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Respiratory

Tiotropium

Spiriva®

Tiotropium is a long-acting muscarinic antagonist (LAMA) for maintenance treatment of COPD and asthma. Provides 24-hour bronchodilation.

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Product Details

Dosage FormInhaler (DPI HandiHaler / Soft Mist Respimat)
Strength18 mcg capsule (DPI); 1.25 mcg, 2.5 mcg per actuation (Respimat)
StorageStore at 25°C. Do not expose capsules to extreme temperatures/moisture.
CategoryRespiratory
AvailabilityAvailable for Transfer

Indication

COPD (maintenance to reduce exacerbations); asthma (add-on maintenance, ≥6 years).

Mechanism of Action

Quaternary ammonium compound that selectively blocks M3 muscarinic receptors in airway smooth muscle. Dissociates very slowly from M3 receptors, providing prolonged bronchodilation.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Tiotropium 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 Tiotropium 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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