Our products

Oxcarbazepine

CAS No.

28721-07-5

Reference product

Trileptal/Novartis

Polymorphic form

Form A

Therapeutic Area

Nervous system

Status

commercial

EU DMF readiness

US DMF readiness

CEP

Pending

Drug description:

Oxcarbazepine belongs to antiepileptic medications.
Oxcarbazepine is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in pediatric patients aged 4 years and above with epilepsy, and as adjunctive therapy in pediatric patients aged 2 years and above with partial seizures.
It is formulated as an oral extended-release tablet, immediate-release tablet, suspension.

Mechanism of action:

The pharmacological activity is primarily exerted through the 10-monohydroxy metabolite (MHD) of Oxcarbazepine. Oxcarbazepine and MHD produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyper excited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. These actions are important in the prevention of seizure spread in the intact brain. In addition, increased potassium conductance and modulation of high-voltage activated calcium channels may contribute to the anticonvulsant effects of the drug. No significant interactions of oxcarbazepine or MHD with brain neurotransmitter or modulator receptor sites have been demonstrated.

Disclaimer
Products protected by valid patents are not offered for commercial sale in countries where the sale of such products constitutes patent infringement but are offered solely for uses reasonably related to the development and submission of information under a law regulating the manufacture, use or sale of drugs. It is within the buyer’s responsibility and liability to check the patent situation of the product in the imported market(s).
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.

LEARN MORE