|Title:||Oral 2-methyl-thieno-benzodiazepine formulation|
|Abstract:||The invention provides a pharmaceutically elegant solid oral formulation of olanzapine and a process for making such formulation.|
|Inventor(s):||Cochran; George Randall (Plainfield, IN), Morris; Tommy Clifford (Indianapolis, IN)|
|Assignee:||Eli Lilly and Company (Indianapolis, IN)|
|Filing Date:||Jan 19, 2001|
|Claims:||1. A method for preparing a stable pharmaceutically elegant solid oral formulation of olanzapine having a polymer coating selected from the group consisting of hydroxypropyl methyl cellulose, hydroxyethyl cellulose, methylhydroxyethylcellulose, sodium carboxymethylcellulose, hydroxypropylcellulose, polyvinyl pyrrolidone, dimethylaminoethyl methacrylatemethylacrylate acid ester copolymer, ethylacrylate-methylacrylate copolymer, methylcellulose, and ethylcellulose, wherein the polymer coating is free of polyethylene glycol, comprised of using a high shear aqueous wet granulation with fluid bed drying. |
2. A method according to claim 1 wherein the polymer coating is selected from the group consisting of hydroxypropyl methyl cellulose, hydroxypropylcellulose, methylcellulose, and ethylcellulose.
3. A method according to claim 1 wherein the polymer coating is hydroxypropyl methyl cellulose.
4. A method according to claim 1 wherein olanzapine is the substantially pure anhydrous Form I crystalline form.
5. A method according to claim 3 wherein olanzapine is the substantially pure anhydrous Form I crystalline form.
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