Description

Technical Parameters

Vardenafil (vardenafil) raw material powder core introduction

Pharmaceutical -grade raw materials | Vardenafil (PDE5 inhibitor )

Chemical name : 2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazin-4-one

CAS number : 224785-90-4

Molecular formula : C₂₃H₃₂N₆O₄S

Molecular weight : 488.61

Melting point : 192-194°C (decomposition)

Appearance : White or off-white crystalline powder

Purity : ≥98% (HPLC)

Core Effects

Vardenafil is a highly selective phosphodiesterase-5 (PDE5) inhibitor . Due to its potent erectile dysfunction-improving effects and rapid onset of action , it is widely used in the treatment of erectile dysfunction, pulmonary hypertension, and sexual function improvement .

✅ Strong erectile function improvement :

Inhibits PDE5 enzyme and increases corpus cavernosum cGMP levels

Promotes vasodilation , improves erection hardness, takes effect within 15-25 minutes

✅ High selectivity advantage :

High selectivity for PDE5 , lower risk of side effects

Little effect on PDE6 , rare visual side effects

✅ Fast-acting properties :

Rapid absorption , peak time 0.5-1 hour

Duration of action : 4-6 hours

✅ Advantages :

Potent PDE5 inhibition , 5-10 times more potent than sildenafil

High-fat diet has little impact , and medication time is more flexible

End Product Preparation Guidelines

1. Preparation of oral tablets (10 mg/tablet) :

Example recipe (for 1000 tablets):

Vardenafil raw material: 10.0g

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 of orally disintegrating tablets (10 mg/tablet) :

Example recipe (for 1000 tablets):

Vardenafil raw material: 10.0g

Microcrystalline cellulose: 50.0g

Mannitol: 60.0g

Cross-linked polyvinylpyrrolidone: 10.0g

Aspartame: 2.0g

Magnesium stearate: 1.5g

Preparation process :

Direct compression process : the raw materials and excipients are mixed and then compressed directly into tablets

Low temperature drying : Dry below 40°C to protect active ingredients

Aluminum foil packaging : moisture-proof and light-proof packaging

3. Preparation Notes :

Raw material characteristics : Poor water solubility, requiring micronization to improve bioavailability

Production environment : relative humidity ≤ 40%, moisture-proof treatment

Packaging requirements : Aluminum foil blister packaging, light and moisture-proof

Usage Protocol

1. Oral tablets :

Standard dose : 10 mg/time, up to once daily

Taking time : Take 25-60 minutes before activity

Maximum dose : no more than 20 mg/day

2. Adjustments for special populations :

Hepatic insufficiency : Mild impairment: 5 mg is recommended, moderate or severe impairment is not recommended

Elderly : 65 years and older: Start with 5mg

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

3. Precautions for use :

Avoid high-fat diets : Although the effect is minimal, it is still recommended to take on an empty stomach or after a light meal.

Contraindications : Nitrates are absolutely contraindicated.

Adverse reaction monitoring : headache, flushing, indigestion, etc., usually mild and reversible

Why choose Vardenafil ?

Strong PDE5 inhibition , clinical efficacy exceeding 80%

Quick onset , takes effect in 15-25 minutes

High selectivity , low risk of side effects

Quality Assurance :

GMP -compliant production , each batch HPLC purity tested (≥98% )

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

Microbial limit testing to ensure safety

Worldwide Shipping :

Original sealed packaging , moisture-proof and light-proof

Private delivery , no logo on the outer packaging

Temperature -controlled transportation to ensure stability

Conclusion

Vardenafil raw material can be prepared into an oral dosage form using a standard tableting process . It is particularly suitable for the treatment of erectile dysfunction, pulmonary hypertension, and sexual function improvement research . The recommended dose is 10mg/dose .

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