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Vilanterol (CAS 503068-34-6): Applications and Competitive Advantages of Leading Manufacturers
Introduction
Vilanterol (CAS 503068-34-6), a long-acting β2-adrenoceptor agonist (LABA), is a cornerstone in the treatment of chronic respiratory diseases such as chronic obstructive pulmonary disease (COPD) and asthma. Developed by GlaxoSmithKline (GSK), this inhaled bronchodilator is renowned for its sustained 24-hour efficacy, making it a preferred choice for once-daily maintenance therapy. With a molecular formula of C₂₄H₃₃Cl₂NO₅ and a molecular weight of 486.43 g/mol, Vilanterol’s structural specificity enables high receptor affinity and selectivity, reducing systemic side effects compared to earlier β2 agonists. This article explores the therapeutic applications of Vilanterol and highlights the manufacturing excellence of key producers, emphasizing their technological innovations, quality control, and market competitiveness.
Chemical and Pharmacological Profile
Vilanterol’s pharmacological activity stems from its ability to bind selectively to β2-adrenergic receptors in bronchial smooth muscles, inducing relaxation and improving airflow. Key characteristics include:
- Mechanism of Action : Prolonged activation of β2 receptors increases intracellular cAMP, leading to bronchodilation.
- Pharmacokinetics : Rapid absorption via inhalation, with peak plasma concentrations within 5–15 minutes and a half-life of 11–16 hours.
- Synergistic Formulations : Often combined with corticosteroids like fluticasone furoate (e.g., Breo Ellipta®) to enhance anti-inflammatory effects in COPD and asthma management.
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Therapeutic Applications
1. Chronic Obstructive Pulmonary Disease (COPD)
Vilanterol is pivotal in COPD management, particularly for patients with a history of exacerbations. Clinical trials demonstrate its ability to:
- Improve Lung Function : Significant increases in FEV1 (forced expiratory volume in 1 second) within 15–30 minutes post-inhalation.
- Reduce Exacerbations : Long-term use lowers hospitalization rates and disease progression.
2. Asthma
Approved for adults with inadequately controlled asthma, Vilanterol:
- Enhances Symptom Control : When combined with inhaled corticosteroids, it reduces nocturnal symptoms and rescue medication use.
- Minimizes Systemic Exposure : Localized action via inhalation limits cardiovascular risks compared to oral β2 agonists.
3. Emerging Research
Preclinical studies explore Vilanterol’s potential in mitigating pulmonary fibrosis and silicosis, though clinical data remain limited.
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Manufacturing Excellence: Key Players and Competitive Advantages
1. MedChemExpress (MCE)
A global leader in bioactive small molecules, MCE distinguishes itself through:
- High-Purity Standards : Vilanterol batches undergo rigorous LC-MS and NMR validation, ensuring ≥98% purity.
- Scalability : Multi-kilogram synthesis capabilities meet bulk demands from pharmaceutical partners.
- Global Logistics : Cold-chain distribution networks guarantee product stability, with 24/7 technical support for researchers.
2. Hangzhou Biosun Pharmaceutical Co., Ltd.
Specializing in API and intermediate synthesis, Biosun leverages:
- GMP Compliance : State-of-the-art facilities in Hangzhou and Huzhou adhere to ISO9001 and CMA standards.
- Custom Synthesis : Expertise in isotopically labeled derivatives (e.g., Vilanterol-d4) supports advanced pharmacokinetic studies.
- Sustainability : Solvent recycling and biocatalytic processes minimize environmental impact.
3. Anhui Dexinjia Biopharm Co., Ltd.
A pioneer in green chemistry, Dexinjia’s patented synthesis route for Vilanterol intermediates offers:
- Process Optimization : A novel cyclization method for intermediate 5 achieves 98.0–99.5% purity, reducing residual impurities like p-toluenesulfonic acid to <0.6%.
- Cost Efficiency : Catalyst recycling lowers production costs by 30%, enhancing market competitiveness.
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Quality Control and Regulatory Compliance
Leading manufacturers prioritize:
- Analytical Precision : HPLC and LC-MS protocols validate identity, potency, and impurity profiles.
- Stability Testing : Long-term studies confirm shelf-life integrity under recommended storage conditions (-20°C for powders).
- Regulatory Alignment : Compliance with FDA, EMA, and ICH guidelines ensures global market access.
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Market Dynamics and Pricing
The global Vilanterol market is projected to grow at a CAGR of 5.7% (2025–2030), driven by rising COPD prevalence and biosimilar development. Competitive pricing strategies include:
- Bulk Discounts : MCE offers tiered pricing for research-grade Vilanterol, starting at $1,475/2mg.
- Custom Quotes : Biosun provides flexible pricing for API batches (e.g., $4,007/10mg), tailored to client specifications.
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Future Directions
- Nanotechnology : Nano-encapsulation for enhanced pulmonary delivery.
- Biosimilars : Cost-effective alternatives to branded formulations like Breo Ellipta®.
- AI-Driven Synthesis : Accelerating process optimization and impurity profiling.
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Conclusion
Vilanterol (CAS 503068-34-6) remains indispensable in respiratory therapeutics, offering rapid and sustained bronchodilation with minimal side effects. Manufacturers such as MCE, Biosun, and Dexinjia lead the market through technological innovation, stringent quality control, and sustainable practices. As research expands its applications, collaborations between industry and academia will drive advancements in formulation and accessibility, ultimately improving outcomes for millions of patients worldwide.
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Note : Prices and specifications are subject to change. For the latest quotations and technical details, consult official supplier platforms or contact sales representatives directly.