← Back to Products
Respiratory

Tiotropium

Spiriva®

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

Request Technology Transfer Request a Dossier Scope

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 Dossier

Market-ready regulatory dossier sections for a named territory, scoped per programme.

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?

Scope and timing for the complete know-how package are confirmed in writing after a confidentiality agreement. Book a consultation to discuss your specific requirements.

Request a Programme Review Tech Transfer & CTD