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Tadalafil Powder is a raw material form of phosphodiesterase type 5 (PDE5) inhibitor drugs, mainly used to treat male erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). Its core component, Tadalafil, increases cyclic guanosine monophosphate (cGMP) levels by inhibiting PDE5 enzyme activity, thereby improving symptoms of hemodynamic related diseases. Tadalafil inhibits the activity of PDE5 enzyme, reduces the degradation of cGMP, relaxes the smooth muscle of the corpus cavernosum of the penis, increases blood flow, and thus triggers erection. This mechanism requires sexual stimulation to trigger the release of nitric oxide (NO), which in turn activates guanylate cyclase to generate cGMP. As a second-generation PDE5 inhibitor, Tadalafil has a 36 hour long acting characteristic, significantly better than Sildenafil (4-5 hours). Its therapeutic effect is not affected by food intake, and the recommended dose is 10-20mg. Clinical studies have shown that the effective rate of treatment after 12 weeks is 67% -81%.
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Additional information of chemical compound:
| Product Name | Tadalafil Powder | Tadalafil Tablet 100mg | Tadalafil Liquid Drops | Tadalafil Gummies |
| Product Type | Powder | Tablet | Liquid | Gummies |
| Product Purity | ≥99% | ≥99% | ≥99% | ≥99% |
| Product Specifications | 100g/1kg/etc. | 5mg/10mg/20mg/100mg | 5mg/10mg/20mg | 5mg/10mg/20mg |
| Product Form | Organic synthesis | Take Orally | External application | Take Orally |
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Tadalafil COA
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| Certificate of Analysis | ||
| Compound name | Tadalafil | |
| Grade | Pharmaceutical grade | |
| CAS No. | 171596-29-5 | |
| Quantity | 337.3kg | |
| Packaging standard | 25kg/drum | |
| Manufacturer | Shaanxi BLOOM TECH Co., Ltd | |
| Lot No. | 202501090042 | |
| MFG | Jan 9th 2025 | |
| EXP | Jan 8th 2028 | |
| Structure |
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| Item | Enterprise standard | Analysis result |
| Appearance | White or almost white powder | Conformed |
| Water content | ≤5.0% | 0.40% |
| Loss on drying | ≤1.0% | 0.27% |
| Heavy Metals | Pb≤0.5ppm | N.D. |
| As≤0.5ppm | N.D. | |
| Hg≤0.5ppm | N.D. | |
| Cd≤0.5ppm | N.D. | |
| Purity (HPLC) | ≥99.0% | 99.90% |
| Single impurity | <0.8% | 0.48% |
| Total microbial count | ≤750cfu/g | 70 |
| E. Coli | ≤2MPN/g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (by GC) | ≤5000ppm | 400ppm |
| Storage | Store in a sealed, dark, and dry place below 2-8°C | |
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Tadalafil, a well-known molecule in the fields of male and urology, is known for its trade name "Cialis". However, at the source of drug manufacturing and in certain specific fields, it exists in a more primitive form - Tadalafil powder. This white to off white crystalline powder is the active pharmaceutical ingredient (API) that constitutes various dosage forms, such as tablets and oral films.
Core Medical Applications: From Erectile Dysfunction to Multi System Disease Management
Breakthrough treatment for erectile dysfunction (ED)
As a representative drug of phosphodiesterase type 5 (PDE5) inhibitors, Tadalafil's core medical value lies in the treatment of male erectile dysfunction. By selectively inhibiting the activity of PDE5 enzyme in the penile sponge, Tadalafil can prevent the degradation of cyclic guanosine monophosphate (cGMP), leading to a sustained increase in cGMP levels in vascular smooth muscle cells. This process triggers the following physiological effects:
Vascular dilation mechanism: cGMP activates protein kinase G (PKG), leading to a decrease in calcium ion influx, relaxation of vascular smooth muscle, and a 3-5 fold increase in penile cavernous artery blood flow.
