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Respiratory

Fluticasone / Salmeterol

Advair®

Fluticasone/Salmeterol is a combination ICS/LABA inhaler for maintenance treatment of asthma and COPD. One of the most prescribed respiratory medications globally.

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Product Details

Dosage FormInhaler (DPI / MDI)
Strength100/50, 250/50, 500/50 mcg (DPI); 45/21, 115/21, 230/21 mcg (MDI)
StorageStore at 20–25°C. Discard 1 month after removal from foil pouch (DPI).
CategoryRespiratory
AvailabilityAvailable for Transfer

Indication

Asthma (maintenance, patients ≥4 years); COPD (maintenance, to reduce exacerbations).

Mechanism of Action

Fluticasone (ICS) reduces airway inflammation by activating glucocorticoid receptors. Salmeterol (LABA) relaxes bronchial smooth muscle via beta-2 adrenergic stimulation.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Fluticasone / Salmeterol 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 Fluticasone / Salmeterol 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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