Paroxetine Hydrochloride Controlled-Release Tablets
【CONTENTS】Paroxetine Hydrochloride and Paroxetine Hydrochloride Controlled-Release Tablets(PAXIL CR)
【SPECIFICATIONS】12.5mg, 25mg
【INDICATIONS】 Major Depressive Disorder
【DOSAGE AND ADMINISTRATION】
The recommended initial dose is 25 mg/day. Patients were dosed in a range of 25 mg to 62.5 mg/day in the clinical trials demonstrating the effectiveness of PAXIL CR in the treatment of major depressive disorder.
【REGISTRY CLASSIFICATION】6+6
【INTRODUCTION】
PAXIL CR was first developed by GSK and was approved by FDA in February, 1999 and entered the Chinese market in March, 2012. PAXIL CR has more advantages:
The plasma drug concentration peak valley small fluctuations, the occurrence of adverse reactions was effectively reduced.
Individual differences do not affect the clinical treatment of PAXIL CR.
Good efficacy and tolerability.
Lower outage probability of treatment and the risk of drugs replacement.
Reduce the frequency of drug use, taking more convenient.
By 2020, depression will become the second biggest disease,which after cardiovascular. Paroxetine had the biggest market share in 2006-2011,with a dominant market position.
【INTELLECTUAL PROPERTY】
There is no risk of infringement.
【TRANSFER TARGETS】
Process of active pharmaceutical ingredients
Process of tablets production
Data for declaring
【RESEARCH PROGRESS】
Active pharmaceutical ingredients
Enlarge production has completed. The size of enlarge production is 2Kg each batch and single impurity is less than 0.1%.
Tablets
Enlarge production has completed. The size of enlarge production is 50-100 thousand each batch.
Study of test methods has completed.