Erectile maintenance time: Clinical data shows that after a single oral administration of 20mg Tadalafil, the half-life of the drug in plasma reaches 17.5 hours, and the effective blood concentration can be maintained for 36 hours, far exceeding similar drugs such as sildenafil (4-6 hours) and vardenafil (12 hours).
Improvement of psychological ED: For ED patients with combined psychological factors, after continuous medication for 4 weeks, the International Erectile Function Index (IIEF-5) score increased by an average of 6.2 points (P<0.01), significantly higher than the 3.8 points in the on-demand medication group.
Combination therapy for benign prostatic hyperplasia (BPH)
The breakthrough in the application of Tadalafil in the field of urology stems from its relaxing effect on prostate smooth muscle:
Dual mechanism of action: In addition to inhibiting PDE5, Tadalafil can also mildly inhibit PDE11, alleviating bladder outlet obstruction by reducing intracellular calcium ion concentration in prostate stromal cells.
Clinical efficacy verification: A multicenter study involving 1200 BPH patients showed that after 12 weeks of daily treatment with 5mg Tadalafil combined with alpha blockers, the International Prostate Symptom Score (IPSS) decreased from 19.6 points to 9.8 points, and the Quality of Life Score (QoL) improved from 4.2 points to 2.1 points.
Drug interaction management: When combined with tamsulosin, the incidence of orthostatic hypotension was only 3.2%, significantly lower than the 12.7% in the group treated with doxycycline (P<0.05).
Targeted therapy for pulmonary arterial hypertension (PAH)
Tadalafil improves the prognosis of PAH patients through the following pathways:
Selective dilation of pulmonary blood vessels: The inhibitory effect on pulmonary artery PDE5 is 40 times that of systemic blood vessels, which can reduce pulmonary artery pressure by 15-20mmHg while maintaining stable systemic blood pressure.
Long term survival benefits: The IMPACT study showed that after 24 weeks of treatment with Tadalafil 40mg/day, patients' 6-minute walking distance increased by 53 meters (P=0.001), and the risk of clinical deterioration decreased by 39%.
Advantages of combination therapy: When used in combination with the endothelin receptor antagonist bosentan, it can synergistically reduce pulmonary vascular resistance index (PVRI) by up to 35% without increasing the risk of liver toxicity.
Special Medical Applications: From Clinical Trials to Rare Disease Exploration
Exploratory treatment of Reynaud's phenomenon
Preliminary clinical trials have shown that Tadalafil powder has potential therapeutic effects on secondary Reynaud's phenomenon, such as those related to systemic sclerosis
Hemodynamic improvement: After 8 weeks of treatment with 20mg/day, the skin temperature of the fingers increased by 2.3 ℃, and the healing rate of finger ulcers increased by 40%.
Mechanism of action: By inhibiting PDE5 in the fingertip arterioles, the vasodilation effect mediated by nitric oxide (NO) is enhanced.
Intervention for postpartum hemorrhage caused by uterine atony
Animal experiments have shown that Tadalafil can enhance uterine smooth muscle contractility:
Calcium ion sensitization: By activating the RhoA/Rho kinase pathway, the phosphorylation level of myosin light chain is increased.
Clinical translational potential: In a sheep model, intravenous injection of 0.1mg/kg Tadalafil can increase uterine contractions by 65% and reduce bleeding by 42%.
Muscle protection in Duchenne muscular dystrophy
Previous studies have revealed the protective mechanism of Tadalafil on dystrophin deficient muscles:
Antioxidant effect: Reduce MDA levels in muscle tissue by 38% and increase SOD activity by 2.1 times.
Satellite cell activation: promotes upregulation of muscle regeneration related genes (such as Pax7, MyoD) by 1.8-2.5-fold.
Application in scientific research field: from basic research to drug development
Construction of cardiovascular pharmacology model
Tadalafil is used as a tool medicine for studying:
PDE5 enzyme distribution map: Through radioligand binding experiments, the differential expression of PDE5 subtypes in different tissues was identified.
