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Claims for Patent: 5,919,485

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Claims for Patent: 5,919,485

Title: Oral 2-methyl-thieno-benzodiazepine formulation
Abstract:The invention provides a pharmaceutically acceptable solid oral formulation of olanzapine and a process for making such formulation.
Inventor(s): Cochran; George Randall (Indianapolis, IN), Morris; Tommy Clifford (Indianapolis, IN)
Assignee: Eli Lilly and Company (Indianapolis, IN)
Application Number:08/716,922
Patent Claims: 1. A solid oral formulation comprising olanzapine, wherein the formulation is coated with a polymer selected from hydroxypropyl methyl cellulose, hydroxyethyl cellulose, methyl hydroxyethyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, dimethylaminoethyl methacrylate, methyl acrylate acid ester copolymer, ethyl acrylate-methyl methacrylate copolymer, methyl cellulose, and ethyl cellulose.

2. The formulation of claim 1 wherein the polymer is hydroxypropyl methyl cellulose, hydroxypropyl cellulose, methyl cellulose, or ethyl cellulose.

3. A formulation of claim 2 wherein the polymer is hydroxypropyl methyl cellulose.

4. A formulation of claim 1 wherein the coating is free of propylene glycol.

5. A formulation of claim 4 wherein the bulking agent in the formulation is lactose.

6. A formulation of claim 4 wherein the binder in the formulation is hydroxypropyl cellulose and the disintegrant is crospovidone.

7. A formulation of claim 1 wherein the dry binder in the formulation is microcrystalline cellulose.

8. A formulation of claim 1 wherein the lubricant in the formulation is magnesium stearate.

9. A formulation of claim 3 wherein the hydroxypropyl methyl cellulose coating is further coated with an aqueous dispersion film coat.

10. A formulation of claim 9 wherein the solid formulation is imprinted using an edible ink.

11. A formulation of claim 9 wherein the formulation comprises from about 1 to about 3% w/w olanzapine; from about 69.5 to about 87.5% w/w lactose; from about 3.5 to about 4.5% w/w hydroxypropyl cellulose; from about 4 to about 6% w/w crospovidone; from about 9 to about 11% w/w microcrystalline cellulose; and from about 0.25 to 1% magnesium stearate.

12. A formulation of claim 1 wherein the solid formulation is a tablet.

13. A formulation of claim 12 wherein each tablet provides a 1, 2.5, 5, 7.5, 10, 15, or 20 mg dose of olanzapine.

14. A formulation of claim 1 wherein the solid formulation is in the form of granules.

15. A solid formulation of claim 1 wherein the formulation is for use in treating a condition selected from psychosis, schizophrenia, a schizophriform disorder, mild anxiety, a gastrointestinal disorder, and acute mania.

16. A formulation of claim 12 wherein each tablet provides a 25 mg dose of olanzapine.

17. The formulation of claim 1 wherein the olanzapine is substantially in the form of the Form II polymorph.

18. A process for preparing a formulation of claim 1 comprising high shear aqueous wet granulation with fluid bed drying.

19. The process of claim 18 wherein the olanzapine is substantially in the form of the Form II polymorph.
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