Aripiprazole Orally Disintegrating Tablets
【CONTENTS】Aripiprazole and Aripiprazole Orally Disintegrating Tablets(ABILIFY DISCMELT)
【SPECIFICATIONS】10mg
【INDICATIONS】 Schizophrenia
【DOSAGE AND ADMINISTRATION】
The recommended starting and target dose for ABILIFY is 10 or 15 mg/day administered on a once-a-day schedule without regard to meals. Dosage increases should generally not be made before 2 weeks, the time needed to achieve steady-state.
【REGISTRY CLASSIFICATION】6+6
【INTRODUCTION】
Aripiprazole was first developed by Otsuka and Bristol-Myers Squibb as a new type of atypical antipsychotic drugs. ABILIFY DISCMELT was approved by EMA and FDA in June 2006.
Unlike old typical antipsychotics ,which can Completely block D2 receptors, aripiprazole is the partial agonist of D2. At the same concentration aripiprazole has exciting action to the independent receptor of presynaptic D2 dopamine and has antagonistic effect to postsynaptic D2 dopamine .On the one hand,the unique pharmacological action mechanism of aripiprazole can improve the positive and negative symptoms of schizophrenia .One the other hand,the extrapyramidal side effects and inner secretory side effects(such as increased prolactin)of aripiprazole are less than the one of traditional antipsychotics or old atypical antipsychotics.
Patients with schizophrenia prevalence was 6.55% in our country, there are more than 8 million, and is growing at 1% a year. Schizophrenia not only harm to patients themselves, also seriously affected the social and family. As patients generally need lifelong medication, aripiprazole will has the steady growth of the market.
【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 100 thousand each batch.
Study of test methods has completed.