Flibanserin is used to treat women with hypoactive sexual desire disorder (HSDD; a low sexual desire that causes distress or interpersonal difficulty) who have not experienced menopause (change of life; the end of monthly menstrual periods).Flibanserin is in a class of medications called a serotonin receptor 1A agonist/serotonin receptor 2A antagonist. It works by changing the activity of serotonin and other natural substances in the brain.
Flibanserin comes as a tablet to take by mouth. It is usually taken once daily at bedtime. Take flibanserin at bedtime every day.
| Items |
Specification |
| pH |
3.5-4.5 |
| Identification |
1, red to dark purple color appears |
|
with(III)iron chloride |
|
2, light red precipitate formed with reinecke salt TS |
|
3, UV spectrum meet the reference |
|
4, solution (1%) responds to the qualitative test for chloride |
| Melting point |
139-143 celcius degree |
| Clarity and color of solution |
clear and colorless |
| Sulfate |
0.048%max |
| Heavy metals |
10ppm max |
| As |
2ppm max |
| Organic acid(0.1M NaOH) |
0.54ml max |
| Loss on drying |
0.5% max |
| Residue on ignition |
0.1%max |
| Residual organic Solvents (GC) |
Xylol 0.217%max |
|
Isopropanol 0.5%max |
| Related substances(HPLC) |
Total impurity 1.5%max |
|
Single impurity0.5%max |
|
Free P-chloro phenoxy acetic 0.5%max |
| Count of bacteria |
bacillus 1000/1g max |
|
Mildew 100/1g max |
|
Microzyme 100/1g max |
| Assay(C12H16CINO3.HCl,on dry basis) |
98%min |
Application
HSDD is the most commonly reported form of female sexual dysfunction. HSDD is defined as a persistent or recurrent deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty, and which is not better accounted for by a medical, substance-related , psychiatric (e.g., depression) or other sexual condition. The cause of HSDD is believed to involve a multitude of social, psychological and biological factors and may be attributed to a complex interplay of these factors.
Flibanserin is a novel, nonhormonal drug that has been studied in clinical trials for the treatment of HSDD in premenopausal and postmenopausal women. The application submitted to the FDA is for premenopausal women.
Flibanserin is believed to work on key neurotransmitters, or chemicals, in the brain that affect sexual desire. More specifically, it is thought that flibanserin corrects an imbalance of levels of these neurotransmitters by increasing dopamine and norepinephrine (both responsible for sexual excitement) and decreasing serotonin (responsible for sexual inhibition). In clinical studies, flibanserin was evaluated for its ability to increase the frequency of satisfying sexual events, increase the intensity of sexual desire and decrease the associated distress women feel from its loss.
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