| abstract |
A lyophilized formulation comprising 2-methyl-4- (4-methyl-1-piperazinyl) -10H-thieno [2,3-b] [1,5] benzodiazepine (olanzapine), a solubilizer and a stabilizer. The formulation is administered via intramuscular injection. Preferably, olanzapine is in an amorphous state, the solubilizer is tartaric acid and the stabilizer is lactose. Use of an earlier formulation for the manufacture of a medicament for the treatment of excitation. A manufacturing article, comprising packaging material and a formulation containing the described formulation, said packaging material comprises a label or packing insert indicating that said formulation contains olanzapine and can be used to treat the excitation, where the excitation is associated with the disorders selected from the group consisting of psychotic disorders, schizophrenia, bipolar disorder (both manic and mixed states), dementia and associated disorders and neurodegenerative disorders. A process for preparing said formulation comprising, lyophilization of a solution comprising olanzapine, a solubilizer and a stabilizer. Preferably, the solution that is lyophilized is an aqueous solution. |