Aqueous suspensions of submicron 9-hydroxyrisperidone fatty acid esters
AssigneeJanssen Pharmaceutica NV
InventorsMarc Karel Jozef François, Willy Maria Albert Carlo Dries, Esther Dina Guido Basstanie
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AssigneeJanssen Pharmaceutica NV
InventorsMarc Karel Jozef François, Willy Maria Albert Carlo Dries, Esther Dina Guido Basstanie
Estimating the term…
The present invention is concerned with a pharmaceutical composition suitable as a depot formulation for administration via intramuscular or subcutaneous injection, comprising: (1) as an active ingredient a therapeutically effective amount of a 9-hydroxy-risperidone fatty acid ester or a salt, or a stereoisomer or a stereoisomeric mixture thereof in submicron form and (2) a pharmaceutically acceptable carrier; wherein the pharmaceutically acceptable carrier is water and the active ingredient is suspended therein: and with a process of preparing such a composition. The invention further concerns such a pharmaceutical composition for use as a medicament in the treatment of psychosis, schizophrenia, schizoaffective disorders, non-schizophrenic psychoses, behavioural disturbances associated with neurodegenerative disorders, e.g. in dementia, behavioural disturbances in mental retardation and autism, Tourette's syndrome, bipolar mania, depression, anxiety.
A pharmaceutical composition suitable as a depot formulation for administration by intramuscular or subcutaneous injection, comprising a dispersion of particles consisting essentially of a therapeutically effective amount of a crystalline 9-hydroxyrisperidone fatty acid ester having the formula
A composition according to ciaim 3 wherein the preservative is benzyl alcohol and the isotonizing agent is mannitol or a phosphate buffer.
Dependencies are inferred from the claim text.