Description

Technical Parameters

Flibanserin 100mg 30 tablets/bottle Core Information *

Pharmaceutical -grade preparations | 5-HT1A receptor agonist/5-HT2A receptor antagonist (for the treatment of female hypoactive sexual desire disorder )

Chemical name : 2H-benzimidazol-2-one, 1,3-dihydro-1-[2-[4-[3-(trifluoromethyl)phenyl]-1-piperazinyl]ethyl]

CAS number : 167933-07-5

Molecular formula : C₂₀H₂₁F₃N₄O

Molecular weight : 390.41

Specifications : 100mg/tablet, 30 tablets/bottle

Dosage form : Film-coated tablets

Appearance : Pink or white tablets with a dividing line

Core Effects

Flibanserin is a first-in-class, non-hormonal treatment for female hypoactive sexual desire disorder (HSDD) . Due to its unique modulatory effects on the dopamine and serotonin systems , it is specifically designed to treat HSDD in premenopausal women .

✅ Neurotransmitter balance regulation :

Stimulation of 5 -HT1A receptors , increasing dopamine and norepinephrine activity

5 -HT2A receptor antagonism , reducing the inhibitory effect of serotonin

Restores sexual motivation balance and improves spontaneous sexual desire

✅ Improvement of female sexual function :

Increase the number of satisfying sexual behaviors , clinical studies have shown significant results

Improve sexual desire-related pain and enhance sexual satisfaction

✅ Highly selective effect :

Designed specifically for female HSDD , with a highly targeted mechanism of action

Non- hormonal route , avoiding hormone-related side effects

✅ Advantages of use :

Take once a day before bed , simple dosage

Long-term effects are stable and significant improvements are seen with continued use

End Product Preparation Guide

1. Tablet preparation (100 mg/tablet) :

Example recipe (for 1000 tablets):

Flibanserin raw material: 100.0g

Microcrystalline cellulose: 80.0g

Lactose: 50.0g

Cross-linked carboxymethyl cellulose sodium: 8.0g

Magnesium stearate: 2.0g

Preparation process :

Raw material pretreatment : micronization (D90≤10μm)

Equal amount incremental mixing : gradually mix with diluent

Wet granulation : granulate with appropriate amount of purified water and dry in fluid bed at 50°C

Granulation : 20 mesh sieve granules, add flow aids and lubricants

Tableting : 8mm round die, 8-10kN pressure tableting

Film coating : Gastro-soluble film coating to improve stability and palatability

Quality Control :

Content uniformity : RSD≤3% (UV-HPLC detection)

Dissolution rate : ≥85% in 30 minutes (paddle method, 50 rpm)

Related substances : Single impurity ≤ 0.5%, total impurities ≤ 1.0%

2. Preparation Notes :

Anti- cross contamination : Dedicated production line to avoid cross contamination with other drugs

Stability protection : Protect from light and moisture, aluminum foil blister packaging

Female operator protection : Pay attention to protection during production

Usage Protocol

1. Suitable population and dosage :

Applicable population : Premenopausal women with hypoactive sexual desire disorder (HSDD)

Standard dose : 100 mg/day, taken at bedtime

Usage requirements :

Avoid drinking alcohol: Do not drink alcohol while taking the medicine

Fixed time: Take at roughly the same time every night before bed

2. Dosage adjustment plan :

Starting dose : 100 mg/day, orally at bedtime

Dosage adjustments :

If tolerated, continue at 100 mg/day

If side effects such as drowsiness occur, the dose can be reduced to 50 mg/day

Medication discontinuation guidelines :

If no effect after 8 weeks, consider discontinuing the drug

The dose should be gradually reduced when the drug is discontinued

3. Usage time and treatment course :

Best time to take : 1 hour before bedtime

Onset time :

Initial results: Beginning to show up in 4 weeks

Significant improvement: Stable results after 8 weeks

Long-term maintenance: continuous use is required

4. Use in special populations :

Liver dysfunction : Mild damage can be used, moderate or severe damage can be prohibited

Renal insufficiency : Mild to moderate, no adjustment required; use with caution in severe cases

Elderly : Limited safety data for those aged >65 years

Why choose Flibanserin ?

Pioneering mechanism : The first non-hormonal medication approved for female HSDD

Precise Targeting : Targeting the Neuroregulatory Mechanism of Female Sexual Desire

Clinical validation : Multiple studies have confirmed its effectiveness

Quality Assurance :

GMP compliant production , content uniformity testing for each batch

Stability test : Accelerated test for 6 months meets the standard

Third-party laboratory report (COA) is included with the product

Professional Packaging :

Moisture-proof bottle : 30 tablets/bottle, built-in desiccant

Light- proof : Brown glass bottle or aluminum-plastic blister

Child safety cap : prevent children from accidentally swallowing

Conclusion

Flibanserin tablets are a specific treatment option for female hypoactive sexual desire disorder (HSDD) , particularly suitable for the standard treatment of HSDD in premenopausal women . The recommended dose is 100 mg/day, taken at bedtime .

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