Ibuprofen Lysinate
Overview
Ibuprofen Lysinate (CAS 53081-25-7) is a derivative of ibuprofen, chemically bonded to lysine to enhance water solubility and bioavailability. Developed to address the slow dissolution of standard ibuprofen, it is particularly effective in fast-acting oral formulations. The compound retains the therapeutic effects of ibuprofen—analgesic, antipyretic, and anti-inflammatory—while offering quicker onset times, making it suitable for acute symptom relief. As a pharmaceutical intermediate, it is primarily supplied to drug manufacturers for incorporation into tablets, effervescent preparations, and pediatric solutions. Regulatory approvals vary by region, but it is widely recognized in Europe and Asia for over-the-counter (OTC) and prescription medications.
Physical and Chemical Properties
Ibuprofen Lysinate appears as a white to off-white crystalline powder with a molecular weight of 343.40 g/mol. Its key advantage lies in its high aqueous solubility (>100 mg/mL), which contrasts sharply with the poor water solubility of free ibuprofen (0.021 mg/mL). This property enables faster gastrointestinal absorption and reduced time to peak plasma concentration. The compound is stable under standard storage conditions but degrades upon prolonged exposure to heat, light, or humidity. Its melting point ranges between 75-78°C, and it exhibits negligible volatility. Analytical methods such as HPLC and titration are commonly employed for quality control to ensure compliance with pharmacopeial specifications.
Main Applications
The primary use of Ibuprofen Lysinate is in the pharmaceutical industry, where it serves as an active ingredient in rapid-release formulations. It is favored for migraine medications, dental pain relievers, and pediatric suspensions due to its quick action and improved palatability. In Europe, effervescent tablets containing this compound are popular for treating dysmenorrhea and post-operative pain. Beyond human medicine, it is occasionally used in veterinary applications for pain management in small animals. Ongoing research explores its potential in combination therapies with other NSAIDs or adjuvants to minimize gastrointestinal side effects while maintaining efficacy.
Safety and Storage
While Ibuprofen Lysinate is generally safe when used as directed, improper handling during industrial processing may pose risks. Dust inhalation can irritate respiratory tracts, and direct skin contact may cause mild dermatitis. Facilities must adhere to GMP guidelines, including local exhaust ventilation and PPE (gloves, masks) for workers. Storage requires protection from moisture and light to prevent degradation. Bulk quantities should be kept in sealed containers with desiccants at 15-25°C. Shelf life typically exceeds two years under optimal conditions. Disposal must comply with local regulations for pharmaceutical waste to avoid environmental contamination.
B2B Procurement Guide
Procuring Ibuprofen Lysinate requires attention to regulatory and quality benchmarks. Buyers should prioritize suppliers with ISO 9001 or WHO-GMP certification, ensuring batch-to-batch consistency. Key documentation includes Certificate of Analysis (CoA), residual solvent reports, and microbial limits testing. Pricing varies by order volume and purity grade (98%-99.5%). For large-scale purchases (>100 kg), negotiate contracts with manufacturers to secure bulk discounts. Logistics planning is critical—opt for temperature-controlled shipping if transit exceeds 48 hours. Alternatives like ibuprofen sodium may be considered for cost-sensitive projects, though efficacy profiles differ.
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