Description

Technical Parameters

Cialis (tadalafil) raw material powder core introduction

Pharmaceutical -grade raw materials | Tadalafil (PDE5 inhibitor )

Chemical name : (6R,12aR)-6-(1,3-benzodioxol-5-yl)-2-methyl-2,6,7,12,12a-pentahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione

CAS number : 171596-29-5

Molecular formula : C₂₂H₁₉N₃O₄

Molecular weight : 389.41

Melting point : 301-302°C (decomposition)

Appearance : White or off-white crystalline powder

Purity : ≥98% (HPLC)

Core Effects

Tadalafil (Cialis) is a highly selective phosphodiesterase-5 (PDE5) inhibitor . Due to its long-lasting action and stable efficacy , it is widely used to treat erectile dysfunction, relieve symptoms of benign prostatic hyperplasia, and treat pulmonary arterial hypertension .

✅ Long-term erectile function improvement :

Inhibits PDE5 enzyme and increases corpus cavernosum cGMP levels

Promotes vasodilation , improves erectile function, and lasts for 36 hours

✅ Benign prostatic hyperplasia relief :

Relieve lower urinary tract symptoms and improve urination function

Reduce nocturia and improve quality of life

✅ Long-lasting properties advantages :

The duration of action is up to 36 hours , providing a more natural window for sexual activity

Fast -acting (within 30 minutes) to meet spontaneous needs

✅ Advantages :

Not affected by high-fat diet , more flexible medication time

Well tolerated and safe for long-term use

End Product Preparation Guidelines

1. Oral tablet preparation (20 mg/tablet) :

Example recipe (for 1000 tablets):

Tadalafil raw material: 20.0g

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 :

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-proof and moisture-proof

Why choose Tadalafil ?

Long-acting PDE5 inhibitor , providing 36 hours of action

Dual functional benefits , can treat both erectile dysfunction and benign prostatic hyperplasia

High flexibility in medication , not affected by diet

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

Tadalafil 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, symptom relief of benign prostatic hyperplasia, and the treatment of pulmonary hypertension . The recommended dose is 10-20mg/dose .

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