Shaanxi BLOOM Tech Co., Ltd. is one of the most experienced manufacturers and suppliers of posaconazole tablet 300mg in China. Welcome to wholesale bulk high quality posaconazole tablet 300mg for sale here from our factory. Good service and reasonable price are available.
Posaconazole tablet 300mg are usually rectangular yellow coated tablets with a smooth surface and regular edges. The tablet specification is mainly 100mg/tablet, and each box contains 24 tablets, which is convenient for patients to take in divided doses. Its yellow coating adopts a special process design, mainly composed of enteric coated materials such as polymethyl methacrylate (Eudragit L30D-55), which can dissolve in the alkaline environment of the intestine. It aims to protect the core components of the drug from damage by gastric acid, ensure the release of the drug in specific parts of the intestine, and optimize absorption efficiency. This enteric coating technology is one of the key physical characteristics that distinguishes Posaconazol tablets from oral suspensions, significantly improving the bioavailability and therapeutic window of the drug.
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Stability and storage conditions:
Posaconazol tablets exhibit good stability when stored at room temperature (20-25 ℃), allowing for short-term storage (such as during transportation) at 15-30 ℃. Its stability is affected by the following factors:
Light exposure: Store in the dark to prevent drug decomposition.
Humidity: Tablets should be stored in a dry environment to avoid moisture absorption that may cause the coating to rupture.
Oxidants: Avoid contact with strong oxidants to prevent drug oxidation and degradation.
In contrast, posaconazol oral suspension needs to be refrigerated at 2-8 ℃ and used within 4 weeks after opening the bottle, while the stability advantage of enteric coated tablets significantly reduces storage and transportation costs.
Additional information of chemical compound:
| Product Name | Posaconazole Injection | Posaconazole Powder | Posaconazole Tablet |
| Product Type | Injection | Powder | Tablets |
| Product Purity | ≥99% | ≥99% | ≥99% |
| Product Specifications | Customizable | Customizable | Customizable |
| Product Package | Customizable | Customizable | Customizable |
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Toltrazuril +. COA
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Certificate of Analysis |
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Compound name |
Posaconazole | |
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CAS No. |
171228-49-2 | |
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Grade |
Pharmaceutical grade | |
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Quantity |
Customized | |
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Packaging standard |
Customized | |
| Manufacturer | Shaanxi BLOOM TECH Co., Ltd | |
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Lot No. |
20250109001 |
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MFG |
Jan 12th 2025 |
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EXP |
Jan 8th 2029 |
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Structure |
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| TEST STANDARD | GB/T24768-2009 Industry. Stnndard | |
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Item |
Enterprise standard |
Analysis result |
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Appearance |
White or almost white powder |
Conformed |
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Water content |
≤4.5% |
0.30% |
| Loss on drying |
≤1.0% |
0.15% |
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Heavy Metals |
Pb≤0.5ppm |
N.D. |
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As≤0.5ppm |
N.D. | |
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Hg≤0.5ppm |
N.D. | |
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Cd≤0.5ppm |
N.D. | |
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Purity (HPLC) |
≥99.0% |
99.5% |
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Single impurity |
<0.8% |
0.48% |
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Residue on ignition |
<0.20% |
0.064% |
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Total microbial count |
≤750cfu/g |
80 |
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E. Coli |
≤2MPN/g |
N.D. |
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Salmonella |
N.D. | N.D. |
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Ethanol (by GC) |
≤5000ppm |
400ppm |
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Storage |
Store in a sealed, dark and dry place at-20 degrees |
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As a second-generation triazole broad-spectrum antifungal drug, the bioavailabilit of oral formulations of posaconazole tablet 300mg is a key factor affecting clinical efficacy. Posaconazol tablets have significantly improved the absorption efficiency and stability of the drug through a unique formulation process design, making them an important choice for the prevention and treatment of invasive fungl diseases (IFD).
Bioavailabilit refers to the proportion and rate at which drugs enter the systemic circulation, and is a core indicator for evaluating the absorption efficiency of oral formulations. There are significant individual differences in the bioavailabilit of posaconazol after oral administration, and the bioavailabilit of traditional oral suspensions is only 8% -47%. This low absorption rate is mainly constrained by the following factors:
Gastric acid degradation: Posaconazol has extremely low solubility in gastric acid (pH 1-3) and is easily destroyed by gastric acid, resulting in significant loss of the drug in the stomach.
Food dependence: A high-fat diet can significantly enhance the absorption of suspensions, but patient dietary compliance is difficult to guarantee.
Gastrointestinal motility effects: Proton pump inhibitors (PPIs), metoclopramide, and other drugs can reduce gastric emptying rate and decrease the contact time between drugs and absorption sites.
Disease state interference: After chemotherapy or transplantation, patient often suffer from gastrointestinal mucosal inflammation, diarrhea, and other diseases, further weakening drug absorption.
Key strategies for enhancing bioavailability of posaconazol tablets
Posaconazol tablets overcome the limitations of traditional dosage forms through the following innovative designs, increasing bioavailabilit to 50% -70%:
1. Enteric coating technology
PH dependent release: Coated with enteric coated materials such as polymethyl methacrylate (Eudragit L30D-55), the drug remains intact in the acidic environment of the stomach and only dissolves in the alkaline environment of the intestine (pH 6-8).