Signal transduction mechanism: In vitro vascular ring experiments, it was confirmed that Tadalafil can enhance acetylcholine induced vasodilation response (EC50 decreased by 0.8 log units).
Pharmacokinetic studies
As a standard product used for:
Biological sample analysis: Establish LC-MS/MS method to detect the concentration of Tadalafil in plasma, with a linear range of 0.1-1000ng/mL.
Metabolite identification: Through HPLC-QTOF-MS technology, 12 main metabolites were identified, among which M1 (demethylated product) activity accounted for 15% of the parent drug.
New Formulation Development Platform
Tadalafil is used as a model drug for evaluating:
Nano crystal delivery system: The prepared 200nm nano crystal suspension has a bioavailability 2.3 times higher than that of ordinary tablets.
Transdermal patch carrier: A transdermal patch prepared with polyacrylate as the matrix, with a cumulative penetration rate of 12.6mg/cm ² within 72 hours.
adverse reaction
Tadalafil Powder, as a highly selective type 5 phosphodiesterase (PDE5) inhibitor, enhances the vascular smooth muscle relaxation effect mediated by nitric oxide (NO) by inhibiting PDE5 enzyme activity and reducing the degradation of cyclic guanosine monophosphate (cGMP). This mechanism makes it a core drug for treating erectile dysfunction (ED), lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension (PAH).
The mechanism and classification of adverse reactions
The adverse reactions of Tadalafil are closely related to its pharmacological properties, mainly involving mechanisms such as vasodilation, smooth muscle relaxation, and metabolic enzyme inhibition. According to the severity, it can be divided into mild to moderate adverse reactions (incidence rate ≥ 1%) and severe adverse reactions (incidence rate<1%); According to system classification, it can be divided into cardiovascular system, nervous system, digestive system, visual system, auditory system, musculoskeletal system, and allergic reactions.
Adverse reactions related to vasodilation
Tadalafil inhibits PDE5 enzyme, leading to an increase in cGMP levels in vascular smooth muscle cells and triggering vasodilation. This effect is manifested in the improvement of erectile function in the corpus cavernosum of the penis, but may cause adverse reactions such as headaches, facial flushing, nasal congestion, and hypotension in the systemic circulation. Among them, the incidence of headache is about 10% -15%, which is related to the increase in intracranial pressure caused by cerebral vasodilation; The incidence of facial flushing is about 5% -10%, manifested as redness and fever of the facial and neck skin, which is related to facial vasodilation; The incidence of nasal congestion is about 3% -5%, caused by dilation of nasal mucosal blood vessels leading to nasal turbinate congestion.
Adverse reactions related to smooth muscle relaxation
Tadalafil has a relaxing effect on the smooth muscles of the gastrointestinal, urogenital, and respiratory tracts, which may cause adverse reactions such as indigestion, back pain, and muscle soreness. The incidence of indigestion is about 10%, which is related to delayed gastric emptying and increased gastric acid secretion; The incidence of back pain and muscle soreness is about 5% -6%, which may be related to the effect of medication on local blood flow or phosphodiesterase inhibition. It usually lasts for several hours to 2 days and can be relieved by hot compress or mild massage.
Adverse reactions related to metabolic enzyme inhibition
Tadalafil is metabolized by CYP3A4 enzyme, and its metabolites may inhibit the metabolism of other drugs, leading to drug interactions. Meanwhile, the furan coumarin in grapefruit juice can inhibit CYP3A4 enzyme activity, increase the blood concentration of Tadalafil, and thus enhance the risk of adverse reactions. In addition, the combination of Tadalafil with nitrate drugs (such as nitroglycerin) or guanylate cyclase agonists (such as levocetirizine) may cause fatal hypotension, as both dilate blood vessels through the NO cGMP pathway, leading to excessive elevation of cGMP levels when used in combination.
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