Claims for Patent: 5,736,541

Summary 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.