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Respiratory

Ciclesonide

Alvesco®

Ciclesonide is a prodrug ICS activated in the lungs, minimizing systemic side effects. Used for prophylactic maintenance treatment of persistent asthma.

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Product Details

Dosage FormInhaler (MDI)
Strength80 mcg, 160 mcg per actuation
StorageStore at 25°C.
CategoryRespiratory
AvailabilityAvailable for Transfer

Indication

Persistent asthma (prophylactic maintenance, patients ≥12 years).

Mechanism of Action

Prodrug converted to active desisobutyryl-ciclesonide (des-CIC) by esterases in the lungs. Des-CIC binds glucocorticoid receptors with high affinity, reducing inflammation with minimal systemic exposure.

Technology Transfer Package

Each Burrard Pharmaceuticals technology transfer package for Ciclesonide 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 Ciclesonide 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.

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