Targeted release optimization: The coating thickness and porosity are precisely designed to ensure rapid drug release in the duodenum to jejunum segment, avoiding the risk of gastric degradation.
Stability improvement: Enteric coating can protect drugs from the effects of humidity, light, and oxidants, extending the shelf life of tablets to 24 months at room temperature of 25 ℃.
2. Innovation in formulation process
Hot melt extrusion technology: Mixing drugs and excipients through high-temperature melting to form a uniform solid dispersion, increasing the contact area between drugs and the gastrointestinal tract.
Synergistic effect of excipients: Adding fillers such as microcrystalline cellulose and lactose improves tablet hardness, while crosslinking disintegrants such as polyvinylpyrrolidone promote rapid drug release.
3. Optimization of food synergy effect
High fat diet enhances efficiency: When taken together with high-fat foods, the Cmax (peak blod concentration) and AUC (area under the drug time curve) of posaconazol tablets increae by 4 times and 3.8 times, respectively, significantly higher than the suspension's 3.6 times and 3.3 times.
Nutrient replacement solution: For patient who cannot tolerate a high-fat diet, taking nutrient solutions such as Boost Plus can achieve similar synergistic effects, with an AUC increae of 2.8 times.
Acidic beverage supplement: When taken together with carbonated beverages, it can lower the pH value in the stomach, reduce drug precipitation in the stomach, and increae AUC by 1.8 times.
Clinical significance of improving bioavailability
The optimization of the bioavailabilit of posaconazol tablets directly translates into the following clinical advantages:
1. Improve the compliance rate of preventive treatment
Breakthrough infection risk reduction: In a multicenter study of 86 patient, the incidence of breakthrough IFD after prevention with posaconazol tablets was reduced by 42% compared to suspension, and the median blod concentration compliance rate increaed from 29% to 71%.
Enhanced protection for high-risk populations: For chemotherapy patient with severe mucosal inflammation, the absolute bioavailabilit of posaconazol tablets is 51.4%, significantly higher than the suspension's 32.6%, effectively covering the immune deficiency window period.
2. Optimization of therapeutic drug dosage
Rapid achievement of steady-state concentration: Posaconazol tablets can reach steady-state blod drug concentration within 7-10 days after being administered once a day, while suspensions require four doses per day and the time to reach the standard is extended to 14 days.
Drug resistance risk control: High bioavailabilit ensures that drug concentrations remain above the minimum inhibitory concentration (MIC), reducing the risk of fungl resistance such as Aspergillus.
3. Extension of applicability to special populations
Patient with liver dysfuntion: The Cmax of patient with moderate liver dysfuntion is 39% higher than that of healthy individuals, but the AUC only increaes by 36%, indicating no need to adjust the dosage.
Patient with renal insufficiency: The medicaton is mainly excreted through feces (77%), and hemodialysis does not affect pharmacokinetis. Patient with chronic kidney disease do not require dose adjustment.
Frequently Asked Questions
Why does its oral suspension need to be taken with meals or high-fat drinks, but not with 300mg enteric coated tablets?
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The core lies in the formulation design: the absorption of the suspension depends on lipids, while 300mg enteric coated tablets are coated with a stomach acid resistant enteric coating and pH regulators (sodium bicarbonate) are added to ensure that the tablets only disintegrate and release after entering a specific alkaline environment in the intestine, thereby eliminating the dependence on food for absorption.
Why is it considered one of the "last line of defense" drugs for treating "mucormycosis"?
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Aspergillus is naturally resistant to the vast majority of antifungal drugs. Posaconazole has a unique high affinity for the cytochrome P450 enzyme of this type of fungus, which can effectively inhibit the synthesis of its key cell membrane component ergosterol. Therefore, it has become one of the few drugs that can cover this severe infection and is commonly used when other treatments fail or cannot be tolerated.
Why is the "therapeutic window" for monitoring plasma concentration particularly important and varies greatly among individuals?
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The efficacy and toxicity are closely related to the blood drug concentration. Low concentration can easily lead to treatment failure and drug resistance; Excessive concentration significantly increases the risk of liver toxicity. Individual differences are mainly caused by gastrointestinal status (such as diarrhea), concomitant medications (such as proton pump inhibitors), and genetic polymorphisms (such as CYP3A4 enzyme activity), therefore blood drug concentration monitoring needs to be carried out like monitoring antibiotics.
In terms of drug interactions, it is both a "victim" and a "perpetrator". What are the specific mechanisms?
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As a 'victim', it is mainly metabolized by CYP3A4 enzyme, so any drug that induces this enzyme (such as rifampicin) will significantly reduce its blood drug concentration. As a 'perpetrator', it is a strong inhibitor of CYP3A4 and can significantly increase the blood concentration of other drugs metabolized by this enzyme (such as certain immunosuppressants and sedatives), which may lead to serious adverse reactions.
Apart from antifungal treatment, what potential applications does it have in a very niche non infectious field?
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We are studying its use to inhibit the proliferation of acute myeloid leukemia cells. The mechanism is to utilize its antifungal "byproduct" - the ability to inhibit the Hedgehog signaling pathway, which is crucial for the growth and survival of certain leukemia cells. This belongs to the forefront exploration of "new use of old drugs".
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