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Tulobuterol (CAS 41570-61-0): Applications and Competitive Advantages in Manufacturing
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Introduction
Tulobuterol (CAS 41570-61-0), a long-acting β2-adrenergic receptor agonist (LABA), is a pivotal therapeutic agent in managing chronic respiratory disorders such as chronic obstructive pulmonary disease (COPD) and asthma. With its molecular formula C₁₂H₁₈ClNO and molecular weight of 227.73 g/mol, Tulobuterol is distinguished by its selective binding to β2-adrenergic receptors, inducing bronchodilation with minimal systemic side effects. Originally developed for sustained 24-hour symptom relief, this compound has become a cornerstone in respiratory medicine. Beyond its clinical applications, Tulobuterol is increasingly utilized in biochemical research, drug development, and specialized pharmaceutical formulations. This article examines the diverse applications of Tulobuterol and highlights the manufacturing excellence of leading companies, emphasizing their technological innovation, quality control, and market leadership.
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Chemical and Pharmacological Profile
Tulobuterol’s pharmacological efficacy arises from its stereospecific interaction with β2-adrenergic receptors in bronchial smooth muscle cells. Key characteristics include:
- Mechanism of Action : Activation of β2 receptors increases intracellular cyclic adenosine monophosphate (cAMP), leading to protein kinase A (PKA)-mediated smooth muscle relaxation and bronchodilation.
- Pharmacokinetics : Rapid absorption via inhalation, with peak plasma concentrations within 15–30 minutes and a half-life of 11–16 hours, enabling once-daily dosing.
- Synergistic Formulations : Often combined with corticosteroids (e.g., fluticasone furoate) in products like Breo Ellipta® to enhance anti-inflammatory effects in COPD and asthma management.
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Therapeutic Applications
1. Chronic Respiratory Diseases
- COPD Management : Clinical trials demonstrate Tulobuterol’s ability to improve forced expiratory volume (FEV1) by 15–30% within minutes of inhalation, significantly reducing exacerbation frequency and hospitalization rates.
- Asthma Control : As an adjunct to inhaled corticosteroids, it reduces nocturnal symptoms and reliance on rescue medications, with localized action minimizing cardiovascular risks compared to oral β2 agonists.
2. Emerging Research Applications
- Pulmonary Fibrosis : Preclinical studies suggest potential in mitigating fibrotic pathways, though clinical validation is ongoing.
- Antigen Conjugation : Tulobuterol-BSA/OVA conjugates are used in antibody production and vaccine development, leveraging its structural specificity for immunological research.
3. Veterinary Medicine
Tulobuterol derivatives are explored for managing bronchoconstriction in livestock, enhancing respiratory health in agricultural settings.
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Manufacturing Excellence: Key Players and Competitive Advantages
1. Xi’an Qiyue Biotech Co., Ltd. (China)
- Scalability and Customization : Offers bulk production (up to kg-scale) with 99% purity, supporting both research and commercial pharmaceutical needs.
- Advanced Formulations : Specializes in transdermal patches and sustained-release hydrogels, enhancing drug delivery efficiency.
- Global Distribution : Ensures rapid delivery with cold-chain logistics for temperature-sensitive batches.
2. Delta Bio (Deltabio, China)
- High-Purity Standards : Produces Tulobuterol with ≥95% purity, validated via HPLC and LC-MS, meeting pharmacopeial guidelines.
- Green Chemistry : Employs solvent recycling and biocatalytic processes to reduce environmental impact.
- Cost Efficiency : Patented synthesis routes lower production costs by 30%, enabling competitive pricing for API batches.
3. Santa Cruz Biotechnology (USA)
- Research-Grade Excellence : Supplies Tulobuterol with ≥95% purity for preclinical studies, backed by detailed analytical certificates.
- Technical Support : Provides 24/7 customer service for academic and industrial researchers.
4. Toronto Research Chemicals (TRC, Canada)
- Custom Synthesis : Expertise in isotopically labeled derivatives (e.g., Tulobuterol-d4) for pharmacokinetic and metabolic studies.
- Inventory Scale : Maintains over 250,000 specialty chemicals, ensuring rapid availability for niche research needs.
5. Hangzhou Biosun Pharmaceutical Co., Ltd. (China)
- GMP Compliance : Operates ISO9001-certified facilities, ensuring API batches meet FDA and EMA standards.
- Sustainability Focus : Implements solvent recovery systems and energy-efficient catalysis.
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Quality Control and Regulatory Compliance
Leading manufacturers prioritize:
- Analytical Rigor : Advanced techniques like NMR, GC-MS, and HPLC validate identity, potency, and impurity profiles (residual solvents <0.6%).
- Stability Testing : Long-term studies confirm shelf-life integrity under recommended storage (-20°C for powders, 2–8°C for solutions).
- Regulatory Alignment : Adherence to ICH, FDA, and EMA guidelines facilitates global market access.
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Market Dynamics and Pricing Strategies
The global Tulobuterol market is projected to grow at a CAGR of 5.7% (2025–2030), driven by rising COPD prevalence and biosimilar development. Competitive pricing models include:
- Bulk Discounts : Xi’an Qiyue offers Tulobuterol at $1,475/2mg for research-grade batches, with tiered pricing for commercial orders.
- Custom Quotes : Delta Bio provides API batches at $4,007/10mg, tailored to client specifications.
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Future Directions and Innovations
- Nanotechnology : Nano-encapsulation for targeted pulmonary delivery, enhancing bioavailability and reducing dosing frequency.
- Biosimilars : Development of cost-effective alternatives to branded formulations like Breo Ellipta®.
- AI-Driven Synthesis : Machine learning optimizes reaction pathways, reducing impurities and production timelines.
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Conclusion
Tulobuterol (CAS 41570-61-0) exemplifies the synergy between pharmacological innovation and advanced manufacturing. Its applications in respiratory therapy, antigen conjugation, and veterinary medicine underscore its versatility, while manufacturers like Xi’an Qiyue, Delta Bio, and Toronto Research Chemicals lead the market through technological prowess, stringent quality control, and sustainable practices. As research uncovers new therapeutic potentials, collaboration between industry and academia will drive breakthroughs in formulation and accessibility, ultimately improving global health outcomes.
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Note : Prices and specifications are subject to change. For detailed quotations and technical support, consult official supplier platforms or contact sales representatives directly.