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Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor widely used in the management of erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension (PAH). It works by inhibiting PDE5 enzyme, increasing cyclic GMP levels in smooth muscle cells of the corpus cavernosum, leading to smooth muscle relaxation and enhanced blood flow, thereby facilitating penile erection during sexual stimulation.
Bluepill Express manufactures high-purity Tadalafil API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring consistent quality, stability, and compliance with global pharmacopoeial standards (IP, BP, USP, EP). This API is suitable for oral tablet formulations and combination therapies.
Therapeutic Uses
- Erectile Dysfunction (ED): Improves erectile function in men
- Benign Prostatic Hyperplasia (BPH): Relieves lower urinary tract symptoms
- Pulmonary Arterial Hypertension (PAH): Reduces pulmonary arterial pressure
- Combination Therapy: Can be used with antihypertensives and other cardiovascular drugs for specific conditions
- Long-acting PDE5 inhibitor: Suitable for once-daily or on-demand dosing
Mechanism of Action
Tadalafil selectively inhibits phosphodiesterase type 5 (PDE5), preventing the breakdown of cyclic GMP in penile smooth muscle. Elevated cGMP levels cause smooth muscle relaxation, increased blood flow to the corpus cavernosum, and enhanced erectile response. Its long half-life (~17.5 hours) allows for extended efficacy compared to other PDE5 inhibitors.
Pharmacological Information
- Chemical Name: (6R-trans)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione
- Molecular Formula: C22H19N3O4
- Molecular Weight: 389.4 g/mol
- CAS Number: 171596-29-5
- Therapeutic Class: PDE5 Inhibitor
- Pharmacological Class: Erectile Dysfunction / Pulmonary Hypertension
- ATC Code: G04BE08
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to off-white crystalline powder |
| Solubility | Practically insoluble in water; soluble in ethanol, methanol, and DMSO |
| Melting Point | 301°C – 303°C |
| pH (1% aqueous solution) | 4.5 – 6.5 |
| Storage | Store below 25°C in a dry, ventilated area, protected from light and moisture |
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR, UV, and HPLC positive |
| Assay (Purity) | ≥ 99.0% (HPLC) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Heavy Metals | ≤ 10 ppm |
| Related Substances | ≤ 0.5% (individual impurity) |
| Bulk Density | 0.35 – 0.50 g/mL |
| Tapped Density | 0.50 – 0.65 g/mL |
Applications
Tadalafil API is used in:
- Oral tablet formulations for ED and BPH
- Pulmonary arterial hypertension formulations
- Combination therapy with other cardiovascular drugs
- Pharmaceutical bulk API for export markets
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Method of Analysis (MOA)
- Stability Data (ICH-compliant)
- Regulatory Dossier / DMF (on request)
Packaging & Export Details
- Available Packs: 1 kg | 5 kg | 10 kg | 25 kg HDPE drums with double poly liners
- Labeling: Product name, batch number, manufacturing/expiry dates, storage instructions
- Shelf Life: 36 months under recommended storage conditions
- Export Markets: Africa, Asia, Latin America, Europe, Middle East
