

17. A Form II olanzapine polymorph as claimed by claim 16 which is substantially pure.

18. A Form II olanzapine polymorph as claimed by claim 17 which contains less than about 5% Form I olanzapine polymorph.

19. A Form II olanzapine polymorph as claimed by claim 16 which is solvate free.

20. A Form II olanzapine polymorph as claimed by claim 17 which is anhydrous.

21. A pharmaceutical formulation comprising as an active ingredient Form II olanzapine polymorph as claimed by claim 16 associated with one or more pharmaceutically acceptable carriers, excipients, or diluents therefor.

22. A method for treating a condition selected from the group consisting of a psychotic condition, mild anxiety and gastrointestinal conditions comprising administering an effective amount Form II olanzapine polymorph as claimed in claim 16 to a patient in need thereof.

23. A pharmaceutical formulation comprising as an active ingredient Form II olanzapine polymorph as claimed in claim 17 associated with one or more pharmaceutically acceptable carriers, excipients, or diluents therefor.

24. A Form II olanzapine polymorph as claimed by claim 17 which contains less than about ten percent (10%) Form I olanzapine polymorph.

25. A Form II olanzapine polymorph as claimed by claim 17 which contains less than one half percent (0.5%) related substances.
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