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Immunology

Methotrexate

Trexall® / Otrexup®

Low-dose methotrexate is a cornerstone DMARD for rheumatoid arthritis and psoriasis. Anti-inflammatory effects at low doses differ from high-dose oncology mechanism.

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Product Details

Dosage FormOral Tablet / SC Injectable (Autoinjector)
Strength2.5 mg (oral); 7.5–25 mg/week (SC)
StorageStore at 20–25°C. Protect from light.
CategoryImmunology
AvailabilityAvailable for Transfer

Indication

Rheumatoid arthritis; psoriasis (severe, recalcitrant); juvenile idiopathic arthritis; off-label: various autoimmune conditions.

Mechanism of Action

At low doses, primarily increases adenosine release, which has anti-inflammatory effects. Also inhibits aminoimidazole carboxamide ribonucleotide (AICAR) transformylase and mildly inhibits DHFR.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Methotrexate includes comprehensive documentation and support:

Master Formula

Complete formulation with manufacturing parameters, excipient specifications, and process controls.

Analytical Methods

Validated methods for assay, impurities, dissolution, and stability-indicating analysis.

CTD/eCTD Templates

Market-ready regulatory dossier templates — available through Burrard Intelligence subscription.

Stability Data

ICH-compliant stability studies (accelerated and long-term) with detailed protocols.

Manufacturing Protocols

Scale-up procedures, batch records, equipment specifications, and in-process controls.

Expert Support

Direct advisory access to formulation scientists and regulatory specialists throughout transfer.

Ready for Methotrexate Technology Transfer?

Our team can deliver the complete know-how package within 2–21 business days. Book a consultation to discuss your specific requirements.

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