| Customization: | Available |
|---|---|
| Powder: | Yes |
| Certification: | ISO 9001, FDA |
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| product name | Posaconazole |
| CAS NO. | 171228-49-2 |
| Specification | 99% |
| Appearance | White powder |
| packing | 1kg/bag,25kgs/drum |
| MOQ | 1KG |
Posaconazole is a derivative of itraconazole and a second-generation triazole antifungal drug launched by the FDA in 2006.
Posaconazole is an antifungal drug that can produce antifungal effects by inhibiting lanosterol 14-demethylase on the fungal cell membrane.
Main diseases
Posaconazole can prevent invasive Aspergillus and Candida infections. It is suitable for patients aged 13 years and above who have an increased risk of infection due to immunodeficiency and can treat oropharyngeal candidiasis.
| Item | Specification | Test result |
| Appearance | white powder | Conforms |
| Assay | 99% | Conforms |
| Heavy metal | ≤10ppm | Conforms |
| Lead | ≤2.0ppm | Conforms |
| As | ≤2.0ppm | Conforms |
| Ca | ≤1.0ppm | Conforms |
| Me | ≤0.1ppm | Conforms |
| Total aerobic microbial count | ≤1000CFU/g | Conforms |
| Total moulds&yeast count | ≤100CFU/g | Conforms |
| Enterobacterial | ≤10MPN/g | Conforms |
| Salmonella | N.D/25g | Conforms |
| Escherichia coli | N.D/10g | Conforms |
| Staphylococcus aureus | N.D/10g | Conforms |
| Pseudomonas aeruginosa | N.D/10g | Conforms |
| Conclusion: Conform with specification. | ||
Pharmacological Action
Posaconazole is derived from itraconazole. Phase III clinical trials are currently underway. The pharmacological effects are the same as those, but compared with itraconazole, it has a stronger inhibitory effect on sterol C14 demethylation, especially against Aspergillus.
Pharmacokinetics
Studies on dosage and administration schedule have shown that the absorption and elimination rates of this product conform to the single-compartment model. The relative bioavailability of oral suspension varies significantly between different doses. times) can significantly improve bioavailability, with a protein binding rate of 98% to 99%. Compared with tablets, the bioavailability of suspensions is increased, and food can significantly increase the absorption rate and extent of drugs. The results of a study examining the effect of abnormal renal function on the pharmacokinetics of this drug showed that this product is not cleared by hemodialysis and is not affected by hemodialysis. Single-dose studies have shown that no dose adjustment is required for patients with varying degrees of chronic kidney disease. The half-life is approximately 25 hours and it is metabolized primarily by the liver.
Indications
This product is suitable for fungemia caused by Candida and Cryptococcus fungi, respiratory, digestive tract, urinary tract fungal diseases, peritonitis, meningitis, etc.
Dosage
It can be used clinically to treat aspergillosis, zygomycosis and fusariosis, and can also be used to treat some fluconazole-resistant Candida infections. Studies have shown that posaconazole can be widely and effectively used to treat phaeohyphomycosis and improve the survival rate of patients infected with Exophiala dermatitidis, and the effect is dose-dependent. As a second-line drug, the drug is effective at 44% to 78% against invasive aspergillosis resistant to amphotericin B or itraconazole, and is effective at 71% against zygomycete infections. This drug is an oral suspension. The recommended dose is 200 mg, 4 times a day, taken orally with meals for 7 to 10 days. This dose can then be maintained or changed to 400 mg, taken orally twice a day. Steady-state blood drug concentrations can be achieved within 7 to 10 days.
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