Polpharma API characteristics:

• Anhydrous crystalline form, same as in innovator’s product
• Control strategy set with limited genotoxic impurities needed to be tested in API
• Product from manufacturer experienced in Aripiprazole chemistry
• PSD tailored to FDF needs (up to D(0,9) < 10 μm)
• Independent process
• Technical support available on request – chosen preformulation data available

Drug description:

Brexpiprazole is an atypical antipsychotic and adjunctive antidepressant.
Brexpiprazole is indicated for the treatment of schizophrenia, as a maintenance treatment of schizophrenia in adults and as an adjunctive treatment of major depressive disorder (MDD).
It is formulated as tablets and film coated tablets for oral route of administration.

Mechanism of action:

Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors. Dopamine partial agonist distinguishing characteristic is their mechanism of action. These drugs are partial agonists at dopamine D2/D3 receptors and can act as dopaminergic stabilizers, performing as dopamine antagonists in conditions of dopamine hyperactivity and exhibiting dopamine agonist properties in states of hypoactivity.