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Brexpiprazole

CAS No.

913611-97-9

Reference product

REXULTI/OTSUKA

Polymorphic form

Polymorphic form I

Therapeutic Area

Nervous system

Status

pipeline

EU DMF readiness

US DMF readiness

032347

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)
  • Dihydrate crystalline form can be considered upon request
  • 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.

DISCLAIMER
The above product is presented solely for informational purposes and does not constitute an offer in any sense. Products with PIPELINE & EARLY DEVELOPMENT STATUS under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.
Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).

The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.

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