Amlexanox

Source high-purity Amlexanox, a potent anti-inflammatory and anti-allergic active pharmaceutical ingredient (API) widely used in dermatological and oral care formulations. This small molecule inhibitor targets key inflammatory pathways, offering effective relief for aphthous ulcers and potential benefits in acne treatment. Ideal for manufacturers developing specialized topical gels, pastes, and cosmetic actives. High-quality raw material. Get a quote today!

Product Specification

• Product Name: Amlexanox (Pharmaceutical/Cosmetic Grade)
• Appearance: White to off-white crystalline powder
• CAS No.: 52712-80-0
• Molecular Formula: C₁₆H₁₄N₂O₄
• Specification: Purity ≥98.5% (HPLC); Molecular Weight: 298.29 g/mol; Loss on Drying: <0.5%; Residual Solvents: Compliant with ICH guidelines
• Ingredient Information: Synthetic isoquinoline derivative; Insoluble in water, soluble in organic solvents like DMSO and ethanol; Anti-inflammatory agent

Product Description

Amlexanox is a specialized low-molecular-weight compound renowned for its dual anti-inflammatory and anti-allergic properties. It functions primarily by inhibiting the release of chemical mediators such as histamine and leukotrienes from mast cells, and by suppressing the production of pro-inflammatory cytokines. Clinically established for the treatment of recurrent aphthous stomatitis (canker sores), it accelerates healing and reduces pain. Beyond oral care, emerging research highlights its efficacy in treating mild-to-moderate acne by reducing inflammation and sebum production. Its stable chemical structure and proven safety profile make it a valuable active ingredient for niche pharmaceutical and dermocosmetic applications targeting inflammatory skin and mucosal conditions.

Product Uses

This ingredient is primarily utilized in the manufacturing of pharmaceutical topical formulations, specifically oral pastes and gels for the treatment of mouth ulcers and canker sores. It is also increasingly incorporated into dermatological products, including creams and lotions for acne treatment, leveraging its ability to reduce redness and swelling. In the cosmetic industry, Amlexanox is explored as an active component in soothing serums and anti-redness solutions designed for sensitive or inflamed skin. Additionally, it serves as a key reference standard in pharmacological research studying inflammatory pathways, mast cell stabilization, and metabolic regulation. Its application is strictly regulated depending on the region, primarily approved for drug use but gaining traction in specialized cosmeceuticals.

Formulation Recommendation

Recommended Usage Level: For oral pastes, typical concentrations range from 2% to 5% w/w. In topical acne formulations, usage levels often range from 0.5% to 2% w/w, depending on the desired potency and vehicle.
Addition Method: Due to poor water solubility, Amlexanox should be dissolved in a suitable solvent (e.g., ethanol, propylene glycol, or PEG) or micronized thoroughly before incorporation into the base. For oral pastes, disperse uniformly in a hydrophilic gel base (e.g., carboxymethylcellulose). For creams, add to the oil phase or use a solubilizer system to ensure even distribution.
Compatibility: Compatible with common pharmaceutical excipients like methylcellulose, polyethylene glycols, and preservatives such as parabens. Avoid strong alkaline environments which may affect stability. Synergizes well with other anti-inflammatory agents like licorice extract or allantoin in cosmetic formulations. Protect from light and moisture during storage to maintain potency.