Exploring the 505(b)(2) route for systemic and regional therapy via pulmonary delivery

Drug products that can be administered through inhalation offer many benefits. While other dosage forms, such as oral solids, are currently more common, inhaled formulations offer direct access to the central nervous system, bypassing the digestive system and liver.

Inhalation is one of the oldest methods of drug delivery.

This highly targeted delivery method means that the drug can take effect much more quickly, as well as allowing for a much lower dosage than other forms, thus reducing potentially harmful side effects.

Aditya R. Das, Ph.D., MBA, director of business development at Recipharm, spoke to International Biopharmaceutical Industry to discuss the advantages of inhaled drug products, and the best regulatory application route to bring inhalation drugs to market.

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